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 .
Response to Amendment
This is an office action in response to applicant’s arguments and remarks filed on February 12, 2026. Claims 1-16 are pending in the application and are being examined herein.
Status of Objections and Rejections
The objection to claim 14 is maintained.
All other objections to the claims are withdrawn in view of Applicant’s amendment.
New objections to the claims are necessitated by the amendments.
All rejections from the previous office action are withdrawn in view of Applicant’s amendment.
New grounds of rejection under nonstatutory double patenting and 35 U.S.C. 103 are necessitated by the amendments.
Claim Objections
Claim 1 is objected to because of the following informalities: in line 8, “the total area” should read “a total area”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: in lines 14-15, “the total area of the holes has a size having a total area of at most” should read “a total area of the holes has a size of at most”. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: in line 1, “an analyte sensor according to claim 1” should read “the analyte sensor according to claim 1”. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of copending Application No. 18/415,736 in view of Tonks et al. (US 2014/0178909 A1). Claim 9 of copending Application No. 18/415,736 requires all of the limitations of instant claim 1 except for an enzyme and a hydrophobic polymer.
Tonks teaches a device for providing accurate measurement of a property of a sample such as a concentration of an analyte which may be glucose (Tonks, abstract, para. [0004], [0012]). Tonks teaches that a sensing layer including an analyte specific enzyme that reacts with the analyte to generate an analyte concentration dependent signal is disposed on the working electrode (Tonks, para. [0087], [0097]). Tonks teaches that insulative layers of the sensor may be made of a flexible polymer such as thermoplastic polyurethane (Tonks, para. [0091]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first electrode of copending Application No. 18/415,736 to include an analyte specific enzyme as taught by Tonks in order to yield the predictable result of generating an analyte concentration dependent signal. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A).
It also would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the material of the at least one protective layer of copending Application No. 18/415,736 with thermoplastic polyurethane as taught by Tonks in order to yield the predictable result of an insulative layer covering the at least one second electrode. Simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. V. Teleflex Inc., 127 S. Ct. 1727, 82 U.S.P.Q.2d 1385 (2007); MPEP § 2143(I)(B). Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07. As evidenced by Applicant's instant specification, a hydrophobic polymer includes a thermoplastic polyurethane (see para. [0091], [0096]-[0097] of the instant US PGPub), so the thermoplastic polyurethane is a hydrophobic polymer.
Furthermore, the at least one protective layer comprising at least one opening having a total area of at most 0.15 mm2 of claim 9 of copending Application No. 18/415,736 is inherently capable of selectively allowing one or more molecules or compounds to pass through the at least one protective layer and restricting passage of one or more other molecules or compounds.
This is a provisional nonstatutory double patenting rejection.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of copending Application No. 18/442,749 in view of Simpson et al. (US 2006/0257995 A1). Claim 9 of copending Application No. 18/442,749 requires all of the limitations of instant claim 1 except for an enzyme and the holes having a total area of at most 0.15 mm².
Simpson teaches an analyte sensor for implantation into a host (Simpson, para. [0002]). Simpson teaches a glucose oxidase enzyme situated at the surface of the working electrode 100 that catalyzes oxidation to detect the glucose analyte (Simpson, Figs. 6B-6C, para. [0170]). Simpson teaches a reference electrode 104 comprising silver/silver chloride (Simpson, Fig. 6B, para. [0165]), and the reference electrode 104 is separated from tissue surrounding the implant by a non-conductive layer 112 that may be formed from polyurethane (Simpson, Fig. 6B, para. [0163]-[0164]). Simpson teaches that a plurality of pores/openings 114/115 are formed on the non-conductive layer 112 and extend therethrough to the reference electrode 104 (Simpson, Figs. 6A-6B, para. [0162]-[0163], [0167], [0169]). Simpson teaches that a substantial number of the pores are not less than 20 microns in the shortest dimension (Simpson, Figs. 6A-6B, para. [0168]). Simpson teaches wherein the size and distribution of the pores (and thus the total area of the pores) are result-effective variables. Specifically, Simpson teaches that the size of the pores are such that tissue may enter the pores, however the size and distribution of the pores are sufficient to disrupt the continuity of cells growing within the pores, thus preventing formation of a barrier cell layer on the interior surface of the pores (Simpson, Figs. 6A-6B, para. [0167]). Since these particular parameters are recognized as result-effective variables, i.e. a variable which achieves a recognized result, the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See In re Boesch, 617 F. 2d 272, 205 U.S.P.Q. 215 (C.C.P.A. 1980).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the working electrode of copending Application No. 18/442,749 to include a glucose oxidase enzyme as taught by Simpson in order to yield the predictable result of catalyzing oxidation to detect the glucose analyte. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A).
