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 Objections
Claim 1, 7, and 14 are objected to because of the following informalities:
Claim 1 recites the limitations “the relative position” and “the shape” should read “a relative position” and “a shape”.
Claim 7 recites the limitation “The method of claim 1, further comprising a lock to secure at least one of the surgical devices.” Should read either “The method of claim 1, said system further comprises a lock to secure the at least one surgical device.” Or “The method of claim 1, further comprising securing the at least one surgical device using a lock.”.
Claim 14 recites the limitations “the relative position” and “the shape” should read “a relative position” and “a shape”.
Appropriate correction is required.
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.
Claims 14-20 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.
Claim 14 recites the limitation “A system for performing catheterization comprising use of a system for fixing the relative position of a catheter and at least one surgical device”. It is unclear whether the claimed system for performing catheterization comprises the recited fixation system as a structural component or whether the claim requires the act of using the fixation system. A system is defined by its components and structural/functional limitations, whereas “use of” appears to recite an activity performed with a system. Accordingly, the metes and bounds of the claimed subject matter are unclear. The examiner interoperates the limitation as a system comprising a handle for fixing a relative position of a catheter and at least one surgical device.
The rest of the claims are rejected based on their dependency.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim17-18 of U.S. Patent No. 11,864,791. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and U.S. Patent No. 11,864,791 recite a method for performing a catheterization procedure, said method comprising use of a system for fixing the relative position of a catheter to a device, said system comprising a handle assembly comprising a void region complimentary to the shape of the surgical device and wherein said cardiac catheterization procedure further comprises balloon valvuloplasty.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of U.S. Patent No. 12,364,505. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variation of one another (refer to the table below).
Current application
U.S. Patent No. 12,364,505
Claim 1: A method for performing catheterization comprising use of a system for fixing the relative position of a catheter and at least one surgical device, said system comprising a handle assembly comprising a void region complimentary to the shape of the catheter.
Claim 1: A method for performing trans-septal heart catheterization comprising use of a system for fixing the relative position of a catheter and at least one surgical device, said system comprising a handle assembly comprising a void region complimentary to the shape of the catheter, and said handle assembly further comprising a retractable rear track.
Claim 2: The method of claim 1, wherein said catheter comprises a dual lumen catheter.
Claim 2: The method of claim 1, wherein said catheter comprises a dual lumen catheter.
Claim 3: The method of claim 1, wherein said at least one surgical device comprises an imaging unit.
Claim 3: The method of claim 1, wherein said at least one surgical device comprises an imaging unit.
Claim 4: The method of claim 3, wherein said imaging unit comprises an ultrasound unit.
Claim 4: The method of claim 3, wherein said imaging unit comprises an ultrasound unit.
Claim 5: The method of claim 4, wherein said ultrasound unit comprises a 2D, 3D, or 4D ultrasound unit.
Claim 5: The method of claim 4, wherein said ultrasound unit comprises a 2D, 3D, or 4D ultrasound unit.
Claim 6: The method of claim 5, wherein said 2D, 3D, or 4D ultrasound unit comprises a 3D ultrasound unit
Claim 6: The method of claim 5, wherein said 2D, 3D, or 4D ultrasound unit comprises a 3D ultrasound unit.
Claim 7: The method of claim 1, further comprising a lock to secure at least one of the surgical devices.
Claim 7: The method of claim 1, further comprising a lock to secure at least one of the surgical devices.
Claim 8: The method of claim 1, wherein said catheterization comprises catheter ablation.
Claim 8: The method of claim 1, wherein said trans-septal heart catheterization comprises catheter ablation.
Claim 9: The method of claim 1, wherein said catheterization comprises valve repair.
Claim 9: The method of claim 1, wherein said trans-septal heart catheterization comprises valve repair.
Claim 10: The method of claim 1, wherein said catheterization comprises valve replacement.
Claim 10: The method of claim 1, wherein said trans-septal heart catheterization comprises valve replacement.
Claim 11: The method of claim 1, wherein said catheterization comprises left appendage closure.
Claim 11: The method of claim 1, wherein said trans-septal heart catheterization comprises left appendage closure.
Claim 12: The method of claim 1, wherein said catheterization comprises valvuloplasty.
Claim 12: The method of claim 1, wherein said trans-septal heart catheterization comprises valvuloplasty.
Claim 13: The method of claim 1, wherein said catheterization comprises balloon valvuloplasty.
Claim 13: The method of claim 1, wherein said trans-septal heart catheterization comprises balloon valvuloplasty.
