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 December 30, 2025. Claims 1-17 are pending in the application and are being examined herein.
Status of Objections and Rejections
The objection to claim 10 is maintained and modified as necessitated by the amendments.
All other objections to the claims are withdrawn in view of Applicant’s amendment.
The rejection of claim 13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is maintained.
All other rejections from the previous office action are withdrawn in view of Applicant’s amendments and remarks.
New grounds of rejection under 35 U.S.C. 103 are necessitated. Particularly, a different embodiment of Hoss is now relied on for the modification in claim 1.
Claim Objections
Claim 10 is objected to because of the following informalities: in line 11, “form at least one opening” should read “form the at least one opening”. 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.
Claim 13 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.
Claim 13 recites the limitation "the length of each of the multiple fields" in lines 2-3 of the claim. There is insufficient antecedent basis for “the length” and “the multiple fields” in the claim.
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 1-8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hoss et al. (US 2010/0230285 A1).
Regarding claim 1, Hoss teaches an analyte sensor for determining at least one analyte (an implantable analyte sensor 900, Figs. 9A-9C, para. [0106]), the analyte sensor comprising:
a substrate comprising at least one first conductive material and at least one second conductive material (a substrate 902 having a top conductive layer 904a and a bottom conductive layer 904b, Figs. 9A-9C, para. [0107]),
at least one first electrode which is located on the at least one first conductive material (a sensing component 906 disposed over the top conductive layer 904a to form an active area of a working electrode, Figs. 9A & 9C, para. [0109]),
at least one second electrode which is located on the at least one second conductive material, the at least one second electrode comprising silver and having a width and a length (a secondary conductive Ag/AgCl layer 910 disposed over the bottom conductive layer 904b to collectively form a reference electrode, Figs. 9B-9C, para. [0112]; the secondary conductive Ag/AgCl layer 910 has a width and a length),
at least one protective layer covering the at least one second electrode (an insulation/dielectric layer 908b covering the secondary conductive Ag/AgCl layer 910, Figs. 9B-9C, para. [0113]), the at least one protective layer having a length greater than the length of the at least one second electrode (the insulation/dielectric layer 908b has a length greater than the length of the secondary conductive Ag/AgCl layer 910 in the left-right direction of Figs. 9B-9C, para. [0112]-[0113]). Drawings and pictures can anticipate claims if they clearly show the structure which is claimed. In re Mraz, 455 F.2d 1069, 173 USPQ 25 (CCPA 1972). See MPEP § 2125(I).
Hoss teaches that the secondary conductive Ag/AgCl layer 910 is provided in a continuous stripe/band between and substantially orthogonal to the substrate's side edges 914a, 914b (Fig. 9B, para. [0112]), and the secondary conductive Ag/AgCl layer 910 appears to have the same width as the insulation/dielectric layer 908b in the up-down direction of Fig. 9B. This embodiment of Hoss fails to teach wherein the at least one protective layer has a width greater than the width of the at least one second electrode.
However, Hoss teaches other embodiments where the working electrode 504/506 (Figs. 5A-5B) and the working electrode 804/806 (Figs. 8A-8B) are smaller in width than the respective insulation/dielectric layers 508/808 (para. [0088]-[0092], [0102]). Hoss also teaches that the same materials and methods may be used to fabricate the top (working) and bottom (reference) electrodes (para. [0110]).
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 width of the reference electrode (both the secondary conductive Ag/AgCl layer 910 and the bottom conductive layer 904b) to be less than the width of the insulation/dielectric layer 908b as taught by other embodiments of Hoss in order to yield the predictable result of forming the reference electrode of the sensor. Furthermore, the Federal Circuit has held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). MPEP § 2144.04(IV)(A).
Modified Hoss teaches the insulation/dielectric layer 908b covering the secondary conductive Ag/AgCl layer 910 (Figs. 9B-9C, para. [0113]). Modified Hoss fails to teach wherein the at least one protective layer comprises at least one opening, wherein the at least one opening is designed to provide access to the at least one second electrode for the at least one analyte.
