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 .
Claim Rejections - 35 USC § 103
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 1-2, 4-6, 11-13, 16, 32-34, 36-39, and 41-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0077930 A1 to Little et al. (“Little”) in view of US 2019/0183339 A1 to Shah et al. (“Shah”).
As to claim 1, Little discloses an analyte sensor to measure a concentration of at least one analyte at varying depths within a user comprising:
a connector configured to communicate with one or more hardware processors (see Fig 1, element 500); and an
elongated skin penetrating member having a length extending from a distal end to a proximal end, wherein the proximal end extends from the connector, and wherein the elongated skin penetrating member is configured to be at least partially implanted in a user, the elongated skin penetrating member comprising:
a semi-rigid substrate layer having a first side and a second side (see Fig 2 and [0038], [0042]);
at least one metal layer positioned on first side of the semi-rigid substrate layer comprising a first plurality of electrode sets arranged along the length of the elongated skin penetrating member, each electrode set comprising a working electrode, at least one reference electrode, and at least one counter electrode, wherein the working electrode is positioned adjacent to the at least one reference electrode therein, wherein the working electrode is adjacent to the at least one counter electrode, and wherein, when the elongated skin penetrating member is implanted in a user (see (see Fig 2 showing the distributed working, counter and reference electrodes; see also US 2010/0025238 A1, Figure 6A, incorporated by reference and [0052]; see also [0111]-[0112] of US 2010/0025238 A1 – “Optionally, the plurality of working, counter and reference electrodes are grouped together as a unit and positionally distributed on the conductive layer in a repeating pattern of units…. Optionally, the working electrode, the counter electrode and the reference electrode are positionally distributed on conductive layer in a configuration arranged so that the working electrode is disposed in a region on a first edge of the elongated base layer; the counter electrode is disposed in a region on an opposite edge of the elongated base layer; and the reference electrode is disposed in a region of the elongated base layer that between the working electrode and the counter electrode.” ),
at least one insulation layer surrounding the at least one metal layer (see Fig. 12B-C).
In the embodiment disclosed by Little, it is not clear that the working electrode comprises a plurality of working electrodes. But this is shown in the microarray of Little in another embodiment (see, e.g., Fig 13A2). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the single working electrode in each electrode set to comprise a plurality of working electrodes as such discrete structures are known to offer better performance in mitigating thick diffusion layers where analyte is unable to be rapidly replenished as consumed at the electroactive layer of the working electrode.
Little further does not show at least one of the plurality of electrode sets is configured to measure a concentration of an analyte at an adipose layer, and at least one other of the plurality of the electrode sets is configured to measure a concentration of the analyte at a dermis layer of the user.
However, this is shown by Shah (see [0055]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the sensor of Little with the length including all of the adipose layer and at a dermis layer since Shah teaches that such varied length allows the user to better understand the microcirculation of the user and how it may affect the measured analyte levels.
As to claim 2, Little further discloses wherein the plurality of working electrodes is in electrical communication with the connector and wherein a voltage is applied to the plurality of working electrodes to generate at least one measurement of the concentration of the at least one analyte (see [0011]).
As to claim 4, Little further discloses at least one metal layer positioned on the second side of the semi-rigid substrate layer comprising a second plurality of electrode sets (see Figs 13D1-D3).
As to claim 5, Little discloses three electrode sets on first and second sides of the sensor (see Fig 13D1) and not four electrode sets positioned on the distal end of the elongated skin penetrating member on the first side, and the second plurality of electrode sets comprises four electrode sets along a length of the elongated skin penetrating member on the second side.
But this is merely duplicating what has already been shown by Little. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to increase the number to four order to achieve the predictable result of increasing the resolution of sensor signal over a greater depth in the tissue.
As to claim 6, Little further discloses wherein the at least one reference electrode, and the at least one counter electrode comprise at least one of platinum, gold, silver, silver chloride, rhodium, or iridium ([0061]).
As to claim 11, Little further discloses wherein the analyte sensor is configured to be disposed in a semi-permeable electrochemical cell (see [0032]).
As to claim 12, Little further discloses wherein each of the plurality of electrode sets comprises a series of individual working electrodes electrically connected and spaced equidistantly from each other (see Fig 13D1-D3).
