DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 19 and 34 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.
The term “short” in claim 19 is a relative term which renders the claim indefinite. The term “short” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “short” in claim 34 is a relative term which renders the claim indefinite. The term “short” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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 16-17, 19, 21, 31-32 and 34 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Nollert (US 2020/0281638).
Regarding claim 16, Nollert discloses a cryogenic ablation device comprising: a shaft (fig.2 and fig.4; catheter 2) having a proximal end (proximal end of catheter 2) and a distal end (fig.2 and fig.4; distal end of catheter 2); a first balloon (fig.4; cryoballoons 3a or 3b) located at the distal end of the shaft (fig.4); and a second balloon (fig.4; proximal balloon 12) located on the shaft proximally to the first balloon (fig.4), wherein the shaft includes: at least one first outlet (fig.2; connecting piece 7a) within the first balloon (fig.2), at least one first supply lumen ending in the at least one first outlet (cooling lumen 6), at least one second outlet (fig.4; supply conduit 14) within the second balloon [0048], and at least one second supply lumen ending in the at least one second outlet [0048].
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Regarding claim 17, Nollert discloses the device of claim 16, wherein an outer shape of the first balloon and the second balloon is rotationally symmetric around the shaft (fig.4).
Regarding claim 19, Nollert teaches the device of claim 16, wherein the first balloon and the second balloon are short (see annotated figure above).
Regarding claim 21, Nollert discloses the device of claim 16, wherein the shaft further comprises a first exhaust lumen (fig.4; return conduit 8) connected to an inside of the first balloon [0042].
Regarding claim 31, Nollert discloses a cryogenic ablation device comprising: a shaft (fig.2 and 4; catheter 2) having a proximal end (proximal end of catheter 2) and a distal end (fig.2 and 4; distal end of catheter 2); a cryoballoon (fig.2 and 4; cryoballoons 3a and 3b) located at the distal end of the shaft (fig.4); and a positioning balloon (fig.4; proximal balloon 12) located on the shaft proximally to the cryoballoon for positioning the cryoballoon at a target location (fig.4), wherein the shaft includes: at least one first outlet (fig.2; connecting piece 7a) within the cryoballoon, at least one first supply lumen ending in the at least one first outlet (cooling lumen 6), wherein the other end of the first supply lumen, that is the end not ending in the at least one first outlet, is configured to be connected to a cryogenic medium source [0037], at least one second outlet (fig.4; supply conduit 14) within the positioning balloon [0048], and at least one second supply lumen ending in the at least one second outlet [0048], wherein the positioning balloon is configured to by supplied with a fill medium through the at least one second outlet and the at least one second supply lumen [0048], and wherein the shaft further comprises a first exhaust lumen (fig.2; return conduit 8) connected to an inside of the cryoballoon [0037].
Regarding claim 32, the device of claim 31, wherein the outer shape of the cryoballoon and the positioning balloon is rotationally symmetric around the shaft (fig.4).
Regarding claim 34, the device of claim 31, wherein the cryoballoon and the positioning balloon are short, wherein short means that the largest diameter of a balloon is larger than the length of the balloon when inflated with a nominal pressure (see annotated figure below).
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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 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.
Claims 20 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Nollert (US 2020/0281638).
Regarding claim 20 and 35, Nollert does not disclose wherein a distance between the first balloon and the second balloon along the shaft is 5 cm or less. However, Nollert teaches that second catheter 11 can be shifted relative to the catheter 2 in the direction of the longitudinal axis of the catheter 2 and therefore in the direction of the longitudinal axis of the second catheter 11. The proximal balloon 12 can thus be shifted relative to the distal balloon 10 and the cryoballoons 3a and 3b (fig.4, see also [0047]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to move the second catheter to the desired distance length including a distance between the first balloon and the second balloon along the shaft is 5 cm or less for the purpose of achieving the desired treatment.
Claims 18, 22-24, 28-30 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Nollert (US 2020/0281638) in view of Wittenberger (US 2002/0007180).
