DETAILED ACTION
Summary
Claims 1-27 are pending in the application. Claims 1-26 rejected under 35 U.S.C. 112(b). Claims 1-27 are rejected under 35 USC 103.
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 .
Claim Objections
Claim 2, 10, and 15-16 objected to because of the following informalities:
Claim 2 recites “said pressure volume loops” in line 2. It should recite “said one or more pressure volume loops”.
Claim 10 recites “said ultrasound transducer(s)” in line 3. It should recite “said one or more ultrasound transducer(s)”.
Claim 15 recites “determining the displacement” in line 5. It should recite “determining a displacement”.
Claim 16 recites “assessment of cardiac health” in line 12. It should recite “assessment of said cardiac health”.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The limitations interpreted under 112(f) will be interpreted as follows:
“wireless pressure sensing means” means in claim 1 will be interpreted as wireless pressure sensors, consistent with pages 21-26 of the specification.
“communication means” in claims 2 and 16 will be interpreted as Wi-Fi, or equivalents thereof, consistent with Pg. 28, ¶2, of the specification.
“means to extract and process raw spatial data” in claim 10 will be interpreted as a processing module, consistent with page 8, ¶ 4 of the specification.
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 1-26 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 1 recites “cardiac health” in line 14. It is not clear if this is referring to the cardiac health previously set forth, or if this is setting forth new cardiac health. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 1 recites “cardiac health is determined… non-invasively” in line 14. However, the sensors are set forth as being deployed in a cardiac chamber (See lines 2-4), which is necessarily an invasive procedure. It is therefore not clear how the health is determined non-invasively when the procedure is invasive. Clarification is required. For the purpose of examination, the claim will be interpreted as the cardiac health being determined using the deployed sensors and the external sensors without an additional invasive step.
Claim 1 recites “(subsequent to implantation of said sensors and sensing means)”. It is not clear if the portion in the parentheses is part of the claimed invention. Clarification is required. For the purposes of examination, the portion in the parentheses will not be considered part of the claimed invention.
The term “high ultrasound and/or electromagnetic reflectivity” in claim 3 is a relative term which renders the claim indefinite. The term “high ultrasound and/or electromagnetic reflectivity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination, if the sensor can reflect ultrasound and/or electromagnetic signals, it will be considered as having high reflectivity.
Claim 7 recites the limitation "said pressure sensor resonant frequencies" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the claim will be interpreted as referring to resonant frequencies of the wireless pressure sensing means.
Claim 7 recites “a cardiac chamber pressure” in line 2. It is not clear if this is referring to “a pressure within said cardiac chamber” set forth in claim 1, or if this is setting forth a new pressure. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 7 recites “said sensors” in line 2. It is not clear if this is referring to the wireless position sensors, or the wireless pressure sensing means. Clarification is required. For the purposes of examination, the latter definition will be used.
Claim 7 recites the limitation "the measured value" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the claim will be interpreted as stating “a measured value”.
Claim 15 recites “pressure-volume loops” in line 9. It is not clear if this is referring to the pressure-volume loops previously set forth, or if this is setting forth additional pressure-volume loops. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 15 recites “cardiac health is determined… non-invasively” in line 13. However, the sensors are set forth as being deployed in a cardiac chamber (See lines 3-4), which is necessarily an invasive procedure. It is therefore not clear how the health is determined non-invasively when the procedure is invasive. Clarification is required. For the purpose of examination, the claim will be interpreted as the cardiac health being determined using the deployed sensors and the external sensors without an additional invasive step.
Claim 15 recites “(subsequent to initial affixing of said sensors)”. It is not clear if the portion in the parentheses is part of the claimed invention. Clarification is required. For the purposes of examination, the portion in the parentheses will not be considered part of the claimed invention.
The term “high ultrasound and/electromagnetic reflectivity” in claim 17 is a relative term which renders the claim indefinite. The term “high ultrasound and/electromagnetic reflectivity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination, if the sensor can reflect ultrasound and/electromagnetic signals, it will be considered as having high reflectivity.
Claim 20 recites “said wireless pressure sensors” in line 2. However, the “said particular frequencies” are referring to the “wireless position sensors” in claim 19. It is therefore not clear if claim 19 is referring to the position sensors or the pressure sensors. Clarification is required. For the purposes of examination, the claim will be interpreted as referring to the pressure sensors.
