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
Applicant’s election without traverse of Group I and Species A in the reply filed on 02/05/2026 is acknowledged. Claims 14-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II and III, there being no allowable generic or linking claim. Applicant further indicates that Claims 1-13 are drawn to elected Species A. However, it is the examiners position that only claims 1-11 are drawn to elected Species A. The limitations of claims 12 and 13 recite features of Species B, particularly the third outer sheath ([0047-0048] of specification of the present invention disclose these limitations pertain to the embodiment of FIGs 7-9, which is nonelected Species B). Therefore, claims 12 and 13 are withdrawn from further consideration at this time.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 recites “the catheter is advanced to deploy the first stent and then retracted to deploy the second stent” in lines 3-4. The claims are drawn to an apparatus but “is advanced” and “is retracted” appears to recite method steps of using the device. Examiner suggests amending the claim to recite “the catheter is configured to be advanced to deploy the first stent and then retracted to deploy the second stent”.
Appropriate correction is required.
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.
Claim(s) 1-5, 7, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Karpiel (US 2007/0067013).
Regarding claim 1, Karpiel discloses a stent delivery system (FIG 1, [0030] and [0030-0031] and [0060-0062]. Examiner notes that FIGs 10-11 illustrate a different method of using the device, but the embodiment of the device itself is the same), comprising: a first outer sheath (20, FIG 1, 4-6) configured to surround a first stent (16, FIG 1, 6 and 11, [0030-0033]); and a second outer sheath (24) configured to surround a second stent (22, FIG 1, 9 and 10, [0030-0033]).
Regarding claim 2, Karpiel discloses the stent delivery system is configured to deploy the first stent and the second stent by deploying the first stent (FIG 5, [0055]), then retracting the first outer sheath while the second stent remains within the second outer sheath (FIGs 6-7, [0056-0057]), then deploying the second stent (FIG 8, [0058]), and then retracting the second outer sheath (FIG 9, [0059]).
Regarding claim 3, Karpiel discloses the first stent and the second stent (Examiner notes that as written, the first and second stent are not positively recited elements of the claim and therefore the following limitations recited an intended use of the device) are deployed via a single vascular access site (Both are deployed over guidewire 50 and contained by the same introducer apparatus 10, which is understood to constitute a single vascular access site, [0052]).
Regarding claim 4, Karpiel discloses the first stent and the second stent (Examiner notes that as written, the first and second stent are not positively recited elements of the claim and therefore the following limitations recited an intended use of the device) are deployed via a single catheter insertion (FIG 1-2, wherein 10 forms the single catheter which introduces both stents, [0050-0053]).
Regarding claim 5, Karpiel discloses he first stent is offset from the second stent (Examiner notes that as written, the first and second stent are not positively recited elements of the claim and therefore the following limitations recited an intended use of the device)along an axis of the second outer sheath before the first stent is deployed (FIG 1).
Regarding claim 7, Karpiel discloses an inner support shaft (50) that runs through the first outer sheath and the second outer sheath (FIG 1-2).
Regarding claim 8, Karpiel discloses a drive system that separately retracts the first outer sheath and the second outer sheath (52 and 58 are independently operable to retract the first and second outer sheath, [0043-0046]).
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.
Claim(s) 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Karpiel (US 2007/0067013) in view of Ringwala et al. (US 2021/0137715).
Regarding claim 6, Karpiel discloses the invention substantially as claimed, as set forth above for claim 1.
Karpiel is silent regarding a catheter that comprises the first stent, the first outer sheath, the second stent, and the second outer sheath, wherein the catheter is advanced to deploy the first stent and then retracted to deploy the second stent.
However, Ringwala et al. teaches in the same field of endeavor a stent delivery device (FIGs 6-7. [0068-0072]) for deploying a stent (120) and being delivered over a guidewire ([0068]) wherein the system further comprises a catheter (158) which houses the elements of the delivery system (FIG 6) and is advanced to position the stent and retracted to deploy the stent ([0068-0069]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the system Karpiel to further comprise a catheter surrounding and comprising the other elements of the delivery system, as taught by Ringwala, for the purpose of providing a guide catheter to be advanced over the guidewire to the delivery site prior to placement of the remainder of the delivery system, for the purpose of using a commonly known delivery mechanism for accessing the desired treatment site via guidewire to ensure proper placement prior to deployment of the stent. In the device as modified, the catheter comprises the first stent, the first outer sheath, the second stent, and the second outer sheath as required by the claim because each of these elements are introduced through the catheter to the treatment site.
