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 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.
No claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 12 is objected to because of the following informalities:
in claim 12, line 2: “the” should be inserted before “two second sensing sections”; and
in claim 12, line 3: “the” should be inserted before “two second working electrodes”.
Appropriate correction is required.
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.
Claim 12 is 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 12 recites “two opposite sides of the first sensing section” in lines 3-4, but it is not clear if this recitation is the same as, related to, or different from “at least one side of the first sensing section” of claim 8, lined 10. The relationship between these two recitations should be made clear.
Claim Rejections - 35 USC § 102
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 16 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP 2003-503090 JP 2003-503090 (JP 090). Citations to JP 090 will refer to the machine English translation that accompanies this Office Action.
With respect to claim 16, JP 090 teaches a sensing structure of a micro biosensor for implantation under a skin (the sensor is implanted in the body subcutaneously; abstract and page 2 of JP 090) to measure a physiological parameter of a target analyte (glucose is the target analyte; page 2 of JP 090) of a biofluid and reduce an interference of an interferant of the biofluid on a measurement by an electrochemical reaction (using the two electrode configuration to remove interfering substances; page 6 of JP 090), comprising:
a substrate (the base layer 112 made from biocompatible thin polymeric sheet material; page 3 of JP 090) having a surface;
a first working electrode (the working electrode 104 of JP 090) configured above the surface of the substrate, and having an active surface (pages 3-4 of JP 090);
at least one second working electrode configured on the surface of the substrate and adjacent to at least one side of the first working electrode, for consuming the interferant by the electrochemical reaction (the electrode at the entrance of the diffusion passage that is oxidizes interferents; page 6 of JP 090).
an isolated layer (the top layer 116 of JP 090) at least configured with respect to at least a part of the active surface to form a space between the isolated layer and the at least one second working electrode, wherein the space is configured to program a diffusive distribution of the interferant when the biofluid flows through the at least one second working electrode (the space between the top layer 116 of JP 090 and the electrode at the entrance of the diffusion passage that is oxidizes interferents is so configured; page 6 of JP 090), wherein:
wherein at least the interferant of the biofluid passes through the at least one second working electrode over a time period and is consumed by the at least one second working electrode by the electrochemical reaction (the biofluid passes over the electrode at the entrance of the diffusion passage first so as to oxidize interferents before proceeding to the working electrode 104 of JP 090; page 6 of JP 090).
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.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2003-503090 JP 2003-503090 (JP 090), in view of U.S. Patent Application Publication No. 2013/0008802 (Hsu), and further in view of U.S. Patent Application Publication No. 2012/0283537 (Petisce). Citations to JP 090 will refer to the machine English translation that accompanies this Office Action.
With respect to claims 1 and 8, JP 090 teaches a micro biosensor for implantation under a skin (the sensor is implanted in the body subcutaneously; abstract and page 2 of JP 090) to measure a physiological parameter of a target analyte (glucose is the target analyte; page 2 of JP 090) of a biofluid and reduce an interference of an interferant of the biofluid on a measurement by an electrochemical reaction (using the two electrode configuration to remove interfering substances; page 6 of JP 090), comprising:
a substrate (the base layer 112 made from biocompatible thin polymeric sheet material; page 3 of JP 090) being a sheet and having a first surface and a second surface which are oppositely configured;
a first working electrode (the working electrode 104 of JP 090) at least including a first sensing section configured above the first surface of the substrate, wherein the first sensing section of the first working electrode includes a first conductive material (the conductive material of the working electrode 104; pages 3-4 of JP 090);
at least one second working electrode configured on the first surface of the substrate, and including a second sensing section, wherein the second sensing section is configured adjacent to at least one side of the first sensing section, and the second sensing section of the at least one second working electrode includes a second conductive material different from the first conductive material (the electrode at the entrance of the diffusion passage that is oxidizes interferents; page 6 of JP 090; Hsu suggests that the same type of material for measurement electrodes can also be the same for the material for interferents-removal due to its teaching that the same electrodes can be used for measurement and interferent removal (see Abstract of Hsu); It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the same type of material for the interferent removal electrode of JP 090 as the material for the measurement electrode of JP 090 since a type of material is required and Hsu teaches that the same type of material may apply to both.).
