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 .
Prosecution Reopened
In view of the Appeal Brief filed on June 10th 2026, PROSECUTION IS HEREBY REOPENED. A new ground(s) of rejection is/are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/CHARLES A MARMOR II/ Supervisory Patent Examiner, Art Unit 3791
Claims 1, 37-38, 40-42, 44, 47-49, 52-62, 64-65, 69, and 71-74 remain pending in the application.
Response to Arguments
Applicant's arguments in the Appeal Brief, filed June 10th, 2026 with respect to the rejections under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Vaddiraju et al. Design and Fabrication of a High-Performance Electrochemical Glucose Sensor. Journal of Diabetes Science and Technology. 2011;5(5):1044-1051. doi:10.1177/193229681100500504, with respect to claim 1, and Liu (US 20120132525 A1), Bordunov (US 20080017512 A1), and Papadimitrakopoulos (US 20140262775 A1), with respect to claims 37-38,40-42,44,47-49, 52-62,64-65, 69, and 71-74.
Claim Objections
Claim 72 is objected to because of the following informalities:
Claim 72 “the glucose monitor” in line 4 should recite “the glucose monitoring device”.
Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a computing device configured to receive measurements from the glucose monitoring device and control the insulin administration system” in claim 74.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The computing device is defined, in para. [0111-113], as one or more user devices 102 including a smart device, such as a smart watch, smart phone, tablet, computer.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 1 is 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.
The term “substantially” in claim 1 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the limitation “wherein the rate of the first reaction of the glucose oxidase in the enzymatic layer and the rate of the second reaction of the oxygen-generating enzyme in the oxygen-replenishing layer are substantially the same such that the glucose monitoring device is temperature independent within an operating temperature range” is rendered indefinite.
Claim 1 recites the limitation "the rate of the first reaction" in line 16. There is insufficient antecedent basis for this limitation in the claim. It is suggested the limitation recite “a rate of the first reaction”.
Claim 1 recites the limitation "the rate of the second reaction" in line 16. There is insufficient antecedent basis for this limitation in the claim. It is suggested the limitation recite “a rate of the second reaction”.
Claim Rejections - 35 USC § 102 and/or 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 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.
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 1 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Vaddiraju (Vaddiraju et al. Design and Fabrication of a High-Performance Electrochemical Glucose Sensor. Journal of Diabetes Science and Technology. 2011;5(5):1044-1051. doi:10.1177/193229681100500504).
Regarding claim 1, Vaddiraju teaches a glucose monitoring device (fig. 1, Abstract) comprising: a reference electrode (Reference Electrode Ag/AgCl, fig. 1); a working electrode (Pt working Electrode, fig. 1, pages 1045-1046, Experimental Details), wherein the working electrode is disposed in a vicinity of the reference electrode (as seen in fig. 1, “close proximity”, pages 1045-1046, Experimental Details); an enzymatic layer (Layer 2, fig. 1, “GOx layer”, page 1045) comprising glucose oxidase (“GOx enzyme”, page 1046, Experimental Details), wherein the glucose oxidase is capable of catalyzing a first reaction of glucose and oxygen to generate one or more oxidized species (“GOx-generated H2O2”, page 1046, Results and Discussion); a first permeability-selective layer (Layer 3, fig. 1) for reducing or blocking a diffusion of glucose to the enzymatic layer (Glucose Flux limiting PU Membrane, fig. 1, “semipermeable membrane on top of the GOx-containing layer to limit glucose flux and afford high sensor linearity”, page 1045 & page 1046, Results and Discussion); an oxygen-replenishing layer (Layer 4, fig. 1) comprising one or more enzymes (“catalase layer”, page 1047, Results and Discussion), wherein at least one enzyme in the oxygen-replenishing layer is capable of catalyzing a second reaction consuming at least one oxidized species from the first reaction in the enzymatic layer and generating oxygen (“converts H2O2 to O2”, pages 1046-1047, Results and Discussion), wherein the first permeability-selective layer is positioned between the oxygen-replenishing layer and the enzymatic layer (as seen in fig. 1, “careful layer stratification ...” page 1045); and an outer protective layer (Layer 5, Outer hydrogel membrane (PVA), fig. 1, “careful layer stratification ...”, page 1045); wherein the enzymatic layer is in closer proximity to the working electrode than the oxygen-replenishing layer (as seen in fig. 1, “careful layer stratification ...”, page 1045).
Vaddiraju teaches the recited structure of claim 1 and meets the functional limitations. Vaddiraju does not explicitly teach the rate of the first reaction of the glucose oxidase in the enzymatic layer and the rate of the second reaction of the oxygen-generating enzyme in the oxygen-replenishing layer are substantially the same such that the glucose monitoring device is temperature independent within an operating temperature range.
However, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112.01. Therefore, the limitation “wherein the rate of the first reaction of the glucose oxidase in the enzymatic layer and the rate of the second reaction of the oxygen-generating enzyme in the oxygen-replenishing layer are substantially the same such that the glucose monitoring device is temperature independent within an operating temperature range” is inherent to the structure of Vaddiraju.