Claim 14: A system for performing catheterization comprising use of a system for fixing the relative position of a catheter and at least one surgical device, said system comprising a handle assembly comprising a void region complimentary to the shape of the catheter.
Claim 14: A system for performing trans-septal heart catheterization comprising use of a system for fixing the relative position of a catheter and at least one surgical device, said system comprising a handle assembly comprising a void region complimentary to the shape of the catheter, and said handle assembly further comprising a retractable rear track.
Claim 15: The system of claim 14, wherein said catheter comprises a dual lumen catheter.
Claim 15: The system of claim 14, wherein said catheter comprises a dual lumen catheter.
Claim 16: The system of claim 14, wherein said catheterization comprises catheter ablation.
Claim 16: The system of claim 14, wherein said trans-septal heart catheterization comprises catheter ablation.
Claim 17: The system of claim 14, wherein said catheterization comprises valve repair.
Claim 17: The system of claim 14, wherein said trans-septal heart catheterization comprises valve repair.
Claim 18: The system of claim 14, wherein said catheterization comprises valve replacement.
Claim 18: The system of claim 14, wherein said trans-septal heart catheterization comprises valve replacement.
Claim 19: The system of claim 14, wherein said catheterization comprises left appendage closure.
Claim 19: The system of claim 14, wherein said trans-septal heart catheterization comprises left appendage closure.
Claim 20: The system of claim 14, wherein said catheterization comprises valvuloplasty.
Claim 20: The system of claim 14, wherein said trans-septal heart catheterization comprises valvuloplasty.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cully et al. (US 2011/0166455).
Regarding claim 1, Cully teaches a method for performing catheterization comprising use of a system for fixing the relative position of a catheter and at least one surgical device (paras. 0195-0197; The catheter 1000 may be inserted into a body of a patient, and portions of the catheter 1000 within the body may be manipulated utilizing another portion of the catheter 1000 such as a portion located outside of the body. Thus, when the catheter 1000 is inserted into a body, a proximal end of the catheter 1000 remains outside of the body and accessible to a clinician for control of distal portions of the catheter 1000 positioned within the body. The catheter 1000 may be employed for a wide variety of purposes, including: the positioning and/or delivery of electronic devices such as diagnostic devices (e.g., imaging devices) and devices which delivery therapies such as therapeutic compounds or energy (e.g., ablation catheters); the deployment and/or retrieval of implantable devices (e.g., stents, stent grafts, vena cava filters); or any combination thereof. The catheter 1000 includes a catheter body 1001. The catheter body 1001 is an elongate member with a proximal end and a distal end. The catheter body 1001 may comprise, for example, a shaft (e.g., a solid shaft, a shaft comprising at least one lumen), an outer tubular body, an inner tubular body, or any combination thereof. The catheter body 1001 may optionally include a lumen. Such a lumen may run all or a portion of the length of the catheter body 1001 and may have a port at or near the distal end of the catheter body 1001. Such a lumen may be used to convey a device and/or material therethrough (e.g., deliver a device and/or material to or near to the distal end of the catheter body 1001). In another example, the lumen may be used to deliver a therapeutic device, an imaging device, an implantable device, a dosage of a therapeutic compound, or any combination thereof to or proximate to the distal end of the catheter body 1001. The examiner notes that a system that comprise a catheter with at least one lumen used to deliver a surgical device such as an imaging unit is fixed an controlled at the proximal end of the catheter to a handle), said system comprising a handle assembly comprising a void region complimentary to the shape of the catheter (fig. 5A, para. 0232; a catheter 50 that includes a deflectable member 52 and a catheter body 54. The catheter body 54 may be flexible and capable of bending to follow the contours of a body vessel into which it is being inserted. The deflectable member 52 may be disposed at a distal end 53 of the catheter 50. The catheter 50 includes a handle 56 that may be disposed at a proximal end 55 of the catheter 50. During a procedure where the deflectable member 52 is inserted into the body of a patient, the handle 56 and a portion of the catheter body 54 remain outside of the body. The user (e.g., physician, technician, interventionalist) of the catheter 50 may control the position and various functions of the catheter 50. For example, the user may hold the handle 56 and manipulate a slide 58 to control a deflection of the deflectable member 52. In this regard, the deflectable member 52 may be selectively deflectable. The handle 56 and slide 58 may be configured such that the position of the slide 58 relative to the handle 56 may be maintained, thereby maintaining the selected deflection of the deflectable member 52. Such maintenance of position may at least partially be achieved by, for example, friction (e.g., friction between the slide 58 and a stationary portion of the handle 56), detents, and/or any other appropriate means. The catheter 50 may be removed from the body by pulling (e.g., pulling the handle 56).).
