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.
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 limitations use 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: “a calibration bridge” in independent claims 1, 26, and 33, and an “ion-to-electron transducer” in claim 5.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 14 and 31 are objected to because of the following informalities:
a) in claim 14, line 1 ”f” should be – of --; and
b) in claim 31, last line, the space between “electrode and the period” should be deleted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Note that dependent claims will have the deficiencies of base and intervening claims.
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 1-34 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:
a) independent claims 1, 26, and 33 are for “[a] self-calibrated electrochemical (SCE) sensor, . . . . [italicizing by the Examiner]” The scope of the term “self-calibrated” is indefinite. As evidenced by Chapter 7, Calibration Theory, of the NICO2000 Beginners Guide to ISE Measurement, and by Figure 9 and col. 10:4-50 of Michael Nichols US 4,312,734, calibration of an ion-selective electrode conventionally involves exposing the ion-selective electrode to multiple standard solutions each with a known different concentration of the target ion, measuring the ion-selective electrode response to each standard solution (such as potential difference relative to a reference electrode), plotting these data points (electrical response vs, target ion concertation) and best-fitting a line or curve through the data points. In self-calibration the standard solutions are included in the sensor itself (that is, not introduced from outside the sensor) or generated by the sensor itself. See, for example, Baker et al. US 4,654,127 the title, Abstract, col. 3:13-21, and col. 4:36-48; in Enzer et al. US 4,871,439 the title, Abstract, and
col. 4:20-34; and Bryan et al. US 5,098,547 the title and Abstract. However, the Examiner has not found any disclosure in Applicant’s specification of calibration, that is, of mathematically relating target analyte concentration to an indicator electrode electrical measurement response. Most especially, Applicant’s Example 3, which refers to Figures 3A and 3B each only show electromotive force versus time for a fixed K+ level. They at best demonstrate stability of the electrochemical sensor over time for certain K+ levels, not self-calibration of the sensor. Also, the calibration bridge in Applicant’s two working examples (110 in Figure 1A and 416 in Figures 4D and 5C) actually appear to be just be a conventional salt bridge (see also Applicant’s originally filed specification page 12, lines 28-29, and page 16, lines 9-12). Applicant is requested to clarify how he is using the terms “calibration” and “self-calibration”. If Applicant is being his own lexicographer, please heed MPEP 2173.05(a).
b) in independent claims 1, 26, and 33 the scope of the term “calibration bridge”, which appears to be unique to Applicant, is not clear. In Applicant’s example embodiment shown in Figure 1A the calibration bridge (capillary tube 110) appears to be what is conventionally understood in the electrochemical sensor art to be a salt bridge (see also Applicant’s originally filed specification page 12, lines 28-29). Likewise for the calibration bridge 416 in Applicant’s Figures 4D and 5C. See also Applicant’s specification page 16, lines 9-12. Applicant is requested to clarify how he is using the term “calibration bridge”. In particular, how is it different from a conventional salt bridge? If Applicant is being his own lexicographer, please heed MPEP 2173.05(a).
c) Claim 4 limitation “ion-to-electron transducer” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There does not appear to be example ion-to-electron transducer or shown (at least not any discernable detail) in any figure. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
d) Claim 30 recites the limitation " the calibration phase " in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
e) Claim 30 recites the limitation " the reference and/or counter electrode " in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
f) it is not clear what claim 31 further requires as it seems self-contradictory. For example, claim 31 requires “. . . .,introducing the aqueous sample and detecting the corresponding change of the current signal relative to the baseline current before introducing the aqueous sample . . . “ How can the aqueous sample be introduced before it is introduced? Also, it is not clear whether introducing the aqueous sample does or does not occur while continuing the coupling of the calibration phase to the indicator electrode and the reference and/or counter electrode.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 10-13, 16, 17, and 23 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lan et al. US 2016/0033438 A1 (hereafter “Lan”).
