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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 31st, 2026 has been entered.
Claims 1-20 remain pending in the application.
Response to Arguments
Applicant’s arguments, filed 3/31/26, with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections under 35 U.S.C. 112(b) are withdrawn. However, additional rejections are added.
Applicant's arguments, filed 3/31/26 with respect to the rejections under 35 U.S.C. 103 with respect to the combination of Conklin and Schwarcz have been fully considered but they are not persuasive.
At pages 8-9, Applicant argues that there is no motivation to combine the teachings of Conklin with the teachings of Schwarcz because Conklin discloses a heart valve sizer to determine the size of the native anulus and displays the diameter, that Conklin uses a torque or linear force sensor to determine the level of reaction force and a person skilled in the art would not have recognized the need to measure both the linear displacement of the shaft and the linear force required to operate the heart valve sizer device in Conklin because the clutch system in Conklin a simple solution to indicate the endpoint of radial expansion. Examiner respectfully disagrees. In response to applicant' s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Conklin is directed to a force-based heart valve sizer and discloses in para. [0094-0096] a force feedback-based sizing system using a torque sensor/linear in the handle and, in para. [0109]/figs. 3A-3B, a size indicator 133 to display the diameter of the sizing element at all times. Schwarcz directed to a measurement device to monitor the real-time diameter and/or radial force of a prosthetic heart valve (Abstract, para. [0007]) discloses in para. [0087, 0092, 0095, 0098, 0100] using sensor 212/linear displacement sensor disposed in the handle to provide an accurate measurement of the diameter of the prosthetic valve and a load cell in the handle to measure tensile force and is used to calculate the radial force applied by the valve on the surrounding tissue. Schwarcz further discloses that measurement methods relying on measuring the displacement of an actuation mechanism fail to account for factors such as compression of the delivery device and/or elongation of the actuation mechanism under tension and that the prosthetic valve diameter measurement can be more accurate because it accounts for radial expansion and compression of the valve (para. [0006-0007, 0172]). Both Conklin and Schwarcz are directed to devices for determining valve diameters and reaction forces from the surrounding tissue to the valve sizer/prosthetic valve.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Conklin such that the catheter comprises a plurality of sensors located within the handle, the sensors comprising at least one force sensor and at least one displacement sensor; a central lumen extending through the inner shaft; wherein the plurality of sensors are configured to obtain sensor data and measure: linear displacement of the shaft and scaffold as the scaffold is expanded by activating the actuator; and linear force required to achieve such linear displacement against a radially compressive force exerted by the blood vessel; and wherein the sensor data are processed to determine the scaffold diameter and radial expansion force in view of the teachings of Schwarcz, as such a modification would have been merely a substitution of the inner shaft of Conklin for the actuator/shaft of Schwarcz in order to receive a second actuator that extends through the actuator/shaft to aid in applying a proximally directed force for expanding the prosthetic valve/valve sizer and further as such a modification would have been merely a substitution of the handle of Conklin for the handle of Schwarcz and would aid in more accurately measuring the diameter by accounting for radial expansion and compression of the prosthetic valve/valve sizer (Schwarcz, para. [0006-0007, 0172]).
At pages 12-13, Applicant’s arguments with respect to the rejections under 35 U.S.C. 103 regarding “wherein the sensor data are processed in a non-linear fashion by accounting for non-linear force sensitivity in expansion of the scaffold to determine the scaffold diameter and radial expansion force” have been considered but are not persuasive. 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). Schwarcz does disclose that the prosthetic valve diameter measurement can be more accurate because it accounts for radial expansion and compression of the valve (para. [0006-0007, 0172]). However, Schwarcz does not disclose accounting for non-linear force sensitivity in expansion of the scaffold and Schwarcz was not relied upon to teach processing the sensor data in a non-linear fashion by accounting for non-linear force sensitivity in expansion of the scaffold. Furthermore, Applicant’s arguments are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim 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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an actuator configured to create linear motion” in claims 1 and 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The actuator defined as a user-operated actuator or rotary drive body, knob, slide, motor, gear track, linear gear train in para. [0017, 0046, 0080].
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 lines 22-24 and Claim 12 lines 33-35 (claims 2-11 and 13-20 by virtue of dependency, respectively) recites “non-linear force sensitivity in expansion of the scaffold”. However, the specification at the time of the effective filing date does not define “non-linear force sensitivity”. It is unclear whether the non-linear force sensitivity is referring to the sensitivity of the sensor or the sensitivity of the force data or the force sensitivity of the scaffold and how the non-linear force sensitivity is measured. The specification at the time of the effective filing date does disclose in para. [0009,0075] measuring and calibrating the non-linear behavior of various features of the device in response to forces applied, however this does not provide details as to how the non-linear behavior/non-linear force sensitivity is measured or define what the non-linear force sensitivity is. The specification at the time of the effective filing date further discloses in para. [0099] calibrating scaffold-specific non-linearities and hysteresis and non-linear scaffold deployment force, however this does not define or disclose the non-linear force sensitivity or how the non-linear force sensitivity is measured.
