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 .
Response to Amendment
The amendments filed 22 April 2026 have been entered. Claims 1 – 14 are pending. Applicant’s amendments have overcome each and every objection to the drawings, specification, and claims previously applied in the office action dated 26 January 2026. Applicant’s amendments have overcome each and every rejection under 35 U.S.C. 112 previously applied in the office action dated 26 January 2026.
Drawings
The drawings were received on 22 April 2026. These drawings are accepted.
Claim Interpretation
Applicant has not made an amendment regarding the 112(f) Claim Interpretations applied in the Office Action dated 26 January 2026. Applicant has not provided any reason to withdraw the 112(f) claim interpretation, so the interpretation detailed in the Office Action dated 26 January 2026. is maintained for the terms “transmitter unit” and “receiver” in Claim 14.
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.
Claims 1 – 6, 8 – 11, and 13 – 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Srinivasan et. al., (United States Patent Application Publication US 2019/0008425 A1), hereinafter Srinivasan.
Regarding Claim 1, Srinivasan discloses A micro analyte sensor ([Abstract]; [0007]), comprising
a substrate ([0072] “a base substrate”; [0216] “base substrate 402, 902”) comprising an internal part ([0102] “regions at a distal end to form sensor electrodes…”) and an external part ([0102] “regions at a proximal end to form contact pads…”)
at least one electrode group ([0101] “the conductive layer 404 comprises one or more electrically conductive elements that function as electrodes.”), located on a surface of the internal part (Fig 2, “conductive layer 404”; [0102] “regions at a distal end to form sensor electrodes…”), wherein the electrode group comprises at least one working electrode and at least one additional electrode ([0101] “An operating sensor 400 typically includes a plurality of electrodes such as a working electrode, a counter electrode and a reference electrode.”; [0209] “forming a working electrode WE on the base substrate 402,”; Fig 2, Fig 4); and
pads ([0102] “contact pads…”), wherein the pads corresponding to the at least one working electrode and the at least one additional electrode ([0108] “…contact pads are generally adapted for a direct wired electrical connection …for monitoring a user's condition in response to signals derived from the sensor electrodes 20”; [0102]). are arranged in the external part ([0102] “regions at a proximal end to form contact pads…”) and the pads are electrically connected with the at least one working electrode and the at least one additional electrode through wires ([0102] “electrical circuit for the sensor 400…two or more adjacent conductive paths with regions at a proximal end to form contact pads and regions at a distal end to for sensor electrodes”), each of two opposite surfaces of the at least one working electrode and/or the at least one additional electrode is provided with a micro structure ([0089] “One or more of the working, counter, reference and counter/reference electrodes comprise the pillar structures described herein.”; Fig 2, both sides of “electroactive surface 914” of “pillars 904” relative to the “analyte sensing layer 410” and “base substrate layer 402”; Fig 9C outward (top) surface to the left, inward (bottom) surface of the micro structure pillars to the right; [0007] “…electrodes formed from sputtering processes…the pillars form an electroactive surface of an electrode…height of not more than 10 micrometers…”; [0009]) (Examiner notes that the “electroactive surface 914” made up of “pillars 904” has an outward (up)-facing surface that is provided with the top portion of the micro structure pillars that interfaces with the “analyte sensing layer 410” and an opposite, inward (down)-facing surface that is provided with the base of the micro structure pillars that mates with the “base substrate layer 402”.)
Regarding Claim 2, Srinivasan discloses as described above, According to the micro analyte sensor mentioned in claim 1. For the remainder of Claim 2, Srinivasan discloses wherein the at least one additional electrode includes a counter electrode ([0101] “An operating sensor 400 typically includes a plurality of electrodes such as…a counter electrode…”).
Regarding Claim 3, Srinivasan discloses as described above, According to the micro analyte sensor mentioned in claim 2. For the remainder of Claim 3, Srinivasan discloses wherein the at least one additional electrode includes a reference electrode ([0101] “An operating sensor 400 typically includes a plurality of electrodes such as…a reference electrode…”).
