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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 4 is objected to because of the following informalities:
Regarding claim 4, Examiner respectfully suggests amending the limitation “a step of coating plating” in line 3 to “a step of coating” or “a step of plating”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 and 6-9 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 4 contains the trademark/trade name Nafion. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a sulfonated tetrafluoroethylene based fluoropolymer-copolymer and, accordingly, the identification/description is indefinite.
Claim 6 recites the limitation “wherein the step a) includes:” in line 9. It is unclear whether step a) is step a) recited in line 10 or whether it is step S11 recited in line 3. For the purpose of examination, Examiner will interpret said limitation as “wherein the step S11 includes:”. However, clarification and correction is required.
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.
Claim(s) 1 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Voelcker et al. (WO2021232109), as evidenced by Kidwell et al. (US20200347267), and further in view of Pushpala et al. (US20170086724) and Kendall et al. (US20230053962).
Regarding claim 1, Voelcker teaches a manufacturing method of a microneedle biosensor including a support layer, comprising:
a) a step of forming molds by forming grooves (“Prior to fabrication of pMNA polydimethylsiloxane (PDMS) mould (Figure 22A) was prepared using Si-MNA previously fabricated for electrochemical glucose sensing as described above. Before pouring PDMS, Si-MNA were silanized overnight in gas phase using tricholoro (1 H, 1 H, 2H, 2H-perfluorooctyl)- silane in vacuum. After silanization, Si-MNA were covered with PDMS (10:1 , polymer: curing agent) and degassed for 1 h in order to remove entrapped air bubbles. Next, PDMS was cured in an oven at 60°C for 4 h. Then, cured PDMS was demolded from the Si-MNA substrate”- see pg. 46) corresponding to shapes of microneedles of a working electrode, a counter electrode, and a reference electrode in a solid resin block (“A preferred sensor system of the invention comprises an electrochemical cell comprising the following components: a reference (RE) electrode comprising a reference electrode substrate supporting an array of electrically conductive biocompatible microneedles at a density of at least 2,000 microneedle/cm.sup.2 disposed on the reference electrode substrate; a counter (CE) electrode comprising a counter electrode substrate supporting an array of electrically conductive biocompatible microneedles at a density of at least 2,000 microneedle/cm.sup.2 disposed on the counter electrode substrate; and a working (WE) electrode comprising a working electrode substrate supporting an array of electrically conductive biocompatible microneedles at a density of at least 2,000 microneedle/cm.sup.2 disposed on the working electrode substrate”- see pg. 12-13);
b) a step of imprinting the working electrode, the counter electrode, and the reference electrode using acryl on the mold (“OrmoComp.sup.® (a UV curable silica-polymer hybrid) based MNA were fabricated using the PDMS mould. OrmoComp.sup.® was poured onto the PDMS mold and degassed in desiccator until all entrapped air in the polymer was removed. Afterwards, PDMS/OrmoComp.sup.® mould was exposed to UV light for 90 s and then PDMS mould was carefully removed from the crosslinked OrmoComp.sup.®”- see pg. 46-47; Kidwell teaches that Ormocomp is an acryl polymer in [0004] IP-DIP and OrmoComp® are both acrylate-based polymers, with OrmoComp® being a mixed acrylate-siloxane polymer);
c) a step of forming the support layer after performing the step b) (“a conducting polymer layer or a metal sputtered layer or a metal sputtered layer undercoated with a thinner layer of a second different metal, as an adhesive layer”- see pg. line 19);
d) a step of forming a metal layer on the working electrode, the counter electrode, and the reference electrode and sputtering an Au layer, after performing the step c) (“at least the microneedles of one or more of the reference electrode substrate, the counter electrode substrate and working electrode substrate are coated with or otherwise provided with at least one thin film of an electrically conductive but chemically inert material…the at least one film is a sputtered metal film, e.g., formed by sputtering or an electrodeposited metal film. Preferably, the inert material, is a biocompatible material, e.g., silicon, zinc oxide, carbon, gold or platinum, most preferably gold or carbon”- see pg. 19); and
e) forming a passivation layer on the metal layer (“The conformal nanofilm is modified with a monolayer of immunocapture biorecognition elements”- see pg. 9).
While Voelcker teaches the support layer may improve adhesion between the acryl and metal layer and minimize wear when the microneedles are exposed to in vivo conditions for an extended period of time (“The additional layer of compatible material is one which may improve the adhesion of the outer electrically conductive but chemically inert material to the needles and substrate… This layer may useful for facilitating the formation of the conformal outer/surface layer and for allowing it to support a sensing chemistry that is subjected to skin piercing friction on transdermal introduction as well as withstanding exposure to in vivo conditions when being worn for an extended period of time”- see pg. 17-18), Voelcker fails to teach the support layer is an epoxy- or urethane-based photo-curable adhesion.
