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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6, 10, 13-16, and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2012/0150005 A1 to Hoss et al. (“Hoss ‘005”).
As to claim 1, Hoss ‘005 discloses a monitor for determining analyte concentrations in vivo, comprising:
a housing configured to adhere to the skin of a subject (see [0171]);
a flexible sensor body (see [0160] – “In some embodiments, the substrate is flexible.”) configured to extend from the housing into a patient's skin, the sensor body being elongate and extending along a longitudinal axis in a length direction, and further having a width and a thickness each measured perpendicular to the length (see Figs 5A-C); and
an analyte sensing region formed on the sensor body, wherein the analyte sensing region has opposite ends in the length direction, and wherein a maximum length of the analyte sensing region measured between the opposite ends is less than 80 um (see Figs 5A-C and [0083] – “Embodiments of the present disclosure relate to methods and devices for reducing variation in sensor sensitivity by including a sensing surface that includes two or more sensing elements disposed laterally to each other, where the sensing surface is on a working electrode of the sensor, such as in vivo and/or in vitro analyte sensors, including continuous and/or automatic in vivo analyte sensors.” (emphasis added) and [0087] – “Depending upon the use, any or all of the arrays may be the same or different from one another and each may contain multiple spots or features (e.g., sensing elements). For example, an array may include two or more, 5 or more, ten or more, 25 or more, 50 or more, 100 or more features, or even 1000 or more features, in an area of 100 mm2 or less, such as 75 mm2 or less, or 50 mm2 or less, for instance 25 mm2 or less, or 10 mm2 or less, or 5 mm2 or less, such as 2 mm2 or less, or 1 mm2 or less, 0.5 mm2 or less, or 0.1 mm2 or less. For example, features may have widths (that is, diameter, for a round spot) in the range from 0.1 μm to 1 mm, or from 1 μm to 1 mm, such as ranging from 1 μm to 500 μm, including from 10 μm to 250 μm, for example from 50 μm to 200 μm. In certain embodiments, the sensing elements have an average diameter of 500 μm or less, such as 250 μm or less, including 200 μm or less, or 150 μm or less, or 100 μm or less, such as 50 μm or less, or 10 μm or less, or 1 μm or less, or 0.1 μm or less.”) (emphasis added)).
As to claim 2, Hoss ‘005 further discloses wherein the maximum length of the analyte sensing region measured between the opposite ends is 40 um or less (see treatment of claim 1).
As to claim 3, Hoss ‘005 further discloses wherein the monitor is a glucose monitor configured to determine glucose levels of the patient in vivo (see [0016]).
As to claim 4, Hoss ‘005 further discloses wherein the analyte sensing region is positioned near a free end of the sensor body (see Figs 5A-C)
As to claim 6, Hoss ‘005 further discloses wherein when the sensor body extends into the patient's skin, the analyte sensing region is configured to be held in the dermis of the skin of the patient (given that the dermis is approximately 1-4 mm thick, this is inherently true).
As to claim 10, Hoss ‘005 further discloses wherein when the sensor body extends into the patient's skin, a free end of the sensor body is configured to be held in the dermis of the skin of the patient (given that the dermis is approximately 1-4 mm thick, this is inherently true).
As to claim 13, Hoss ‘005 discloses a sensor member for a monitor that is configured to determine analyte concentrations in vivo, wherein the sensor member comprises:
a flexible sensor body configured to extend into a patient's skin, the sensor body being elongate and extending along a longitudinal axis in a length direction (see treatment of claim 1, above); and
an analyte sensing region that is formed on the sensor body by utilizing at least one microfabrication technique (see [0131]), wherein the analyte sensing region has opposite ends in the length direction, and wherein a maximum length of the analyte sensing region measured between the opposite ends is less than 80 um (see Figs 5A-C and [0083] – “Embodiments of the present disclosure relate to methods and devices for reducing variation in sensor sensitivity by including a sensing surface that includes two or more sensing elements disposed laterally to each other, where the sensing surface is on a working electrode of the sensor, such as in vivo and/or in vitro analyte sensors, including continuous and/or automatic in vivo analyte sensors.” (emphasis added) and [0087] – “Depending upon the use, any or all of the arrays may be the same or different from one another and each may contain multiple spots or features (e.g., sensing elements). For example, an array may include two or more, 5 or more, ten or more, 25 or more, 50 or more, 100 or more features, or even 1000 or more features, in an area of 100 mm2 or less, such as 75 mm2 or less, or 50 mm2 or less, for instance 25 mm2 or less, or 10 mm2 or less, or 5 mm2 or less, such as 2 mm2 or less, or 1 mm2 or less, 0.5 mm2 or less, or 0.1 mm2 or less. For example, features may have widths (that is, diameter, for a round spot) in the range from 0.1 μm to 1 mm, or from 1 μm to 1 mm, such as ranging from 1 μm to 500 μm, including from 10 μm to 250 μm, for example from 50 μm to 200 μm. In certain embodiments, the sensing elements have an average diameter of 500 μm or less, such as 250 μm or less, including 200 μm or less, or 150 μm or less, or 100 μm or less, such as 50 μm or less, or 10 μm or less, or 1 μm or less, or 0.1 μm or less.”) (emphasis added)).
