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 Objections
Claim 3 is objected to because of the following informalities:
In line 4 of claim 3, “cover” should be deleted.
Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1, 2, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Tully et al. (US 2012/0253471) in view of DeGraaf et al. (US 2018/0161557).
Regarding claim 1, Tully et al. disclose a stent graft delivery system (300; Figures 11-23) comprising: an inner lumen (lumen of 310) including an elongate inner lumen body (310) and an inner lumen tip (312) at a distal longitudinal end of the inner lumen body; a stent graft (200; ¶[0040]) positionable over the inner lumen (Figure 19); a stent graft cover (304) slidably positionable over the stent graft (¶[0050]) and the inner lumen, the stent graft cover configured to retract proximally to expose a longitudinal portion of the stent graft (¶[0050]), the stent graft cover including an elongate cover body having a distal longitudinal end (where it meets 306 - Figure 11); and a stent graft cutter (326) coupled to the inner lumen tip and configured to circumferentially cut the stent graft and shorten the length of the stent graft to a desired length (¶[0059]).
Tully et al. fail to disclose that the cutter is a thermal cutter configured to selectively generate and direct heat from inner lumen tip to cut the stent graft as claimed.
DeGraaf et al. disclose a stent cutter (416) for cutting a stent (408), using a shearing action similar to Tully et al. (¶[0059], [0060]; Figures 4A-4E). DeGraaf et al. further teach that a heated blade is a suitable alternative to a mechanical cutting blade (¶[0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of DeGraaf et al. to have provided the stent graft cutter of Tully et al. as a heated blade or thermal stent graft cutter as claimed since one skilled in the art would recognize that the addition of heat to the cutter could potentially enhance the cutting action of the stent graft cutter.
Regarding claim 2, the longitudinal portion of the stent graft exposed outside the stent graft cover is configured to radially expand (¶[0050] of Tully et al.).
Regarding claim 9, Tully et al. disclose a method of delivering a stent graft to a treatment site within a subject, the method comprising: inserting an assembled stent graft delivery system (300; Figures 11-23) into a lumen of a subject (¶[0048]-[0049]), wherein the assembled stent graft delivery system comprises: an inner lumen (lumen of 310) including an elongate inner lumen body (310) and an inner lumen tip (312) at a distal longitudinal end of the inner lumen body; a stent graft (200; ¶[0040]) disposed over the inner lumen; a stent graft cover (304) slidably positionable over the stent graft and the inner lumen (¶[0050]); and a stent graft cutter (326) coupled to the inner lumen tip; retracting the stent graft cover to expose a longitudinal portion of the stent graft (¶[0050]-[0056]); activating the stent graft cutter to cut the stent graft outside the stent graft cover and shorten the length of the stent graft to a desired length (¶[0057]).
Tully et al. fail to the cutter is a thermal cutter which generates and directs heat to circumferentially cut the stent graft as claimed.
DeGraaf et al. disclose a stent cutter (416) for cutting a stent (408), using a shearing action similar to Tully et al. (¶[0059], [0060]; Figures 4A-4E). DeGraaf et al. further teach that a heated blade is a suitable alternative to a mechanical cutting blade (¶[0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of DeGraaf et al. to have provided the stent graft cutter of Tully et al. as a heated blade or thermal stent graft cutter and to have used heat as claimed since one skilled in the art would recognize that the addition of heat to the cutter could potentially enhance the cutting action of the stent graft cutter.
Regarding claim 10, retracting the stent graft cover to expose a longitudinal portion of the stent graft causes the longitudinal portion of the stent graft exposed outside the stent graft cover to radially expand (¶[0050] of Tully et al.).
Claims 3, 4 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Tully et al. (US 2012/0253471) in view of DeGraaf et al. (US 2018/0161557), as applied to claim 2 above, and further in view of Chew et al. (US 2003/0135266).
Regarding claims 3, 11 and 12, Tully et al. disclose retracting the inner lumen through the expanded longitudinal portion of the stent graft exposed outside the stent graft cover to a retracted position in which a circumferential portion of the stent graft cover is sandwiched between the thermal stent graft cutter on the inner lumen tip and the stent graft cover (¶[0057]; 314 being part of the cover).
Tully fails to disclose that the stent graft cover is sandwiched between the thermal stent graft cutter and a distal longitudinal end of the stent graft cover.
Chew et al. disclose that a stent graft can be cut using a shearing action between a inner lumen tip (132) and a distal longitudinal end (at 136) of a stent graft cover (126; ¶[0069]; Figure 9B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Chew et al. to have provided member 314 of Tully et al. at the distal longitudinal end of the cover since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 4, the inner lumen tip includes a proximally-facing shoulder (the tip is a proximally facing shoulder of 310 - Figure 25 of Tully et al.), wherein the thermal stent graft cutter is coupled to the proximally-facing shoulder.
Regarding claim 13, Tully et al. disclose pressing the sandwiched circumferential portion of the stent graft against the thermal stent graft cutter with the proximally-facing shoulder of the inner lumen tip (¶[0057]).
Claims 5-7, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Tully et al. (US 2012/0253471) in view of DeGraaf et al. (US 2018/0161557) and Chew et al. (US 2003/0135266), as applied to claim 3 above, and further in view of Andreas et al. (US 2007/0265637).
Regarding claims 5 and 14, Tully et al. fail to disclose a safety system and detecting a parameter as claimed.
Andreas et al. disclose a stent graft delivery system (Figures 1 and 9-11) and further disclose a sensor (210, 220 or 230) configured to detect a parameter relating to a relationship between a tip and the distal longitudinal end of a stent graft cover (25; via signaling how far the stent graft cover has been retracted which is a direct indication of its position relative to the tip) in order to allow determination of how much of the stent graft has been exposed by retraction of the stent graft cover (¶[0101]-[0108]).
Since Tully et al. need to know a specific location of the stent graft cover relative to the stent graft prior to cutting (¶[0050]-[0056] of Tully et al.) it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have adapted the sensor system of Andreas et al. to determine an amount of retraction of the longitudinal end of the Tully et al. stent graft cover (and therefore its distance relative to the inner lumen tip). Such a modification would also allow a determination of whether the stent graft material is properly located between the inner lumen tip and the distal longitudinal end of the stent graft cover.
Regarding claims 6 and 15, the sensor is coupled to at least one of the inner lumen tip and the stent graft cover (¶[0110 of Andreas et al.).
Regarding claim 7, the safety system further includes a controller (205 of Andreas et al.) in communication with the sensor, wherein the controller is configured to receive the signal from the sensor and determine a position of the stent graft cover based on the received signal (¶[0107] of Andreas et al.) which would be a necessary part of determining whether the stent graft is suitably sandwiched between the inner lumen tip and the distal longitudinal end of the stent graft cover.
Allowable Subject Matter
Claims 8, 16 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Dinger et al. (US 2002/0128672) disclose a distal tip (40; Figures 13, 14 and 22) having a thermal cutter (18) for cutting a graft (10; ¶[0041]).
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771