Addressing claim 1, Lan discloses an electrochemical sensor (see the title and Figure 8), comprising:
an indicator electrode (Figure 8a), comprising an ion-sensitive phase (“ISM” in Figure 8c, which represents ion-selective membrane (paragraph [0016])) coupled to a first electron conductor (in Figure 8c the Examiner is construing the wire (represented by a black line) between the voltmeter (represented by “V” in a circle; note “potentiometric ion sensing” in the title and see paragraphs [0050] and [0051]) and the Ag/AgCl of the ion-selective electrode as a first electron conductor) and including a sample first contact surface configured to interface an aqueous sample (from Figures 8a-c taken together (especially noting “sample zone” in Figure 8b) the “Paper” region of the bottom layer in Figure 8c to the left of ‘Salt bridge” and underneath ‘ISM” may be construed as the claimed sample first contact surface);
a reference electrode (Figures 8a and 8c), comprising a reference phase (AgAgCl (Figure 8c)), coupled to a second electron conductor (in Figure 8c the Examiner is construing the wire (represented by a black line) between the voltmeter (represented by “V” in a circle) and the Ag/AgCl of the reference electrode as a second electron conductor) and including a sample second contact surface configured to interface the aqueous sample (although apparently not intended, from Figures 8a-c taken together the “Paper” region of the bottom layer in Figure 8c to the right of “Salt bridge” and underneath “Ag/AgCl” could be used as the claimed sample second contact surface); and
a bridge, coupled to and between the indicator electrode and reference electrode (the Examiner is construing the “Salt bridge” in Figure 8c as this bridge).
Lan, though, does not disclose that the electrochemical sensor is a self-calibrated electrochemical (SCE) sensor. As a first matter, it is not clear what Applicant means by “self-calibrated” (see the first rejection of claim 1 under
35 U.S.C 112(b) above). In any event, since the electrochemical sensor of Lan is structurally and compositionally the same as claimed (most importantly include a calibration bridge as claimed ) it is assumed to have the same properties or functions as the claimed electrochemical sensor. See MPEP 2112 (I), 2112(II), 2112(V), and MPEP 2112.01(I).
Lan also does not explicitly disclose whether or not the salt bridge functions as calibration bridge configured to establish a baseline electrochemical signal. However, since the electrochemical sensor of Lan is structurally and compositionally the same claimed (most importantly, it is salt bridge as is the calibration bridge in Applicant’s two working examples1 ( capillary tube 110 in Applicant’s Figure 1A and 416 in Applicant’s Figures 4D and 5C. See also Applicant’s originally filed specification page 12, lines 28-29 , and specification page 16, lines 9-12 )) it is assumed to have the same properties or functions as the claimed electrochemical sensor. See MPEP 2112 (I), 2112(II), 2112(V), and MPEP 2112.01(I).
Addressing claim 2, for the additional limitation of this claim see Lan paragraph [0090], which discloses using conventional ISMs. Also, see paragraphs [0107] and [0113], which disclose particular polymer ISMs.
Addressing claim 3, for the additional limitation of this claim see Lan paragraphs [0107] and [0113], noting especially the following underlined features (ionophore and polymer (PVC)) of the ISMs
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Addressing claim 4, one of ordinary skill in the electrochemical sensor art would understand the first electron conductor for the indicator electrode (recall from the rejection of underlying claim 1, the black line in Figure 8c between the voltmeter (represented by “V” in a circle) and the Ag/AgCl of the ion-selective electrode) to be a metal wire.
Addressing claim 5, as a first matter is not clear from Applicant’s disclosure what is encompassed by “ion-to-electron transducer”, which invokes 35 U.S.C. 112(f). As such the Examiner construes the Ag/AgCl of the ion-selective electrode in Lan Figure 8c as an ion-to-electron transducer as one surface faces the ISM and the opposing surface is connected to the first electron conductor.
Addressing claims 10 and 11, for the additional limitations of these claims note the following in Lan paragraph [0031], “ A 10−3 M KCl solution was used as the inner filling and the reference solution. [italicizing by the Examiner]”
Addressing claim 12, note the additional limitation of this claim only further modifies an optional reference phase embodiment (hydrogel)2. Thus, claim 12 may be rejected on the same basis upon which claim 10 has been rejected, as Lan discloses the alternative aqueous solution embodiment.
Addressing claim 13, note the additional limitation of this claim only further modifies an optional reference phase embodiment (hydrogel)3. Thus, claim 12 may be rejected on the same basis upon which claim 10 has been rejected, as Lan discloses the alternative aqueous solution embodiment.
