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
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.
Claims 1-6, 9-14, 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bowman et al. (US 2018/0140315 A1).
Regarding claim 1, Bowman discloses a large bore catheter 200 comprising: a longitudinal axis (i.e., along 201); an elongate body 201 comprising a lumen, a proximal end (Fig. 3), and a distal end (Fig. 3); and a support frame (i.e., 203) at the distal end of the elongate body having a collapsed delivery configuration and an expanded deployed configuration (para. [0056]), the support frame comprising a framework of struts (i.e., each individual piece 203), the framework of struts comprising one or more hoop segments and at least one axial row of a plurality of deformable closed cells configured to assume an axially extended profile when the support frame is in the collapsed delivery configuration and expand to a radially extended profile when the support frame is in the expanded deployed configuration (see Fig. 3 reproduced below as well as paras. [0056]); wherein the expanded deployed configuration of the support frame is sized to have a larger inner diameter than an inner diameter of an outer sheath (Fig. 3 is expanded configuration, para. [0056] discloses the collapsed configuration when sheathed), and wherein in the collapsed delivery configuration the one or more hoop segments extend circumferentially between the at least one axial row of the plurality of deformable closed cells (Fig. 3 reproduced below) in a direction of a plane perpendicular to the at least one axial row of the plurality of deformable closed cells (see Fig. 2 reproduced below; note that although this is the expanded configuration, the same applies to the collapsed configuration).
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Regarding claim 2, Bowman discloses the catheter of claim 1. Bowman also discloses wherein the struts of the plurality of deformable closed cells comprise an angle with the longitudinal axis of less than 30 degrees in the collapsed delivery configuration (para. [0056] discloses that they would be sheathed in the collapsed configuration such that the angle would be less than 30 degrees. See also Fig. 3).
Regarding claim 3, Bowman discloses the catheter of claim 1. Bowman also discloses wherein the struts of the plurality of deformable closed cells comprise an angle with the longitudinal axis of greater than 45 degrees in the expanded deployed configuration (Fig. 3).
Regarding claim 4, Bowman discloses the catheter of claim 1. Bowman also discloses the support frame further comprising one axial row of deformable closed cells (Fig. 3 reproduced above).
Regarding claim 5, Bowman discloses the catheter of claim 1. Bowman also discloses the support frame further comprising two axial rows of deformable closed cells (i.e., each extending piece comprises at least one closed cell such that there are several rows when placed together as shown in Fig. 3; see for example embodiment of Fig. 9 which shows a similar architecture such that each branch in the background has a deformable closed cell).
Regarding claim 6, Bowman discloses the catheter of claim 1. Bowman also discloses wherein the plurality of deformable closed cells comprise less than 30% of a circumference of the support frame when the support frame is in the collapsed delivery configuration (i.e., at least since the connecting hoop members would comprise most if not all the circumference in the collapsed position as the extend outward of the closed cells).
Regarding claim 9, Bowman discloses the catheter of claim 1. Bowman also discloses wherein a difference between an inner diameter of the support frame in the expanded deployed configuration and an inner diameter of the support frame in the collapsed delivery configuration is more than 10% of the inner diameter in the collapsed delivery configuration (i.e., at least as evidenced by Fig. 3 in the expanded configuration compared to in a collapsed, sheathed position).
Regarding claim 10, Bowman discloses the catheter of claim 1. Bowman also discloses wherein the one or more hoop segments account for a percentage of a circumference of the support frame, the percentage being greater in the collapsed delivery configuration (i.e., at least since the hoops extend outward of the closed cells which are collapsed against the longitudinal axis) than the percentage in the expanded deployed configuration (i.e., which comprises most of the circumference (see e.g., Fig. 3)).
Regarding claim 11, Bowman discloses the catheter of claim 1. Bowman also discloses wherein the struts of the plurality of deformable closed cells comprise a first arc length in the collapsed delivery configuration that is less than a second arc length in the expanded deployed configuration (i.e., arc length would be compressed by a delivery catheter, expanded is as shown in Fig. 3).
Regarding claim 12, Bowman discloses the catheter of claim 1. Bowman also discloses the support frame further comprising one or more connecting spines 312 connecting the hoop segments of the support frame with the elongate body (para. [0065], Fig. 5).
Regarding claim 13, Bowman discloses the catheter of claim 1. Bowman also discloses the support frame further comprising a maximum outer diameter in the expanded deployed configuration that is less than an inner diameter of a target vessel at a treatment site (para. [0070]; i.e., at least by way of navigating in a vessel).
Regarding claim 14, Bowman discloses the catheter of claim 1. Bowman also discloses wherein the struts of the plurality of deformable closed cells form a cell angle with the longitudinal axis of greater than 70 degrees in the expanded deployed configuration (Fig. 3).
Regarding claim 21, Bowman discloses the catheter of claim 1. Bowman also discloses wherein the plurality of deformable closed cells are connected by the hoop segments (Fig. 3).
Regarding claim 22, Bowman discloses the method of claim 19. Bowman also discloses wherein the plurality of deformable closed cells are connected by the hoop segments (Fig. 3).
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 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Bowman.
Regarding claims 7 and 8, Bowman discloses the catheter of claim 1. Bowman does not directly disclose the support frame further comprising a longitudinal length sized to be less than three times an inner diameter of the elongate body; the support frame further comprising an inner diameter of approximately 0.070 inches in the collapsed delivery configuration and a maximum inner diameter in a range of approximately 0.080-0.120 inches in the expanded deployed configuration.
Bowman does disclose that in the collapsed position, the device is sheathed in a delivery device (para. [0056]) and as such the diameter and length need to be optimized to be easily deployed by the delivery device. As seen in Fig. 3, the device must also be expanded to substantially larger than the delivery device and each segment 306 must be deployed such that the diameter and the length are disclosed to be a result effective variable in that changing the length and diameter of the device changes how easily the device may be delivered through the delivery device. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Bowman device to have the required length and diameter, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Bowman by making the longitudinal length sized to be less than three times an inner diameter of the elongate body, the support frame further comprising an inner diameter of approximately 0.070 inches in the collapsed delivery configuration and a maximum inner diameter in a range of approximately 0.080-0.120 inches in the expanded deployed configuration as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 15, Bowman discloses the catheter of claim 1. Bowman also discloses wherein the struts of at least a portion of the support frame form a flare angle with the longitudinal axis, the flare angle configured to be approximately zero degrees in the collapsed delivery configuration (i.e., by virtue of being constrained by a delivery catheter) and approximately 90 degrees in the expanded deployed configuration (i.e., as shown in Fig. 3, it is approximately 90 degrees).
Response to Arguments
Applicant's arguments filed December 18, 2025 have been fully considered but they are not persuasive. Regarding Applicant’s argument that Bowman fails to disclose at least one axial row of a plurality of deformable cells, wherein the one or more hoop segments extend circumferentially between the at least one axial row of the plurality of deformable closed cells in a direction of a plane perpendicular to the at least one axial row of the plurality of deformable closed cells, Examiner disagrees. Applicant specifically argues that Bowman shows hoop segments that extend in a direction that is parallel to the longitudinal axis. Examiner agrees and notes that each of the plurality of deformable cells extend in a direction perpendicular to the longitudinal axis as shown in Fig. 2 reproduced above such that the hoop segment would extend between two separate rows of deformable cells in a direction perpendicular to the rows.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/SHAUN L DAVID/ Primary Examiner, Art Unit 3771