As to claim 13, Little further discloses wherein each of the plurality of electrode sets comprises exactly one reference electrode (see Fig 13D1-D3 and the cited portions of US 2010/0025238 A1 in the treatment of claim 1).
As to claim 16, Little discloses an analyte measurement system for measuring a concentration of an analyte within a user, the system comprising:
an analyte sensor comprising: a connector configured to communicate with one or more hardware processors (see Fig 1, element 500);
an elongated skin penetrating member having a length extending from a distal end to a proximal end, wherein the proximal end extends from the connector, and wherein the elongated skin penetrating member is configured to be at least partially implanted in a user, the elongated skin penetrating member comprising:
a semi-rigid substrate layer having a first side and a second side (see Fig 2 and [0038], [0042]);
at least one metal layer positioned on the first side of the semi-rigid substrate layer comprising a first plurality of electrode sets arranged along the length of the elongated skin penetrating member, each electrode set comprising a working electrode, at least one reference electrode, and an at least one counter electrode, wherein the working electrode is positioned adjacent to the at least one reference electrode therein, wherein the working electrode is adjacent to the at least one counter electrode (see Fig 2 showing the distributed working, counter and reference electrodes; see also US 2010/0025238 A1, Figure 6A, incorporated by reference and [0052]; see also [0111]-[0112] of US 2010/0025238 A1 – “Optionally, the plurality of working, counter and reference electrodes are grouped together as a unit and positionally distributed on the conductive layer in a repeating pattern of units…. Optionally, the working electrode, the counter electrode and the reference electrode are positionally distributed on conductive layer in a configuration arranged so that the working electrode is disposed in a region on a first edge of the elongated base layer; the counter electrode is disposed in a region on an opposite edge of the elongated base layer; and the reference electrode is disposed in a region of the elongated base layer that between the working electrode and the counter electrode.”),; and at least one insulation layer surrounding the at least one metal layer (see Fig. 12B-C);
a medication catheter configured to deliver medication to a user (see [0099]);
a physiological sensor configured to communicate physiological values (see [0011] – the sensor can measure multiple analytes, an additional one of which is a sensor configured to communicate physiological values);
an at least one communication component configured to transmit and receive information associated with the one or more hardware processors (see [0095]); and
an at least one user interfacing component configured to accept and receive user input (see [0095] – “In this system, radio signals from the transmitter can be sent to the pump receiver at regular time periods (e.g. every 5 minutes) to provide real-time sensor glucose (SG) values. Values/graphs can be displayed on a monitor of the pump receiver so that a user can self monitor blood glucose and deliver insulin using their own insulin pump. Typically, the sensor systems disclosed herein can communicate with a other medical devices/systems via a wired or wireless connection. Wireless communication can include for example the reception of emitted radiation signals as occurs with the transmission of signals via RF telemetry, infrared transmissions, optical transmission, sonic and ultrasonic transmissions and the like. Optionally, the device is an integral part of a medication infusion pump (e.g. an insulin pump).”).
In the embodiment disclosed by Little, it is not clear that the working electrode comprises a plurality of working electrodes. But this is shown in the microarray of Little in another embodiment (see, e.g., Fig 13A2). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the single working electrode in each electrode set to comprise a plurality of working electrodes as such discrete structures are known to offer better performance in mitigating thick diffusion layers where analyte is unable to be rapidly replenished as consumed at the electroactive layer of the working electrode.
Little does not disclose wherein, when the elongated skin penetrating member is implanted in a user, at least one of the plurality of electrode sets is configured to measure a concentration of an analyte at an adipose layer, and at least one other of the plurality of the electrode sets is configured to measure a concentration of the analyte at a dermis layer of the user.
However, this is shown by Shah (see [0055]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the sensor of Little with the length including all of the adipose layer and at a dermis layer since Shah teaches that such varied length allows the user to better understand the microcirculation of the user and how it may affect the measured analyte levels.
