DETAILED ACTION
Specification
The disclosure is objected to because of the following informalities:
[0001] – states that this “application is a continuation of U.S. Patent Application No. claims priority to International Application No. 16/756,681”, thereby forgetting to put the US application while incorrectly noting that a US application as an international application.
[0016] – describes “Fig. 4B” but appears it is intended be “Fig. 5B”.
[0019] – “Operating Principal” should be “Operating Principle”.
[0033] – “potientiostats” should be “potentiostats”.
Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: devices for the application of excitation pulses to the electrochemical sensor and the acquisition of time-resolved faradaic current decay from the electrochemical sensor in claim 13.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1, 2, 4, 6, 11, and 13 objected to because of the following informalities:
Claims 1, 11, and 13 recite “faradic” which should be “faradaic”.
Claims 1 and 13 recite “and thereby calculate the concentration” should be “thereby calculating the concentration”.
Claim 4 recites “a pep□de”, which should be “peptide”; and “neurotransmiter", which should be “neurotransmitter”. The claim also redundantly recites a hormone and a metabolite twice.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11-14 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.
Claims 11 and 13 recite that “a derivative of the sensor output is substantially consistent with a mathematical relationship between a measure of faradaic current decay and target species concentration for a class of sensors to which the sensor belongs”. This is unclear. The specifications never uses the term “derivative”. Accordingly, it is unclear how the term is being used, whether it is referring to the mathematical derivative (e.g. dA/dt) or whether it’s merely stating the source from which any quantity is derived (e.g. output B being derived or a derivative of input A). It is unclear from the specifications which is intended. Second, the specifications also fail to disclose a standard for how close a derivative must be to a relationship to be substantially consistent. While ([0079]) of the printed publication discusses that sensors of the same class may have divergences under a certain percentage, those appear to be merely a listing of possible divergences but does not reflect any standard for what is considered substantially consistent.
Claim 14 recites the limitation "the recognition element" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 13 recites “a plurality of recognition elements” and “each recognition element”. Applicant is advised to amend to recite “each of the recognition elements” instead.
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.
(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.
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Ferguson et al. (US 2016/0166186).
As to claim 11, Ferguson teaches an electrochemical sensor, the electrochemical sensor comprising: an electrode functionalized with a plurality of recognition elements that undergo a conformation change upon target binding, each recognition element being functionalized with one or more redox reporters ([0052] – aptamer immobilized on an electrode and including a redox reporter, [0125], [0213]); wherein the electrochemical sensor, when deployed in a sample, outputs a faradaic current which varies in a concentration dependent manner with the concentration of a target species in a sample ([0240], [0247]).
Ferguson does not expressly state that a derivative of the sensor output is substantially consistent with a mathematical relationship between a measure of faradic current decay and target species concentration for a class of sensors to which the sensor belongs. However, as Ferguson’s sensor is structurally identical to the recited sensor, this limitation merely recites a property that necessarily flows from the sensor’s structure.
As to claim 12, Ferguson teaches the class of sensors to which the sensor belongs comprises sensors having the same recognition element type, redox reporter type, and attachment chemistry for conjugation to the electrode ([0211], [0213], [0249]).
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.
Claim(s) 1-4, 7-10, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferguson et al. (US 2016/0166186) in view of Deng (US 2009/0194432) and White et al. (“Exploiting Binding-Induced Changes in Probe Flexibility for the Optimization of Electrochemical Biosensors”).
As to claims 1 and 13, Ferguson teaches a method of measuring a target species concentration in a sample using an electrochemical sensor ([0052-0054]) the method comprising: deploying an electrochemical sensor having an electrode functionalized with a plurality of recognition elements that undergo a conformation change upon binding with the target species such that the electrochemical sensor is exposed to a sample ([0052] – conformation-switching aptamer immobilized on an electrode; [0240] – target binding induces conformation change); applying one or more excitation pulses to the electrochemical sensor, wherein a faradic current output is generated by each pulse and varied by the conformation change of the recognition elements([0065] – square0wave potential pulses applied; [0240] – binding induced conformational change; [0240]; [0247]); applying a mathematical relationship between the selected measure of current decay and the target species concentration … and thereby calculate the concentration of the target species ([0247] – analyte concentration determined by a standard curve; [0250] – a calibration curve used for kanamycin).
Ferguson fails to expressly teach “acquiring time-resolved faradaic current data following each of the one or more excitation pulses; calculating a value of a selected measure of current decay from the acquired time-resolved faradic current data” and to apply the relationship between the “selected measure of current decay” and the concentration. It is noted that Ferguson samples each pulse’s current only at the end of the pulse ([0065]) and correlates a peak-current derived signal with concentration ([0214],[0247]).
Deng teaches a device for device for measuring analyte by acquiring time-resolved faradaic current data following each of the one or more excitation pulses ([0057-58]), calculating a value of a selected measure of current decay from the acquired time-resolved current data ([0082], [0089-90]), and applying a mathematical relationship between the selected measure of current decay and the target species concentration and thereby calculate the concentration ([0062] – calibration curve to determine analyte concentration and can be expressed as [0076] – equations or algorithms; [0090] – concentration calculated from decay-derived value and a calibration curve).