In the same field of endeavor pertaining to a method for manufacturing microneedles ([0023] The array of filaments can be an array of fibers, an array of pillars, an array of microneedles, and/or any other suitable array configured to facilitate analyte detection in a user), Pushpala teaches the support layer is a urethane-based photo-curable adhesion ([0020] Any filament 120 of the array of filaments 110 can further comprise an adhesion coating 180 configured to maintain contact between layers, coatings, and/or substrates of the filament 120 and [0034] the adhesion coating 180 is composed of any one or more of: a polyurethane, nafion, cellulose acetate, polyvinyl alcohol, polyvinyl butyrate). The adhesion coating of Pushpala can prevent delamination between the layers and is biocompatible, anti-inflammatory, and anti-microbial material that maintains contact between layers over the lifetime usage of a microsensor ([0034] The adhesion coating 180 can further function to bond the layers, coatings, and/or substrates, and can prevent delamination between the layers, coatings, and/or substrates. The adhesion coating 180 is preferably an appropriately bio-safe, anti-inflammatory, and anti-microbial material, and preferably maintains contact between layers, coatings, and/or substrates of the filament 120 over the lifetime usage of the microsensor 100).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the support layer of Voelcker to be a urethane-based photo-curable adhesion, as taught by Pushpala, for the benefit of having a biocompatible, anti-inflammatory, and anti-microbial material that maintains contact between layers over the lifetime usage of a microsensor.
However, Voelcker fails to teach the metal layer is formed by shadow masks corresponding to patterns of the working electrode.
In the same field of endeavor pertaining to a method for manufacturing microneedles, Kendall teaches the metal layer is formed by shadow masks corresponding to patterns of the working electrode ([0584] A shadow mask 1708 is applied to the substrate 1701 with the microstructures 1706 being coated with gold 1707 (FIG. 17O) through selective deposition, before the mask is removed (FIG. 17P), leaving selectively metallized microstructures that act as electrode; see Figure 17 and Figure 17P).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to have the metal layer of Voelcker modified with Pushpala be formed by shadow masks corresponding to patterns of the working electrode, as taught by Kendall, for the benefit of selectively forming the metal layer on the microneedles that act as electrodes.
Regarding claim 5, Voelcker modified with Pushpala and Kendall teaches the manufacturing method of a microneedle biosensor including a support layer of claim 1.
Further, Voelcker teaches the method further comprising: after performing the step e), a step of coating the microneedle of the reference electrode with Ag/AgCl (“the microneedles of the reference (RE) electrode are further coated or modified with a suitable reference electrode chemistry or material which has a stable and well-known electrode potential. Suitable reference materials are well-known in the art and include iridium oxide and graphite/AgCI, for example. Preferably, the reference electrode material forms an Ag/AgCI reference electrode material. During manufacture, the AgCI is preferably applied to the microneedles of the reference electrode in the form of drop cast AgCI ink which is subsequently dried to form the AgCI coating. Preferably the reference electrode material is provided as a conformal layer”- see pg. 17).
Claim(s) 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Voelcker et al. (WO2021232109), Pushpala et al. (US20170086724) and Kendall et al. (US20230053962) as evidenced by Kidwell et al. (US20200347267), and further in view of Berner et al. (US20050027179).
Regarding claim 2, Voelcker modified with Pushpala and Kendall teaches the manufacturing method of a microneedle biosensor including a support layer of claim 1.
While Voelcker teaches the electrodes can have various configurations, including linear, staggered or radial arrangements (“It will be understood that each electrode and connector support may be mounted on a base in the form of a fixing frame or a fixing board for mounting, positioning and fixing the individual electrode and connector supports in a desired configuration, e.g., linear, staggered, or a radial arrangement of the electrodes, as desired”- see pg. 19) and that the plurality of microneedles perpendicularly protrude from a base of the respective electrodes (see plurality of microneedles perpendicularly protruding from a base of the reference, working, and counter electrode in Figure 1E), Voelcker fails to teach wherein the working electrode includes a first base of a circular thin film type, a plurality of microneedles which perpendicularly protrudes on the first base, and a first wiring line which extends from one end of a circumference of the first base, the counter electrode includes a second base of a strip thin film type which forms a part of a second circumference spaced apart from the circumference of the first base with a setting distance to be concentric with the first base, a plurality of microneedles which perpendicularly protrudes on the second base, and a second wiring line which extends from one end of the second base to be horizontally disposed with the first wiring line, and the reference electrode includes a third base of the strip thin film type which is spaced apart from the other end of the second base with a setting interval and forms the second circumference with a strip shape of the second base, a plurality of microneedles which perpendicularly protrudes on the third base, and a third wiring line which extends from one end of the third base.
