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 .
Claim Objections
Claim 59 is/are objected to because of the following informalities: “comprising” should be “comprises”.
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not). Since claim 69 is missing, misnumbered claims 70-72 have been renumbered 69-71, with the misnumbered indicated in [] below – e.g., 69[70].
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 1, 64, 69[70] and associated dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1 and 69[70], a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims recites the broad recitation “a life span of the continuous glucose sensor is 22 days or more”, and the claim also recites “the life span is selected from the group consisting of about 22 days, about 23 days, about 24 days, about 25 days, about 26 days, about 27 days, about 28 days, about 29 days, and about 30 days” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 64 recites the limitation "the whole sensor". There is insufficient antecedent basis for this limitation in the claim. It is not clear whether the “whole sensor” refers to the continuous glucose sensor or the claimed continuous glucose sensor is part of a whole sensor.
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.
Claim(s) 1, 3-6, 9-10, 46, 50, and 54, 56, 58-62, 64-71 are rejected under 35 U.S.C. 103 as being unpatentable over McCanless (WO 2019/222615, cited previously) in view of Zou (US 2017/0191955) and Feldman (US 2005/0173245, cited previously).
Regarding claim 1, McCanless teaches a continuous glucose sensor (“implanted sensors may collect analyte data continuously,” par. 4; “sensing an analyte of interest, such as glucose,” par. 36) comprising:
(i) a proximal portion configured to be positioned above a user’s skin and to be electrically coupled with electronics disposed in an electronics housing of a sensor control device [0033, 35: sensor control device 102 includes sensor housing 103 housing circuitry/power];
(ii) a distal portion (analyte sensor tail 202, Fig. 2C) configured to be transcutaneously positioned through the user’s skin [0036] and in contact with a bodily fluid of the user, wherein the distal portion is configured to detect glucose in the bodily fluid [0036, 56], wherein the distal portion comprises at least (a) a first working electrode (working electrode 214 is disposed on substrate 212, par. 55) and (b) a counter and/or a reference electrode (counter/reference electrode 216, Figs. 2A-2C);
(iii) an active area disposed upon a surface of the first working electrode for detecting glucose (sensing element 218 can comprise glucose oxidase or glucose dehydrogenase, par. 62);
(iv) a mass transport limiting membrane permeable to glucose that overcoats at least the active area (membrane 220; “membrane 220 may comprise one or more polymeric membrane materials having capabilities of limiting analyte flux to sensing element 218,” par. 56); and
(v) a polymer composition comprising a polymer (membrane 220 and/or non-electrochemical functions layers 240a, 240b comprise polymers and can incorporate an agent, par. 87; see paras. 69-74, 94 for polymeric material used for each component; a coating may comprise a polymer carrier, para. 116) and an agent (antimicrobial quality, paras. 87-88; the antimicrobial quality may be formed in the coating comprising a polymer carrier, paras. 114-115), wherein the polymer composition comprises up to about 80% by weight of the agent (“In some embodiments, the antimicrobial compounds are present in an amount of about 0.1% to about 50% by weight of the membrane polymer before crosslinking,” par. 133);
wherein the polymer composition is disposed upon the counter electrode, the reference electrode, the mass transport limiting membrane, the working electrode, or upon a substrate of the distal portion (Figs. 2A-2C show membrane 220 or non-electrochemical functional layers 240a, 240b in which the antimicrobial quality can be incorporated into, disposed over the preceding elements; an antimicrobial quality can be applied as a separate film or layer over the sensor tail components, paras. 114-115),
wherein the polymer composition has a thickness from 1-500 µm (“the membrane described herein may have a thickness ranging from about 0.1 micrometers (µm) to about 1000 µm, encompassing any value and subset therebetween,” par. 77) and a length of 0.1 mm to 10 mm (“The membrane which may have an antimicrobial quality…may additionally be disposed over any portion of the sensor tail,” par. 93; “the sensor tail has a length…within a range of less than about 20 millimeters,” par. 60; since the membrane can be disposed on any portion on the sensor tail, which has a length less than 20 mm, the length of the membrane or other coating must be less than 20 mm; additionally, the sensing region may be disposed only on a portion of the sensing tail, see par. 103).
wherein a life span of the continuous glucose sensor is 22 days or more, and wherein the life span is selected from the group consisting of about 22 days, about 23 days, about 24 days, about 25 days, about 26 days, about 27 days, about 28 days, about 29 days, and about 30 days [0192].