Addressing claim 16, one of ordinary skill in the electrochemical sensor art would understand the second electron conductor (recall from the rejection of underlying claim 1, the black line in Figure 8c between the voltmeter (represented by “V” in a circle) and the Ag/AgCl of the reference electrode) to be a metal wire.
Addressing claim 17, from Lan Figure 2 when viewed along-side
Figures 2a and 2c one of ordinary skill in the art would understand that the reference phase (Ag/AgCl) comprises a direct coating of the reference phase onto the second electron conductor (wire lead).
Addressing claim 23, for the additional limitation of this claim note the following in Lan
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Claim 6 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lan as evidenced by Yeon et al. US 2009/0288949 A1 (hereafter “Yeon”).
Addressing claim 6, as a first matter Lan alone meets all of the limitations of underlying claim 5. See the rejection of claim 5 above under 35 U.S.C 102(a)(2) based on Lan. Also, as indicated in that rejection, “the Examiner construes the Ag/AgCl of the ion-selective electrode in Lan Figure 8c as an ion-to-electron transducer”. Yeon paragraph [0009] evidences that Ag and AgCl are redox-active chemicals.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Lan in view of Gahlings et al. US 2020/0264123 A1 (hereafter “Gahlings”) and Matthaeus Speck US 2019/0195824 A1 (hereafter ‘Speck”).
Addressing claim 22, as a first matter Lan alone meets all of the limitations of underlying claim 1. See the rejection of claim 1 above under 35 U.S.C 102(a)(2) based on Lan. While Lan does not explicitly disclose that the electrochemical signal includes a combination of two or more different members of a group consisting of potential, current, impedance, conductance, and charge, if not already inherent, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to have the electrochemical signal include a combination of two or more different members listed in claim 22 because
(1) the calibration bridge in Lan is a salt bridge, and
(2) it was known in the art that various electrical properties had to be controlled if it was to properly perform its intended function. For example,
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(see Gahlings), and
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(see Speck).
Put another way, in light of the above disclosures of Gahlings and Speck it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to have the electrochemical signal include a combination of two or more different members listed in claim 22 (if not already inherent) because this is prima facie obvious as routine optimization of known result effective variables for salt bridges in electrochemical sensors. See MPEP 2144.05(II).
Claims 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Lan in view of Kuhlman US 6,730,201 B1 (hereafter ‘Kuhlman”), Anderson et al. US 2001/0051109 A1 (hereafter “Anderson”), and Ma et al. US 5,236,570 (hereafter “Ma”).
Addressing claim 24, as a first matter Lan alone meets all of the limitations of underlying claim 1. See the rejection of claim 1 above under 35 U.S.C 102(a)(2) based on Lan.
Lan, though, does not disclose the step of measuring the baseline signal established by the calibration bridge coupled to the indicator electrode and the reference electrode. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to perform this step because as disclosed by Kuhlman the baseline in ISEs (ion-sensitive electrodes) may be subject to shifting (Kuhlman col. 6:41-44 – “Self-diagnosis of performance in situ and dynamic recalibration are highly desirable for treatment of changing operation conditions and shifting baselines in the individual ISE sensors.”), or because as disclosed by Anderson interferants may the baseline measurement (Anderson paragraph [0022] – “The invention further deals with interfering species in a manner which eliminates the need for additional sensor or separate baseline measurements and employs a system which introduces a time delay potentiometric determination which enables the determination of the amount of background potential produced by interfering species prior to detection of the potential, including the analyte of interest which may be the same as an interfering ion species.”), or as disclosed by Ma if the sensor is to be used for more than one sample measurement a delay between measurements may be needed to allow the baseline to return to its initial value (Ma col. 9:27-28).
Put another way, in light of Kuhlman, Anderson, and Ma, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to perform the step of measuring the baseline signal established by the calibration bridge because this will help ensure the accuracy of the measurements by correcting a baseline shift, which may be due to various reasons.
