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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 10, 2023; January 17, 2024; June 04, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on July 10, 2023 are accepted.
Election/Restrictions
Applicants election of Invention IV is acknowledged. Applicant argues that groups I and III are not distinct from group IV but rather generic to the claims. Examiner agrees and accordingly claims 1-13, 26-32 and 33-68 remain pending.
Claim Objections
Claims 7, 27, 35, 36, 55 are objected to because of the following informalities: “senor” in the last line of claim 7 should read “sensor”. Claims 27, 35, 36, 55 and 56 have the same issues.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 33-52, 57 and 59 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 33 recites the limitation “said expandable balloon”, and recites directly before that, “an inflatable balloon” it is unclear if they are the same. The language should remain consistent and clear. There is insufficient antecedent basis for this limitation in the claim.
Claim 59 recites the limitation ““said reference container”. There is no “reference container” recited in claim 53 from which it depends, claim 55 recites the reference container. There is insufficient antecedent basis for this limitation in the claim.
Dependent claims depending on a rejected base claim are rejected based on their dependency.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5-6, 11-13, 26, 33-34, 39, 41, 45, 47, 49, 51, 53-54, 61, 63, 65 and 67 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kassab (US 2018/0296162 A1) (“Kassab”).
Regarding claim 1, Kassab discloses A method for measuring a) a diameter of at least a portion or all of a medical device that is positioned in a body passageway, b) a cross-sectional area of at least a portion or all of said medical device that is positioned in said body passageway, and/or c) a volume of at least a portion or all of said medical device that is positioned in said body passageway comprising (Abstract and entire document):
providing said medical device; said medical device includes a balloon catheter; said balloon catheter includes a catheter body having a distal portion, a central portion, and proximal portion (FIG. 1-9 and associated paragraphs, balloon catheter 39);
said balloon catheter includes an inflatable balloon connected at or near said distal portion (FIG. 1-9 and associated paragraphs, balloon 30);
providing a diameter measurement device (DMD) that is configured to measure a) said diameter of at least a portion or all of said medical device that is positioned in said body passageway, b) said cross-sectional area of at least a portion or all of said medical device that is positioned in said body passageway, and/or c) said volume of at least a portion or all of said medical device that is positioned in said body passageway; said DMD includes a plurality of excitation electrodes and a plurality of sensor electrodes; said plurality of excitation electrodes and said plurality of sensor electrodes are positioned inside said inflatable balloon; said plurality of excitation electrodes and said plurality of sensor electrodes are spaced from one another (FIG. 1b, electrodes 40, 41, 42, 43 positioned inside the balloon and spaced from one another);
inserting said distal portion and a portion of said central portion of said catheter into said body passageway; moving said distal portion of said catheter in said body passageway until said distal portion is positioned at a treatment area; expanding said inflatable balloon at said treatment area ([0138] describing inserting catheter to region of interest and showing the balloon then inflated see at least fig. 9a and associated paragraphs); and
measuring a change in impedance by said DMD to determine at said treatment area a) said diameter of at least a portion or all of said medical device that is positioned in said body passageway, b) said cross-sectional area of at least a portion or all of said medical device that is positioned in said body passageway, and/or c) said volume of at least a portion or all of said medical device that is positioned in said body passageway, and wherein said change in impedance is at least partially related to said cross-sectional area and/or a pressure of said inflatable balloon ([0104 – 0107] and [0165 – [0166], determining balloon cross sectional area positioned in a body passageway, how the impedance changes is at least partially based on the size of the balloon and inflation at that size which is the size of the annulus).
Regarding claim 2, Kassab discloses The method as defined in claim 1, wherein said measuring a) said diameter of at least a portion or all of said medical device that is expanded in said body passageway, b) said cross-sectional area of at least a portion or all of said medical device that is expanded in said body passageway, and/or c) said volume of at least a portion or all of said medical device that is expanded in said body passageway is in real time or near real time ([0172], [0187]).