McCanless explicitly teaches all limitations of claim 1 except for the agent being an anti-inflammatory agent and the polymer composition comprises about 0.1-20 µg of the anti-inflammatory agent. McCanless discloses that immune response can interfere with analyte measurements (“microorganisms can interfere with analyte sensor measurement by causing an immune response at or near the insertion site,” par. 48). Zou teaches an analogous analyte sensor with a polymer composition comprising up to 50% by weight of an anti-inflammatory agent (paras. 95, 125, 339; “the biointerface layer can increase sensor longevity and decrease sensor inaccuracy by reducing the biomaterial-associated inflammation response,” par. 122). Zou also teaches that multiple bioactive agents can be combined, including anti-inflammatory and antimicrobial agents (“bioactive agents can be used alone or in combination,” par. 323; exemplary agents disclosed in paras. 308-322). Zou’s polymer composition can have a thickness of 0.1-250 µm (par. 172).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify McCanless to include an anti-inflammatory agent in a coating in an amount of up to 50% by weight of the sensor membrane (Zou par. 339). This could be done by either incorporating an anti-inflammatory agent into McCanless’s sensor in a similar manner to the antimicrobial quality or by using Zou’s membrane, with a thickness of 0.1-250 microns, in McCanless’s sensor. One would be motivated to do so in order to improve the host response to the implanted sensor (McCanless par. 48, 107; Zou paras. 122, 125) and combining multiple agents for that purpose was suggested by McCanless and Zou (McCanless par. 107; Zou par. 323). Furthermore, both Zou and McCanless disclose similar membrane compositions and methods of manufacture, which suggests that such a modification would yield successful results (both references disclose the polymer can comprise polyvinylpyridine, polyvinylimidazole, polyacrylate, polyurethane, polyether urethane, silicone, and/or polyethylene glycol, McCanless par. 64, 69, 102, 116, 121 and Zou paras. 8, 82, 104, 120, 147, 191; manufacturing techniques disclosed in McCanless paras. 76-77 and Zou paras. 76, 117).
Regarding the amount of agent, McCanless and Zou teach methods for creating the membrane including dipping, spraying, or spin-coating (McCanless paras. 76-77; Zou paras. 76, 117). Feldman teaches an analogous analyte sensor with a membrane (Fig. 2A; “transcutaneous amperometric biosensor,” Abstract), specifically that a membrane may be loaded with a catalyst in an amount of 5.7% weight relative to the membrane, yielding a load of 13 µg of the catalyst (par. 123). In another example, a catalyst in an amount of 5% weight relative to a membrane, may result in a load of 20 µg (par. 113). This suggests than a membrane weight of a transcutaneous sensor may be around 0.228 mg to 0.4 mg.
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify McCanless in view of Zou by forming the polymer composition to have a total weight within 0.228 mg and 0.4 mg. McCanless and Zou do not explicitly teach a total weight of any membrane or sensor layer, thus one would be motivated to look within the art to see how much membrane polymer to use, and Feldman indicates a total membrane weight of 0.228 mg or 0.4 mg was known in the art. This modification would yield successful results because McCanless and Feldman teach similar sensors (see McCanless Fig. 2A vs. Feldman Fig. 2A) and methods for making sensor membranes (Feldman paras. 15, 96; McCanless paras. 76-77; Zou par. 117). Zou discloses an anti-inflammatory agent amount of 1-50% by weight, and Feldman suggests a membrane weight of 0.228 mg or 0.4 mg, so an amount of anti-inflammatory can be within a range of 2-114 µg. This overlaps with claimed range. Thus, McCanless in view of Zou and Feldman teaches or suggests all limitations of claim 1.