As to claim 32, Little discloses a method of measuring a concentration of at least one analyte in a user at an injection site, the method comprising:
inserting an elongated skin penetrating member having a plurality of electrode sets arranged along a length of the elongated skin penetrating member at least into an injection site of a user, wherein the injection site comprises at least one analyte of the user (see Fig 2 showing the distributed working, counter and reference electrodes; see also US 2010/0025238 A1, Figure 6A, incorporated by reference and [0015], [0052]);
applying a voltage to the plurality of electrode sets, wherein a working electrode of each of the electrode sets generate an electrical potential corresponding to a plurality of measurements of the at least one analyte at one or more depth of the injection site (see Fig 11 and [0103]);
communicating the plurality of measurements to a processor to determine a plurality of analyte concentration values (see [0095]); and
reporting the plurality of analyte concentration values at the injection site to the user (see [0095]).
In the embodiment disclosed by Little, it is not clear that the working electrode comprises a plurality of working electrodes. But this is shown in the microarray of Little in another embodiment (see, e.g., Fig 13A2). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the single working electrode in each electrode set to comprise a plurality of working electrodes as such discrete structures are known to offer better performance in mitigating thick diffusion layers where analyte is unable to be rapidly replenished as consumed at the electroactive layer of the working electrode.
Little fails to disclose wherein the injection site additionally comprises of at least a dermis and an adipose,
However, this is shown by Shah (see [0055]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the sensor of Little with the length including all of the adipose layer and at a dermis layer since Shah teaches that such varied length allows the user to better understand the microcirculation of the user and how it may affect the measured analyte levels.
As to claim 33 Little further discloses wherein each electrode set comprises a series of individual working electrodes electrically connected and spaced equidistantly from each other (see Fig 13D1-D3).
As to claim 34, Little further discloses wherein each electrode set comprises one reference electrode (see Fig 13D1-D3 and the cited portions of US 2010/0025238 A1 in the treatment of claim 1).
As to claim 36, Little further discloses wherein the plurality of working electrodes is in electrical communication with the connector and wherein a voltage is applied to the plurality of working electrodes to generate at least one measurement of the concentration of the at least one analyte (see [0011]).
As to claim 37, Little further discloses at least one metal layer positioned on the second side of the semi-rigid substrate layer comprising a second plurality of electrode sets (see Figs 13D1-D3).
As to claim 38, Little discloses wherein the first plurality of electrode sets comprises three electrode sets and not four electrode sets positioned on the distal end of the elongated skin penetrating member on the first side; and the second plurality of electrode sets comprises three electrode sets and not four electrode sets along a length of the elongated skin penetrating member on the second side.
But this is merely duplicating what has already been shown by Little. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to increase the number to four order to achieve the predictable result of increasing the resolution of sensor signal over a greater depth in the tissue.
As to claim 39, Little further discloses wherein the at least one reference electrode, and the at least one counter electrode comprise at least one of platinum, gold, silver, silver chloride, rhodium, or iridium ([0061]).
As to claim 41, Little further discloses wherein the analyte sensor is configured to be disposed in a semi-permeable electrochemical cell (see [0032]).
As to claim 42, Little further discloses wherein the plurality of working electrodes contains each of the first plurality of electrode sets comprises a series of individual working electrodes electrically connected and spaced equidistantly from each other (see Fig 13D1-D3 and the cited portions of US 2010/0025238 A1 in the treatment of claim 16).
Response to Arguments
Applicant's arguments filed December 30, 2025 have been fully considered but they are not persuasive.
Applicants argue that Shah does not teach the required limitations because Shah relies on multiple sensors while not integrating them into a single probe. Examiner does not need Shah to teach the argued structures, or else Shah would be a 102. Examiner only needs there to be a reason why one of ordinary skill in the art would place the sensors of Little (which are already taught as spanning several depths) in the adipose and dermis of the user, which Shah provides. The other aspects of Shah, as teaching interprobe measurements, are not relevant to the obviousness analysis. Shah teaches that analytes may be present at different depths that reveal how these analytes are transported within these tissues. Those having ordinary skill in the art knew that oxygen is required to convert glucose to gluconolactone and hydrogen peroxide in the presence of glucose oxidase. Local ischemia caused by a lack tissue perfusion at different depths in the local tissue microenvironment would therefore be critical information to determine whether the readings from the sensor were reflective of glucose or a lack of oxygen. For at least these reasons, the rejections are maintained.
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 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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/ERIC J MESSERSMITH/ Primary Examiner, Art Unit 3791