In the same field of endeavor pertaining to a microneedle biosensor (Abstract: An automated system for continual transdermal extraction of analytes present in a biological system is provided and [0051] These methods can, of course, be coupled with application of skin penetration enhancers or skin permeability enhancing technique such as tape stripping or pricking with micro-needles), Berner teaches wherein
a working electrode includes a first base of a circular thin film type (see electrode assemblies printed onto polymeric substrate 16 in Figure 2 and working electrode 31 in Figure 3), and a first wiring line which extends from one end of a circumference of the first base (see annotated Figure 2 below),
the counter electrode (see annotated Figure 2 below and counter electrode 30 in Figure 3) includes a second base of a strip thin film type which forms a part of a second circumference spaced apart from the circumference of the first base with a setting distance to be concentric with the first base, and a second wiring line which extends from one end of the second base to be horizontally disposed with the first wiring line (see annotated Figure 2 below), and
the reference electrode (see annotated Figure 2 below and reference electrode 32 in Figure 3) includes a third base of the strip thin film type which is spaced apart from the other end of the second base with a setting interval and forms the second circumference with a strip shape of the second base, and a third wiring line which extends from one end of the third base (see annotated Figure 2 below).
Further, Berner teaches the method can be coupled with the application of skin penetration enhancers such as pricking with microneedles ([0051] These methods can, of course, be coupled with application of skin penetration enhancers or skin permeability enhancing technique such as tape stripping or pricking with micro-needles). The electrode configuration for Berner has a suitable geometric surface area and background noise so as to be effective in sampling ([0022] The sensor element comprises an electrode having suitable geometric surface area and background noise so as to be effective in the present sampling system). The electrode configuration provides for a larger working electrode, and ensures that the counter electrode does not limit the current at the working electrode ([0092] The design of the present invention provides for a larger sensing electrode (see for example, FIG. 3) than previously designed and [0093] Two methods exist to ensure that the counter electrode does not limit the current at the sensing electrode: (1) the bi-modal electrode is made much larger than the sensing electrode, or (2) a facile counter reaction is provided).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to configure the electrodes of Voelcker modified with Pushpala and Kendall such that the working electrode includes a first base of a circular thin film type, the counter electrode includes a second base of a strip thin film type which forms a part of a second circumference spaced apart from the circumference of the first base with a setting distance to be concentric with the first base, and the reference electrode includes a third base of the strip thin film type which is spaced apart from the other end of the second base with a setting interval and forms the second circumference with a strip shape of the second base, as taught by Berner, for the benefit of providing a larger working electrode that allows for effective sampling, and ensuring that the counter electrode does not limit the current at the working electrode.
Further, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to have the plurality of microneedles perpendicularly protrude on the first, second, and third base of Voelcker modified with Pushpala, Kendall, and Berner, since Berner teaches the method can be coupled with the application of skin penetration enhancers such as pricking with microneedles and Voelcker teaches the microneedles perpendicularly protruding from the respective electrodes.
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Regarding claim 3, Voelcker modified with Pushpala, Kendall, and Berner teaches the manufacturing method of a microneedle biosensor including a support layer of claim 2.
Further, Berner teaches wherein the second base occupies 3/4 of the second circumference and the third base occupies 1/4 of the second circumference (see annotated Figure 2 in the rejection of claim 2 above where counter electrode occupies ¾ of the second circumference and reference electrode occupies ¼ of the second circumference).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to configure the electrodes of Voelcker modified with Pushpala, Kendall, and Berner such that the second base occupies 3/4 of the second circumference and the third base occupies 1/4 of the second circumference, as taught by Berner, for the benefit of providing a larger working electrode that allows for effective sampling, and ensuring that the counter electrode does not limit the current at the working electrode.
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Voelcker et al. (WO2021232109), Pushpala et al. (US20170086724), and Kendall et al. (US20230053962), as evidenced by Kidwell et al. (US20200347267), and further in view of Windmiller et al. (US20220031244).
Regarding claim 4, Voelcker modified with Pushpala and Kendall teaches the manufacturing method of a microneedle biosensor including a support layer of claim 1.
