DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 1 and 10 are objected to because of the following informalities:
In claim 1, line 3, “the shaft” lacks proper antecedent basis. It is unclear if this shaft same as “an elongate shaft” or a different shaft being recited. If it is the same, appropriate corrections required.
The issue relating antecedent basis are identified in claim 1, but any remaining similar issues for any other later claims should also be addressed.
In claim 10, the applicant uses the term “thickness” while defining it by a “diameter” measurement. Although the specification (page 4) indicates “the diameter describing the "thickness" of the catheter refers to an outer diameter of the cross section of the catheter, as opposed to the diameters that are used to describe the curves of the catheter”, applicant may wish to amend the claim to explicitly recite “outer diameter” rather than “thickness” for better clarity.
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.
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.
Claim 8 and 12 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.
Regarding Claim 8, “the first diameter is in a range between 4.250 centimeters (cm.) and 5.750 cm., inclusive, the second diameter is in a range between 5.100 cm. and 6.900 cm., inclusive, and the third diameter is in a range between 1.275 cm. and 1.725 cm., inclusive” is indefinite for failing to particularly point out and distinctly claim the subject matter. Claim 8 depends on claim 7, which require “a third diameter that is greater than the first diameter and the second diameter”. However, claim 8 recites the third diameter range less than the first and second diameter. This numerical range recited in claim 8 are inconsistent with the limitation of claim 7. Accordingly, the scope of claim 8 cannot be determined, therefore claim 8 is indefinite.
Regarding Claim 12, “at least one second electrode comprises at least one second electrode or at least two second electrodes” is indefinite and unclear for failing to particularly point out and distinctly claim the subject matter and scope of the claim.
In the present instance, claim 12 recites the broad recitation “at least one …” followed by a narrower range “at least two …” and so there is some ambiguity as to scope. “At least one” already fully encompasses “at least two”, so the addition of the “at least two” language does nothing to change the scope of the claim. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 22 and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 and 19 respectively of U.S. Patent No. 11,925,808. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the patented claims directed to substantially the same scope of subject matter.
The only substantive deviation from the claimed subject matter is that the instant application is not patentably distinct from patented claim because the instant claims recite a system where the claimed invention recites a method. Although the claims are not identical, the differences in the instant claims are anticipated by the Claims of the patented claims.
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.
Claim(s) 1-5, 7-8, and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016138263 A1 to Lampropoulos et al. (hereinafter “Lampropoulos”) in view of US 20210001116 A1 to Waldhauser et al. (hereinafter “Waldhauser”) and further in view of WO 2011019838 A2 to Kim et al. (hereinafter “Kim”).
Regarding Claim 1, Lampropoulos teaches a catheter (see Abstract: “A multi-lumen catheter can be used to measure pressure at multiple locations within the vasculature”) for assessing cardiac function of a heart of a patient (see Para 22), the catheter comprising:
an elongate shaft extending from a proximal end to a distal end (see Abstract: “The multi-lumen catheter can include multiple segments, such as a proximal portion, an intermediate portion, and a distal portion”), the shaft having a first curve, a second curve, a third curve, and a fourth curve, the third curve having a diameter that is larger than that of the second curve (see Fig1, 5-8 and Para 47 (though it does not teach four specific curves and less diameter for specific curve, however, shows that the catheter has multiple curves and diameter could be reduced to create trapped region in between the portion) and Para 86), the shaft comprising:
at least one lumen for receiving at least one of a guide wire or a saline flush (see Para 52: “a wire or other elongate member … a guidewire may be inserted in the main lumen”, Para 19-20, 23);
at least one first electrode disposed on the second curve of the shaft configured to (see Para 22: “a first electrode may be delivered through a first lumen of a catheter to a first location within a patient”), in use, contact a septal wall of a left ventricle of the heart, sense electrical signals, and apply pacing to the heart (see Para 22: “electrodes disposed in this manner may be used to monitor electrical pulses across a heart or to function as a defibrillator or pacemaker by delivering one or more electrical pulses to the heart, and Para 44);
at least one second electrode disposed on the third curve of the shaft configured to, in use, contact a free wall of the left ventricle of the heart, sense electrical signals, and apply pacing to the heart (see Para 22: “second electrode may be delivered to a second location within a patient. Disposed in this manner, the electrodes may be used to monitor or deliver one or more electrical pulses. More particularly, electrodes disposed in this manner may be used to monitor electrical pulses across a heart or to function as a defibrillator or pacemaker by delivering one or more electrical pulses to the heart”),
at least one sensor disposed on the shaft (see Para 38: “the catheter 100 includes a first inline pressure sensor 124 in communication with the first separate lumen 120, and a second inline pressure sensor 134 in communication with the second separate lumen 130”) for detecting an event relating to a rapid increase in a rate of pressure increase within the left ventricle of the heart (see Para 98, Para 20); and
communication means configured to transmit data received from the at least one first electrode, the at least one second electrode, and the at least one sensor (see Para 38-44: “The single pressure readout device 160 is in communication with the first inline pressure sensor 124 and the second inline pressure sensor 134. The first inline pressure sensor 124, the second inline pressure sensor 134, and the single pressure readout device 160 are integrated in a single device … in addition to the inline pressure sensors (such as, for example, pH sensors, electrical sensors, and temperature sensors). The catheter 100 may also include therapeutic elements such as pacing electrodes, antennae or other elements”).