Claim 20 recites “said pressure” in lines 2. It is not clear if this is referring to the pressure in the cardiac chamber or the external pressure. Clarification is required. For the purposes of examination, the former definition will be used.
Claim 23 recites the limitation "said pressure sensing means" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the claim will be interpreted as referring to the pressure sensor.
All claims dependent from the above claims rejected under 35 USC 112(b) are also rejected, as the limitations of the dependent claims fail to cure the deficiencies identified above.
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, 5, 12, 15, 24, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Charthad et al. (U.S PGPub 2022/0265157 A1) in view of Lau et al. (U.S PGPub 2022/0079550 A1)
Regarding Claim 1, Charthad teaches a system for wireless cardiac diagnostics (Abstract) comprising:
a set of wireless position sensors configured to be implanted in a cardiac chamber [0150]+[0179];
wireless pressure sensing means [0017] adapted for sensing a pressure within said cardiac chamber [0102]+[0179];
an external device (Fig. 1, 114) [0035]+[0095] adapted to:
determine displacements between said wireless position sensors [0150]+[0179];
determine the pressure from said pressure sensing means [0179];
determine one or more pressure-volume loops based on said displacements and said pressure [0179]
whereby said cardiac health is determined wirelessly [0067], non-invasively (subsequent to implantation of said sensor and sensing means) [0067] (as the external wireless monitor is not in the patient when determining the data, which is acquired when the sensors are implanted [0179], it is considered a non-invasive acquisition), continuously [0005], and without a need to acquire or analyze echocardiographic images [0179]+[0190].
Charthad fails to explicitly teach determine instantaneous measures of cardiac health based on said pressure-volume loop.
Lau teaches a system for monitoring cardiac health (Abstract). This system determines pressure volume loops of the patient [0055]+[0101]. These loops are then used to determine instantaneous measure of cardiac health [0101].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to calculate a pressure volume loop and to determine instantaneous measures of cardiac health based on the pressure-volume loop, as taught by Lau, because this provides an accurate measure of heart failure, as recognized by Lau [0002]-[0003], thereby allowing the physician to better diagnose the patient.
Regarding Claim 5, the combination of references teaches the invention substantially as claimed. Charthad further teaches wherein further indicators of cardiac health selected from the group consisting of: ejection fraction [0063], Stroke Volume [0062], Cardiac Output [0062].
Regarding Claim 12, the combination of references teaches the invention substantially as claimed. Charthad further teaches wherein said pressure sensing means is incorporated into one or more of said wireless position sensors [0179].
Regarding Claim 15, Charthad teaches a method for noninvasive determination of cardiac pressure-volume loops (Abstract) comprising the steps:
affixing two or more wireless position sensors and a wireless pressure sensor in a cardiac chamber [0179];
continuously [0043] determining the displacement between said position sensors by means of an external device adapted for this determination [0150]+[0179];
continuously [0043] determining pressure in said cardiac chamber by means of said external device [0179];
forming pressure-volume loops from said displacement and said pressure [0179];
whereby said cardiac health is determined wirelessly [0067], non-invasively (subsequent to initial affixing of said sensors) [0067] (as the external wireless monitor is not in the patient when determining the data from the affixed sensors, it is considered a non-invasive acquisition), continuously [0005], and without a need to acquire or analyze echocardiographic images [0179]+[0190].
Charthad fails to explicitly teach calculating parameters of said pressure-volume loops adapted to indicate cardiac health.
Lau teaches a system for monitoring cardiac health (Abstract). This system determines pressure volume loops of the patient [0055]+[0101]. These loops are then used to determine instantaneous measure of cardiac health [0101].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to calculate a pressure volume loop and to determine instantaneous measures of cardiac health based on the pressure-volume loop, as taught by Lau, because this provides an accurate measure of heart failure, as recognized by Lau [0002]-[0003], thereby allowing the physician to better diagnose the patient
Regarding Claim 24, the combination of references teaches the invention substantially as claimed. Charthad further teaches wherein said pressure sensor is incorporated into one or more of said wireless position sensors [0179].
