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 § 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.
Claim(s) 1-4, 6, 9-13, 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kleinberger (US 2007/0043342) in view of Newell (US 2017/0333105).
Regarding claim 1, Kleinberger teaches a medical device comprising:
a shaft defining a lumen (shaft 100 with lumen 105 as in Fig. 2) and having a distal end portion that includes an inflatable balloon (inflatable balloon 42 as in Fig. 2 and par. [0133]), wherein a needle closes a distal end of the shaft (needle at the end of the shaft as in Fig. 2 and similar tip 52 of Fig. 1); Kleinberger is not explicit regarding a tube movable along the lumen, the tube being in fluid communication with the balloon and configured to supply a cryogenic fluid to the needle and to the balloon; wherein the medical device is movable between a first configuration in which a distal end of the tube abuts a proximal end of the needle while the balloon is deflated, and a second configuration in which the distal end of the tube is proximal to the balloon, wherein supplying the cryogenic fluid through the tube inflates the balloon in the second configuration.
However, Newell teaches a diffuser to disperse refrigerant into a balloon (diffuser 36), at a proximal end of the needle when the balloon is deflated (Fig. 2a), and a configuration where the tube is proximal to the balloon and inflates the balloon in the second configuration (Fig. 2c).It would have been obvious to one of ordinary skill of the art to modify Kleinberger with the tube of Newell, to have a source of cryogen for both the needle and the balloon.
Regarding claim 2, Kleinberger is not explicit wherein a wall of the distal end portion of the shaft includes at least one port that provides fluid communication between the lumen and the balloon.However, Newell teaches wherein a wall of the distal end portion of the shaft includes at least one port that provides fluid communication between the lumen and the balloon (ports 40 as in Figs. 5a-c and par. [0070]).It would have been obvious to one of ordinary skill of the art to modify Kleinberger with the tube of Newell, to have a source of cryogen for both the needle and the balloon.
Regarding claim 3, Kleinberger is not explicit, but Newell teaches two ports disposed opposite one another (ports 40 opposite each other as in Figs. 5a-c and par. [0070]).It would have been obvious to one of ordinary skill of the art to modify Kleinberger with the tube of Newell, to have a source of cryogen for both the needle and the balloon.
Regarding claim 4, Kleinberger is not explicit, but Newell teaches wherein the balloon when inflated is symmetric about the shaft (Fig. 2b).It would have been obvious to one of ordinary skill of the art to modify Kleinberger with the tube of Newell, to have a source of cryogen for both the needle and the balloon.
Regarding claim 6, Kleinberger teaches the balloon comprises nylon or polyethylene terephthalate (col. 18 lines 4-7 of Zvuloni (US 6,875,209), incorporated by reference to Kleinberger).
Regarding claim 9, Kleinberger is not explicit, but Newell teaches wherein the balloon when inflated has an oblong shape (Fig. 2b).It would have been obvious to one of ordinary skill in the art to modify Kleinberger with the balloon shape of Newell, as a shape that is capable of being inserted into the body.
Regarding claim 10, Kleinberger teaches wherein the medical device comprises a handle at a proximal end of the shaft (72), but is not explicit regarding the handle including a valve configured to control a flow of the cryogenic fluid.However, Newell teaches a pressure relief valve 130 from a handle as in Fig. 12.It would have been obvious to one of ordinary skill in the art to modify Kleinberger with the valve of Newell, to have a way to reduce undesired pressure through the fluid system.
Regarding claim 11, Kleinberger is not explicit wherein the valve is a pressure relief valve.However, Newell teaches a pressure relief valve 130 from a handle as in Fig. 12.It would have been obvious to one of ordinary skill in the art to modify Kleinberger with the valve of Newell, to have a way to reduce undesired pressure through the fluid system.
Regarding claim 12, Kleinberger teaches a medical device comprising:
a shaft defining a lumen and having a distal end portion that includes a port and an inflatable balloon (shaft 105 with a lumen through, port to 110, and inflatable balloon 42 as in Fig. 2 and par. [0133]), wherein a needle closes a distal end of the shaft proximate the balloon and the port (needle at the end of the shaft as in Fig. 2 and similar tip 52 of Fig. 1).Kleinberger is not explicit regarding a tube movable along the lumen, the tube being in fluid communication with the balloon and configured to supply a cryogenic fluid to the needle and to the balloon;
wherein the medical device is movable between a first configuration in which a distal end of the tube abuts the needle while the balloon is deflated, and a second configuration in which the distal end of the tube is proximal to the port, wherein supplying the cryogenic fluid through the tube inflates the balloon in the second configuration.However, Newell teaches a diffuser to disperse refrigerant into a balloon (diffuser 36), at a proximal end of the needle when the balloon is deflated (Fig. 2a), and a configuration where the tube is proximal to the balloon and inflates the balloon in the second configuration (Fig. 2c).It would have been obvious to one of ordinary skill of the art to modify Kleinberger with the tube of Newell, to have a source of cryogen for both the needle and the balloon.
Regarding claim 13, Kleinberger is not explicit, but Newell teaches two ports disposed opposite one another (ports 40 opposite each other as in Figs. 5a-c and par. [0070]).It would have been obvious to one of ordinary skill of the art to modify Kleinberger with the tube of Newell, to have a source of cryogen for both the needle and the balloon.
