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 09/21/22 have been considered by the examiner.
Amendment Entered
In response to the amendment filed on June 8, 2026, amended claims 1-3 and 13 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.
Regarding claim 1, Applicant appears to argue the following:
The apparatus of Roberts is structurally different from the claimed invention." (remarks, pg. 2, 3)
Applicant further argues that the claimed invention requires the measurement steps to be performed while the sensor system is implanted, whereas Roberts discloses an in vitro test strip for external analysis. Examiner notes that while Roberts does teaches external analysis, the system of Roberts cited can be translated to an implantable device. Examiner additionally notes that Ribet is relied on to teach the implantable aspect of the device.
The method of Roberts is different from the claimed invention (remarks, pg. 4, 5)
Applicant further argues that the purpose of the protocol in Roberts is to validate that a fluid sample has been correctly applied and to reject false positives before the primary analyte measurement begins, and that Roberts does not teach “further measuring an output electrical current between the working electrode and the pseudo-reference electrode while applying a second electrical potential, the second electrical potential being greater than the first electrical potential.” Examiner notes that while the method of Roberts is performed for ESD prevention, the steps of Roberts are the same as the steps of the present application. Additionally, Roberts teaches, as shown in fig. 3, that a second voltage is applied that is greater than the first potential. Further, current is measured between the working electrode and the pseudo-reference electrode [col. 6: lines 25-52]. Therefore, this equates to further measuring an output electrical current between the working electrode and the pseudo-reference electrode while applying a second electrical potential, the second electrical potential being greater than the first electrical potential, when taking into consideration broadest reasonable interpretation.
It would not be obvious to combine the teachings of Roberts with those of Ribet (remarks, pg. 5, 6)
Applicant argues that Examiner’s motivation for combining Roberts and Ribet is vague, generic and based on hindsight. Examiner disagrees and notes that a reasoning for incorporating the teachings of Ribet to increase stability of the device is an obvious improvement on Rogers.
Ribet does not teach a method of applying one potential, checking the resulting current against a threshold, and then switching to a different potential based on that check (remarks, pg. 6, 7)
Examiner notes that the Ribet is not relied on for this teahing, and that Roberts instead is relied upon. Therefore, this argument is moot.
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 1-5, 7-8, 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Roberts (U.S. Patent Number 8486245) and in further view of Ribet (U.S. Patent Application Publication 2020/0342985 A1)
Roberts and Ribet were applied in the previous office action
Regarding claims 1 and 13, Roberts teaches a method and device of measuring a human body analyte (2) concentration in an interstitial fluid of a user by a device (1) [col. 2: lines 49-67] comprising: - a control unit (3) [col. 3: lines 18-40], - at least a working electrode (4) [fig. 2, element 12; col. 4: lines 64-67-col. 5: lines 1-7] and a pseudo-reference electrode (5) [fig. 2, element 10; col. 4: lines 64-67-col. 5: lines 1-7], the working electrode (4) and the pseudo-reference electrode (5) being configured for an implantation in the dermis of the user by at least one microneedle (7) so as to be in contact with the interstitial fluid of the user [col. 6: lines 1-5], - an enzyme (8) configured for oxidizing the analyte (2), the enzyme (8) being attached to at least a part of the working electrode [col. 5: lines 44-61],
a mediator (9) being fixed on said part of the working electrode (4), the mediator (9) being a redox mediator (9) having a reduced state and an oxidized state, and being configured for being in a reduced state below the predetermined threshold electrical potential Vt, and in an oxidized state above the predetermined threshold electrical potential Vt [col. 5: lines 62-67-col. 6: lines 1-24],
the method comprising the step of: a) measuring a first electrical current I1 between the working electrode (4) and the pseudo-reference electrode (5) while applying a first potential V1 between the working electrode (4) and the pseudo-reference electrode (5) [col. 3: lines 1-17, col. 6: lines 25-52], the first potential V1 being less than a predetermined threshold potential Vt, the magnitude of the first electrical current I1 being greater than the magnitude of a predetermined first threshold current It1 [col. 3: lines 1-17], and further measuring an output electrical current to between the working electrode (4) and the pseudo-reference electrode (5) while applying a second electrical potential V2, the second electrical potential V2 being greater than the first electrical potential V1 [fig. 3; col. 3: lines 1-17, col. 6: lines 25-52],
and/or comprising the step of b) measuring a second electrical current 12 between the working electrode (4) and the pseudo-reference electrode (5) while applying a third electrical potential V3 between the working electrode (4) and the pseudo-reference electrode (5) while the working electrode and the pseudo-reference electrode are implanted in the dermis of the user, the third potential V3 being greater than the threshold potential Vt, the magnitude of the second electrical current 12 being less than a magnitude of a predetermined second threshold current Itz, and then measuring the output electrical current to while applying a fourth electrical potential V4, the fourth electrical potential V4 being inferior to the third electrical potential V3.
