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 .
Election/Restrictions
Claims 1-9 & 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/21/2026. Claims being examined are group I: claims 10-15.
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.
Claim 10 is rejected under 35 U.S.C 102(a)(1) as being anticipated by Rafiee (US 20210212756) herein referred to as Rafiee.
Regarding claim 10, Rafiee discloses A basilica system for use in replacement heart valve implant procedures (Figure 1A), comprising: a delivery catheter (Figure 1A, 22); a first catheter slidably disposed within the delivery catheter (Figure 1A, 20); a second catheter slidably disposed within the delivery catheter (Figure 1A, 10); a conductive guidewire slidably disposed within the first catheter and configured to be electrically coupled to a source of RF energy (Paragraph [0017], [0019] & [0022]; wherein a conductive guidewire is slidably disposed in the first catheter 20 and is electrically couped to a radiofrequency power supply), the conductive guidewire including a distal end configured to puncture a leaflet of a replacement heart valve implant (Paragraph [0023]); and a snare shaft slidably disposed within a lumen of the second catheter (Paragraph [0018]), the snare shaft comprising a wire loop extending from a distal end of the snare shaft and configured to grasp the distal end of the conductive guidewire (Paragraph [0018]).
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 11-15 are rejected under 35 U.S.C 103 as being unpatentable over Rafiee in view of Pulugurtha et al. (US 20250177036) herein referred to as Pulugurtha.
Regarding Claim 11, Rafiee discloses the basilica system according to claim 10 wherein in a deployed configuration, the first catheter comprises a preformed recurve portion disposed proximal the distal tip (Figure 2A, 20), and an elongate portion extending proximally from the preformed recurve portion (Figure 2A, 20). However, Rafiee does not explicitly disclose wherein the first catheter comprises a side port disposed in the preformed recurve portion of the first catheter when the first catheter is in the deployed configuration.
Pulugurtha discloses a basilica system (Figure 1) wherein the first catheter comprises a side port disposed in the preformed recurve portion of the first catheter when the first catheter is in the deployed configuration (Figure 9; 762). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the first catheter taught by Rafiee to include a side port as taught by Pulugurtha. The motivation being to advance or retract the catheter via guidewire (Pulugurtha, Paragraph [0034]).
Regarding claim 12, Rafiee in view of Pulugurtha discloses the basilica system according to claim 11. Rafiee also discloses wherein the preformed recurve portion is shaped and configured to align with a cusp of the leaflet of the replacement heart valve implant (Paragraph [0031]; wherein deploying the first elongate inner body so that the distal end of the first elongate inner body curls around the edge of the patient's valve leaflet).
Regarding claim 13, Rafiee in view of Pulugurtha discloses the basilica system according to claim 11. Rafiee also discloses wherein in a deployed configuration, the second catheter includes a distal portion having a pre-shaped bend configured to orient a distal end of the second catheter towards the side port (Figure 1B; wherein with combination of the distal port taught by Pulugurtha in claim 11, the pre-shaped bend would be oriented towards the side port since it is on outer edge of the distal end of the catheter seen in Pulugurtha Figure 9).
Regarding claim 14, Rafiee in view of Pulugurtha discloses the basilica system according to claim 13. Rafiee discloses wherein when the first catheter is in the deployed configuration and the second catheter is in the deployed configuration (Figure 1B), distal advancement of the delivery catheter relative to the first catheter and the second catheter urges the distal end of the second catheter closer to the side port formed in the first catheter than to the distal tip of the first catheter (Paragraph [0031]; wherein distal advancement of the delivery catheter relative to the first catheter and the second catheter urges the distal end of the second catheter closer to the guidewire such that as taught by Pulugurtha above in claim 11, the guidewire comes out of the side port).
Regarding claim 15, Rafiee in view of Pulugurtha discloses the basilica system according to claim 14. Rafiee also discloses wherein when the distal end of the second catheter is in close proximity to the side port (Paragraph [0031]; wherein distal advancement of the delivery catheter relative to the first catheter and the second catheter urges the distal end of the second catheter closer to the guidewire such that as taught by Pulugurtha above in claim 11, the guidewire comes out of the side port), wherein conductive wire is directed towards the wire loop when the conductive wire is advanced distally relative to the first catheter (Paragraph [0031]). Pulugurtha also discloses the side port is configured to direct the conductive wire out (Paragraph [0063]). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the first catheter taught by Rafiee to include a side port as taught by Pulugurtha. The motivation being to advance or retract the catheter via guidewire (Pulugurtha, Paragraph [0034]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M PAPE whose telephone number is (703)756-5947. The examiner can normally be reached M-F 7:30-5:00.
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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