This is further evidenced by Vaddiraju teaching that the profound effect of the catalase layer on sensor hysteresis provides a qualitative insight into the mass transfer of various participating species within the sensor geometry and that together with the high turnover rate of catalase for H2O2 conversion to O2, suggests that the observed hysteresis improvement are directly related to (1) efficient withdrawal of H2O2 from the inner sensor compartments and (2) facile equilibration of glucose and O2 across both sides of the PU membrane (pages 1047-1048, Sensor Response Time and Hysteresis). Vaddiraju further teaches that sensors that employ the outer PU/catalase/PVA layers showed negligible temperature dependence in sensitivity and operation within its linear range where minimal temperature dependence is anticipated (page 1048-1049, Temperature Dependence, fig. 5).
Claims 37, 44, 49, 56-57, and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Liu (US 20120132525 A1) in view of Bordunov (US 20080017512 A1), and further in view of Papadimitrakopoulos (US 20140262775 A1).
Regarding claim 37, Liu discloses Regarding claim 37, a glucose monitoring device (Abstract, figs. 5-6) comprising: a reference electrode (Ag/AgCl counter/reference electrode 29b, figs. 4A-6); a working electrode (working electrode 29a, figs. 4A-6), wherein the working electrode is disposed in a vicinity of the reference electrode (as seen in figs. 4A-6, para. [0178, 0180]); an enzymatic layer (enzyme sensing layer 18a, fig. 4A-6) comprising glucose oxidase and a polymeric mediator (“sensing layer 18a ... consists of crosslinked glucose oxidase and a low potential polymeric osmium complex mediator”, para. [0178]) for facilitating electron transfer between the glucose oxidase and the working electrode (“electron transport”; “transfers electrons”, para. [0058-0060, 0109, 0171-0172]), wherein the polymeric mediator comprises a backbone material (“polymeric backbone”, para. [0032, 0101-0102, 0170-0172], fig. 3), one or more redox mediator moieties (“transition metal complex”, para. [0058, 0065, 0171]), and one or more functional groups (“functional group”, para. [0057, 0101]), wherein the one or more redox mediator moieties are attached to the backbone material (“transition metal complex ... bound to the polymer backbone”; “anchored”, para. [0012, 0170-0171]), optionally the redox mediator moieties are attached to the backbone material through one or more linkers (“transition metal complex can be bound to the polymer backbone”, col. 30 line 63 - col. 31 line 7, “anchored ... via bidentate linkage”, para. [0171]); and an outer protective layer (interfacing membrane 30a, fig. 6).
Liu does not disclose one or more functional groups for improving the hydrophilicity of the polymeric mediator, and wherein the one or more functional groups are attached to the backbone material, optionally the functional groups are attached to the backbone material through one or more linkers.
However, Bordunov directed to microfluidic devices comprised of polymer coatings with triggerable analyte capture moieties discloses a polymeric mediator (fig. 1, “polymer”, para. [0038]) comprising a backbone material (“polymeric backbone A”, para. [0038]), one or more redox mediator moieties (“activatable capture groups Y ... anthraquinone derivatives”, para. [0038]), and one or more functional groups for improving the hydrophilicity of the polymeric mediator (“hydrophilic functional groups X”; “groups X provide a hydrophilic functionality which is compatible with aqueous media”, para. [0038, 0044]), wherein the one or more functional groups are attached to the backbone material (fig. 1, “attached”, para. [0047-0048]), optionally the functional groups are attached to the backbone material through one or more linkers (“interactions between A and the X and/or Y containing polymer strands can be independently hydrophobic, hydrophilic, hydrogen bonding, metal ion chelation and coordination, electrostatic interactions, .pi.-.pi. interactions and others”; “via various interactions ... no covalent connection ... independently ...”, para. [0043-0044, 0047-0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, such that the polymeric mediator comprises one or more functional groups for improving the hydrophilicity of the polymeric mediator, and such that the one or more functional groups are attached to the backbone material, optionally the functional groups are attached to the backbone material through one or more linkers, in view of the teachings of Bordunov, as this would aid in providing a hydrophilic functionality which is compatible with aqueous media by incorporating/grafting the functional groups of Bordunov into the backbone of Liu.
Liu, as modified by Bordunov hereinabove, does not disclose a first permeability-selective layer for reducing or blocking a diffusion of glucose to the enzymatic layer.
However, Papadimitrakopoulos directed to a device that functions as a glucose sensor discloses a first permeability-selective layer (semi-permeable membrane 114, fig. 1) for reducing or blocking a diffusion of glucose to the enzymatic layer (“regulate in inward diffusion of glucose”, para. [0064-0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, as modified by Bordunov hereinabove, such that the glucose monitoring device comprises a first permeability-selective layer for reducing or blocking a diffusion of glucose to the enzymatic layer, in view of the teachings of Papadimitrakopoulos, as this would aid in regulating the amount of glucose with respect to oxygen and ensure better sensor linearity.