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 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 lines 22-24 and Claim 12 lines 33-35 (claims 2-11 and 13-20 by virtue of dependency, respectively) recites “non-linear force sensitivity in expansion of the scaffold”. It is unclear whether the non-linear force sensitivity is referring to the sensitivity of the sensor or the sensitivity of the force data and further it is unclear how the non-linear force sensitivity is measured or defined. The specification in para. [0009, 0075, 0099] discloses calibrating various parameters and calibration curves to compensate for non-linear scaffold deployment force. For examination purposes, the Examiner is interpreting the calibration/compensation/accounting of scaffold-specific non-linearities/non-linear behavior of the scaffold as the non-linear force sensitivity in expansion of the scaffold.
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 1-4 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Conklin (US 20130345801 A1 – previously cited) in view of Schwarcz (US 20210282921 A1 – previously cited), and further in view of Alberti (US 20160001411 A1).
Regarding claim 1, Conklin discloses a catheter (heart valve sizer 700, figs. 17A-B, “catheter”, para. [0017]) for measuring a force required to radially expand a blood vessel of a subject to an indicated diameter while maintaining blood flow (“orifice … diameter is being measured … linear force sensor … reaction force of the annulus”, para. [0095-0096, 0102, 0116]), the catheter comprising: a tubular body (tubular threaded portion 121B, fig. 2; heart valve sizer 700, figs. 17A-B), a shaft assembly (“shaft”, para. [0065, 0100]) comprising an outer shaft (outer tube 703, figs. 17A-B, shaft 104, figs. 2A-C) and an inner shaft (inner shaft 709, “inside”, figs. 17A-B, rod 120, figs. 2A-C) within the outer shaft (figs. 2A-C & 17A-B, para. [0100]), the outer shaft and the inner shaft configured to move relative to one another (“move longitudinally”, para. [0100]); a handle (handle 102/702, figs. 2A-C & 17A-B) on a proximal end of the tubular body (“proximal end”, para. [0100], as seen in figs. 2A-C & 17A-B), the handle comprising: an actuator (actuator assembly 106/705, figs. 2A-C & 17A-B) configured to (Examiner’s Note: functional language, i.e., capable of) create a linear motion in the shaft assembly (“linear”; “move longitudinally”, para. [0096, 0100], “axial movement”, Abstract); a radially expandable scaffold (valve sizer 207/707, figs. 9A-B & 17A-B, “radially expandable”, Abstract, para. [0109]) fixedly coupled to the shaft assembly (“fixed”, para. [0004, 0010, 0100], as seen in figs. 9A-B & 17A-B), the shaft assembly extending axially through the tubular body (as seen in figs. 2A-C); wherein a proximal end of the scaffold is attached to one of the inner shaft or outer shaft (“703 … valve sizer 707 disposed at the distal end”, para. [0100], as seen in figs. 9A-B & 17A-B) and a distal end of the scaffold is attached to the other one of the inner shaft or outer shaft (“707 is attached to a flexible inner shaft 709”, para. [0100], as seen in figs. 9A-B & 17A-B). Conklin further discloses size indicators 133 that display the diameter of the sizing element 1250 at all times and a linear force sensor to measure tension and determine the level of the reaction force of the annulus against the petals 108 (para. [0068, 0096, 0116]).
Conklin does not disclose a plurality of sensors located within the handle, the sensors comprising at least one force sensor and at least one displacement sensor; a central lumen extending through the inner shaft; wherein the plurality of sensors are configured to obtain sensor data and measure: linear displacement of the shaft and scaffold as the scaffold is expanded by activating the actuator; and linear force required to achieve such linear displacement against a radially compressive force exerted by the blood vessel; and wherein the sensor data are processed in a non-linear fashion to determine the scaffold diameter and radial expansion force.
