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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/11/21, 11/29/22, 02/28/23, 03/31/23, 09/11/23, 11/10/23, 11/28/23, 03/08/24, 10/07/24 and 08/15/25 have been considered by the examiner.
Amendment Entered
In response to the amendment filed on February 2, 2026, amended claims 1 and 14 have been entered.
Response to Arguments
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were fully considered, but they were not persuasive. Applicant argues:
Hoss 2017 does not teach a distal most active spot is located 50 um- 500 um from a tip of the working electrode
Hoss does not teach the sensing portion comprises a plurality of active spots disposed in a 1xN grid along a length of the working electrode, wherein N is an integer between 2 to 20
Applicant argues Hoss 2017 merely teaches a distance between adjacent sensing structures. Applicant further argues the distance between adjacent sensing spots is irrelevant to the distance from any sensing spot and a distal most edge of the working electrode. Examiner notes that although Hoss 2017 teaches the distance between each sensing structure [par. 46], Hoss 2017 also teaches a large range of the number of arrays of sensing spots within a large range of areas [par. 45]. A specific number of sensing spots chosen from the range at a specific distance between each other within a specific area chosen from the range of areas would inherently require the distal most sensing spot to be within 50 um to 500 um from the edge of the electrode. Additionally, as shown in figures 8 and 9 of Hoss 2017, the sensing spot is close to the edge of the working electrode. Examiner notes that since Hoss 2017 provides several potential sensing spot arrays, distances between sensing spots and areas of sensing spots, the required range necessary to meet the limitation of the claim is encompassed by these ranges taught by Hoss 2017. Examiner holds that the specific ratio of sensing spot area to electrode area along with the number of spots taught in Hoss 2017, would not only cause the sensing spots to be spaced apart from each other by the claimed distance, but also cause the sensing spot to be the claimed distance from the tip. If there are a certain number of sensing spots that are a certain size and spaced apart from each other a specific distance on an electrode of a specific size, then once the sensing spots are spaced apart this specific distance on the electrode, the remaining electrode area, meaning the space between the sensing spot and the edge of the electrode, would be within the claimed range. Therefore, this equates to a distal most active spot is located 50 um- 500 um from a tip of the working electrode, when taking into consideration broadest reasonable interpretation.
Applicant argues the claim recites a particular arrangement of sensing spots disposed at a specific distance with respect to the tip of the working electrode and the sensor as a whole that is not disclosed, taught, or suggested in the references relied upon. Specifically, claim 1 recites a configuration of sensor elements that permits a reduction in the exposed sensor area of a working electrode by shifting the sensing area towards the distal tip of the sensor to minimize signals associated with interferents and to place the sensing spots most distally into the bodily fluid when in use. Examiner notes that Hoss does in fact teach the sensing portion comprises a plurality of active spots disposed in a 1xN grid along a length of the working electrode, wherein N is an integer between 2 to 20 [fig. 6; par. 70]. Additionally, the claims do not clearly state that the sensing spots are spaced from the tip of the electrode and arranged in a 1xN configuration to minimize signals associated with interferences and to place the sensing spots most distally into the bodily fluid. Although Examiner agrees a single reference does not teach every limitation of the claim, Examiner has cited multiple references that together teach all the limitations of the claims. Therefore, the teachings of Hoss equate to the sensing portion comprises a plurality of active spots disposed in a 1xN grid along a length of the working electrode, wherein N is an integer between 2 to 20, when taking into consideration broadest reasonable interpretation.
Applicant’s remaining arguments filed with respect to the 103 rejections raised in the previous office action were fully considered, but are moot in view of the current combination of references that were necessitated by amendment. Please see prior art section below for more detail, updated citations (Lin reference), and updated obviousness rationale.
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 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.