Regarding claim 3, Kassab discloses The method as defined in claim 1, wherein said medical device includes a stent or prosthetic heart valve that is at least partially positioned about said inflatable balloon (As shown in FIG. 1 and 9 and associated paragraphs see [0104], stent).
Regarding claim 5, Kassab discloses The method as defined in claim 1, wherein said DMD includes multiplexed inputs ([0134]).
Regarding claim 6, Kassab discloses The method as defined in claim 1, wherein said DMD includes a wireless transmitter that wirelessly transmits data to a remote location so that data can be stored and/or displayed at said remote location ([0135]).
Regarding claim 11, Kassab discloses The method as defined in claim 1, wherein said step of measuring a change in said impedance includes impedance planimetry, wherein a constant voltage source having a high precision waveform is used across a known calibration resistor and impedance measurements are sequenced across electrodes for segmental impedance measurements ([0132]).
Regarding claim 12, Kassab discloses The method as defined in claim 1, further includes a flow sensor to provide information about a total volume of fluid into said inflatable balloon, and wherein said flow sensor can be used to monitor a fluid flow rate and/or a total fluid volume delivered to said inflatable balloon to provide additional information for determining said diameter, said cross- sectional area and/or said volume of at least a portion or all of said medical device based on known relationships of said inflatable balloon ([0121 – 0126] and [0163] discussing measuring flow/fluid present in the balloon).
Regarding claim 13, Kassab discloses The method as defined in claim 1, further includes a pressure sensor located distally in said inflation balloon and/or proximally in an inflating system, and wherein said pressure sensor is used to facilitate determining said diameter, said cross-sectional area and/or said volume of at least a portion or all of said medical device by known pressure volume compliance calculations for said inflatable balloon and/or said inflating system ([0108], [0163] pressure transducer 48).
Regarding claim 26, Kassab discloses A method for obtaining real-time or near real-time information regarding a) a diameter of at least a portion of a medical device that is being expanded in a heart valve, b) a cross-sectional area of at least a portion of said medical device that is being expanded in said heart valve, and/or c) a volume of at least a portion of said medical device that is being expanded in said heart valve comprising (Abstract and entire document):
providing said medical device; said medical device includes a balloon catheter and a prosthetic heart valve; said balloon catheter includes a catheter body having a distal portion, a central portion, and proximal portion (FIG. 1-9 and associated paragraphs, balloon catheter 39);
said balloon catheter includes an inflatable balloon connected at or near said distal portion; said prosthetic heart valve at least partially positioned about said inflatable balloon (FIG. 1-9 and associated paragraphs, balloon 30);
providing a diameter measurement device (DMD) that is configured to measure a) said diameter of at least a portion said inflatable balloon that is positioned in said body passageway, b) said cross-sectional area of at least a portion said inflatable balloon that is positioned in said body passageway, and/or c) said volume of at least a portion said inflatable balloon that is positioned in said body passageway; said DMD includes a plurality of excitation electrodes and a plurality of sensor electrodes; said plurality of excitation electrodes and said plurality of sensor electrodes are positioned inside said inflatable balloon; said plurality of excitation electrodes and said plurality of sensor electrodes are spaced from one another; a majority or all of said plurality of excitation electrodes and said plurality of sensor electrodes that are located on said distal portion of said catheter are positioned inside said inflatable balloon (FIG. 1b, electrodes 40, 41, 42, 43 positioned inside the balloon and spaced from one another);
inserting said distal portion of said catheter into said heart valve; expanding said inflatable balloon in said heart valve to cause said prosthetic heart valve to expand in said heart valve ([0138] describing inserting catheter to region of interest and showing the balloon then inflated see at least fig. 9a and associated paragraphs);
obtaining real-time or near real-time information of said inflatable balloon as said inflatable balloon is expanded in said heart valve; said real-time or near real-time information at least partially obtained by measuring a change in impedance by said DMD to determine at said heart valve wherein said inflatable balloon is expanded a) said diameter of at least a portion of said inflatable balloon as said inflatable balloon is expanded in said heart valve, b) said cross-sectional area of at least a portion of said inflatable balloon as said inflatable balloon is expanded in said heart valve, and/or c) said volume of at least a portion of said inflatable balloon as said inflatable balloon is expanded in said heart valve; and wherein said change in impedance is at least partially related to said cross-sectional area of said inflatable balloon and/or a pressure inside of said inflatable balloon ([0104 – 0107] and [0165 – [0166], determining balloon cross sectional area positioned in a body passageway, how the impedance changes is at least partially based on the size of the balloon and inflation at that size which is the size of the annulus).
