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 .
Election/Restrictions
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 19, 2025.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 7, 9, 11, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0077497 A1 to Oster et al. (“Oster”) in view of US 2015/0053575 A1 to Bridges et al. (“Bridges”) (both cited in Applicants’ IDS).
Regarding claim 1, Oster discloses a system (Fig 1, abstract) comprising:
a sensing interface (104) configured to detect multiple biomarkers (i.e., glucose molecules) in bodily fluids (i.e., blood) of a subject (Fig 1, para [0026], the biomedical sensor system of the present disclosure include sensors for sensing one or more of blood oxygen saturation, glucose..", para [0032], “..each sensor (e.g., electrode 104) can communicate with one or more hubs 102.");
a coupling unit (102) (Fig 1, para [0032], ..the hub 102 provides a single connection site for the biomedical sensor system 100.."); and
a stretchable wire (106) connecting the sensing interface (104) and the coupling unit (102) (Fig 1, 2, para [0030], “...FIG. 1 illustrates the biomedical sensor system 100 in a first, unstretched, state, and a second, stretched, state..", para [0051], “the connector 106 is at least partially formed of a viscoelastic material...‘Stretchable Electrical Connector..’” para [0057], “...the connector 106 is illustrated in FIG. 2 as comprising a wire as a conductor 162…").
Oster fails to disclose that the sensing interface comprises an inductor-capacitor (LC) circuit. Bridges is also related to a sensing interface for sensing biofluid (Fig 1, abstract, para [0059], "The passive sensor device (block 120) may be located embedded in, in contact with, adjacent to, or otherwise proximate a material such as, biological fluids…” and suggests the sensing interface comprises an inductor-capacitor (LC) circuit (para [0022], “…the circuit portion of the passive sensor device may include at least one of an inductive loop coupled to a capacitor (e.g., a varactor diode) that changes capacitance based on the measured parameter, an inductive loop coupled to a capacitor (e.g., a varactor diode) that changes capacitance based a potential difference between two electrodes exposed to the material...").
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide the sensing interface of Oster to comprise an inductor-capacitor (LC) circuit to of Bridges in order to achieve the predictable result of allowing measurements of parameters of biological fluids, as suggested by Bridges.
Regarding claim 2, Bridges further discloses wherein the sensing interface is configured to use an LC resonance of a coil (i.e., "inductive loop") and a varactor diode electrically connected with a functionalized biochemical interface for potentiometric (i.e., "potential difference") sensing (Fig 1, para [0059], "The passive sensor device (block 120) may be located embedded in, in contact with, adjacent to, or otherwise proximate a material such as biological fluids..", para [0022], .resonant frequency of the signal shifts in response to changes in the measured parameter the circuit portion of the passive sensor device may include at least one of an inductive loop coupled to a capacitor (e.g., a varactor diode) that changes capacitance based on the measured parameter, an inductive loop coupled to a capacitor (e.g., a varactor diode) that changes capacitance based a potential difference between two electrodes exposed to the material..").
Regarding claim 3, Bridge further discloses wherein the LC circuit comprises at least one of a capacitor or a varactor configured to control a working frequency band (para [0022]," .resonant frequency of the signal shifts in response to changes in the measured parameter. The circuit portion of the passive sensor device may include at least one of an inductive loop coupled to a capacitor (e.g., a varactor diode) that changes capacitance based on the measured parameter, an inductive loop coupled to a capacitor (e.g., a varactor diode) that changes capacitance based a potential difference between two electrodes exposed to the material..").
Regarding claim 7, Oster further discloses wherein the bodily fluids comprise at least one of sweat, cerebrospinal fluid, blood, plasma, interstitial fluid, saliva, tear, breast milk, amniotic fluid, mucus, gastric acid, or urine (Fig 1, para [0026], the biomedical sensor system of the present disclosure include sensors for sensing one or more of blood oxygen saturation, glucose..").
