DETAILED ACTION
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 6-9 and 14-15 are 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.
Claim 6 recites the limitation "the aneurism sac" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 7 and 8 each recite “the reference signal” and “the aneurism sac”. Claim 1 recites “a reference” and not “a reference signal” and does not recite an aneurism sac. There are insufficient antecedent basis for these limitations in the claims.
Claim 9 recites “the characteristic of the subsequent response signal” and “the characteristic of the reference signal”. There are insufficient antecedent basis for these limitations in the claim.
Claim 14 recites “and/or or” in line 3 which is grammatically incorrect. For purposes of examination it will be understood as “and/or”.
Claim 15 recites that the impedance of the response signals is indicative of “a p” which appears to be an incomplete statement. From the disclosure, it appears that this should be “a penetration of liquid into the aneurism sac” ([0068] of the printed publication) and will be treated as such.
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.
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oliveira et al. (“A Stent-Graft Endoleakage Monitor: Telemetry System based on Inductive-Coupling Transmission for implantable pressure sensors”).
As to claim 12, Oliveira teaches a system for monitoring a physiological condition inside a patient's body (Abstract – direct arterial pressure monitoring system), the system comprising: a passive implantable antenna adapted for placement in an aneurism sac of the patient during an endovascular procedure (p2 – components can be modelled as passive elements, receiver capable of energizing the passive pressure sensors; p3 – biological tissue between the antenna and the sensor); and a transmitter and a receiver that are external to the patient's body, wherein the transmitter is configured to trigger a response signal from the passive implantable antenna (p2 – external reader delivers energy and detects the different resonance frequencies through an inductive-coupling link), and wherein the receiver is configured to determine the presence of an endoleak in the aneurism sac based on a shift in the antenna's resonant frequency and/or the antenna's impedance (Abstract – post stent-graft implantation complications, such as endoleaks, can be detected).
As to claim 13, Oliveira teaches wherein the transmitter and the receiver are configured to be in radio communication with the antenna (p2 – each one allocated to a specific frequency in the 12.5-20 MHz range)
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) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oliviera et al. (“A Methodology to Test a Stent-Graft Endoleak Monitor”) in view of Oliveira et al. (“A Stent-Graft Endoleakage Monitor: Telemetry System based on Inductive-Coupling Transmission for implantable pressure sensors”; hereinafter Oliviera’II for the 103 rejection) and Hunter (US 2015/0335290).
As to claim 1, Oliviera teaches a system configured to monitor a physiological condition at a region located inside a living body (p251 – a wireless based endoleakage monitoring system based on detection of pressure variations within the aneurysm sac), the system comprising: an element configured to be implanted at a region inside the living body (p251 – sensor measures pressure within aneurysm thrombus); a signal detector located outside the living body and configured to actuate the element to generate a response signal, the signal detector being further configured to receive the response signal; (p251 – external reader delivers energy and detect sensor’s resonance frequency through an inductive-coupling link); a processor configured to compare a resonant frequency and/or an attenuation of the response signal to a reference (p253 – when sensor is calibrated and ready to be placed, all the circuit elements values are known. In cases where measured ABP is outside the nominal range, distinguishing these values are caused by the pressure is of utmost importance; p255 – if the measured oscillating frequency is higher or lower than the expected one), and a variation from the reference is indicative of a change in the physiological condition (p255 – if a sensor provides a high pressure reading due to a endoleak; telemetry system allows detecting endoleaks).
Oliveira fails to expressly teach that the implanted resonant element is “an antenna”. Oliveira’II teaches that the implanted resonant element of this same system is an antenna (Abstract). It would have been obvious, if not necessarily inherent, to call/modify the implanted resonant element of Oliveira an antenna as the same author later explicitly recognizes it as one.
The above combination fails to expressly teach to activate an indicator and/or record a notice when the resonant frequency and/or the attenuation varies from the reference. Hunter teaches a device for generating a notification upon detection of a prescribed condition from an implanted stent-graft sensor ([0098], with the interrogation module and control unit outside the body (Fig. 3) and discloses why this indicator is needed ([0040] – since most endoleaks are asymptomatic to the patient, an increase in stent graft adluminal pressure is an important early indicator). Accordingly, it would have been obvious to modify the above combination with Hunter to enable the output of an indicator, so that the user can seek treatment while it is still possible.