preventing overexpansion of said prosthetic heart valve in said heart valve is prevent by said monitoring said real-time or near real-time information of said inflatable balloon as said inflatable balloon is expanded in said heart valve ([0172], [0187]); and
Regarding claim 33, Kassab discloses A method for measuring a) a diameter of at least a portion or all of a medical device that is positioned in a body passageway, b) a cross-sectional area of at least a portion or all of said medical device that is positioned in said body passageway, and/or c) a volume of at least a portion or all of said medical device that is positioned in said body passageway comprising (Abstract and entire document):
providing said medical device; said medical device includes an inflatable balloon; said expandable balloon is located on a delivery device (FIG. 1-9 and associated paragraphs, balloon catheter 39/ balloon 30);
providing a diameter measurement device (DMD) that is configured to measure a) said diameter of at least a portion or all of said inflatable balloon that is positioned in said body passageway, b) said cross-sectional area of at least a portion or all of said inflatable balloon that is positioned in said body passageway, and/or c) said volume of at least a portion or all of said inflatable balloon that is positioned in said body passageway; said DMD includes a plurality of excitation electrodes and a plurality of sensor electrodes; said plurality of excitation electrodes and said plurality of sensor electrodes are positioned inside said inflatable balloon; said plurality of excitation electrodes and said plurality of sensor electrodes are spaced from one another (FIG. 1b, electrodes 40, 41, 42, 43 positioned inside the balloon and spaced from one another);
providing a reference system; said reference system is configured to provide data that is used to adjust data obtained by said diameter measurement device arrangement so as to improve an accuracy of a calculated diameter, a calculated cross-sectional area, and/or a calculated volume of said inflatable balloon when inflated; said reference system is located remote to said inflatable balloon and located outside said body passageway ([0107 – 0111], electrodes near distal end for immediate measurement of the cross-sectional area and then electrodes inside the balloon, the measurements are compared as reference for selecting the stent and deploying to the desired cross-sectional area);
inserting said inflatable balloon into said body passageway via said delivery device; moving said inflatable balloon in said body passageway until said inflatable balloon is positioned at a treatment area; expanding said inflatable balloon at said treatment area ([0138] describing inserting catheter to region of interest and showing the balloon then inflated see at least fig. 9a and associated paragraphs); and
measuring a change in impedance as determined by said DMD by use of said excitation electrodes and a plurality of sensor electrodes and using data from said reference system to determine at said treatment area a) said diameter of at least a portion or all of said inflatable balloon that is positioned in said body passageway, b) said cross-sectional area of at least a portion or all of said inflatable balloon that is positioned in said body passageway, and/or c) said volume of at least a portion or all of said inflatable balloon that is positioned in said body passageway, and wherein said change in impedance is at least partially related to said cross-sectional area and/or a pressure of said inflatable balloon ([0104 – 0107] and [0165 – [0166], determining balloon cross sectional area positioned in a body passageway, how the impedance changes is at least partially based on the size of the balloon and inflation at that size which is the size of the annulus).
Regarding claim 34, Kassab discloses The method as defined in claim 33, further including a stent or a prosthetic heart valve that is at least partially positioned about said inflatable balloon; said inflatable balloon is configured to expand said stent or said prosthetic heart valve at said treatment site when said inflatable balloon is expanded (As shown in FIG. 1 and 9 and associated paragraphs see [0104], stent).
Regarding claim 39, Kassab discloses The method as defined in claim 33, wherein said DMD includes multiplexed inputs ([0134]).