Petisce teaches a flux-limiting membrane disposed over the at least one interferent-reducing layer and the enzyme layer (Abstract of Petisce). The flux limiting membrane is positioned over the layers so as to alter or change the rate of flux of one or more of the analytes (paragraph 0082 of Petisce). As a result, the upper limit of linearity of the measurement is extended to a much higher value than that which is achieved without the flux limiting membrane (paragraph 0083 of Petisce). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the flux-limiting membrane disposed over the electrodes since the upper limit of linearity of the measurement is extended to a much higher value than that which is achieved without the flux limiting membrane. Thus, the combination teaches or suggests a first functional membrane (the flux limiting membrane of Petisce and the analyte-reactive detection layer of JP 090; page 2 of JP 090) covering the first sensing section of the first working electrode and the second sensing section of the at least one second working electrode, for regulating a diffusion amount of the biofluid to the first sensing section of the first working electrode and the second sensing section of the at least one second working electrode, wherein the first functional membrane includes a chemical reagent (the analyte-reactive detection layer of JP 090; page 2 of JP 090) at least covering a part of the first conductive material to define an active surface of the first sensing section, for reacting with the target analyte of the biofluid so as to obtain a resultant.
The combination further teaches:
an isolated layer (the top layer 116 of JP 090) at least configured with respect to at least a part of the active surface of the first sensing section of the first working electrode to form a space between the isolated layer and the at least one second working electrode, wherein the space is configured to optimize/delineate a diffusive path of the interferant of the biofluid when the interferant passes through the second sensing section of the at least one second working electrode or when the interferant causes the biofluid to gain an increased opportunity to interact with the second sensing section of the at least one second working electrode or wherein the space is configured to program a diffusive distribution of the interferant when the biofluid flows through the at least one second working electrode (the space between the top layer 116 of JP 090 and the electrode at the entrance of the diffusion passage that is oxidizes interferents is so configured; page 6 of JP 090), wherein:
the biofluid diffuses to the second sensing section over a time period, and then diffuses to the first sensing section after passing through the second sensing section (the biofluid passes over the electrode at the entrance of the diffusion passage first so as to oxidize interferents before proceeding to the working electrode 104 of JP 090; page 6 of JP 090).
Hsu teaches that the voltage for measuring analytes is less than the voltage for interferents-removal (abstract and paragraphs 0028-0030 of Hsu). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a first voltage at the interferent-removing electrodes for a first time period and to use a second voltage at the analyte measuring electrodes for a second time period in which the first voltage is greater than the second since voltages for operating the electrodes are required and Hsu teaches such voltages. Thus, the combination teaches or suggests:
when the first working electrode is driven by a first working voltage, the first sensing section reacts with the resultant for outputting a physiological signal corresponding to the physiological parameter of the target analyte (the lower second voltage suggested by Hsu); and
when the at least one second working electrode is driven by a second working voltage, the second sensing section consumes the interferant of the biofluid by the electrochemical reaction during the time period (the higher first voltage suggested by Hsu), and a remaining part of the biofluid diffuses to the first sensing section of the first working electrode after passing through the second sensing section, for reducing the interference of the interferant to the physiological signal (page 6 of JP 090) or wherein at least the interferant of the biofluid passes through the at least one second working electrode over a time period and is consumed by the at least one second working electrode by the electrochemical reaction (page 6 of JP 090).
With respect to claims 2, 7, 9, 11, and 13, the combination teaches or suggests that the isolated layer is configured on the first functional membrane and at least with respect to the first sensing section of the first working electrode to at least shield a part of the active surface and to isolate the interferant from diffusing to the active surface directly (the top layer 116 of JP 090 is so configured relative to the working electrode 104 of JP 090).