Regarding Claim 4, Srinivasan discloses as described above, According to the micro analyte sensor mentioned in claim 3. For the remainder of Claim 4, Srinivasan discloses wherein each of the at least one working electrode, the reference electrode and the counter electrode ([0101] “…operating sensor 400 typically includes…working electrode, a counter electrode, and a reference electrode…”; [0100] “FIG. 2 illustrates a cross-section of a typical sensor embodiment 400 of the present invention”) at least include an electron conduction layer ([0075] “electrically conductive layer on the base substrate that function as one or more sensing elements.”; [0101] “conductive layer 404”), an anti-interference layer ([0081] “some compositions for use in the adhesion promoter layer are selected to play a role in interference rejection”; Fig 2, “adhesion promoter layer” 414), an enzyme layer ([0103] “the analyte sensing layer 410 is an enzyme layer.”; [0079]), an adjustment layer ([0097] “analyte modulating constituent…element 412 in FIG 2…modulate the diffusion of one or more analytes, such as glucose, through the constituents”)(Examiner notes that Applicant’s specification notes at [Page 4, 5th Full Paragraph] that the “adjustment layer d is mainly used to regulate the transmittance of oxygen and glucose transferred to the enzyme layer”, which describes modulating the diffusion of one or more analytes.) and a biological compatible layer ([0102] “polymer coatings for use as the insulating protective cover layer 406 can include, but are not limited to, non-toxic biocompatible polymers”; [0099]).
Regarding Claim 5, Srinivasan discloses as described above, According to the micro analyte sensor mentioned in claim 4. For the remainder of Claim 5, Srinivasan discloses wherein each of the electron conduction layer (Fig 2, “conductive layer 404”) of the at least one working electrode and the electron conduction layer (Fig 2, “conductive layer 404”) of the counter electrode ([0101] “…operating sensor 400 typically includes…working electrode, a counter electrode, and a reference electrode…”; [0100] “FIG. 2 illustrates a cross-section of a typical sensor embodiment 400 of the present invention”) is one of graphite, glassy carbon or noble metal ([0006] “metal (e.g. platinum) on the surface of an electrode...”; [0129] “Block 506…metal (e.g., Pt) pillar deposition…create metal pillars…gold, silver…iridium, platinum”; [0089] “One or more of the working, counter, reference and counter/reference electrodes comprise the pillar structures described herein.”).
Regarding Claim 6, Srinivasan discloses as described above, According to the micro analyte sensor mentioned in claim 5. For the remainder of Claim 6, Srinivasan discloses wherein each of the electron conduction layer (Fig 2, “conductive layer 404”) of the at least one working electrode and the electron conduction layer (Fig 2, “conductive layer 404”) of the counter electrode ([0101] “…operating sensor 400 typically includes…working electrode, a counter electrode, and a reference electrode…”; [0100] “FIG. 2 illustrates a cross-section of a typical sensor embodiment 400 of the present invention”) is platinum ([0006] “metal (e.g. platinum) on the surface of an electrode...”; [0129] “Block 506…metal (e.g., Pt) pillar deposition…create metal pillars…platinum”; [0089]).
Regarding Claim 8, Srinivasan discloses as described above, According to the micro analyte sensor mentioned in claim 4. For the remainder of Claim 8, Srinivasan discloses wherein the micro structure ([0007] “pillar structure”; [0129] “…metal pillars”) is arranged on the electron conduction layer ([0007] “the pillars form an electroactive surface of an electrode…have a height of not more than 10 micrometers and have a diameter in a range of 1 nanometer (nm)-1000 nm”); Fig 2, “conductive layer 404”; [0066] “sputtered pillar architecture”; [0076] “a thin film conductive layer by electrode deposition, surface sputtering…”) .