Regarding claim 2, Cully teaches the method of claim 1, wherein said catheter comprises a dual lumen catheter (para. 0196; The catheter 1000 includes a catheter body 1001. The catheter body 1001 is an elongate member with a proximal end and a distal end. The catheter body 1001 may comprise, for example, a shaft (e.g., a solid shaft, a shaft comprising at least one lumen), an outer tubular body, an inner tubular body, or any combination thereof.).
Regarding claim 3, Cully teaches the method of claim 1, wherein said at least one surgical device comprises an imaging unit (para. 0197; The catheter body 1001 may optionally include a lumen. Such a lumen may run all or a portion of the length of the catheter body 1001 and may have a port at or near the distal end of the catheter body 1001. Such a lumen may be used to convey a device and/or material therethrough (e.g., deliver a device and/or material to or near to the distal end of the catheter body 1001). In another example, the lumen may be used to deliver a therapeutic device, an imaging device, an implantable device, a dosage of a therapeutic compound, or any combination thereof to or proximate to the distal end of the catheter body 1001.).
Regarding claim 4, Cully teaches the method of claim 3, wherein said imaging unit comprises an ultrasound unit (para. 0202; he driven member 1006 may be an electrical device such as an imaging, diagnostic and/or therapeutic device. The driven member 1006 may include a transducer array. The driven member 1006 may include an ultrasound transducer. The driven member 1006 may include an ultrasound transducer array, such as a one dimensional array or a two dimensional array. In an example, the driven member 1006 may include a one dimensional ultrasound transducer array that may be reciprocally pivoted by the motor 1005 such that an imaging plane of the one dimensional ultrasound transducer array is swept through a volume, thus enabling the generation of 3D images and 4D image sequences).
Regarding claim 5, Cully teaches the method of claim 4, wherein said ultrasound unit comprises a 2D, 3D, or 4D ultrasound unit (para. 0202; he driven member 1006 may be an electrical device such as an imaging, diagnostic and/or therapeutic device. The driven member 1006 may include a transducer array. The driven member 1006 may include an ultrasound transducer. The driven member 1006 may include an ultrasound transducer array, such as a one dimensional array or a two dimensional array. In an example, the driven member 1006 may include a one dimensional ultrasound transducer array that may be reciprocally pivoted by the motor 1005 such that an imaging plane of the one dimensional ultrasound transducer array is swept through a volume, thus enabling the generation of 3D images and 4D image sequences).
Regarding claim 6, Cully teaches the method of claim 5, wherein said 2D, 3D, or 4D ultrasound unit comprises a 3D ultrasound unit (para. 0202; he driven member 1006 may be an electrical device such as an imaging, diagnostic and/or therapeutic device. The driven member 1006 may include a transducer array. The driven member 1006 may include an ultrasound transducer. The driven member 1006 may include an ultrasound transducer array, such as a one dimensional array or a two dimensional array. In an example, the driven member 1006 may include a one dimensional ultrasound transducer array that may be reciprocally pivoted by the motor 1005 such that an imaging plane of the one dimensional ultrasound transducer array is swept through a volume, thus enabling the generation of 3D images and 4D image sequences).
Regarding claim 7, Cully teaches the method of claim 1, further comprising a lock to secure at least one of the surgical devices (para. 0496; In use, the user may hold the handle 5701 and manipulate one or both sliders 5707a, 5707b to steer the catheter body 5703 as the catheter 5702 is moved to a desired anatomical position. The handle 5701 and sliders 5707a, 5707b may be configured such that the position of the sliders 5707a, 5707b relative to the handle 5701 may be maintained, thereby maintaining or "locking" the selected position of the catheter body 5703. The deflection controller 5708 may then be used to deflect the deflectable member 5704 to a desired position. The handle 5701 and deflection controller 5708 may be configured such that the position of the deflection controller 5708 relative to the handle 5701 may be maintained, thereby maintaining or "locking" the selected deflection of the deflectable member 5704. Also, the deflection of the deflectable member 5704 may be selectively locked, and the shape of the catheter body 5703 may be selectively locked, independently. Such maintenance of position may at least partially be achieved by, for example, friction, detents, and/or any other appropriate means. The controls for the steering, deflection, and motor may all be independently operated and controlled by the user.).