However, Roberts does not teach after implanting the working electrode and the pseudo- reference electrode by the at least one microneedle: a) measuring a first electrical current, while the working electrode and the pseudo-reference electrode are implanted in the dermis of the user
Ribet teaches after implanting the working electrode and the pseudo- reference electrode by the at least one microneedle: a) measuring a first electrical current, while the working electrode and the pseudo-reference electrode are implanted in the dermis of the user [92, 94, 107]
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 Roberts, to incorporate after implanting the working electrode and the pseudo- reference electrode by the at least one microneedle: a) measuring a first electrical current, while the working electrode and the pseudo-reference electrode are implanted in the dermis of the user, for allowing the sensor to be capable of detecting analyte of interest in the bodily fluid and for increasing stability, as evidence by Ribet [par. 92, 107]
Regarding claim 2, Roberts further teaches the method comprising the step of: a) measuring a first electrical current I1 between the working electrode (4) and the pseudo-reference electrode (5) while applying a first potential V1 between the working electrode (4) and the pseudo-reference electrode (5) [col. 3: lines 1-17, col. 6: lines 25-52], the first potential V1 being less than a predetermined threshold potential Vt, the magnitude of the first electrical current I1 being greater than the magnitude of a predetermined first threshold current It1 [col. 3: lines 1-17], and further measuring an output electrical current to between the working electrode (4) and the pseudo-reference electrode (5) while applying a second electrical potential V2, the second electrical potential V2 being greater than the first electrical potential V1, wherein the second electrical potential V2 is greater than the threshold electrical potential Vt [fig. 3; col. 3: lines 1-17, col. 6: lines 25-52]
However, Roberts does not teach measuring an electrical current, while the working electrode and the pseudo-reference electrode are implanted in the dermis of the user [92, 94, 107]
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 Roberts, to incorporate measuring an electrical current, while the working electrode and the pseudo-reference electrode are implanted in the dermis of the user, for allowing the sensor to be capable of detecting analyte of interest in the bodily fluid and for increasing stability, as evidence by Ribet [par. 92, 107]
Regarding claim 3, Roberts teaches the method comprising the step of: a) measuring a first electrical current I1 between the working electrode (4) and the pseudo-reference electrode (5) while applying a first potential V1 between the working electrode (4) and the pseudo-reference electrode (5) [col. 3: lines 1-17, col. 6: lines 25-52], the first potential V1 being less than a predetermined threshold potential Vt, the magnitude of the first electrical current I1 being greater than the magnitude of a predetermined first threshold current It1 [col. 3: lines 1-17], and further measuring an output electrical current to between the working electrode (4) and the pseudo-reference electrode (5) while applying a second electrical potential V2, the second electrical potential V2 being greater than the first electrical potential V1 [fig. 3; col. 3: lines 1-17, col. 6: lines 25-52],
Although Roberts does not explicitly teach the method comprising the step of: b) measuring a second electrical current 12 between the working electrode (4) and the pseudo-reference electrode (5) while applying a third electrical potential V3 between the working electrode (4) and the pseudo-reference electrode (5), the third potential V3 being greater than the threshold potential Vt, the magnitude of the second electrical current 12 being less than a magnitude of a predetermined second threshold current Itz, and then measuring the output electrical current to while applying a fourth electrical potential V4, the fourth electrical potential V4 being inferior to the third electrical potential V3, this would be obvious to a person having ordinary skill in the art when the invention was filed, since Roberts also suggests measuring a first current, a magnitude of the current within a threshold, and applying a first and second potential within a threshold [col. 3: lines 1-17, col. 6: lines 25-52]. Additionally, Roberts teaches testing glucose for multiple time periods for reducing noise [col. 11: lines 4-35]. Therefore, incorporating repeating these measurements for a second time would involve only routine skill in the art.
