DETAILED ACTION
This action is in response to preliminary amendments received on 2/21/2024. It is acknowledged that claims 2-18 have been amended and new claims 19-20 added. A complete action on the merits of claims 1-20 follows below.
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 .
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.
Claim Objections
Claims 2-7 and 18 are objected to because of the following informalities:
the second recitation of “a vessel” in each of claims 2-7 should be amended to --the vessel--.
“RF energy” in line 4 of claim 18 should be amended to recite --radiofrequency (RF) energy--.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coates (US Pub. No. 2019/0223949).
Regarding Claim 1, Coates teaches a catheter 110 (Fig. 1 and [0040]) comprising:
an elongate body 16 comprising a proximal portion and a distal portion (Fig. 1A); and
a plurality of electrodes (distal and proximal electrodes 20a-20b and at least one intermediate electrodes 22 are interpreted to be the plurality of electrodes) carried by the distal portion (Figs. 1A-4B and [0069]), wherein the distal portion of the catheter is configured to transform from a low-profile delivery state (straight as seen in Figs. 1A-4B) to a radially expanded deployed state (Figs. 6A-6B) in which at least some electrodes of the plurality of electrodes are deployed at different circumferential positions of the radially expanded deployed state (Figs. 6A-6B), wherein a ratio of a deployed electrode length to a diameter of the distal portion of the catheter in the radially expanded deployed state is less than or equal to about 2.0 ([0157] teaches “an apparatus positioned within a renal artery, such as elongated member 16, should conform to the geometry of the artery in some examples. Renal artery vessel diameter, DRA, may be in a range of about 2-10 mm, with most of the patient population having a DRA of about 4 mm to about 8 mm and an average of about 6 mm” and [0100] teaches “electrodes of electrode array 14a may be spaced any suitable distance from each other, and the spacing between the respective electrodes of electrode array 14a as well as other dimensions of catheter 12 may vary based on the particular application for which catheter 12 is intended to be used” since the elongate member conforms to the geometry of the artery depending on the diameter of the artery and the spacing between the electrodes can be chosen based on a particular application, examiner takes the position that in the radial configuration positioned within an artery in a patient body, the curl of the elongate member changes and thus a ratio of a deployed electrode length to a diameter of the distal portion of the catheter in the radially expanded deployed state is configured to be less than or equal to about 2.0), and wherein the deployed electrode length is a distance between, in the radially expanded deployed state, a proximal-most point of a proximal-most electrode of the plurality of electrodes and a distal-most point of a distal-most electrode of the plurality of electrodes (see the following annotated figure).
PNG
media_image1.png
311
207
media_image1.png
Greyscale
Regarding Claim 2, Coates teaches wherein the diameter of the distal portion is configured to be constrained by a vessel in which the distal portion is positioned, and wherein the ratio of the deployed electrode length to the diameter of the distal portion in the radially expanded deployed state is less than or equal to about 2.0 for a vessel having a diameter of between about 3 mm and about 8 mm ([0157] teaches “an apparatus positioned within a renal artery, such as elongated member 16, should conform to the geometry of the artery in some examples. Renal artery vessel diameter, DRA, may be in a range of about 2-10 mm, with most of the patient population having a DRA of about 4 mm to about 8 mm and an average of about 6 mm” and [0100] teaches “electrodes of electrode array 14a may be spaced any suitable distance from each other, and the spacing between the respective electrodes of electrode array 14a as well as other dimensions of catheter 12 may vary based on the particular application for which catheter 12 is intended to be used” since the elongate member conforms to the geometry of the artery depending on the diameter of the artery and the spacing between the electrodes can be chosen based on a particular application, examiner takes the position that in the radial configuration positioned within an artery in a patient body, the curl of the elongate member changes and thus the ratio of the deployed electrode length to the diameter of the distal portion in the radially expanded deployed state is configured to be about less than or equal to about 2.0 for a vessel having a diameter of between about 3 mm and about 8 mm).