Regarding claim 41, Kassab discloses The method as defined in claim 33, wherein said DMD includes a wireless transmitter that wirelessly transmits data to a remote location so that data can be stored and/or displayed at said remote location ([0135]).
Regarding claim 45, Kassab discloses The method as defined in claim 33, wherein said reference system is used to calculate a medium conductivity of a medium that is a same medium is used to inflate said inflatable balloon ([0107 – 0111], electrodes near distal end for immediate measurement of the cross-sectional area and then electrodes inside the balloon, the measurements are compared as reference for selecting the stent and deploying to the desired cross-sectional area).
Regarding claim 47, Kassab discloses The method as defined in claim 33, wherein said step of measuring a change in said impedance includes impedance planimetry, wherein a constant voltage source having a high precision waveform is used across a known calibration resistor and impedance measurements are sequenced across electrodes for segmental impedance measurements ([0132]).
Regarding claim 49, Kassab discloses The method as defined in claim 33, further includes a flow sensor to provide information about a total volume of fluid into said inflatable balloon, and wherein said flow sensor can be used to monitor a fluid flow rate and/or a total fluid volume delivered to said inflatable balloon to provide additional information for determining said diameter, said cross- sectional area and/or said volume of at least a portion or all of said medical device based on known relationships of said inflatable balloon ([0121 – 0126] and [0163] discussing measuring flow/fluid present in the balloon).
Regarding claim 51, Kassab discloses The method as defined in claim 33, further includes a pressure sensor located distally in said inflation balloon and/or proximally in an inflating system, and wherein said pressure sensor is used to facilitate determining said diameter, said cross-sectional area and/or said volume of at least a portion or all of said medical device by known pressure volume compliance calculations for said inflatable balloon and/or said inflating system ([0108], [0163] pressure transducer 48).
Regarding claim 53, Kassab discloses A method for measuring a) a diameter of at least a portion or all of a medical device that is positioned in a body passageway, b) a cross-sectional area of at least a portion or all of said medical device that is positioned in said body passageway, and/or c) a volume of at least a portion or all of said medical device that is positioned in said body passageway comprising (Abstract and entire document):
providing said medical device; said medical device includes an inflatable balloon; said expandable balloon is located on a delivery device (FIG. 1-9 and associated paragraphs, balloon catheter 39/ balloon 30);
providing a diameter measurement device (DMD) that is configured to measure a) said diameter of at least a portion or all of said inflatable balloon that is positioned in said body passageway, b) said cross-sectional area of at least a portion or all of said inflatable balloon that is positioned in said body passageway, and/or c) said volume of at least a portion or all of said inflatable balloon that is positioned in said body passageway; said DMD includes a plurality of excitation electrodes and a plurality of sensor electrodes; said plurality of excitation electrodes and said plurality of sensor electrodes are spaced from one another (FIG. 1b, electrodes 40, 41, 42, 43 positioned inside the balloon and spaced from one another);
providing a reference system; said reference system is configured to provide data that is used to adjust data obtained by said diameter measurement device arrangement so as to improve an accuracy of a calculated diameter, a calculated cross-sectional area, and/or a calculated volume of said inflatable balloon when inflated; said reference system is located remote to said inflatable balloon and located outside said body passageway ([0107 – 0111], electrodes near distal end for immediate measurement of the cross-sectional area and then electrodes inside the balloon, the measurements are compared as reference for selecting the stent and deploying to the desired cross-sectional area);
inserting said inflatable balloon into said body passageway via said delivery device; moving said inflatable balloon in said body passageway until said inflatable balloon is positioned at a treatment area; expanding said inflatable balloon at said treatment area ([0138] describing inserting catheter to region of interest and showing the balloon then inflated see at least fig. 9a and associated paragraphs);
measuring a change in impedance as determined by said DMD by use of said excitation electrodes and a plurality of sensor electrodes and using data from said reference system to determine at said treatment area a) said diameter of at least a portion or all of said inflatable balloon that is positioned in said body passageway, b) said cross-sectional area of at least a portion or all of said inflatable balloon that is positioned in said body passageway, and/or c) said volume of at least a portion or all of said inflatable balloon that is positioned in said body passageway, and wherein said change in impedance is at least partially related to said cross-sectional area and/or a pressure of said inflatable balloon ([0104 – 0107] and [0165 – [0166], determining balloon cross sectional area positioned in a body passageway, how the impedance changes is at least partially based on the size of the balloon and inflation at that size which is the size of the annulus); and
using data from said reference system to adjust measurements determined by said DMD ([0107 – 0111], electrodes near distal end for immediate measurement of the cross-sectional area and then electrodes inside the balloon, the measurements are compared as reference for selecting the stent and deploying to the desired cross-sectional area).
