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 .
Specification
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length. See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it is below the 50-word minimum. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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.
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.
Claims 1, 3, 11, 13-14, 18, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raisoni (US 20180228408 A1).
Regarding claim 1, Raisoni teaches an apparatus arranged to be entirely subcutaneously-implanted [0040 “…the sensor 110 may be small, fully subcutaneously implantable sensor measures analyte (e.g., glucose) concentrations in a medium (e.g., interstitial fluid) of a living animal (e.g., a living human)”], the apparatus comprising:
an electrochemical sensor [Fig. 3 Item 110] for sensing at least one analyte [0046 “…sensor 110 may be a different type of analyte sensor, such as, for example, an electrochemical sensor…”], and
a near-field communication, NFC, interface [Fig. 3 Item 114 “inductive element”] for percutaneous communication of information sensed by the electrochemical sensor [0040 “…the transceiver 120 may remotely power and/or communicate with the sensor to initiate and receive the measurements (e.g., via near field communication (NFC))”, see also 0041 “…the transceiver 120 may include an inductive element 103, such as, for example, a coil. The transceiver 120 may generate an electromagnetic wave or electrodynamic field (e.g., by using a coil) to induce a current in an inductive element 114 of the sensor 110, which powers the sensor 110. The transceiver 120 may also convey data (e.g., commands) to the sensor 110”].
Regarding claim 3, Raisoni teaches the apparatus of claim 1, wherein the NFC interface [Fig 3 Item 114] is a passive component [0041 “…the transceiver 120 may include an inductive element 103, such as, for example, a coil. The transceiver 120 may generate an electromagnetic wave or electrodynamic field (e.g., by using a coil) to induce a current in an inductive element 114 of the sensor 110, which powers the sensor 110. The transceiver 120 may also convey data (e.g., commands) to the sensor 110.”. The examiner notes that the applicant’s specification (see page 10 lns. 30-34) discloses “ …there are no active power sources (such as batteries) within the electronic circuit 500, which may be considered a passive circuit in that regard”. There is no other disclosure of anything defined as “passive” within the specification. Therefore, in lieu of the specification, the examiner is interpreting the “inductive element” of Raisoni as meeting the claim limitation as it does not have an active power source].
Regarding claim 11, Raisoni teaches the apparatus of claim 1, wherein the electrochemical sensor is arranged to sense at least one of pH, sodium, calcium potassium, lactate, luteinizing hormone, glucose [0040 “…the sensor 110 may be small, fully subcutaneously implantable sensor measures analyte (e.g., glucose)…”], cortisol, estrogen, and progesterone.
Regarding claim 13, Raisoni teaches the apparatus of claim 1, wherein the NFC interface is arranged to harvest power from an electromagnetic field [0041 “The transceiver 120 may generate an electromagnetic wave or electrodynamic field (e.g., by using a coil) to induce a current in an inductive element 114 of the sensor 110, which powers the sensor 110”].
Regarding claim 14, Raisoni teaches the apparatus of claim 1, wherein the apparatus does not comprise a battery [0041 “The transceiver 120 may generate an electromagnetic wave or electrodynamic field (e.g., by using a coil) to induce a current in an inductive element 114 of the sensor 110, which powers the sensor 110”; The examiner notes the only “battery” disclosed in Raisoni is that of the “transceiver”, which is a separate device than the “apparatus”; see Fig. 1].
Regarding claim 18, Raisoni teaches a method of sensing an analyte, the method performed in the apparatus of claim 1 when the apparatus is entirely subcutaneously-imlanted [see claim 1 rejection above], the method comprising:
sensing, using the electrochemical sensor [Fig. 1 Item 110, see also 0046 “…sensor 110 may be a different type of analyte sensor, such as, for example, an electrochemical sensor…”], at least one analyte [0040 “…the sensor 110 may be small, fully subcutaneously implantable sensor measures analyte (e.g., glucose) concentrations in a medium (e.g., interstitial fluid) of a living animal (e.g., a living human)”]; and
transmitting, using the NFC interface [Fig. 3 Item 114 “inductive element”], information sensed by the electrochemical sensor [0040 “…the transceiver 120 may remotely power and/or communicate with the sensor to initiate and receive the measurements (e.g., via near field communication (NFC))”, see also 0041 “…the transceiver 120 may include an inductive element 103, such as, for example, a coil. The transceiver 120 may generate an electromagnetic wave or electrodynamic field (e.g., by using a coil) to induce a current in an inductive element 114 of the sensor 110, which powers the sensor 110. The transceiver 120 may also convey data (e.g., commands) to the sensor 110”].