Regarding Claim 3, Coates teaches wherein the diameter of the distal portion is configured to be constrained by a vessel in which the distal portion is positioned, and wherein the ratio of the deployed electrode length to the diameter of the distal portion in the radially expanded deployed state is less than or equal to about 1.5 for a vessel having a diameter of between about 4 mm and about 8 mm ([0157] teaches “an apparatus positioned within a renal artery, such as elongated member 16, should conform to the geometry of the artery in some examples. Renal artery vessel diameter, DRA, may be in a range of about 2-10 mm, with most of the patient population having a DRA of about 4 mm to about 8 mm and an average of about 6 mm” and [0100] teaches “electrodes of electrode array 14a may be spaced any suitable distance from each other, and the spacing between the respective electrodes of electrode array 14a as well as other dimensions of catheter 12 may vary based on the particular application for which catheter 12 is intended to be used” since the elongate member conforms to the geometry of the artery depending on the diameter of the artery and the spacing between the electrodes can be chosen based on a particular application, examiner takes the position that in the radial configuration positioned within an artery in a patient body, the curl of the elongate member changes and thus the ratio of the deployed electrode length to the diameter of the distal portion in the radially expanded deployed state is configured to be about less than or equal to about 1.5 for a vessel having a diameter of between about 4 mm and about 8 mm).
Regarding Claim 4, Coates teaches wherein the diameter of the distal portion is configured to be constrained by a vessel in which the distal portion is positioned, and wherein the ratio of the deployed electrode length to the diameter of the distal portion in the radially expanded deployed state is less than or equal to about 1.2 for a vessel having a diameter of between about 5 mm and about 8 mm ([0157] teaches “an apparatus positioned within a renal artery, such as elongated member 16, should conform to the geometry of the artery in some examples. Renal artery vessel diameter, DRA, may be in a range of about 2-10 mm, with most of the patient population having a DRA of about 4 mm to about 8 mm and an average of about 6 mm and [0100] teaches “electrodes of electrode array 14a may be spaced any suitable distance from each other, and the spacing between the respective electrodes of electrode array 14a as well as other dimensions of catheter 12 may vary based on the particular application for which catheter 12 is intended to be used” since the elongate member conforms to the geometry of the artery depending on the diameter of the artery and the spacing between the electrodes can be chosen based on a particular application, examiner takes the position that in the radial configuration positioned within an artery in a patient body, the curl of the elongate member changes and thus the ratio of the deployed electrode length to the diameter of the distal portion in the radially expanded deployed state is configured to be about less than or equal to about 1.2 for a vessel having a diameter of between about 5 mm and about 8 mm).
Regarding Claim 5, Coates teaches wherein the diameter of the distal portion is configured to be constrained by a vessel in which the distal portion is positioned, and wherein the ratio of the deployed electrode length to the diameter of the distal portion in the radially expanded deployed state is less than or equal to about 1.0 for a vessel having a diameter of between about 6 mm and about 8 mm ([0157] teaches “an apparatus positioned within a renal artery, such as elongated member 16, should conform to the geometry of the artery in some examples. Renal artery vessel diameter, DRA, may be in a range of about 2-10 mm, with most of the patient population having a DRA of about 4 mm to about 8 mm and an average of about 6 mm” and [0100] teaches “electrodes of electrode array 14a may be spaced any suitable distance from each other, and the spacing between the respective electrodes of electrode array 14a as well as other dimensions of catheter 12 may vary based on the particular application for which catheter 12 is intended to be used” since the elongate member conforms to the geometry of the artery depending on the diameter of the artery and the spacing between the electrodes can be chosen based on a particular application, examiner takes the position that in the radial configuration positioned within an artery in a patient body, the curl of the elongate member changes and thus the ratio of the deployed electrode length to the diameter of the distal portion in the radially expanded deployed state is configured to be about less than or equal to about 1.0 for a vessel having a diameter of between about 6 mm and about 8 mm).
Regarding Claim 6, Coates teaches wherein the diameter of the distal portion is configured to be constrained by a vessel in which the distal portion is positioned, and wherein the ratio of the deployed electrode length to the diameter of the distal portion in the radially expanded deployed state is less than or equal to about 0.9 for a vessel having a diameter of between about 7 mm and about 8 mm ([0157] teaches “an apparatus positioned within a renal artery, such as elongated member 16, should conform to the geometry of the artery in some examples. Renal artery vessel diameter, DRA, may be in a range of about 2-10 mm, with most of the patient population having a DRA of about 4 mm to about 8 mm and an average of about 6 mm” and [0100] teaches “electrodes of electrode array 14a may be spaced any suitable distance from each other, and the spacing between the respective electrodes of electrode array 14a as well as other dimensions of catheter 12 may vary based on the particular application for which catheter 12 is intended to be used” since the elongate member conforms to the geometry of the artery depending on the diameter of the artery and the spacing between the electrodes can be chosen based on a particular application, examiner takes the position that in the radial configuration positioned within an artery in a patient body, the curl of the elongate member changes and thus the ratio of the deployed electrode length to the diameter of the distal portion in the radially expanded deployed state is configured to be about less than or equal to about 0.9 for a vessel having a diameter of between about 7 mm and about 8 mm).
