DETAILED CORRESPONDENCE
Summary
This is the initial Office Action based on the Antoine, et al. application filed with the Office on 6 September 2022.
Claims 1-20 are currently pending and have been fully considered.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application claims priority to a US Provisional Patent Application, 63/242,977, filed on 10 September 2021. Thus, the effective filing date of the instant application is 10 September 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted regarding the present application filed on 6 September 2022, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner.
Claim Interpretation
All the present claims are currently drawn to an apparatus, which include recited limitations that define the intended use of the claimed apparatus. It has held that 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). The reference(s) applied in the prior art rejection(s) below teach the claimed structural elements.
A claimed apparatus must be distinguished from the prior art apparatus on the basis of structure. Therefore, the patentability of an apparatus claim depends only on the claimed structure, not on the use or purpose of that structure, Catalina Marketing Int'l., Inc. v. Coolsavings.com Inc., 289 F.3d 801, 809 (Fed. Cir. 2002), or the function or result of that structure. In re Danly, 263 F.2d 844, 848 (CCPA 1959); In re Gardiner, 171 F.2d 313, 315-16 (CCPA 1948). “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb, Inc., 909 F.2d 1464, 1468, 15 USPQ2d 1525 (Fed. Cir. 1990).
The United State Court of Appeals for the Federal Circuit has held that a statement of intended use in an apparatus claim cannot distinguish over a prior art apparatus that discloses all the recited structural limitations and is capable of performing the recited function. See In re Schreiber, 128 F.3d 1473, 1477 [44 USPQ2d 1429] (Fed. Cir. 1997). It has also been noted that “[a]n intended use or purpose usually will not limit the scope of the claim because such statements usually do no more than define a context in which the invention operates.” See Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 [65 USPQ2d 1961] (Fed. Cir. 2003). Although “[s]uch statements often … appear in the claim's preamble,” a statement of intended use or purpose can appear elsewhere in a claim. In re Stencel, 828 F.2d 751, 754 [4 USPQ2d 1071] (Fed. Cir. 1987). It is well settled that language in an apparatus claim directed to the function, operation, intent-of-use, and materials upon which these apparatus components work, that does not structurally limit the claimed apparatus components or patentably differentiate the claimed apparatus from an otherwise identical prior art apparatus, will not support patentability. See, e.g., In re Rishoi, 197 F.2d 342, 344-45 (CCPA 1952); In re Otto, 312 F.2d 937, 940 (CCPA 1963); In re Ludtke, 441 F.2d 660, 663-64 (CCPA 1971); In re Yanush, 477 F.2d 958, 959 (CCPA 1973); Pearson, 494 F.2d 1399, 1403, 181 USPQ 641, 644 (CCPA 1974); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Sinex, 309 F.2d 488, 135 USPQ 302 (CCPA 1962).
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.
Claims 1-5, and 8-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a US Patent Application Publication to Balasubramanian, et al. (US 2014/0262831 A1; hereinafter, “Balasubramanian”).
Regarding claim 1, Balasubramanian discloses a sensor assembly for sensing an analyte in a sample matrix (“…the exemplary sensor card including the hemolysis sensor in the bank of sensors in the sensor assembly…”, [0012]), the sensor assembly comprising:
an electrode assembly comprising a set of one or more test electrodes to interact with the analyte and provide a sensor signal based on said interaction (“Other electrodes in the plurality of sensors may include one or more of, glucose 91, lactate 92, creatine 118, creatinine 116, pCO2 93, pH 94, K+ 90, ca++ 86, Na+ 78, and pO2 70.”, [0039]); and
an applicator assembly to enable application of the sample matrix to the set of one or more test electrodes (“… whole blood to be analyzed by the system 8 are introduced through a sample inlet 13a.”, [0037]),
wherein the electrode assembly is to define one or more active test electrodes of the set of one or more test electrodes (“Other electrodes in the plurality of sensors may include one or more of, glucose 91, lactate 92, creatine 118, creatinine 116, pCO2 93, pH 94, K+ 90, ca++ 86, Na+ 78, and pO2 70.”, [0039]),
which one or more active test electrodes contribute to the sensor signal (“The electrical signal generated by the oxidation of hydrogen peroxide at the working electrode 57 is carried by a platinum wire in the working electrode 57 and transferred to the conductor 61 which is in electrical communication with the electrical interface 38 and contacts 36 …”, [0070]).