JP 090 does not teach the relative sizes of the components other than the relative sizes depicted in FIG. 1 of JP 090. This depiction along with the teachings that the sensor is small (page 6 of JP 090) and the dimensions can vary (page 3 of JP 090) suggests that the relative and absolute dimensions of the components are subject to change. The relative and absolute dimensions of the components would depend upon the user and manufacturing preferences. As such, the relative and absolute dimensions of the components are results-effective variables that would have been optimized through routine experimentation based on the user and manufacturing preferences. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the relative and absolute dimensions of the components so as to obtain the desired user and manufacturing preferences.
Also, relative dimensions do not make a claimed device patentable if the claimed device does not perform differently from the prior art device (MPEP 2144.04 citing In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.).
In view of the above, the features of “the isolated layer is 0.5-10 times an area of the active surface of the first sensing section, the isolated layer has a thickness ranging from 1-80 m” of claim 2; “the first functional membrane has a thickness defined by a distance between the isolated layer and the active surface of the first sensing section, and the thickness is no less than 0.05 µm and no larger than 50 µm” of claim 7; “wherein the second sensing section is configured adjacent to the at least one side of the first sensing section with a gap, and the gap is no larger than 0.5 mm” of claim 11; and “wherein a side of the second sensing section extends along a periphery of the first sensing section, and a part of the periphery of the first sensing section adjacent to the second sensing section accounts for 30%-100% of a total length of the periphery of the first sensing section” of claim 13 would have been obvious.
With respect to claim 2, Hsu teaches that the time period for the first voltage ranges from 1-15 seconds (paragraph 0024 of Hsu) or 0.1-1 second (paragraph 0052 of Hsu). This suggests that the time period for the first voltage is subject to change. The time period for the first voltage would depend upon the user preferences and desired interferent removal. As such, the time period for the first voltage is a results-effective variable that would have been optimized through routine experimentation based on the user preferences and desired interferent removal. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the time period for the first voltage, using the time periods suggested by Hsu as a starting point, so as to obtain the desired user preferences and desired interferent removal. Thus, the feature of “the time period is ranged from 10 seconds to 15 minutes” of claim 2 would have been obvious.
With respect to claims 3 and 10, the combination teaches or suggests that the isolated layer is further configured with respect to the second sensing section of the at least one second working electrode to at least shield a part of the second sensing section (the top layer 116 of JP 090 is so configured relative to the electrode at the entrance of the diffusion passage that is oxidizes interferents; page 6 of JP 090).
With respect to claim 4, Hsu teaches that the interferent-removal voltage can be in a range of 0.15-1 volts while the measuring voltage can be in the range of 0.1-0.9 volts (paragraph 0052 of Hsu). This suggests that the measuring and interferent-removal voltages are subject to change. The measuring and interferent-removal voltages would depend upon the user preferences, sensor accuracy, and desired interferent removal. As such, the measuring and interferent-removal voltages are results-effective variables that would have been optimized through routine experimentation based on the user preferences, accuracy, and desired interferent removal. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the measuring and interferent-removal voltages, using the voltage ranges suggested by Hsu as a starting point, so as to obtain the desired user preferences, accuracy, and desired interferent removal. Thus, the feature of “wherein the first working electrode is driven by the first working voltage to allow the first sensing section to have a measurement range, and the at least one second working electrode is driven by the second working voltage to allow the second sensing section to have an interference eliminating range contacting a surrounding of the first working electrode and at least partially overlapping with the measurement range” would have been obvious.
With respect to claim 5, the combination teaches or suggests that the second sensing section of the at least one second working electrode is configured adjacent to at least two sides of the first sensing section of the first working electrode (the electrode at the entrance is adjacent to three sides of the first sensing section of the electrode 104; see the below schematic of JP 090 in which the adjacent sides of the electrode 104 are adjacent to the electrode at the entrance even if they are not parallel with a particular side of the electrode at the entrance), and the isolated layer is further configured with respect to the second sensing section to at least shield a part of the second sensing section configured adjacent to the at least two sides of the first sensing section (the top layer 116 of JP 090 covers the electrode at the entrance).