However, Schwarcz directed to a measurement device to monitor the real-time diameter and/or radial force of a prosthetic heart valve (Abstract, para. [0007]) including a handle 202, actuator assembly 205, an outer shaft 204 and an inner actuator/shaft 206, discloses a plurality of sensors located within the handle (load cell 228 & sensor 212 in handle 202, as seen in fig. 5; “plural … sensors 212”; “plural … load cells 228”, para. [0087, 0100, 0099, 0104]), the sensors comprising at least one force sensor and at least one displacement sensor (load cell 228 & sensor 212; “linear displacement sensor … measure the relative movement”; “measure the tensile force … radial force”, para. [0092, 0100]); a central lumen extending through the inner shaft (unlabeled but as seen in figs. 2-6, see also para. [0075, 0130], “lumen of the first actuator 306”); wherein, the plurality of sensors (“plural … sensors 212”; “plural … load cells 228”; “sensor 314”, para. [0087, 0100, 0099, 0104, 0119]) are configured to obtain sensor data and measure (“signals”, para. [0095, 0099, 0102]): linear displacement of the shaft and scaffold as the scaffold is expanded by activating the actuator (“linear displacement sensor … relative distance corresponding to the diameter of the prosthetic valve … expansion … calculate the diameter of the prosthetic valve” para. [0092-0096]); and linear force required to achieve such displacement against a radially compressive force exerted by the blood vessel (“tensile force … as the prosthetic valve expands”; “tensile force … radial force applied by the prosthetic valve 100 against the surrounding tissue … correlating; “measured compressive and tensile forces”, para. [0011, 0100-0106); wherein the sensor data are processed to determine the scaffold diameter and radial expansion force (“calculate the diameter of the prosthetic valve”; “real-time radial force of the prosthetic valve based on the measured compressive and tensile forces”; “processor”, para. [0092-0096, 0100-0106, 0108-0109]). Schwarcz further discloses that measurement methods relying on measuring the displacement of an actuation mechanism fail to account for factors such as compression of the delivery device and/or elongation of the actuation mechanism under tension and that the prosthetic valve diameter measurement can be more accurate because it accounts for radial expansion and compression of the valve (para. [0006-0007, 0172]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Conklin such that the catheter comprises a plurality of sensors located within the handle, the sensors comprising at least one force sensor and at least one displacement sensor; a central lumen extending through the inner shaft; wherein the plurality of sensors are configured to obtain sensor data and measure: linear displacement of the shaft and scaffold as the scaffold is expanded by activating the actuator; and linear force required to achieve such linear displacement against a radially compressive force exerted by the blood vessel; and wherein the sensor data are processed to determine the scaffold diameter and radial expansion force in view of the teachings of Schwarcz, as such a modification would have been merely a substitution of the inner shaft of Conklin for the actuator/shaft of Schwarcz in order to receive a second actuator that extends through the actuator/shaft to aid in applying a proximally directed force for expanding the prosthetic valve/valve sizer and further as such a modification would have been merely a substitution of the handle of Conklin for the handle of Schwarcz and would aid in more accurately measuring the diameter by accounting for radial expansion and compression of the prosthetic valve/valve sizer (Schwarcz, para. [0006-0007, 0172]).
Schwarcz further discloses that the prosthetic valve diameter measurement can be more accurate because it accounts for radial expansion and compression of the valve (para. [0006-0007, 0172]).
Conklin, as modified by Schwarcz hereinabove, does not disclose that the sensor data are processed in a non-linear fashion by accounting for non-linear force sensitivity in expansion of the scaffold to determine the scaffold diameter and radial expansion force.
However, Alberti directed to a power tool, handled by a human or machine operator, having a motion actuator and a force detector for operating on a workpiece is discloses sensor data (“force detector … signal”, para. [0028]) and that the sensor data are processed in a non-linear fashion by accounting for non-linear force sensitivity in the tool’s response (“sensitivity profile … relationship … force … tool’s response”; “force detector … signal … “derived force” … force … measured … force detector can be calibrated as needed to remove any non-linearities in the tool or tool's sensor(s) … predetermined continuous response sensitivity profile … axial or radial force … algorithmically manipulate to a standard signal … force detector output may be standardized”, para. [0025, 0028-0029]).
Alberti discloses a tool having a force detector, a motion actuator, a sensitivity profile describing a relationship between the amount of pressure, load, force, or moment of force detected on the working surface and the tool's response, and is handled by a human or machine operator (para. [0025-0029]) and the instant application is directed to a catheter system that is user operated including a user-operated actuator, a force sensor, and calibration curves for various performance measurements to compensation for non-linear scaffold deployment force (para. [0009, 0017, 0077, 0098-0099]). Thus, the instant application and Alberti are in the same field of endeavor of calibrating force sensor non-linearities.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Conklin, as modified by Schwarcz hereinabove, such that the sensor data are processed in a non-linear fashion by accounting for non-linear force sensitivity in expansion of the scaffold to determine the scaffold diameter and radial expansion force, as this would aid in outputting standardized measurements that are calibrated to remove any non-linearities in the tool/catheter system or tool's/catheter system’s sensor(s).
