I. ACKNOWLEDGEMENT
This Office Action addresses U.S. Application No. 19/129470 (“’470 Application” or “instant application”). Based upon a review of the instant application, the actual filing date of the instant application is May 13, 2025.
II. STATUS OF CLAIMS
Claims 1-20 were filed with the application. The preliminary amendment filed with this application amends claims 3-6, 11-14, and 16-20. Therefore, as of the date of this Office Action, the status of the claims is:
a. Claim 1-20 (“Pending Claims”).
b. Claims 1-20 are examined (“Examined Claims”).
III. PRIORITY AND CONTINUING DATA
The ‘470 application is a national stage entry of PCT/EP2023/080982, which claims the benefit of provisional application 63/384270, filed November 18, 2022. Because the earliest possible effective filing date is after March 16, 2013, the first to file provision of the AIA , apply to this proceeding.
IV. ART REJECTION
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.
Claim 1, 3, 4, 6-10, 12, 13, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hennessey et al US PG PUB 2007/0191767 in view of Stigall et al Us Patent 10,595,820.
As to claim 1, Hennessey shows in figure 1 a balloon catheter assembly having a rapid exchange joint 60 with a catheter connected thereto, having a distal portion 56 having a balloon 55 connected thereto and a proximal portion 51. The Examiner notes that the terms cryoablation catheter and cryoshaft are intended use limitations and do not serve to distinguish the claims over any shaft and catheter having the same structure. The device has an inflow pipe, i.e. inflation lumen 57, disposed in the proximal and distal portions, and coupled to the inflatable balloon. The proximal and distal portions do not have different cross-sectional shapes. However, Stigall teaches in column 9, lines 24+ having the proximal portion and distal portions of a catheter on opposite sides of a rapid exchange joint have different diameters, i.e. different shapes, so that when the guidewire is introduced through the joint, the ends have the same diameter, preventing the need for an enlarged diameter which is detrimental in blood vessel applications. As such, it would have been obvious to modify Hennessey to use the differing diameters, to maintain a smooth profile and prevent damage to a blood vessel.
As to claims 3 and 4, the proximal portion cross section is elliptical, which has a width larger than height, depending on orientation.
As to claim 6, the device has a guidewire lumen 54 having a first portion within the distal catheter portion and a second portion that past the end of the distal portion of the catheter (figure 2).
As to claim 7, there is a guidewire (not shown) that extends through the guidewire lumen inside the distal potion and outside the proximal portion of the catheter.
As to claim 8, in figures 6-8, Hennessey shows a joint with a guidewire lumen 82 extending through a ramped off wall.
As to claim 9, the inner member extends along the longitudinal axis and the ramped off member is at an angle to the axis.
As to claim 10, each of the distal portion, the joint and the proximal portion have their own longitudinal axis which are parallel to each other.
As to claim 12, at the very bottom of figure 1, the proximal portion has a conical cross section. Hence, the cross section varies.
As to claim 13, the proximal portion has a constant shape.
As to claim 20, the guidewire lumen extends from the distal end of the device out of the catheter and hence is configured to transport exhaust gasses out of the catheter proximally.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hennessey in view of Stigall, as applied to claims 1, 3, 4, 6-10, 12, 13, and 20 above, further in view of Feng et al US PG PUB 2011/0137225.
The combination does not have a proximal elliptical shape and a distal circular shape. Feng shows an alternate vascular catheter, like that of Hennessey that has just such a shape arrangement. As such, it would have been obvious to modify the combination to use such a shape of the catheter, as it is merely the substitution of one known catheter shape for another.
Claims 5 and 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hennessey in view of Stigall, as applied to claims 1, 2, 3, 4, 6-10, 13, and 20 above, further in view of Taylor et al US PG PUB 2016/0016016.
As to claims 14 and 15, the combination does not have the guidewire exterior to the distal portion in a groove. However, in paragraph [0138], Taylor teaches that it is known to position the guidewire in a groove exterior to the catheter. As such, it would have been obvious to modify the combination to use such a groove, as it is merely the substitution of one known method of positioning a guidewire for another.
As to claim 5, since the catheter has a groove, the proximal portion is crescent shaped.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hennessey in view of Stigall, as applied to claims 1, 3, 4, 6-10, 12, 13, and 20 above, further in view of Kawwas et al WO 2023/118194.
The combination does not have the elastomeric jacket. Kawwas teaches in paragraph [0051] using such a jacket (polyether, which is elastomeric) over a guidewire to enhance delivery through the body. As such, it would have been obvious to modify the combination to use such a jacket, as it is merely the4 use of a known element in such catheters in the art.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hennessey in view of Stigall, as applied to claims 1, 3, 4, 6-10, 12, 13, and 20 above, further in view of Blumenkranz et al US PG PUB 2020/0100776.
The combination does not have the outer catheter. However, in paragraph [0061], Blumenkranz teaches that it is well known introduce a vascular catheter, like that of Hennessey, through an outer catheter. As such, it would have been obvious to use such an outer catheter, as it is merely the use of a well-known introduction method in the art. As such, the guidewire would be between the proximal portion and the outer catheter.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Hennessey in view of Stigall, as applied to claims 1, 3, 4, 6-10, 12, 13, and 20 above, further in view of Eversull et al US PG PUB 2016/0082226.