Regarding Claim 9, Srinivasan discloses as described above, According to the micro analyte sensor mentioned in claim 8. For the remainder of Claim 9, Srinivasan discloses wherein the micro structure ([0007] “pillar structure”; [0129] “…metal pillars”) includes micro grooves or micro bulges ([0007] “the pillars form an electroactive surface of an electrode…have a height of not more than 10 micrometers and have a diameter in a range of 1 nanometer (nm)-1000 nm”; [0136] “a grain size of approximately 10-100 nm with fissures separating grain clusters (a fibrous film structure with open porosity)”; Fig 9A)(Examiner notes that the micro “pillars” form micro bulges on the surface, as seen with the lighter portions (bulges of the top of pillars) between the darker pockets (spaces between pillars) shown in Fig 9A.).
Regarding Claim 10, Srinivasan discloses as described above, According to the micro analyte sensor mentioned in claim 9. For the remainder of Claim 10, concerning the micro grooves include…micro notches. Claim 9 (from which this claim depends) recites “wherein the micro structure includes micro grooves or micro bulges.” The limitations of that claim do not require that there is necessarily a micro groove present, therefore in the absence of micro grooves, there is no antecedent basis for the micro groove of Claim 5. As the limitations of Claim 10 concern the micro grooves, which are not required for Claim 9, the limitations of the claim are satisfied without the application of additional art, as the claimed invention does not require the micro grooves.
Regarding Claim 11, Srinivasan discloses as described above, According to the micro analyte sensor mentioned in claim 1. For the remainder of Claim 11, Srinivasan discloses wherein a diameter of the micro structure is 0.001-100µm ([0007] “pillars…diameter in a range of 1 nanometer (nm) – 1000 nm)(Examiner notes that 1 nm = 0.001 µm and 1000 nm = 1 µm, so this disclosed range of diameters for Srinivasan is 0.001 µm – 1 µm.)
Regarding Claim 13, Srinivasan discloses as described above, According to the micro analyte sensor mentioned in claim 1. For the remainder of Claim 13, Srinivasan discloses wherein the substrate comprises one or more combinations of polytetrafluoroethylene, polyethylene, polyvinyl chloride, acrylonitrile-butadiene-styrene copolymer, polymethyl methacrylate, polycarbonate and polyimide ([0072] “a base substrate comprising a dielectric material (e.g. a polyimide).”)(Examiner notes that a “polyimide” is made up of a combination of monomer units, so a polyimide is overall broadly one combination.)
Regarding Claim 14, Srinivasan discloses A continuous analyte monitoring device ([Abstract]; [0107]), comprising
a bottom shell ([0109] “lower layer 38”; Fig 3) configured to be installed on a surface of a host ([0109] “a mounting base 30 adapted for placement onto the skin of a user”, “The mounting base 30 includes upper and lower layers 36 and 38” ; Fig 3)(Examiner notes that “stalled” is broadly interpreted as “installed” or “mounted” on the surface of the host.);
a sensor unit ([0109] “subcutaneous sensor set 10”) comprising a base ([0109] “a mounting base 30) and at least one micro analyte sensor according to claim 1 (See citations in Claim 1), wherein the at least one micro analyte sensor ([0109] “sensor 12”) is fixed on the base([0109] “proximal part of the sensor 12 is mounted in a mounting base 30”) and the sensor unit is installed on the bottom shell through the base ([0109] “proximal part of the sensor 12 is mounted in a mounting base 30”, “…the connection portion 24 of the flexible sensor 12 being sandwiched between the layers 36 and 38”)(Examiner notes that the “connection portion 24” is part of the overall “subcutaneous sensor set 10.”) to detect analyte parameter information in the host ([0111] “The sensor 12 monitors glucose levels in the body; [0107]);
a transmitter unit ([0108] “characteristic monitor transmitter 200”) electrically connected with the sensor unit for outputting the analyte parameter information (Fig 3; [0108] “…connection portion 24… connected electrically to…a characteristic monitor transmitter 200”, “sensing set 10 includes….sensing portion 18…sensing portion 18 is joined to a connection portion 24”; [0107] “radio signals from the transmitter can be sent…provide real-time sensor glucose (SG) values.”);
a battery ([0110] “…monitor 400 includes…batteries 110”; Fig 3) configured to provide electric energy ([0113] “monitor 200 may include a power source”); and
a receiver configured to receive the analyte parameter information ([0107] “radio signals … can be sent to the pump receiver…to provide real-time sensor glucose (SG) values.”) and to display ([0107] “Values/graphs…displayed on a monitor of the pump receiver…self monitor blood glucose”)
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.