Regarding claim 2, Conklin, as modified by Schwarcz and Alberti hereinabove, discloses the catheter of Claim 1, a collapsed first position (fig. 27A, para. [0116]), and an expanded second position (fig. 27C, para. [0116]). Conklin, as modified by Schwarcz and Alberti hereinabove, does not disclose wherein in a collapsed first position, the scaffold includes a first length and a first radial diameter, and in an expanded second position, the scaffold includes a second length and a second radial diameter, the second length shorter than the first length, the second radial diameter larger than the first radial diameter.
However, Schwarcz comprising a prosthetic device 10 (scaffold) disclose wherein in a collapsed first position (as seen in fig. 3), the scaffold includes a first length (“H = crimped height “, as seen in fig. 3, para. [0093]) and a first radial diameter (diameter D, as seen in fig. 3), and in an expanded second position, the scaffold includes a second length (“h=current/expanded height”, para. [0093], as seen in fig. 4) and a second radial diameter (“current diameter d”, para. [0094]), the second length shorter than the first length (as seen in figs. 3-4, para. [0093]), the second radial diameter larger than the first radial diameter (as seen in figs. 3-4, para. [0093]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Conklin, as modified by Schwarcz and Alberti hereinabove, such that in a collapsed first position, the scaffold includes a first length and a first radial diameter, and in an expanded second position, the scaffold includes a second length and a second radial diameter, the second length shorter than the first length, the second radial diameter larger than the first radial diameter, in view of the teachings of Schwarcz, as such a modification would have been merely a substitution of the sizing element of Conklin for the prosthetic device of Schwarcz as this would aid in providing a sizing element for determining a size of a valve annulus.
Regarding claim 3, Conklin, as modified by Schwarcz and Alberti hereinabove, discloses the catheter of Claim 1. Conklin, as modified by Schwarcz and Alberti hereinabove, does not disclose a shuttle coupled to the actuator, the shuttle configured to advance or retract responsive to activating the actuator.
However, Schwarcz discloses a shuttle (measurement device 210 comprising core 226 & tube 224, figs. 5 & 7, para. [0092-0093]) coupled to the actuator (“proximal end portion of the first actuator 206 can be connected directly to the tube 224”, para. [0072-0075, 0092-0093, 0117]), the shuttle configured to advance or retract responsive to activating the actuator (“core moves relative to the tube 224 … voltage differential”, para. [0092-0093, 0117]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Conklin, as modified by Schwarcz and Alberti hereinabove, such that the catheter comprises a shuttle coupled to the actuator, the shuttle configured to advance or retract responsive to activating the actuator, in view of the teachings of Schwarcz, as this would aid in determining the diameter of the prosthetic device by creating a voltage differential that is converted by the displacement sensor into a relative distance corresponding to the diameter (Schwarcz, para. [0092]).
Regarding claim 4, Conklin, as modified by Schwarcz and Alberti hereinabove, discloses the catheter of Claim 3. Conklin, as modified by Schwarcz and Alberti hereinabove, does not disclose wherein the shuttle comprises a slot, the displacement sensor comprises a post, the post of the displacement sensor configured to be positioned in the slot of the shuttle.
However, Schwarcz discloses wherein the shuttle comprises a slot (tube 224, fig. 7), the displacement sensor (measurement device 210 having sensor 212, para. [0092]) comprises a post (core 226, fig. 7), the post of the displacement sensor configured to be positioned in the slot of the shuttle (as seen in fig. 7, para. [0092, 0117]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Conklin, as modified by Schwarcz and Alberti hereinabove, such that the shuttle comprises a slot, the displacement sensor comprises a post, the post of the displacement sensor configured to be positioned in the slot of the shuttle, in view of the teachings of Schwarcz, as this would aid in calculating a real-time diameter of the sizing element/prosthetic device based on the relative displacement between the first and second motion-transmitting members.
Regarding claim 8, Conklin, as modified by Schwarcz and Alberti hereinabove, discloses the catheter of Claim 1, wherein the catheter is configured such that the scaffold or the shaft assembly does not include a sensor (para. [0094-0099], fig. 15).
Regarding claim 9, Conklin, as modified by Schwarcz and Alberti hereinabove, discloses the catheter of Claim 1, further comprising a digital display (screen 640 and digital readout 640a, fig. 16) configured to provide one or more of: an indication of a diameter of the scaffold, an axial displacement of the shaft assembly, a constrictive wall force of the blood vessel, and/or an axial force on the scaffold (“force gauge”; “axial forces”, para. [0018, 0096-0097, 0100, 0105]).