As for the claim 24 limitation, “. . . ., and introducing the aqueous sample to the SCE sensor of claim 1, in a manner that interfaces the aqueous sample to both the ion-sensitive phase and the reference phase…”, this step will inherently occur when the electrochemical sensor of Lan is used as intended because, on the one hand, when aqueous sample is applied to the sample zone it will interface with ion-sensitive phase as the indicator electrode is part of the sample zone (Lan Figures 8a-c), and, on the other hand, will interface with the reference phase because Lan discloses
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Addressing claim 25, the additional limitations of this claim may be inferred from Lan paragraph [0051]
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One of ordinary skill in the art would understand that E0 is the baseline signal.
Claims 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Lan in view of Bihar et al., “A fully inkjet-printed disposable glucose sensor on paper.” npj Flexible Electronics (2018) 30 (hereafter “Bihar”).
Addressing claim 26, Lan discloses an electrochemical sensor (see the title and Figure 8), comprising:
an indicator electrode (Figure 8a), comprising an ion-sensitive phase (“ISM” in Figure 8c, which represents ion-selective membrane (paragraph [0016])) coupled to a first electron conductor (in Figure 8c the Examiner is construing the wire (represented by a black line) between the voltmeter (represented by “V” in a circle; note “potentiometric ion sensing” in the title and see paragraphs [0050] and [0051]) and the Ag/AgCl of the ion-selective electrode as a first electron conductor) and including a sample first contact surface configured to interface an aqueous sample (from Figures 8a-c taken together (especially noting “sample zone” in Figure 8b) the “Paper” region of the bottom layer in Figure 8c to the left of ‘Salt bridge” and underneath ‘ISM” may be construed as the claimed sample first contact surface);
a reference electrode (Figures 8a and 8c), comprising a reference phase (AgAgCl (Figure 8c)), coupled to a second electron conductor (in Figure 8c the Examiner is construing the wire (represented by a black line) between the voltmeter (represented by “V” in a circle) and the Ag/AgCl of the reference electrode as a second electron conductor) and including a sample second contact surface configured to interface the aqueous sample (although apparently not intended, from Figures 8a-c taken together the “Paper” region of the bottom layer in Figure 8c to the right of “Salt bridge” and underneath “Ag/AgCl” could be used as the claimed sample second contact surface); and
a bridge, coupled to and between the indicator electrode and reference electrode (the Examiner is construing the “Salt bridge” in Figure 8c as this bridge).
Lan, though, does not disclose that the electrochemical sensor is a self-calibrated electrochemical (SCE) sensor. As a first matter, it is not clear what Applicant means by “self-calibrated” (see the first rejection of claim 1 under
35 U.S.C 112(b) above). In any event, since the electrochemical sensor of Lan is structurally and compositionally the same as claimed (most importantly include a calibration bridge as claimed ) it is assumed to have the same properties or functions as the claimed electrochemical sensor. See MPEP 2112 (I), 2112(II), 2112(V), and MPEP 2112.01(I).
Lan also does not explicitly disclose whether or not the salt bridge functions as calibration bridge configured to establish a baseline electrochemical signal. However, since the electrochemical sensor of Lan is structurally and compositionally the same claimed (most importantly, it is salt bridge as is the calibration bridge in Applicant’s two working examples4 ( capillary tube 110 in Applicant’s Figure 1A and 416 in Applicant’s Figures 4D and 5C. See also Applicant’s originally filed specification page 12, lines 28-29 , and specification page 16, lines 9-12 )) it is assumed to have the same properties or functions as the claimed electrochemical sensor. See MPEP 2112 (I), 2112(II), 2112(V), and MPEP 2112.01(I).
In the Figure 8 embodiment relied upon above the indicator electrode is an ion-selective electrode. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to instead have the indicator electrode be a glucose measurement electrode, particularly one using glucose oxidase, because (1) Lan discloses
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, and (2) in light of Bihar, which discloses a paper-based glucose sensor using glucose oxidase (see the title, abstract, and Figure 1c), such a substitution of indicator electrode (glucose indicator electrode, such as that of Bihar, for an ion-selective indicator electrode) is prima facie obvious as simple substitution of one known element (indicator electrode) for another to obtain predictable results. See MPE 2143(I)(B).