Regarding claim 21, Raisoni teaches the mehod of claim 18, further comprising sensing at least one of pH, sodium, calcium potassium, lactate, luteinizing hormone, glucose [0040 “…the sensor 110 may be small, fully subcutaneously implantable sensor measures analyte (e.g., glucose)…”], cortisol, estrogen, and progesterone.
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.
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.
Claims 2, 12, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Raisoni as applied to claim 1 and 18 above, and further in view of Reghabi (US 8948836 B2).
Regarding claim 2, Raisoni teaches apparatus of claim 1, wherein Raisoni further teaches the electrochemical sensor is arranged to sense one analyte [0040 “…the sensor 110 may be small, fully subcutaneously implantable sensor measures analyte (e.g., glucose) concentrations in a medium (e.g., interstitial fluid) of a living animal (e.g., a living human)”], but fails to explicitly teach the electrochemical sensor is arranged to simultaneously sense more than one analyte.
Reghabi teaches the electrochemical sensor [col. 3 lns. 7-9 “At least one of the plurality of implantable sensors may be (…) an electrochemical sensor…”] is arranged to simultaneously sense more than one analyte [col. 4 lns. 39-40 “…embodiments of the present invention may be used in hospitals to simultaneously measure multiple analytes”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Raisoni and incorporate the teachings of Reghabi to include the electrochemical sensor is arranged to simultaneously sense more than one analyte. Doing so configures the system to be used “for critical care, intensive care or emergency environments” where “simultaneous measurement of biological or physiological parameters or analytes is desired”, as recognized by Reghabi col. 4 lns. 37-38 and col. 4 lns. 42-44, respectively.
Regarding claim 12, Raisoni teaches the apparatus according to claim 1, wherein Riasoni teaches the electrochemical sensor [Fig. 3 Item 110] is configured to sense glucose [0040], but fails to explicitly teach the electrochemical sensor is arranged to simultaneously sense: one of: pH, sodium, calcium, potassium; and one of: lactate, glucose, cortisol.
Reghabi teaches the electrochemical sensor col. 3 lns. 7-9 “At least one of the plurality of implantable sensors may be (…) an electrochemical sensor…”] is arranged to simultaneously sense [col. 4 lns. 39-40 “…embodiments of the present invention may be used in hospitals to simultaneously measure multiple analytes”]:
one of: pH, sodium, calcium, potassium [col. 4 ln. 62 “potassium”]; and
one of: lactate [col. 4 ln. 61 “lactate”], glucose [col. 4 ln. 61 “glucose”], cortisol.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Raisoni and incorporate the teachings of Reghabi to include the electrochemical sensor is arranged to simultaneously sense: one of: pH, sodium, calcium, potassium; and one of: lactate, glucose, cortisol. Doing so configures the system to be used “for critical care, intensive care or emergency environments” where “simultaneous measurement of biological or physiological parameters or analytes is desired”, as recognized by Reghabi col. 4 lns. 37-38 and col. 4 lns. 42-44, respectively.
Regarding claim 22, Raisoni teaches the method of claim 18, wherein Riasoni teaches the electrochemical sensor [Fig. 3 Item 110] is configured to sense glucose [0040], but fails to explicitly teach the electrochemical sensor is arranged to simultaneously sense: one of: pH, sodium, calcium, potassium; and one of: lactate, glucose, cortisol.
Reghabi teaches the electrochemical sensor col. 3 lns. 7-9 “At least one of the plurality of implantable sensors may be (…) an electrochemical sensor…”] is arranged to simultaneously sense [col. 4 lns. 39-40 “…embodiments of the present invention may be used in hospitals to simultaneously measure multiple analytes”]:
one of: pH, sodium, calcium, potassium [col. 4 ln. 62 “potassium”]; and
one of: lactate [col. 4 ln. 61 “lactate”], glucose [col. 4 ln. 61 “glucose”], cortisol.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Raisoni and incorporate the teachings of Reghabi to include the electrochemical sensor is arranged to simultaneously sense: one of: pH, sodium, calcium, potassium; and one of: lactate, glucose, cortisol. Doing so configures the system to be used “for critical care, intensive care or emergency environments” where “simultaneous measurement of biological or physiological parameters or analytes is desired”, as recognized by Reghabi col. 4 lns. 37-38 and col. 4 lns. 42-44, respectively.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Raisoni as applied to claim 1 above, and further in view of Shah (US 20050272989 A1).