Regarding Claim 27, Charthad teaches an implantable medical device for monitoring variable body geometry (Abstract) comprising:
one or more wireless position sensors configured to be implanted at a set of bodily positions [0150]+[0179];
an external device (Fig. 1, 114) [0035]+[0095] adapted to:
determine displacements between said one or more wireless position sensors [0150]+[0179];
whereby said variable body geometry may be monitored continuously [0005], noninvasively [0067] (as the external wireless monitor is not in the patient when determining the data, it is considered a non-invasive acquisition), and without a need to acquire or analyze echocardiographic images [0179]+[0190].
Charthad fails to explicitly teach determine instantaneous measures of cardiac health based on said displacements.
Lau teaches a system for monitoring cardiac health (Abstract). This system determines pressure volume loops of the patient [0055]+[0101]. These loops are then used to determine instantaneous measure of cardiac health [0101].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to calculate a pressure volume loop and to determine instantaneous measures of cardiac health based on the pressure-volume loop, as taught by Lau, because this provides an accurate measure of heart failure, as recognized by Lau [0002]-[0003], thereby allowing the physician to better diagnose the patient.
Claims 2 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Charthad in view of Lau as applied to claims 1 and 15, respectively, above, and further in view of Brenner et al. (U.S PGPub 2021/0259666 A1) and Thakur et al. (U.S PGPub 2019/0274655 A1).
Regarding Claim 2, the combination of references teaches the invention substantially as claimed. Charthad fails to explicitly teach a cloud server adapted to store and analyze said pressure volume loops, and communications means adapted to transfer information between said cloud server and said external device, said cloud server performing analyses selected from the group consisting of: comparison of parameters derived from said pressure-volume loops with parameters derived from previous pressure-volume loops for a given patient so as to perform patient-specific trend analysis; comparison of parameters derived from said pressure-volume loops with normal and pathological pressure-volume parameter ranges derived from a constantly updated database from multiple patients, performing correlations between parameters derived from said pressure volume loops and other clinical parameters relevant for assessment of said cardiac health.
Brenner teaches a system for measuring cardiovascular parameters (Abstract). This system uses a cloud server (Fig. 1, 110) adapted to store and analyze said pressure volume loops [0037]+[0065], and communications means adapted to transfer information between said cloud server and said external device [0092].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to use a cloud server, as taught by Brenner, because this allows the user to obtain the data and analysis wherever internet is available, as recognized by Brenner [0092], thereby simplifying the transfer of data to a physician’s computer for analysis and diagnosis.
Brenner fails to explicitly teach performing correlations between parameters derived from said pressure volume loops and other clinical parameters relevant for the assessment of cardiac health.
Thakur teaches a system for determining cardiac parameters (Abstract). This system derives parameters from pressure volume loops [0066]+[0070]. This system correlates the parameters derived from pressure loops to other clinical parameters relevant to cardiac health [0076].
It would have been obvious to one ordinary skill in the art before the effective filing date to modify the combined system to correlated the derived parameters to other clinical parameters, as taught by Thakur, because this provides an effective way to monitor patient recovery, as recognized by Thakur [0004]-[0005].
Regarding Claim 16, the combination of references teaches the invention substantially as claimed. Charthad fails to explicitly teach a cloud server adapted to store and analyze said pressure volume loops, and communications means adapted to transfer information between said cloud server and said external device, said cloud server performing analyses selected from the group consisting of: comparison of parameters derived from said pressure-volume loops with parameters derived from previous pressure-volume loops for a given patient so as to perform patient-specific trend analysis; comparison of parameters derived from said pressure-volume loops with normal and pathological pressure-volume parameter ranges derived from a constantly updated database from multiple patients, performing correlations between parameters derived from said pressure volume loops and other clinical parameters relevant for assessment of cardiac health.
Brenner teaches a system for measuring cardiovascular parameters (Abstract). This system uses a cloud server (Fig. 1, 110) adapted to store and analyze said pressure volume loops [0037]+[0065], and communications means adapted to transfer information between said cloud server and said external device [0092].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to use a cloud server, as taught by Brenner, because this allows the user to obtain the data and analysis wherever internet is available, as recognized by Brenner [0092], thereby simplifying the transfer of data to a physician’s computer for analysis and diagnosis.
Brenner fails to explicitly teach performing correlations between parameters derived from said pressure volume loops and other clinical parameters relevant for the assessment of cardiac health.