However, Hoss teaches that the secondary conductive Ag/AgCl layer has a portion that is not covered by the insulation/dielectric layer and is exposed to the in vivo environment when in operative use (para. [0114]). Hoss teaches another embodiment wherein an insulating coverlay material 118 covers the electrodes 121a, 121b, 121c which includes the Ag/AgCl reference electrode 121c (Figs. 3A-3B, para. [0076]-[0077]). Hoss teaches that openings 120 may be created in the insulating coverlay material 118 to expose one or more of the electrodes 121a, 121b, 121c (Figs. 3A-3B, para. [0078]).
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 include an opening as taught by another embodiment of Hoss in order to yield the predictable result of exposing the secondary conductive Ag/AgCl layer 910 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).
Regarding claim 2, Modified Hoss teaches wherein the substrate comprises a first side and a second side and wherein the at least one first conductive material is located on the first side of the substrate and the at least one second conductive material is located on the second side of the substrate (the substrate 902 having the top conductive layer 904a which is disposed on the top side of the substrate 902 and the bottom conductive layer 904b which is disposed on the bottom side of the substrate 902, Figs. 9A-9C, para. [0107]).
Regarding claim 3, Modified Hoss teaches wherein the substrate has a width and wherein the width of the at least one second electrode is smaller than the width of the substrate (the width of the secondary conductive Ag/AgCl layer 910 is less than the width of the substrate 902 since the width of the substrate 902 is the same as the width of the insulation/dielectric layer 908b, see modification supra).
Regarding claim 4, Modified Hoss teaches wherein the at least one first electrode is at least one working electrode (the sensing component 906 disposed over the top conductive layer 904a defines the active area of the working electrode, Figs. 9A & 9C, para. [0109]).
Regarding claim 5, Modified Hoss teaches wherein the at least one second electrode is selected from the group consisting of a counter electrode, a reference electrode and a combined counter/reference electrode (the secondary conductive Ag/AgCl layer 910 disposed over the bottom conductive layer 904b collectively form the reference electrode, Figs. 9B-9C, para. [0112]).
Regarding claim 6, Modified Hoss teaches wherein the at least one second electrode comprises elemental Ag, AgCl or Ag/AgCl (the secondary conductive Ag/AgCl layer 910, Figs. 9B-9C, para. [0112]).
Regarding claim 7, Modified Hoss teaches wherein the at least one protective layer does not cover the at least one first electrode (the insulation/dielectric layer 908b does not cover the sensing component 906, Fig. 9C, para. [0113]). Drawings and pictures can anticipate claims if they clearly show the structure which is claimed. In re Mraz, 455 F.2d 1069, 173 USPQ 25 (CCPA 1972). See MPEP § 2125(I).
Regarding claim 8, Modified Hoss teaches the insulation/dielectric layer 908b covering the secondary conductive Ag/AgCl layer 910 (Figs. 9B-9C, para. [0113]). Modified Hoss is silent with respect to the material of the insulation/dielectric layer 908b, and therefore fails to teach wherein the at least one protective layer comprises at least one polymer selected from the group consisting of polyurethanes, polyureas, polyolefins, poly(meth)acrylates, polyesters, polyethers, polyamides, polyvinylchlorides, polyvinylbutyral-co-vinylalcohol-co-vinylacetate. and UV hardening resins.
However, Hoss teaches another embodiment wherein an insulating coverlay material 118 covers the electrodes 121a, 121b, 121c which includes the Ag/AgCl reference electrode 121c (Figs. 3A-3B, para. [0076]-[0077]). Hoss teaches that the insulating coverlay material 118 may include polyester or polyurethane (Fig. 3B, para. [0077], [0080]).
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 908b of Modified Hoss with polyester or polyurethane as taught by alternative embodiments of Hoss in order to yield the predictable result of an insulating material 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.