As to claim 14, Hoss ‘005 further discloses wherein the maximum length of the analyte sensing region measured between the opposite ends is 40 um or less (see treatment of claim 13).
As to claim 15, Hoss ‘005 further discloses wherein the monitor is a glucose monitor configured to determine glucose levels of the patient in vivo (see [0016]).
As to claim 16, Hoss ‘005 further discloses wherein the sensor body has a length such that when the sensor body extends into the patient's skin, a free end of the sensor body is configured to be held in the dermis of the skin of the patient (given that the dermis is approximately 1-4 mm thick, this is inherently true).
As to claim 19, Hoss ‘005 further discloses wherein the at least one microfabrication technique comprises electrochemical plating (see [0131]).
As to claim 20, Hoss ‘005 further discloses wherein the sensor body is formed on a wafer, and wherein the at least one microfabrication technique comprises layering functional chemistry on the wafer by spinning as material substrates are deposited as liquid (see [0131]).
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 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoss ‘005 in view of US 2021/0219885 A1 to Wang et al. (“Wang”).
As to claim 5, Hoss ‘005 fails to show wherein a width of the sensor body approximate the analyte sensing region is greater than a width of another portion of the sensor body away from the analyte sensing region. However, this is shown by Wang (see Figs. 5G-H and [0070-[0072]). 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 teachings of Hoss ‘005 and Wang in order to achieve the predictable result that is dip-coated membrane that is quickly and easily manufactured.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoss ‘005 in view of US 2015/0051457 A1 to Matsumoto et al. (“Matsumoto”).
As to claim 11, Hoss ‘005 fails to disclose wherein when the sensor body extends into the patient's skin, the sensor body extends at an acute angle to a surface of the patient's skin. However, this is shown by Matsumoto (see [0075]). 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 Hoss ‘005 with the acute angle of Matsumoto given that Matsumoto teaches that such an angle makes it easier to pierce the skin.
As to claim 12, Hoss ‘005 fails to disclose wherein the housing comprises a base having a surface configured to adhere to the skin of the subject and a separate transmitter configured to be assembled to the base after the sensor body is implanted into the patient's skin. This is shown by Matsumoto (see Figs 7A-B, 8 and [0108]-[0109]). It would have been obvious to one of ordinary skill in the art to combine the sensor of Hoss ‘005 with the separate transmitter of Matsumoto in order to achieve the predictable result that is a transmitter that can be reused.
Claim(s) 7-9 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoss ‘005 in view of US 2010/0230285 A1 to Hoss (“Hoss ‘285”).
As to claims 7-9, Hoss ‘005 fails to disclose wherein the analyte sensing region comprises a plurality of electrodes, wherein the plurality of electrodes comprises a working electrode, wherein the plurality of electrodes further comprises at least one of a counter electrode or a reference electrode.
However, Hoss ‘285 teaches that it was well known to use the back side of such planar electrodes in order to conserve space (see, e.g., Fig 10C, elements 1006 and 1010 and [0112]). 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 Hoss ‘005 with the electrodes on either side of a substrate as shown by Hoss ‘285 given that it was a well-known technique for conserving space on an electrode. Such electrodes comprise both a working electrode and a reference electrode (see [0111]-[0113]).
As to claims 17-18, Hoss ‘005 fails to disclose wherein the at least one microfabrication technique comprises photo lithography or wherein the at least one microfabrication technique comprises ultraviolet (UV) etching.
However, in a related invention having similar sizes, Hoss ‘285 shows each of these techniques (see [0077]-[0078] and [0132]). It would have been obvious to combine the sensor of Hoss ‘005 with the techniques of Hoss ‘285 given that they are explicitly suggested for such purposes by Hoss ‘285.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Messersmith whose telephone number is (571)270-7081. The examiner can normally be reached M-F, 830am-5pm.
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/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791