Thakur teaches a system for determining cardiac parameters (Abstract). This system derives parameters from pressure volume loops [0066]+[0070]. This system correlates the parameters derived from pressure loops to other clinical parameters relevant to cardiac health [0076].
It would have been obvious to one ordinary skill in the art before the effective filing date to modify the combined system to correlated the derived parameters to other clinical parameters, as taught by Thakur, because this provides an effective way to monitor patient recovery, as recognized by Thakur [0004]-[0005].
Claims 3-4, 10, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Charthad in view of Lau as applied to claims 1 and 15, respectively, above, and further in view of Brenner et al. (U.S PGPub 2018/0035971 A1) (Brenner’971) and Masters (U.S Patent 5,201,715).
Regarding Claim 3, the combination of reference teaches the invention substantially as claimed. Charthad is silent regarding said wireless position sensors are solid, porous, or hollow forms selected from the group consisting of: sphere, coil, cylinder, polyhedron, corner cube, ellipsoid, ring, shapes adapted to have high ultrasound and/or electromagnetic reflectivity, and arrays of any of said forms.
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.
While Brenner’971 teaches the sensors are reflectors, Brenner’971 is silent that the sensors are used as position sensors.
Masters teaches an ultrasound marker system (Abstract). This system has ultrasonic markers which have an ultrasonic signature such that an ultrasound can determine the position of the marker (Col 4, lines 45-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system so that the echographic wireless sensors of Brenner’971 are used as position sensors, as taught by Masters, because this allows the user to easily distinguish the sensor from the surrounding tissue without the sensor being radiopaque or magnetic, as recognized by Masters (Col 2, lines 15-30).
Regarding Claim 4, the combination of references teaches the invention substantially as claimed. Charthad fails to explicitly teach wherein said wireless position sensors are passive electromagnetic or ultrasound reflectors.
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].
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.
While Brenner’971 teaches the sensors are reflectors, Brenner’971 is silent that the sensors are used as position sensors.
Masters teaches an ultrasound marker system (Abstract). This system has ultrasonic markers which have an ultrasonic signature such that an ultrasound can determine the position of the marker (Col 4, lines 45-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system so that the echographic wireless sensors of Brenner’971 are used as position sensors, as taught by Masters, because this allows the user to easily distinguish the sensor from the surrounding tissue without the sensor being radiopaque or magnetic, as recognized by Masters (Col 2, lines 15-30).
Regarding Claim 10, the combination of references teaches the invention substantially as claimed. Charthad further teaches wherein said external device comprises one or more ultrasound transducer(s) (Fig. 1, 114+120) [0071]+[0077]+[0122].
Charthad fails to explicitly teach means to extracts and process raw spatial data from said ultrasound transducer(s) to determine said displacement of said wireless 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 means 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.
While Brenner’971 teaches the sensors are reflectors, Brenner’971 is silent that the sensors are used as position sensors, and thus to determine said displacement of said wireless position sensors.
Masters teaches an ultrasound marker system (Abstract). This system has ultrasonic markers which have an ultrasonic signature such that an ultrasound can determine the position of the marker (Col 4, lines 45-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system so that the echographic wireless sensors of Brenner’971 are used as position sensors, as taught by Masters, because this allows the user to easily distinguish the sensor from the surrounding tissue without the sensor being radiopaque or magnetic, as recognized by Masters (Col 2, lines 15-30). One of ordinary skill would recognize determining the position of the ultrasound sensor as taught by Masters, when viewed with the teaching of Charthad of determining the relative positions of sensors, suggests determining the displacement of the sensors from the extracted data.
Regarding Claim 17, the combination of reference teaches the invention substantially as claimed. Charthad is silent regarding said wireless position sensors are solid, porous, or hollow forms selected from the group consisting of: sphere, coil, cylinder, polyhedron, corner cube, ellipsoid, ring, shapes adapted to have high ultrasound and/or electromagnetic reflectivity, and arrays of any of said forms.
Brenner’971 teaches a system for measuring cardiac parameters (Abstract). The uses wireless sensors which are solid, porous, or hollow forms which are 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.
While Brenner’971 teaches the sensors are reflectors, Brenner’971 is silent that the sensors are used as position sensors.