As to the recited limitation: “wherein at least one of the electrode assembly and the applicator assembly is to adjust a quantity of the analyte provided to the one or more active test electrodes, per unit time, for said interaction based at least in part on an analyte characteristic”, it is intended use language, as indicated via the phrase “is to adjust a quantity”. This intended usage language does not provide a difference in the claimed structure, but rather dictates the action during usage of the claimed apparatus. Therefore, as the Balasubramanian reference teaches all the structure of the claimed sensor assembly, the instant claim is not considered to differentiate from the prior art.
Regarding claim 2, Balasubramanian teaches the analyte characteristic includes at least one of a concentration of the analyte in the sample matrix (“… the hemolysis sensor, according to the invention, is useful for assessing whether or not an increase in the concentration of various analytes in a patient's blood sample …”, [0032]).
Regarding claim 3, the recited limitations are drawn to intended use language, as indicated via the phrases “is to obtain an initial indication” and “is to adjust a quantity”. This intended usage language does not provide a difference in the claimed structure, but rather dictates the action during usage of the claimed apparatus. Therefore, as the Balasubramanian reference teaches all the structure of the claimed sensor assembly, the instant claim is not considered to differentiate from the prior art.
Regarding claim 4, the recited limitations are drawn to intended use language, as indicated via the phrase “is to adjust the number”. This intended usage language does not provide a difference in the claimed structure, but rather dictates the action during usage of the claimed apparatus. Therefore, as the Balasubramanian reference teaches all the structure of the claimed sensor assembly, the instant claim is not considered to differentiate from the prior art.
Regarding claim 5, the recited limitations are drawn to intended use language, as indicated via the phrase “is to switch”. This intended usage language does not provide a difference in the claimed structure, but rather dictates the action during usage of the claimed apparatus. Therefore, as the Balasubramanian reference teaches all the structure of the claimed sensor assembly, the instant claim is not considered to differentiate from the prior art.
Regarding claim 8, the recited limitations are drawn to intended use language, as indicated via the phrase “is to adjust”. This intended usage language does not provide a difference in the claimed structure, but rather dictates the action during usage of the claimed apparatus. Therefore, as the Balasubramanian reference teaches all the structure of the claimed sensor assembly, the instant claim is not considered to differentiate from the prior art.
Regarding claim 9, the recited limitations are drawn to intended use language, as indicated via the phrase “is to adjust”. This intended usage language does not provide a difference in the claimed structure, but rather dictates the action during usage of the claimed apparatus. Therefore, as the Balasubramanian reference teaches all the structure of the claimed sensor assembly, the instant claim is not considered to differentiate from the prior art.
Regarding claim 10, the recited limitations are drawn to intended use language, as indicated via the phrase “is to adjust”. This intended usage language does not provide a difference in the claimed structure, but rather dictates the action during usage of the claimed apparatus. Therefore, as the Balasubramanian reference teaches all the structure of the claimed sensor assembly, the instant claim is not considered to differentiate from the prior art.
Regarding claim 11, Balasubramanian discloses a sensor assembly for sensing an analyte in a sample matrix (“…the exemplary sensor card including the hemolysis sensor in the bank of sensors in the sensor assembly…”, [0012]), the sensor assembly comprising:
an electrode assembly comprising a set of one or more test electrodes to interact with the analyte and provide a sensor signal based on said interaction (“Other electrodes in the plurality of sensors may include one or more of, glucose 91, lactate 92, creatine 118, creatinine 116, pCO2 93, pH 94, K+ 90, ca++ 86, Na+ 78, and pO2 70.”, [0039]);
wherein the electrode assembly is to define one or more active test electrodes of the set of one or more test electrodes (“Other electrodes in the plurality of sensors may include one or more of, glucose 91, lactate 92, creatine 118, creatinine 116, pCO2 93, pH 94, K+ 90, ca++ 86, Na+ 78, and pO2 70.”, [0039]),
which one or more active test electrodes contribute to the sensor signal (“The electrical signal generated by the oxidation of hydrogen peroxide at the working electrode 57 is carried by a platinum wire in the working electrode 57 and transferred to the conductor 61 which is in electrical communication with the electrical interface 38 and contacts 36 …”, [0070]).