Addressing claim 27, for the additional limitation of this claim see Bihar Figure 1c noting the Nafion membrane, Mediator (ferrocene), and Dielectric.
Claims 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Lan in view of Bihar as applied to claim 27 above, and further in view of Kuhlman, Anderson, and Ma.
Addressing claim 30, as for the step of “. . . ., obtaining a baseline current from an SCE sensor according to claim 27, based on the coupling of the indicator electrode and the reference and/or counter electrode by the calibration phase before introducing the aqueous sample to the sensor…”, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to perform this step because as disclosed by Kuhlman the baseline in ISEs (ion-sensitive electrodes) may be subject to shifting (Kuhlman col. 6:41-44 – “Self-diagnosis of performance in situ and dynamic recalibration are highly desirable for treatment of changing operation conditions and shifting baselines in the individual ISE sensors.”), or because as disclosed by Anderson interferants may the baseline measurement (Anderson paragraph [0022] – “The invention further deals with interfering species in a manner which eliminates the need for additional sensor or separate baseline measurements and employs a system which introduces a time delay potentiometric determination which enables the determination of the amount of background potential produced by interfering species prior to detection of the potential, including the analyte of interest which may be the same as an interfering ion species.”), or as disclosed by Ma if the sensor is to be used for more than one sample measurement a delay between measurements may be needed to allow the baseline to return to its initial value (Ma
col. 9:27-28).
Put another way, in light of Kuhlman, Anderson, and Ma, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to perform the step of obtaining a baseline current5 established by the calibration bridge because this will help ensure the accuracy of the measurements by correcting a baseline shift, which may be due to various reasons.
Addressing claim 31, as a first matter it is not clear what is intended by the additional limitation of this claim. See the rejection of this claim under 35 U.S.C. 112(b) above. As best understood by the Examiner it would be inherently met by Lan as modified by Bihar because any current measurement in the sensor, whether the aqueous sample has been introduced or not, would require coupling of the calibration phase to the indicator electrode and the reference electrode.
Addressing claim 32, for the additional limitation of this claim first note the following on Bihar page 4, “In order to evaluate the sensor performance, we
monitored the real-time changes in the current of the sensor upon additions of cumulative concentrations of glucose (from 50 μM to 2 mM) into the measurement solution (Fig. 3c). [italicizing by the Examiner”]” It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to have the measured change in current be relative to the baseline current in order to make the measurement more accurate (see again the reasons for measuring baseline current in the rejection of underlying claim 30).
Other Relevant Prior Art
The International Search Report for International application No. PCT/US2022/041841 cites US 2015/0101938 A1 as a “Y” document against claims 1-25 of that application, US 6,554,982 B1 as a “Y” document against claims 1-25, an article by Vanamo et al. as a “Y” document against claims 5 and 6; an article by Galiullin et al. as a “Y” document against claims 7-9, KR 10-2018-0044040 A as a “Y” document against claims 13 and 14; and US 2020/0363367 A is cited as a “Y” document against claim 17. The corresponding Written Opinion deems claims 1-25 to have novelty, but lack an inventive step over the documents cited as “Y” documents in the International Search Report.
US 2015/0101938 A1 is the base document in the rejections in the Written Opinion. More importantly, it is relied upon in the rejection of claim 1 for “self-calibrating” and a “calibration bridge”. While self-calibrated electrochemical sensor of US 2015/0101938 A1 can be said to in one mode of use (calibrating) to disclose a calibration bridge (paragraph [0081] –“ The pumped reference solution is configured to cover reference electrode 360 and indicating electrode 375 completing an electrical circuit to which electronics module 320 is connected.”) as set forth in claim 1 of U.S. application 18/682532, during this mode of use the indicator electrode no longer includes a sample first contact surface configured to interface an aqueous sample, as the indicator electrode will be covered with refence solution, and likewise the reference electrode no longer includes a sample second contact surface configured to interface the aqueous sample. When the self-calibrated electrochemical sensor of
US 2015/0101938 A1 is not in self-calibration mode (for example, when measuring a sample), the indicator electrode and reference electrode can possibly be viewed to be as set forth in claim 1 of U.S. application 18/682532; however, fluidic channel 359 no longer appears to be a calibration bridge. US 2015/0101938 A1 in fact discloses that in some embodiments it functions as a gate (paragraph [0075]). The other “Y” documents do not overcome these deficiencies.