Regarding claim 15, Modified Hoss teaches an analyte sensor system (an analyte monitoring system, para. [0057], [0169]) comprising:
the analyte sensor according to claim 1 (the implantable analyte sensor 900, Figs. 9A-9C, para. [0057], [0106], [0169], see rejection of claim 1 supra), and
an electronics unit, the electronics unit being electronically connected to the analyte sensor (an electronics assembly and control unit electrically connected to the implantable analyte sensor, para. [0057], [0169]-[0170], [0183]).
Claims 9-11, 13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Hoss as applied to claim 1 above, and further in view of Say et al. (US 2004/0111017 A1).
Regarding claim 9, Modified Hoss teaches wherein the at least one opening comprises one or more openings (the insulation/dielectric layer 908b includes an opening, see modification supra). Modified Hoss fails to teach wherein the one or more openings have a total area of at most 0.15 mm2.
Say teaches an in vivo electrochemical sensor arranged for implantation into the body of a mammal for contact with body fluids (Say, abstract). Say teaches that the sensor body 501 includes a small hole 552 in the top layer 516 to permit analyte diffusion to the electrode (Say, Fig. 16, para. [0053]). Say teaches that the hole 552 is typically small enough to restrict mass transport of the analyte, in order to eliminate or reduce the need for a mass transport limiting membrane (Say, Fig. 16, para. [0053]). Thus, Say teaches wherein the size (and thus total area) of the hole is a result-effective variable. Specifically, Say teaches that the size (and thus total area) of the hole controls the transport of the analyte. 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 total area of the opening of Modified Hoss to be at most 0.15 mm2 through routine experimentation because doing so would yield the predictable desired transport of the analyte through the insulation/dielectric layer 908b.
Regarding claim 10, Modified Hoss teaches a method for producing the analyte sensor according to claim 1 (the sensor fabrication process, Hoss, para. [0119]-[0120], see rejection of claim 1 supra), the method comprising the steps:
a) providing a raw substrate, the raw substrate comprising the at least one first conductive material and the at least one second conductive material (a continuous film or web of substrate material is provided, and the primary top and bottom conductive layers 904a, 904b are then formed on opposite sides of the substrate web, Hoss, Figs. 9A-9C, para. [0120]-[0121]),
b) preparing the at least one first electrode on the at least one first conductive material (the sensing layer 906 is formed on the primary top conductive layer 904a, Hoss, Figs. 9A & 9C, para. [0122]),
c) applying a silver comprising layer in a manner that it partially covers the at least one second conductive material to obtain the at least one second electrode (the secondary conductive Ag/AgCl layer 910 is applied on and partially covers the primary bottom conductive layer 904b, Hoss, Figs. 9B-9C, para. [0122]),
d) applying the at least one protective layer in a manner that it fully covers the silver comprising layer applied in the step c) (the insulation/dielectric layer 908b is formed to fully cover the secondary conductive Ag/AgCl layer 910, Hoss, Figs. 9B-9C, para. [0113]-[0114], [0124]).
Modified Hoss teaches that the insulation/dielectric layer 908b includes an opening (see modification in claim 1 supra). Modified Hoss fails to teach e) irradiating the at least one protective layer with at least one laser beam to form at least one opening so that the at least one opening is designed to provide access to the at least one second electrode for the at least one analyte.
Say teaches an in vivo electrochemical sensor arranged for implantation into the body of a mammal for contact with body fluids (Say, abstract). Say teaches that the sensor body 501 includes a small hole 552 in the top layer 516 to permit analyte diffusion to the electrode (Say, Fig. 16, para. [0053]). Say teaches that the hole 552 is typically small enough to restrict mass transport of the analyte, in order to eliminate or reduce the need for a mass transport limiting membrane (Say, Fig. 16, para. [0053]). Say teaches that the hole 552 may be formed using a laser (Say, Fig. 16, para. [0053]).
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 sensor fabrication process of Modified Hoss to use a laser to form the opening in the insulation/dielectric layer 908b as taught by Say in order to yield the predictable result of an opening for transport of the analyte therethrough. MPEP § 2143(I)(D).
