Prosecution Insights
Last updated: April 19, 2026
Application No. 18/439,796

ELECTROLYTE ANALYSIS DEVICE AND ELECTROLYTE ANALYSIS METHOD

Non-Final OA §102§103§112
Filed
Feb 13, 2024
Examiner
SUN, CAITLYN MINGYUN
Art Unit
1795
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Omron Healthcare Co. Ltd.
OA Round
1 (Non-Final)
64%
Grant Probability
Moderate
1-2
OA Rounds
3y 0m
To Grant
76%
With Interview

Examiner Intelligence

Grants 64% of resolved cases
64%
Career Allow Rate
183 granted / 288 resolved
-1.5% vs TC avg
Moderate +12% lift
Without
With
+12.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
80 currently pending
Career history
368
Total Applications
across all art units

Statute-Specific Performance

§101
1.5%
-38.5% vs TC avg
§103
47.9%
+7.9% vs TC avg
§102
17.3%
-22.7% vs TC avg
§112
28.8%
-11.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 288 resolved cases

Office Action

§102 §103 §112
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 . Election/Restrictions Applicant’s election without traverse of Group I, claims 1-10, drawn to an electrolyte analysis device in the reply filed on January 6, 2026 is acknowledged. Priority Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on February 18, 2022. It is noted, however, that applicant has not filed a certified copy of the JP2022-024118 application as required by 37 CFR 1.55. 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. 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 limitation(s) is/are: "peeling determination unit" in claims 1, 3, 6, and 8-9; “notification unit” in claim 4; “first calculation unit” in claim 5; “second calculation unit” in claims 6 and 8-9; “switching control unit” in claim 9. 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. The specification discloses the control unit 11 includes a micro controller unit (MCU) including a central processing unit (CPU) operated by software, and controls the entire operation of the electrochemical sensor (PGpub, ¶58), and the control unit 11 serves as a peeling determination unit (¶61), as a notification unit (¶81), as a first calculation unit (¶94), as a second calculation unit (¶71), and as a switching control unit (¶77). Thus, all of these units are the same control unit. 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. Claim(s) 4-9 is/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 pre-AIA the applicant regards as the invention. Claim 1 recites "peeling determination unit" and claims 4-9 recite “notification unit” in claim 4, “first calculation unit” in claim 5, “second calculation unit” in claims 6 and 8-9, and “switching control unit” in claim 9. Since the written description discloses the control unit 11 serves as a peeling determination unit (¶61), as a notification unit (¶81), as a first calculation unit (¶94), as a second calculation unit (¶71), and as a switching control unit (¶77), they are the same structure as the control unit 11 (¶58). Thus, “a peeling determination unit” in claim 1 is objected and suggested to be “a control unit.” Claims 4-6 and 8-9 are rejected and all of these units are suggested to be “the control unit” based on the antecedent basis “a control unit” in claim 1. Dependent claim(s) 7-9 is/are rejected based on rejected claim 6. Dependent claim(s) 9 is/are rejected based on rejected claim 8. 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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention. Claim(s) 1, 3-8 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Iwamoto (US 2014/0105788). Regarding claim 1, Iwamoto teaches an electrolyte analysis device (Fig. 1, 3; ¶29: a multi-ion sensor 1) for measuring a concentration of ions contained in an electrolyte (¶29: for measuring a concentration ratio of sodium ions to potassium ions in a sample solution; here, the preamble deemed to be a statement with regard to the intended use and are not further limiting in so far as the structure of the product is concerned. In article claims, a claimed intended use 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. MPEP § 2111.02(II)), the electrolyte analysis device comprising: a substrate (Fig. 3: substrate 11) extending in one direction from one end to an other end (Fig. 3: one end with electrodes 26, 27, 28 (referred as the tip side thereafter) and the other end with lead portions 21A, 22A, 25A (referred as the base side thereafter); a main electrode layer including a main base portion (Fig. 3: electrodes 26, 27) and a main extension portion (Fig. 3: conductive parts 21, 22) provided on one main surface of a pair of main surfaces of the substrate, the main base portion being provided in a specific region on a side of the one end in the one direction (Fig. 3: through hole 83, 84 on the tip side), the main extension portion extending from the main base portion to a side of the other end (Fig. 3: conductive parts 21, 22 extending from electrodes 26, 27 on the tip side to the base side); an ion selective film (Fig. 3: sodium ion sensitive membrane 15 and potassium ion sensitive membrane 16) provided to be in contact with the main base portion so as to cover the main base portion in the specific region (Fig. 3: membranes 15 and 16 covering the electrodes 26, 27 at through holes 83, 84), the ion selective film having a property of selectively allowing the ions to pass through the ion selective film (the sodium ion sensitive membrane 15 is inherently selectively permeable to sodium ions and potassium ion sensitive membrane 16 is inherently selectively permeable to potassium ions); and an auxiliary electrode layer including an auxiliary base portion (Fig. 3: electrode 28) and an auxiliary extension portion (Fig. 3: conductive part 25) provided on the one main surface of the pair of main surfaces of the substrate, the auxiliary base portion being