Allowable Subject Matter
Claims 7-9, 14-21, 24, 28, 29, 33, and 34 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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:
a) in claim 7 the combination of limitations requires “. . . .wherein the reference phase comprises a water-immiscible material containing a hydrophobic salt. [underlining by the Examiner]”
In contrast, in Lan the reference phase comprises AgCl, which while being a water-immiscible salt, as it is insoluble (see, for example, Battaglia et al. US 4,214,968 col. 8:32-43 and col. 10:22-28), cannot clearly be said to be hydrophobic (repelling water, and typically non-polar).
b) claims 8 and 9 each depend from allowable claim 7.
c) in claim 14 the combination of limitations requires “. . . .wherein the aqueous solution comprises an aqueous solution first part, which is coupled to the first electron conductor, and an aqueous solution second part, which interfaces with the aqueous sample, the aqueous solution first part contains one salt, the aqueous solution second part contains a different salt, and the SCE sensor further comprises a barrier that separates the aqueous solution first part from the aqueous solution second part, and the barrier is configured to allow slow ion diffusion and not allow fast mixing of the aqueous solution first part and the aqueous solution second part.”
In contrast, Lan does not disclose an aqueous solution as claimed. More importantly, perhaps, Lan does not disclose a barrier as claimed.
d) in claim 15 the combination of limitations requires “. . . .wherein the reference phase comprises a polymer containing one or more inorganic salts.”
In contrast, in Lan the reference phase comprises a metal coating (Ag/AgCl)6 and paper containing aqueous salt solution (KCl). See Lan Figures 8C and 9, and paragraphs [0029], [0031], and [0045].
e) in claim 18 the combination of limitations requires “. . . ., wherein the calibration bridge comprises a calibration phase and a barrier, the barrier being configured to prevent mixing of the calibration phase with the aqueous sample.”
In contrast, there is no such barrier in the electrochemical sensor of Lan; the calibration bridge is a middle region of a paper channel extending in one direction to the indicator electrode and in another direction to reference electrode. See Lan Figure 8C and paragraph [0041].
f) clams 19-21 each depend from allowable claim 18.
g) in claim 24 the combination of limitations requires the step of “. . . ., . . . . introducing the aqueous sample to the SCE sensor of claim 1, in a manner that interfaces the aqueous sample to both the ion-sensitive phase and the reference phase.”
h) in claim 28 the combination of limitations requires “ . . . ., wherein the calibration bridge includes a calibration phase made of a solution, hydrogel, or polymer that contains a known concentration of glucose.”
In contrast, in the electrochemical sensor of Lan as modified by Bihar as discussed in the rejection of underlying claim 26 the calibration bridge (salt bridge) would likely stay the same even though tie ion-selective indicator electrode of Lan Figure 8 is replaced. Even if the composition of the calibration bride were to altered it is not likely that it will have a known concentration of glucose.
i) claim 29 depends from allowable claim 28.
j) in claim 33 the combination of limitations requires “an indicator electrode comprising an electron conductor modified with functional coatings for detection of specific analytes, a reference electrode, and a calibration bridge that couples the indicator electrode with the reference.”
In contrast, in Lan if the electrochemical sensor were to be modified to be able to detect multiple specific analytes, multiple indicator electrodes would be provided, each presumably optimized for a specific analyte. See in Lan
Figure 5(a) and paragraphs [0025] and [0068]-[0070]
k) claim 34 depends from allowable claim 33.
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/ALEXANDER S NOGUEROLA/Primary Examiner, Art Unit 1795 October 28, 2025
1 The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings."). "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
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See MPEP 804 II.B.2(a).
2 Underlining claim 10 states, “wherein the reference phase comprises a hydrogel containing one or more salts or an aqueous solution containing one or more salts. [underlining by the Examiner]”
3 Underlining claim 10 states, “wherein the reference phase comprises a hydrogel containing one or more salts or an aqueous solution containing one or more salts. [underlining by the Examiner]”
4 The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings."). "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
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