Regarding claim 9, Oster further discloses wherein the sensing unit (104), the coupling unit (102), and the stretchable wire (106) are comprised within a wearable device (100) (Fig 1, para [0002], "..adapted for contact (e.g., with an adhesive) with the subject (e.g., a subject's skin).", note: "wearable" is deemed to be satisfied since the device is capable of being held in contact with a subject's skin).
Regarding claim 11, Oster further discloses wherein the system is configured to monitor at least one of a physiological status or a pathological status of the subject without battery and configured to transmit data wirelessly (Fig 1, abstract, "..sensor adapted to create a signal based on a physiological characteristic from a subject..", para [0032], the hub 102 can wirelessly communicate with downstream computing, processing, displaying and/or archiving equipment..", note: no battery is taught within the sensor system 100 by Oster thus it is deemed operational as a passive sensor, i.e., without a battery, Bridges also teaches that the sensing is passive, i.e., without a battery, see abstract, para [0066]).
Regarding claim 13, Oster further discloses a receiver (110) and a transducer (103), wherein the transducer comprises the coupling unit (102), the stretchable wires (106), and a potentiometric sensor (electrode 104) (Fig 1, 13, para [0034], [0035]).
Claims 1 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oster in view of US 2016/0278651 A1 Lu et al. (“Lu”) (cited in Applicants’ IDS).
Regarding claim 1, Oster discloses a system (Fig 1, abstract) comprising:
a sensing interface (104) configured to detect multiple biomarkers (i.e., glucose molecules) in bodily fluids (i.e., blood) of a subject (Fig 1, para [0026], "..the biomedical sensor system of the present disclosure include sensors for sensing one or more of blood oxygen saturation, glucose..", para [0032]. "..each sensor (e.g., electrode 104) can communicate with one or more hubs 102.");
a coupling unit (102) (Fig 1, para [0032], "..the hub 102 provides a single connection site for the biomedical sensor system 100.."); and a stretchable wire (106) connecting the sensing interface (104) and the coupling unit (102) (Fig 1, 2, para [0030], "..FIG. 1 illustrates the biomedical sensor system 100 in a first, unstretched, state, and a second, stretched, state..", para [0051], the connector 106 is at least partially formed of a viscoelastic material Stretchable Electrical Connector'..' para [0057], '..the connector 106 is illustrated in FIG. 2 as comprising a wire as a conductor 162..").
Oster fails to disclose that the sensing interface comprises an inductor-capacitor (LC) circuit.
Lu is also related to a stretchable biosensing interface (abstract, para [0003]) and suggests the sensing interface comprises an inductor-capacitor (LC) circuit to facilitate strain measurement (para [0031]-[0033]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide the sensing interface of Oster to comprise an inductor-capacitor (LC) circuit to facilitate measurements of strain, as suggested by Lu (para [0031]-[0033]).
Regarding claim 6, Oster fails to disclose a damping resistor in series with the sensing interface and configured to minimize strain or environment induced changes in electronic properties of the LC circuit.
Lu suggests that a series damping resistor (Rr or Rs in Fig 5a) is part of the LC circuit to minimize strain and environment (temperature) induced changes in electronic properties of the LC circuit (Fig 5a, 6b, para [0050], "..the serpentine wires act as both an inductor and a resistor, which results in a standard RLC circuit..", para [0069], "..eliminate the temperature effect the longitudinal resistor properly accommodates the longitudinal strain.
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 damping resistor in series with the sensing interface of Oster in view of Lu and configured to minimize strain or environment induced changes in electronic properties of the LC circuit to eliminate temperature effects and accommodate strain, as suggested by Lu (Fig 5a, 6b, para [0050], "..the serpentine wires act as both an inductor and a resistor, which results in a standard RLC circuit..", para [0069], eliminate the temperature effect. the longitudinal resistor properly accommodates the longitudinal strain..")
Claims 1 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oster in view of an article entitled "Fully Printed, Wireless, Stretchable Implantable Biosystem toward Batteryless, Real-Time Monitoring of Cerebral Aneurysm Hemodynamics" to Herbert et al. (“Herbert”) (cited in Applicants’ IDS).