PNG
media_image1.png
492
825
media_image1.png
Greyscale
Schematic FIG based on arrangement suggested by JP 090
With respect to claim 6, the combination teaches or suggests that when the first working electrode is driven by the first working voltage (the electrode 104 is driven by the second voltage of Hsu for measuring), the first conductive material has a first sensitivity to the resultant (the sensitivity is implied or implicit by the measurements taken), and when the at least one second working electrode is driven by the second working voltage (the electrode at the entrance is derive by the first voltage of Hsu for interferent-removing), the second conductive material has a second sensitivity, which is smaller than the first sensitivity, to the resultant (this sensitivity is implied or implicit since the electrode at the entrance is not used for measurement).
With respect to claim 7, the combination teaches or suggests that the isolated layer is configured on the first functional membrane (the top layer 116 of JP 090 is configured on the flux limiting membrane of Petisce).
With respect to claim 12, Petisce teaches that interferents removing components can have a number of at least one (abstract of Petisce) and can include two, three or more (paragraphs 0007 and 0069 of Petisce) with the measuring component located therebetween (paragraphs 0007 and 0073 of Petisce). Hsu also teaches the use of multiple electrodes for interferent-removal with the use of the expression “at least two electrodes” (abstract of Hsu). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include two, three or more interferent-removing electrodes with at least the measuring electrode positioned between two of them since it provide for better removal of the interferent and/or it is a mere duplication of parts that does not provide a new and unexpected result (MPEP 21044.04 citing In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.). Thus, the combination teaches or suggests that a number of the at least one second working electrode is two (two interferent-removing electrodes of JP 090), and two second sensing sections of two second working electrodes are respectively configured adjacent to two opposite sides of the first sensing section (the placement is suggested by Petisce and/or it is a mere rearrangement of parts (MPEP 21044.04 citing In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice).).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over JP 2003-503090 JP 2003-503090 (JP 090), in view of U.S. Patent Application Publication No. 2013/0008802 (Hsu), and further in view of U.S. Patent Application Publication No. 2012/0283537 (Petisce), and further in view of U.S. Patent No. 6,129,823 (Hughes). Citations to JP 090 will refer to the machine English translation that accompanies this Office Action.
Hughes teaches the use of a mesh layer to protect the components of the sensor from physical damage (col. 4, lines 50-65 of Hughes). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a mesh layer over the components of the sensor so as to protect the components from physical damage.
With respect to claim 15, the combination teaches or suggests at least one counter electrode (the counter electrode 108 of JP 090) configured on the second surface, and coupled to at least one of the first working electrode and the at least one second working electrode; and a second functional membrane (the mesh layer of Hughes on the components of the sensor) wrapping the first surface and the second surface of the substrate to cover the first functional membrane and the isolated layer.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over JP 2003-503090 JP 2003-503090 (JP 090), in view of U.S. Patent Application Publication No. 2012/0283537 (Petisce), and further in view of WO 2007/147475 (Staib). Citations to JP 090 will refer to the machine English translation that accompanies this Office Action.
Petisce teaches a flux-limiting membrane disposed over the at least one interferent-reducing layer and the enzyme layer (Abstract of Petisce). The flux limiting membrane is positioned over the layers so as to alter or change the rate of flux of one or more of the analytes (paragraph 0082 of Petisce). As a result, the upper limit of linearity of the measurement is extended to a much higher value than that which is achieved without the flux limiting membrane (paragraph 0083 of Petisce). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the flux-limiting membrane disposed over the electrodes since the upper limit of linearity of the measurement is extended to a much higher value than that which is achieved without the flux limiting membrane.
Staib teaches that a diffusion barrier can protect the sensor from mechanical damage during the implantation process (pages 9-10 of Staib). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to wrap the flux-limiting membrane around the substrate so as to protect the sensor from mechanical damage during the implantation process.
