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 Invention I in the reply filed on August 11th 2026 is acknowledged. Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 102
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, 2, 4-7, 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bar et al. (US 2016/0096308).
Regarding claim 1, Bar et al. disclose a method for forming a protective balloon configuration for stent delivery, comprising: providing a stent delivery system comprising a first elongate shaft (85; Figure 1) and a first radially expandable member (75) disposed on a distal portion of the first elongate shaft; inserting the first radially expandable member into a cavity (30 or interior of 20) in a mold (10 or 15 or 20 can be considered as a mold); applying heat and pressure to the first radially expandable member while disposed in the cavity in the mold to form a shape memory portion comprising a first bulbous region (“pillow” - ¶[0033], [0034]); loading a stent onto the first radially expandable member such that an edge of the stent abuts the first bulbous region (¶[0034]; the claim does not require this step to occur after the heating and pressure step); and wherein the first bulbous region is configured to fold over and cover the edge of the stent during delivery (¶[0034] - the portion contacting either stent edge 70b or 70c can be regarded as a folded over portion).
Regarding claim 2, the first radially expandable member is a balloon (¶[0032]).
Regarding claim 4, the first bulbous region has a diameter (exterior diameter) larger than a diameter (interior diameter) of the stent (Figure 2).
Regarding claim 5, the method further comprises forming a second bulbous region on an opposite end of the first radially expandable member from the first bulbous region (the pillow at “75” in Figure 2 can be the first or second bulbous region with the opposite bulbous region being the other of the first or second bulbous region).
Regarding claim 6, applying heat and pressure comprises: heating the mold to between 40° C. and 80° C.; and applying pressure between 100 psi and 150 psi to the first radially expandable member (¶[0037]).
Regarding claim 7, the first bulbous region comprises a dumbbell shape (the entire balloon shape can be regarded as a dumbbell shape as evident from Figure 2, therefore each bulbous region can be regarded as having a dumbbell shape - noting that Applicant’s bulbous regions do not individually appear to have a classical dumbbell shape).
Regarding claim 9, the mold (noting that the entire apparatus 10 can be regarded as the mold since it is a molding apparatus) comprises: a first cavity (e.g. portion of 15 between tubes 20 and 25) having a first diameter; a second cavity (e.g. 35) having a second diameter smaller than the first diameter; and a tapered portion (where ends of arrows are in Figure 1) connecting the first and second cavities (alternatively connector 95 tapers from a larger diameter section to a smaller diameter air line as evident from Figure 1).
Regarding claim 10, the method further comprises constraining a portion of the first radially expandable member with a protective sheath (20) during the applying of heat and pressure (10 or 15 being the mold).
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 nonobviousness.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Bar et al. (US 2016/0096308).
Regarding claim 3, Bar et al. fail to disclose that the shape memory portion is maintained after a plurality of cycles of inflating and deflating the first radially expandable member.
However, Bar et al. disclose storing and shipping the stent while mounted on the balloon for later use (¶[0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the shape memory portion so that it is maintained for at least 2 cycles of inflating and deflating so that the balloon would not have to be held in the inflated state during shipment and/or storage.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bar et al. (US 2016/0096308) in view of Bourang (US 2014/0100647).
Regarding claim 8, Bar et al. fail to disclose that loading the stent comprises positioning the stent between a proximal radiopaque marker and a distal radiopaque marker on the first elongate shaft.
Bourang discloses providing a distal radiopaque marker (3834) on a distal portion of an elongate balloon catheter shaft (3826; Figure 38D) and a proximal radiopaque marker (3836) on a proximal portion of the elongate shaft with a stent (3842) positioned between the markers in order to help visualize the ends of the balloon and help align the balloon during delivery (¶[0175]).
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 Bourang to have provided a distal and proximal radiopaque marker on the first elongate shaft with the stent positioned therebetween as claimed in order to help visualize the ends of the balloon align the balloon during subsequent delivery.
Conclusion
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