Masters teaches an ultrasound marker system (Abstract). This system has ultrasonic markers which have an ultrasonic signature such that an ultrasound can determine the position of the marker (Col 4, lines 45-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system so that the echographic wireless sensors of Brenner’971 are used as position sensors, as taught by Masters, because this allows the user to easily distinguish the sensor from the surrounding tissue without the sensor being radiopaque or magnetic, as recognized by Masters (Col 2, lines 15-30).
Regarding Claim 18, the combination of references teaches the invention substantially as claimed. Charthad fails to explicitly teach wherein said wireless position sensors are passive electromagnetic or ultrasound reflectors.
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].
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.
While Brenner’971 teaches the sensors are reflectors, Brenner’971 is silent that the sensors are used as position sensors.
Masters teaches an ultrasound marker system (Abstract). This system has ultrasonic markers which have an ultrasonic signature such that an ultrasound can determine the position of the marker (Col 4, lines 45-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system so that the echographic wireless sensors of Brenner’971 are used as position sensors, as taught by Masters, because this allows the user to easily distinguish the sensor from the surrounding tissue without the sensor being radiopaque or magnetic, as recognized by Masters (Col 2, lines 15-30).
Claims 6, 9, 11, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Charthad in view of Lau as applied to claims 1 and 15, respectively, above, and further in view of Lichtenstein et al. (U.S PGPub 2007/0265690 A1).
Regarding Claim 6, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein said wireless position sensors have one or more distinct ultrasound and/or electromagnetic resonances at particular frequencies, and wherein said external device uses electromagnetic or ultrasound transmitters and receivers to induce and sense said resonances of said wireless position sensors.
Lichtenstein teaches a position tracking system (Abstract). This system has wire position sensors with one or more distinct electromagnetic resonances at particular frequencies [0007]+[0012]. The system uses an external electromagnetic transmitter (Fig. 2, 38+34) and receiver (Fig. 2, 40) to induce and sense the resonances of the wireless position sensors [0033]-[0035].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to use sensors with resonant frequencies, as taught by Lichtenstein, because these sensors don’t have wired connections, allowing the sensor to remain operable longer and without surgical procedures to replace the batter, as recognized by Lichtenstein [0037].
Regarding Claim 9, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein said external device uses true range multilateration or triangulation to determine said displacements of said wireless position sensors.
Lichtenstein teaches a position tracking system (Abstract). This system uses triangulation to determine the 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.
Regarding Claim 11, the combination of references teaches the invention substantially as claimed. Charthad fails to explicitly teach said pressure sensing means and/or said position sensors are passive, having no internal power supply.
Lichtenstein further teaches the wireless position sensors [0038] are passive [0037].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the position sensors of the combination with passive position sensors, as taught by Lichtenstein, 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 the passive transponder are reasonably predictable.
Regarding Claim 19, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein said wireless position sensors have one or more distinct resonances at particular frequencies, and wherein said external device uses electromagnetic or ultrasound transmitters and receivers to induce and sense said resonances of said wireless position sensors.
Lichtenstein teaches a position tracking system (Abstract). This system has wire position sensors with one or more distinct resonances at particular frequencies [0007]+[0012]. The system uses an external electromagnetic transmitter (Fig. 2, 38+34) and receiver (Fig. 2, 40) to induce and sense the resonances of the wireless position sensors [0033]-[0035].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to use sensors with resonant frequencies, as taught by Lichtenstein, because these sensors don’t have wired connections, allowing the sensor to remain operable longer and without surgical procedures to replace the batter, as recognized by Lichtenstein [0037].
Regarding Claim 21, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein said external device uses true range multilateration or triangulation to determine said displacement of said wireless position sensors.
Lichtenstein teaches a position tracking system (Abstract). This system uses triangulation to determine the 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.
Claims 7, 13, 23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Charthad in view of Lau as applied to claims 1 and 15, respectively, above, and further in view of Kaplan (U.S PGPub 2005/0288590 A1).
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 pressure sensor resonant frequencies are affected by a cardiac chamber pressure surrounding said sensors, whereby said cardiac chamber pressure may be determined by correlating the measured value of said pressure sensor resonant frequencies with a predetermined calibration curve relating pressure to resonance frequency.
Kaplan teaches a sensor with vibrating members (Abstract). 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 13, the combination of references teaches the invention substantially as claimed. Charthad fails to explicitly teach wherein said pressure sensing means employs a passive sensor having a pressure-dependent resonant frequency.