Regarding claims 3-4, Zou teaches the anti-inflammatory agent comprises at least one of triamcinolone, betamethasone, dexamethasone, dexamethasone sodium phosphate, hydrocortisone, prednisone, methylprednisolone, acetylsalicylic acid, isobutylphenylpropanoic acid (paras. 125, 308, 315).
Regarding claim 5, McCanless in view of Zou and Feldman teaches the anti-inflammatory agent is covalently bound to the polymer (“the antimicrobial compounds may be…chemically bound (e.g., covalently bound) to the surface of the substrate or membrane,” McCanless par. 106; “the bioactive agent is cross-linked with the membrane system,” Zou par. 326).
Regarding claim 6, McCanless teaches the antimicrobial quality is covalently bound to the polymer via a hydrolyzable bond (McCanless indicates that the antimicrobial agent can be covalently bonded and released through exposure of the polymer composition to water, thus, the covalent bonds must be hydrolyzable: “the antimicrobial compound is released slowly by contact with water,” par. 108; “a film or layer of antimicrobial applied to a surface by any means including…surface functionalization (e.g., crosslinking, graft polymer linking, and the like of the surface and the antimicrobial)…Carriers may be used that, when applied to a surface, can themselves be degradable and allow a slow-release (e.g., upon water exposure…of an antimicrobial,” emphasis added, par. 114; “the impregnatable materials…which may be particularly compatible with a hydrophobic antimicrobial compound…which can be released from the cyclodextrin complex upon contact with water,” emphasis added, par. 125). While Zou teaches that anti-inflammatory compounds may be covalently bound, McCanless in combination with Zou does not explicitly teach an anti-inflammatory agent covalently bound via a hydrolyzable bond.
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify McCanless in view of Zou and Feldman to covalently bind the immunosuppressant agent to the polymeric materials through a hydrolyzable bond, as taught by McCanless. One would be motivated to do so because this method would allow some control over the release of an anti-inflammatory agent as McCanless teaches with an antimicrobial quality (“the antimicrobial quality for use in the present disclosure is designed to slowly release an antimicrobial compound…released slowly by contact with water,” par. 108; “the antimicrobial quality may be designed…to achieve prolonged, localized, and/or sequential diffusion of the antimicrobial compound(s),” par. 110). This modification would yield a reasonable expectation of success because McCanless and Zou teach similar polymers for creating membranes (Zou paras. 82, 104, 125, 147; McCanless paras. 64, 69-71, 116, 121).
Regarding claims 9 and 46, McCanless in view of Zou and Feldman teaches the polymer comprises a polyvinylpyridine-based polymer (“a membrane composed of…polymers of polyvinylpyridine,” McCanless par. 69; Zou par. 191), a polyvinylimidazole (Zou par. 191), polyacrylate (McCanless par. 121; Zou par. 82), a polyurethane (McCanless par. 69, 116; Zou par. 82), a polyether urethane (McCanless par. 69; Zou par. 104), a silicone (McCanless par. 69, 102; Zou par. 104), a polylactide (McCanless par. 116), a polyglycolide (McCanless par. 116), a polyethylene glycol (McCanless paras. 70-71; Zou par. 147), a block copolymer, or a derivative or a combination thereof.
Regarding claim 50, McCanless teaches the distal portion further comprises a substrate (substrate 212), wherein the first working electrode and the counter and/or the reference electrode are disposed upon the substrate (Figs. 2A-2C).
Regarding claim 54, McCanless in view of Zou and Feldman teaches the polymer composition has a thickness of 10-100 µm (“the membrane described herein may have a thickness ranging from about 0.1 micrometers (µm) to about 1000 µm, encompassing any value and subset therebetween,” McCanless par. 77; the biointerface domain has a thickness of 0.1-250 µm, Zou par. 172).