Regarding claim 1, Oster discloses a system (Fig 1, abstract) comprising:
a sensing interface (104) configured to detect multiple biomarkers (i.e., glucose molecules) in bodily fluids (i.e., blood) of a subject (Fig 1, para [0026]. the biomedical sensor system of the present disclosure include sensors for sensing one or more of blood oxygen saturation, glucose..", para [0032], '..each sensor (e.g., electrode 104) can communicate with one or more hubs 102.");
a coupling unit (102) (Fig 1, para [0032], ..the hub 102 provides a single connection site for the biomedical sensor system 100.."); and
a stretchable wire (106) connecting the sensing interface (104) and the coupling unit (102) (Fig 1, 2, para [0030], .FIG. 1 illustrates the biomedical sensor system 100 in a first, unstretched, state, and a second, stretched, state..", para [0051], ...the connector 106 is at least partially formed of a viscoelastic material. 'Stretchable Electrical Connector' para [0057], "..the connector 106 is illustrated in FIG. 2 as comprising a wire as a conductor 162.."). Oster fails to disclose that the sensing interface comprises an inductor-capacitor (LC) circuit.
Herbert is also related to a stretchable biosensing interface (abstract) and suggests the sensing interface comprises an inductor-capacitor (LC) circuit to facilitate wireless sensing readout (pg 6, section 2.4).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide the sensing interface of Oster to comprise an inductor-capacitor (LC) circuit to provide the predictable result of allowing a wireless sensing readout, as suggested by Herbert (pg 6, section 2.4).
Regarding claim 10, Oster fails to disclose wherein the sensing unit, the coupling unit, and the stretchable wire are comprised within a biomedical implant. Herbert suggests placing the sensing unit and associated electronics within a biomedical implant to facilitate wireless sensing readout of cerebral aneurysm hemodynamics (abstract, ..implantable stent.."). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide the predictable result of facilitating wireless sensing readout of cerebral aneurysm hemodynamics, as suggested by Herbert (abstract).
Claims 1 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oster in view of US 2016/0338624 A1 to Min et al. (“Min”) (cited in Applicants’ IDS)..
Regarding claim 1, Oster discloses a system (Fig 1, abstract) comprising:
a sensing interface (104) configured to detect multiple biomarkers (i.e., glucose molecules) in bodily fluids (i.e., blood) of a subject (Fig 1, para [0026], the biomedical sensor system of the present disclosure include sensors for sensing one or more of blood oxygen saturation, glucose..' para [0032], '..each sensor (e.g., electrode 104) can communicate with one or more hubs 102.");
a coupling unit (102) (Fig 1, para [0032], the hub 102 provides a single connection site for the biomedical sensor system 100.."); and
a stretchable wire (106) connecting the sensing interface (104) and the coupling unit (102) (Fig 1, 2, para [0030], "..FIG. 1 illustrates the biomedical sensor system 100 in a first, unstretched, state, and a second, stretched, state.." para [0051], the connector 106 is at least partially formed of a viscoelastic material Stretchable Electrical Connector'.. para [0057], .the connector 106 is illustrated in FIG. 2 as comprising a wire as a conductor 162..").
Oster fails to disclose that the sensing interface comprises an inductor-capacitor (LC) circuit. Min is also related to a blood glucose sensor (abstract) and suggests the sensing interface comprises multiple inductor-capacitor (LC) circuits (60, 70) to facilitate detection of both blood glucose and cardiovascular pressure (Fig 1B, para [0040], ..first LC resonant circuit 60 second LC resonant circuit 70..", para [0041], resonant frequency of the LC resonant circuit 60 varies in response to changes in blood glucose. para [0044], the resonant frequency of the second LC resonant circuit 70 varies in response to changes in pressure in the cardiovascular pathway..").
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide the sensing interface of Oster to comprise an inductor-capacitor (LC) circuit in order to achieve the predictable result of allowing blood glucose and/or pressure measurements, as suggested by Min (Fig 1B, para [0040], [0041], [0044]).