The combination does not have thermocouple wires running through the distal portion. However, Eversull in paragraph [0023] that it is known in a catheter like that of Hennessey to provide such a thermocouple wireless, to monitor the treatment. As such, it would have been obvious to modify the combination to include a thermocouple and associated wires, to as to better control treatment.
Claim 1, 6-10, 13, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hennessey et al US PG PUB 2007/0191767 in view of Kato et al JP 2023004052.
As to claim 1, Hennessey shows in figure 1 a balloon catheter assembly having a rapid exchange joint 60 with a catheter connected thereto, having a distal portion 56 having a balloon 55 connected thereto and a proximal portion 51. The Examiner notes that the terms cryoablation catheter and cryoshaft are intended use limitations and do not serve to distinguish the claims over any shaft and catheter having the same structure. The device has an inflow pipe, i.e. inflation lumen 57, disposed in the proximal and distal portions, and coupled to the inflatable balloon. The proximal and distal portions do not have different cross-sectional shapes. However, with respect to figure 4B, two paragraphs above where the disclosure says second embodiment, Kato teaches that a distal portion of a balloon catheter can gradually change to improve safety, from a circular to an elliptical cross section. As such, it would have been obvious to modify Hennessey to use the differing shapes, to maintain a smooth profile and prevent damage to a blood vessel.
As to claim 6, the device has a guidewire lumen 54 having a first portion within the distal catheter portion and a second portion that past the end of the distal portion of the catheter (figure 2).
As to claim 7, there is a guidewire (not shown) that extends through the guidewire lumen inside the distal potion and outside the proximal portion of the catheter.
As to claim 8, in figures 6-8, Hennessey shows a joint with a guidewire lumen 82 extending through a ramped off wall.
As to claim 9, the inner member extends along the longitudinal axis and the ramped off member is at an angle to the axis.
As to claim 10, each of the distal portion, the joint and the proximal portion have their own longitudinal axis which are parallel to each other.
As to claim 12, at the very bottom of figure 1, the proximal portion has a conical cross section. Hence, the cross section varies.
As to claim 13, the proximal portion has a constant shape.
As to claim 19, a portion of the proximal and distal portions have the same cross section.
As to claim 20, the guidewire lumen extends from the distal end of the device out of the catheter and hence is configured to transport exhaust gasses out of the catheter proximally.
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Hennessey in view of Kato, as applied to claims 1, 6-10, 12, 13, 19, and 20 above, further in view of above, further in view of Feng.
As to claims 2 and 4, the combination does not have a proximal elliptical shape and a distal circular shape. Feng shows an alternate vascular catheter, like that of Hennessey that has just such a shape arrangement. As such, it would have been obvious to modify the combination to use such a shape of the catheter, as it is merely the substitution of one known catheter shape for another.
As to claim 3, the height and width meet the requirements, depending on which way the catheter is oriented.
Claims 5 and 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hennessey in view of Kato, as applied to claims 1, 6-10, 12, 13, 19, and 20 above, further in view of Taylor.
As to claims 14 and 15, the combination does not have the guidewire exterior to the distal portion in a groove. However, in paragraph [0138], Taylor teaches that it is known to position the guidewire in a groove exterior to the catheter. As such, it would have been obvious to modify the combination to use such a groove, as it is merely the substitution of one known method of positioning a guidewire for another.
As to claim 5, since the catheter has a groove, the proximal portion is crescent shaped.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hennessey in view of Kato, as applied to claims 1, 6-10, 12, 13, 19, and 20 above, further in view of Kawwas et al .
The combination does not have the elastomeric jacket. Kawwas teaches in paragraph [0051] using such a jacket (polyether, which is elastomeric) over a guidewire to enhance delivery through the body. As such, it would have been obvious to modify the combination to use such a jacket, as it is merely the4 use of a known element in such catheters in the art.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hennessey in view of Kato, as applied to claims 1, 6-10, 12, 13, 19, and 20 20 above, further in view of Blumenkranz.
The combination does not have the outer catheter. However, in paragraph [0061], Blumenkranz teaches that it is well known introduce a vascular catheter, like that of Hennessey, through an outer catheter. As such, it would have been obvious to use such an outer catheter, as it is merely the use of a well-known introduction method in the art As such, the guidewire would be between the proximal portion and the outer catheter.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Hennessey in view of Kato, as applied to claims 1, 6-10, 12, 13, 19, and 20 above, further in view of Eversull et al.
The combination does not have thermocouple wires running through the distal portion. However, Eversull in paragraph [0023] that it is known in a catheter like that of Hennessey to provide such a thermocouple wireless, to monitor the treatment. As such, it would have been obvious to modify the combination to include a thermocouple and associated wires, to as to better control treatment.
V. CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT L NASSER whose telephone number is (571)272-4731. The examiner can normally be reached M-F 8-6.
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, Alexander Kosowski can be reached at (571) 272-3744. 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.
/ROBERT L NASSER/ Primary Examiner, Art Unit 3992
Prosecution Insights