Regarding claim 56, McCanless in view of Zou and Feldman teaches the polymer composition has a length of 0.1 mm to 2.0 mm (sensor tail length is less than 20 mm, par. 60; the portion of the sensor tail comprising an antimicrobial quality may comprise 10-75% of the sensor tail substrate, par. 102; based on paragraphs 102 and 218, the antimicrobial sublayer may have length of 0.1-7.5 mm (par. 218).
Regarding claim 58, McCanless in view of Zou and Feldman teaches the mass transport limiting membrane comprises one or more polymers (materials for the mass transport limiting membrane can include polyvinylpyridine, polyurethane, polyvinylimidazole, silicone , McCanless par. 69), and wherein the polymer of the polymer composition is different from the one or more polymers of the mass transport limiting membrane (polymer coatings to carry the agent may include polyacrylate, polylactide, polyglycolide, McCanless par. 116, 121; Zou paras. 82, 104, 191).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify McCanless in view of Zou and Feldman such that the mass transport limiting membrane comprises a polymer that is different from the polymer of the polymer composition. McCanless and Zou teach various polymers for the mass transport limiting membrane and for a membrane or coating that carries an agent (McCanless paras. 69, 116, 121; Zou paras. 82, 104, 191). It would be obvious to try using two different polymers based on the limited number of polymers disclosed for each purpose, and two different polymers is a possible configuration.
Regarding claim 59, McCanless in view of Zou and Feldman teaches wherein the cross-linking agent comprising a glycidyl ether [McCanless: 0066, 75].
Regarding claim 60, McCanless in view of Zou and Feldman teaches wherein the cross-linking agent is triglycidyl glycerol [McCanless: 0066, 0075].
Regarding claim 61, McCanless in view of Zou and Feldman teaches wherein the cross-linking agent is a branched glycidyl ether [McCanless: 0075; branched versions with similar terminal chemistry are also suitable].
Regarding claim 62, McCanless in view of Zou and Feldman teaches wherein the lifespan of the continuous glucose sensor is about 30 days or more [McCanless: 0192; Zou: 0075].
Regarding claim 64, McCanless in view of Zou and Feldman teaches wherein the whole sensor comprises 0.1 to 20 µg of the anti-inflammatory agent [see discussion in reference to claim 1].
Regarding claim 65, McCanless in view of Zou and Feldman teaches wherein the polymer composition has a length of 0.1 mm to 10 mm (McCanless: “The membrane which may have an antimicrobial quality…may additionally be disposed over any portion of the sensor tail,” par. 93; “the sensor tail has a length…within a range of less than about 20 millimeters,” par. 60; since the membrane can be disposed on any portion on the sensor tail, which has a length less than 20 mm, the length of the membrane or other coating must be less than 20 mm; additionally, the sensing region may be disposed only on a portion of the sensing tail, see par. 103).
Regarding claim 66, McCanless in view of Zou and Feldman teaches wherein the polymer composition has a thickness of 1-500 µm (McCanless: “the membrane described herein may have a thickness ranging from about 0.1 micrometers (µm) to about 1000 µm, encompassing any value and subset therebetween,” par. 77).
Regarding claim 67, McCanless in view of Zou and Feldman teaches wherein the polymer composition comprises a polyvinylpyridine-based polymer crosslinked with a crosslinking agent [McCanless: 0069, 71, 75].
Regarding claim 68, McCanless in view of Zou and Feldman teaches wherein the polyvinylpyridine-based polymer is a polyvinylpyridine-co-styrene copolymer [McCanless: 0071].
Regarding claim 69[70], McCanless in view of Zou and Feldman teaches the shared limitations as discussed above in reference to claim 1. McCanless further discloses wherein the polymer composition is disposed upon the counter electrode, or disposed upon the reference electrode, or disposed upon the first working electrode, or disposed upon a substrate of the distal portion [0057-59].