Claims 7 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Srinivasan in view of Zhu, (United States Patent Application Publication US 20160157765 A1), hereinafter Zhu.
Regarding Claim 7, Srinivasan discloses as described above, According to the micro analyte sensor mentioned in claim 4. For the remainder of Claim 7, Srinivasan does not disclose wherein the electron conduction layer of the reference electrode is one of Ag/AgCl or calomel. Srinivasan is open to combine with a different metal composition for the conductive layer of a reference electrode as disclosed at [0129] “ Any metal that is sputter or e-beam deposited could be used to create metal pillars. At a minimum (and for example purposes) this includes, but is not limited to… silver…Combinations of these metals (and others) could also be used along with…other materials (Ex. Titanium Nitride),” and [0072] “…a variety of different electrically conductive elements can be disposed on the base substrate”)
Zhu teaches film materials for biosensors to sense glucose, including a reference electrode made of Ag/AgCl and layered compositions for the reference, counter, and working electrodes. Specifically for Claim 7, Zhu teaches wherein the electron conduction layer of the reference electrode is one of Ag/AgCl or calomel ([0064] “the reference electrode is an Ag/AgCl electrode”).
Srinivasan provides a motivation to combine at [0072] with “…a variety of different electrically conductive elements can be disposed on the base substrate”). A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that Ag/AgCl is an electrically-conductive element that would be useful as a reference electrode material in a biosensing device.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the micro analyte sensor system with a working, counter, and reference electrode disclosed in Srinivasan with the Ag/AgCl material for the reference electrode taught by Zhu, creating a single micro analyte sensor system using Ag/AgCl as a conductive element in the reference electrode as a design choice.
In the interest of compact prosecution, should the limitation wherein the substrate comprises one or more combinations of be interpreted as requiring more than one listed material in the recited list of materials, then the following 35 U.S.C. 103 rejection applies:
Regarding Claim 13, Srinivasan discloses as described above, According to the micro analyte sensor mentioned in claim 1. For the remainder of Claim 13, Srinivasan discloses wherein the substrate comprises one or more combinations of polytetrafluoroethylene, polyethylene, polyvinyl chloride, acrylonitrile-butadiene-styrene copolymer, polymethyl methacrylate, polycarbonate and polyimide ([0072] “a base substrate comprising a dielectric material (e.g. a polyimide).”)(Examiner notes that a “polyimide” is made up of a combination of monomer units, so a polyimide is overall broadly one combination.)
Srinivasan does not specifically teach a combination that is more than one material in the list of recited materials.
Zhu teaches a biocompatible film sensor made of a combination of materials. Specifically for Claim 13, Zhu teaches wherein the substrate comprises ([0012] “the organosilicon polymer includes: …”) one or more combinations ([0012] “the organosilicon polymer includes: “(a) – (d)”), of polytetrafluoroethylene ([0012] “the organosilicon polymer includes: …(d) a property modifier or an reinforcing filler…filler may include polytetrafluoroethylene nano particles…”), polyethylene, polyvinyl chloride, acrylonitrile-butadiene-styrene copolymer, polymethyl methacrylate, polycarbonate ([0012] “the organosilicon polymer includes: …(b) a hydrophilic copolymer…which may be polycarbonate…”), and polyimide
Zhu provides a motivation to combine at [0012] with “The organosilicon polymer film material has good oxygen permeability, an adjustable water absorption rate, and can be used to adjust the permeability of analyte (e.g., glucose)…” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using the film layers would be useful for tuning the permeability of the analyte, which is a shared goal with the “modulation layer” disclosed by Srinivasan.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the layered micro analyte sensor with a modulation layer disclosed in Srinivasan with the organosilicon polymer for an electrode taught by Zhu, creating a single micro analyte sensor system using an organosilicon polymer to adjust the permeability of the glucose analyte of interest.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Srinivasan in view of Fukuda et. al,, (United States Patent Application Publication US 2011/0042237 A1), hereinafter Fukuda.