Lampropoulos teaches the catheter having curves (sized and shape adapt to measure pressure across the heart (Para 76)) and electrodes. However, does not specifically teach the number of curves and the electrode position (the second curve or the third curve) along the shaft.
Another reference, Waldhauser teaches a catheter include an elongate body (see Para 08), the shaft having a first curve, a second curve, a third curve, and a fourth curve the third curve having a diameter that is larger than that of the second curve (see Para 20: “a catheter includes an elongate body having a peripheral surface and a longitudinal center axis extending between a first end and a second end. The elongate body of this example has an offset region defined by a series of predefined curves along the longitudinal center axis. The predefined curves include a first portion having a first curve and a second curve in the longitudinal center axis, a second portion following the first portion, where the second portion has a zero curvature (e.g., a straight portion), and a third portion following the second portion, the third portion having a third curve and a fourth curve”, also Para 814-815 and Fig. 14B and Fig. 5-10) and at least one electrode disposed on the second curve and third curve of the shaft (see Para 20: “One or more electrodes are positioned on the elongate body along the second portion of the offset region of the elongate body” and Para 123, 145).
An additional reference, Kim also teach the shapes, curves, and positioning of the electrodes along the shaft of a mapping catheter which includes an elongated body for inserting into patient vasculature (see Fig. 5A-9B).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to combine Waldhauser and Kim teaching to modify the invention of Lampropoulos in order to incorporate the shapes (geometric configuration) of the catheter and the position of the electrodes (see Para 20 (Waldhauser)), thereby improving electrode positioning for reliable sensing and pacing at different anatomical location and multi curved configuration for easier and safer navigation within the heart.
Regarding Claim 2, Lampropoulos teaches the modified catheter of claim above, wherein the at least one sensor is one or more of a pressure sensor, a piezoelectric sensor, a fiberoptic sensor, or an accelerometer (see Para 19-21: “one or more sensors (e.g., pressure sensor(s), pH sensor(s), or temperature sensor(s))”, and Para 44).
Regarding Claim 3, Lampropoulos teaches the modified catheter of claim above, wherein a stiffness of the shaft varies along a length of the elongate shaft between the proximal end and the distal end (see Para 36: “one or more portions of the catheter 100 may be of different hardness, such as described in further detail below in connection with FIGS. 6-1 1 . In other embodiments, each portion of the catheter 100 may be of substantially the same hardness”, also Para 74).