It would have also been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the size and distribution of the holes in the protective layer of copending Application No. 18/442,749 such that the total area of the holes has a size of at most 0.15 mm2 through routine experimentation because doing so would yield the predictable desired tissue entering the pores while sufficiently disrupting the continuity of cells growing within the pores, thus preventing formation of a barrier cell layer on the interior surface of the pores (Simpson, Figs. 6A-6B, para. [0167]). MPEP § 2144.05(II).
Furthermore, the protective layer comprising the at least one hole having a total area of at most 0.15 mm2 of claim 9 of copending Application No. 18/442,749 is inherently capable of selectively allowing one or more molecules or compounds to pass through the protective layer and restricting passage of one or more other molecules or compounds.
This is a provisional nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 and 7-16 are rejected under 35 U.S.C. 103 as being unpatentable over Hoss et al. (US 2010/0230285 A1) in view of Tonks et al. (US 2014/0178909 A1) and further in view of Simpson et al. (US 2006/0257995 A1), as evidenced by Applicant’s specification with respect to claims 1, 7, 9, and 11, and as evidenced by Angreen, Comprehensive Analysis of TPU Melting Point and Glass Transition Temperature (2024) (hereinafter “Angreen”) with respect to claim 8.
Regarding claim 1, Hoss teaches an analyte sensor (an implantable analyte sensor 900, Hoss, Figs. 9A-9C, para. [0106]), comprising:
a substrate having first and second sides (a substrate 902 having a top side and a bottom side, Hoss, Figs. 9A-9C, para. [0107]);
a working electrode positioned on the first side of the substrate, the working electrode comprising an electrically conductive material and an enzyme (a sensing layer 906 disposed over a top conductive layer 904a to form a working electrode on the top side of the substrate 902, Hoss, Figs. 9A & 9C, para. [0108]-[0109]; the sensing layer of the working electrode comprises an enzyme, Hoss, para. [0067], [0074], [0087]);
a second electrode positioned on the second side of the substrate, the second electrode comprising silver (a reference electrode provided on the bottom side of the substrate 902, the reference electrode comprising a secondary conductive Ag/AgCl layer 910 disposed over a bottom conductive layer 904b, Hoss, Figs. 9B-9C, para. [0112]);
a membrane, wherein the membrane is located on top of the second electrode (an insulation/dielectric layer 908b covering the secondary conductive Ag/AgCl layer 910 and the bottom conductive layer 904b, Hoss, Figs. 9B-9C, para. [0113]). Hoss is silent with respect to the material of the insulation/dielectric layer 908b, and therefore fails to teach that the membrane comprises a hydrophobic polymer.
Tonks teaches a device for providing accurate measurement of a property of a sample such as a concentration of an analyte which may be glucose (Tonks, abstract, para. [0004], [0012]). Tonks teaches that insulative layers of the sensor may be made of a flexible polymer such as thermoplastic polyurethane (Tonks, para. [0091]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the material of the insulation/dielectric layer of Hoss with thermoplastic polyurethane as taught by Tonks in order to yield the predictable result of an insulative layer covering the secondary conductive Ag/AgCl layer. Simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 82 U.S.P.Q.2d 1385 (2007); MPEP § 2143(I)(B). Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07. As evidenced by Applicant's instant specification, a hydrophobic polymer includes a thermoplastic polyurethane (see para. [0091], [0096]-[0097] of the instant US PGPub), so the thermoplastic polyurethane of Modified Hoss is a hydrophobic polymer.
Modified Hoss teaches the insulation layer 908b covering the secondary conductive Ag/AgCl layer 910 (Hoss, Figs. 9B-9C, para. [0113]), and that the secondary conductive Ag/AgCl layer has portions that are not covered by the insulation layer and are exposed to the in vivo environment when in operative use (Hoss, para. [0114]). Modified Hoss fails to wherein the membrane comprises holes and the total area of the holes has a size of at most 0.15 mm2.