provided in an auxiliary region different from the specific region (Fig. 3: through hole 82) and on the side of the one end in the one direction (Fig. 3: the tip side), the auxiliary extension portion extending from the auxiliary base portion to the side of the other end (Fig. 3: conductive part 25 extending from the electrode 28 on the tip side to the base side), wherein the auxiliary electrode layer is disposed in a state separated from the main electrode layer (Fig. 3), and the electrolyte analysis device further comprises a peeling determination unit (¶29: a circuit board constituting the arithmetic processing unit) that obtains, in a state where the electrolyte is in contact with the side of the one end of the substrate so as to cover the side of the one end (¶41: drops of an appropriate amount of the sample solution is applied onto the common electrode 28, sodium ion sensitive membrane 15 and potassium ion sensitive membrane 16), a potential of the main base portion via the main extension portion (¶9: ENa represents a potential of the sodium ion electrode, EK represents a potential of the potassium ion electrode) and a potential of the auxiliary base portion via the auxiliary extension portion (¶10: a potential ECOM of the common electrode), respectively, and determines whether or not the ion selective film is peeled from the main base portion based on a potential difference between an obtained potential of the main base portion and an obtained potential of the auxiliary base portion (¶41: the electromotive forces are detected as potential differences to thereby calculate ratios). Here, this limitation is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Iwamoto teaches all structural limitations of the presently claimed electrolyte analysis device which measures the potentials of the ions electrodes (Fig. 1: 41, 42) and the common electrode (Fig. 1: 28), and calculating the potential differences to calculate the concentration ratio of ions, and thus would have the ability of determining whether or not the ion selective film is peeled or not based on the potential difference between an obtained potential of the main base portion and an obtained potential of the auxiliary base portion. Regarding claim 3, the designation “wherein the peeling determination unit determines whether or not the ion selective film is peeled from the main base portion based on whether or not the potential difference is below a predetermined threshold value” is functional limitation in apparatus claims. MPEP 2114 (II). It does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Regarding claim 4, Iwamoto teaches a notification unit (¶29: a circuit board constituting the arithmetic processing unit). The limitation “that gives a notification of an occurrence of abnormality indicating that the ion selective film is peeled when it is determined that the ion selective film is peeled from the main base portion” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Iwamoto teaches all structural limitations of the presently claimed electrolyte analysis device which calculates the concentration ratio in the arithmetic processing unit to be displayed in the display unit 31 (¶42), and thus would have the ability of giving a notification of an occurrence of abnormality indicating that the ion selective film is peeled when it is determined that the ion selective film is peeled from the main base portion. Regarding claim 5, Iwamoto teaches a first calculation unit (¶29: a circuit board constituting the arithmetic processing unit). The limitation “that calculates, triggered by a determination, upon the determination, that the ion selective film is not peeled from the main base portion, the concentration of the ions contained in the electrolyte based on the potential difference between the potential of the main base portion and the potential of the auxiliary base portion” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Iwamoto teaches all structural limitations of the presently claimed electrolyte analysis device which measures the potentials of the ions electrodes (Fig. 1: 41, 42) and the common electrode (Fig. 1: 28), and calculating the potential differences for calculation of the concentration ratio of ions by the arithmetic processing unit (¶42), and thus would have the ability of calculating the concentration of the ions contained in the electrolyte based on the potential difference after the determination that the ion selective film is not peeled from the main base portion. Regarding claim 6, Iwamoto teaches wherein the electrolyte contains a first ion species and a second ion species different from each other (¶29: sodium ions and potassium ions), the specific region includes a first specific region and a second specific region (Fig. 3: through holes 83, 84) separated from each other on the side of the one end in the one direction on the one main surface (Fig. 3: the tip side), the main electrode layer includes, on the one main surface of the substrate (Fig. 3: the top surface of substrate 11), a first main base portion provided in the first specific region (Fig. 3: internal electrode 26 in the through hole 83), and a first main extension portion (Fig. 3: conductive part 21) extending from the first main base portion to the side of the other end, and a second main base portion provided in the second specific region (Fig. 3: internal electrode 27 in the through hole 84), and a second main extension portion (Fig. 3: conductive part 22) extending from the second main base portion to the side of the other end, the first main base portion and the first main extension portion being disposed in a state separated from the second main base portion and the second main extension portion (Fig. 3), the ion selective film includes a first ion selective film provided to