Regarding claim 9, Karpiel discloses the invention substantially as claimed, as set forth above for claim 8.
Karpiel is silent regarding a handle that includes a first thumbwheel and a second thumbwheel, wherein the drive system comprises the first thumbwheel and the second thumbwheel, the first thumbwheel is configured to retract the first outer sheath, and the second thumbwheel is configured to retract the second outer sheath.
However, Ringwala et al. teaches in the same field of endeavor a stent delivery device (FIGs 6-7. [0068-0072]) having a drive system (FIG 15, [0085]) configured to separately retract a first outer sheath (155) and a second elongate member (152), the device comprising a handle (180 and 160, FIG 15) that includes a first thumbwheel (162 on handle 160) and a second thumbwheel (162 on handle 180), wherein the drive system comprises the first thumbwheel and the second thumbwheel (Thes elements are a part of the drive system which separately controls first and second sheaths 152, 150), where first thumbwheel is configured to retract the first outer sheath ([0085]) and the second thumbwheel is configured to retract the second outer sheath ([0085]). Ringwala further discloses in [0086] that “Any of the previously described handles can be manually driven via a thumbwheel or similar mechanism”, demonstrating that the thumbwheel is a commonly known mechanism for controlling retraction and extension of shafts.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the push pull handle mechanism taught by Karpiel to instead be a first and second thumbwheel used on control retraction of the first and second outer sheaths, as taught by Ringwala, for the purpose of substituting a commonly known handle member for stent delivery devices to achieve the predictable result of reliably and separately controlling the retraction of a first and second sheath.
Claim(s) 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Karpiel (US 2007/0067013) in view of Bourang (US 2014/0100647).
Regarding claims 10 and 11, Karpiel discloses the invention substantially as claimed, as set forth above for claim 1. Karpiel further discloses the second outer sheath is disposed around the second stent prior to deployment (FIG 1)
Karpiel is silent regarding the first stent being crimped over the second outer sheath and wherein the second outer sheath is disposed within the first stent prior to deployment such that a second diameter of the second outer sheath around the second stent is larger than a first diameter of the second outer sheath within the first stent. Karpiel instead shows a configuration where the second outer sheath is disposed around the first stent prior to deployment.
However, Bourang teaches a stent delivery system (500, FIG 5A-5B) for deploying a first stent (508, [0121]) and a second stent (542, [0122]), a first outer sheath (524) configured to surround the first stent (524 has a lumen 526 that is sized to receive both 504 and 532, and it is understood that the stents are passed through the lumen as well in order to form the assembled state of FIG 5B), wherein the second stent is associated with a second sheath (530) and the first stent is crimped over the second sheath (FIG 5B, [0121]) and wherein the second sheath is disposed within the first stent prior to deployment (FIG 5B, [0121-0122]). Bourang further shows second sheath having a narrowed diameter at the portion which passes through stent 508 relative to the portion which engages second stent 542. Bourang also teaches that “while the stents disclosed herein are preferably balloon expandable, one of skill in the art will appreciate that self-expanding stents may also be used” [0194]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the second outer sheath of Karpiel such that proximal to the second stent, the shaft passes through the inside of at least a portion of the first stent such that the first stent is crimped over the second outer sheath, as taught by Bourang, instead of passing radially outward over the first stent, for the purpose of substituting one commonly known arrangement for another and achieving the predictable result of delivering two stents in an axially offset configuration using one delivery system. In the device as modified, it is understood that the distal portion of the second outer sheath would keep its same diameter shown in FIG 1 of Karpiel but have a smaller diameter as it passes through the interior of the first stent, as shown in Bourang, in order to maintain a uniform and reduced delivery profile.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771