Simpson teaches an analyte sensor for implantation into a host (Simpson, para. [0002]). Simpson teaches a reference electrode 104 comprising silver/silver chloride (Simpson, Fig. 6B, para. [0165]), and the reference electrode 104 is separated from tissue surrounding the implant by a non-conductive layer 112 that may be formed from polyurethane (Simpson, Fig. 6B, para. [0163]-[0164]). Simpson teaches that a plurality of pores/openings 114/115 are formed on the non-conductive layer 112 and extend therethrough to the reference electrode 104 (Simpson, Figs. 6A-6B, para. [0162]-[0163], [0167], [0169]). Simpson teaches that a substantial number of the pores are not less than 20 microns in the shortest dimension (Simpson, Figs. 6A-6B, para. [0168]). Simpson teaches wherein the size and distribution of the pores (and thus the total area of the pores) are result-effective variables. Specifically, Simpson teaches that the size of the pores are such that tissue may enter the pores, however the size and distribution of the pores are sufficient to disrupt the continuity of cells growing within the pores, thus preventing formation of a barrier cell layer on the interior surface of the pores (Simpson, Figs. 6A-6B, para. [0167]). Since these particular parameters are recognized as result-effective variables, i.e. a variable which achieves a recognized result, the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See In re Boesch, 617 F. 2d 272, 205 U.S.P.Q. 215 (C.C.P.A. 1980).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the insulation/dielectric layer 908b of Modified Hoss to have openings/pores as taught by Simpson in order to yield the predictable result of exposing portions of the secondary conductive Ag/AgCl layer to the in vivo environment when in operative use. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A). It would have also been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the size and distribution of the pores in the insulation/dielectric layer 908b of Modified Hoss such that the total area of the holes has a size of at most 0.15 mm2 through routine experimentation because doing so would yield the predictable desired tissue entering the pores while sufficiently disrupting the continuity of cells growing within the pores, thus preventing formation of a barrier cell layer on the interior surface of the pores (Simpson, Figs. 6A-6B, para. [0167]). MPEP § 2144.05(II).
The limitation “selectively allows one or more molecules or compounds to pass through the membrane and restricts passage of one or more other molecules or compounds” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The insulation/dielectric layer 908b comprising pores with a total area of at most 0.15 mm2 as disclosed by Modified Hoss teaches all of the structural limitations of the claim and thus is configured for and capable of selectively allowing one or more molecules or compounds to pass through the insulation/dielectric layer 908b and restricting passage of one or more other molecules or compounds. For example, molecules or compounds smaller than the pores can pass through, while other molecules or compounds larger than the pores are prevented from passing through.
Regarding claim 2, Modified Hoss teaches wherein the analyte sensor is an implantable sensor (the implantable analyte sensor 900, Hoss, Figs. 9A-9C, para. [0106]).
Examiner further notes that the limitation "implantable" is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The implantable analyte sensor disclosed by Modified Hoss teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use language as recited in the rejection supra.
Regarding claim 3, Modified Hoss teaches wherein the second electrode is selected from the group consisting of a counter electrode, a reference electrode and a combined counter/reference electrode (the reference electrode comprising the secondary conductive Ag/AgCl layer 910 disposed over the bottom conductive layer 904b, Hoss, Figs. 9B-9C, para. [0112]).
Regarding claim 4, Modified Hoss teaches wherein the first and second sides of the substrate are positioned opposite each other (the top and bottom sides of the substrate 902 are positioned opposite each other, Hoss, Figs. 9A-9C, para. [0107]).
Regarding claim 5, Modified Hoss teaches wherein the second electrode comprises Ag/AgCl (the reference electrode comprises the secondary conductive Ag/AgCl layer 910, Hoss, Figs. 9B-9C, para. [0112]).
Regarding claim 7, Modified Hoss teaches wherein the hydrophobic polymer comprises a hydrophobic thermoplastic polyurethane (the thermoplastic polyurethane insulation layer 908b, Hoss, Figs. 9B-9C, para. [0113], Tonks, para. [0091], see modification supra). As evidenced by Applicant's instant specification, a hydrophobic polymer includes a thermoplastic polyurethane (see para. [0091], [0096]-[0097] of the instant US PGPub), so the thermoplastic polyurethane of Modified Hoss is a hydrophobic polymer.
Regarding claim 8, Modified Hoss teaches wherein the hydrophobic polymer has a glass transition temperature in the range from -100°C to 0°C (the thermoplastic polyurethane insulation layer 908b, Hoss, Figs. 9B-9C, para. [0113], Tonks, para. [0091], see modification supra). As evidenced by Angreen, thermoplastic polyurethane has a glass transition temperature ranging from -50°C to -30°C (Angreen, pg. 1).