Further, Kendall teaches after metallization, the microneedle tip of the working electrode is coated with Nafion ([0324] In some embodiments, the aptamer comprises a moiety for attaching or immobilising the aptamer on the surface of the microstructure, such as a functional group or compound, preferably via a covalent bond. Suitable moieties for attaching or immobilising the aptamer on the surface of the microstructure include, but are not limited to, a thiol, amine, carboxylic acid, alcohol, carbodiimide, nafion). Nafion is an aptamer which binds to one or more analytes of interest in a biosensor ([0308]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to coat the microneedle tip of the working electrode with nafion, as taught by Kendall, to allow for binding of one or more analytes in a biosensor. Voelcker teaches aptamers are coated on the microneedle tip as biorecognition elements (see claim 18 and 19 of Voelcker), and therefore one of ordinary skill would look to examples of aptamers that bind to one or more analytes in a biosensor.
However, Voelcker modified with Pushpala and Kendall fails to teach the microneedle tip of the working electrode is coated with Pt-black.
In the same field of endeavor pertaining to a microneedle biosensor, Windmiller teaches a microneedle tip of a working electrode is coated with Pt-black ([0128] In some variations, the electrode material 1612 may be coated with a highly porous electrocatalytic layer, such as a platinum black layer 1613, which may augment the electrode surface area for enhanced sensitivity. Additionally or alternatively, the platinum black layer 1613 may enable the electrocatalytic oxidation or reduction of the product of the biorecognition reaction facilitated by the biorecognition layer 1614… [0129] The biorecognition layer 1614 may be arranged over the electrode material 1612 (or platinum black layer 1613 if it is present) and functions to immobilize and stabilize the biorecognition element which facilitates selective analyte quantification for extended time periods).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to coat the microneedle tip of the working electrode of Voelcker modified with Pushpala and Kendall with Pt-black, as taught by Windmiller, for the benefit of enhancing the electrode sensitivity.
Claim(s) 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Voelcker et al. (WO2021232109), as evidenced by Kidwell et al. (US20200347267), and further in view of Kendall et al. (US20230053962).
Regarding claim 6, Voelcker teaches a manufacturing method of a microneedle biosensor using a reverse mold, comprising:
a step S11 of forming a mold for forming a microneedle polymer layer (“Prior to fabrication of pMNA polydimethylsiloxane (PDMS) mould (Figure 22A) was prepared using Si-MNA previously fabricated for electrochemical glucose sensing as described above”- see pg. 46);
a step S12 of imprinting a working electrode, a counter electrode, and a reference electrode using acryl on the mold (“OrmoComp.sup.® (a UV curable silica-polymer hybrid) based MNA were fabricated using the PDMS mould. OrmoComp.sup.® was poured onto the PDMS mold and degassed in desiccator until all entrapped air in the polymer was removed. Afterwards, PDMS/OrmoComp.sup.® mould was exposed to UV light for 90 s and then PDMS mould was carefully removed from the crosslinked OrmoComp.sup.®”- see pg. 46-47; Kidwell teaches that Ormocomp is an acryl polymer in [0004] IP-DIP and OrmoComp® are both acrylate-based polymers, with OrmoComp® being a mixed acrylate-siloxane polymer); and
a step S13 of forming a metal layer of the working electrode, the counter electrode, and the reference electrode and sputtering an Au, after performing the step S12 (“at least the microneedles of one or more of the reference electrode substrate, the counter electrode substrate and working electrode substrate are coated with or otherwise provided with at least one thin film of an electrically conductive but chemically inert material…the at least one film is a sputtered metal film, e.g., formed by sputtering or an electrodeposited metal film. Preferably, the inert material, is a biocompatible material, e.g., silicon, zinc oxide, carbon, gold or platinum, most preferably gold or carbon”- see pg. 18),
wherein the step S11) includes:
(a) a step of forming a primary microneedle polymer layer (“Prior to fabrication of pMNA polydimethylsiloxane (PDMS) mould (Figure 22A) was prepared using Si-MNA previously fabricated for electrochemical glucose sensing as described above”- see pg. 46);
(b) a step of placing the primary microneedle polymer layer in a container with a mold shape (see step (i) in Figure 22A);
(c) a step of forming a support layer on the primary microneedle polymer layer placed in the container (“Before pouring PDMS, Si-MNA were silanized overnight in gas phase using tricholoro (1 H, 1 H, 2H, 2H-perfluorooctyl)- silane in vacuum”- see pg. 46)
(d) a step of inputting and curing polydimethylsiloxane (PDMS) which is a mold material after drying the support layer in the step (c) (“After silanization, Si-MNA were covered with PDMS (10:1 , polymer: curing agent)”- see pg. 46); and
(e) a step of completing the reverse mold by separating the PDMS mold cured in the step (d) (“Next, PDMS was cured in an oven at 60°C for 4 h. Then, cured PDMS was demolded from the Si-MNA substrate”- see pg. 46 and Figure 22A).
