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 . Claims 1-17 are pending examination below.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6 and 11-15 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US 2021/0008345 A1 (hereinafter, " Edminster ").
In regards to claim 1, Edminster teaches a system (para 0002) for positioning an intraluminal device (para 0027, treating tool) comprising: (a) a catheter (Fig. 1, steerable guide catheter, 10, para 0028) having an elongated catheter body (Fig. 1, guide tube, 12, para 0028), said elongated catheter body having a distal portion configured for delivering the intraluminal device and including a catheter tube having a wire spanning a length thereof (Fig. 2A/B, tensioning lines, 20, para 0028-0029); and (b) a handle (Fig. 1, handle, 40, para 0028) attached to said elongated catheter body and having at least one steering mechanism (para 0028, discloses steering mechanism in handle, 40) configured for pushing said catheter tube in a distal direction (para 0017); thereby steering said distal portion of said elongated catheter body and positioning the intraluminal device for delivery (para 0027, treating tool).
In regards to claim 2, Edminster further teaches, wherein said at least one steering mechanism (para 0028) is also configured for pulling said wire (Fig. 1, tensioning lines, 20, para 0017 and 0028) in a proximal direction (para 0017, teaches proximal end connection of tension line would generate pulling force).
In regards to claim 3, Edminster further teaches, wherein a first end of said wire (Fig. 2A, tensioning lines, 20, in combination with guide tube, 12b, para 0029) is attached to a distal end of said catheter tube (Fig. 1 and 2A, guide tube, 12, para 0017 and 0029) and further wherein said second end of said wire is attached to said at least one steering mechanism (Fig. 2A, para 0028-0029).
In regards to claim 4, Edminster further teaches, wherein said at least one steering mechanism (para 0028) includes a first translatable element (Fig. 1, front actuator, 18, para 0028) attached to said second end of said wire (Fig. 1, tensioning lines, 20, para 0028) and a second translatable element (Fig. 1, proximal actuator, 19, para 0028) attached to a proximal portion of said catheter tube (Fig. 1, guide tube, 12, para 0028).
In regards to claim 5, Edminster further teaches, wherein at least one steering mechanism (para 0028, located in handle 40) further includes a rotatable knob (Fig. 5, arrows C and D, para 0028) for translating said first and said second translatable elements (Fig. 5, actuators, para 0028) in opposite directions (para 0028).
In regards to claim 11, Edminster discloses a method (para 002 and 0013) of positioning an intraluminal device (para 0027, treating tool), in a lumen of a vessel comprising para 0025): (a) advancing into the lumen of a vessel a catheter (guide catheter, 10, para 0030-0031) having an elongated catheter body (guide tube, 12, para 0030) having a distal portion carrying the intraluminal device (para 0027, treating tool, introduced about guide catheter, 10), said elongated catheter body including a catheter tube (guide tube, 12, para 0030) having a wire spanning a length thereof (Fig. 2A/B, tensioning lines, 20, para 0028-0029); and (b) steering said distal portion of elongated catheter body via at least one steering mechanism (para 0028, discloses steering mechanism in handle, 40) configured for pushing said catheter tube in a distal direction (para 0017); thereby positioning the intraluminal device for delivery (para 0027, treating tool).
In regards to claim 12, Edminster further teaches wherein (b) is also carried out by pulling said wire ( (Fig. 1, tensioning lines, 20, para 0017 and 0028) in a proximal direction (para 0017, teaches proximal end connection of tension line would generate pulling force).
In regards to claim 13, Edminster further teaches, wherein a first end of said wire (Fig. 2A, tensioning lines, 20, in combination with guide tube, 12b, para 0029) is attached to a distal end of said catheter tube (Fig. 1 and 2A, guide tube, 12, para 0017 and 0029) and further wherein said second end of said wire is attached to said at least one steering mechanism (Fig. 2A, para 0028-0029).
In regards to claim 14, Edminster further teaches, wherein said at least one steering mechanism (para 0028) includes a first translatable element (Fig. 1, front actuator, 18, para 0028) attached to said second end of said wire (Fig. 1, tensioning lines, 20, para 0028) and a second translatable element (Fig. 1, proximal actuator, 19, para 0028) attached to a proximal portion of said catheter tube (Fig. 1, guide tube, 12, para 0028).
In regards to claim 15, Edminster further teaches, wherein at least one steering mechanism (para 0028, located in handle 40) further includes a rotatable knob (Fig. 5, arrows C and D, para 0028) for translating said first and said second translatable elements (Fig. 5, actuators, para 0028) in opposite directions (para 0028).
Claim Rejections - 35 USC § 103
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 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 6-10 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Edminster in view of US 2020/0281720 A1 (hereinafter, "Jackson").
In regards to claim 6, Edminster teaches the system (para 0002) of claim 1, with an elongated catheter body (Fig. 1, guide tube, 12, para 0028). However it does not explicitly teach the system further comprising a sheath covering a distal portion of the elongated catheter body.