Regarding Claim 4, Lampropoulos teaches the modified catheter of claim above, wherein a middle part of the shaft disposed between the proximal end and the distal end (see Para 67: “an intermediate portion 306 disposed between the proximal portion 304 and the distal portion 302”) has a stiffness that is less than that of the proximal end (see Para 70: “the intermediate portion 306 is less radiodense than both the distal portion 302 and the proximal portion 304”), the shaft having a flexible tip at the distal end (see Para 72: “the catheter tip 350 (which may form both the distal portion 302 and the intermediate portion 306) comprises an elastomer that renders the catheter tip 350 "softer" and/or more flexible than the elongate catheter body 370”),
wherein the shaft comprises a multi-lumen extrusion having a first cover around the proximal end, a second cover around the middle part and a third cover around the distal end (see Fig. 2, 9-11, 14), the first cover, the second cover, and the third cover having differing stiffnesses (see Abstract, 36, 48, 72, 74-75 (the catheter have different hardness through different portion)), and
wherein the multi-lumen extrusion comprises Pebax 63D (see Para 45, 72, 74 (the catheter may be made from a polyether block amide, such as, for example, PEBAX)), the first cover comprises Nylon 11 or Nylon 12 and a braid wire (see Para 45, 78, 80, 90), the second cover comprises Pebax 35D, and the third cover comprises Pebax 75D or Pebax 55D (see Para 45, 72, 74 (the catheter may be made from a polyether block amide, such as, for example, PEBAX)).
Regarding Claim 5, Kim further teaches the modified catheter of claim above, wherein the at least one first electrode and the at least one second electrode are disposed along the shaft such that, in use, at least two electrodes of the at least one first electrode and the at least one second electrode are positioned opposing each other in the heart of the patient (see Fig 8B-9B), and
wherein at least one electrode of the at least one first electrode or the at least one second electrode is configured to be placed in contact with a contralateral wall of the patient (see Fig 5B-9B (the catheter with the electrode positioned at targeted locations in patient vascular are present in the reference)) .
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to combine Kim teaching to further modify the invention of Lampropoulos in order for the catheter to have the electrode positioned opposing each other for electrically mapping a region of patient tissue (see attached Document). This would improve the catheter ability to map electrical activity and signal acquisition from different cardiac tissue by positioning electrode at opposite location within the heart, thereby would facilitate more accurate and effective cardiac assessment procedure for pacing and sensing between different cardiac region.
Regarding Claim 7, Kim further teaches the modified catheter of claim above, wherein the first curve is a counterclockwise counter clockwise curve having a first diameter, the second curve is a clockwise curve having a second diameter that is greater than the first diameter, the third curve is a clockwise curve having a third diameter that is greater than the first diameter and the second diameter, and the fourth curve is a clockwise curve having a fourth diameter that is less than the first diameter, and preferably wherein the fourth diameter is smaller than the first diameter, the first diameter is smaller than the second diameter, and the second diameter is smaller than the third diameter (see Fig 8B-9B).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to combine Kim teaching to further modify the invention of Lampropoulos in order for the curve to be in different direction and to form suitable diameter for facilitating stabilization of at least one of the orientation or the position of the catheter (see attached Document). Such modifications would improve the catheter tissue contact, positioning, and stability, thereby will improve the placement accuracy within the heart and effectiveness of the cardiac assessment by obtaining useful electrical and/or physiological measurements.
Regarding Claim 8, Lampropoulos further teaches the modified catheter of claim above, wherein the first curve is an arc having an angle in a range between 33 and 45°, inclusive, the second curve is an arc having an angle in a range between 97.5 and 131.5°, inclusive, and the third curve is an arc having an angle in a range between 66.4° and 87.4°, inclusive (see Para 67-69 (suggest that “position and/or structure of the bend(s) may be altered for any number of purposes. For example, the distance between bends, the angle(s) traversed by one or more of the bends, and the number of bends may be altered based on the intended use of the catheter, the anatomy of the patient”, therefore it would be obvious design change in the catheter”), or
wherein the first diameter is in a range between 4.250 centimeters (cm.) and 5.750 cm., inclusive, the second diameter is in a range between 5.100 cm. and 6.900 cm., inclusive, and the third diameter is in a range between 1.275 cm. and 1.725 cm., inclusive (see Para 66).
Regarding Claim 10, Lampropoulos further teaches the modified catheter of claim above, wherein the shaft has catheter is provided with a first thickness of the catheter towards the proximal end, a second thickness that is less than the first thickness, and a third thickness at the distal end that is less than the second thickness, the wherein the first thickness is greater than the second thickness, and the second thickness is greater than the third thickness, and preferably wherein the first thickness is a diameter of 6 French (Fr) [[Fr]], the second thickness is a diameter of 5 Fr, and the third thickness is a diameter of 3.5 Fr (see Para 88-91, 47, 66).
