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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 6, 8-1012, 17, and 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2023/0389837 A1 to Krishnamani et al. (“Krishnamani”).
As to claim 1, Krishnamani discloses a monitor for determining analyte concentrations in vivo, comprising:
a housing configured to adhere to a patient's skin (see [0045] – “A housing of the disease management system 200 may consist of a combination of flexible and rigid material so as to both provide support for the components of the disease management system 200 and allow conforming, at least in part, of the disease management system 200 to the skin of the user.”); and
a sensor member comprising an elongate body configured to extend from the housing into the patient's skin, and at least a first working electrode and a separate second working electrode both formed along the elongate body that are independently connected to electronics in the housing via separate electrical connections and that function independently from one another (see Fig Fig 3B, 5A and [0085] – “The analyte sensor 500 can include one or more of working electrode 534, for example two, three, four or more. In an example implementation, an analyte sensor 500 can include at least three of working electrode 534. The at least three of working electrode 534 may be positioned sequentially along the elongated skin penetrating member 520 such that a first of the one or more working electrodes 534 of the analyte sensor 500 penetrates deeper into the skin of a user a second working electrode 534. Additionally, a second working electrode 534 may be positioned such that the second working electrode 534 penetrates farther into the skin of a user than a third working electrode 534. Additionally and/or alternatively, the analyte sensor 500 can include more than three working electrodes 534 wherein at least one or more additional working electrodes 534 are sequentially positioned along the elongated skin penetrating member 520 of the analyte sensor 500.” and [0098] – “As described herein, the working electrode may be positioned at varying depths along an analyte sensor such that when the analyte sensor penetrates the surface of the skin of a user, the working electrodes are located at a varying depth within the user's skin with respect to one or more other working electrodes. Advantageously, having more than one working electrodes positioned at different depths within the skin of a user can be used to determine a gradient, similar to the gradient as illustrated in FIG. 3B.”);
wherein an entire sensing region of the first working electrode is completely spaced apart axially from an entire sensing region of the second working electrode in a length direction of the body (see Fig 5A).
As to claim 2, Krishnamani further discloses wherein the first and second working electrodes are both configured to determine analyte concentrations for the same analyte (see treatment of claim 1 with respect to the gradient, above).
As to claim 3, Krishnamani further discloses a single counter electrode and a single reference electrode that are utilized by both the first and second working electrodes (see Fig 5A, element 532, 536).
As to claim 4, Krishnamani further discloses a first counter electrode and a first reference electrode utilized by the first working electrode, and a second counter electrode and a second reference electrode utilized by the second working electrode ([0066]-[0069] – “The one or more electrodes of the electrode groupings 310 may include a plurality of counter electrodes 312, a plurality of working electrodes 314, and a plurality of reference electrodes 316.”).
As to claim 6, Krishnamani further discloses wherein the first and second working electrodes are formed on a same face of the sensor member (see Fig 5A-B).
As to claim 8, Krishnamani further discloses wherein when the sensor member is implanted in the patient's skin, the first and second working electrodes are configured to be positioned in different tissue spaces in the patient's skin (see Fig 3B).
As to claim 9, Krishnamani further discloses wherein wherein the first working electrode is configured to be positioned in the dermis, and the second working electrode is configured to be positioned in a layer of the patient's skin that is different from the dermis (see Fig 3B).
As to claim 10, Krishnamani further discloses wherein a first counter electrode and a first reference electrode utilized by the first working electrode, and a second counter electrode and a second reference electrode utilized by the second working electrode (see [0067]-[0069]).
As to claim 12, Krishnamani further discloses wherein wherein the first working electrode is formed on a first face of the sensor member, and the second working electrode is formed away from the first face of the sensor member (see [0077] – “Additionally and/or alternatively, electrodes 432, 434, and/or 436 may be located on at least two sides of the elongated skin penetrating member 420.”).
As to claim 17, Krishnamani further discloses wherein the first and second working electrodes are operated concurrently (see [0098]).
As to claim 20, Krishnamani further discloses wherein the monitor is configured to determine a blood glucose level of the patient (see [0005]).
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.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krishnamani in view of US 2019/0183339 A1 to Shah et al. (“Shah”).
As to claim 11, it is not clear that Krishnamani discloses wherein the first and second counter electrodes are connected to one another in series, and the first and second reference electrodes are connected to one another in series. However, in a similar invention, Shah shows this (see Fig 2B, elements 210 and 214). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the sensor of Krishnamani with the counter and reference electrode configuration of Shah in order to achieve the predictable result that is a more stable and predictable electrode performance.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krishnamani in view of US 6,134,461 A to Say et al. (“Say”).
As to claim 13, it is not clear that Krishnamani discloses that a majority of the respective electrical connections for the first and second working electrodes are formed on an opposite second face of the sensor member. Say teaches that it is advantageous to place vias in the substrate to contact pads on an opposing side of the substrate in order to allow contact pads to be placed on only one side of the electrode (see col 15, ln 19-26). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine these teachings so that a majority of the respective electrical connections for the first and second working electrodes are formed on an opposite second face of the sensor member to make the contact pads easier to interface by placing them on the same side of the substrate as taught by Say.
As to claim 14, while Krishnamani teaches that the sensors may be glucose sensors, it is not made explicit that these include an enzyme layer formed on both the first and second working electrodes. Say makes it explicit that such sensors do include enzymes (see col 17, ln 24-41). It would have been obvious to one of ordinary skill in the art to make the sensors of Krishnamani using enzymes as instructed by Say in order to achieve the predictable result of glucose sensors.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krishnamani in view of US 6,120,676 A to Heller et al. (“Heller”).
As to claim 15, it is not clear that Krishnamani discloses wherein an enzyme layer is formed on the first working electrode, but is not formed on the second working electrode. However, this was a very common technique for mitigating the effects of interferents, such as ascorbic acid and/or acetaminophen in continuous glucose sensors as shown by Heller (see col 17, ln 44-60) and would have been an obvious combination with the invention of Shah for this reason before the effective filing date of the claimed invention.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krishnamani in view of US 2007/0027384 A1 to Brister et al. (“Brister”)
As to claim 16, it is not clear that Krishnamani discloses wherein a first diffusion layer is formed on the first working electrode, but is not formed on the second working electrode. However, this was a very common technique for mitigating the effects of interferents, such as ascorbic acid and/or acetaminophen or other confounding background signals in continuous glucose sensors as shown by Brister (see, e.g., [0415]) and would have been an obvious combination with the invention of Krishnamani for this reason before the effective filing date of the claimed invention.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krishnamani in view of US 2018/0146896 A1 to Simpson et al. (“Simpson”).
As to claim 18, Shah does not appear to disclose wherein the first working electrode is activated when the monitor is initially applied to the patient, while the second working electrode is preserved. However, this has been done as shown by Simpson (see, e.g., [0175]). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the sensors of Shah with the initial operation of one electrode while another is only allowed to be activated after a second time period, preserving its activity for later as shown by Simpson in order to achieve the predictable result of allowing the user to be aware of relevant analyte concentrations over a wider time horizon.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shah in view of Simpson and further in view of US 6,666,821 B2 to Keimel et al. (“Keimel”).
As to claim 19, Shah and Simpson fail to disclose wherein when the first working electrode fails or otherwise stops working, the monitor activates the second working electrode to replace the first working electrode. However, in a similar invention, Keimel shows this (see col 5, ln 39-50). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to make this combination in order to achieve the predictable result that is longer overall sensor life.
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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/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791