UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte BRIAN J. BROWN and MICHAEL L. DAVIS
__________
Appeal 2010-011603
Application 09/934,178
Technology Center 3700
__________
Before TONI R. SCHEINER, DEMETRA J. MILLS, and ERIC GRIMES,
Administrative Patent Judges.
SCHEINER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 9, 10, 13-22, 24-26, and 28-30, directed to a stent. The claims have
been rejected on the grounds of anticipation and obviousness. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse.
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BACKGROUND
The Specification teaches that expandable, articulated stents with a
variety of configurations are known in the art, including stents with “a
plurality of aligned, expandable, relatively inflexible, circular segments . . .
interconnected by flexible elements to form a generally tubular body” (Spec.
2: 8-9), and stents with “[a] diamond configuration with diagonal
connections between each and every diamond of each segment” (id. at 2: 18-
19).
According to the Specification, a problem with the former is that
“binding, overlapping or interference can occur between adjacent segments
on the inside of a bend due to the segments moving toward each other . . . or
on the outside of a bend the segments can move away from each other
leaving large gaps” (id. at 2: 10-14). A problem with the latter is that “such
closed configurations lack flexibility” (id. at 2: 19-20).
In contrast, the Specification discloses an expandable stent “of open
configuration” that “avoids these problems and exhibits improved flexibility
(radially and longitudinally) in the stent body segments thereof rather than in
flexible joints between the segments” (id. at 2: 22-24). The stent comprises
“a plurality of . . . open cylindrical segments aligned on a common
longitudinal axis to define a generally tubular stent body, each segment
being defined by a member formed in an undulating flexible pattern” (id. at
2: 28-30), “interconnected by a plurality of interconnecting elements
extending from some of the connected end portions on one segment to some
of the connected end portions on adjacent segments” (id. at 3: 2-4). “[U]pon
expansion of the stent the adjacent segments are displaced relative to each
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other about the periphery of the stent body to accommodate flexing of the
stent . . . without interference between adjacent segments (id. at 3: 9-11).
Figures 1 and 3 of the Specification are reproduced below:
Figure 1 depicts a stent that meets the limitations of the claims, in its
unexpanded configuration, while Figure 3 depicts the same stent in its
expanded configuration. The stent is “made up of a plurality of adjacent
segments . . . 16, each of which is formed in an undulating flexible pattern of
substantially parallel struts 18” (Spec. 4: 1-3). “Interconnecting elements 20
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extend from one end portion 19 of one segment 16 to another end portion 19
of another adjacent segment 16 but not to an oppositely positioned end
portion 19” (id. at 4: 16-17). “Interconnecting elements 20 and adjacent
segments 16 form a plurality of cells 24” (id at 4: 18-19).
1
STATEMENT OF THE CASE
Claims 9, 10, 13-22, 24-26, and 28-30 are pending and on appeal;
claims 1-8, 11, 12, 23, and 27 have been canceled (App. Br. 6). Claims 9,
16, and 17 are representative:
9. A stent having a plurality of cells and a plurality of segments which
form a tubular body, the body having a circumference and comprising:
a plurality of annular elements, each annular element having a
compressed state and an expanded state, each annular element formed in a
generally serpentine wave pattern and containing alternating valley portions
and peak portions,
a plurality of connecting members connecting adjacent annular
elements to form a plurality of cells which are bounded at a first end by a
portion of one annular element, at a second end by a portion of another
annular element and two connecting members which extend between the one
annular element and the other annular element, the first end offset in a
circumferential direction from the second end relative to the circumference
of the body,
each annular element having a structure, the structure of a first annular
element of the stent providing the stent with less compression resistance than
provided by the structure of a second annular element of the stent, the valley
portions of the first annular element having the same shape as the peak
portions of the first annular element, wherein the first annular element is
located at an end of the stent, and
wherein each cell of the stent is bounded at a first end by a portion of
one annular element, at a second end by a portion of another annular
element, and by two connecting members which extend between the one
annular element and the other annular element.
1
The paragraph starting at line 16 of page 4 of the Specification was
amended to include this language on May 28, 2003.
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16. A stent comprising an expandable framework defining a tubular body
having a plurality of cells, the framework comprising:
a plurality of annular elements, each annular element having a
compressed state and an expanded state, each annular element formed in a
generally serpentine wave pattern having a plurality of peaks and troughs,
a plurality of connecting members connecting adjacent annular
elements from peak to trough, each connecting member having a first end
and a second end, the second end offset in a circumferential direction from
the first end relative to a circumference of the body,
each annular element having a structure, the structure of a first annular
element of the stent providing the stent with less compression resistance than
provided by the structure of a second annular element of the stent, wherein
the first annular element is located at an end of the stent, and
wherein each cell of the stent is bounded at a first end by a portion of
one annular element, at a second end by a portion of another annular
element, and by two of the connecting members which extend between the
one annular element and the other annular element.
