DETAILED ACTION
Summary
Claims 1, 3-4, 6-13, 15, and 17-25 are pending in the application. Claims 1, 3-4, and 6-13 are rejected under 35 USC 103.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/15/2026 has been entered.
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.
Claims 1, 3-4, 7, 10, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Charthad et al. (U.S PGPub 2022/0265157 A1) in view of Brenner et al. (U.S PGPub 2018/0035971 A1) (Brenner’971), and Kaplan et al. (U.S PGPub 2005/0288590 A1).
Regarding Claim 1, Charthad teaches a system for wireless cardiac diagnostics (Abstract) comprising:
a. a plurality of ultrasound position sensors [0179] configured to be implanted at respective positions on a wall of a cardiac chamber [0178] and to return reflected ultrasound or a resonant ultrasound response when interrogated from outside a body [0179] (one of ordinary skill would recognize the external wireless device imaging the monitor to determine their position indicates the monitors are reflecting ultrasound);
b. a pressure sensor [0179] configured to be implanted in said cardiac chamber [0179]; and
c. an external device (Fig. 1, 114) [0045] adapted to:
i. transmit ultrasound into said body [0071]-[0072]+[0077] and determine relative positions of said ultrasound position sensors from ultrasound signals returned from said ultrasound position sensors [0099]+[0179] (the external monitor has ultrasound transducers, and images the position sensors, then the external monitor is transmitting ultrasound and receiving the reflected ultrasound);
ii. determine distances between said ultrasound position sensors and determine a cardiac chamber volume from said distance [0179];
iii. determine pressure in said cardiac chamber [0179]
iv. generate one or more pressure-volume loops of said cardiac chamber from said determined cardiac chamber volume and said determined pressure [0179].
Charthad fails to explicitly teach the ultrasound position sensors are passive ultrasound position sensors, each lacking an internal power supply.
Brenner’971 teaches a system for non-invasive ultrasound measurement of blood pressure (Abstract). This system uses passive reflectors, without an internal power supply, as ultrasound reflectors [0082]+[0094].
It would have been obvious to one of ordinary skill to substitute the position sensor of Charthad with the position sensor of Brenner’971, as the substitution for one known position sensor with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a passive ultrasound reflector are reasonably predictable. One of ordinary skill would recognize that, as the system of Charthad requires a position sensor which is ultrasonically reflective, and the sensors of Brenner’971 are ultrasonically effective, the sensors of Brenner’971 are capable of being used as the position sensors when incorporated in the system of Charthad.
The combination fails to explicitly teach passive resonant pressure sensors, lacking an internal power supply, that the pressure sensor exhibits a resonance frequency that varies with surrounding pressure, and determining pressure by correlating a measured resonance frequency of said passive resonant pressure sensor with a calibration curve relating pressure to resonance frequency.
Kaplan teaches a sensor with vibrating members (Abstract). The sensor is a passive sensor which lacks an internal power supply [0047]. This system can be a pressure sensor where the resonant frequency of the sensor is affected by the external pressure around the sensor [0116]. The pressure is determined by correlating the measures value of the resonance frequency with a predetermined calibration curve relating the external pressure to a resonance frequency [0116].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have the pressure sensor have resonant frequencies affected by the external pressure and calibrated using a calibration curve, as taught by Kaplan, because using protected, calibrated, resonating pressure sensors increases the accuracy of the measured pressure, as recognized by Kaplan [0031]. One of ordinary skill would recognize that, in the combination, the external pressure of Kaplan would be the cardiac chamber pressure, as taught by Charthad [0179].
Regarding Claim 3, the combination of reference teaches the invention substantially as claimed. Charthad is silent regarding wherein said passive ultrasound position sensors are selected from solid, porous, and hollow forms comprising spheres, coils, cylinders, polyhedra, corner cubes, ellipsoids, rings, or arrays thereof.
Brenner’971 teaches a system for measuring cardiac parameters (Abstract). The system uses a wireless sensors are solid, porous, or hollow forms which is a ring [0088].
It would have been obvious to one of ordinary skill in the art to substitute the position sensor of Charthad with a solid, porous, or hollow form ring, as taught by Brenner’971, as the substitution for one known sensor with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a ring are reasonably predictable.