Kaplan teaches a sensor with vibrating members (Abstract). This system can be a passive pressure sensor [0013] with a pressure dependent resonant 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, as taught by Kaplan, because using protected, calibrated, resonating pressure sensors increases the accuracy of the measured pressure, as recognized by Kaplan [0031].
Regarding Claim 23, the combination of references teaches the invention substantially as claimed. Charthad further teaches said pressure sensing means is passive, having no internal power supply.
Kaplan teaches a sensor with vibrating members (Abstract). This system can be a passive pressure sensor where the resonant frequency of the sensor is affected by the external pressure around the sensor [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 passive 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].
Regarding Claim 25, the combination of references teaches the invention substantially as claimed. Charthad fails to explicitly teach wherein said wireless pressure sensor employs a passive sensor having a pressure-dependent resonant frequency.
Kaplan teaches a sensor with vibrating members (Abstract). This system can be a passive pressure sensor [0013] with a pressure dependent resonant 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, as taught by Kaplan, because using protected, calibrated, resonating pressure sensors increases the accuracy of the measured pressure, as recognized by Kaplan [0031].
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Charthad in view of Lau and Lichtenstein as applied to claim 6 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].
Claims 14 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Charthad in view of Lau as applied to claims 1 and 15, respectively, above, and further in view of Gilkerson et al. (U.S PGPub 2007/0129765 A1).
Regarding Claim 14, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein parameters derived from said one or more pressure-volume loops from a given examination of a patient are used in comparison to parameters derived from previous pressure-volume loops measured from said patient to determine changes in said cardiac health over time.
Gilkerson teaches a system for generating pressure-volume loops (Abstract). This system wherein parameters (Fig. 8, 830) [0040] derived from said pressure-volume loops (Fig. 8, 820) from a given examination of a patient [0039]-[0040] are used in comparison to parameters derived from previous pressure-volume loops measured from said patient to determine changes in said cardiac health over time [0040]-[0041].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combine system to use the pressure-volume loops to monitor the cardiac health over time, as taught by Gilkerson, because this helps to optimize the therapy the patient receives, thereby increasing the quality of care, as recognized by Gilkerson [0005].
Regarding Claim 26, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein parameters derived from said pressure-volume loops from a given examination of a patient are used in comparison to parameters derived from previous pressure-volume loops measured from said patient to determine changes in said cardiac health over time.
Gilkerson teaches a system for generating pressure-volume loops (Abstract). This system wherein parameters (Fig. 8, 830) [0040] derived from said pressure-volume loops (Fig. 8, 820) from a given examination of a patient [0039]-[0040] are used in comparison to parameters derived from previous pressure-volume loops measured from said patient to determine changes in said cardiac health over time [0040]-[0041].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combine system to use the pressure-volume loops to monitor the cardiac health over time, as taught by Gilkerson, because this helps to optimize the therapy the patient receives, thereby increasing the quality of care, as recognized by Gilkerson [0005].
Claim 20 are rejected under 35 U.S.C. 103 as being unpatentable over Charthad in view of Lau and Lichtenstein as applied to claim 19 above, and further in view of Kaplan (U.S PGPub 2005/0288590 A1).
Regarding Claim 20, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein said particular frequencies are affected by an external pressure surrounding said wireless pressure sensor, whereby said pressure may be determined by correlating a measured value of said particular frequencies with a predetermined calibration curve relating external pressure to said particular frequencies.
Kaplan teaches a sensor with vibrating members (Abstract). 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].
Claim 22 are rejected under 35 U.S.C. 103 as being unpatentable over Charthad in view of Lau and Lichtenstein as applied to claim 19 above, and further in view of Brenner’971 and Masters.
Regarding Claim 22, the combination of references teaches the invention substantially as claimed. Charthad further teaches wherein said external device comprises one or more ultrasound transmitters and receivers (Fig. 1, 114+120) [0071]+[0077]+[0122].
Charthad fails to explicitly teach means to extracts and process raw spatial data from said ultrasound transmitters and receivers to determine said displacement of said wireless 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 means 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.
While Brenner’971 teaches the sensors are reflectors, Brenner’971 is silent that the sensors are used as position sensors, and thus to determine said displacement of said wireless position sensors.