As to the recited limitation: “wherein the electrode assembly is to adjust a quantity of the analyte provided to the one or more active test electrodes, per unit time, for said interaction based at least in part on an analyte characteristic by varying an effective active test electrode area”, it is intended use language, as indicated via the phrase “is to adjust a quantity”. This intended usage language does not provide a difference in the claimed structure, but rather dictates the action during usage of the claimed apparatus. Therefore, as the Balasubramanian reference teaches all the structure of the claimed sensor assembly, the instant claim is not considered to differentiate from the prior art.
Regarding claim 12, the recited limitations are drawn to intended use language, as indicated via the term “varying”. This intended usage language does not provide a difference in the claimed structure, but rather dictates the action during usage of the claimed apparatus. Therefore, as the Balasubramanian reference teaches all the structure of the claimed sensor assembly, the instant claim is not considered to differentiate from the prior art.
Regarding claim 13, the recited limitations are drawn to intended use language, as indicated via the phrase “is to adjust”. This intended usage language does not provide a difference in the claimed structure, but rather dictates the action during usage of the claimed apparatus. Therefore, as the Balasubramanian reference teaches all the structure of the claimed sensor assembly, the instant claim is not considered to differentiate from the prior art.
Claims 11 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a US Patent Application Publication to Zhou, et al. (US 2008/0087544 A1; hereinafter, “Zhou”).
Regarding claims 11 and 12, Zhou teaches an electrochemical chip (200) that may be used with one or more microelectrode arrays that include individualized gold working electrodes (116) strategically arranged in an array fashion to detect heavy metal ions in aqueous solutions (Figure 2; [0142]). These arrays have the capability to run as individual addressable microelectrodes while performing numerous tests in a single experiment, or to run as one electrode, increasing the overall surface area of the electrode. In addition, or in another embodiment, the arrays provide some intermediate partial individualization and partial colonization of the electrodes ([0142]). Thus, by individual addressing the microelectrodes under partial or as one collective electrode, Zhou teaches varying the effective active test electrode area, and wherein varying the effective active test electrode area comprises a varying the number of electrodes (by adjusting the number of individually addressable electrodes) of the set of one or more tests electrodes.
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Balasubramanian as applied to claim 1 above, and further in view of a US Patent Application Publication to Easley, et al. (US 2018/0259483 A1; hereinafter, “Easley”).
Regarding claim 7, Balasubramanian teaches the limitations of instant claim 1, as outlined above.
Balasubramanian does not teach a set of one or more control electrodes.
However, Easley discloses a method of target molecule detection includes simultaneously obtaining a first signal from a first working electrode and a second signal from a second working electrode, wherein the first signal is responsive to interaction of the first recognition element with the target molecule in a sample, and the second signal is indicative of background noise from the sample (Abstract). The method further includes generating a modified signal that is proportional to an instantaneous difference between the first and second signals, wherein the modified signal indicates an amount of the target molecule present in the sample (Abstract). Easley further teaches the second working electrode is in communication with the sample cell is not coated with the first recognition element, and the second working electrode is configured to measure a second signal indicative of background noise from the sample ([0004]). The configuration of the first and second working electrodes shown in Figure 1B demonstrate that the amount of analyte provided to each of the first working electrode (i.e., the test electrode) and the second working electrode (i.e., the control electrode) is substantially equal.
At the time of the filing of the instant application it would have been obvious to one of ordinary skill in the art to adapted the control electrodes taught by Easley into the sensor assembly disclosed by Balasubramanian as it would allow correction of the concentration measurements of the analyte to yield more accurate measurements.
Claims 14, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Balasubramanian in view of Easley.
Regarding claim 14, a sensor assembly for sensing an analyte in a sample matrix (“…the exemplary sensor card including the hemolysis sensor in the bank of sensors in the sensor assembly…”, [0012]), the sensor assembly comprising:
an electrode assembly, comprising: a set of one or more test electrodes (“Other electrodes in the plurality of sensors may include one or more of, glucose 91, lactate 92, creatine 118, creatinine 116, pCO2 93, pH 94, K+ 90, ca++ 86, Na+ 78, and pO2 70.”, [0039]),
the set of one or more test electrodes comprising an analyte interaction portion to interact with the analyte and provide a sensor signal based on said interaction (“The electrical signal generated by the oxidation of hydrogen peroxide at the working electrode 57 is carried by a platinum wire in the working electrode 57 and transferred to the conductor 61 which is in electrical communication with the electrical interface 38 and contacts 36 …”, [0070]), and
a flow path to provide the sample matrix to the electrode assembly (“… whole blood to be analyzed by the system 8 are introduced through a sample inlet 13a.”, [0037]).
