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 .
Claims 1-9 are pending.
Specification
2. The disclosure is objected to because of the following informalities: the status of the related applications listed in paragraph [0001] should be updated.
Appropriate correction is required.
Double Patenting
3. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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4. Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,740,202 in view of Hnaien et al ("Immobilization of specific antibody on SAM functionalized gold electrode for rabies virus detection by electrochemical impedance spectroscopy", Biochemical Engineering Journal, 39, 2008, 443 -449); hereafter referred to as Hnaien), and Durst et al (US 5,753,519; hereafter referred to as Durst).
Patent ‘202 claims:
1. An apparatus for detecting one or more analytes in a bodily fluid sample utilizing Electrochemical Impedance Spectroscopy (EIS) or Electrochemical Capacitance Spectroscopy (EC S), comprising:
an electrochemical sensor comprising:
a substrate;
a plurality of electrodes including a working electrode disposed on the substrate,
a filter paper interfaced with the plurality of electrodes, the filter paper (i) disposed on the plurality of electrodes and (ii) arranged to collect the bodily fluid and wet the plurality of electrodes with the bodily fluid, and
a plurality of target-capturing molecules immobilized to the working electrode,
wherein an electrochemical impedance or electrochemical capacitance measurement of one or more analytes in the bodily fluid is measured based on a current applied to the plurality of electrodes when the one or more analytes bind to the plurality of target-capturing molecules of the plurality of target-capturing molecules.
2. The apparatus of claim 1, wherein said working electrode comprises one or more of a carbon conductive ink, a silver/silver chloride ink, and a mesoporous carbon ink.
3. The apparatus of claim 1, wherein said target-capturing molecule is an antibody.
4. The apparatus of claim 3, wherein said antibody is coupled to said sensor in dry form.
5. The apparatus of claim 1, wherein the target-capturing molecule binds to the one or more analytes that is one of HER-2, α-Defensin 1, α-Defensin 2, α-Defensin 3, CLEC3B, KLK8, C8A, HRC, KLK13, C7, ALDH1A1, APOL1, MUC-1, BLMH, SPRR1B, SERPINB2, putative uncharacterized protein, RAB-30, C4A, PRDX6, CFHR1, A1BG, GGH, EZR, SERPINF2, HPX, CRISP3, CPA4, PGLYRP2, CASP14, 1 g Kappa Chain V-III region POM, ALB, CFH, SCL34A2, GAS6, CTSL1, SFRP1, BP1, CHID1, MSN, ERAP1, OPCT, ATRN, and LTF.
6. The apparatus of claim 1, wherein the electrochemical sensor further comprises an insulating layer disposed over first portions of each of the plurality of electrodes and wherein second portions of each of the plurality of electrodes are uncovered by the insulating layer, wherein the filter paper is disposed over the second portions.
7. The apparatus of claim 6, wherein the filter paper overlaps with part of the insulating layer, and wherein the filter paper and the insulating layer together expose third portions of each of the plurality of electrodes.
8. The apparatus of claim 7, wherein the substrate is an elongated strip having a first end and a second end, wherein the second portions of each of the plurality of electrodes are disposed on the first end and the third portions of the plurality of electrodes are disposed on the second end.
9. The apparatus of claim 1, further comprising a handheld structure with an opening, wherein the electrochemical sensor, including a part of each of the plurality of electrodes, is positioned partially inside the opening.
The apparatus in Patent ‘202 differs from the instant invention in failing to teach a reference and counter electrode in combination with the working electrode and a power supply.
Hnaien teaches an immunosensor device for the detection of rabies virus antigens. Specifically, Hnaien teaches the use of a three electrode system with a modified gold working electrode, a platinum counter electrode, and a saturated calomel reference electrode. Anti-rabies IgG antibodies were coupled to the modified gold electrode, then electrochemical impedance spectroscopy (EIS) measurements were taken between the interactions of the immobilized anti-rabies antibodies and rabies antigen in solution. (Pg. 445, 2.5.4. Antibody coupling, 2.5.6. Impedance spectroscopy (EIS) measurements).
Durst discloses a device for performing immunoassays that includes
electrodes. As shown in Figure 3, the device comprises an absorbent material (312),
such as filter paper, that collects a fluid sample and wets working electrode (318),
reference electrode (320), and counter electrode (322) (Col. 10, lines 38-50, and Col.
