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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “Receiver 105” from [Page 11, 1st Full Paragraph]. It is described as being part of Figure 6.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
“chassis” and “bottom shell” are both indicated as part 101 on [Page 11, 1st Full Paragraph]. It is unknown if those are intended to be interchangeable terms.
Reference character 102 has been used to indicate both “sensor unit” and “flyer unit” on [Page 11, 1st Full Paragraph] It is unknown if they are intended to be interchangeable terms.
Appropriate correction is required.
Claim Objections
Claim 12 is objected to because of the following informalities: Claim 12 recites the limitation “wherein a density of the micro structure is 1 * 10^2 ~ 1 * 10^10/cm^2”. The units recited are not specifically a density, as that requires a numerator unit per unit area. However, it appears that the intent is the “density” of unit structures within a unit area is intended to be claimed. It is suggested to modify the term to read “wherein a density of the micro structure is 1 * 10^2 ~ 1 * 10^10 unit structures/cm^2. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: Claim 14 recites the limitation “a bottom shell is stalled on a surface of a host”. For readability, it is suggested to change the term to read “configured to be installed on a surface of a host” or “configured to be mounted on a surface of a host”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
“transmitter unit” in claim 14 to “output the analyte parameter information”
The claim limitation is interpreted according to [Page 11, 1st Full Paragraph] “The transmitter unit 103 comprises an internal circuit 1031, an transmitter 1032 and an electrical connection area 1033. The electrical connection area 1033 is electrically connected with the sensor unit 102. The internal circuit 1031 stores the predetermined conditions of the electrode switching described above, and the transmitter 1032 is used to send the analytical parameter information to the outside world. “ The “Transmitter unit” is shown as 103 in Figure 6, encompassing parts “internal circuit 1031”, “transmitter 1032”, and “electrical connection area 1033”.
“receiver” in claim 14 to “display”
The claim limitation is interpreted according to [Page 11, 1st Full Paragraph] as “Receiver 105 is used to receive analyte parameter information and indicate to the user” and is described as being part of Figure 6. While the icon is unlabeled with a number, it appears that the transmission wave lines are directed toward an icon of a mobile device or tablet (to receive signals) in Figure 6.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 - 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 (lines 7, 9, and 10), Claim 4 (line 2), Claim 5 (line 3) and Claim 6 (line 3) each recite the limitation "the working electrode". There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is intended to be the same or different than the “at least one working electrode” previously recited in Claim 1. For the purposes of examination, the term "the working electrode" is deemed to claim “the at least one working electrode.” Claims 3 – 13 are similarly rejected due to their dependence on Claim 1.
Claim 1 (lines 8 - 11), Claim 2 (line 2), and Claim 3 (line 2), each recite the limitation "the additional electrode". There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is intended to be the same or different than the “at least one additional electrode” previously recited in Claim 1. For the purposes of examination, the term "the additional electrode" is deemed to claim “the at least one additional electrode”. Claims 3 – 13 are similarly rejected due to their dependence on Claim 1.
Claim 4 (line 3) and Claim 7 (lines 2 – 3) each recite the limitation "the reference electrode." There is insufficient antecedent basis for this limitation in Claim 4. There is no previously recited reference electrode in Claim 4 or the claims from which the Claim 4 depends. For the purposes of examination, the term “the reference electrode” in Claim 4 is deemed to claim “a reference electrode”. Assuming that the antecedent basis issue is corrected in Claim 4, the term “the reference electrode” in Claim 7 is deemed to claim “the reference electrode”. Claims 5 – 10 are similarly rejected due to their dependence on Claim 4.
The term “wherein a diameter of the micro structure is 0.001~100µm” in claim 11 is a relative term which renders the claim indefinite. The term “wherein a diameter of the micro structure is 0.001~100µm” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The tilde symbol “ ~ “ used for the range indicates that the desired range is “between about” 0.001 and 100 µm. The metes and bounds of the claim are unclear, as it is not indicated how close a value must be to 0.001 or 100 µm. For the purposes of examination, the term “wherein a diameter of the micro structure is 0.001 ~ 100µm” is deemed to claim ” wherein a diameter of the micro structure is 0.001 - 100µm”, with a dash instead of a tilde.
The term “1 * 102 ~ 1 * 1010 /cm2” in claim 12 is a relative term which renders the claim indefinite. The term “1 * 102 ~ 1 * 1010 /cm2” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The tilde symbol “ ~ “ used for the range indicates that the desired range is “between about” “1 * 102 and 1 * 1010 /cm2. The metes and bounds of the claim are unclear, as it is not indicated how close a value must be to 1 * 102 and 1 * 1010. For the purposes of examination, the term “1 * 102 ~ 1 * 1010 /cm2” is deemed to claim “1 * 102 - 1 * 1010 /cm2” with a dash instead of a tilde.
Claim 14 recites the limitation "the micro analyte sensor" in line 5. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is intended to be the same or different than the “at least one micro analyte sensor” previously recited in the claim. For the purposes of examination, the term “the micro analyte sensor" is deemed to claim “the at least one micro analyte sensor”.
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 working electrode and the 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 working electrode and the 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”), at least one surface of the working electrode and/or the additional electrode ([0089] “One or more of the working, counter, reference and counter/reference electrodes comprise the pillar structures described herein.”) is provided with a micro structure ([0007] “…electrodes formed from sputtering processes…the pillars form an electroactive surface of an electrode…height of not more than 10 micrometers…”; [0009] “pillar structures are disposed in multi electrode arrays, such as micro-electrode arrays.”) .
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 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 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 2. For the remainder of Claim 4, Srinivasan discloses wherein each of the 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 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 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) stalled 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 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*1010/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*1010/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.
Conclusion
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