Claims 1, 3, 5-7, 9, 10, 12-14, 16, 18-20, 22, 23, 25, 26 are rejected under 35 U.S.C. 103 as being unpatentable over Hoss (U.S. Patent Application Publication 2012/0150005 A1) and in further view of Feldman (U.S. Patent Application Publication 2019/0125230 A1), Lin (U.S. Patent Application Publication 2017/0184584 A1), Hoss 2017 (U.S. Patent Application Publication 2017/0363564 A1) and Brister (U.S. Patent Application Publication 2019/0261907 A1)
Hoss, Feldman, Hoss 2017 and Brister were applied in the previous office action
Regarding claims 1 and 14, Hoss teaches a method for exposing an analyte sensor to a bodily fluid [par. 102] and an analyte sensor comprising: a substrate comprising a top surface and a bottom surface [fig. 11, element 1110; par. 107]; a working electrode [par. 7] disposed on the top surface of the substrate, [fig. 11; element 1140; par. 107] the working electrode having sensing portion [par. 7 “sensing elements”] and an exposed electrode portion [par. 7, Examiner notes the exposed electrode portion is the portion of the electrode in which the sensing portion is not] and at least one additional electrode, the at least one additional electrode comprising a reference electrode, a counter electrode, or both [par. 107], wherein the sensing portion comprises an active area [par. 98] having an analyte- responsive enzyme disposed thereupon [par. 8] and the exposed electrode portion comprises no analyte- responsive enzyme [par. 11, 95], an analyte sensor having a greater ratio of the exposed electrode portion to the sensing portion [fig. 12, element 1250; Examiner notes it is inherent that the exposed electrode portion would be greater than the sensing portion as it is known in the art that this decreases interferents]; wherein the sensing portion comprises a plurality of active spots disposed in a 1xN grid along a length of the working electrode, wherein N is an integer between 2 to 20 [fig. 6; par. 70]; .
Although Hoss does not explicitly teach a ratio of the exposed electrode portion to the sensing portion is in the range of about 1:10 to about 10:1, this would be obvious to a person having ordinary skill in the art when the invention was filed since Hoss also suggests inter-feature areas free of the analyte-responsive enzyme [par. 11]. Additionally, Hoss suggests a range of sizes of the sensing elements and inter-feature areas [par. 87, 88]. Therefore, a sensor comprising a ratio of exposed electrode to sensing portion in the range of 1:10 to 10:1 would involve only routine skill in the art. Furthermore, modifying Hoss such that a ratio of the exposed electrode portion to the sensing portion is in the range of about 1:10 to about 10:1 would have been obvious to person having ordinary skill in the art when the invention was filed since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. It is noted that the applicants’ disclosure does not have any criticality towards the claimed range.
Although Hoss does not explicitly teach the analyte sensor exhibits a reduction in interferent signal of an interferent compared to an analyte sensor having a greater ratio of the exposed electrode portion to the sensing portion, this would be obvious to a person having ordinary skill in the art when the invention was filed since Hoss also suggests inter-feature areas free of the analyte-responsive enzyme [par. 11]. Additionally, Hoss suggests a smaller totally sensing element area per sensor results in lower variation in sensor sensitivity [par. 84]. Furthermore, it is known in the art that having a greater ratio of the exposed portion results in a reduction in interferents.
Therefore, exhibiting a reduction in interferent signal of an interferent compared to an analyte sensor having a greater ratio of the exposed electrode portion to the sensing portion would involve only routine skill in the art.
However, Hoss does not teach wherein the at least one additional electrode is disposed on the bottom surface of the substrate.
Feldman teaches wherein the at least one additional electrode is disposed on the bottom surface of the substrate [fig. 1B, elements 102, 114; par. 37; Examiner notes that although the additional electrode is not directly contacting the substrate, the electrode is still positioned on the bottom of the substrate since the electrode is on an element which is on the bottom surface of the electrode]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Hoss, to incorporate wherein the at least one additional electrode is disposed on the bottom surface of the substrate, as this is a standard configuration of electrodes, as evidence by Feldman [par. 37].
However, Hoss does not teach the sensor is configured to reduce an interferent signal of an interferent at the working electrode relative to a signal associated with an analyte of interest, wherein the analyte sensor exhibits a linear reduction in interferent signal
Lin teaches the sensor is configured to reduce an interferent signal of an interferent at the working electrode relative to a signal associated with an analyte of interest, wherein the analyte sensor exhibits a linear reduction in interferent signal [par. 61]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Hoss, to incorporate the sensor is configured to reduce an interferent signal of an interferent at the working electrode relative to a signal associated with an analyte of interest, wherein the analyte sensor exhibits a linear reduction in interferent signal, for enhancing the signal strength, as evidence by Lin [par. 61].