Modified Hoss teaches f) cutting the raw substrate to obtain the analyte sensor (the template of substrate material is cut to obtain the implantable sensors, Hoss, para. [0124]-[0125]).
Regarding claim 11, Modified Hoss teaches wherein the step b) comprises the step:
b1) applying at least one layer of a sensing material in a manner that it partially covers the at least one first conductive material to obtain the at least one first electrode (the sensing layer 906 is formed on and partially covers the primary top conductive layer 904a, Hoss, Figs. 9A & 9C, para. [0122]).
Regarding claim 13, Modified Hoss teaches wherein the at least one protective layer has the length which is larger than the length of each of the multiple fields of the silver comprising layer (the insulation/dielectric layer 908b has a length which is larger than the length of the secondary conductive Ag/AgCl layer 910 in the left-right direction of Figs. 9B-9C, para. [0112]-[0113]). Drawings and pictures can anticipate claims if they clearly show the structure which is claimed. In re Mraz, 455 F.2d 1069, 173 USPQ 25 (CCPA 1972). See MPEP § 2125(I).
Regarding claim 16, Modified Hoss teaches wherein the method further comprises a step b2) comprising applying at least one layer of a flux limiting membrane polymer in a manner that it fully covers the at least one first electrode (a first membrane layer 916 is provided fully over the sensing layer 906 to modulate the rate of diffusion or flux of the analyte to the sensing layer 906, Hoss, Fig. 9C, para. [0115]).
Claims 12, 14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hoss in view of Say as applied to claim 10 above, and further in view of Burke et al. (US 2005/0013731 A1).
Regarding claim 12, Modified Hoss teaches that the secondary conductive Ag/AgCl layer 910 is applied on and partially covers the primary bottom conductive layer 904b (Hoss, Figs. 9B-9C, para. [0122]), and that the width of the secondary conductive Ag/AgCl layer 910 is smaller than the width of the insulation/dielectric layer 908b (see modification in claim 1 supra). Modified Hoss fails to teach wherein in the step c) the silver comprising layer is applied in the form of multiple fields onto the at least one second conductive material, wherein each of the multiple fields has a width and a length.
Burke teaches a method of mass producing biosensors for testing of analytes in body fluids (Burke, para. [0002], [0016]). Burke teaches that a plurality of separated electrode sets 182 including silver/silver chloride are formed on a web 188 of substrate material, and the web is cut into the plurality of biosensors by cutting through the dashed lines 264 between adjacent electrode sets 182 (Burke, Figs. 7-8 & 13-14, para. [0016]-[0017], [0075], [0204]-[0205], [0215]).
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 sensor fabrication process of Modified Hoss to apply the secondary conductive Ag/AgCl layer in the form of a plurality of separated electrodes as taught by Burke in order to yield the predictable result of mass producing the plurality of biosensors each comprising the Ag/AgCl layer having a smaller width than that of the insulation/dielectric layer 908b. MPEP § 2143(I)(D).
Regarding claim 14, Modified Hoss teaches wherein in the step f) the raw substrate is cut between two of the multiple fields of the silver comprising layer (the template of substrate material is cut between the adjacent separated Ag/AgCl electrodes to obtain the plurality of implantable sensors, Hoss, para. [0124]-[0125], Burke, Figs. 7-8 & 13-14, para. [0016]-[0017], [0075], [0204]-[0205], [0215], see modification supra).
Regarding claim 17, Modified Hoss teaches wherein the multiple fields are separated from one another (the plurality of separated Ag/AgCl electrodes, see modification supra).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot in light of new grounds of rejection. An alternative embodiment of Hoss is now relied on for the feature of the protective layer having a width greater than the width of the at least one second electrode in claim 1 as recited in the rejection and modification supra.
Conclusion
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/V.T./Examiner, Art Unit 1794
/JAMES LIN/Supervisory Patent Examiner, Art Unit 1794
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