White teaches that the faradaic current produce by a sensor after each square-wave pulse decays at a rate determine by the probe’s binding rate, with the target free probe decaying at about 60 s-1 while the bound probe decays at about 6 s-1 (Fig. 2) such that at a low enough frequency (5 Hz), the faster current has largely decayed before it could even be sampled (Fig. 2 – c vs d).
It would have been obvious to modify Ferguson with Deng to acquire the faradaic current after each pulse at a plurality of time points, calculate the measure of it’s decay, and obtain a concentration value using the relationship, as White teaches that bound and unbound probes produce currents that decay at different rates, and thereby allow for the tuning of the frequency of measurements to enhance the obtained signal (p73). As for claim 13, Ferguson teaches the electrochemical analyzer and programming for applying the pulses and recording current ([0214]) and Deng teaches the circuitry and processors for applying the excitation and then measure the current at a plurality of time points ([0032], [0044], [0058], [0066], etc).
As to claim 2, Ferguson teaches wherein the sample is selected from the group consisting of whole blood including flowing whole blood, serum, saliva, urine, sweat, interstitial fluid, spinal fluid, cerebral fluid, tissue exudates, macerated tissue samples, cell solutions, intracellular compartments, water, wash water, wastewater, groundwater, food, and beverages ([0194] – urine, interstitial fluid, saliva, etc; [0247] – whole blood).
As to claim 3, Ferguson teaches the electrochemical sensor is deployed in an unprocessed and/or undiluted sample ([0215] – blood drawn through a cannula directly into the device).
As to claim 4, Ferguson teaches the target species is selected from the group consisting of a small molecule drug, a metabolite, a hormone, a “peptide”, a protein, a carbohydrate, a nucleic acid, a lipid, a hormone, a metabolite, a growth factor, a neurotransmiter, a nutrient, and a pollutant, a pathogen-induced or pathogen-derived factor, a pathogen, or a cell ([0240], [0250]).
As to claim 7, Deng teaches “wherein the mathematical relationship between the selected measure of current decay and target species concentration is a relationship determined for and applicable to all sensors of the same class as the deployed electrochemical sensor” ([0046-48] – same calibration data for a lot-specific manufactured sensors). It would have been obvious to modify the above combination further with Deng, such that sensors made under the same conditions could utilize calibration information from one in a lot instead of individually calibrated to save on manufacturing costs.
As to claim 8, Deng teaches the electrochemical sensor is deployed without calibration thereof ([0046-0048] – the use of calibration data that’s specific to a manufactured test lot means the specific sensor is deployed without calibration, since the information has already been obtained for that lot elsewhere). It would have been obvious to modify the above combination further with Deng, such that sensors made under the same conditions could utilize calibration information from one in a lot instead of individually calibrated to save on manufacturing costs.
As to claim 9, Ferguson teaches the repeated measurements are obtained over hours, days, months, or longer ([0248] – over 4.5 hours).
As to claim 10, Ferguson teaches wherein the electrochemical sensor is deployed in vivo, in a human subject, in a non-human animal, or in a point-of-care system ([0008]).
As to claim 14, Ferguson teaches wherein the recognition element comprises an aptamer ([0052]).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ferguson et al. (US 2016/0166186), Deng (US 2009/0194432), and White et al. (“Exploiting Binding-Induced Changes in Probe Flexibility for the Optimization of Electrochemical Biosensors”), and further in view of Willner (US 2003/0148169).
As to claim 5, the above combination fails to expressly teach the selected measure of current decay is selected from a decay constant, an average lifetime, a half-life, and a relative amplitude. Willner teaches a biosensor with an immobilized redox enzyme in which the current transient follows an exponential decay ([0067]). It would have been obvious to modify the above combination with Willner as the selection of an exponential will yield similar, and thus predictable, results.
As to claim 6, the above combination fails to expressly teach that the selected measure of current decay is derived from an exponential fit of the time-resolved current data, from a monoexponential fit of the time resolved current data, or from a biexponential fit of the time-resolved current data (Fig. 4 reflects a monoexponential fit as it shows a single rate constant). It would have been obvious to modify the above combination with Willner as the selection of an exponential will yield similar, and thus predictable, results.
Double Patenting
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,257,050. Although the claims at issue are not identical, they are not patentably distinct from each other because the recited claims are a broader recitation of the claims or various combinations of claims in the above patent.
Claims 11-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,257,050 in view of Ferguson (US 2016/0166186). As to claims 11 and 12, the recited sensor is the sensor the patented method requires, and claiming such a sensor is an obvious variant of the patented method of using it. Ferguson teaches fabricating such sensors with identical probe, reporter, and thiol-gold attachment chemistry ([0211], [0213]).
Claims 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,257,050 in view of Ferguson (US 2016/0166186) in view of Deng (US 2009/0194432). As to claims 13 and 14, the recited sensor is the sensor the patented method requires, and claiming such a sensor is an obvious variant of the patented method of using it. Ferguson teaches fabricating such sensors with identical probe, reporter, and thiol-gold attachment chemistry ([0211], [0213]), and Deng’s meter and processor supply the hardware and program ([0032], [0066], [0076]).
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 10/3/26
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