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 § 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.
Claims 1-4, 6, 8-16, and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Delaloye et al US Patent Pub. 2013/0274873A1.
Delaloye et al discloses a stent-valve (10) comprising a stent (12) including a plurality of struts defining a plurality of cells arranged in circumferential rows (See Fig. 18) and a plurality of commissural supports (20). The stent (12) defining an inflow end and an outflow end (See figure below), wherein at least two circumferential rows of cells extend upstream (see figure below) of the plurality of commissural supports (20). A plurality of valve leaflets (paragraph 55) coupled to the stent; and a seal (40) extending circumferentially around an exterior of the stent (See figure 18) and extending radially outward (see figure below) from the stent. The seal (40) positioned adjacent (see figure below) the inflow end of the stent with a portion of the stent (see figure below) extending upstream of the seal.
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Regarding claim 2, loops 1 and 2 in the figure above clearly show that the struts are at the outflow end.
Regarding claims 3, 4 and 16, see figure above showing the plurality of loops extending downstream, radially outward from the plurality of commissures supports, each loop curves radially inward and the loops are larger than the rest of the cells.
Regarding claims 6 and 18, the element (30) as the inner skirt.
Regarding claims 8 and 19, see figure above for the attachment elements.
Regarding claim 9, the envelope has been interpreted as element (42) and the swellable material as element (44).
Regrading claim 10, element (42) comprises a continuous section of material extending around the entire circumference of the stent.
Regarding claim 11, see paragraph 79, lines 8-11, disclosing that the fabric can have fibers of swellable material.
Regarding claim 12, it is inherent that the polymer (hydrogel) has a lower melting temperature that the fabric.
Regarding claim 13, the seal is incorporated into a skirt (32) of the stent-valve.
Regarding claim 14, it’s a combination of claims 1-3.
Regarding claim 15, see figure above showing that at least two circumferential rows of cells are extending upstream of the commissural supports.
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.
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.
Claims 5, 7, 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Delaloye et al US Patent Pub. 2013/0274873A1 in view of Garde et al US patent 9,675,451B2.
Delaloye et al discloses the invention substantially as claimed. However, Delaloye et al does not disclose a portion of the stent extending upstream of the seal is less than half of a cell and a seal positioned upstream of the inner skirt.
Garde et al discloses a stent-graft having a seal. As disclosed in Figs. 3, 9, 12 and 17 the seal is disposed in different areas of the upstream area of the implant. Figures 17 and 12 show that a portion of the stent extending upstream of the seal is less than half of a cell for the purpose of attaching the stent to the patient heart annulus and create a good seal.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to lower the seal of the Delaloye et al reference as shown in the Garde et al reference, since it has been held that finding an optimum distance value to make a full seal connection of a result effective variable involves only routine skill in the art. In re Boesch, 617 F. 2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 7, if the seal is lowered enough toward the upstream end to have a portion of the stent less than half of a cell, then it will be inherent to have a seal positioned upstream of the inner skirt of Delaloye et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 8/17/26
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