Regarding claims 70[71]-71[72], McCanless in view of Zou and Feldman teaches wherein the anti-inflammatory agent reduces a loss in sensitivity of the continuous glucose sensor compared to an analyte sensor that does not comprise the anti-inflammatory agent [Zou: 0315, 0338-39].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over McCanless in view of Zou and Feldman, as applied to claim 6 above, and further in view of Carpenter.
Regarding claim 7, ester, amide, or hydrazone-based bonds are not explicitly taught by McCanless, Zou, or Feldman. McCanless and Zou teach that membrane may be modified with different functional groups (“poly(4-vinylpyridine), in which a portion of the monomer units are functionalized with an alkylcarboxylate side chain,” McCanless par. 64; McCanless paras. 70-71; “Polymers with domains or segments that are functionalized to permit cross-linking can be made by methods known in the art,” Zou par. 120). McCanless and Zou also discloses various agents comprising functional groups such as carboxylic acid, amine, hydroxyl and ketone groups and polymers comprising groups such as amines, hydroxyl groups, and carboxylates (McCanless paras. 64, 70-71, 116, 120-121 disclose exemplary polymers and polymer functionalization; exemplary agents and polymers disclosed in Zou paras. 82, 104, 147, 191, and 308-322).
Carpenter teaches analogous polymer coatings that can promote healing around implanted devices (“a coating on the surface of an implantable surgical device to deliver wound healing agents,” Abstract). The bioactive polymers and the bioactive agents are covalently attached through amide or ester bonds (“a polymer of the present invention can be linked to the bioactive agent via a carboxyl group (e.g., COOH) of the polymer…with an amino functional group of a bioactive agent or a hydroxyl functional group of a bioactive agent to provide a biodegradable, bioactive polymer having a bioactive agent attached via an amide linkage or carboxylic ester linkage, respectively,” par. 120). Although bioactive healing agents are the preferred embodiment, Carpenter teaches that the bioactive agent can comprise anti-inflammatory agents (paras. 69, 169). Additionally, other types of bonds are known in the art (“a bioactive agent can be linked to any of the polymers of structures (I)-(VI) through an amide, ester, ether, amino, ketone,” par. 119; “those skilled in the art can select suitably functional starting materials that can be derived from a residue of a compound of formula (I)-(VI) and from a given residue of a bioactive agent using procedures that are known in the art,” par. 141).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify McCanless in view of Zou and Feldman such that the anti-inflammatory agent is immobilized via ester or amide bonds. In combining McCanless and Zou, one would be motivated to find ways to bind Zou’s anti-inflammatory agents to the membrane because McCanless suggests cross-linking of an agent with the membrane via hydrolysable bonds (“a film or layer of antimicrobial applied to a surface by any means including…crosslinking, graft polymer linking, and the like of the surface and the antimicrobial…Carriers may be used that, when applied to a surface, can themselves be degradable and allow a slow-release (e.g., upon water exposure…of an antimicrobial,” par. 114). Forming ester or amide bonds would be obvious to try because such bonds were already known in the art to link a bioactive agent and polymer, as taught by Carpenter paragraphs 119-120, 141-143. The results of this modification would be predictable because McCanless, Zou and Carpenter teach similar agents and polymers (polyurethanes, polyethylene glycol, polyacrylates disclosed in McCanless paragraphs 69-71, 116, and 121, Zou paragraphs 82 and 147 and Carpenter paragraphs 83, 121; dexamethasone and heparin disclosed in Zou paragraphs 308, 314 and Carpenter paragraphs 69, 182). It is further noted that Applicant discloses similar reactions between these functional groups, thus providing additional evidence that the same reactions would occur in the combination of McCanless, Zou, Feldman, and Carpenter (Specification paras. 362-384).
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over McCanless in view of Zou and Feldman, as applied to claim 1 above, and further in view of US 2008/0135408, cited previously hereinafter Sjolander.