With respect to claim 17, the combination teaches or suggest a first functional membrane (the flux limiting membrane of Petisce and the analyte-reactive detection layer of JP 090; page 2 of JP 090) configured between the first working electrode and the isolated layer, and wrapping the substrate, the first working electrode and the at least one second working electrode (the sensor is also wrapped in the flux limiting membrane), for regulating a diffusion amount of the biofluid diffused to the first working electrode and the at least one second working electrode (the flux-limiting membrane of Petisce is so designed), wherein the first functional membrane comprises a chemical reagent (the analyte-reactive detection layer of JP 090; page 2 of JP 090) at least covering a part of the first working electrode to define the active surface for reacting with the target analyte of the biofluid so as to obtain a resultant; wherein the diffusive distribution is that at least a remaining part of the biofluid reaches the first working electrode after passing through the at least one second working electrode (the biofluid passes over the electrode at the entrance of the diffusion passage first so as to oxidize interferents before proceeding to the working electrode 104 of JP 090; page 6 of JP 090); and wherein the surface is a top surface of the substrate, and both of the first working electrode and the at least one second working electrode are configured on the top surface (the electrode at the entrance and the electrode 104 are so positioned on the base layer 112 of JP 090).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2003-503090 JP 2003-503090 (JP 090), in view of U.S. Patent Application Publication No. 2012/0283537 (Petisce), and further in view of WO 2007/147475 (Staib), in view of U.S. Patent Application Publication No. 2013/0008802 (Hsu). Citations to JP 090 will refer to the machine English translation that accompanies this Office Action.
Hsu teaches that the voltage for measuring analytes is less than the voltage for interferents-removal (abstract and paragraphs 0028-0030 of Hsu). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a first voltage at the interferent-removing electrodes for a first time period and to use a second voltage at the analyte measuring electrodes for a second time period in which the first voltage is greater than the second since voltages for operating the electrodes are required and Hsu teaches such voltages.
With respect to claim 18, the combination teaches or suggest that when the first working electrode is driven by a first working voltage, the first working electrode reacts with the resultant for outputting a physiological signal corresponding to the physiological parameter of the target analyte (the second voltage of Hsu for measuring); and when the at least one second working electrode is driven by a second working voltage, the at least one second working electrode consumes the interferant by performing the electrochemical reaction within the time period for reducing the interference of the interferant to the physiological signal (the first voltage of Hsu for interferent removal).
With respect to claim 19, Hsu teaches that the interferent-removal voltage can be in a range of 0.15-1 volts while the measuring voltage can be in the range of 0.1-0.9 volts. This suggests that the measuring and interferent-removal voltages are subject to change. The measuring and interferent-removal voltages would depend upon the user preferences, sensor accuracy, and desired interferent removal. As such, the measuring and interferent-removal voltages are results-effective variables that would have been optimized through routine experimentation based on the user preferences, accuracy, and desired interferent removal. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the measuring and interferent-removal voltages, using the voltage ranges suggested by Hsu as a starting point, so as to obtain the desired user preferences, accuracy, and desired interferent removal. Thus, the feature of “wherein the first working voltage is 0.2-0.8 volt, and the second working voltage is 0.2-0.8 volt” would have been obvious.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over JP 2003-503090 JP 2003-503090 (JP 090), in view of U.S. Patent Application Publication No. 2013/0008802 (Hsu). Citations to JP 090 will refer to the machine English translation that accompanies this Office Action.
Hsu teaches that the voltage for measuring analytes is less than the voltage for interferents-removal (abstract and paragraphs 0028-0030 of Hsu). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a first voltage at the interferent-removing electrodes for a first time period and to use a second voltage at the analyte measuring electrodes for a second time period in which the first voltage is greater than the second since voltages for operating the electrodes are required and Hsu teaches such voltages.