However, Voelcker fails to teach the metal layer is formed by shadow masks corresponding to patterns of the working electrode.
In the same field of endeavor pertaining to a method for manufacturing microneedles, Kendall teaches the metal layer is formed by shadow masks corresponding to patterns of the working electrode ([0584] A shadow mask 1708 is applied to the substrate 1701 with the microstructures 1706 being coated with gold 1707 (FIG. 17O) through selective deposition, before the mask is removed (FIG. 17P), leaving selectively metallized microstructures that act as electrode; see Figure 17 and Figure 17P).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to have the metal layer of Voelcker be formed by shadow masks corresponding to patterns of the working electrode, as taught by Kendall, for the benefit of selectively forming the metal layer on the microneedles that act as electrodes.
Regarding claim 9, Voelcker modified with Kendall teaches the manufacturing method of a microneedle biosensor using a reverse mold of claim 6.
Voelcker teaches the method further comprising: after performing the step S13, a step of forming a passivation layer on the metal layer (“The conformal nanofilm is modified with a monolayer of immunocapture biorecognition elements”- see pg. 9).
Claim(s) 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Voelcker et al. (WO2021232109) and Kendall et al. (US20230053962), as evidenced by Kidwell et al. (US20200347267), and further in view of Berner et al. (US20050027179).
Regarding claim 7, Voelcker modified with Kendall teaches the manufacturing method of a microneedle biosensor using a reverse mold of claim 6.
While Voelcker teaches the electrodes can have various configurations, including linear, staggered or radial arrangements (“It will be understood that each electrode and connector support may be mounted on a base in the form of a fixing frame or a fixing board for mounting, positioning and fixing the individual electrode and connector supports in a desired configuration, e.g., linear, staggered, or a radial arrangement of the electrodes, as desired”- see pg. 19) and that the plurality of microneedles perpendicularly protrude from a base of the respective electrodes (see plurality of microneedles perpendicularly protruding from a base of the reference, working, and counter electrode in Figure 1E), Voelcker fails to teach wherein the working electrode includes a first base of a circular thin film type, a plurality of microneedles which perpendicularly protrudes on the first base, and a first wiring line which extends from one end of a circumference of the first base, the counter electrode includes a second base of a strip thin film type which forms a part of a second circumference spaced apart from the circumference of the first base with a setting distance to be concentric with the first base, a plurality of microneedles which perpendicularly protrudes on the second base, and a second wiring line which extends from one end of the second base to be horizontally disposed with the first wiring line, and the reference electrode includes a third base of the strip thin film type which is spaced apart from the other end of the second base with a setting interval and forms the second circumference with a strip shape of the second base, a plurality of microneedles which perpendicularly protrudes on the third base, and a third wiring line which extends from one end of the third base.
In the same field of endeavor pertaining to a microneedle biosensor (Abstract: An automated system for continual transdermal extraction of analytes present in a biological system is provided and [0051] These methods can, of course, be coupled with application of skin penetration enhancers or skin permeability enhancing technique such as tape stripping or pricking with micro-needles), Berner teaches wherein
a working electrode includes a first base of a circular thin film type (see electrode assemblies printed onto polymeric substrate 16 in Figure 2 and working electrode 31 in Figure 3), and a first wiring line which extends from one end of a circumference of the first base (see annotated Figure 2 in the rejection of claim 2 above),
the counter electrode (see annotated Figure 2 in the rejection of claim 2 above and counter electrode 30 in Figure 3) includes a second base of a strip thin film type which forms a part of a second circumference spaced apart from the circumference of the first base with a setting distance to be concentric with the first base, and a second wiring line which extends from one end of the second base to be horizontally disposed with the first wiring line (see annotated Figure 2 in the rejection of claim 2 above), and
the reference electrode (see annotated Figure 2 in the rejection of claim 2 above and reference electrode 32 in Figure 3) includes a third base of the strip thin film type which is spaced apart from the other end of the second base with a setting interval and forms the second circumference with a strip shape of the second base, and a third wiring line which extends from one end of the third base (see annotated Figure 2 in the rejection of claim 2 above).
