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 § 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mangiardi et al. (2004/0193243) in view Austen et al. (WO 2020/191400) and further in view of Tabor (US 2011/0251683).
Claim 1.
Catheter, guidewire, and adjustable exposed stent length:
E.G. Mangiardi discloses catheter apparatus 10 advanced over guidewire 12, with a stent constrained by tubular member 50 and progressively exposed for expansion by withdrawing member 50 relative to inner member 30 ([0132]-[0139])).
Adjustment-tube passage and connected guide tip.
E.G. Mangiardi’s inner member 30 defines lumen 32 receiving guidewire 12; attached distal tip 60 defines communicating passage 68 ([0134]-[0135]).
Note: Member 30 corresponds to the claimed adjustment tube.
Photosensitizer coating and laser activation:
E.G. Austen teaches applying photosensitizer to an expandable device and illuminating the treatment region using an optical fiber, including laser illumination after expansion ([0052], [0084]-[0085], [0102]).
It would have been obvious to provide Mangiardi’s stent with Austen’s photosensitizer and laser-delivery arrangement to provide localized photodynamic treatment.
Moveable optical fiber:
E.G. Austen expressly teaches inserting and positioning an optical fiber within an already inflated balloon and replacing a guidewire with the fiber ([0102], [0104]). These teachings support providing a catheter passage accommodating successive guidewire and optical-fiber insertion.
Three-tube arrangement:
E.G. Tabor teaches inner shaft assembly 44, delivery sheath assembly 42 comprising shaft 60/capsule 50, and outer stability tube 52, corresponding respectively to the adjustment, moving, and support tubes ([0037]-[0049]).
Radial order and relative movement:
E.G. Tabor expressly places sheath assembly 42 coaxially and slidably between inner assembly 44 and stability tube 52 ([0066]; Fig. 7), establishing the claimed inside-to-outside order.
Stent accommodation and expansion-length adjustment:
E.G. Tabor discloses capsule 50 contains the stent and retracts to permit expansion ([0039]-[0045], [0066], [0072]).
Support relationship:
E.G. Tabor discloses inner assembly 44 and outer assembly 46 are fixed to common housing 180 ([0066]-[0069]).
It would have been obvious to incorporate Tabor’s outer stability tube around Mangiardi’s moveable sheath to isolate deployment from introducer friction, reduce kinking, and limit unintended stent displacement while preserving sheath withdrawal ([0073]-[0074]).
Claim 4.
Expansion length adjusted in proportion to moving-tube travel:
E.G. Tabor teaches that shaft 60 transmits axial movement to capsule 50, with sheath travel selected according to stent length; partial withdrawal exposes a corresponding portion for expansion ([0040], [0066], [0079]; Figs. 5A-5B, 11B).
Using this controlled withdrawal in the combined apparatus would predictably permit selection of the exposed treatment length by controlling sheath travel.
Claim 5.
Stent compressed between adjustment and moving tubes:
E.G. Tabor places the compressed stent over inner assembly 44, including tube 92, and which capsule 50 of sheath assembly 42 ([0041]-[0045], [0072]; Fig. 5A).
Expansion upon release of pressure:
E.G. The self-expanding stent returns toward its normal expanded configuration when the capsule’s compressive restraint withdrawn ([0032]-[0034], [0045]).
Incorporating this disclosed loading arrangement would maintain a reduced delivery profile and permit controlled self-expansion at the treatment site.
Claim 6.
Read end fixed the catheter:
E.G. Tabor’s hub 94 includes fingers 112 and flange 114 that capture the proximal stent end and impede axial movement while constrained [0045].
Front end free:
E.G. During partial deployment, the distal region expands while the proximal region remains capture by the inner assembly ([0079]; Fig. 11B).
Note: Based on the broadest reasonable interpretation the “free end” alternative satisfies the front-end limitation. “Fixed” can encompass releasable securement if consistent with the specification.
Retaining the proximal end during partial expansion permits position assessment and recapture before final release.
Claim 7.
