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 .
Notice of Amendment
The Amendment filed 7/17/2026 has been entered. Claims 1-10 are pending in the application with claims 1 amended, claims 11-20 withdrawn.
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)(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 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saadat et al. (US Patent Application Publication No. 2005/0065397, hereinafter Saadat).
In regard to claim 1, Saadat discloses a retroflexion device (30, Fig. 1) for retroflexing a flexible elongate member (34,36) of a medical device (40, Figs. 2,6), said retroflexion device comprising:
a distal mount (distal tip of bending section (34)) configured to be mounted with respect to the distal end of the flexible elongate member (Fig. 2 illustrates tool (48) mounted to the tip of the bending section (34));
a pivot mount (distal end of shaft (36)) configured to be mounted with respect to the flexible elongate member proximal to the distal mount (Figs. 1-2 illustrate the shaft (46) of the medical device disposed within the (36)); and
an elongated actuation component (96) having a proximal end and a distal end with a length extended therebetween selected to extend along the length of the flexible elongate member (Figs. 1, 11,12A,12B);
wherein:
a proximal end of said actuation component is controllable along a proximal end of the flexible elongate member (via steering cuff (35), Fig. 1);
a distal end of said actuation component is operatively associated with a distal end of the flexible elongate member via said distal mount (Figs. 12A,12B); and
an actuation region of said actuation component pivots with respect to said pivot mount when said actuation component is pulled proximally to cause the flexible elongate member to retroflex beyond 90° from its initial direction (Figs. 6, 12A,12B).
In regard to claim 2, Saadat teaches further comprising a flexible tubular elongate member (34) having at least one lumen extending therethrough through which said actuation component extends (Figs. 27A,27B illustrate lumens through which pull wires (96) extend).
In regard to claim 3, Saadat teaches wherein said flexible tubular elongate member is configured to be mounted along the flexible elongate member (the flexible elongate member is disposed within the flexible tubular elongate member, Figs. 27A,27B).
In regard to claim 4, Saadat teaches wherein:
said flexible tubular elongate member has a proximal end and a distal end defining a length therebetween selected to be less than the length of the flexible elongate member (Fig. 2);
said flexible tubular elongate member is configured to be mounted with respect to the flexible elongate member with the distal end of the flexible tubular elongate member proximal to the distal end of the flexible elongate member (Fig. 2); and
the distal end of said flexible tubular elongate member forms said pivot mount for said actuation component (the distal end of flexible tubular elongate member (34) is considered the pivot mount since the bending section (36) pivots with respect to the pivot mount).
In regard to claim 5, Saadat teaches wherein said flexible tubular elongate member has more than one lumen extending therethrough to allow additional devices to be extended through said flexible tubular elongate member (via a plurality of pull wires lumens and central lumen for insertion of an instrument therethrough, Figs. 27A-27B).
In regard to claim 6, Saadat teaches wherein:
said flexible tubular elongate member has a proximal end and a distal end; and said retroflexion device further comprises a proximal mount (35) provided along the proximal end of said flexible tubular elongate member (Figs. 25A-25B); and the proximal end of said actuation component is operatively associated with said proximal mount (manipulation of the proximal mount (35) causes corresponding actuation of the actuation components).
In regard to claim 7, Saadat teaches further comprising a proximal mount (35), the proximal end of said actuation component being operatively associated with said proximal mount (Figs. 1, 27A,27B).
In regard to claim 8, Saadat teaches further comprising a pull handle (44) on the proximal end of said actuation component (Figs. 1, 27A,27B).
In regard to claim 9, Saadat teaches wherein said proximal mount includes a pull handle mount (44, Figs. 1,27A,27B).
In regard to claim 10, Saadat teaches further comprising a locking system (170) mounted on said proximal mount and configured to temporarily retain said actuation component under tension to retroflex said flexible elongate member (Par. 107, Figs. 25A-25B).
Response to Arguments
Applicant’s arguments with respect to claims 1-10 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 August 27, 2026
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