Regarding claim 8, Cully teaches the method of claim 1, wherein said catheterization comprises catheter ablation (para. 0195; The catheter 1000 may be employed for a wide variety of purposes, including: the positioning and/or delivery of electronic devices such as diagnostic devices (e.g., imaging devices) and devices which delivery therapies such as therapeutic compounds or energy (e.g., ablation catheters); the deployment and/or retrieval of implantable devices (e.g., stents, stent grafts, vena cava filters); or any combination thereof.).
Regarding claim 9, Cully teaches the method of claim 1, wherein said catheterization comprises valve repair (paras. 0007 and 00625; Clinical procedures that may be performed from the left atrium include without limitation, left atrial appendage occlude placement, mitral valve replacement, aortic valve replacement, and cardiac ablation for atrial fibrillation.).
Regarding claim 10, Cully teaches the method of claim 1, wherein said catheterization comprises valve replacement (paras. 0007 and 00625; Clinical procedures that may be performed from the left atrium include without limitation, left atrial appendage occlude placement, mitral valve replacement, aortic valve replacement, and cardiac ablation for atrial fibrillation.).
Regarding claim 11, Cully teaches the method of claim 1, wherein said catheterization comprises left appendage closure (paras. 0007 and 00625; Clinical procedures that may be performed from the left atrium include without limitation, left atrial appendage occlude placement, mitral valve replacement, aortic valve replacement, and cardiac ablation for atrial fibrillation.).
Regarding claim 12, Cully teaches the method of claim 1, wherein said catheterization comprises valvuloplasty (paras. 0007 and 0062; the catheter may also include a lumen for conveyance of a device and/or material such as delivering an interventional device extending through the outer tubular body from the proximal end of the outer tubular body to a point distal thereto. For purposes hereof, "interventional device" includes without limitation diagnostic devices (e.g., pressure transducers, conductivity measurement devices, temperature measurement devices, flow measurement devices, electro- and neuro-physiology mapping devices, material detection devices, imaging devices, central venous pressure (CVP) monitoring devices, intracardiac echocardiography (ICE) catheters, balloon sizing catheters, needles, biopsy tools), therapeutic devices (e.g., ablation catheters (e.g., radio-frequency, ultrasonic, optical), patent foramen ovale (PFO) closure devices, cryotherapy catheters, vena cava filters, stents, stent-grafts, septostomy tools), and agent delivery devices (e.g., needles, cannulae, catheters, elongated members). Visualizing the three dimensional (3D) architecture of the heart, for example, on a real-time basis during intervention is highly desirable from a clinical perspective as it facilitates more complex procedures such as left atrial appendage occlusion, mitral valve repair, and ablation for atrial fibrillation.).
Regarding claim 14, Cully teaches a system for performing catheterization comprising use of a system for fixing the relative position of a catheter and at least one surgical device (paras. 0195-0197; The catheter 1000 may be inserted into a body of a patient, and portions of the catheter 1000 within the body may be manipulated utilizing another portion of the catheter 1000 such as a portion located outside of the body. Thus, when the catheter 1000 is inserted into a body, a proximal end of the catheter 1000 remains outside of the body and accessible to a clinician for control of distal portions of the catheter 1000 positioned within the body. The catheter 1000 may be employed for a wide variety of purposes, including: the positioning and/or delivery of electronic devices such as diagnostic devices (e.g., imaging devices) and devices which delivery therapies such as therapeutic compounds or energy (e.g., ablation catheters); the deployment and/or retrieval of implantable devices (e.g., stents, stent grafts, vena cava filters); or any combination thereof. The catheter 1000 includes a catheter body 1001. The catheter body 1001 is an elongate member with a proximal end and a distal end. The catheter body 1001 may comprise, for example, a shaft (e.g., a solid shaft, a shaft comprising at least one lumen), an outer tubular body, an inner tubular body, or any combination thereof. The catheter body 1001 may optionally include a lumen. Such a lumen may run all or a portion of the length of the catheter body 1001 and may have a port at or near the distal end of the catheter body 1001. Such a lumen may be used to convey a device and/or material therethrough (e.g., deliver a device and/or material to or near to the distal end of the catheter body 1001). In another example, the lumen may be used to deliver a therapeutic device, an imaging device, an implantable device, a dosage of a therapeutic compound, or any combination thereof to or proximate to the distal end of the catheter body 1001. The examiner notes that a system that comprise a catheter with at least one lumen used to deliver a surgical device such as an imaging unit is fixed an controlled at the proximal end of the catheter to a handle), said system comprising a handle assembly comprising a void region complimentary to the shape of the catheter (fig. 5A, para. 0232; a catheter 50 that includes a deflectable member 52 and a catheter body 54. The catheter body 54 may be flexible and capable of bending to follow the contours of a body vessel into which it is being inserted. The deflectable member 52 may be disposed at a distal end 53 of the catheter 50. The catheter 50 includes a handle 56 that may be disposed at a proximal end 55 of the catheter 50. During a procedure where the deflectable member 52 is inserted into the body of a patient, the handle 56 and a portion of the catheter body 54 remain outside of the body. The user (e.g., physician, technician, interventionalist) of the catheter 50 may control the position and various functions of the catheter 50. For example, the user may hold the handle 56 and manipulate a slide 58 to control a deflection of the deflectable member 52. In this regard, the deflectable member 52 may be selectively deflectable. The handle 56 and slide 58 may be configured such that the position of the slide 58 relative to the handle 56 may be maintained, thereby maintaining the selected deflection of the deflectable member 52. Such maintenance of position may at least partially be achieved by, for example, friction (e.g., friction between the slide 58 and a stationary portion of the handle 56), detents, and/or any other appropriate means. The catheter 50 may be removed from the body by pulling (e.g., pulling the handle 56).).