McCanless in view of Zou and Feldman teaches an analyte sensor with a length of less than 20 mm and more specifically in the range of 1-7 mm (McCanless par. 60), but neither McCanless, Zou, nor Feldman explicitly teach or suggest the polymer composition has an area of about 0.01 mm2 to about 3.0 mm2. Sjolander teaches an analogous transcutaneous analyte sensor with narrow widths ranging from 0.2-0.8 mm (Figs. 1a, 1b, 3; par. 104).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to configure the analyte sensor of McCanless in view of Zou and Feldman to have a width between 0.2-0.8mm, as taught by Sjolander. One would be motivated to do so because Sjolander teaches minimizing sensor width reduces tissue damage and pain (“it is important to minimize the width (a) to avoid or minimize tissue damage, possible formation of scar tissue, and/or unacceptable pain during insertion into the skin of a user,” par. 104). The result of this modification should be predictable because both McCanless and Sjolander teach similar layered analyte sensors (McCanless Figs. 2B-2C; Sjolander Fig. 1b). Since the polymer composition is disposed on the surface of a sensor, as shown in McCanless Figs. 2A-2C, the area the polymer composition is disposed on would be in a range of 0.2 mm2 to 5.6 mm2 (using a length of 1-7mm as disclosed by McCanless par. 60 and the width of 0.2-0.8mm disclosed by Sjolander). It is noted that Applicant does not claim an overall surface area of the polymer composition, so an area is interpreted as length*width of the polymer composition.
Claims 10, 44 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over McCanless in view of Zou and Feldman as applied to claim 1 above, and further in view of US 2009/0298104, hereinafter Liu.
Regarding claim 44, McCanless teaches that additional sensing spots may be disposed on the working electrode to measure a second analyte of interest using an analyte specific enzyme (“both single analytes and any combination of the foregoing analytes may be assayed,” par. 36; “sensing element 218 in analyte sensor tails 201 and 202 may comprise multiple spots or a single spot configured for detection of an analyte of interest,” par. 57; “the sensing element(s) may comprise at least an analyte-responsive enzyme,” par. 53). McCanless also suggests additional working electrodes (“one or more working electrode(s),” par. 89) but does not explicitly teach a second working electrode with a second active area responsive to a second analyte, wherein the second active area comprises at least one enzyme responsive to the second analyte.
Liu teaches an analogous biosensor (Figs. 5A-5B) that can monitor more than one analyte at a time (“embodiments that monitor more than one analyte, the analytes may be monitored at the same or different times,” par. 52). Liu further teaches “that greater or fewer electrodes may be provided on a sensor. For example, a sensor may include more than one working electrode,” (par. 71). Liu also teaches that each working electrode includes a sensing layer (“for these analytes, each working electrode includes a sensing layer,” par. 77).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to configure the analyte sensor of McCanless in view of Zou and Feldman to have an additional working electrode with a second active area comprising an enzyme responsive to a second analyte, as taught by Liu paragraphs 52, 71, and 77. One would be motivated to do so because sensing multiple analytes with one sensor is advantageous, as suggested by McCanless and Liu (“any combination of the foregoing analytes may be assayed,” McCanless par. 36; “sensing element 218 in analyte sensor tails 201 and 202 may comprise multiple spots…for detection of an analyte of interest,” McCanless par. 57; “embodiments that monitor more than one analyte, the analytes may be monitored at the same or different times,” Liu par. 52). The result of this modification should be predictable because McCanless already suggests including multiple working electrodes and sensing multiple analytes using respective analyte-responsive enzymes (“sensing element 218 in analyte sensor tails 201 and 202 may comprise multiple spots…configured for detection of an analyte of interest,” par. 57; “the sensing element(s) may comprise at least an analyte-responsive enzyme,” par. 53; “one or more working electrode(s),” par. 89).
