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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 90a, 90b, 86a, and 86b in fig 7. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim(s) 1-4, 7, 14, and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Strauss (US 20140249616 A1).
Regarding claim 1, Strauss teaches a stent (see annotated figure 15), comprising: an elongated tubular member (see annotated figure 15)expandable from a radially collapsed configuration to a radially expanded configuration ([0045] or [0050], expandable radially), the elongate tubular member comprising a first plurality of filaments extending in a first helical direction (see annotated figure 15) and a second plurality of filaments extending in a second helical direction (see annotated figure 15), the first plurality of filaments extending in the first helical direction and the second plurality of filaments extending in the second helical direction overlapping to form a plurality of cells arranged in rows extending circumferentially about the elongated tubular member (see annotated figure 15); wherein at least some of the cells within one or more rows are adapted to provide increased flexibility to the stent (structure is capable of this, [0045]).
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Annotated figure 15
Regarding claim 2, Strauss further teaches wherein at least some of the first plurality of filaments and at least some of the second plurality of filaments within one or more rows of the plurality of rows are cut away to disrupt at least some of the cells (see annotated figure 15), thereby increasing flexibility of the stent (structure is capable of this, [0045]).
Regarding claim 3, Strauss further teaches wherein at least some of the plurality of cells have a generally diamond shape having four sides formed by a pair of filaments of the first plurality of filaments extending in the first helical direction and a pair of filaments of the second plurality of filaments extending in the second helical direction (see annotated figure 15).
Regarding claim 4, Strauss further teaches wherein a disrupted cell comprises a cell that has had at least one of the four sides of the generally diamond shape removed (see annotated figure 15).
Regarding claim 7, Strauss further teaches wherein one or more rows of cells include only disrupted cells (see annotated figure 15), thereby separating the elongate tubular member into two or more distinct segments (see annotated figure 15).
Regarding claim 14, Strauss teaches a braided stent (see annotated figure 15), comprising an elongated tubular member (see annotated figure 15) expandable from a radially collapsed configuration to a radially expanded configuration ([0045] or [0050], expandable radially), the elongate tubular member including: a first segment comprising a first plurality of filaments extending in a left to right helical direction (see annotated figure 15) and a second plurality of filaments extending in a right to left helical direction (see annotated figure 15), the first plurality of filaments and the second plurality of filaments together forming a first plurality of cells arranged in rows extending circumferentially about the first segment (see annotated figure 15); and a second segment comprising a third plurality of filaments extending in the left to right helical direction (see annotated figure 15) and a fourth plurality of filaments extending in the right to left helical direction (see annotated figure 15), the third plurality of filaments and the fourth plurality of filaments together forming a second plurality of cells arranged in rows extending circumferentially about the second segment (see annotated figure 15); wherein the first segment and the second segment are coupled together in a manner that provides the braided stent with increased flexibility (structure is capable of this, [0045]).
Regarding claim 17, Strauss further teaches wherein: the first segment has a first end having a plurality of cells within a first terminal row (see annotated figure 15); the second segment has a second end having a plurality of cells within a second terminal row (see annotated figure 15); and the first segment and the second segment are coupled together via a fixation element woven between the plurality of cells within the first terminal row and the plurality of cells within the second terminal row (see annotated figure 15).
Regarding claim 18, Strauss further teaches comprising a third segment (see annotated figure 15) comprising a fifth plurality of filaments extending in a left to right helical direction (see annotated figure 15) and a sixth plurality of filaments extending in a right to left helical direction (see annotated figure 15), the first plurality of filaments and the second plurality of filaments together forming a first plurality of cells arranged in rows extending circumferentially about the first segment (see annotated figure 15); wherein the second segment and the third segment are coupled are coupled together in a manner that provides the braided stent with increased flexibility (structure is capable of this, [0045]).
Regarding claim 19, Strauss teaches a braided stent (see annotated figure 15), comprising: an elongated tubular member (see annotated figure 15) expandable from a radially collapsed configuration to a radially expanded configuration ([0045] or [0050], expandable radially), the elongate tubular member comprising a plurality of cells arranged in rows that extend circumferentially about the elongated tubular member (see annotated figure 15); wherein at least some of the plurality of cells are adapted to increase flexibility of the stent (structure is capable of this, [0045]).
Regarding claim 20, Strauss further teaches wherein the elongated tubular member (see annotated figure 15) comprises a first plurality of filaments extending in a first helical direction (see annotated figure 15) and a second plurality of filaments extending in a second helical direction (see annotated figure 15), the first plurality of filaments extending in the first helical direction and the second plurality of filaments extending in the second helical direction overlapping to form a plurality of cells arranged in rows extending circumferentially about the elongated tubular member (see annotated figure 15); wherein at least some of the first plurality of filaments and at least some of the second plurality of filaments within one or more rows of the plurality of rows are cut away to disrupt at least some of the cells (see annotated figure 15), thereby increasing flexibility of the stent (structure is capable of this, [0045]).
