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 § 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 1-5 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bencini US 2009/0299355.
Regarding claim 1, Bencini discloses a medical device system 100 comprising: a console 127,133,145 [0038, 0041-0043] comprising: a control system 133, a pump 124, a fluid reservoir 121, and a fluid cooling system 215,219, a fluid line 212,224 defining a fluid supply lumen 212 and a fluid return 224 lumen, and a balloon 103 attached or attachable at a distal end portion of the fluid line 212,224 (figs. 1, 2a, [0028-0050]).
Regarding claim 2, Bencini further discloses one or more electrodes 112 coupled to the balloon 103 or the distal end portion of the fluid line 212,224 (figs. 1, 2B, 3, 6, [0053-0061].
Regarding claim 3, Bencini further discloses one or more electrical wires A,B,C,D that are: (i) extending along the fluid line 212,224 [0030,0050] (ii) connected or connectable to the one or more electrodes 112, and (iii) connected or connectable to the control system 133 via 127,145 [0030,0050].
Regarding claim 4, Bencini further discloses the control system 127,133,145 is programmed and operable via 127,133 to: analyze EKG data (mapping of electrical activity in the heart, also see figs. 5A-5D, and step 1404 in fig. 14) collected by the one or more electrodes 112 to identify a cardiac arrhythmia (abnormal electrical activity in cardiac tissue, [0006-0007, 0031-0033, 0055-0064] and in response to identifying the cardiac arrhythmia (abnormal cardiac activity), activate the pump 124 via 139 to supply a cooled fluid (cryotherapy delivery, [0008] which includes activating the pump 124 to delivery cooling fluid to balloon, also see step 1410 in fig. 14) from the fluid reservoir 121 via 136 [0034-0038, 0076-0083].
Regarding claim 5, Bencini further discloses the control system 133 via 127,145, is further programmed and operable to: after activating the pump 124, further analyze the EKG data (mapping of electrical activity in the heart, also see figs. 5A-5D, and steps 1404 and 1413 in fig. 14) collected by the one or more electrodes 112 to identify cessation of the cardiac arrhythmia (see step 1416, detection of reduction in undesirable electrical activity), and in response to identifying the cessation of the cardiac arrhythmia, deactivate the pump 124 [0081] to cease the supply of the cooled fluid from the fluid reservoir 121 ([0081], see step 1422 for allowing tissue to warm up).
Regarding claim 8, Bencini further discloses the balloon 103 comprises a doppler wire or electrodes 112 (112 are electrodes) by which a coronary artery can be detected using the control system 133.
Regarding claim 9, Bencini further discloses the balloon 103 comprises a fluid pressure sensor (pressure sensor, [0029,0036,0038]).
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.
Claims 6 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bencini US 2009/0299355 in view of Algawi US 2020/0205885.
Regarding claim 6, Bencini discloses the invention as discussed above. Bencini does not expressly disclose a steerable sheath configured contain the balloon in a deflated configuration and to percutaneously deliver the balloon to an epicardial space and/or epicardial surface.
Algawi teaches a steerable sheath 47 (sheath 47 is steerable as it is rotatable, retractable) configured to contain an analogous balloon 45 in a deflated configuration and to percutaneously (via a cut in the thorax) deliver the balloon 45 to an epicardial space and/or epicardial surface 57 (epicardium sub-layer is a part of the epicardial space, figs2-3, [0023,0026-0041], Examiner notes: any procedure involving the insertion of tools or catheters into body is considered percutaneous, because a puncture in the skin is required), providing an insertion sheath that facilitates the deployment of the ballon to stabilize the medical device by pushing against the epicardium layer from one end of the balloon [0023].
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the medical device system of Bencini with the steerable sheath 47 as taught by Algawi in order to have provided an improved medical device system that facilitates insertion of a balloon through a steerable sheeth into the thorax, to and near the vicinity of the heart, so to deploy of the ballon to stabilize the medical device by pushing against the epicardium layer from one end of the balloon to conduct treatment (Algawi, [0023]).