Regarding claim 10, Conklin, as modified by Schwarcz and Alberti hereinabove, discloses the catheter of Claim 1. Conklin, as modified by Schwarcz and Alberti hereinabove, does not disclose a plurality of struts, each of the plurality of struts comprising branching arms to promote preferential radial expansion of the scaffold while maintaining an apex portion of the scaffold with a profile that is approximately: flat, concave, or convex.
However, Schwarcz directed to a prosthetic device/scaffold 10 discloses a plurality of struts (struts 28/116, figs. 1-4), each of the plurality of struts (struts 28/116, figs. 1-4) comprises branching arms (unlabeled but as seen in figs. 1-4, “lattice-type pattern”, para. [0058]) to promote preferential radial expansion of the scaffold (“expansion”, par. [0070]) while maintaining an apex portion (unlabeled but as seen in figs. 3-4, para. [0070]) of the scaffold with a profile that is approximately: flat, concave, or convex (unlabeled but as seen in figs. 3-4, para. [0070]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Conklin, as modified by Schwarcz and Alberti hereinabove, such that the catheter comprises a plurality of struts, each of the plurality of struts comprising branching arms to promote preferential radial expansion of the scaffold while maintaining an apex portion of the scaffold with a profile that is approximately: flat, concave, or convex, in view of the teachings of Schwarcz as such a modification would have been merely a substitution of the sizing element of Conklin for the prosthetic device of Schwarcz as this would aid in providing a sizing element for determining a size of a valve annulus.
Regarding claim 11, Conklin, as modified by Schwarcz and Alberti hereinabove, discloses the catheter of Claim 1. Conklin, as modified by Schwarcz and Alberti hereinabove, does not disclose wherein the actuator is one of a knob, a slide, a gear track, a linear gear train, or a motor.
However, Schwarcz discloses wherein the actuator is one of a knob, a slide, a gear track, a linear gear train, or a motor (“handle can include a slidable or rotatable adjustment knob that is operatively connected to the actuator assembly 205 … produce axial movement”, para. [0079]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Conklin, as modified by Schwarcz and Alberti hereinabove, such that the actuator is one of a knob, a slide, a gear track, a linear gear train, or a motor, in view of the teachings of Schwarcz, as such a modification would have been merely a substitution of the actuator of Conklin for the slidable or rotatable adjustment knob of Schwarcz and would aid in producing axial movement.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Conklin in view of Schwarcz and Alberti, as applied to claim 4 above, and further in view of Burgkart (US 20090305213 A1 – previously cited).
Regarding claim 5, Conklin, as modified by Schwarcz and Alberti hereinabove, discloses the catheter of Claim 4. Conklin, as modified by Schwarcz and Alberti hereinabove, does not disclose wherein the force sensor is positioned between an adapter of the outer shaft and a portion of the shuttle, the force sensor configured to contact the adapter.
However, Burgkart directed to a heart valve delivery system having a handle assembly 500 discloses wherein the force sensor (load cell 592, fig. 16) is positioned between an adapter (distal plate assembly 502, fig. 16) of the outer shaft (delivery sleeve 24, figs. 12 & 16) and a portion of the shuttle (first side opening 564 in the proximal plate assembly 504, figs. 14A & 16), the force sensor configured to contact the adapter (as seen in fig. 16, “592, which is secured to the distal plate 502 … connected as known in the art to a device (not shown) which measures the displacement on the load cell 592”, para. [0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Conklin, as modified by Schwarcz and Alberti hereinabove, such that the force sensor is positioned between an adapter of the outer shaft and a portion of the shuttle, the force sensor configured to contact the adapter, in view of the teachings of Burgkart, as such a modification would have been merely a substitution of the handle of Conklin, as modified by Schwarcz and Alberti hereinabove, for the handle assembly of Burgkart and would aid in measuring force and displacement.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Conklin in view of Schwarcz and Alberti, as applied to claim 1 above, and further in view of Wu (US 20110264011 A1 – previously cited).
Regarding claim 6, Conklin, as modified by Schwarcz and Alberti hereinabove, discloses the catheter of Claim 1. Conklin, as modified by Schwarcz and Alberti hereinabove, does not expressly disclose wherein the force sensor comprises a piezoresistive sensor.
However, Wu directed to multi-directional deflectable catheter apparatuses having a sensor 42 (fig. 19A) discloses wherein the force sensor comprises a piezoresistive sensor (“sensor 42 … a piezo-resistive element … contact force”, para. [0279]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Conklin, as modified by Schwarcz and Alberti hereinabove, such that the force sensor comprises a piezoresistive sensor, in view of the teachings of Wu, as such a modification would have been merely a substitution of the force sensor of Conklin for the piezo-resistive element of Wu and would aid in measuring force.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Conklin in view of Schwarcz and Alberti, as applied to claim 1 above, and further in view of Shelton (US 20200405403 A1 – previously cited).