Regarding claim 44, Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, discloses the glucose monitoring device of claim 37, wherein the backbone material comprises polyethylenimine (PEI), polyallylamine, cellulose, cellulose acetate, chitosan, poly(acrylic acid), poly(lactic acid), carbon nanofibers, carbon nanotubes, or metal nanofibers, or combinations thereof (“poly(acrylic acid) (Formula II)”, para. [0103]).
Regarding claim 49, Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, discloses the glucose monitoring device of claim 37, wherein the one or more redox mediator moieties of the polymeric mediator comprise ferrocene, transition metal complexes, or organic molecules, or combinations thereof (“ferrocenes”; “transition metal complexes”, para. [0010, 0101]).
Regarding claim 56, Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, discloses the glucose monitoring device of claim 37. Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, does not expressly disclose the first permeability-selective layer is disposed between the enzymatic layer and the outer protective layer.
However, Papadimitrakopoulos discloses that the first permeability-selective layer (114, fig. 1) is disposed between the enzymatic layer (110, fig. 1) and the outer protective layer (118 & 122 & 126, fig. 1) (as seen in fig. 1, para. [0064, 0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, such that the first permeability- selective layer is in direct contact with one or both of the enzymatic layer and the outer protective layer, in view of the teachings of Papadimitrakopoulos, as this would aid in regulating the amount of glucose with respect to oxygen and ensure better sensor linearity.
Regarding claim 57, Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, discloses the glucose monitoring device of claim 56. Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, does not expressly disclose the first permeability-selective layer is in direct contact with one or both of the enzymatic layer and the outer protective layer.
However, Papadimitrakopoulos discloses that the first permeability-selective layer (114, fig. 1) is in direct contact with one or both of the enzymatic layer (110, fig. 1) and the outer protective layer (118 & 122 & 126, fig. 1) (as seen in fig. 1, para. [0064, 0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, such that the first permeability-selective layer is in direct contact with one or both of the enzymatic layer and the outer protective layer, in view of the teachings of Papadimitrakopoulos, as this would aid in regulating the amount of glucose with respect to oxygen and ensure better sensor linearity.
Regarding claim 69, Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, discloses the glucose monitoring device of claim 37, wherein the glucose monitoring device is an implantable continuous glucose monitoring device (“implantable analyte sensing system”, para. [0035-0036]).
Claims 38 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Bordunov and Papadimitrakopoulos, as applied to claim 37 above, and further in view of Lavanant (US 20120150006 A1).
Regarding claim 38, Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, discloses the glucose monitoring device of claim 37. Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, does not expressly disclose the glucose oxidase and the polymeric mediator are present in a hydrogel matrix comprising one or more materials selected from the group consisting of cellulose acetate, chitosan, poly(2-hydroxyethyl methacrylate)(pHEMA), polyethylene glycol diamine, 3,6,9-Trioxaundecanedioic acid, sodium citrate, polyvinyl alcohol and polyethylenimine(PEI), and combinations thereof.
However, Lavanant directed to a glucose responsive membrane discloses the glucose oxidase and the polymeric mediator are present in a hydrogel matrix (“glucose responsive hydrogel ... polymeric matrix”, para. [0013, 0051, 0079-0082]) comprising one or more materials selected from the group consisting of cellulose acetate, chitosan, poly(2-hydroxyethyl methacrylate)(pHEMA), polyethylene glycol diamine, 3,6,9-Trioxaundecanedioic acid, sodium citrate, polyvinyl alcohol and polyethylenimine(PEI), and combinations thereof (“cellulose acetate”; “poly(2-hydroxyethyl Methacrylate) (PHEMA)”, para. [0073, 0120, 0168]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, such that the glucose oxidase and the polymeric mediator are present in a hydrogel matrix comprising one or more materials selected from the group consisting of cellulose acetate, chitosan, poly(2-hydroxyethyl methacrylate)(pHEMA), polyethylene glycol diamine, 3,6,9-Trioxaundecanedioic acid, sodium citrate, polyvinyl alcohol and polyethylenimine(PEI), and combinations thereof, in view of the teachings of Lavanant, as this would aid in exhibiting good selectivity for glucose, sensitivity to glucose under physiological conditions, significant glucose response, and responding reversibly and reproducibly to high and low glucose concentrations (of Lavanant, para. [0082-0083]).
Regarding claim 40, Liu, as modified by Bordunov, Papadimitrakopoulos, and Lavanant hereinabove, discloses the glucose monitoring device of claim 38, wherein the hydrogel matrix comprises two or more crosslinked materials (“cross-linked, glucose-transducing gel”, para. [0016, 0060, 0112-0121]).
Claims 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Bordunov, Papadimitrakopoulos, and Lavanant, as applied to claim 38 above, and further in view of Crane (US 20130040404 A1).
Regarding claim 41, Liu, as modified by Bordunov, Papadimitrakopoulos, and Lavanant hereinabove, discloses the glucose monitoring device of claim 38. Liu, as modified by Bordunov, Papadimitrakopoulos, and Lavanant hereinabove, does not disclose that the hydrogel matrix further comprises one or more polymeric materials that render the hydrogel matrix with a negative charge.