Regarding claim 13, Bencini discloses a method of treating cardiac arrhythmia (abnormal electrical activity in the heart, fig. 14, [0076-0083]) using the medical device system 100 of claim 1, the method comprising, identifying, by the control system 133, a cardiac arrhythmia by analyzing EKG data collected by one or more electrodes 112 on the balloon 103 and/or on the distal end portion of the fluid line 212,224 (figs. 1, 2, 3, 6), and in response to identifying the cardiac arrhythmia (undesired electrical activity in the heart tissue, e.g. steps 1404, 1416, abnormal electrical activity in cardiac tissue, [0006-0007, 0031-0033, 0055-0064] and in response to identifying the cardiac arrhythmia (abnormal cardiac activity), activating the pump 124 via 136,139 to supply a cooled fluid from the fluid reservoir 121 to the balloon 103 so that the balloon cools the epicardial space and/or the epicardial surface (tissue surface, see step 1410, 1419 [0034-0038, 0076-0083].
Bencini does not expressly disclose percutaneously navigating, within a patient, a steerable sheath containing the balloon in a deflated configuration; deploying the balloon from the sheath to an epicardial space and/or epicardial surface of a heart of the patient.
Algawi teaches the step of percutaneously navigating (Examiner notes: any procedure involving the insertion of tools or catheters into body is considered percutaneous, because a puncture in the skin is required), within a patient (once through the cut and into the thorax) a steerable sheath 47 (sheath 47 is steerable as it is rotatable, retractable) configured to contain an analogous balloon 45 in a deflated configuration and to percutaneously (via a cut in the thorax), deploy the balloon 45 from the sheath 47 to an epicardial space and/or epicardial surface 57 of a heart of a patient (epicardium sub-layer is a part of the epicardial space, figs2-3, [0023,0026-0041], , providing an insertion sheath that facilitates the deployment of the ballon to stabilize the medical device by pushing against the epicardium layer from one end of the balloon [0023].
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the method of treating cardiac arrhythmia using the medical device system of Bencini with the step of percutaneously navigating, within a patient, a steerable sheath 47 containing the balloon in a deflated configuration; deploying the balloon from the sheath to an epicardial space and/or epicardial surface of a heart of the patient as taught by Algawi in order to have provided an improved method of treating cardiac arrhythmia using an improved medical device system that facilitates insertion of a balloon through a steerable sheath into the thorax, to and near the vicinity of the heart, so to deploy of the ballon to stabilize the medical device by pushing against the epicardium layer from one end of the balloon to conduct treatment (Algawi, [0023]).
Regarding claim 14, Bencini in view of Algawi discloses the invention as discussed above. Bencini further discloses after activating the pump 124, further analyze the EKG data (mapping of electrical activity in the heart, also see figs. 5A-5D, and steps 1404 and 1413 in fig. 14) collected by the one or more electrodes 112 to identify cessation of the cardiac arrhythmia (see step 1416, detection of reduction in undesirable electrical activity), and in response to identifying the cessation of the cardiac arrhythmia, deactivate the pump 124 [0081] to cease the supply of the cooled fluid from the fluid reservoir 121 ([0081], see step 1422 for allowing tissue to warm up).
Regarding claim 15, Bencini in view of Algawi discloses the invention as discussed above. Bencini in view of Algawi further discloses, the obvious steps of percutaneously withdrawing the balloon 45 from the epicardial space and/or the epicardial surface of the heart of the patient by positioning the balloon 45 in the steerable sheath 47 or another sheath (deflating the balloon and withdrawing the balloon and catheter through the sheath 47 out of the body). One skilled in the art would have recognized that to remove the balloon and medical device of Algawi that the balloon 45 would necessarily need to be deflated and pulled back to be withdrawn over the guidewire and through the insertion sheath 47 (since the sheath 47 keeps the cut open). Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device.
Claims 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Bencini US 2009/0299355 in view of Bhola US 2005/0171527.
Regarding claim 7, Bencini discloses the invention as discussed above. Bencini does not expressly disclose the balloon comprises an hourglass shape.
Bhola teaches an analogous balloon 1020 that is hourglass shape (fig. 10, [0158-0159]), providing a narrowed waist having a reduced diameter between two portions of the balloon such that the narrowed waist allows the balloon to seat and anchor in a thicker ostium while facilitating local treatment [0158-0159].
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the shape of the balloon 103 with the hourglass shape (having a narrowed waist) as taught by Bhola in order to have provided a medical device system having an improved balloon shape that has a narrowed waist that allows the balloon to seat and anchor more stably in a thicker ostium while facilitating local treatment (Bhola, [0158-0159]).