Regarding claim 7, Conklin, as modified by Schwarcz and Alberti hereinabove, discloses the catheter of Claim 1. Conklin, as modified by Schwarcz and Alberti hereinabove, does not disclose wherein the displacement sensor comprises a slide potentiometer.
However, Shelton directed to a control system 470 of a surgical instrument or tool having a position sensor 472 suitable for measuring linear displacement (para. [0525, 0532]) discloses wherein the displacement sensor comprises a slide potentiometer (“slide potentiometer”, para. [0532]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Conklin, as modified by Schwarcz and Alberti hereinabove, such that the displacement sensor comprises a slide potentiometer, in view of the teachings of Shelton, as this would aid in measuring linear displacement for calculating the diameter of the prosthetic device/sizing element.
Claims 12-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Schwarcz in view of Tegg (US 20190374282 A1 – previously cited), and further in view of Alberti.
Regarding claim 12, Schwarcz discloses a catheter for measuring a force required to radially expand a blood vessel of a subject to an indicated diameter while maintaining blood flow (Abstract, para. [0002, 0054] delivery apparatus 200, fig. 5), the catheter (fig. 5) comprising: a body portion (delivery apparatus 200, fig. 5), comprising: a handle (handle 202 fig. 5); an actuator (“rotatable knob … connected to the actuator assembly 205”, para. [0072-0075, 0079], fig. 5) configured to (Examiner’s Note: functional language, i.e., capable of) create a linear motion (“produce axial movement of the actuator assembly 205 in the proximal and distal directions relative to the outer shaft 204”, para. [0079]); a scaffold (prosthetic valve 100, figs. 2-5) configured to expand and contract in a transverse direction (“radial expansion and compression”; “expand and/or contract”, para. [0068, 0108, 0114], as seen in figs. 3-4), the scaffold comprising a plurality of struts (struts 116, figs. 2-5), the scaffold configured to be variable in expansion and contraction movement (“fully or partially expanded to different diameters and retain”, para. [0064, 0114-0116]) between a collapsed first position (radially compressed configuration, as seen in fig. 3, para. [0052, 0114-0116]) and an expanded second position (radially expanded configuration, as seen in fig. 4, para. [0052, 0114-0116]); a shaft assembly coupled with the body portion (first elongated shaft 204, as seen in fig. 5, para. [0072-0075]), the shaft assembly connecting the body portion to the scaffold (“distal end portion of the outer shaft 204 can form a sheath that is sized and shaped to receive and house the prosthetic valve”, para. [0080], fig. 5) and configured to translate force between the body portion and the scaffold (“outer shaft 204 and the actuator assembly 205 can be moved relative to one another (axially and/or rotationally) to facilitate delivery and positioning of the prosthetic valve 100”; “applying a distally directed force …”, para. [0079-0080, 0111]), the shaft assembly (first elongated shaft 204, as seen in fig. 5, para. [0072-0075]) comprising: an outer shaft (“outer shaft 204”, para. [0072-0075], fig. 5); an inner shaft within the outer shaft (“extend axially through the shaft 204 … actuator 206 … shaft”, para. [0073-0074], figs. 5-6), the inner shaft and the outer shaft movable relative to one another (“204 … move axially … actuators 206, 208”, para. [0080]); and a central lumen defined by a channel in the inner shaft (unlabeled but as seen in figs. 2-6, see also para. [0130], “lumen of the first actuator 306”) and configured to (Examiner’s Note: functional language, i.e., capable of) receive a guidewire (“second actuator 208 … wire … extending through first actuator 206”, para. [0075]); a plurality of sensors (load cell 228 & sensor 212, as seen in fig. 5; “plural … sensors 212”; “plural … load cells 228”; “sensor 314”, para. [0099, 0104, 0119]), comprising: a force sensor (load cell 228, fig. 5); a displacement sensor (sensor 212, fig. 5, “displacement sensor”, para. [0092, 0104]); wherein, the transverse direction (“radially”, para. [0058, 0114-0116]) is transverse relative to a longitudinal axis of the shaft assembly (“radially offset from, a longitudinal axis”, para. [0058], as seen in figs. 2& 5-6), and plurality of sensors (“plural … sensors 212”; “plural … load cells 228”; “sensor 314”, para. [0087, 0100, 0099, 0104, 0119]) are configured to obtain sensor data and measure (“signals”, para. [0095, 0099, 0102]): linear displacement of the shaft and scaffold as the scaffold is expanded by activating the actuator (“linear displacement sensor … relative distance corresponding to the diameter of the prosthetic valve … expansion … calculate the diameter of the prosthetic valve” para. [0092-0096]); and linear force required to achieve such displacement against a radially compressive force exerted by the blood vessel (“tensile force … as the prosthetic valve expands”; “tensile force … radial force applied by the prosthetic valve 100 against the surrounding tissue … correlating; “measured compressive and tensile forces”, para. [0011, 0100-0106); wherein the sensor data are processed to determine the scaffold diameter and radial expansion force (“calculate the diameter of the prosthetic valve”; “real-time radial force of the prosthetic valve based on the measured compressive and tensile forces”; “processor”, para. [0092-0096, 0100-0106, 0108-0109]).