Regarding claim 14, Oster in view of Min disclose the subject matter of claim 1, as described above, wherein Min discloses the coupling unit comprises multiple LC circuits (60, 70) configured with separated resonance frequency bands (as part of previous combination above) (Fig 1B, para [0040], first LC resonant circuit 60 second LC resonant circuit 70..", para [0041], "..a resonant frequency of the LC resonant circuit 60 varies in response to changes in blood glucose.. para [0044], .the resonant frequency of the second LC resonant circuit 70 varies in response to changes in pressure in the cardiovascular pathway..").
Claims 4, 5, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oster in view of Bridges and further in view of US 2017/0347925 A1 to Wang et al. (“Wang”) (cited in Applicants’ IDS).
Regarding claim 4, Oster in view of Bridges disclose the subject matter of claim 1, as described above, but fails to disclose wherein the sensing interface comprises at least one type of potentiometric bio-recognition element.
Wang is also related to sensing biofluids (abstract) and suggests that it was well known in the art to include, in a sensing interface, at least one type of potentiometric bio-recognition element (para [0004], "Sensing biological events in vitro and in vivo can provide real-time detection of physiologically relevant compounds Biosensors can use biological materials as the biologically sensitive component, e.g., such as biomolecules including enzymes, antibodies, nucleic acids, etc., as well as living cells..", para [0007], ...functionalized probes can be detected using at least one of amperometry, voltammetry, or potentiometry.."
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide the sensing interface of Oster in view of Bridges to comprise at least one type of potentiometric bio-recognition element, to achieve the predictable result of allowing real-time detection of physiologically relevant compounds, as suggested by Wang (para [0004], [0007]).
Regarding claim 5, Wu further discloses wherein the at least one least one type of potentiometric biorecognition element comprises at least one of metal oxides, ion-selective membranes, aptamers, antibodies, molecularly imprinted polymers (MIPs), and/or enzymes (para [0004], Biosensors can use biological materials as the biologically sensitive component, e.g., such as biomolecules including enzymes, antibodies, nucleic acids, etc., as well as living cells..").
Regarding claim 8, Oster in view of Bridges discloses the subject matter of claim 1, as described above, but fails to disclose wherein the biomarkers comprise at least one of antigens, metabolites, neurotransmitters, hormones, electrolytes, or cells. Wang is also related to sensing biofluids (abstract) and suggests that it was well known in the art to include, in a sensing interface, biomarkers comprising at least one of antigens, metabolites, neurotransmitters, hormones, electrolytes, or cells (para [0004], "Sensing biological events in vitro and in vivo can provide real-time detection of physiologically relevant compounds, such as monitoring of metabolites, electrolytes, biochemicals, neurotransmitters, medically relevant molecules, cancer biomarkers, and pathogenic microorganisms..")
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide the biomarkers of Oster in view of Bridges to comprise at least one of metabolites, neurotransmitters, or electrolytes in order to achieve the predictable result that is real-time detection of physiologically relevant compounds, as suggested by Wang (para [0004]).
Claim 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oster in view of Bridges and further in view of US 2007/0244380 A1 to Say et al. (“Say”) (cited in Applicants’ IDS)
Regarding claim 12, Oster discloses the system is configured to transmit data wirelessly (Fig 1, para [0032], the hub 102 can wirelessly communicate with downstream computing, processing, displaying and/or archiving equipment, but fails to disclose wherein the wireless data transmission is via a frequency modulation mechanism.
Say is also related to biosensors (abstract) and suggests transmitting data using frequency modulation (Fig 1, para [0253], ..analyte monitoring device 40 RF communication high reliability RF link employs frequency modulation..").
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide the wireless data transmission of Oster in view of Bridges via a frequency modulation mechanism to provide the predictable result that is a high reliability of communicating data from biosensors, as suggested by Say (Fig 1, para [0253], ..analyte monitoring device 40 RF communication.. high reliability RF link employs frequency modulation..").
Conclusion
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/ERIC J MESSERSMITH/ Primary Examiner, Art Unit 3791