Regarding Claim 12, Srinivasan discloses as described above, According to the micro analyte sensor mentioned in claim 1. For the remainder of Claim 12, Srinivasan does not particularly disclose wherein a density of the micro structure is 1*102-1*1010unit structures/cm.2
Fukuda teaches an electrochemical sensor device for detecting analytes which has a plurality of conductive pillars on the surface. Specifically for Claim 12, Fukuda teaches wherein a density of the micro structure is 1*102-1*1010unit structures/cm2 (Fig 18, “Number of Pillars” 30, 143, 550 in surface area 0.42, 0.7, 1.11 (mm2), respectively.)(Examiner notes that using unit conversion, the number of pillars expressed in pillars/ cm2 would be 8,571 pillars/cm2, 20429 pillars/cm2, and 49550 pillars/cm2, respectively.; [0168] “…cylindrical protrusions (pillars) each having a diameter of 20 µm and a height of 50 µm were formed in the range of the working electrode portion.”)
Srinivasan and Fukuda both teach and disclose creating pillar structures disposed on an electrode surface: Srinivasan with “pillar structures” of the electrodes of the sensor and Fukuda with “cylindrical protrusions” “formed in the range of the working electrode portion” (Fukuda [0168]). Fukuda provides a motivation to combine at [0204] with “In particular, it was confirmed that, as the diameter of each of the pillars 51 was reduced and the number of the pillars increased, it was possible to cause ascorbic acid in the solution flowing above the working electrode 20 to react with the working electrode 20 in a larger amount with higher accuracy.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that specifying the number of pillars per area would be useful for determining how increasing or decreasing the coverage of pillars in a given area can increase or decrease the accuracy of the electrode.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the pillar structures of the electrodes of the analyte sensor with the density of number of pillars per area of an electrode taught by Fukuda, creating a single micro analyte sensor system to sense the analyte of interest at a particular level of accuracy.
Response to Arguments
Applicant's arguments filed 22 April 2026 have been fully considered but they are not persuasive.
Regarding Rejections under 35 U.S.C. 102/103:
Applicant argues at [Page 10, “Discussion of Claim Rejections under 35 U.S.C. 103” Section] – [Page 12, Paragraph 2] and [Page 13, Paragraph 3] that Srinivasan disclosed pillars 904 as the whole working electrode instead of structures provided onto the two opposite surfaces of the working electrode. As claimed, the microstructure must broadly provide each of two opposite surface of the at least one working electrode and/or the at least one additional electrode, which would broadly include the microstructure providing the entire structure of the electrode, with a top surface and a bottom surface to each of the pillars. It is not particularly claimed that the microstructure is adhered to two opposing surfaces with a different material sandwiched into the center. The argument is not persuasive.
Applicant argues at [Page 12, Paragraph 3] – [Page 13, 2nd Full Paragraph] that the main purpose of the pillar structures of Srinivasan is different from the purpose of the pillar structures of the amended claim 1, since Srinivasan’s are for addressing the defects in previously electroplated electrodes. In response to applicant's argument that the main purpose of the pillar structures of Srinivasan is different from the purpose of the pillar structures of the amended Claim 1, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2144 II. The argument is not persuasive.
Applicant argues at [Page 13, 3rd Full Paragraph] that Zhu and Fukuda do not disclose the microstructures on two opposite sides of the working electrode. As described in the 35 U.S.C. 102 rejection and the discussion above, Srinivasan discloses the microstructure providing two opposite sides of the working electrode as claimed. The argument is not persuasive.
Applicant summarily argues at [Page 13,4th Full Paragraph] - [Page 13, Bottom] that amended claim is in condition for allowance, and claims 2 – 14 are also allowable due to their dependency. Based on the 35 U.S.C. 102/103 rejections and the discussion above, Claim 1 remains rejected under 35 U.S.C. 102. The argument is not persuasive.
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 MELISSA J MONTGOMERY whose telephone number is (571)272-2305. The examiner can normally be reached Monday - Friday 7:30 - 5:00 ET.
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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