Schwarcz further discloses that the sensor 212 can be mounted outside of the handle 202 and/or can be removably coupled to the delivery apparatus 200 (para. [0087]).
Schwarcz does not expressly disclose the force sensor positioned in one of: the shaft assembly; partially in the shaft assembly and body portion; or partially in the scaffold, shaft, and body portion; the displacement sensor positioned in one of: the shaft assembly; partially in the shaft assembly and body portion; or partially in the scaffold, shaft assembly, and body portion.
However, Tegg directed to an electrophysiological catheter system having a force sensor (para. [0068]) discloses the force sensor (“multi-core fiber … one or more fiber Bragg grating force sensors”, para. [0068]) positioned in one of: the shaft assembly (“one or more fiber Bragg grating force sensors are within three respective cores and within the force body 303”, para. [0068], figs. 4 & 15); partially in the shaft assembly and body portion; or partially in the scaffold, shaft, and body portion; the displacement sensor (“optical displacement Bragg sensors”, para. [0058-0059]) positioned in one of: the shaft assembly (“multi-core optical fiber is also employed with additional Bragg gratings arranged in the intermediate flexible lumen such that the flexing shape of the lumen itself can also be tracked in addition to the tip force”, para. [0060], fig. 15); partially in the shaft assembly and body portion; or partially in the scaffold, shaft assembly, and body portion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Schwarcz such that the plurality of sensors further comprises the force sensor positioned in one of: the shaft assembly; partially in the shaft assembly and body portion; or partially in the scaffold, shaft, and body portion; the displacement sensor positioned in one of: the shaft assembly; partially in the shaft assembly and body portion; or partially in the scaffold, shaft assembly, and body portion, in view of the teachings of Tegg, as such a modification would have been merely a substitution of the sensors and load cell of Schwarcz for the optical displacement Bragg sensors and force sensors of Tegg located in a multi-core fiber to sense force and displacement.
Schwarcz further discloses that the prosthetic valve diameter measurement can be more accurate because it accounts for radial expansion and compression of the valve (para. [0006-0007, 0172]).
Schwarcz, as modified by Tegg hereinabove, does not disclose that the sensor data are processed in a non-linear fashion by accounting for non-linear force sensitivity in expansion of the scaffold to determine the scaffold diameter and radial expansion force.
However, Alberti directed to a power tool, handled by a human or machine operator, having a motion actuator and a force detector for operating on a workpiece is discloses sensor data (“force detector … signal”, para. [0028]) and that the sensor data are processed in a non-linear fashion by accounting for non-linear force sensitivity in the tool’s response (“sensitivity profile … relationship … force … tool’s response”; “force detector … signal … “derived force” … force … measured … force detector can be calibrated as needed to remove any non-linearities in the tool or tool's sensor(s) … predetermined continuous response sensitivity profile … axial or radial force … algorithmically manipulate to a standard signal … force detector output may be standardized”, para. [0025, 0028-0029]).
Alberti discloses a tool having a force detector, a motion actuator, a sensitivity profile describing a relationship between the amount of pressure, load, force, or moment of force detected on the working surface and the tool's response, and is handled by a human or machine operator (para. [0025-0029]) and the instant application is directed to a catheter system that is user operated including a user-operated actuator, a force sensor, and calibration curves for various performance measurements to compensation for non-linear scaffold deployment force (para. [0009, 0017, 0077, 0098-0099]). Thus, the instant application and Alberti are in the same field of endeavor of calibrating force sensor non-linearities.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Conklin, as modified by Schwarcz hereinabove, such that the sensor data are processed in a non-linear fashion by accounting for non-linear force sensitivity in expansion of the scaffold to determine the scaffold diameter and radial expansion force, as this would aid in outputting standardized measurements that are calibrated to remove any non-linearities in the tool/catheter system or tool's/catheter system’s sensor(s).