However, Hoss does not teach distal most active spot is located 50 um to 500 um from a tip of the working electrode.
Hoss 2017 teaches a distance between adjacent sensing structures is in a range of 0.1 um- 250 um [par. 46].
Although Hoss 2017 does not explicitly teach distal most active spot is located 50 um to 500 um from a tip of the working electrode, this would be obvious to a person having ordinary skill in the art when the invention was filed since Hoss 2017 also suggests a distance between adjacent sensing structures is in a range of 0.1 um- 250 um [par. 46]. Examiner notes since Hoss 2017 teaches distances between sensing areas in the range claimed in the present Application, incorporating the distal most active spot being located 50 um to 500 um from a tip of the working electrode would have been obvious to person having ordinary skill in the art when the invention was filed since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. It is noted that the applicants’ disclosure does not have any criticality towards the claimed range.
However, Hoss does not teach the tip of the working electrode is identical to a distal tip of analyte sensor.
Brister teaches the tip of the working electrode is identical to a distal tip of analyte sensor [fig. 9A, 9B, elements E1 and E2; Examiner notes the electrodes make up the tip of the analyte sensor; par. 43].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Hoss, to incorporate the tip of the working electrode is identical to a distal tip of analyte sensor, for positioning the working electrode below the skin, as evidence by Brister [par. 43].
Regarding claims 3 and 16, although Hoss does not explicitly teach the reduction in interferent signal of the interferent is greater than about 20%, this would be obvious to a person having ordinary skill in the art when the invention was filed since Hoss also suggests inter-feature areas free of the analyte-responsive enzyme [par. 11]. Additionally, Hoss suggests a range of sizes of the sensing elements and inter-feature areas [par. 87, 88]. Additionally, Hoss suggests a smaller totally sensing element area per sensor results in lower variation in sensor sensitivity [par. 84]. Therefore, adjusting the ratio of the area of the sensing portion to the area of the exposed electrode for a 20% reduction in interferent signal would involve only routine skill in the art.
Regarding claims 5 and 18, Hoss further teaches the working electrode is a carbon working electrode [par. 131].
Regarding claims 6 and 19, Hoss further teaches an area of the exposed electrode portion is in the range of about 0.1 mm2 to about 5 mm2 [par. 87]
Regarding claims 7 and 20, Hoss further teaches an area of the sensing portion is in the range of about 0.01 mm2 to about 3 mm2 [par. 87].
Regarding claims 9 and 22, Hoss further teaches the active area is comprised of a plurality of discontiguous active areas, and wherein each discontiguous active area has a diameter in the range of about 50 m to about 500 m [par. 88]
Regarding claims 10 and 23, Hoss further teaches the active area is comprised of a plurality of discontiguous active areas separated by a pitch having a distance in the range of about 50 m to about 800 m [par. 88]
Regarding claims 12 and 25, Hoss further teaches a mass transport limiting membrane is disposed upon at least the sensing portion [par. 54 and 57].
Regarding claims 13 and 26, Hoss further teaches the analyte-responsive enzyme is at least one of a glucose-responsive enzyme or a lactate-responsive enzyme [par. 98].
Claims 4 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hoss, Feldman, Lin, Hoss 2017 and Brister and in further view of Boock (U.S. Patent Application Publication 2017/0265795 A1).
Boock was applied in the previous office action
Regarding claims 4 and 17, Hoss, Feldman, Lin, Hoss 2017 and Brister teach a method for exposing an analyte sensor to a bodily fluid, as disclosed above.
However, Hoss, Feldman, Lin, Hoss 2017 and Brister do not teach the interferent is ascorbic acid
Boock teaches the interferent is ascorbic acid [par. 112].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Hoss, Feldman, Lin, Hoss 2017 and Brister, to incorporate the interferent is ascorbic acid, since ascorbic acid is a known interfering species of glucose sensors, as evidence by Boock [par. 112].
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 extension fee 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 date of this final action.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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