20). Durst teaches a potentiostat that is electrically coupled to the working, reference, and counter electrodes (Col. 19, lines 41-58) to power the electrodes.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include a reference and counter electrode, as taught by Hnaien, to the apparatus of patent ‘202 because patent ‘202 recites an apparatus with a plurality of electrodes including a working electrode for impedance measurements and Hnaien teaches it to be conventional to include a reference and counter electrode with a working electrode in an apparatus for measuring impedance. A person of ordinary skill in the art reasonably would have expected success because both patent ‘202 and Hnaien are directed to electrode apparatus for measuring impedance.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add a power supply, as taught by Durst, to the apparatus of pattent ‘202 because a power source is need to power the electrodes in the apparatus of patent ‘202. A person of ordinary skill in the art reasonably would have expected success because the power supply in Durst is for powering a plurality of electrodes in an electrochemical assay device similar to the apparatus of patent ‘202.
5. Claims 1-4 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 7, and 11 of U.S. Patent No. 11,714,083 in view of Hnaien et al ("Immobilization of specific antibody on SAM functionalized gold electrode for rabies virus detection by electrochemical impedance spectroscopy", Biochemical Engineering Journal, 39, 2008, 443 -449); hereafter referred to as Hnaien), and Durst et al (US 5,753,519; hereafter referred to as Durst).
Patent ‘083 claims:
1. An apparatus for detecting one or more analytes in a bodily fluid sample utilizing Electrochemical Impedance Spectroscopy (EIS) or Electrochemical Capacitance Spectroscopy (ECS), comprising:
an electrochemical sensor operably configured to provide an electrochemical impedance or electrochemical capacitance measurement of an analyte in said fluid, said sensor including a target-capturing molecule immobilized to a working electrode in a three electrode configuration, wherein the target-capturing molecule is an antibody, and wherein the antibody is physically adsorbed to the working electrode and covalently crosslinked by exposure to glutaraldehyde, thereby the antibody is directly immobilized onto the working electrode surface in dry form.
2. The apparatus of claim 1, wherein said working electrode comprises one or more of a carbon conductive ink, a silver/silver chloride ink, and a mesoporous carbon ink.
5. The apparatus of claim 1, wherein the antibody is a lactoferrin antibody or an IgE antibody.
7. The apparatus of claim 1, wherein the apparatus is a handheld device.
11. A system for detecting one or more analytes in a bodily fluid sample utilizing Electrochemical Impedance Spectroscopy (EIS) or Electrochemical Capacitance Spectroscopy (ECS), comprising:
the apparatus of claim 1; and
a reader operably configured to provide an electrochemical impedance or electrochemical capacitance measurement of a complex of said target-capturing molecule of the apparatus and said one or more analytes from said fluid on the working electrode of the apparatus.
The apparatus of patent ‘083 differs from the instant invention in failing to teach a reference and counter electrode in combination with the working electrode, filter paper interfaced with the electrodes, and a power supply.
Hnaien teaches an immunosensor device for the detection of rabies virus antigens. Specifically, Hnaien teaches the use of a three electrode system with a modified gold working electrode, a platinum counter electrode, and a saturated calomel reference electrode. Anti-rabies IgG antibodies were coupled to the modified gold electrode, then electrochemical impedance spectroscopy (EIS) measurements were taken between the interactions of the immobilized anti-rabies antibodies and rabies antigen in solution. (Pg. 445, 2.5.4. Antibody coupling, 2.5.6. Impedance spectroscopy (EIS) measurements).
Durst discloses a device for performing immunoassays that includes
electrodes. As shown in Figure 3, the device comprises an absorbent material (312),
such as filter paper, that collects a fluid sample and wets working electrode (318),
reference electrode (320), and counter electrode (322) (Col. 10, lines 38-50, and Col.
20). Durst teaches a potentiostat that is electrically coupled to the working, reference, and counter electrodes (Col. 19, lines 41-58) to power the electrodes.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include a reference and counter electrode, as taught by Hnaien, to the apparatus of patent ‘083 because patent ‘083 recites an apparatus with a plurality of electrodes including a working electrode for impedance measurements and Hnaien teaches it to be conventional to include a reference and counter electrode with a working electrode in an apparatus for measuring impedance. A person of ordinary skill in the art reasonably would have expected success because both patent ‘083 and Hnaien are directed to electrode apparatus for measuring impedance.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a filter paper, as taught by Durst, to the apparatus of patent ‘083 because Durst shows it to be conventional to use filter paper as means to collect and direct sample fluid to working, reference, and counter electrodes as in the apparatus of patent ‘083. A person of ordinary skill in the art reasonably would have expected success in incorporating the filter paper of Durst et al in the device of patent ‘083 because the apparatus of Durst et al and patent ‘083 both comprise a three electrode configuration and both are for analyzing liquid samples.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add a power supply, as taught by Durst, to the apparatus of patent ‘083 because a power source is need to power the electrodes in the apparatus of patent ‘083. A person of ordinary skill in the art reasonably would have expected success because the power supply in Durst is for powering a plurality of electrodes in an electrochemical assay device similar to the apparatus of patent ‘083.
6. Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 7, and 11 of U.S. Patent No. 11,714,083 in view of Hnaien et al ("Immobilization of specific antibody on SAM functionalized gold electrode for rabies virus detection by electrochemical impedance spectroscopy", Biochemical Engineering Journal, 39, 2008, 443 -449); hereafter referred to as Hnaien) and Durst et al (US 5,753,519; hereafter referred to as Durst) and further in view of Diaconu et al (“Electrochemical immunosensors in breast and ovarian cancer”, Clinica Chimica Acta, 425, 2013, 128-138; hereafter referred to as Diaconu).
See above for the teachings of patent ‘083, Hnaien, and Durst.
Patent ‘083 further differs from the instant invention in failing to teach target-capture molecules immobilized on the working electrode that are specific for any of the analytes listed in claim 5.
Diaconu teaches the use of electrochemical immunosensors in the detection of breast and ovarian cancer. Specifically, Diaconu teaches a method for detection of CA15-3 cancer antigen, also known as Mucin 1 (MUC1), in which MUC1 antibodies are immobilized onto a ferrocene carboxylic modified gold electrode and measurements were taken before and after the MUC1 antibody – antigen interaction (Pg. 132, 1.3.2. Cancer antigen CA15-3 (MUC1)).
It would have been obvious to one of ordinary skill in the art at the time of the invention to use the cancer detecting antibodies of Diaconu in the apparatus of patent ‘083 because patent ‘083 is generic with respect to the antibody on the apparatus and the skilled artisan would use the appropriate antibodies to detect the desired antigen. For the detection of cancer antigens (i.e. MUC1) one would use the MUC1 antibodies of Diaconu. A skilled artisan would have a reasonable expectation of success in using the MUC1 antibodies of Diaconu in the sensor of patent ‘083 because both patent ‘083 and Diaconu teach immobilization of antibodies to electrodes.
Claim Rejections - 35 USC § 103
7. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
8. 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.
9. Claim(s) 1, 3, and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hnaien et al ("Immobilization of specific antibody on SAM functionalized gold electrode for rabies virus detection by electrochemical impedance spectroscopy", Biochemical Engineering Journal, 39, 2008, 443 -449); hereafter referred to as Hnaien), in view of Durst et al (US 5,753,519; hereafter referred to as Durst).
Hnaien teaches an immunosensor device for the detection of rabies virus antigens. Specifically, Hnaien teaches the use of a three electrode system with a modified gold working electrode, a platinum counter electrode, and a saturated calomel reference electrode. Anti-rabies IgG antibodies were coupled to the modified gold electrode, then electrochemical impedance spectroscopy (EIS) measurements were taken between the interactions of the immobilized anti-rabies antibodies and rabies antigen in solution. (Pg. 445, 2.5.4. Antibody coupling, 2.5.6. Impedance spectroscopy (EIS) measurements).
Hnaien differs from the instant invention in failing to teach a filter paper arranged to collect wet and wet the three electrode system and a power supply for the three electrode system.
Durst discloses a device for performing immunoassays that includes
electrodes. As shown in Figure 3, the device comprises an absorbent material (312),
such as filter paper, that collects a fluid sample and wets working electrode (318),
reference electrode (320), and counter electrode (322) (Col. 10, lines 38-50, and Col.
20).
It would have been obvious to one of ordinary skill in the art at the effective filing date of the instant invention to incorporate a filter paper as taught by Durst to the device of Hnaien because Durst shows it to be conventional to use filter paper as means to collect and wet a working, reference, and counter electrode with a sample. One of ordinary skill in the art would have a reasonable expectation of success in incorporating the filter paper of Durst et al in the device of Hnaien because the device of Durst et al and Hnaien both comprise a three electrode configuration (working, reference, and counter) and both are for analyzing liquid samples.
With respect to a power supply electrically coupled to the electrodes, Durst teaches a potentiostat that is electrically coupled to the working, reference, and counter electrodes (Col. 19, lines 41-58) to power the electrodes and thus would be obvious to the skilled artisan to add the power supply of Durst to power the similar three electrode system of Hnaien, because the electrodes need a power source for them to function.
10. Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hnaien et al ("Immobilization of specific antibody on SAM functionalized gold electrode for rabies virus detection by electrochemical impedance spectroscopy", Biochemical Engineering Journal, 39, 2008, 443 -449); hereafter referred to as Hnaien), in view of Durst et al (US 5,753,519; hereafter referred to as Durst) as applied to claim 1 above, and further in view of LaBelle et al (US 2017/0234894; hereafter referred to as LaBelle).