As to claim 2, Oliveira teaches reference is a resonant frequency and/or attenuation of a previously recorded response signal (p253).
As to claim 3, Oliveira teaches wherein the reference is a calculated trend in or pattern of resonant frequencies and/or attenuations of previous response signals recorded over a predetermined period of time (Fig. 7).
As to claim 4, Oliveira teaches the predetermined period of time begins after the antenna has been implanted in the region (Fig. 7 – all values after implantation).
As to claim 5, Oliveira teaches the region is an aneurism sac (p251).
As to claim 6, Oliveira teaches the physiological condition is an amount of blood or fluid leaking into the aneurism sac (p255 – allows detecting endoleaks and is performed after measurement of aneurysm sac pressure).
As to claim 7, Oliveira teaches the difference between the resonant frequency of the response signal and the resonant frequency of the reference signal that is greater than a threshold indicates a leakage of blood into the aneurism sac (p255 – if measured oscillating frequency is higher/lower than expected).
As to claim 8, Oliveira teaches wherein a difference between the attenuation of the response signal and the attenuation of the reference signal that is greater than a threshold indicates a leakage of blood into the aneurism sac (p255 – measure of the power transmission as well as impedance, Fig. 8-9).
As to claim 9, Oliveira teaches the element is periodically actuated, and the characteristic of the subsequent response signal is compared to the characteristic of the reference signal and/or previous response signals (p253 – 100-200 Hz sampling frequency; p254 – m frequency sweets to obtain the inductive coupling power spectrum).
Claim(s) 12 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oliviera et al. (“A Methodology to Test a Stent-Graft Endoleak Monitor”) in view of Oliveira et al. (“A Stent-Graft Endoleakage Monitor: Telemetry System based on Inductive-Coupling Transmission for implantable pressure sensors”; hereinafter Oliviera’II for the 103 rejection).
As to claim 12, Oliveira teaches a system for monitoring a physiological condition inside a patient's body (Abstract) comprising a passive implantable element adapted for placement in an aneurism sac of the patient during an endovascular procedure (p252 – circuit is powerless and energy is transmitted via inductive coupling; p251 – implanting sac pressure sensor), a a transmitter and a receiver that are external to the patient's body, wherein the transmitter is configured to trigger a response signal from the passive implantable element (p251 – external reader delivers energy and detects sensor’s resonance frequency through an inductive coupling link), and wherein the receiver is configured to determine the presence of an endoleak in the aneurism sac based on a shift in the element’s resonant frequency and/or the element’s impedance (p253 – when sensor is calibrated and ready to be placed, all the circuit elements values are known. In cases where measured ABP is outside the nominal range, distinguishing these values are caused by the pressure is of utmost importance; p255 – if the measured oscillating frequency is higher or lower than the expected one; if a sensor provides a high pressure reading due to an endoleak; telemetry system allows detecting endoleaks).
Oliveira fails to expressly teach that the implanted resonant element is “an antenna”. Oliveira’II teaches that the implanted resonant element of this same system is an antenna (Abstract). It would have been obvious, if not necessarily inherent, to call/modify the implanted resonant element of Oliveira an antenna as the same author later explicitly recognizes it as one.
As to claim 14, Oliviera teaches the receiver is configured to receive a radio signal indicative of the element’s resonant frequency and/or impedance, and wherein the shift of the resonant frequency and/or or a change in the impedance is indicative of a penetration of liquid into the aneurism sac (p253 – when sensor is calibrated and ready to be placed, all the circuit elements values are known. In cases where measured ABP is outside the nominal range, distinguishing these values are caused by the pressure is of utmost importance; p255 – if the measured oscillating frequency is higher or lower than the expected one; if a sensor provides a high pressure reading due to an endoleak; telemetry system allows detecting endoleaks; allows detecting endoleaks and is performed after measurement of aneurysm sac pressure).