However, Crane directed to a barrier layer for glucose sensor, discloses a hydrogel matrix comprising one or more polymeric materials that render the hydrogel matrix with a negative charge (“one or more negatively charged monomers ... heparin. ... incorporated into a hydrogel”, para. [0010, 0055]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, as modified by Bordunov, Papadimitrakopoulos, and Lavanant hereinabove, such that the hydrogel matrix further comprises one or more polymeric materials that render the hydrogel matrix with a negative charge, in view of the teachings of Crane, as this would aid in repelling proteins and provide the added benefit of being antithrombogenic.
Regarding claim 42, Liu, as modified by Bordunov, Papadimitrakopoulos, Lavanant, and Crane hereinabove, discloses the glucose monitoring device of claim 41, wherein the one or more polymeric materials comprise poly(sodium 4-styrenesulfonate), poly(4-styrenesulfonic acid-co- maleic acid) sodium salt, poly(acrylic acid-co-maleic acid), or poly(vinylsulfonic acid) sodium salt, or combinations thereof (“poly(sodium 4-styrene sulfonate) (Formula 18)”, para. [0103]).
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Bordunov and Papadimitrakopoulos, as applied to claim 37 above, and further in view of McDonald (US 20040051083 A1).
Regarding claim 47, Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, discloses the glucose monitoring device of claim 37. Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, does not disclose the functional groups comprise -So3-, -PO3, -NH3+, or -N(CH3)3+, or combinations thereof.
However, McDonald directed to polymer-based coatings and materials, discloses functional groups comprise -So3-, -PO3, -NH3+, or -N(CH3)3+, or combinations thereof (para. [0010], “polymer having side chains along a backbone ... an amino group (--NRH, --NH.sub.2, --NRH.sub.2.sup.+, --NH.sub.3.sup.+)).
Upon the modification of Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove to incorporate hydrophilic functional groups, as described with respect to claim 37 above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, such that the functional groups comprise -So3-, -PO3, -NH3+, or -N(CH3)3+, or combinations thereof, in view of the teachings of McDonald, as such a modification would have been merely a substitution of the functional groups of Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, for the -NH3+ side chain of McDonald.
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Bordunov and Papadimitrakopoulos, as applied to claim 37 above, and further in view of Ettlinger (US 20130203065 A1).
Regarding claim 48, Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, discloses the glucose monitoring device of claim 37. Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, does not disclose the one or more linkers comprises an alkylene linker, a heteroalkylene linker, a polyethylene glycol (PEG) linker, or combinations thereof.
However, Ettlinger directed to a method for electrochemical detection of binding reactions, discloses the one or more linkers comprises an alkylene linker, a heteroalkylene linker, a polyethylene glycol (PEG) linker, or combinations thereof (“polyethylene glycol linkers ... most frequently used”; “2000 Da diamino-PEG linker ... couple ... redox mediator”, para. [0046-0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, such that the one or more linkers comprises an alkylene linker, a heteroalkylene linker, a polyethylene glycol (PEG) linker, or combinations thereof, in view of the teachings of Ettlinger, as this would aid in accessing analytes not soluble in water for testing by incorporating the PEG linker of a sufficient length to couple the redox mediator.
Claims 52-53 are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Bordunov and Papadimitrakopoulos, as applied to claim 37 above, and further in view of Ouyang (US 20200237277 A1).
Regarding claim 52, Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, discloses the glucose monitoring device of claim 37. Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, does not expressly disclose the enzymatic layer further comprises a second enzyme.
However, Ouyang directed to analyte sensors and sensing methods for dual detection of glucose and ethanol discloses wherein the enzymatic layer further comprises a second enzyme (“catalase ... clear hydrogen peroxide (e.g., as a catalase-hydrogen peroxide complex)”; “active area 414c may comprise glucose oxidase, catalase, and a second polymer”; “stabilizers ... catalase”, para. [0061, 0079, 0106]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, such that the enzymatic layer further comprises a second enzyme, in view of the teachings of Ouyang, as this would aid in promoting response stability by incorporating catalase into the enzyme sensing layer of Liu to form a catalase-hydrogen peroxide complex.
Regarding claim 53, Liu, as modified by Bordunov, Papadimitrakopoulos, and Ouyang hereinabove, discloses the glucose monitoring device of claim 52, wherein the second enzyme is horseradish peroxidase or catalase (“catalase”, para. [0132]).
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Bordunov and Papadimitrakopoulos, as applied to claim 37 above, and further in view of Petisce (US 20120283537 A1).