See above for the teachings of Hnaien in view Durst.
Hnaien further differs from the instant invention in failing to teach a working electrode comprising mesoporous carbon ink.
LaBelle et al teach the use of mesoporous carbon ink to make an electrode that
supports immobilized antibodies. Mesoporous carbon inks have been found to block
interferents which leads to better results ([0038]).
It would have been obvious to one of ordinary skill in the art at the effective filing
date of the instant application to use mesoporous carbon ink, as taught by Labelle, to
make the working electrode in the device of Hnaien because Labelle teaches that
mesoporous carbon ink can support antibodies and provide the advantage of blocking
interferents which leads to better results.
One of ordinary skill in the art would have a reasonable expectation of success in
using mesoporous carbon ink as taught by Labelle to make the antibody supporting
working electrode in the device of Hnaien because Labelle shows mesoporous carbon
ink can be used to make a working electrodes that support antibodies.
11. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hnaien et al ("Immobilization of specific antibody on SAM functionalized gold electrode for rabies virus detection by electrochemical impedance spectroscopy", Biochemical Engineering Journal, 39, 2008, 443 -449); hereafter referred to as Hnaien), in view of Durst et al (US 5,753,519; hereafter referred to as Durst) as applied to claim 1 above, and further in view of Diaconu et al (“Electrochemical immunosensors in breast and ovarian cancer”, Clinica Chimica Acta, 425, 2013, 128-138; hereafter referred to as Diaconu).
See above for the teachings of Hnaien in view Durst.
Hnaien further differs from the instant invention in failing to teach target-capture molecules immobilized on the working electrode that are specific for any of the analytes listed in claim 5.
Diaconu teaches the use of electrochemical immunosensors in the detection of breast and ovarian cancer. Specifically, Diaconu teaches a method for detection of CA15-3 cancer antigen, also known as Mucin 1 (MUC1), in which MUC1 antibodies are immobilized onto a ferrocene carboxylic modified gold electrode and measurements were taken before and after the MUC1 antibody – antigen interaction (Pg. 132, 1.3.2. Cancer antigen CA15-3 (MUC1)).
It would have been obvious to one of ordinary skill in the art at the time of the invention to substitute the cancer detecting antibodies of Diaconu for the anti-rabies antibodies in the device of Hnaien because the skilled artisan would use the appropriate antibodies to detect the desired antigen. In Hnaien, anti-rabies antibodies are used for the detection of rabies. However, for the detection of cancer antigens (i.e. MUC1) in the sensor of Hnaien, one would use the MUC1 antibodies of Diaconu. A skilled artisan would have a reasonable expectation of success in substituting the MUC1 antibodies of Diaconu in the sensor of Hnaien because both Hnaien and Diaconu teach immobilization of antibodies to gold electrodes.
12. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hnaien et al ("Immobilization of specific antibody on SAM functionalized gold electrode for rabies virus detection by electrochemical impedance spectroscopy", Biochemical Engineering Journal, 39, 2008, 443 -449); hereafter referred to as Hnaien), in view of Durst et al (US 5,753,519; hereafter referred to as Durst) as applied to claim 1 above, and further in view of Ker (US 2017/0014822).
See above for the teachings of Hnaien in view Durst.
Hnaien further differs from the instant invention in failing to teach a hand-held structure with an opening receives and holds a portion of the immunosensor device.
Ker discloses a potentiastat reader device with an opening for receiving an electrode device on which electrochemical assays are performed thereon. The electrochemical device comprises a reference, a working, and a counter electrode. The reader device measures voltage or current from the electrode device ([0039], [0040]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a hand-held reader, as taught by Ker, with the immunosensor device of Hnaien because a reader is required to measure the electrochemical response on the immunosensor of Hnaien. The reader of Ker is capable of measuring voltage or current which allows for the measurement of impedance by the relationship of impedance to current and current. A person of ordinary skill in the art reasonably would have expected success because the reader of Ker is designed for receiving electrode devices with 3 electrodes (reference, working, and counter), such as the device of Hnaien.
Allowable Subject Matter
13. Claims 6-8 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 prior art of record fails to teach an electrode apparatus that includes an insulating layer situated relative to a filter paper layer in the manner recited in claims 6-8.
Conclusion
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L CHIN whose telephone number is (571)272-0815. The examiner can normally be reached Monday - Friday, 10:00am - 6:30pm.
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/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
4/4/2026