Regarding Claim 4, the combination of references teaches the invention substantially as claimed. Charthad fails to explicitly teach wherein said passive ultrasound position sensors comprise passive ultrasound reflectors.
Brenner’971 teaches a system for measuring cardiac parameters (Abstract). The system uses a passive ultrasound reflector which indicates a position in the cardiac chamber [0084].
It would have been obvious to one of ordinary skill in the art to substitute the position sensor of Charthad with an ultrasound reflector, as taught by Brenner’971, as the substitution for one known sensor with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a fiducial marker to indicate position is reasonably predictable.
Regarding Claim 6, the combination of references teaches the invention substantially as claimed. Charthad further teaches the position sensors and pressure sensors can be incorporated into one sensor [0179]
Charthad fails to explicitly teach wherein at least two of said passive ultrasound position sensors have respective distinct resonant ultrasound responses at respective frequencies.
Kaplan further teaches that multiple passive sensors can be used which have respective distinct resonate ultrasound responses at respective frequencies [0245].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system so at least two of the position sensors have distinct resonant frequencies, as taught by Kaplan, because this allows for the system to obtain more accurate pressure readings, as recognized by Kaplan [0010].
Regarding Claim 7, the combination of references teaches the invention substantially as claimed. Charthad further teaches the sensors in the cardiac chamber [0179].
The combination fails to explicitly teach wherein said passive resonant pressure sensor comprises a resonant body having a resonance frequency that varies with pressure of the medium by which said passive resonant pressure sensor is surrounded, and wherein said pressure in said cardiac chamber is determined by correlating a measured resonance frequency of said passive resonant pressure sensor with said calibration curve relating pressure to resonance frequency.
Kaplan teaches a sensor with vibrating members (Abstract). This sensor can be a passive resonant pressure sensor comprises a resonant body having a resonance frequency that varies with pressure of the medium by which said passive resonant pressure sensor is surrounded [0115]-[0116]. The pressure is determined by correlating a measured resonance frequency of said passive resonant pressure sensor relating the external pressure to a resonance frequency [0116].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have the pressure sensor have resonant frequencies affected by the external pressure and calibrated using a calibration curve, as taught by Kaplan, because using protected, calibrated, resonating pressure sensors increases the accuracy of the measured pressure, as recognized by Kaplan [0031]. One of ordinary skill would recognize that, in the combination, the external pressure of Kaplan would be the cardiac chamber pressure, as taught by Charthad [0179].
Regarding Claim 10, the combination of references teaches the invention substantially as claimed. Charthad fails to explicitly teach wherein said external device extracts and processes raw spatial data from returned ultrasound signals received by said one or more ultrasound transducers to determine the relative positions of said passive ultrasound position sensors.
Brenner’971 teaches a system for measuring cardiac parameters (Abstract). The system uses an ultrasound reflector which indicates a position in the cardiac chamber [0084]. This system contains a device to extracts and process raw spatial data from said ultrasound transducer(s) [0094]+[0111]+[0115].
It would have been obvious to one of ordinary skill in the art to substitute the position sensor of Charthad with an ultrasound reflector, as taught by Brenner’971, as the substitution for one known sensor with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a fiducial marker to indicate position is reasonably predictable. One of ordinary skill would recognize that, as the system of Charthad determines the relative positions, the combined system would process the raw spatial data and determined the relative position.
Regarding Claim 12, the combination of references teaches the invention substantially as claimed. Charthad further teaches wherein said passive resonant pressure sensor is incorporated into one of said passive ultrasound position sensors [0179].
Regarding Claim 13, the combination of references teaches the invention substantially as claimed. Charthad further teaches wherein said one passive ultrasound position sensor is used both for position sensing and for pressure sensing [0179].
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Charthad in view of Brenner’971 and Kaplan as applied to claim 7 above, and further in view of Nunez et al. (U.S PGPub 2008/0281212 A1).
Regarding claim 8, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein said sensors are nonrigid and compressible.
Nunez teach an implantable medical sensor device (Abstract). This sensor is both nonrigid [0007] and compressible [0060].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the sensors of the combination to be nonrigid and compressible, as taught by Nunez, because this allows for implantable sensors designed for accurate and stable long term monitoring [0032].
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Charthad in view of Brenner’971 and of Kaplan as applied to claim 1 above, and further in view of Lichtenstein et al. (U.S PGPub 2007/0265690 A1).