Regarding Claim 7, Coates teaches wherein the diameter of the distal portion is configured to be constrained by a vessel in which the distal portion is positioned, and wherein the ratio of the deployed electrode length to the diameter of the distal portion in the radially expanded deployed state is less than or equal to about 0.8 for a vessel having a diameter of about 8 mm ([0157] teaches “an apparatus positioned within a renal artery, such as elongated member 16, should conform to the geometry of the artery in some examples. Renal artery vessel diameter, DRA, may be in a range of about 2-10 mm, with most of the patient population having a DRA of about 4 mm to about 8 mm and an average of about 6 mm” and [0100] teaches “electrodes of electrode array 14a may be spaced any suitable distance from each other, and the spacing between the respective electrodes of electrode array 14a as well as other dimensions of catheter 12 may vary based on the particular application for which catheter 12 is intended to be used” since the elongate member conforms to the geometry of the artery depending on the diameter of the artery and the spacing between the electrodes can be chosen based on a particular application, examiner takes the position that in the radial configuration positioned within an artery in a patient body, the curl of the elongate member changes and thus the ratio of the deployed electrode length to the diameter of the distal portion in the radially expanded deployed state is configured to be about less than or equal to about 0.8 for a vessel having a diameter of about 8 mm).
Regarding Claim 8, Coates teaches wherein the deployed electrode length is less than or equal to about 6 mm ([0157] teaches “an apparatus positioned within a renal artery, such as elongated member 16, should conform to the geometry of the artery in some examples. Renal artery vessel diameter, DRA, may be in a range of about 2-10 mm, with most of the patient population having a DRA of about 4 mm to about 8 mm and an average of about 6 mm” and [0100] teaches “electrodes of electrode array 14a may be spaced any suitable distance from each other, and the spacing between the respective electrodes of electrode array 14a as well as other dimensions of catheter 12 may vary based on the particular application for which catheter 12 is intended to be used” since the elongate member conforms to the geometry of the artery depending on the diameter of the artery and the spacing between the electrodes can be chosen based on a particular application, examiner takes the position that the deployed electrode is configured to have a length of less than or equal to about 6 mm).
Regarding Claim 9, Coates teaches wherein, when the elongate body 16 is in the low-profile delivery state, a spacing between electrodes of the plurality of electrodes is less than or equal to 6 mm ([0100] teaches “electrode array 14a may be spaced any suitable distance from each other, and the spacing between the respective electrodes of electrode array 14a as well as other dimensions of catheter 12 may vary based on the particular application for which catheter 12 is intended to be used” and [0157] teaches “an apparatus positioned within a renal artery, such as elongated member 16, should conform to the geometry of the artery in some examples. Renal artery vessel diameter, DRA, may be in a range of about 2-10 mm, with most of the patient population having a DRA of about 4 mm to about 8 mm and an average of about 6 mm” since the elongate member conforms to the geometry of the artery depending on the targeted artery the spacing of the electrodes are chosen accordingly. By looking at Fig. 6B when the elongate body is in the deployed configuration, the diameter is between 2-10mm with an average diameter of 6mm and therefore, the space between the first and third electrode is about 6mm thus the space between each of the electrodes when the elongate body 16 is in the low-profile delivery state, is less than or equal to 6 mm).
Regarding Claim 10, Coates teaches wherein the diameter of the distal portion is configured to be constrained by an anatomical lumen, and wherein, in the radially expanded deployed state, electrodes of the plurality of electrodes are substantially evenly positioned about an inner circumference of the anatomical lumen (Figs. 1A-B and [0100] where the spacing between the electrodes are equal, also see Fig. 6C).
Regarding Claim 11, Coates teaches wherein the plurality of electrodes comprises at least three electrodes (Figs. 1-6C and [0069]).
Regarding Claim 12, Coates teaches wherein the catheter includes exactly three electrodes (“electrode array comprises a distal electrode, a proximal electrode proximal to the distal electrode, and at least one intermediate electrode between the distal electrode and the proximal electrode” [0004]).
Regarding Claim 13 and 14, Coates teaches a diameter of an electrode of the plurality of electrodes is about 1 mm or a diameter of each electrode of the plurality of electrodes is about 1 mm (“electrodes of electrode array 14a may differ in length (or surface area) to generate substantially uniform electric fields. Distal electrode 20a may have a length L1, intermediate electrodes 22a and 22b may have respective lengths L2 and L3, and proximal electrode 20b may have a length L4” [0097] and “L1, L2, L3, or L4 may be set to any suitable value”, based on the diameter of the artery in which the electrodes are placed therein “Renal artery vessel diameter, DRA, may be in a range of about 2-10 mm, with most of the patient population having a DRA of about 4 mm to about 8 mm and an average of about 6 mm” [0157], examiner takes the position that at least for the use of the electrode array in a smaller diameter artery for example less than 6mm, the length of at least one of the electrodes or in the case where the lengths are equal, each of the electrodes is configured to be chosen to be about 1 mm, see Figs. 1-6c).