Regarding claim 4, Raisoni teaches the apparatus of claim 1, wherein Raisoni teaches the electrochemical sensor [col. 3 lns. 7-9 “At least one of the plurality of implantable sensors may be (…) an electrochemical sensor…”], but fails to explicitly teach the electrochemical sensor comprises a selective layer, a sensing layer, and an external biocompatible layer.
Shah teaches the electrochemical sensor [0017 “electrochemical sensors”] comprises a selective layer [Fig. 2 Item 112 “analyte modulating layer”], a sensing layer [Fig. 2 Item 110 “analyte sensing layer”], and an external biocompatible layer [Fig. 2 Item 106 “insulating protective cover layer”, see also 0031 “Acceptable polymer coatings for use as the insulating protective cover layer 106 can include, but are not limited to, non-toxic biocompatible polymers such as silicone compounds, polyimides, biocompatible solder masks, epoxy acrylate copolymers, or the like”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Raisoni and incorporate the teachings of Shah to include the electrochemical sensor comprises a selective layer, a sensing layer, and an external biocompatible layer. Doing so configures the system to “….allow a wide variety of sensor configurations to be designed to examine a wide variety of analyte species”, as recognized by Shar par. 0026.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Raisoni as applied to claim 1 above, and further in view of DeCerce (US 20210228153 A1).
Regarding claim 5, Raisoni teaches the apparatus of claim 1, wherein Raisoni teaches the electrochemical sensor [Fig. 3 Item 110] and a printed circuit board [Fig. 3 Item 116], but fails to explicitly teach the electrochemical sensor is arranged on a pad of a printed circuit board.
DeCerce teaches the sensor is arranged on a pad of a printed circuit board [0061 “…medical sensor 116 is precisely placed onto a printed circuit board such that pads 130, 132, 134, and 136 are soldered to corresponding pads on the printed circuit board”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Raisoni and incorporate the teachings of DeCerce to include the electrochemical sensor is arranged on a pad of a printed circuit board. Doing so yields compactness, accuracy, stability, faster response, and cost savings, while enabling smarter, more responsive electronic systems.
Regarding claim 6, Raisoni and DeCerce teach the apparatus of claim 5, wherein the pad of the printed circuit board is not covered by any solder mask [see DeCerce Figs. 1 and 2, no solder mask appears present].
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Raisoni and DeCerce as applied to claim 6 above, and further in view of Maharbiz (US 20230095948 A1).
Regarding claim 7, Raisoni and DeCerce teach the apparatus of claim 5, wherein DeCerce teaches the PCB comprises pads [DeCerce 0061 “…medical sensor 116 is precisely placed onto a printed circuit board such that pads 130, 132, 134, and 136 are soldered to corresponding pads on the printed circuit board”], but fails to explicitly teach the pad comprises a contact layer comprising gold.
Maharbiz teaches the PCB comprises a contact layer comprising gold [0141 “…the wireless sensor was built on a 100 μm-thick polyimide, flexible PCB with electroless nickel immersion gold (ENIG) coating (Rigiflex Technology)”].
In the same field of implantable sensors, it would have been obvious to one skilled in the art at the filing date of the invention to modify the teachings of Raisoni and DeCerce by Maharbiz, since it has been held to be within the general skill of a worker in the art to select a known component or material on the basis of suitability for the intended use as a matter of obvious mechanical design expediency. In re Leshin, 125 USPQ 416. Also see MPEP 2144.07. Sinclair & Carroll Co. v. Interchemical Corp. states "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.).
Regarding claim 8, a modified Raisoni and DeCerce in view of Maharbiz teaches the apparatus of claim 7, wherein the contact layer further comprises nickel [Maharbiz 0141 “…the wireless sensor was built on a 100 μm-thick polyimide, flexible PCB with electroless nickel immersion gold (ENIG) coating (Rigiflex Technology)”].
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Raisoni as applied to claim 1 above, and further in view of Qiang (US 20110315563 A1).
Regarding claim 9, Raisoni teaches the apparatus according to claim 1, wherein Raisoni teaches the electrochemical sensor [Fig. 3 Item 110], but fails to specifically teach the electrochemical sensor is arranged to simultaneously perform voltammetry and amperometry.