be in contact with the first main base portion so as to cover the first main base portion in the first specific region (Fig. 3: sodium ion sensitive membrane 15 covering the internal electrode 21 in the through hole 83; ¶75: the gel internal solution 14a may be omitted), the first ion selective film having a property of selectively allowing the first ion species to pass through the first ion selective film (the sodium ion sensitive membrane 15 is inherently selectively permeable to sodium ions), and a second ion selective film provided to be in contact with the second main base portion so as to cover the second main base portion in the second specific region (Fig. 3: sodium ion sensitive membrane 16 covering the internal electrode 22 in the through hole 84; ¶75: the gel internal solution 14b may be omitted), the second ion selective film having a property of selectively allowing the second ion species to pass through the second ion selective film (the potassium ion sensitive membrane 15 is inherently selectively permeable to potassium ions), and the peeling determination unit (¶29: a circuit board constituting the arithmetic processing unit) obtains, in a state in which the electrolyte is in contact with the side of the one end of the substrate so as to cover the side of the one end (¶41: drops of an appropriate amount of the sample solution is applied onto the common electrode 28, sodium ion sensitive membrane 15 and potassium ion sensitive membrane 16), a first potential indicated by the first main base portion via the first main extension portion (¶9: ENa represents a potential of the sodium ion electrode), a second potential indicated by the second main base portion via the second main extension portion (¶9: EK represents a potential of the potassium ion electrode), and a third potential indicated by the auxiliary base portion via the auxiliary extension portion (¶10: a potential ECOM of the common electrode), respectively. The designation “determines whether or not the first ion selective film is peeled from the first main base portion based on a potential difference between an obtained first potential and an obtained third potential, and whether or not the second ion selective film is peeled from the second main base portion based on a potential difference between an obtained second potential and the obtained third potential” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Iwamoto teaches all structural limitations of the presently claimed electrolyte analysis device which measures the potentials of the ions electrodes (Fig. 1: 41, 42) and the common electrode (Fig. 1: 28), and calculating the potential differences for calculation of the concentration ratio of ions, and thus would have the ability of determining whether or not the first ion selective film is peeled from the first main base portion based on a potential difference between an obtained first potential and an obtained third potential (potential difference between ENa and ECOM), and whether or not the second ion selective film is peeled from the second main base portion based on a potential difference between an obtained second potential and the obtained third potential (potential difference between EK and ECOM). Regarding claim 7, Iwamoto teaches a second calculation unit (¶29: a circuit board constituting the arithmetic processing unit). The limitation “that calculates, triggered by a determination, upon the determination, that the first ion selective film is not peeled from the first main base portion and the second ion selective film is not peeled from the second main base portion, a concentration ratio between the first ion species and the second ion species contained in the electrolyte based on a potential difference between the first potential and the second potential” is deemed to be functional limitation in apparatus claims. MPEP 2114 (II). "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Here, Iwamoto teaches all structural limitations of the presently claimed electrolyte analysis device which measures the potentials of the ions electrodes (Fig. 1: 41, 42) and the common electrode (Fig. 1: 28), and calculates the potential differences for calculation of the concentration ratio of ions by the arithmetic processing unit (¶42), and thus would have the ability of calculating the concentration ratio between the first ion species and the second ion species based on the potential after the determination that neither ion selective film is not peeled from the main base portion. Regarding claim 8, Iwamoto teaches a test strip (Fig. 1: planar sensor 4) including the substrate (Fig. 3: substrate 11), the main electrode layer (Fig. 3: 26, 21 and 27, 22), the ion selective film (Fig. 3: 15, 16), and the auxiliary electrode layer (Fig. 3: 28, 25); and a main body (Fig. 1: main body 2) to which the test strip is detachably mounted (¶30), wherein the main body includes a connector (Fig. 1: the inserting lead portions 21A, 22A, 25A on the base side of the planar sensor 4) including a first contact electrode (Fig. 1: 21A), a second contact electrode (Fig. 1: 22A), and a third contact electrode (Fig. 1: 25A) that respectively come into contact with the first main extension portion, the second main extension portion, and the auxiliary extension portion (Fig. 3) when the side of the other end of the test strip is inserted in the connector (Fig. 1: being inserted into the insertion opening 2B), wherein the peeling determination unit and the second calculation unit are mounted on the main body (¶30: inserting the lead portions 21A, 22A and 25A of the planar sensor 4 into the insertion opening 2B, the lead portions 21A, 22A and 25A are connected to a circuit board constituting the arithmetic processing unit incorporated in the main body 2). Regarding claim 10, Iwamoto teaches wherein the auxiliary electrode layer is provided on the one main surface of the pair of main surfaces (Fig. 3: the layer of common electrode 28 and its conductive part 25 are on the top surface of the substrate 11). 