Regarding claim 15, Kleinberger teaches a method of treating a subject, the method comprising:
introducing a medical device into a bodily lumen of the subject (cryoprobe into subject), wherein the medical device includes a shaft defining a lumen with a distal end portion that includes an inflatable balloon (inflatable balloon 42 as in Fig. 2 and par. [0133]), wherein a needle closes a distal end of the shaft proximate the balloon (needle at the end of the shaft as in Fig. 2 and similar tip 52 of Fig. 1);
at least partially inserting the needle into a target tissue site (par. [0025]);
supplying a cryogenic fluid to at least one of the needle or the balloon (par. [0093])
wherein the cryogenic fluid freezes at least a portion of tissue in contact with the needle and/or the balloon (par. [0066]).Kleinberger is not explicit regarding supplying the fluid through a tube movable along the lumen.However, Newell teaches a diffuser to disperse refrigerant into a balloon (diffuser 36), at a proximal end of the needle when the balloon is deflated (Fig. 2a), and a configuration where the tube is proximal to the balloon and inflates the balloon in the second configuration (Fig. 2c).It would have been obvious to one of ordinary skill of the art to modify Kleinberger with the tube of Newell, to have a source of cryogen for both the needle and the balloon.
Regarding claim 16, Kleinberger teaches wherein the cryogenic fluid comprises argon, nitrogen, or krypton (par. [0071]).
Regarding claim 17, Kleinberger teaches wherein a distal end of the tube is adjacent to a proximal end of the needle when supplying the cryogenic fluid.However, Newell teaches a diffuser to disperse refrigerant into a balloon (diffuser 36), at a proximal end of the needle when the balloon is deflated (Fig. 2a), and a configuration where the tube is proximal to the balloon and inflates the balloon in the second configuration (Fig. 2c).
Regarding claim 18, Kleinberger is not explicit wherein a distal end of the tube is proximal to the balloon when supplying the cryogenic fluid, such that the balloon inflates.However, Newell teaches a diffuser to disperse refrigerant into a balloon (diffuser 36), at a proximal end of the needle when the balloon is deflated (Fig. 2a), and a configuration where the tube is proximal to the balloon and inflates the balloon in the second configuration (Fig. 2c).It would have been obvious to one of ordinary skill of the art to modify Kleinberger with the tube of Newell, to have a source of cryogen for both the needle and the balloon.
Regarding claim 19, Kleinberger is not explicit regarding wherein supplying the cryogenic fluid to at least one of the needle or the balloon through the tube includes:
supplying the cryogenic fluid through the tube while the balloon is deflated and a distal end of the tube abuts a proximal end of the needle, the distal end of the tube being distal to a port of the shaft in fluid communication with the balloon;
moving the tube in a proximal direction such that the distal end of the tube is proximal to the port; and supplying the cryogenic fluid through the tube to inflate the balloon.However, Newell teaches a diffuser to disperse refrigerant into a balloon (diffuser 36), at a proximal end of the needle when the balloon is deflated (Fig. 2a), and a configuration where the tube is proximal to the balloon and inflates the balloon in the second configuration (Fig. 2c).It would have been obvious to one of ordinary skill of the art to modify Kleinberger with the tube of Newell, to have a source of cryogen for both the needle and the balloon.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kleinberger in view of Newell, in further view of Tegg (US 2021/0177482).
Regarding claim 5, Kleinberger is not explicit wherein the balloon when inflated is asymmetric about the shaft.However, Tegg teaches a balloon that expands asymmetrically par. [0028].It would have been obvious to one of ordinary skill in the art to modify Kleinberger with the balloon expanding asymmetrically. This would allow for different chapes according to a desired treatment.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kleinberger in view of Newell, in further view of Reynolds (US 2006/0129142).
Regarding claim 7, Kleinberger is not explicit wherein the balloon has a length ranging from about 8 mm to about 15 mm.However, Reynolds teaches balloons with a 10 mm length (par. [0043] length of at least 1 cm).It would have been obvious to one of ordinary skill in the art to modify Kleinberger with the balloon shape of Reynolds, so allow for a balloon dimension for treating desired tissue cavities.
Regarding claim 8, Kleinberger is silent wherein the balloon has a diameter ranging from about 8 to about 15 mm.However, Reynolds teaches balloons with a cryogen balloon with a 10 mm diameter (par. [0043] 10 mm diameter).It would have been obvious to one of ordinary skill in the art to modify Kleinberger with the balloon shape of Reynolds, so allow for a balloon dimension for treating desired tissue cavities.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kleinberger in view of Newell, in further view of Cohn (US 2022/0047314).
Regarding claim 14, Kleinberger is not explicit wherein the balloon when deflated has a plurality of preformed folds, the balloon being configured to inflate with a bellows shape.However, Cohn teaches balloons as bellows shaped (par. [0115]) to allow for the balloon to better anchor into tissue.It would have been obvious to one of ordinary skill in the art to modify Kleinberger such that the balloon is bellows shaped with folds, as in Cohn, to allow for the balloon to better anchor to tissue.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kleinberger in view of Newell, in further view of Thomas (US 2003/0181897).
Regarding claim 20, Kleinberger is not explicit regarding wherein the bodily lumen is a urethra, and the target tissue site is in a bladder or a kidney.However, Thomas teaches using cryogenic treatment with a balloon in the urethra to treat the bladder (par. [0014]).It would have been obvious to one of ordinary skill in the art to modify Kleinberger with the treatment being through the urethra to treat a bladder as in Thomas, as a desired treatment location for a cryoprobe.
Conclusion
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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