Regarding Claim 11-12, Kim further teaches the modified catheter of claim above, wherein one or more electrodes and at least one sensor is disposed in different curve (see Fig 5B-9B).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to combine Kim teaching to further modify the invention of Lampropoulos in order to have plurality of electrode disposed in any suitable shape for contacting patient tissue and map electrical activity within walls of pulmonary vein, also to include sensors for monitoring one or more conditions (e.g., pressure, temperature, or the like) (see attached Document). Such modifications would enable acquisition of data from multiple cardiac locations simultaneously, thereby improving assessment and evaluation for cardiac resynchronisation therapy.
Claim(s) 15-22, and 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lampropoulos in view of Waldhauser and Kim also further in view of GB 2583496 A to Hans (hereinafter “Hans”).
Regarding Claim 15, Hans discloses a method and system for measuring time to fusion as a means of determining degree of parallel activation of the heart (see Page 1, (see attached document)) comprising:
the catheter of claim 1 (see Page 12: “a pressure catheter located in the left ventricle”, also Page 29 (line 26-32) and claim 1 above);
a signal amplifier (see Page 42: “a signal amplifier (ECG, electrograms and sensor signals)”);
a stimulator (see Page 19: “multiple electrodes for stimulation”); and
a data processing module (see Page 8: “the data processing module may be configured to perform steps as set out above”),
wherein the catheter is configured to be in signal communication with the stimulator, the signal amplifier, and the data processing module such that the at least one first electrode, the at least one second electrode, and the at least one sensor provide sensed data to the data processing module for further processing, and the at least one first electrode and the at least one second electrode provide pacing to the patient-s heart (see Page 2: “applying pacing through an additional electrode and/or electrodes provided in an alternative position”, also Page 4: “… The computer system … the one or more sensor(s) to measure biopotentials; the one or more electrodes for providing pacing; and the data processing module which is configured to perform method steps as set out above” also Page 12 (line22) – Page 13 (line 34)).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the invention of Lampropoulos with the teaching of Hans to include stimulator, signal amplifier, and data processing module in communication with the catheter since it would predictably enable real-time acquisition, processing, and evaluating of physiological signal/data, thereby providing more accurate monitoring and controlled pacing response.
Regarding Claim 16, Hans further discloses wherein the data processing module is configured to determine a characteristic response relating to an onset of myocardial synergy from the event relating to the rapid increase in the rate of pressure increase within the left ventricle of the heart (see Page 10: “By characterising cardiac synchronicity using measurements resulting from the onset of myocardial synergy, for example via measurement of electrical activation or by the measuring of events that reflect mechanical action within the heart, … data may be obtained using at least one sensor of any suitable known type, including sensors commonly used for measurements of the heart, both non-invasively and via implanted sensors, with examples including pressure sensors, ECG electrodes, accelerometers and ultrasound sensors”, also Fig. 4a-4b).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the invention of Lampropoulos with the teaching of Hans to have the data processing module configured to determine a characteristic response relating to an onset of myocardial synergy since it would enable automatic identification and would provide more accurate assessment of cardiac response to pacing therapy.
Regarding Claim 17, Hans further discloses wherein the at least one sensor is configured to provide pressure data regarding the pressure within the heart to the data processing module (see Page 10: “data may be obtained using at least one sensor of any suitable known type, including sensors commonly used for measurements of the heart, both non-invasively and via implanted sensors, with examples including pressure sensors”),
wherein the data processing module is configured to filter the pressure data to identify the characteristic response relating to the onset of myocardial synergy (see Page 9 (line 21-37): “method for identifying reversible cardiac dyssynchrony of a patient by detecting a shortening of a delay to onset of myocardial synergy”, also Page 10) , and
wherein the characteristic response comprises a beginning of a pressure rise above a pressure floor in a pressure signal filtered above a first harmonic of the pressure signal (see Fig. 4a-5b).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the invention of Lampropoulos with the teaching of Hans to predictably improve signal quality and to provide more precise and reliable detection of relevant pressure based cardiac events.