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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Iwamoto in view of Heinz-Erian (US 2020/0309726). Regarding claim 2, Iwamoto discloses all limitations of claim 1, but fails to teach wherein a conductive material forming the main base portion is same as a conductive material forming the auxiliary base portion. However, Heinz-Erian teaches a single-use test-strip for the quantitative determination of sodium concentration and creatinine concentration and for the subsequent determination of their ratio (¶1), including two working electrodes and a reference electrode 8 (Fig. 1; ¶92). The working electrodes may be made of any conductive material (¶28), and the reference electrode is made from the same material as the working electrodes (¶31) to provide a controlled potential in biological fluids (¶30). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Iwamoto by using the same material for both the main base portion and the auxiliary base portion functioning as working electrodes and reference electrode as taught by Heinz-Erian because the working electrodes may be made of any conductive material (¶28), and the reference electrode is made from the same material as the working electrodes (¶31) as long as it provide a controlled potential in biological fluids (¶30). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A). Allowable Subject Matter Claim(s) 9 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: The prior art does not disclose nor render obvious all of the cumulative limitations of claim 9 with particular attention to the limitations: wherein the switching control unit controls the changeover switch to sequentially create, for the peeling determination unit, a first connection state in which the first contact electrode and the third contact electrode of the connector are electrically connected to the peeling determination unit via the wiring group, and a second connection state in which the second contact electrode and the third contact electrode are electrically connected to the peeling determination unit via the wiring group, and create, for the second calculation unit, a third connection state in which the first contact electrode and the second contact electrode of the connector are connected to the second calculation unit via the wiring group. Here, Iwamoto discloses all limitations of claim 8, including a test strip (Fig. 1: planar sensor 4) and a main body (Fig. 1: main body 2) so that when the test strip is inserted into the insertion opening of the main body 2 (Fig. 1: 2B), the lead portions 21A, 22A, 25A are connected to a circuit board constituting the arithmetic processing unit (¶30). The pertinent art, Elder (AU 2014202161), teaches a glucose test strip (Fig. 2: 24) connected to the microcontroller 122 upon the insertion of the test strip into the strip port opening 22 so as to be connected with the contacts (e.g., Fig. 2: 214, 224, 234) of the test strip port connector (SPC) 104 (Fig. 2; ¶23). The main body (Fig. 2: right side after the SPC) includes a wiring group (Fig. 2: the connecting lines between the SPC contacts 214, 224, 234 and the microcontroller 122), a changeover switch (Fig. 2: 225), and a switching control unit (Fig. 2: microcontroller 122). When a blood sample is provided to the test strip 24 by a user, the sample makes physical contact with the open circuit electrodes 208, 210 thereby closing the circuit and establishing an electrical connection with SPC contact 224 which shorts it to reference ground 236, thereby generating a negative going sample-detect interrupt signal transmitted to the microcontroller over the sample-detect output 232 (¶25). In response to receiving the sample-detect interrupt signal, microcontroller 122 energizes the blood glucose measurement circuit 242 and electronically activates switch 225 to connect SPC contact 224 to blood glucose measurement circuit input 240, thereby connecting the blood glucose measurement electrodes 208, 210 of the test strip 24 to the blood glucose current measurement circuit 242, whereupon a blood glucose assay (¶26). In another word, the microcontroller detects whether the test strip 24 is inserted into the port and then active the switch 225 to start glucose measurement upon the determination of insertion. However, neither Iwamoto nor Elder teaches the controller controls the switch to sequentially create a first connection state with the first contact electrode and the third contact electrode (sodium electrode and common electrode), and a second connection state with the second contact electrode and the third contact electrode (potassium electrode and common electrode), and create a third connection state with the first contact electrode and the second contact electrode of the connector are connected to the second calculation unit via the wiring group. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLYN M SUN whose telephone number is (571)272-6788. The examiner can normally be reached M-F: 8:30am - 5:30pm. 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, Luan Van can be reached on 571-272-8521. 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. /C. SUN/Primary Examiner, Art Unit 1795
Read full office action

Prosecution Timeline

Feb 13, 2024
Application Filed
Feb 19, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
64%
Grant Probability
76%
With Interview (+12.3%)
3y 0m
Median Time to Grant
Low
PTA Risk
Based on 288 resolved cases by this examiner. Grant probability derived from career allow rate.

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