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.
Claim(s) 5 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strauss (US 20140249616 A1) in further view of Lu (US 20070179590 A1).
Regarding claim 5, Strauss fails to teach a polymeric covering. Lu teaches a flexible stent device (abstract) wherein the stent further comprises a polymeric covering ([0037-0040]) extending along the elongate tubular member [0056].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Strauss by including the polymeric covering, as taught by Lu, in order to eliminate the need to interconnect stent regions with filament ([0056]).
Regarding claim 16, Strauss fails to teach a polymeric covering. Lu teaches a flexible stent device (abstract) wherein the first segment (element 410) and the second segment (element 408) are coupled together by a continuous polymeric layer that extends over at least part of the first segment and at least part of the second segment ([0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Strauss by including the polymeric covering, as taught by Lu, in order to eliminate the need to interconnect stent regions with filament ([0056]).
Claim(s) 6 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strauss (US 20140249616 A1) in further view of Cattaneo (DE 102011102939 A1).
Regarding claim 6, Strauss fails to teach a terminal row with intact and disrupted cells. Cattaneo teaches a stent device (figure 1) wherein one or more rows of cells include at least one intact cell and a plurality of disrupted cells (there is complete diamonds and broken diamonds in the row before and after the gapped areas, see fig 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Strauss by substituting some of the disrupted cells for complete cells, as taught by Cattaneo, in order to complete a simple substitution of one known element, disrupted cells, for another, complete cells, to obtain predictable results of an alternative way to connect the sections (MPEP 2143).
Regarding claim 15, Strauss fails to teach the details of the filament extensions. Cattaneo teaches a stent device (figure 1) wherein the first segment (top section before disrupted cells, see fig 1) and the second segment (bottom section after disrupted cells, see fig 1) are coupled together by having one or more of the third plurality of filaments being extensions of one or more of the first plurality of filaments (left to right filament extends through disrupted region, see fig 1) and/or by having one or more of the fourth plurality of filaments being extensions of one or more of the second plurality of filaments (right to left filament extends through disrupted region, see fig 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Strauss by substituting some of the disrupted cells for complete cells made from extensions, as taught by Cattaneo, in order to complete a simple substitution of one known element, disrupted cells, for another, complete cells, to obtain predictable results of an alternative way to connect the sections (MPEP 2143).
Claim(s) 8-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strauss (US 20140249616 A1) in further view of Richter (US 8382821 B2).
Regarding claim 8, Strauss further teaches wherein a first segment of the two or more distinct segments has a first end having a plurality of cells within a first terminal row (see annotated figure 15); a second segment of the two or more distinct segments has a second end having a plurality of cells within a second terminal row (see annotated figure 15). Strauss fails to teach nested terminal rows. Richter teaches an expandable filament stent (abstract) wherein the second segment (fig 7, 2nd row) is rotated relative to the first segment (fig 7, 1st row) such that the plurality of cells within the first terminal row (peaks, incomplete cells) nest (see fig 7) between the plurality of cells within the second terminal row (valleys, incomplete cells).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Strauss by substituting the terminal end connection for a rotated nested connection, as taught by Richter, in order to complete a simple substitution of one known element, a spaced apart connection, for another, a nested connection, to obtain predictable results of a functional and alternative way to connect the sections (MPEP 2143).
Regarding claim 9, Strauss further teaches wherein a first segment of the two or more distinct segments have a first braiding pattern and a second segment of the two or more distinct segments have a second braiding pattern that is different from the first braiding pattern (see annotated figure 15).
Regarding claim 10, Strauss further teaches wherein the first braiding pattern differs from the second braiding pattern in one or more of filament count, braid angle, and filament diameter (see annotated figure 15).
Regarding claim 11, Strauss further teaches wherein the two or more distinct segments are joined together via a fixation element woven between adjacent segments (see annotated figure 15).
Regarding claim 12, Strauss further teaches wherein the fixation element comprises a filament (see annotated figure 15).
Regarding claim 13, Strauss further teaches wherein the two or more distinct segments are formed by disrupting all of the cells within a row of cells (see annotated figure 15).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA LOUISE PASQUALINI whose telephone number is (703)756-1984. The examiner can normally be reached Telework 7:30PM-5:00PM EST M-F (occasionally off Fridays).
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/H.L.P./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774