Further, Berner teaches the method can be coupled with the application of skin penetration enhancers such as pricking with microneedles ([0051] These methods can, of course, be coupled with application of skin penetration enhancers or skin permeability enhancing technique such as tape stripping or pricking with micro-needles). The electrode configuration for Berner has a suitable geometric surface area and background noise so as to be effective in sampling ([0022] The sensor element comprises an electrode having suitable geometric surface area and background noise so as to be effective in the present sampling system). The electrode configuration provides for a larger working electrode, and ensures that the counter electrode does not limit the current at the working electrode ([0092] The design of the present invention provides for a larger sensing electrode (see for example, FIG. 3) than previously designed and [0093] Two methods exist to ensure that the counter electrode does not limit the current at the sensing electrode: (1) the bi-modal electrode is made much larger than the sensing electrode, or (2) a facile counter reaction is provided).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to configure the electrodes of Voelcker modified Kendall such that the working electrode includes a first base of a circular thin film type, the counter electrode includes a second base of a strip thin film type which forms a part of a second circumference spaced apart from the circumference of the first base with a setting distance to be concentric with the first base, and the reference electrode includes a third base of the strip thin film type which is spaced apart from the other end of the second base with a setting interval and forms the second circumference with a strip shape of the second base, as taught by Berner, for the benefit of providing a larger working electrode that allows for effective sampling, and ensuring that the counter electrode does not limit the current at the working electrode.
Further, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to have the plurality of microneedles perpendicularly protrude on the first, second, and third base of Voelcker modified with Kendall, and Berner, since Berner teaches the method can be coupled with the application of skin penetration enhancers such as pricking with microneedles and Voelcker teaches the microneedles perpendicularly protruding from the respective electrodes.
Regarding claim 8, Voelcker modified with Kendall and Berner teaches the manufacturing method of a microneedle biosensor including a support layer of claim 7.
Further, Berner teaches wherein the second base occupies 3/4 of the second circumference and the third base occupies 1/4 of the second circumference (see annotated Figure 2 in the rejection of claim 2 above where counter electrode occupies ¾ of the second circumference and reference electrode occupies ¼ of the second circumference).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to configure the electrodes of Voelcker modified with Kendall and Berner such that the second base occupies 3/4 of the second circumference and the third base occupies 1/4 of the second circumference, as taught by Berner, for the benefit of providing a larger working electrode that allows for effective sampling, and ensuring that the counter electrode does not limit the current at the working electrode.
Allowable Subject Matter
Claims 10-12 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 10, the closest prior art is Voelcker et al. (WO2021232109), Kendall et al. (US20230053962), Yuzhakov (US6256533), and Stoeber (US20160158514).
Regarding claim 10, Voelcker teaches a manufacturing method of a microneedle biosensor including a support layer, comprising:
a) a step of forming molds by forming grooves (“Prior to fabrication of pMNA polydimethylsiloxane (PDMS) mould (Figure 22A) was prepared using Si-MNA previously fabricated for electrochemical glucose sensing as described above. Before pouring PDMS, Si-MNA were silanized overnight in gas phase using tricholoro (1 H, 1 H, 2H, 2H-perfluorooctyl)- silane in vacuum. After silanization, Si-MNA were covered with PDMS (10:1 , polymer: curing agent) and degassed for 1 h in order to remove entrapped air bubbles. Next, PDMS was cured in an oven at 60°C for 4 h. Then, cured PDMS was demolded from the Si-MNA substrate”- see pg. 46) corresponding to shapes of microneedles of a working electrode, a counter electrode, and a reference electrode in a solid resin block (“A preferred sensor system of the invention comprises an electrochemical cell comprising the following components: a reference (RE) electrode comprising a reference electrode substrate supporting an array of electrically conductive biocompatible microneedles at a density of at least 2,000 microneedle/cm.sup.2 disposed on the reference electrode substrate; a counter (CE) electrode comprising a counter electrode substrate supporting an array of electrically conductive biocompatible microneedles at a density of at least 2,000 microneedle/cm.sup.2 disposed on the counter electrode substrate; and a working (WE) electrode comprising a working electrode substrate supporting an array of electrically conductive biocompatible microneedles at a density of at least 2,000 microneedle/cm.sup.2 disposed on the working electrode substrate”- see pg. 12-13);
b) a step of imprinting the working electrode, the counter electrode, and the reference electrode using acryl on the mold (“OrmoComp.sup.® (a UV curable silica-polymer hybrid) based MNA were fabricated using the PDMS mould. OrmoComp.sup.® was poured onto the PDMS mold and degassed in desiccator until all entrapped air in the polymer was removed. Afterwards, PDMS/OrmoComp.sup.® mould was exposed to UV light for 90 s and then PDMS mould was carefully removed from the crosslinked OrmoComp.sup.®”- see pg. 46-47; Kidwell teaches that Ormocomp is an acryl polymer in [0004] IP-DIP and OrmoComp® are both acrylate-based polymers, with OrmoComp® being a mixed acrylate-siloxane polymer);
c) a step of forming the support layer after performing the step b) (“a conducting polymer layer or a metal sputtered layer or a metal sputtered layer undercoated with a thinner layer of a second different metal, as an adhesive layer”- see pg. 19);
d) a step of forming a metal layer on the working electrode, the counter electrode, and the reference electrode and sputtering an Au layer, after performing the step c) (“at least the microneedles of one or more of the reference electrode substrate, the counter electrode substrate and working electrode substrate are coated with or otherwise provided with at least one thin film of an electrically conductive but chemically inert material…the at least one film is a sputtered metal film, e.g., formed by sputtering or an electrodeposited metal film. Preferably, the inert material, is a biocompatible material, e.g., silicon, zinc oxide, carbon, gold or platinum, most preferably gold or carbon”- see pg. 18); and
e) forming a passivation layer on the metal layer (“The conformal nanofilm is modified with a monolayer of immunocapture biorecognition elements”- see pg. 9).