Regarding claim 9, Modified Hoss teaches wherein the hydrophobic polymer has a water uptake of less than 1% by weight based on the total weight of the hydrophobic polymer (the thermoplastic polyurethane insulation layer 908b, Hoss, Figs. 9B-9C, para. [0113], Tonks, para. [0091], see modification supra). As evidenced by Applicant's instant specification, the hydrophobic polymer is a hydrophobic thermoplastic polyurethane, and has a water uptake of less than 1% by weight based on the total weight of the thermoplastic hydrophobic polymer (see para. [0089]-[0091], [0096]-[0097] of the instant US PGPub).
Examiner further notes that the limitation "a water uptake of less than 1% by weight" is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The thermoplastic polyurethane disclosed by Modified Hoss teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use language as recited in the rejection supra.
Regarding claim 10, Modified Hoss teaches wherein the working electrode is free of the membrane (the working electrode comprising the sensing layer 906 and the top conductive layer 904a on the top side of the substrate 902 is free of the insulation layer 908b, Hoss, Figs. 9A & 9C, para. [0108]-[0109], [0113]).
Regarding claim 11, Hoss teaches a method for manufacturing an analyte sensor (a sensor fabrication process, Hoss, Figs. 9A-9C, para. [0119]-[0120]), the method comprising:
a) providing a raw substrate having a first side and a second side (a continuous film or web of substrate material is provided, and the substrate web has a top side and a bottom side, Hoss, Figs. 9A-9C, para. [0120]);
b) preparing a working electrode region on the first side of the raw substrate (a sensing layer 906 is formed on a primary top conductive layer 904a to form a working electrode on the top side of the substrate web, Hoss, Figs. 9A & 9C, para. [0122]), the preparing of the working electrode region comprising:
b1) applying an electrically conductive material to the first side of the raw substrate (the primary top conductive layer 904a is provided on the top side of the substrate web, Hoss, Figs. 9A & 9C, para. [0120]-[0121]),
b2) applying a sensing material comprising at least one enzyme at least partially on the electrically conductive material (the sensing layer 906 including an enzyme is formed on the primary top conductive layer 904a, Hoss, Figs. 9A & 9C, para. [0067], [0074], [0087], [0108]-[0109], [0122]);
c) preparing a second electrode region on the second side of the raw substrate (a reference electrode is provided on the bottom side of the substrate web, the reference electrode comprising a secondary conductive Ag/AgCl layer 910 disposed over a primary bottom conductive layer 904b, Hoss, Figs. 9B-9C, para. [0112], [0122]), the preparing of the second electrode region comprising:
c1) applying a silver composition on the second side of the raw substrate (the secondary conductive Ag/AgCl layer 910 is applied on the primary bottom conductive layer 904b on the bottom side of the substrate web, Hoss, Figs. 9B-9C, para. [0122]),
d) applying a composition on top of the second electrode region to obtain a membrane (an insulation/dielectric layer 908b is formed to cover the secondary conductive Ag/AgCl layer 910 and the bottom conductive layer 904b, Hoss, Figs. 9B-9C, para. [0113]-[0114], [0124]).
Hoss is silent with respect to the material of the insulation/dielectric layer 908b, and therefore fails to teach that the composition is a hydrophobic polymer composition.
Tonks teaches a device for providing accurate measurement of a property of a sample such as a concentration of an analyte which may be glucose (Tonks, abstract, para. [0004], [0012]). Tonks teaches that insulative layers of the sensor may be made of a flexible polymer such as thermoplastic polyurethane (Tonks, para. [0091]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the material of the insulation/dielectric layer of Hoss with thermoplastic polyurethane as taught by Tonks in order to yield the predictable result of an insulative layer covering the secondary conductive Ag/AgCl layer. Simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. V. Teleflex Inc., 127 S. Ct. 1727, 82 U.S.P.Q.2d 1385 (2007); MPEP § 2143(I)(B). Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07. As evidenced by Applicant's instant specification, a hydrophobic polymer includes a thermoplastic polyurethane (see para. [0091], [0096]-[0097] of the instant US PGPub), so the thermoplastic polyurethane of Modified Hoss is a hydrophobic polymer.