Regarding claim 54, Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, discloses the glucose monitoring device of claim 37. Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, does not disclose the first permeability-selective layer comprises one or more polymers selected from the group consisting of a polyacetal, a polyolefin, a polyacrylic, a polycarbonate, a polystyrene, a polyester, a polyamide, polyamideimides, a polyarylate, a polyarylsulfone, a polyethersulfone, a polyphenylene sulfide, a polyvinyl chloride, a polyethylene oxide, a polysulfone, a polyimide, a polyetherimide, a polytetrafluoroethylene, a polyetherketone, a polyether etherketone, a polyether ketone ketone, a polybenzoxazole, a polyphthalide, a polyacetal, a polyanhydride, a polyvinyl ether, a polyvinyl thioether, a polyvinyl alcohol, a polyvinyl ketone, a polyvinyl halide, a polyvinyl nitrile, a polyvinyl ester, a polysulfonate, a polysulfide, a poly(allyl amine), a polythioester, a polysulfone, a polysulfonamide, a polyurea, a polyphosphazene, a polysilazane, a polyvinylchloride, a polyvinyl acetate, a humic acid, a cellulose acetate, a polythiophene, a polyphenylene diamine, a polypyrrole, a polynaphthalene a polyurethane, an ethylene propylene diene rubber, a polytetrafluoroethylene, a fluorinated ethylene propylene, a sulfonated tetrafluoroethylene based fluoropolymer-copolymer, a perfluoroalkoxyethylene, a polychlorotrifluoroethylene, a polyvinylidene fluoride, and a polysiloxane, and combinations thereof.
However, Petisce directed analyte sensor layers and methods related thereto, discloses the first permeability-selective layer comprises one or more polymers selected from the group consisting of a polyacetal, a polyolefin, a polyacrylic, a polycarbonate, a polystyrene, a polyester, a polyamide, polyamideimides, a polyarylate, a polyarylsulfone, a polyethersulfone, a polyphenylene sulfide, a polyvinyl chloride, a polyethylene oxide, a polysulfone, a polyimide, a polyetherimide, a polytetrafluoroethylene, a polyetherketone, a polyether etherketone, a polyether ketone ketone, a polybenzoxazole, a polyphthalide, a polyacetal, a polyanhydride, a polyvinyl ether, a polyvinyl thioether, a polyvinyl alcohol, a polyvinyl ketone, a polyvinyl halide, a polyvinyl nitrile, a polyvinyl ester, a polysulfonate, a polysulfide, a poly(allyl amine), a polythioester, a polysulfone, a polysulfonamide, a polyurea, a polyphosphazene, a polysilazane, a polyvinylchloride, a polyvinyl acetate, a humic acid, a cellulose acetate, a polythiophene, a polyphenylene diamine, a polypyrrole, a polynaphthalene a polyurethane, an ethylene propylene diene rubber, a polytetrafluoroethylene, a fluorinated ethylene propylene, a sulfonated tetrafluoroethylene based fluoropolymer-copolymer, a perfluoroalkoxyethylene, a polychlorotrifluoroethylene, a polyvinylidene fluoride, and a polysiloxane, and combinations thereof (para. [0083-0084], “vinyl polymers, polyethers, polyesters, polyamides, or thin-film, track-etched polycarbonates, inorganic polymers such as polysiloxanes and polycarbosiloxanes, natural polymers such as cellulosic and protein based materials”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, such that the first permeability-selective layer comprises one or more polymers selected from the group consisting of a polyacetal, a polyolefin, a polyacrylic, a polycarbonate, a polystyrene, a polyester, a polyamide, polyamideimides, a polyarylate, a polyarylsulfone, a polyethersulfone, a polyphenylene sulfide, a polyvinyl chloride, a polyethylene oxide, a polysulfone, a polyimide, a polyetherimide, a polytetrafluoroethylene, a polyetherketone, a polyether etherketone, a polyether ketone ketone, a polybenzoxazole, a polyphthalide, a polyacetal, a polyanhydride, a polyvinyl ether, a polyvinyl thioether, a polyvinyl alcohol, a polyvinyl ketone, a polyvinyl halide, a polyvinyl nitrile, a polyvinyl ester, a polysulfonate, a polysulfide, a poly(allyl amine), a polythioester, a polysulfone, a polysulfonamide, a polyurea, a polyphosphazene, a polysilazane, a polyvinylchloride, a polyvinyl acetate, a humic acid, a cellulose acetate, a polythiophene, a polyphenylene diamine, a polypyrrole, a polynaphthalene a polyurethane, an ethylene propylene diene rubber, a polytetrafluoroethylene, a fluorinated ethylene propylene, a sulfonated tetrafluoroethylene based fluoropolymer-copolymer, a perfluoroalkoxyethylene, a polychlorotrifluoroethylene, a polyvinylidene fluoride, and a polysiloxane, and combinations thereof, in view of the teachings of Petisce, as such a modification would have been merely a substitution of the membrane of Liu for the flux limiting membrane of Petisce for controlling the flux of oxygen and glucose to the underlying layers, preferably providing oxygen in a non-rate-limiting excess (Petisce, para. [0083-0084]).
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Bordunov and Papadimitrakopoulos, as applied to claim 37 above, and further in view of Gerhardt (US 20170079568 A1).
Regarding claim 55, Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, discloses the glucose monitoring device of claim 37. Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, does not disclose the first permeability- selective layer comprises poly(ortho-phenylenediamine) (PoPD), poly(meta-phenylenediamine) (PmPD), or poly(para-phenylenediamine) (PpPD), or combinations thereof.