Masters teaches an ultrasound marker system (Abstract). This system has ultrasonic markers which have an ultrasonic signature such that an ultrasound can determine the position of the marker (Col 4, lines 45-62).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system so that the echographic wireless sensors of Brenner’971 are used as position sensors, as taught by Masters, because this allows the user to easily distinguish the sensor from the surrounding tissue without the sensor being radiopaque or magnetic, as recognized by Masters (Col 2, lines 15-30). One of ordinary skill would recognize determining the position of the ultrasound sensor as taught by Masters, when viewed with the teaching of Charthad of determining the relative positions of sensors, suggests determining the displacement of the sensors from the extracted data.
Response to Arguments
Applicant’s arguments filed 11/9/2025 have been fully considered but they are not persuasive.
Applicant argues Charthad teaches active sensors, while the claimed invention are passive sensors. In response to applicant’s argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the sensors are passive reflectors) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). By the broadest reasonable interpretation of claim 1, the active sensors of Charthad would read on the claimed position sensors and pressure sensing means.
Applicant argues that Charthad does not combine the pressure and volume measurements to create a pressure-volume loop. The Examiner disagrees. Charthad teaches determining pressure-volume loops from the obtained measurements in [0179] (“Such pressure and volume measurements in a heart chamber may be utilized to plot pressure-volume loops for the heart chamber.”).
Applicant argues that Lau does not teach hardware for obtaining pressure-volume loops. In response to applicant’s arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Lau is not relied on to teach the hardware of pressure-volume loops, Charthad is relied on to teach the hardware.
Applicant argues that as the prior art does not teach a measurement system “externally and without requiring sensor power”, the claimed invention has advantages not contemplated by the prior art, and is therefore nonobvious. However, as discussed above, those features are not present in the independent claims. Therefore, the claim remains rejected under 35 USC 103.
Applicant argues that Charthad does not provide a full “reduction to practice” of claim 5. The Examiner notes that a prior art reference is presumed to be enabling, and one of ordinary skill would recognize how to calculate the features of claim 5 using the Charthad reference (See MPEP 2121). Therefore, claim 5 remains rejected under 35 USC 103.
Applicant argues for Claims 10, 11, and 15 that the claimed invention does not require a processing means in the sensors. In response to applicant’s argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the sensors do not contain processing means) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Claim 11 is the only claim which suggests that certain sensors do not contain a power supply, however that claim is now rejected under Charthad in view of Lau and Lichtenstein as detailed above.
Applicant argues that Charthad does not teach the pressure sensing means is incorporated into one or wireless position sensors. The Examiner disagrees. The wireless monitors of Charthad are wireless position sensors ([0179]). The wireless monitors can additionally perform pressure sensing [0179] (“a wireless monitor may additionally measure blood pressure in a heart chamber”). One of ordinary skill would recognize that the pressure sensing means is incorporated into one or more of the wireless position sensors. Lau is not relied upon to teach the argued features of claim 12. Therefore, claim 12 remains rejected under 35 USC 103. Claims 22, 23, 24, 27 also remain rejected for substantially the same reasons.
Applicant argues that Brenner does not teach change to resonant frequency. However, Brenner is not relied on to teach a cloud server, nor is Brenner’971 relied upon to teach measuring the position using resonant frequencies.
Applicant argues that Lichtenstein does not teach measuring the position using resonant frequencies as claimed. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., direct position sensing through ultrasound reflection) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claim also allows for electromagnetic systems to induce and sense resonances. Therefore, claim 6 remains rejected under 35 USC 103.
Applicant argues that Kaplan does not teach obtaining pressure-volume loops. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Charthad and Lau are used to teach those limitations. Therefore, claim 7 remains rejected.
Applicant argues that the nonrigid and compressible sensors of Nunez are more expensive to produce than the claimed invention. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the sensors being simple rubber or metal spheres) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, there is a motivation to combine Nunez with the other references, as it allows for more accurate and stable long-term monitoring. Therefore, the claim remains rejected under 35 USC 103.
Applicant argues that Gilkerson uses internal circuitry, and therefore does not teach the claimed invention. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the sensors not containing internal circuitry) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, the claims 14 and 26 remain rejected under 35 USC 103.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN D MATTSON whose telephone number is (408)918-7613. The examiner can normally be reached Monday - Friday 9 AM - 5 PM PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEAN D MATTSON/Primary Examiner, Art Unit 3798