Modified Hoss teaches the insulation layer 908b covering the secondary conductive Ag/AgCl layer 910 (Hoss, Figs. 9B-9C, para. [0113]), and that the secondary conductive Ag/AgCl layer has portions that are not covered by the insulation layer and are exposed to the in vivo environment when in operative use (Hoss, para. [0114]). Modified Hoss fails to wherein the membrane comprises holes and the total area of the holes has a size having a total area of at most 0.15 mm2.
Simpson teaches an analyte sensor for implantation into a host (Simpson, para. [0002]). Simpson teaches a reference electrode 104 comprising silver/silver chloride (Simpson, Fig. 6B, para. [0165]), and the reference electrode 104 is separated from tissue surrounding the implant by a non-conductive layer 112 that may be formed from polyurethane (Simpson, Fig. 6B, para. [0163]-[0164]). Simpson teaches that a plurality of pores/openings 114/115 are formed on the non-conductive layer 112 and extend therethrough to the reference electrode 104 (Simpson, Figs. 6A-6B, para. [0162]-[0163], [0167], [0169]). Simpson teaches that a substantial number of the pores are not less than 20 microns in the shortest dimension (Simpson, Figs. 6A-6B, para. [0168]). Simpson teaches wherein the size and distribution of the pores (and thus the total area of the pores) are result-effective variables. Specifically, Simpson teaches that the size of the pores are such that tissue may enter the pores, however the size and distribution of the pores are sufficient to disrupt the continuity of cells growing within the pores, thus preventing formation of a barrier cell layer on the interior surface of the pores (Simpson, Figs. 6A-6B, para. [0167]). Since these particular parameters are recognized as result-effective variables, i.e. a variable which achieves a recognized result, the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See In re Boesch, 617 F. 2d 272, 205 U.S.P.Q. 215 (C.C.P.A. 1980).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the insulation/dielectric layer 908b of Modified Hoss to have openings/pores as taught by Simpson in order to yield the predictable result of exposing portions of the secondary conductive Ag/AgCl layer to the in vivo environment when in operative use. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A). It would have also been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the size and distribution of the pores in the insulation/dielectric layer 908b of Modified Hoss such that the total area of the holes has a size of at most 0.15 mm2 through routine experimentation because doing so would yield the predictable desired tissue entering the pores while sufficiently disrupting the continuity of cells growing within the pores, thus preventing formation of a barrier cell layer on the interior surface of the pores (Simpson, Figs. 6A-6B, para. [0167]). MPEP § 2144.05(II).
In method claims, it is the overall method steps that are given patentable weight and not the intended result thereof because the intended result does not materially alter the overall method. In method claims, the intended result is not given patentable weight when it simply expresses the intended result of a process step positively recited. MPEP § 2111.04. The limitation “wherein the membrane selectively allows one or more molecules or compounds to pass through the membrane and restricts passage of one or more other molecules or compounds” is an intended result of a positively recited step, and does not further limit the method or steps. The court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). MPEP 2111.04(I). In this case, the insulation/dielectric layer 908b comprising pores with a total area of at most 0.15 mm2 as disclosed by Modified Hoss teaches the claimed structure, materials, and steps of claim 11 (see rejection supra) and thus is expected to predictably yield the same intended result as claimed. For example, molecules or compounds smaller than the pores can pass through, while other molecules or compounds larger than the pores are prevented from passing through.
Modified Hoss teaches e) cutting the raw substrate comprising the working electrode region, the second electrode region and the membrane to obtain the analyte sensor (the template of the substrate material as well as the conductive, sensing, and dielectric materials are cut to obtain the implantable sensors, Hoss, para. [0124]-[0125]).
Regarding claim 12, Modified Hoss teaches wherein the cutting in the step e) comprises laser-cutting (the cutting protocol includes laser singulation, Hoss, para. [0124]).
Regarding claim 13, Modified Hoss teaches the analyte sensor formed by the method according to claim 11 (the implantable analyte sensor 900 formed by the sensor fabrication process, Hoss, Figs. 9A-9C, para. [0106], [0119]-[0120], [0124]-[0125], see rejection of claim 11 supra).
Regarding claim 14, Modified Hoss teaches an analyte sensor system (an analyte monitoring system, Hoss, para. [0057], [0169]), comprising an analyte sensor according to claim 1 (the implantable analyte sensor 900, Hoss, Figs. 9A-9C, para. [0057], [0106], [0169], see rejection of claim 1 supra) and an electronics unit configured to electronically connect to the analyte sensor (an electronics assembly and control unit electrically connected to the implantable analyte sensor, Hoss, para. [0057], [0169]-[0170]. [0183]).