However, Gerhardt directed to a dual-sided biomorphic bioflex polymer-based microelectrode array and fabrication thereof, discloses wherein the first permeability- selective layer comprises poly(ortho-phenylenediamine) (PoPD), poly(meta-phenylenediamine) (PmPD), or poly(para-phenylenediamine) (PpPD), or combinations thereof (para. [0031], barrier layer 302 ... poly-(meta-phenylenediamine) (mPD) to minimize the oxidization).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, such that the first permeability-selective layer comprises poly(ortho-phenylenediamine) (PoPD), poly(meta-phenylenediamine) (PmPD), or poly(para-phenylenediamine) (PpPD), or combinations thereof, in view of the teachings of Gerhardt, as such a modification would have been merely a substitution of the membrane of Liu for the barrier layer of Gerhardt for reducing the amount of glucose entering the sensor.
Claims 58-61 and 65 are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Bordunov and Papadimitrakopoulos, as applied to claim 37 above, and further in view of Zhang (US 20220104731 A1).
Regarding claim 58, Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, discloses the glucose monitoring device of claim 37. Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, does not disclose a second permeability-selective layer for blocking a contact of one or more redox active species with the working electrode and/or the reference electrode.
However, Zhang directed to an in-vivo glucose specific sensor discloses a first permeability-selective layer (glucose limiting layer 36, fig. 3A) and a second permeability-selective layer (para. [0042-0043], interference layer 34 between the enzyme layer 35 and the conductive surface, fig. 3A) for blocking a contact of one or more redox active species with the working electrode and/or the reference electrode (para. [0043], interference layer 34, ... blocks .... freely passing”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, such that the glucose monitoring device further comprises a second permeability-selective layer for blocking a contact of one or more redox active species with the working electrode and/or the reference electrode, in view of the teachings of Zhang, as this would aid in blocking nearly all of the active electrochemical in the enzyme layer from ever reaching the conductive surface, while freely passing the H2O2 the conductive surface of the conductive wire (Zhang, para. [0043]).
Regarding claim 59, Liu, as modified by Bordunov, Papadimitrakopoulos, and Zhang hereinabove, discloses the glucose monitoring device of claim 58, wherein the second permeability-selective layer is disposed between the working electrode and the enzymatic layer (Zhang, fig. 3A, para. [0042-0043]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, as modified by Bordunov, Papadimitrakopoulos, and Zhang hereinabove, such that the second permeability-selective layer is disposed between the working electrode and the enzymatic, in view of the teachings of Zhang, as this would aid in blocking nearly all of the active electrochemical in the enzyme layer from ever reaching the conductive surface, while freely passing the H2O2 the conductive surface of the conductive wire (Zhang, para. [0043]).
Regarding claim 60, Liu, as modified by Bordunov, Papadimitrakopoulos, and Zhang hereinabove, discloses the glucose monitoring device of claim 59, wherein the second permeability-selective layer is in direct contact with one or both of the working electrode and the enzymatic layer (Zhang, fig. 3A, para.[0042-0043], interference layer 34, which is between the enzyme layer 35 and the conductive surface of the substrate (conductive wire 33)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, as modified by Bordunov, Papadimitrakopoulos, and Zhang hereinabove, such that the second permeability-selective layer is in direct contact with one or both of the working electrode and the enzymatic layer, in view of the teachings of Zhang, as this would aid in blocking nearly all of the active electrochemical in the enzyme layer from ever reaching the conductive surface, while freely passing the H2O2 the conductive surface of the conductive wire (Zhang, para. [0043]).
Regarding claim 61, Liu, as modified by Bordunov, Papadimitrakopoulos, and Zhang hereinabove, discloses the glucose monitoring device of claim 58. Liu, as modified by Bordunov, Papadimitrakopoulos, and Zhang hereinabove, does not disclose the second permeability-selective layer comprises electropolymerized PoPD, electropolymerized PmPD, electropolymerized PpPD, diamino-naphthalene (DAN), amino naphthol, polypyrrole, polyaniline, cellulose acetate, or an ionic polymer, or combinations thereof.
However, Papadimitrakopoulos discloses wherein the second permeability-selective layer comprises electropolymerized PoPD, electropolymerized PmPD, electropolymerized PpPD, diamino-naphthalene (DAN), amino naphthol, polypyrrole, polyaniline, cellulose acetate, or an ionic polymer, or combinations thereof (para. [0048], Intrinsically electrically conducting polymers are polypyrrole, ... intrinsically electrically conducting polymers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, as modified by Bordunov, Papadimitrakopoulos, and Zhang hereinabove, such that the second permeability-selective layer comprises electropolymerized PoPD, electropolymerized PmPD, electropolymerized PpPD, diamino-naphthalene (DAN), amino naphthol, polypyrrole, polyaniline, cellulose acetate, or an ionic polymer, or combinations thereof, in view of the teachings of Papadimitrakopoulos, as this would aid in preventing the diffusion of a number of endogenous species by incorporating the electrically conducting polymers of Papadimitrakopoulos.