Regarding Claim 15, Coates teaches wherein a length of an electrode of the plurality of electrodes is less than or equal to about 1.5 mm, the length being measured along a longitudinal axis of the elongate body (“electrodes of electrode array 14a may differ in length (or surface area) to generate substantially uniform electric fields. Distal electrode 20a may have a length L1, intermediate electrodes 22a and 22b may have respective lengths L2 and L3, and proximal electrode 20b may have a length L4” [0097] and “L1, L2, L3, or L4 may be set to any suitable value”, based on the diameter of the artery in which the electrodes are placed therein “Renal artery vessel diameter, DRA, may be in a range of about 2-10 mm, with most of the patient population having a DRA of about 4 mm to about 8 mm and an average of about 6 mm” [0157], examiner takes the position that at least for the use of the electrode array in a smaller diameter artery for example less than 6mm, the length of at least one of the electrodes is configured to be chosen to be less than about 1.5 mm, see Figs. 1-6c).
Regarding Claim 16, Coates teaches wherein a length of each electrode of the plurality of electrodes is less than or equal to about 1.5 mm, the length being measured along a longitudinal axis of the elongate body; or wherein a length of an electrode of the plurality of electrodes is about 1 mm, the length being measured along a longitudinal axis of the elongate body (“electrodes of electrode array 14a may differ in length (or surface area) to generate substantially uniform electric fields. Distal electrode 20a may have a length L1, intermediate electrodes 22a and 22b may have respective lengths L2 and L3, and proximal electrode 20b may have a length L4” [0097] and “L1, L2, L3, or L4 may be set to any suitable value”, based on the diameter of the artery in which the electrodes are placed therein “Renal artery vessel diameter, DRA, may be in a range of about 2-10 mm, with most of the patient population having a DRA of about 4 mm to about 8 mm and an average of about 6 mm” [0157], examiner takes the position that at least for the use of the electrode array in a smaller diameter artery for example less than 6mm, the length of at least one of the electrodes is configured to be chosen to be less than about 1.5 mm or about 1mm, see Figs. 1-6c).
Regarding Claim 17, Coates teaches wherein the distal portion further comprises a shape memory structure, and wherein the shape memory structure is pre-formed to urge the distal portion toward the radially expanded deployed state ([0081]).
Regarding Claim 18, Coates teaches wherein, in the radially expanded deployed state, the plurality of electrodes are configured to cause a circumferentially continuous lesion to form in tissue surrounding a vessel in which the distal portion is deployed upon delivery of RF energy using the plurality of electrodes ([0155]).
Regarding Claim 19, Coates teaches wherein, when the elongate body is in the low- profile delivery state, a spacing between electrodes of the plurality of electrodes is about 2 mm to about 4 mm ([0100] teaches “electrode array 14a may be spaced any suitable distance from each other, and the spacing between the respective electrodes of electrode array 14a as well as other dimensions of catheter 12 may vary based on the particular application for which catheter 12 is intended to be used” and [0157] teaches “an apparatus positioned within a renal artery, such as elongated member 16, should conform to the geometry of the artery in some examples. Renal artery vessel diameter, DRA, may be in a range of about 2-10 mm, with most of the patient population having a DRA of about 4 mm to about 8 mm and an average of about 6 mm” since the elongate member conforms to the geometry of the artery depending on the targeted artery the spacing of the electrodes are chosen accordingly. By looking at Fig. 6B when the elongate body is in the deployed configuration, the diameter is between 2-10mm with an average diameter of 6mm and therefore, the space between the first and third electrode is about 6mm thus the space between each of the electrodes when the elongate body 16 is in the low-profile delivery state, is less than the diameter of the artery and thus in smaller diameter arteries is about 2 mm to about 4 mm).
Regarding Claim 20, Coates teaches wherein the catheter has only four electrodes (Figs. 1-6C and “electrode array comprises a distal electrode, a proximal electrode proximal to the distal electrode, and at least one intermediate electrode between the distal electrode and the proximal electrode” [0004] and “electrode array 14 includes two intermediate electrodes” [0069]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on (571) 272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794