Regarding claim 18, 28, 30 and 33, Nollert does not disclose wherein a diameter of the second balloon is 2.5 to 5 centimeters and the diameter of the first balloon is 1.25 to 2 times the diameter of the second balloon and wherein the curved connection has a constant radius of 4 to 7 millimeters and wherein shoulders of the first balloon have a truncated conical shape with an opening angle between 70 and 85 degrees.
Wittenberger teaches medical device for cryotreatment of bodily regions that comprises two expandable membranes 305 and 310 are coupled to the catheter shaft 105 (fig.3, see also [0043]). The Both of the inner membranes 305 and 310 are controllably inflated by an inflation medium flowing from the inflation lumen 330, through the inflation orifices 340, and into the respective inflation chambers 320 and 325 [0043]. Each of the inner membranes 305 and 310 may be alternately controllably inflated via inflation orifices 340 to create inflation chambers 320 and 325 of varying shape, thereby creating expansion chambers 360 of varying radius and longitudinal size [0044].Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify as taught by Nollert with alternately controllably inflated balloons as taught by Wittenberger for the purpose of having selective sizes and shapes of balloons for the desired purpose.
Regarding claim 22-24, Nollert discloses the device of claim 16, wherein the shaft comprises a plurality of first outlets distributed around the outer circumference of the shaft or at the distal end of the shaft; wherein a number of first supply lumens equals a number of first outlets and wherein the first supply lumens are uniformly distributed along an inner circumference of the shaft.
Wittenberger teaches medical device for cryotreatment of bodily regions that comprises two expandable membranes 305 and 310 are coupled to the catheter shaft 105 (fig.3, see also [0043]). The Both of the inner membranes 305 and 310 are controllably inflated by an inflation medium flowing from the inflation lumen 330, through the inflation orifices 340, and into the respective inflation chambers 320 and 325 [0043]. Wittenberger further teaches wherein a number of first supply lumens equals a number of first outlets and wherein the first supply lumens are uniformly distributed along an inner circumference of the shaft (fig.3,see also [0043]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify as taught by Nollert with supply lumens equals a number of first outlets and wherein the first supply lumens as taught by Wittenberger for the purpose of controlled inflation.
Regarding claim 29, Nollert/ Wittenberger teaches the device of claim 28, wherein the first balloon further comprises a curved connection between radial outer ends of the shoulders (fig.3 of Wittenberger).
Claims 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Noller (US 2020/0281638) in view of Schaer (US 2013/0197555).
Regarding claim 25, Nollert does not disclose wherein the shaft further comprises a vent lumen having an outlet to an outside of the shaft at the distal end of the shaft; wherein the vent lumen and the second supply lumen are located at radially opposite sides within the shaft and wherein the vent lumen and the second supply lumen are located within a wall of the shaft. Schaer teaches a system configured to one or more cryogenic fluids can be delivered to a target anatomical site of a subject using fluid lumen of a catheter [0245]. The system comprises a vent tube alongside the overtube 500 and overtube balloon 520 to allow air in the stomach to vent out of the patient. The tube could be positioned completely separate from the overtube or advanced through an optional lumen in the overtube (within the wall of overtube), exiting just proximal to the overtube balloon 520. The distal end of the vent tube would be positioned in the stomach 20 distal to the overtube balloon 520 [0221]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify as taught by Nollert with a vent as taught Schaer for the purpose of aspiration of fluids or any discharges.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
PAGEARD (US 2011/0184400) discloses a cryogenic ablation device comprising: a shaft (fig.14a and b) having a proximal end (proximal end of 14a) and a distal end (fig.2 and fig.4; distal end of catheter 2); a first balloon (fig.14a; first balloon) located at the distal end of the shaft (fig.14a); and a second balloon (fig.14a; second balloon) located on the shaft proximally to the first balloon (fig.14a), wherein the shaft includes: at least one first outlet (fig.14a) within the first balloon (fig.14a), at least one first supply lumen ending in the at least one first outlet [0055], at least one second outlet (fig.14a) within the second balloon [0055], and at least one second supply lumen ending in the at least one second outlet [0055].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIGIST S DEMIE whose telephone number is (571)270-5345. The examiner can normally be reached Monday-Friday 8am-5Pm.
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, Joseph Stoklosa can be reached at 571-2721213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794
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