Regarding claim 15, Modified Hoss teaches wherein the total area of the pores in the insulation/dielectric layer 908b has a size of at most 0.15 mm2 (see rejection and modification of claim 1 supra). Modified Hoss fails to teach wherein the total area of the holes has a size in the range of 0.005 to 0.05mm2.
Simpson teaches an analyte sensor for implantation into a host (Simpson, para. [0002]). Simpson teaches a reference electrode 104 comprising silver/silver chloride (Simpson, Fig. 6B, para. [0165]), and the reference electrode 104 is separated from tissue surrounding the implant by a non-conductive layer 112 that may be formed from polyurethane (Simpson, Fig. 6B, para. [0163]-[0164]). Simpson teaches that a plurality of pores/openings 114/115 are formed on the non-conductive layer 112 and extend therethrough to the reference electrode 104 (Simpson, Figs. 6A-6B, para. [0162]-[0163], [0167], [0169]). Simpson teaches that a substantial number of the pores are not less than 20 microns in the shortest dimension (Simpson, Figs. 6A-6B, para. [0168]). Simpson teaches wherein the size and distribution of the pores (and thus the total area of the pores) are result-effective variables. Specifically, Simpson teaches that the size of the pores are such that tissue may enter the pores, however the size and distribution of the pores are sufficient to disrupt the continuity of cells growing within the pores, thus preventing formation of a barrier cell layer on the interior surface of the pores (Simpson, Figs. 6A-6B, para. [0167]). Since these particular parameters are recognized as result-effective variables, i.e. a variable which achieves a recognized result, the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See In re Boesch, 617 F. 2d 272, 205 U.S.P.Q. 215 (C.C.P.A. 1980).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the size and distribution of the pores in the insulation/dielectric layer 908b of Modified Hoss such that the total area of the holes has a size in the range of 0.005 to 0.05mm2 through routine experimentation because doing so would yield the predictable desired tissue entering the pores while sufficiently disrupting the continuity of cells growing within the pores, thus preventing formation of a barrier cell layer on the interior surface of the pores (Simpson, Figs. 6A-6B, para. [0167]). MPEP § 2144.05(II).
Regarding claim 16, Modified Hoss teaches wherein the total area of the pores in the insulation/dielectric layer 908b has a size of at most 0.15 mm2 (see rejection and modification of claim 11 supra). Modified Hoss fails to teach wherein the total area of the holes has a size in the range of 0.005 to 0.05mm2.
Simpson teaches an analyte sensor for implantation into a host (Simpson, para. [0002]). Simpson teaches a reference electrode 104 comprising silver/silver chloride (Simpson, Fig. 6B, para. [0165]), and the reference electrode 104 is separated from tissue surrounding the implant by a non-conductive layer 112 that may be formed from polyurethane (Simpson, Fig. 6B, para. [0163]-[0164]). Simpson teaches that a plurality of pores/openings 114/115 are formed on the non-conductive layer 112 and extend therethrough to the reference electrode 104 (Simpson, Figs. 6A-6B, para. [0162]-[0163], [0167], [0169]). Simpson teaches that a substantial number of the pores are not less than 20 microns in the shortest dimension (Simpson, Figs. 6A-6B, para. [0168]). Simpson teaches wherein the size and distribution of the pores (and thus the total area of the pores) are result-effective variables. Specifically, Simpson teaches that the size of the pores are such that tissue may enter the pores, however the size and distribution of the pores are sufficient to disrupt the continuity of cells growing within the pores, thus preventing formation of a barrier cell layer on the interior surface of the pores (Simpson, Figs. 6A-6B, para. [0167]). Since these particular parameters are recognized as result-effective variables, i.e. a variable which achieves a recognized result, the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See In re Boesch, 617 F. 2d 272, 205 U.S.P.Q. 215 (C.C.P.A. 1980).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the size and distribution of the pores in the insulation/dielectric layer 908b of Modified Hoss such that the total area of the holes has a size in the range of 0.005 to 0.05mm2 through routine experimentation because doing so would yield the predictable desired tissue entering the pores while sufficiently disrupting the continuity of cells growing within the pores, thus preventing formation of a barrier cell layer on the interior surface of the pores (Simpson, Figs. 6A-6B, para. [0167]). MPEP § 2144.05(II).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hoss in view of Tonks and Simpson as applied to claim 5 above, and further in view of Rong et al. (US 2017/0079566 A1).