Regarding Claim 18, Hans further discloses wherein the characteristic response comprises a presence of high frequency components of the pressure signal or a band-pass filtered pressure trace crossing zero(see Fig. 4a-5b), and wherein the high frequency components is above 40 Hz (see Fig. 5b).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the invention of Lampropoulos with the teaching of Hans to enhance the detection of rapid physiological pressure change, thereby improving accuracy in identifying onset of myocardial synergy.
Regarding Claim 19, Hans further discloses wherein the at least one sensor is configured to provide acceleration data from within the heart to the data processing module (see Page 11: “the one or more sensor(s) includes an accelerometer … receiving data from the accelerometer, … and determining the reference time from the point of onset, offset, full duration and matched template of the acceleration data”), and the data processing module is configured to filter the acceleration data to identify the characteristic response relating to the onset of myocardial synergy (see Page 30 (line16) – Page 31 (line 14), and Fig. 4a-5b),
wherein the data processing module is further configured to calculate a center frequency of a continuous wavelet transform of the acceleration data to identify the characteristic response relating to the onset of myocardial synergy that is a peak of the center frequency (see Fig. 4a-5b), and
wherein the data processing module is further configured to average the center frequency over a number of heart cycles (see Fig. 4a and Page 30-31).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the invention of Lampropoulos with the teaching of Hans to include acceleration sensor since it would allow detection of mechanical cardiac motion in time frequency domain, thereby providing more robust identification of onset myocardial synergy across varying cardiac conditions.
Regarding Claim 20, Hans further discloses wherein the data processing module is configured to identify reversible cardiac dyssynchrony by identifying a shortening of a delay to onset of myocardial synergy as a result of pacing and by using the at least one sensor to measure a time of the event relating to the rapid increase in the rate of pressure increase within the left ventricle of the heart by identifying the characteristic response in the data received from the one or more sensors, the event relating to the rapid increase in the rate of pressure increase within the left ventricle being identifiable in each contraction of the heart, the data processing module being configured to measure the time of the event relating to the rapid increase in the rate of pressure increase within the left ventricle (see Page 9 (line 21) – Page 10 (line 24)), by:
processing signals from the at least one sensor to determine a first time delay between the measured time of the identified characteristic response relating to the rapid increase in the rate of pressure increase within the left ventricle and a first reference time (see Page 9 (line 21) – Page 9 (line 37));
comparing the first time delay with a duration of electrical activation of the heart to identify the presence of cardiac dyssynchrony in the patient when the first time delay is longer than a set fraction of electrical activation of the heart (see Page 9 (line 21) – Page 9 (line 37));
following pacing by one or both of the at least one first electrode or the at least one second electrode to the heart, calculating a second time delay between the identified characteristic response relating to the rapid increase in the rate of pressure increase within the left ventricle following pacing and a second reference time following pacing (see Page 9 (line 21) – Page 10 (line 24), also (see Page 12 (line 22) – Page 13 (line 32))) by:
measuring, via signals from the at least one sensor, the timing of the identified characteristic response; and determining the second time delay and the second reference time following pacing; comparing the first time delay and the second time delay; and if the second time delay is shorter than the first time delay, identifying a shortening of a delay to onset of myocardial synergy (OoS) indicating that a time period until a point where all segments of the heart begin to actively or passively stiffen has shortened, thereby identifying the presence of reversible cardiac dyssynchrony in the patient (see Page 9 (line 21) – Page 10 (line 24), also see Page 12 (line 22) – Page 13 (line 32)).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the invention of Lampropoulos with the teaching of Hans to identify reversible cardiac dyssynchrony by comparing two pacing delay to onset of myocardial synergy since it would improve effectiveness of therapy and improvement in cardiac synchronization.
Regarding Claim 21, Hans further discloses wherein the data processing module is further configured to:
identify the absence of cardiac dyssynchrony in the patient if the first time delay is shorter than a set fraction of electrical activation of the heart (see Page 9: “if the first time delay is longer than a set fraction of electrical activation of the heart, then identifying the presence of cardiac dyssynchrony” (the examiner notes that the opposite would identify as absence of cardiac dyssynchrony)); and
identify the absence of cardiac dyssynchrony in the patient if the first time delay is shorter than a set delay (see Page 10: “if the first time delay is longer than a set fraction of the QRS complex duration, then identifying the presence of dyssynchrony in the patient” (the examiner notes that the opposite would identify as absence of cardiac dyssynchrony)).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the invention of Lampropoulos with the teaching of Hans to identify the absence of cardiac dyssynchrony to improve treatment decision and pacing selection.