With respect to claim 20, Hsu teaches that the time period for the first voltage ranges from 1-15 seconds (paragraph 0024 of Hsu) or 0.1-1 second (paragraph 0052 of Hsu). This suggests that the time period for the first voltage is subject to change. The time period for the first voltage would depend upon the user preferences and desired interferent removal. As such, the time period for the first voltage is a results-effective variable that would have been optimized through routine experimentation based on the user preferences and desired interferent removal. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the time period for the first voltage, using the time periods suggested by Hsu as a starting point, so as to obtain the desired user preferences and desired interferent removal. Thus, the feature of “wherein the time period is ranged from 10 seconds to 15 minutes” of claim 20 would have been obvious.
Claims 8 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2013/0008802 (Hsu), and further in view of U.S. Patent Application Publication No. 2012/0283537 (Petisce).
With respect to claim 8, Hsu teaches a micro biosensor, comprising:
a substrate (the strip 20 of Hsu) having a first surface and a second surface which are oppositely configured;
a first working electrode (the electrode 21 of Hsu) at least including a first sensing section configured above the first surface of the substrate, for measuring the physiological parameter of the target analyte;
at least one second working electrode (the electrode 22 of Hsu) configured on the first surface of the substrate, and including a second sensing section, wherein the second sensing section is configured adjacent to at least one side of the first sensing section for consuming the interferant by the electrochemical reaction.
Petisce teaches a flux-limiting membrane disposed over the at least one interferent-reducing layer and the enzyme layer (Abstract of Petisce). The flux limiting membrane is positioned over the layers so as to alter or change the rate of flux of one or more of the analytes (paragraph 0082 of Petisce). As a result, the upper limit of linearity of the measurement is extended to a much higher value than that which is achieved without the flux limiting membrane (paragraph 0083 of Petisce). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the flux-limiting membrane disposed over the electrodes since the upper limit of linearity of the measurement is extended to a much higher value than that which is achieved without the flux limiting membrane. Thus, the combination teaches or suggests a first functional membrane (the flux limiting membrane of Petisce and the reagent 214 of Hsu) covering the first sensing section of the first working electrode and the second sensing section of the at least one second working electrode, for regulating a diffusion amount of the biofluid to the first sensing section of the first working electrode and the second sensing section of the at least one second working electrode, wherein the first functional membrane includes a chemical reagent (the reagent 214 of Hsu) at least covering a part of the first sensing section to define an active surface for reacting with the target analyte of the biofluid so as to obtain a resultant.
The combination further teaches:
an isolated layer (the cover 27 of Hsu) at least configured with respect to at least a part of the active surface to form a space between the isolated layer and the at least one second working electrode, wherein the space is configured to delineate a diffusive path of the interferant when the interferant causes the biofluid to gain an increased opportunity to interact with the second sensing section of the at least one second working electrode (the space between the cover 27 of Hsu and the electrodes is so configured), wherein:
when the first working electrode is driven by a first working voltage, the first sensing section reacts with the resultant for outputting a physiological signal corresponding to the physiological parameter of the target analyte (the lower second voltage of Hsu); and
when the at least one second working electrode is driven by a second working voltage, the second sensing section consumes the interferant of the biofluid by the electrochemical reaction (the higher first voltage suggested by Hsu), and a remaining part of the biofluid diffuses to the first sensing section after passing through the second sensing section, for reducing the interference of the interferant to the physiological signal (the electrode configuration has this effect after the interferents are removed).
With respect to claim 14, the combination teaches or suggests that the chemical reagent (the reagent 214 of Hsu) is further covering a part of the second sensing section of the at least one second working electrode (paragraph 0048 of Hsu).
Response to Arguments
The Applicant's arguments filed 1/20/2026 have been fully considered.
Claim objections
There are new grounds of claim objections that were necessitated by the claim amendments filed on 1/20/2026.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
There are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph that were necessitated by the claim amendments filed on 1/20/2026.
Prior art rejections
The Applicant’s arguments with respect to the rejection of claims 1-20 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. That is, there are new grounds of claim rejections that were necessitated by the claim amendments filed on 1/20/2026.
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 MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
Prosecution Insights