Regarding claim 65, Liu, as modified by Bordunov, Papadimitrakopoulos, and Zhang hereinabove, discloses the glucose monitoring device of claim 58. Liu, as modified by Bordunov, Papadimitrakopoulos, and Zhang hereinabove, does not expressly disclose the second permeability-selective layer is disposed between the working electrode and the enzymatic layer, the enzymatic layer is disposed between the second permeability-selective layer and the first permeability-selective layer, the first permeability-selective layer is disposed between the enzymatic layer and the outer protective layer.
However, Zhang discloses the second permeability-selective layer (interference layer 34, fig. 3A) is disposed between the working electrode (working electrode 31/conductive wire 33, fig. 3A) and the enzymatic layer (enzyme layer 35, fig. 3A) (as seen in fig. 3A, para. [0042-0043]), the enzymatic layer (enzyme layer 35, fig. 3A) is disposed between the second permeability-selective layer (interference layer 34, fig. 3A) and the first permeability-selective layer (glucose limiting layer 36, fig. 3A) (as seen in fig. 3A, para. [0042-0043]), the first permeability-selective layer (glucose limiting layer 36, fig. 3A) is disposed between the enzymatic layer (enzyme layer 35, fig. 3A) and the outer protective layer (as seen in fig. 3A, “protective layer”, para. [0042-0043, 0075, 0077]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, as modified by Bordunov, Papadimitrakopoulos, and Zhang hereinabove, such that the second permeability-selective layer is disposed between the working electrode and the enzymatic layer, the enzymatic layer is disposed between the second permeability-selective layer and the first permeability-selective layer, the first permeability-selective layer is disposed between the enzymatic layer and the outer protective layer, in view of the teachings of Zhang, as this would aid in passing a determined level of glucose to the enzyme layer, blocking nearly all of the active electrochemical in the enzyme layer from ever reaching the conductive surface, while freely passing the H2O2 the conductive surface of the conductive wire, and providing biocompatibility (Zhang, para. [0043, 0077]).
Claims 62 and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Bordunov and Papadimitrakopoulos, as applied to claim 37 above, and further in view of Say (US 20090177056 A1).
Regarding claim 62, Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, discloses the glucose monitoring device of claim 37. Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, does not expressly disclose the outer protective layer comprises a polymer, a hydrogel, or a combination thereof for reducing or inhibiting protein adhesion.
However, Say discloses directed to an analyte monitor having a biocompatible layer 74 discloses wherein the outer protective layer comprises a polymer, a hydrogel, or a combination thereof for reducing or inhibiting protein adhesion (“biocompatible layer 74 may also prevent protein adhesion to the sensor 42 ... biocompatible coating is a hydrogel”, para. [0164-0165]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, such that the outer protective layer comprises a polymer, a hydrogel, or a combination thereof for reducing or inhibiting protein adhesion, in view of the teachings of Say, as this would aid in preventing protein adhesion to the sensor, formation of blood clots, and other undesirable interactions between the sensor and body.
Regarding claim 64, Liu, as modified by Bordunov, Papadimitrakopoulos, and Say hereinabove, discloses the glucose monitoring device of claim 62. Liu, as modified by Bordunov, Papadimitrakopoulos, and Say hereinabove, does not expressly disclose the outer protective layer further comprises an anti-inflammatory drug, an angiogenesis factor, or a combination thereof.
However, Papadimitrakopoulos discloses the outer protective layer further comprises an anti-inflammatory drug, an angiogenesis factor, or a combination thereof (“locally deliver various tissue response modifying (TRM) ... hydrogel coating ... drugs”, para. [0070, 0078]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, as modified by Bordunov, Papadimitrakopoulos, and Say hereinabove, such that the outer protective layer further comprises an anti-inflammatory drug, an angiogenesis factor, or a combination thereof, in view of the teachings of Papadimitrakopoulos, as this would aid in controlling and suppressing inflammation of the surrounding tissue.
Claim 71 is rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Bordunov and Papadimitrakopoulos, as applied to claim 37 above, and further in view of Hoss (US 20120028283 A1).
Regarding claim 71, Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, discloses the glucose monitoring device of claim 37. Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, does not expressly disclose the glucose monitoring device does not comprise or require a temperature sensor, or does not comprise or require algorithmic correction for temperature related variability.
However, Hoss directed to analyte determining methods and devices (e.g., electrochemical analyte monitoring systems) discloses wherein the glucose monitoring device does not comprise or require a temperature sensor, or does not comprise or require algorithmic correction for temperature related variability (“sensor ... signals ... substantially temperature independent ... not necessary to correct the signals ... does not include a temperature detection section”, para. [0026, 0035, 0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, such that the glucose monitoring device does not comprise or require a temperature sensor, or does not comprise or require algorithmic correction for temperature related variability, in view of the teachings of Hoss, as such a modification would aid in generating signals that are substantially temperature independent such that it is not necessary to correct the signals generated by the analyte sensor for changes in temperature by incorporating the membrane structure configured to have an analyte permeability that is substantially temperature independent of Hoss into the sensor of Liu.
Claim 72 is rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Bordunov and Papadimitrakopoulos, as applied to claim 37 above, and further in view of Bremer (US 20170055906 A1).