Regarding Claim 22, Hans further discloses wherein the data processing module is configured to determine a degree of parallel activation of the heart undergoing pacing by:
calculating a vectorcardiogram (VCG) waveform or an electrocardiogram (ECG) waveform from a right ventricular pacing (RVp) and a left ventricular pacing (LVp) (see Page 9 (line 1-20));
generating a synthetic biventricular pacing (BIVP) waveform pacing by summing the VCG of the RVp and the LVp, or by summing the ECG of the RVp and the LVp (see Page 9 (line 1-20));
calculating a corresponding ECG waveform or a VCG waveform from a real BIVP (see Page 9 (line 1-20));
comparing the synthetic BIVP waveform and the real BIVP waveform (see Page 9 (line 1-20)); and
calculating time to fusion by determining the point in time in which the activation from the RVp and the LVp meets and a curve of the synthetic BIVP and a curve of the real BIVP start to deviate (see Page 9 (line 1-20)),
wherein a delay in time to fusion indicates that a larger amount of tissue is activated before wave fronts for electrical activation meet, thereby indicating a higher degree of parallel activation (see Page 9 (line 1-20)).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the invention of Lampropoulos with the teaching of Hans to provide improved assessment of ventricular synchrony and pacing optimization.
Regarding Claim 24, Hans further discloses wherein the data processing module is configured to determine an optimal electrode number and an optimal electrode position for cardiac resynchronization therapy on the heart based on one or more nodes of a three-dimensional (3D) mesh of an at least part of the heart with a calculated degree of parallel activation of a myocardium above a predetermined threshold (see Page 7 (line 5) – Page 8 (line 37)) by:
generating the 3D mesh of the at least part of the heart from a 3D model of the at least part of the heart of the patient, or using a generic 3D model of the heart to obtain a 3D mesh of the at least a part of the heart, the 3D mesh of the at least a part of the heart comprising a plurality of nodes (see Page 7 (line 5) – Page 8 (line 37));
aligning the 3D mesh of the at least part of the heart to images of the heart of the patient (see Page 7 (line 5) – Page 8 (line 37));
placing additional nodes onto the 3D mesh corresponding to a location of the at least one first electrode and the at least one second electrode on the patient (see Page 7 (line 5) – Page 8 (line 37));
calculating a propagation velocity of an electrical activation between the nodes of the 3D mesh corresponding to the location of the at least one first electrode and the at least one second electrode (see Page 7 (line 5) – Page 8 (line 37));
extrapolating the propagation velocity to all of the nodes of the 3D mesh; calculating the degree of parallel activation of the myocardium for each node of the 3D mesh (see Page 7 (line 5) – Page 8 (line 37)); and
determining the optimal electrode number and the optimal electrode position on the heart of the patient based on the nodes of the 3D mesh with the calculated degree of parallel activation of the myocardium above the predetermined threshold (see Page 7 (line 5) – Page 8 (line 37)).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the invention of Lampropoulos with the teaching of Hans to determine optimal electrode number and position using a 3D mesh to improve placement accuracy and enhance therapeutic outcomes.
Regarding Claim 25, Hans further discloses wherein the catheter is configured to be provided into the heart through one or more of arterial access, venal access, subclavian access, radial access, or femoral access such that the at least one first electrode, the at least one second electrode, and the at least one sensor, in use, may be provided within the heart of the patient (see Fig. 1b-2 (show implanted atrial and biventricular electrodes), and Fig. 5a ( show a pressure catheter located within the left ventricle can be utilized to measure ventricular pressure)).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to further modify the invention of Lampropoulos with the teaching of Hans to provide catheter access via any of this standard intracardiac catheterization pathway to provide safe and flexible catheter introduction into the heart.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/I.J./Examiner, Art Unit 3792
/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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