Regarding claim 10, Bencini discloses the invention as discussed above. Bencini does not expressly disclose the balloon comprises at least one insulated portion that is more thermally insulated than other portions of the balloon.
Bhola teaches an analogous balloon 210 that comprises at least one insulated portion 202,204 that is more thermally insulated via 202,204 (insulators) than other portions 203 (band of uninsulated balloon skin) of the balloon 210 (fig. 2, [0073-0074]), for the purpose of allowing the non-insulated portions of the balloon to be a permeable region to ablative energy while the insulated areas of the balloon are non-permeable [0072].
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have modified the balloon of Bencini to comprise at least one insulated portion that is more thermally insulated than other portions of the balloon as taught by Bhola in order to have provided an improved medical device system that has an improved balloon that allows the non-insulated portions of the balloon to be a permeable region to cryo ablative energy while the insulated areas of the balloon are non-permeable (Bhola, [0072]).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Bencini US 2009/0299355 in view of Ibrahim US 2019/0159835.
Regarding claim 11, Bencini discloses a method of treating cardiac arrhythmia (abnormal electrical activity in the heart, fig. 14, [0076-0083]) using the medical device system 100 of claim 1, the method comprising, identifying, by the control system 133, a cardiac arrhythmia by analyzing EKG data collected by one or more electrodes 112 on the balloon 103 and/or on the distal end portion of the fluid line 212,224 (figs. 1, 2, 3, 6), and in response to identifying the cardiac arrhythmia (undesired electrical activity in the heart tissue, e.g. steps 1404, 1416, abnormal electrical activity in cardiac tissue, [0006-0007, 0031-0033, 0055-0064] and in response to identifying the cardiac arrhythmia (abnormal cardiac activity), activating the pump 124 via 136,139 to supply a cooled fluid from the fluid reservoir 121 to the balloon 103 so that the balloon cools the epicardial space and/or the epicardial surface (tissue surface, see step 1410, 1419 [0034-0038, 0076-0083].
Bencini does not expressly disclose during an open chest surgical procedure that exposes a heart of the patient, surgically placing the balloon in an epicardial space and/or on an epicardial surface of the heart.
Ibrahim teaches during an open chest surgical procedure (open surgical procedure that inherently exposes the heart of a patient [0038]) surgically placing an analogous balloon 210 of an analogous medical device system 200 [0056-0060] in an epicardial space and/or on an epicardial surface (the balloons may assist in keeping the ablation device electrodes in correct plane (against epicardium which is an inner surface/wall of the epicardial space), see figs. 5A-5E, [0056]), for the purpose of assisting in keeping the electrodes in correct plane while thermally insulating surrounding tissue and non-target surrounding tissue [0056].
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the method of treating cardiac arrhythmia using the medical device system 100 of Bencini with the step of during an open chest surgical procedure that exposes a heart of the patient, surgically placing the balloon in an epicardial space and/or on an epicardial surface of the heart as taught by Ibrahim in order to have provided an improved method of treating cardiac arrhythmia by facilitating keeping the electrodes in correct plane which helps more accurately mapping tissue and collecting data while thermally insulating surrounding tissue and non-target surrounding tissue (Ibrahim, [0056]).
Regarding claim 12, Bencini in view of Ibrahim discloses the invention as discussed above. Bencini further discloses after activating the pump 124 (see step 1410, pump 124 is activated to cool body tissue by way of inflating the balloon 103), further analyzing the EKG data to identify cessation of the cardiac arrhythmia (see step 1413 where the balloon 103 employs the electrodes 112 to electrically characterize cooled tissue), and in response to identifying the cessation of the cardiac arrhythmia (see step 1416 where assessment is made whether reduction in undesirable electrical activity has occurred) (see fig. 14, 0076-0083]), deactivating the pump 124 to cease the supply of the cooled fluid from the fluid reservoir to the balloon 103 (see step 1422 allowing body tissue to warm up which is the product of turning pump 124 off to stop circulating cool fluid).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALIREZA NIA whose telephone number is (571)270-3076. The examiner can normally be reached Monday-Friday 8 AM - 4 PM.
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, Alford W Kindred can be reached at 571-272-4037. 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.
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786
Prosecution Insights