Regarding claim 6, Modified Hoss teaches AgCl of the second electrode (the reference electrode comprises the secondary conductive Ag/AgCl layer 910, Hoss, Figs. 9B-9C, para. [0112]). Modified Hoss fails to teach wherein a load of AgCl of the second electrode is in the range from 20 µg to 150 µg.
Rong teaches a continuous glucose measurement system including an electrochemical sensor incorporating a silver/silver chloride reference electrode (Rong, abstract). Rong teaches that chloridizing the silver wire enables the manufacture of a reference electrode with optimal in vivo performance (Rong, para. [0213], [0408]). Rong teaches that by controlling the quantity and amount of chloridization of the silver to form silver/silver chloride, improved break-in time, stability of the reference electrode, and extended life has been shown (Rong, para. [0213], [0408]). Rong teaches that the use of silver chloride as described above allows for relatively inexpensive and simple manufacture of the reference electrode (Rong, para. [0213], [0408]). Thus, Rong teaches wherein the amount of chloridization of the silver to form silver/silver chloride (and thus the load of AgCl) is a result-effective variable. Specifically, Rong teaches that the amount of chloridization of the silver to form silver/silver chloride (and thus the load of AgCl) controls the break-in time, stability, and life of the reference electrode. Since these particular parameters are recognized as result-effective variables, i.e. a variable which achieves a recognized result, the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See In re Boesch, 617 F, 2d 272, 205 U.S.P.Q. 215 (C.C.P.A. 1980).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the load of AgCl of the reference electrode of Modified Hoss to be in the range from 20 µg to 150 µg through routine experimentation because doing so would yield the predictable desired break-in time, stability, and life of the reference electrode.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot in light of new grounds of rejection. Prior art Hoss in view of Simpson is now relied on for the feature of wherein the membrane comprises holes and the total area of the holes has a size of at most 0.15 mm2, and wherein the membrane selectively allows one or more molecules or compounds to pass through the membrane and restricts passage of one or more other molecules or compounds as rejected in the rejection and modification supra.
Applicant's arguments filed February 12, 2026 have been fully considered but they are not persuasive.
In the arguments presented on pages 5 and 7 of the amendment, Applicant argues that the instant invention inhibits silver cations and silver chloride from escaping from the second electrode on the second side of the substrate.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., inhibits silver cations and silver chloride from escaping from the second side of the substrate) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In the arguments presented on pages 7-8 of the amendment, Applicant argues that the claimed range “the total area of the holes has a size of at most 0.15 mm2” is critical. Applicant points to instant Fig. 1 and para. [0168]-[0172] of the as-filed specification which discloses that sensor 2 having a total area of holes of 0.03 mm2 is superior and demonstrates a sufficiently high current which remains constant through the entire measurement time. Applicant asserts that sensor 2 is particularly reliable and stable even over a longer time period compared to the other sensors. Applicant asserts that the measurement from sensor 3 (0.1 mm2) also demonstrates comparable reliability and stability with sensor 2 after the run-in time passed. Applicant asserts that new dependent claims 15-16 more narrowly recite the range (0.005 to 0.05 mm2) in which the surprising and superior results are achieved.
Examiner respectfully disagrees. Applicant has not established criticality of the claimed range in claims 1 and 15-16. Fig. 1 and para. [0168] of the instant as-filed specification do not show any results at the end points of the claimed ranges. There is only one test (0.32 mm2) outside of the range in claim 1, and there is no data between 0.1 mm2 to 0.32 mm2, so there is no evidence that 0.15 mm2 in claim 1 is critical. Also, there is only one test (0.03 mm2) inside the range of claims 15-16 and no other tests near or at the end points of the claimed range. To establish unexpected results over a claimed range, applicant should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). The burden is on applicant to establish that results are unexpected and significant. See MPEP § 716.02. Applicant has not shown that the claimed ranges produce unexpected results. As discussed in the rejection supra, Simpson teaches wherein the size and distribution of the pores (and thus the total area of the pores) are result-effective variables. Since the general conditions of the claim are disclosed in the prior art of record, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/V.T./ Examiner, Art Unit 1794
/JAMES LIN/ Supervisory Patent Examiner, Art Unit 1794
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