Ribet teaches measuring an electrical current, while the working electrode and the pseudo-reference electrode are implanted in the dermis of the user [92, 94, 107]
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 Roberts, to incorporate measuring an electrical current, while the working electrode and the pseudo-reference electrode are implanted in the dermis of the user, for allowing the sensor to be capable of detecting analyte of interest in the bodily fluid and for increasing stability, as evidence by Ribet [par. 92, 107]
Regarding claim 4, Roberts teaches step a) [col. 3: lines 1-17, col. 6: lines 25-52]
Although Roberts does not explicitly teach step a) and step b), this would be obvious to a person having ordinary skill in the art when the invention was filed, since Roberts also suggests measuring a first current, a magnitude of the current within a threshold, and applying a first and second potential within a threshold [col. 3: lines 1-17, col. 6: lines 25-52]. Additionally, Roberts teaches testing glucose for multiple time periods for reducing noise [col. 11: lines 4-35]. Therefore, incorporating step a) and step b) would involve only routine skill in the art.
Regarding claim 5, Roberts further teaches step a) and/or step b) comprise(s) a sub-step of computing a concentration of the analyte in the interstitial fluid from the value of the output electrical current I1 [col. 3: lines 1-17].
Regarding claim 7, Roberts further teaches comprising a repetition of the steps of measuring the current between the working electrode (4) and the pseudo-reference electrode and determining a concentration of the analyte (2) in the interstitial fluid from the value of the output electrical current Io [col. 11: lines 4-35]
Regarding claim 8, Roberts further teaches each repetition is separated by a time between 0.5 s and 30 min, and preferably between 15 s and 15 min [fig. 5]
Regarding claim 9, Roberts further teaches the threshold potential Vt is comprised between 10 mV and 650 mV [fig. 3].
Regarding claim 11, Roberts further teaches the enzyme (8) configured for oxidizing the analyte (2) is at least chosen between an enzyme configured for oxidizing glucose and an enzyme configured for oxidizing lactate [col. 5: lines 44-61].
Claims 6 and 10 rejected under 35 U.S.C. 103 as being unpatentable over Roberts and Ribet and in further view of Ringemann (U.S. Patent Application Publication 2019/0079044)
Ringemann was applied in the previous office action
Regarding claim 6, Roberts and Ribet teach a method and device for measuring a human body analyte (2) concentration in an interstitial fluid of a user by a device
However, Roberts and Ribet do not teach the first threshold current It, and the second threshold It2 current are of opposite signs.
Ringemann teaches the first threshold current It, and the second threshold It2 current are of opposite signs [par. 53, 57].
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 Roberts and Ribet, to incorporate the first threshold current It, and the second threshold It2 current are of opposite signs, for allowing the biosensor to be capable of detecting the variables related to the interferent in the body fluid, as evidence by Ringemann [par. 58]
Regarding claim 10, Ringemann further teaches the first threshold current It, is comprised in the range from - 500 nA and -0,1 nA and preferably between - 200 nA and -0,1 nA [fig. 1A; par. 53, 57].
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 Roberts and Ribet, to incorporate the first threshold current It, is comprised in the range from - 500 nA and -0,1 nA and preferably between - 200 nA and -0,1 nA, for allowing the biosensor to be capable of detecting the variables related to the interferent in the body fluid, as evidence by Ringemann [par. 58]
Claims 12 is rejected under 35 U.S.C. 103 as being unpatentable over Roberts and in further view of Lansdorp (U.S. Patent Application Publication 2016/0338627)
Lansdorp was applied in the previous office action
Regarding claim 12, Roberts and Ribet teach a method and device for measuring a human body analyte (2) concentration in an interstitial fluid of a user by a device
However, Roberts and Ribet do not teach the mediator (9) is Prussian blue.
Lansdorp teaches the mediator (9) is Prussian blue [par. 33].
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 Roberts and Ribet, to incorporate the mediator (9) is Prussian blue, for converting hydrogen peroxide, as evidence by Lansdorp [par. 35]
Conclusion
THIS ACTION IS MADE FINAL.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8 AM - 5 PM.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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