Regarding claim 13, Schwarcz, as modified by Tegg and Alberti hereinabove, discloses the catheter of Claim 12, wherein the plurality of struts are coupled to the outer shaft at a proximal end of the scaffold (“stopper 112 … abut or engage the distal end of the first actuator 206”, para. [0076]) and to the inner shaft at a distal end of the scaffold (“actuator member 209 … extend through the stopper 112 … engage internal threads of the nut 110”, para. [0079], as seen in figs. 1-2).
Regarding claim 14, Schwarcz, as modified by Tegg and Alberti hereinabove, discloses the catheter of Claim 12, wherein the plurality of struts are coupled to the inner shaft and the outer shaft with a mechanically restraining component (screw 218 and nut 110, figs. 1-2, para. [0076, 0125).
Regarding claim 15, Schwarcz, as modified by Tegg and Alberti hereinabove, discloses the catheter of Claim 14, wherein the mechanically restraining component (screw 218 and nut 110, figs. 1-2, para. [0076, 0125) comprises a plurality of receiving features (nuts 110, figs. 1-2) configured to mate with the plurality of struts (“received in and threadably engage internal threads”, para. [0076, 0125], figs. 1-2).
Regarding claim 16, Schwarcz, as modified by Tegg and Alberti hereinabove, discloses catheter of Claim 12, wherein the force sensor (load cell 228, fig. 5) and the displacement sensor (sensor 212, fig. 5) are communicatively coupled to a processor (control unit 230, as seen in fig. 5, “operatively coupled”; “processor”, para. [0095, 0109]).
Regarding claim 18, Schwarcz, as modified by Tegg and Alberti hereinabove, discloses the catheter of Claim 12, wherein each of the plurality of struts (struts 28/116, figs. 1-4) comprises branching arms (unlabeled but as seen in figs. 1-4, “lattice-type pattern”, para. [0058]) to promote preferential radial expansion of the scaffold (“expansion”, par. [0070]) while maintaining an apex portion (unlabeled but as seen in figs. 3-4, para. [0070]) of the scaffold with a profile that is approximately: flat, concave, or convex (unlabeled but as seen in figs. 3-4, para. [0070]).
Regarding claim 19, Schwarcz, as modified by Tegg and Alberti hereinabove, discloses the catheter of Claim 12, further comprising a digital display (display 234, fig. 5, para. [0095]) configured to provide one or more of: an indication of a diameter of the scaffold (“ display the diameter of the prosthetic valve 100 on the display 234 in real-time”, para. [0095]), an axial displacement of the shaft assembly, a constrictive wall force of the blood vessel, and/or an axial force on the scaffold (“tensile force … calculated radial force”; “display the real-time radial force exerted by the prosthetic valve 100 on the display 234”; “compressive force”, para. [0100, 0102, 0105]).
Regarding claim 20, Schwarcz, as modified by Tegg and Alberti hereinabove, discloses the catheter of Claim 12, wherein the displacement sensor does not include a spring (as seen in fig. 5, para. [0092]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Schwarcz in view of Tegg and Alberti, as applied to claim 12 above, and further in view of Albu et al. (US 20190328245 A1 – previously cited) (herein Albu).
Regarding claim 17, Schwarcz, as modified by Tegg and Alberti hereinabove, discloses the catheter of Claim 16. Schwarcz, as modified by Tegg and Alberti hereinabove, does not expressly disclose wherein the processor is configured receiving an analog signal through the shaft assembly, convert the analog signal to a digital signal, and calibrate the digital signal to determine a force required to radially expand a vessel of a subject.
However, Albu discloses wherein the processor is configured receiving an analog signal through the shaft assembly (“force sensor … signal is received by the communication subsystem 190 … analog-to-digital conversion of the signal”; “wires … routed through a lumen of the catheter shaft 928”, para. [0037, 0087]), convert the analog signal to a digital signal (“analog-to-digital conversion of the signal”; “digital signal output of the analog-to-digital circuitry”, para. [0037, 0087]); and calibrate the digital signal to determine a force (calibration relates the applied tip force to the resulting transmitted frequency response from the force sensor 405, para. [0056]).
Upon the modification of Schwarcz to incorporate the optical displacement Bragg sensors and force sensors of Tegg, as described with respect to claim 12 above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Schwarcz, as modified by Tegg and Alberti hereinabove, such that the processor is configured receiving an analog signal through the shaft assembly, convert the analog signal to a digital signal, and calibrate the digital signal to determine a force, in view of the teachings of Albu, as this would aid in producing a signal that is less prone to electrical interference and relate the applied tip force to the resulting transmitted frequency response from the force sensor. Furthermore, Schwarcz as modified by Tegg and Albu hereinabove, would further disclose calibrating the digital signal (Albu, “calibrate”, para. [0056]) to determine a force required to radially expand a vessel of a subject (“calculate a radial force”, para. [0100-0101]).
Conclusion
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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