Balasubramanian does not teach a set of one or more control electrodes,
the set of one or more control electrodes providing a control electrode area for providing a control measurement which is independent of the analyte, and wherein the electrode assembly is in the flow path so that amounts of sample matrix provided to each of the set or one or more test electrodes and the set of one or more control electrodes are substantially equal.
However, Easley discloses a method of target molecule detection includes simultaneously obtaining a first signal from a first working electrode and a second signal from a second working electrode, wherein the first signal is responsive to interaction of the first recognition element with the target molecule in a sample, and the second signal is indicative of background noise from the sample (Abstract). The method further includes generating a modified signal that is proportional to an instantaneous difference between the first and second signals, wherein the modified signal indicates an amount of the target molecule present in the sample (Abstract). Easley further teaches the second working electrode is in communication with the sample cell is not coated with the first recognition element, and the second working electrode is configured to measure a second signal indicative of background noise from the sample ([0004]). The configuration of the first and second working electrodes shown in Figure 1B demonstrate that the amount of analyte provided to each of the first working electrode (i.e., the test electrode) and the second working electrode (i.e., the control electrode) is substantially equal.
At the time of the filing of the instant application it would have been obvious to one of ordinary skill in the art to adapted the control electrodes taught by Easley into the sensor assembly disclosed by Balasubramanian as it would allow correction of the concentration measurements of the analyte to yield more accurate measurements.
Regarding claim 15, Easley teaches the configuration of the first and second working electrodes shown in Figure 1B demonstrate that the amount of analyte provided to each of the first working electrode (i.e., the test electrode) and the second working electrode (i.e., the control electrode) is substantially equal, i.e., 50%-50%.
Regarding claim 19, Easley teaches the sensor channel 56 passes through the sensor channel 56 to the output section 34, it passes over a number of sensors, for example, the hemolysis sensor 110, as illustrated in FIG. 2 ([0042]), the electrodes being configured upon a first face of the electrode card substrate, and wherein the electrodes assembly is arranged in the flow path such that the flow path is parallel to the first face of the sensor card.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Balasubramanian in view of Easley as applied to claim 19 above, and further in view of a published International Application to Denuzzio, et al. (WO 2004/001404 A1; hereinafter, “Denuzzio”).
Regarding claim 20, Balasubramanian in view of Easley teaches the limitations of instant claims 14 and 19, as outlined above.
Neither reference teaches interdigitated electrodes.
However, Denuzzio discloses microfabricated sensor arrays, wherein the electrodes of the sensor array may have an interdigitated configuration (102d, Figure 4c).
Therefore, at the time of the filing of the instant application, it would have been obvious to one of ordinary skill in the art to have utilized the taught interdigitated electrode configuration of Denuzzio as the electrode configuration of the sensor assembly taught by Balasubramanian in view of Easley because it would be a simple substitution of a known electrode configuration for another known electrode configuration.
Allowable Subject Matter
Claims 6, 12, and 16-18 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 cited Balasubramanian reference is considered to be the closest prior art to the instant claims. However, Balasubramanian does not anticipate nor render obvious: a) the electrode assembly is configured for switching active and/or inactive electrodes (as required by instant claim 6); b) varying the effective active electrode area comprises varying the number of electrode of defined as active electrodes (as required by instant claim 12); or c) the electrode assembly is arranged within the flow path such that the first face of the substrate crosses the central axis of the flow path (as required by instant claims 16-18).
Interview with the Examiner
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The Automated Interview Request form (AIR) is available to request an interview to be scheduled with the Examiner. First, an authorization for internet communications regarding the case should be filed prior or with an AIR online request.
The internet communication authorization form (SB/0439), which authorizes or withdraws authorization for internet-based communication (e.g., video conferencing, email, etc.) for the application must be signed by the applicant or the attorney/agent for applicant. The form can be found at:
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN C BALL whose telephone number is (571)270-5119. The examiner can normally be reached M - F, 9 am - 5:30 pm.
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/J. Christopher Ball/ Primary Examiner, Art Unit 1795
31 December 2025