However, Voelcker fails to teach the metal layer is formed by shadow masks corresponding to patterns of the working electrode.
In the same field of endeavor pertaining to a method for manufacturing microneedles, Kendall teaches the metal layer is formed by shadow masks corresponding to patterns of the working electrode ([0584] A shadow mask 1708 is applied to the substrate 1701 with the microstructures 1706 being coated with gold 1707 (FIG. 17O) through selective deposition, before the mask is removed (FIG. 17P), leaving selectively metallized microstructures that act as electrode; see Figure 17 and Figure 17P).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to have the metal layer of Voelcker be formed by shadow masks corresponding to patterns of the working electrode, as taught by Kendall, for the benefit of selectively forming the metal layer on the microneedles that act as electrodes.
In the same field of endeavor pertaining to microneedle biosensors, Yuzhakov teaches forming a passivation layer (polymer film 20; Figure 4) includes: placing a polymer film over microneedles and heating the polymer above the melting temperature (col 7 line 38-44). As the polymer film is melted, the melt is removed from the top of the microneedle (col 7 line 66- col 8 line 8).
However, Yuzhakov fails to teach the polymer film comprises a hole with a size smaller than a largest diameter of the microneedle a process of inserting the microneedle into the hole such that the adhesive surface of the plastic adhesive tape with the hole is in contact with a base and inserting the microneedle into the hole of the polymer layer.
Further, in the same field of endeavor pertaining to microneedle biosensors, Stoeber teaches microneedles are coated with a polyethylene terephthalate layer ([0129] An electrically insulating coating may comprise any suitable material including polyethylene terephthalate).
However, Stoeber fails to teach the PET coating is layer that has holes and a process of inserting the microneedle into the hole.
Therefore, Voelcker, Kendall, Yuzhakov, and Stoeber fail to teach to either alone or in combination wherein the step of forming the passivation layer includes: a process of forming a hole with a size smaller than a largest diameter of the microneedle in positions of the microneedles of the working electrode, the counter electrode, and the reference electrode in each of a plastic adhesive tape with an adhesive layer formed on one surface of the metal electrode layer and a polyethylene terephthalate (PET) layer; a process of inserting the microneedle into the hole such that the adhesive surface of the plastic adhesive tape with the hole is in contact with a base and inserting the microneedle into the hole of the PET layer; and a process of pressurizing the PET layer with elastomer and continuing the pressurization on a heated hot plate in that state.
Claims 11 and 12 depend from claim 10 and are, therefore, allowed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1, 2, and 4-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-9 of copending Application No. 18/287,536 (herein referred to as Reference Application) in view of Pushpala et al. (US20170086724) and Voelcker et al. (WO2021232109).
Regarding claim 1, Reference Application teaches manufacturing method of a microneedle biosensor (claim 4 line 1 of Reference Application), comprising:
a) a step of forming molds by forming grooves corresponding to shapes of microneedles of a working electrode, a counter electrode, and a reference electrode in a solid resin block (claim 4 line 2-4 of Reference Application);
b) a step of imprinting the working electrode, the counter electrode, and the reference electrode (claim 4 line 5-6 of Reference Application) using acryl or PLA on the mold (see claim 8 of Reference Application);
d) a step of forming a metal layer by forming shadow masks corresponding to patterns of the working electrode, the counter electrode, and the reference electrode and sputtering an Au or Au + Ti/Cr adhesive layer (claim 4 line 7-9 of Reference Application); and
e) forming a passivation layer on the metal layer (claim 4 line 10 of Reference Application).
However, Reference Application fails to teach a step of forming a support layer by coating an epoxy- or urethane-based photo-curable adhesion after performing the step b) and forming a metal layer after performing the step c).