Cylindrical mesh stent:
E.G. Tabor describes tubular stent frames formed from struts or wire portions and expressly identifies a cylindrical expanded configuration ([0032]-[0036]; Figs. 2A-2B).
Compressed around the adjustment tube, inside the moving tube:
E.G. The frame is crimped over inner assembly 44 and compressively contained within capsule 50 ([0044]-[0045], [0072]).
Note: A tubular open-cell framework supports “cylindrical mesh” where the specification does not require woven or braided construction. Using that frame provides the disclosed combination of compressibility and radial support.
Claim 8.
Pusher connected to the moving tube’s read end:
E.G. Tabor’s user-interface body 260 connects through sheath connector body 200 and mounting boss 300 to proximal shaft end 66 ([0055], [0060], [0064], [0067]).
Pull action releases the stent:
E.G. Sliding body 260 proximally retracts sheath assembly 42; capsule withdrawal releases the compressed stent for expansion ([0070], [0072]).
Push action restores compression:
E.G. moving body 260 forward advances the sheath; before complete deployment, capsule 50 can advance back over the stent for repositioning ([0070], [0072]).
Incorporating this bidirectional actuator permits controlled deployment and recapture to correct treatment-site positioning. The claimed “pusher” performs both actions.
Claim 9.
Specified photosensitizer:
E.G. Austen expressly identifies methylene blue and Toluidine Blue as photosensitizers applied to the expandable device [0052].
Selecting either expressly disclosed agent for the combined apparatus would provide Austen’s light-activated treatment function. Because claim 9 requires “one or more,” establishing either listed agent satisfies the added limitation; all four are unnecessary.
Response to Arguments
Applicant's arguments filed July 23, 2026 have been fully considered but they are not persuasive:
Regarding the rejection under 35 U.S.C. §112(b), the amendment replacing “a length thereof” with “a length of the stent” resolves the previously identified ambiguity. Accordingly, the rejection based on that ambiguity is withdrawn.
Regarding the rejection under 35 U.S.C. §103, Applicant argues that Mangiardi and Austen fail to teach the claimed three-tube arrangement. In view of the amendments and arguments, the rejection has been revised to additionally apply Tabor. Tabor expressly disclosed delivery sheath assembly 42 coaxially and slidably disposed between inner shaft assembly 44 and outer stability tube 52, corresponding respectively to the claimed moving tube, adjustment tube, and support tube ([0066]; Fig. 7). Tabor further discloses lumen 86 receiving a guidewire and distal tip 90 connected to the inner tubular structure ([0041]-[0044]). Thus, Tabor supplies the radial arrangement not established by the previous rejection.
Applicant further argues that Austen does not teach movement of the optical fiber after expansion of the treatment device. This argument is not persuasive as to Austen’s disclosure. Paragraph [00102] expressly describes inserting and positioning an optical fiber within an already inflated balloon, and paragraph [0044]-[0045] disclose a light-emission point and corresponding sheath window located approximately at the axial midpoint of the expandable device, while paragraph [0049] describes centering the light source within the expandable device. These disclosures support post-expansion fiber positioning and central illumination, although their incorporation into the claimed stent apparatus requires the modification identified in the revised rejection.
Regarding Applicant’s assertion of impermissible hindsight, the proposed combination is based on benefits expressly identified in the references. Austen teaches localized treatment through photosensitizer activation and controlled light delivery, whereas Tabor teaches isolating the delivery sheath from introducer friction and reducing kinking and unintended displacement during deployment (Austen, [0043]-[0049], [0052]; Tabor; [0073]-[0074]). These teachings provide reasons, independent of Applicant’s disclosure, for incorporating the respective treatment and stabilization features into Mangiardi’s delivery apparatus.
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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Savage et al. (US 2011/0245917) discloses partial deployment and recapture of a self-expanding stented prosthesis. Vazales et al. (WO 2011/126812) discloses multiple tubular structures and catheter-based photodynamic treatment. Hunt et al. (US 2008/0004686) discloses intraluminal light delivery through an implant for activation of a surface-applied material.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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