Qiang teaches a system configured to simultaneously perform voltammetry and amperometry [0075 The application of constant potential or current includes techniques such as galvanometry, amperometry, potentiometry, cyclic voltammetry and the like. If combinations of the foregoing electrochemical deposition techniques are used, they may be employed simultaneously or sequentially”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Raisoni and incorporate the teachings of Qiang to include the electrochemical sensor is arranged to simultaneously perform voltammetry and amperometry. Doing so configures the system to provide comprehensive data acquisition, improved selectivity, faster analysis, and better validation of results, all achieved in a single, integrated measurement.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Raisoni as applied to claim 1 above, and further in view of Hahn (US 20200069226 A1).
Regarding claim 10, Raisoni teaches the apparatus of claim 1, wherein Raisoni teaches the apparatus detects at least one analyte [0046 “…sensor 110 may be a different type of analyte sensor, such as, for example, an electrochemical sensor…”], but fails to explicitly teach the apparatus is arranged to perform impedance detection of the at least one analyte.
Hahn teaches the apparatus is arranged to perform impedance detection of the at least one analyte [0033 “…electrochemical sensor 10 may produce a current, a potential, or an impedance that may be processed by, for example, processing circuitry operatively coupled to each respective work electrode of work electrodes 18, and which allows detection of an analyte”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Raisoni and incorporate the teachings of Hahn to include the apparatus is arranged to perform impedance detection of the at least one analyte. Doing so configures the system to provide a sensitive, label‑free, real‑time, and mechanistically informative method for detecting and quantifying target substances.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Raisoni as applied to claim 1 above, and further in view of Strano (US 20130035567 A1).
Regarding claim 15, Raisoni teaches the apparatus according to claim 1, wherein Raisoni teaches the electrochemical sensor [Fig. 1 Item 110] is arranged to sense at least one analyte [0040], but fails to teach the at least one analyte is indicative of human fertility.
Strano teaches the sensor is configured to detect at least one analyte is indicative of human fertility [0073 “Non-limiting examples of analytes that can be determined using the compositions and methods described herein include (…), progresterone…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Raisoni and incorporate the teachings of Strano to include the sensor is configured to detect at least one analyte is indicative of human fertility. Doing configures the system to provide early identification of reproductive issues, guides personalized treatment, predict therapy response, and improve the chances of successful conception while reducing healthcare costs and delays.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Raisoni as applied to claim 1 above, and further in view of Fuerst (US 20140083872 A1).
Regarding claim 16, Raisoni teaches the apparatus of claim 1, wherein Raisoni teaches an amplifier configured to amplify a signal to the electrochemical sensor [0055 “…the transceiver 120 may include a power amplifier 918 to amplify the signal to be conveyed by the inductive element 103 to the sensor 110”], but fails to explicitly teach an amplifier arranged to amplify a signal produced by the electrochemical sensor.
Fuerst teaches an amplifier arranged to amplify a signal produced by the electrochemical sensor [0075 “The field effect transistor can be in particular part of an operational amplifier, that is to say of an electronic amplifying component designed to amplify electrical signals, for example electronic signals, in particular voltage and/or current signals”, see also 0017 “In customary electrochemical sensors, the measurement signals are generally conditioned by subsequent signal amplification, for example a charge current and/or an optical signal, analog/digital conversion and processing by means of a suitable microcontroller”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Raisoni and incorporate the teachings of Fuerst to include an amplifier arranged to amplify a signal produced by the electrochemical sensor. Doing so configures the system to be more sensitive, accurate, and robust, enabling detection of trace analytes, and improving measurement reliability.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Raisoni as applied to claim 1 above, and further in view of Patel (US 20090085768 A1).
Regarding claim 17, Raisoni teaches the apparatus of claim 1, wherein Raisoni teaches encrypting the data from the transceiver to a display device [0059 “The information from the transceiver 120 (e.g., calculated analyte concentrations, calculated analyte concentration trends, alerts, alarms, and/or notifications) may be transmitted to a primary display device 130 (e.g., via Bluetooth Low Energy with Advanced Encryption Standard (AES)-Counter CBC-MAC (CCM) encryption) for display by a mobile medical application (MMA) being executed by the primary display device 130”], but fails to explicitly teach the apparatus being arranged to encrypt the information sensed by the electrochemical sensor prior to the percutaneous communication.
Patel teaches encrypting the information sensed by the electrochemical sensor prior to the percutaneous communication [0078 “…the sensor glucose values are encrypted or appended with a security key prior to transmission…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Raisoni and incorporate the teachings of Patel to include encrypting the information sensed by the electrochemical sensor prior to the percutaneous communication. Doing so configures the system to “…prevent unwanted devices from reading the information…”, as recognized by Patel par. 0078.
Conclusion
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/JONATHAN M HANEY/ Examiner, Art Unit 3791