As to claim 15, Olivia teaches a deviation from a trend in or pattern of resonant frequencies and/or impedance of the response signals is indicative of a [penetration of liquid into the aneurism sac] (p253 – when sensor is calibrated and ready to be placed, all the circuit elements values are known. In cases where measured ABP is outside the nominal range, distinguishing these values are caused by the pressure is of utmost importance; p255 – if the measured oscillating frequency is higher or lower than the expected one; if a sensor provides a high pressure reading due to an endoleak; telemetry system allows detecting endoleaks; allows detecting endoleaks and is performed after measurement of aneurysm sac pressure).
Claim(s) 10 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oliviera, Oliveira’ll and Hunter (US 2015/0335290), and further in view of Rokhsaz (US 2018/0365457).
As to claim 10, the above combination fails to expressly teach that the antenna is a radio-frequency identification device. However, Oliviera does note a particular property of the sensor (p252 – corresponding inductance can change due to bending) is derived from a paper on RFID characteristics (Reference 13). Rokhsaz teaches an RFID device in which the antenna itself is the sensing element (claim 1). Accordingly, it would have been obvious to modify the above combination with Rokhsaz to implement the passive implanted resonator as an RFID device as it be a simple substitution yielding predictable results.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oliviera, Oliveira’ll and Hunter (US 2015/0335290), and further in view of O’Brien (US 2005/0187482).
As to claim 11, the above combination does not expressly teach the signal detector is configured to receive the response signal on a posterior side of the living body. O’Brien teaches an inserted pressure transducer sensor that goes into an aneurysm sac (Abstract) and teaches that the signal detector can be positioned on the surface of the body in proximity to the implanted sensor and that it can be easily moved to optimize the coupling between the antenna and the sensor ([0084]). It would have been obvious to modify the above combination with O’Brien to enable detection on any part of the body desired including the posterior side of the patient as the abdominal aorta is retroperitoneal, and the posterior body wall would thus present the closest distance to the implant.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oliviera, Oliveira’ll and Hunter (US 2015/0335290), and further in view of Stiene et al. (US 2004/0072357).
As to claim 16, Oliveira teaches that the implant sits in and is electrically coupled to the material filling the sac (p251 – sensor would measure pressure within aneurysm thrombus around itself) and that the intervening medium governs the link (p252 – affected by the type and thickness of the biological tissue transmission medium). Oliveira fails to expressly teach that the resonant frequency varies on the capacitance of the surrounding environment.
Oliveira’II teaches this (p3 – presence of tissue causes shifting in the received signal frequency; tissue emulating solution with electrical characteristics) as a characteristic of the device. The above combination fails to expressly teach that the variance of the resonant frequency is indicative of a difference between a clot and liquid blood.
Steine teaches that the electrical properties of blood changes significantly as it clots, resulting in a difference in values such as capacitance, impedance, and permittivity ([0026], [0036], [0053]). Accordingly, it would have been obvious to modify the above combination with Steine to utilize a known relationship between liquid blood and clotted blood to for detection purposes and increase the utility of the device.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oliviera, Oliveira’ll and Hunter (US 2015/0335290), and further in view of Sarma et al. (US 2019/0120818).
As to claim 17, as established above, the relationship between the changes in the signal and the intervening medium is well known. The above combination does not expressly teach to determine the presence of an endoleak by detecting a gradual increase of signal loss encountered when communicating with an RFID antenna. However, Sarma teaches an RFID tag-sensor in which the loss in signal in the form of a drop in the strength of the backscatter signal is used as an indication of changes in the medium through which the signal passes. It would have been obvious to modify the above combination with Sarma to utilize signal loss to determine the presence of an endoleak as it would be a predictable result of one, as the progressive accumulation of conductive liquid blood around the implant would progressively increase link loss.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oliviera and Oliveira’ll, and further in view of Sarma et al. (US 2019/0120818).
As to claim 17, as established above, the relationship between the changes in the signal and the intervening medium is well known. The above combination does not expressly teach to determine the presence of an endoleak by detecting a abrupt increase of signal loss encountered when communicating with an RFID antenna. However, Sarma teaches an RFID tag-sensor in which the loss in signal in the form of a drop in the strength of the backscatter signal is used as an indication of changes in the medium through which the signal passes. It would have been obvious to modify the above combination with Sarma to utilize signal loss to determine the presence of an endoleak as it would be a predictable result of one, as the progressive accumulation of conductive liquid blood around the implant would progressively increase link loss.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 8/17/26
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