Jackson in a similar field of endeavor teaches a system with an intraluminal device (Fig. 13, mitral valve, 1165, para 0092) further comprising a sheath (Fig. 11, sheath catheter, 1109, para 0083) covering a distal portion of said elongated catheter body (Fig. 11, delivery apparatus, 1124, par 0081). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the system of Edminster with the sheath of Jackson to allow the device to be constrained during the delivery process and self-expand to the expanded configuration upon delivery. (Jackson, para 0079).
In regards to claim 7, Edminster further teaches a handle (Fig. 1, handle, 40, para 0028). However Edminster is silent to the handle including a sheath retraction mechanism. Jackson further teaches wherein said handle (Fig. 12, handle section, 1103 and 1102, para 0087) includes a sheath retraction mechanism (Fig. 12, para 0087, teaches retracting the sheath from the sheath catheter, 1109). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the system and handle of Edminster with the sheath retraction of Jackson to effectively advance the catheter and retract the sheath upon deployment (Jackson, para 0087).
In regards to claim 8, Edminster teaches the system (para 0002) of claim 1, with an elongated catheter body (Fig. 1, guide tube, 12, para 0028). However it does not explicitly teach the system further comprising a nose cone at the distal end of the catheter body. Jackson further teaches the delivery apparatus further comprising a nose cone (Fig. 15A, flexible tip, 1110, para 0093). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the system of Edminster with the nose cone of Jackson to allow the delivery apparatus to penetrate the apex of the heart (Jackson, para 0081).
In regards to claim 9, Edminster further teaches a handle (Fig. 1, handle, 40, para 0028). However Edminster is silent to the handle including a nose cone extension mechanism. Jackson further teaches a handle (Fig. 12, handle section, 1103 and 1102, para 0087) includes a nose cone (Fig. 15A, flexible tip, 1110, para 0093) extension mechanism (para 0106. Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the system and handle of Edminster with the nose cone extension mechanism of Jackson in order to deploy the intraluminal device and release from the loaded constrained configuration (Jackson, para 0107-0110).
In regards to claim 10, Edminster teaches the system (para 0002) and intraluminal device (para 0027, treating tool). However Edminster is silent to the system where in the proximal portion of the intraluminal device is covered by said sheath and a distal portion is covered by the nose cone. Jackson further teaches the system comprising the intraluminal device (Fig. 13, mitral valve, 1165, para 0092), wherein a proximal portion of the intraluminal device is covered by said sheath (Fig. 13, sheath catheter, 1109, para 0092) and a distal portion of the intraluminal device is covered by said nose cone (Fig. 13, nose catheter, 1121, para 0092). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the system of Edminster to capture and secure the intraluminal device before advancement and allow for it to be more easily introduced. (Jackson, para 0092-0093).
In regards to claim 16, Edminster teaches a method (para 0002 and 0013). However Edminster does not explicitly teach wherein a proximal portion of the intraluminal device is covered by a sheath and distal portion of the intraluminal device is covered by a nose cone. Jackson further teaches wherein a proximal portion of the intraluminal device (Fig. 13, mitral valve, 1165, para 0092 is covered by a sheath (Fig. 13, sheath catheter, 1109, para 0092 and a distal portion of the intraluminal device is covered by a nose cone (Fig. 13, nose catheter, 1121, para 0092).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the method of Edminster to capture and secure the intraluminal device before advancement and allow for it to be more easily introduced. (Jackson, para 0092-0093).
In regards to claim 17, Edminster teaches a method (para 0002 and 0013). However it does not explicitly teach the method, further comprising advancing said nose cone and retracting said sheath to thereby expose the intraluminal device for delivery. Jackson further teaches a method ( for advancing said nose cone (Fig. 15A, flexible tip, 1110, para 0093) and retracting said sheath (Fig. 23C, outer sheath, 2214a and mitral valve, 2319, para 0121) to thereby expose the intraluminal device for said delivery (para 0119-0121).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the method of Edminster to include the nose cone and advancement of Jackson to deploy the intraluminal device and release from the loaded constrained configuration (Jackson, para 0107-0110).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 5,906,590 (hereinafter, "Hunjan") also teaches positioning an intraluminal device (Fig. 1, TAVR device, 30, para 0020), in a lumen of a vessel comprising (Fig. 3, para 0021): (a) advancing into the lumen of a vessel a catheter (Fig. 1, delivery catheter, 32, para 0020 see also Fig. 3, steerable delivery catheter, 50, para 0021) having an elongated catheter body (Fig. 1/3, delivery catheter, 32 and 50, para 0020-0021) having a distal portion carrying the intraluminal device (Fig. 1/3), said elongated catheter body including a catheter tube having a wire spanning a length thereof (para 0024, teaches delivery catheter, 50, has one or more push/pull wires); and (b) steering said distal portion of elongated catheter body via at least one steering mechanism (Fig. 1, slide actuatable handle, 12, col. 4 line 66- col 5, line 5 from US 5,906,590 incorporated by reference) configured for pushing said catheter tube in a distal direction; thereby positioning the intraluminal device for delivery (para 0024-0026, teaches delivery catheter, 50, has one or more push/pull wires).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JICHELE MONIQUE SANDERS whose telephone number is (571)272-2240. The examiner can normally be reached M-Thu 6:30-5:15.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.M.S./Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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