Regarding claim 15, Cully teaches the system of claim 14, wherein said catheter comprises a dual lumen catheter (para. 0196; The catheter 1000 includes a catheter body 1001. The catheter body 1001 is an elongate member with a proximal end and a distal end. The catheter body 1001 may comprise, for example, a shaft (e.g., a solid shaft, a shaft comprising at least one lumen), an outer tubular body, an inner tubular body, or any combination thereof.).
Regarding claim 16, Cully teaches the system of claim 14, wherein said catheterization comprises catheter ablation (para. 0195; The catheter 1000 may be employed for a wide variety of purposes, including: the positioning and/or delivery of electronic devices such as diagnostic devices (e.g., imaging devices) and devices which delivery therapies such as therapeutic compounds or energy (e.g., ablation catheters); the deployment and/or retrieval of implantable devices (e.g., stents, stent grafts, vena cava filters); or any combination thereof.).
Regarding claim 17, Cully teaches the system of claim 14, wherein said catheterization comprises valve repair (paras. 0007 and 00625; Clinical procedures that may be performed from the left atrium include without limitation, left atrial appendage occlude placement, mitral valve replacement, aortic valve replacement, and cardiac ablation for atrial fibrillation.).
Regarding claim 18, Cully teaches the system of claim 14, wherein said catheterization comprises valve replacement (paras. 0007 and 00625; Clinical procedures that may be performed from the left atrium include without limitation, left atrial appendage occlude placement, mitral valve replacement, aortic valve replacement, and cardiac ablation for atrial fibrillation.).
Regarding claim 19, Cully teaches the system of claim 14, wherein said catheterization comprises left appendage closure (paras. 0007 and 00625; Clinical procedures that may be performed from the left atrium include without limitation, left atrial appendage occlude placement, mitral valve replacement, aortic valve replacement, and cardiac ablation for atrial fibrillation.).
Regarding claim 20, Cully teaches the system of claim 14, wherein said catheterization comprises valvuloplasty (paras. 0007 and 0062; the catheter may also include a lumen for conveyance of a device and/or material such as delivering an interventional device extending through the outer tubular body from the proximal end of the outer tubular body to a point distal thereto. For purposes hereof, "interventional device" includes without limitation diagnostic devices (e.g., pressure transducers, conductivity measurement devices, temperature measurement devices, flow measurement devices, electro- and neuro-physiology mapping devices, material detection devices, imaging devices, central venous pressure (CVP) monitoring devices, intracardiac echocardiography (ICE) catheters, balloon sizing catheters, needles, biopsy tools), therapeutic devices (e.g., ablation catheters (e.g., radio-frequency, ultrasonic, optical), patent foramen ovale (PFO) closure devices, cryotherapy catheters, vena cava filters, stents, stent-grafts, septostomy tools), and agent delivery devices (e.g., needles, cannulae, catheters, elongated members). Visualizing the three dimensional (3D) architecture of the heart, for example, on a real-time basis during intervention is highly desirable from a clinical perspective as it facilitates more complex procedures such as left atrial appendage occlusion, mitral valve repair, and ablation for atrial fibrillation.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZAINAB M ALDARRAJI whose telephone number is (571)272-8726. The examiner can normally be reached Monday-Thursday7AM-5PM EST.
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/ZAINAB MOHAMMED ALDARRAJI/ Patent Examiner, Art Unit 3797
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