Regarding claim 72, Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, discloses an implantable glucose monitoring device (figs. 7A-7B, para. [0052, 0181]) and a glucose monitoring device of claim 37 (see claim 37). Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, does not disclose a method of implanting a glucose monitoring device to a subject in need thereof, comprising: contacting a glucose monitoring device of claim 37 with an aqueous medium; and implanting the glucose monitor into a tissue of the subject.
However, Bremer directed to systems and methods for continuous health monitoring using an opto-enzymatic analyte sensor discloses a method of implanting a glucose monitoring device to a subject in need thereof (“glucose monitoring”; “method 3700 of inserting/implanting a sensing element”, Abstract, para. [0406]), comprising: contacting a glucose monitoring device with an aqueous medium (“factory calibration ... sensors are exposed to a well-mixed aqueous glucose solution ... manufacturing process”, para. [0205]); and implanting the glucose monitor into a tissue of the subject (“inserting/implanting a sensing element”, para. [0406]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, such that a method of implanting a glucose monitoring device to a subject in need thereof comprises contacting a glucose monitoring device of claim 37, with an aqueous medium; and implanting the glucose monitor into a tissue of the subject, in view of the teachings of Bremer, as this would aid in calibrating sensor readings and implanting the sensing element into subcutaneous tissue for continuous glucose monitoring (Bremer, Abstract, para. [0205, 0406]).
Claim 73 is rejected under 35 U.S.C. 103 as being unpatentable over Liu in view of Bordunov, Papadimitrakopoulos, and Bremer as applied to claim 72 above, and further in view of Tokimoto (WO-2012169236-A1 English Translation).
Regarding claim 73, Liu, as modified by Bordunov, Papadimitrakopoulos, and Bremer hereinabove, discloses the method of claim 72. Liu, as modified by Bordunov, Papadimitrakopoulos, and Bremer hereinabove, does not disclose the contacting of the glucose monitoring device with the aqueous medium leads to swelling of the enzymatic layer of the glucose monitoring device.
However, Tokimoto directed to a fluorescence sensor for measuring the concentration of an analyte in an aqueous solution and a method for manufacturing the fluorescence sensor, discloses wherein the contacting of the glucose monitoring device with the aqueous medium leads to swelling of the indicator of the glucose monitoring device (“Before insertion ... immersed in sale solution ... pre-swell”, page 8, 1st para. & pages 15-16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Liu, as modified by Bordunov, Papadimitrakopoulos, and Bremer hereinabove, such that the contacting of the glucose monitoring device with the aqueous medium leads to swelling of the enzymatic layer of the glucose monitoring device, in view of the teachings of Tokimoto, as this would aid in pre-swelling the enzymatic layer for insertion into the body and lead to a more rapid and stable measurement state.
Claim 74 is rejected under 35 U.S.C. 103 as being unpatentable over Jain (US 20080154101 A1) in view of Liu, Bordunov, and Papadimitrakopoulos.
Regarding claim 74, Jain discloses a disease management system (“an analyte sensing device”, figs. 1 & 17, Abstract, para. [0002-0003]) comprising: a glucose monitoring device (figs. 2 & 16-17, para. [0008, 0042], “sensor platform; glucose sensor of fig. 17); an insulin administration system (Dispenser subchip#2 (161) & Dispenser subchip#3 (162), fig. 16, “insulin dispenser”, para. [0078], fig. 16); a case (biocompatible coating (68); “encased in a suitable biocompatible coating”, para. [0008, 0054], figs. 2-3); a battery ( “power source ... wireless photovoltaic powering solar cell array”, para. [0039-0040]); and a computing device (the control unit 101D (e.g. modified PDA unit), para. [0078], fig. 16) configured to receive measurements from the glucose monitoring device and control the insulin administration system to provide dosages of insulin to a patient based on measurements from the glucose monitoring device (sensor reading of glucose or insulin ... insulin dispenser to dispense desired amount of insulin, para. [0078]); wherein the case houses one or more of the glucose monitoring device, the insulin administration system, the battery, and the computing device (fig. 2, implantable sensor platform (2) comprising three subchips (4, 5, and 6) that are coated with a biocompatible coating (68) containing, for example, a number of tissue response modifying agents, para. [0054]).
Jain does not disclose a glucose monitoring device of claim 37.
However, Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, discloses a glucose monitoring device of claim 37 (see claim 37 above).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jain such that the disease management system further comprises a glucose monitoring device of claim 37, in view of the teachings of Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, as such a modification would have been merely a substitution of the glucose sensor of Jain for the glucose sensor of Liu, as modified by Bordunov and Papadimitrakopoulos hereinabove, and incorporating the glucose sensor into the analyte sensing device of Jain to provide sensor readings of glucose levels (Jain, para. [0078]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Papadimitrakopoulos (US 8608922 B2) directed to biosensors for continuous monitoring of metabolites and proteins and to methods of manufacture thereof; Garner (US 20190170739 A1) directed to electrochemical detection systems; Al-Bar, O.A. (2012). Characterization of partially purified catalase from camel (Camelus dromedarius) liver. African Journal of Biotechnology, 11, 9633-9640.
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Art Unit 3791
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