Regarding Claim 9, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein said external device determines relative positions of said passive ultrasound position sensors by triangulation or true range multilateration.
Lichtenstein teaches a position tracking system (Abstract). This system uses triangulation to determine the relative position of the sensors [0045].
It been obvious to one of ordinary skill in the art to substitute the method of determining the position of the combination with a triangulation method, as taught by Lichtenstein, as the substitution for one known method of localizing the position sensor with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using triangulation to determine the position are reasonably predictable. One of ordinary skill would recognize that determining the location of the sensor would allow the user the determine the displacements between the sensors, as taught by Charthad.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Charthad in view of Brenner’971 and Kaplan as applied to claim 1 above, and further in view of Gifford, III et al. (U.S PGPub 2018/0177486 A1) and Maessen et al. (U.S PGPub 2022/0068481 A1).
Regarding Claim 11, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein said external device comprises a wearable belt or strap carrying a matrix ultrasound probe or a plurality of ultrasound arrays angled relative to one another.
Gifford, III teaches a device for continuously monitoring the cardiovascular system (Abstract). This device comprises a wearable strap to carry an ultrasound probe [0142].
It would have been obvious to one of ordinary skill in the art to substitute the method of securing the external device of Charthad with a wearable strap, as taught by Gifford, III, as the substitution for one known method of securing a device with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a strap are reasonably predictable.
The combination fails to explicitly teach the probe is a matrix ultrasound probe.
Maessen teaches a system for obtaining physiological measurements (Abstract). This system uses a matrix ultrasound probe to image the body [0081].
It would have been obvious to one of ordinary skill in the art to substitute the probe for imaging the body with a matrix ultrasound probe, as taught by Maessen, as the substitution for one known ultrasound probe with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a matrix ultrasound probe are reasonably predictable.
Allowable Subject Matter
Claims 15, and 17-24 allowed.
Claim 15 recites “implanting first, second, and third passive ultrasound position sensors at respective positions on a wall of said left ventricle and implanting a passive resonant pressure sensor in said left ventricle, said first, second, and third passive ultrasound position sensors and said passive resonant pressure sensor lacking internal power supplies, wherein said first passive ultrasound position sensor is implanted at an apical endocardial location of said left ventricle, said second passive ultrasound position sensor is implanted at a lateral ventricular wall location at a sub-mitral level of said left ventricle, and said third passive ultrasound position sensor is implanted at an opposite location on across-sectional plane at the sub-mitral level of said left ventricle”, “determining, from ultrasound signals returned from said first, second, and third passive ultrasound position sensors, a first distance between said first passive ultrasound position sensor and said second passive ultrasound position sensor and a second distance between said second passive ultrasound position sensor and said third passive ultrasound position sensor”, “determining a left-ventricular volume from said first distance and said second distance based on an ellipsoidal approximation of said left ventricle”, and “generating said one or more pressure-volume loops of said left ventricle from said determined left-ventricular volume and said determined pressure”. These limitations, in combination with the other limitations, are not taught by the prior art without the benefit of improper hindsight.
While Charthad broadly teaches that the volume can be calculated from images of the sensors, Charthad does not teach the claimed locations of implanting the sensors, then using the respective distances to calculate a volume using a ellipsoidal approximation. None of the other cited references teach the claimed limitations. Fukuda et al. (U.S PGPub 2017/0252000 A1) teaches a system for imaging the patient’s heart (Abstract). This system calculated the shape of the ventricle using an ellipsoidal approximation [0102]. However, Fukuda does not teach using passive ultrasonic position sensors in the claimed positions, calculating the distances between them, and then using those distances as the input of the model. Therefore, claim 15 is non-obvious over the prior art, and is allowable.
Claims 17-24 depend on claim 15, and are allowable by virtue of their dependency.
Response to Arguments
Applicant's arguments filed 4/15/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Claim 1 is now rejected under a combination of Charthad, Brenner’971, and Kaplan, as detailed more fully above. Claim 1 therefore remains rejected under 35 USC 103.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fukuda et al. (U.S PGPub 2017/0252000 A1), which teaches a system for ultrasonically analyzing the heart.
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/SEAN D MATTSON/Primary Examiner, Art Unit 3798
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