In the same field of endeavor pertaining to a method for manufacturing microneedles ([0023] The array of filaments can be an array of fibers, an array of pillars, an array of microneedles, and/or any other suitable array configured to facilitate analyte detection in a user), Pushpala teaches a urethane-based photo-curable adhesion support layer ([0020] Any filament 120 of the array of filaments 110 can further comprise an adhesion coating 180 configured to maintain contact between layers, coatings, and/or substrates of the filament 120 and [0034] the adhesion coating 180 is composed of any one or more of: a polyurethane, nafion, cellulose acetate, polyvinyl alcohol, polyvinyl butyrate). The adhesion coating of Pushpala can prevent delamination between the layers and is biocompatible, anti-inflammatory, and anti-microbial material that maintains contact between layers over the lifetime usage of a microsensor ([0034] The adhesion coating 180 can further function to bond the layers, coatings, and/or substrates, and can prevent delamination between the layers, coatings, and/or substrates. The adhesion coating 180 is preferably an appropriately bio-safe, anti-inflammatory, and anti-microbial material, and preferably maintains contact between layers, coatings, and/or substrates of the filament 120 over the lifetime usage of the microsensor 100).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the method Reference Application to include a step of forming a support layer by coating an epoxy- or urethane-based photo-curable adhesion after performing the step b), as taught by Pushpala, for the benefit of having a biocompatible, anti-inflammatory, and anti-microbial material that maintains contact between layers over the lifetime usage of a microsensor.
Regarding claim 2, see claim 9 of Reference Application.
Regarding claim 4, see claim 5 of Reference Application.
Regarding claim 5, see claim 6 of Reference Application.
Regarding claim 6, Reference Application teaches a manufacturing method (claim 4 line 1 of Reference Application) of a microneedle biosensor, comprising:
a step S11 of forming a mold for forming a microneedle polymer layer (claim 4 line 2-4 of Reference Application);
a step S12 of imprinting a working electrode, a counter electrode, and a reference electrode (claim 4 line 2-4 of Reference Application) using acryl or PLA on the mold (see claim 8 of Reference Application); and
a step S13 of forming a metal layer by forming shadow masks corresponding to patterns of the working electrode, the counter electrode, and the reference electrode and sputtering an Au or Au + Ti/Cr adhesive layer, after performing the step S12 (claim 4 line 7-9 of Reference Application).
However, Reference Application fails to teach wherein the step 11 includes: (a) a step of forming a primary microneedle polymer layer; (b) a step of placing the primary microneedle polymer layer in a container with a mold shape; (c) a step of forming a support layer on the primary microneedle polymer layer placed in the container; (d) a step of inputting and curing polydimethylsiloxane (PDMS) which is a mold material after drying the support layer in the step (c); and (e) a step of completing the reverse mold by separating the PDMS mold cured in the step (d).
In the same field of endeavor pertaining to microneedle biosensors, Voelcker teaches wherein the step S11) includes:
(a) a step of forming a primary microneedle polymer layer (“Prior to fabrication of pMNA polydimethylsiloxane (PDMS) mould (Figure 22A) was prepared using Si-MNA previously fabricated for electrochemical glucose sensing as described above”- see pg. line);
(b) a step of placing the primary microneedle polymer layer in a container with a mold shape (see step (i) in Figure 22A);
(c) a step of forming a support layer on the primary microneedle polymer layer placed in the container (“Before pouring PDMS, Si-MNA were silanized overnight in gas phase using tricholoro (1 H, 1 H, 2H, 2H-perfluorooctyl)- silane in vacuum”- see pg. line)
(d) a step of inputting and curing polydimethylsiloxane (PDMS) which is a mold material after drying the support layer in the step (c) (“After silanization, Si-MNA were covered with PDMS (10:1 , polymer: curing agent)”- see pg. line); and
(e) a step of completing the reverse mold by separating the PDMS mold cured in the step (d) (“Next, PDMS was cured in an oven at 60°C for 4 h. Then, cured PDMS was demolded from the Si-MNA substrate”- see pg. line and Figure 22A). Using a template to form a polymeric array of microneedles provides a more convenient manufacture in terms of speed and reduced cost of fabrication (“Use of a template to form a polymeric array provides a more convenient manufacture in terms of speed and reduced cost of reproduction fabrication”- see pg. line).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to form mold for forming a microneedle polymer layer by the template form taught by Voelcker, for the benefit of using a cost and time-efficient procedure for forming the microneedle array.
Regarding claim 7, see claim 9 of Reference Application
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/ARIELLA MACHNESS/Examiner, Art Unit 1743