Regarding claims 10 and 53, McCanless teaches the sensor may sense a second analyte selected from the group consisting of lactate, oxygen, hemoglobin A1C, ketones, and pH (“an analyte of interest, such as glucose or other analyte (e.g., lactate, oxygen, pH, A1C, ketones, drug levels, toxins, and the like). Both single analytes and any combination of the foregoing analytes may be assayed,” par. 36).
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over McCanless in view of Zou and Feldman as applied to claim 1 above, and further in view of Kuebler (WO 2021/001394, cited by Applicant).
Regarding claim 48, while Zou suggests an anti-inflammatory agent can comprise dexamethasone (par. 315), Zou does not explicitly teach or suggest dexamethasone acetate as an agent. Kuebler teaches an analogous subcutaneously implantable sensor that is inserted via an implantation needle coated with an anti-inflammatory agent (“the subcutaneously insertable element may be…an analyte sensor,” pg. 10, lines 7-8; “covering the implantation needle instead of the subcutaneously insertable element,” pg. 22, lines 19-21). Kuebler teaches that the anti-inflammatory agent to increase the biocompatibility of a subcutaneous sensor can include dexamethasone acetate (pg. 14, lines 14-17).
It would be obvious to one of ordinary skill in the art before the effective filing date of the invention to modify McCanless in view of Zou and Feldman to use dexamethasone acetate as an anti-inflammatory agent in a polymer composition. One would be motivated to do so because various anti-inflammatory agents were known in the art of analyte sensors, and one could have substituted one agent for another to carry out the same purpose. While Kuebler teaches that the coating is on an implantation needle, and the function of the coating on an implantable component is analogous to the sensor of McCanless and Zou (“Usually, the subcutaneously insertable element comprises the pharmaceutical compound such as the anti-inflammatory coating…the anti-inflammatory agent may at least partially remain in the body tissue after insertion of the subcutaneously insertable element and may be configured for reducing a physiological reaction of the subcutaneously insertable element,” Kuebler pg. 22, lines 11-19). Since Zou already teaches various anti-inflammatory agents, including dexamethasone (par. 315), the results of such a substitution should be successful.
Response to Arguments
Applicant's arguments along with the Declaration filed 1/21/26 have been fully considered but they are not persuasive.
Applicant argues that there is no teaching/suggestion of 0.1 to 20 µg … Examiner submits that since McCanless did not provide the specific details of the membrane or sensor construction, an ordinary artisan would have looked within the art to find suitable means as discussed above. Consequently, Feldman is used to supply membrane mass/sensing area teachings to convert Zou’s wt% loading into µg as discussed above. The disclosed wt% band still provides finite endpoints, and once membrane mass is known, the corresponding µg values are calculable to result in an effective membrane/sensor. Accordingly, the teachings result in the 2-114 µg which renders the claimed 0.1 to 20 µg obvious [MPEP 2144].
Applicant argues about improper hindsight reconstruction. As discussed above, examiner submits that an ordinary artisan would be motivated to look within the art to import existing membrane/sensor construction that is known to result in an effective membrane/sensor instead of expending resources/time to find similar constructions.
Applicant argues about unexpected results with a Declaration. The Declaration under 37 CFR 1.132 is insufficient to overcome the rejection of claims based upon McCanless in view of Zou and Feldman as set forth in the last Office action because of the following. It is not apparent from the data that the only intended variable was dexamethasone amount – e.g., the polymer chemistry, membrane mass, electrodes, adhesives, sterilization, handling, and subject handling should be identical across comparative groups. If anything else varied, perhaps present data showing that the variation did not produce the outcome. Additionally, the “85% reduction” should be tied to statistically significant results [e.g., p-values] and a statement of statistical significance. Furthermore, the claim covers 0.1 µg–20 µg: however, the data indicates benefit down to 0.35 µg — is there any data that shows the effect is consistently shown across the entire claimed interval (0.1–20 µg)?
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. “Moussy”, US Publication 20030099682, discloses dexamethasone as a representative tissue response modifier and its local delivery by polymer systems to improve implant lifetime.
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/TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791
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