Regarding claim 54, Kassab discloses The method as defined in claim 53, further including a stent or a prosthetic heart valve that is at least partially positioned about said inflatable balloon; said inflatable balloon is configured to expand said stent or said prosthetic heart valve at said treatment site when said inflatable balloon is expanded (As shown in FIG. 1 and 9 and associated paragraphs see [0104], stent).
Regarding claim 61, Kassab discloses The method as defined in claim 53, wherein said reference system is used to calculate a medium conductivity of a medium that is a same medium is used to inflate said inflatable balloon ([0107 – 0111], electrodes near distal end for immediate measurement of the cross-sectional area and then electrodes inside the balloon, the measurements are compared as reference for selecting the stent and deploying to the desired cross-sectional area).
Regarding claim 63, Kassab discloses The method as defined in claim 53, wherein said step of measuring a change in said impedance includes impedance planimetry, wherein a constant voltage source having a high precision waveform is used across a known calibration resistor and impedance measurements are sequenced across electrodes for segmental impedance measurements ([0132]).
Regarding claim 65, Kassab discloses The method as defined in claim 53, further includes a flow sensor to provide information about a total volume of fluid into said inflatable balloon, and wherein said flow sensor can be used to monitor a fluid flow rate and/or a total fluid volume delivered to said inflatable balloon to provide additional information for determining said diameter, said cross-sectional area and/or said volume of at least a portion or all of said medical device based on known relationships of said inflatable balloon ([0121 – 0126] and [0163] discussing measuring flow/fluid present in the balloon).
Regarding claim 67, Kassab discloses The method as defined in claim 53, further includes a pressure sensor located distally in said inflation balloon and/or proximally in an inflating system, and wherein said pressure sensor is used to facilitate determining said diameter, said cross-sectional area and/or said volume of at least a portion or all of said medical device by known pressure volume compliance calculations for said inflatable balloon and/or said inflating system ([0108], [0163] pressure transducer 48).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kassab in view of Kassab (US 2018/03387707 A1) (“Kassab2”).
Regarding claim 4, Kassab discloses The method as defined in claim 1, Kassab fails to disclose wherein said distal portion of said catheter includes a temperature sensor.
However, in the same field of endeavor, Kassab2 teaches wherein said distal portion of said catheter includes a temperature sensor (FIG. 1 and [0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Kassab to include wherein said distal portion of said catheter includes a temperature sensor as taught by Kassab2 for optimal stent deployment ([0034]).
Allowable Subject Matter
Claims 7-10, 27-32, 55-56, 58, 60, 62 and 64 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The prior art fails to anticipate or render obvious the limitations, “wherein said DMD includes a reference container; said reference container has a) fixed and constant cross-sectional area along a longitudinal length of said reference container, b) a fixed and constant volume, c) a fixed and constant cross-sectional area along a longitudinal length of said reference container, and/or d) a fixed and constant cross-sectional shape along a longitudinal length of said reference container; said reference container includes a plurality of reference electrodes located in said reference container; a number, orientation, and/or spacing of said plurality of reference electrodes in said reference container is the same or substantially the same as a number, orientation, and/or spacing of said excitation and senor electrodes in said inflatable balloon.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH A TOMBERS/ Examiner, Art Unit 3791
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