17. A stent comprising an expandable framework defining a tubular body
having a plurality of cells, the framework comprising:
a plurality of serpentine bands, wherein each band has a proximal end
and a distal end and comprises alternating peaks and valleys, the peaks
located at the proximal end and the valleys located at the distal end; adjacent
serpentine bands connected by connecting members, each connecting
member connected between a peak and a valley, each cell of the stent
defined by two of the connecting members and portions of two different
serpentine bands, one of the portions being proximal to the other portion, the
proximal portion including a plurality of said peaks, the other portion
including a plurality of said valleys, the peaks of the proximal portion being
offset circumferentially from the valleys of the distal portion relative to a
circumference of the body.
The Examiner relies on the following evidence:
Palmaz US 5,102,417 Apr. 7, 1992
Pinchasik et al. US 5,499,373 Sep. 12, 1995
Lau et al. US 5,514,154 May 7, 1996
Israel et al. US 5,733,303 Mar. 31, 1998
Kleshinski et al. US 5,902,317 May 11, 1999
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The claims stand rejected as follows:
I. Claims 17, 20, 29, and 30 under 35 U.S.C. § 102(e) as
anticipated by Pinchasik;
II. Claims 17, 20, 29, and 30 under 35 U.S.C. § 102(b) as
anticipated by Palmaz;
III. Claims 18 and 19 under 35 U.S.C. § 103(a) as unpatentable
over Palmaz or Pinchasik, each in view of Lau;
IV. Claims 16, 25, 26, and 28 under 35 U.S.C. § 103(a) as
unpatentable over Pinchasik and Kleshinski;
V. Claim 16, 25, 26, and 28 under 35 U.S.C. § 103(a) as
unpatentable over Palmaz and Kleshinski;
VI. Claims 9, 10, 13-15, 21, 22, and 24 under 35 U.S.C. § 103(a) as
unpatentable over Israel, Pinchasik, and Kleshinski.
ANTICIPATION
I.
The Examiner rejected independent claim 17, and dependent claims
20, 29, and 30 as anticipated by Pinchasik (Ans. 4-5).
Claim 17 is directed, in relevant part, to a stent with an expandable
framework having a plurality of cells, where the framework comprises “a
plurality of serpentine bands, wherein each band . . . comprises alternating
peaks and valleys,” “adjacent serpentine bands [are] connected by
connecting members . . . connected between a peak and a valley,” and each
cell is “defined by” two of the connecting members, a portion of a serpentine
band comprising a plurality of peaks, and a portion of an adjacent serpentine
band comprising a plurality of valleys.
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The Examiner finds that Figure 2C of Pinchasik depicts an expandable
stent with “serpentine band peaks and valleys and . . . cell peaks and valleys”
and “[e]ach cell has two cross supports between a cell peak or valley and a
band peak or valley” (Ans. 4). In particular, the Examiner finds that “each
of the segments (102) of Pinchasik . . . has a [serpentine] structure” (id. at
11).
Figure 2C of Pinchasik is reproduced below:
Figure 2C depicts Pinchasik‟s stent in its expanded configuration.
The stent comprises “a number of substantially rigid segments 102
connected by connectors 110” wherein “[s]egments 102 . . . present a fine
diamond mesh of interconnected diamond shaped cells 108” and wherein
“[c]onnectors 110 comprise links 112 connecting . . . adjacent segments 102
. . . in a substantially helical fashion between apexes of diamond shaped
cells 108 . . . of adjacent segments 102 such that the number of links 112
equals the number of cells 108” (Pinchasik, col. 3, ll. 25-39).
Appellants contend that Pinchasik‟s “diamond shaped cells [108] do
not meet the specific requirements” of the cells required by claim 17 because
the diamond shaped cells are not “defined by two . . . connecting members
and portions of two different serpentine bands” (App. Br. 14).
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Appellants further contend that even if adjacent rigid segments 102
are considered to be serpentine bands defining cells (along with connectors
112), “then Pinchasik fails to disclose „serpentine bands, wherein each band
. . . comprises alternating peaks and valleys . . . .‟” (id. at 15), and wherein
one portion of a given cell includes “a plurality of said peaks, [and] the other
portion includ[es] a plurality of said valleys” (Reply Br. 2). Stated another
way, Appellants contend that “[s]uch cells . . . do not have a proximal
portion including a plurality of said peaks or a portion including a plurality
of said valleys” (id. at 2-3) because the number of connectors (i.e., links
112) in Pinchasik‟s stent equals the number of cells 108 (id. at 3).
Appellants‟ arguments are persuasive. We agree that Pinchasik does
not disclose a stent with cells defined, or bounded by, two connecting
members and a portion of a serpentine band comprising a plurality of peaks,
and a portion of an adjacent serpentine band comprising a plurality of
valleys, as required by claim 17.
The rejection of claims 17, 20, 29, and 30 as anticipated by Pinchasik
is reversed.
II.
The Examiner also rejected claims 17, 20, 29, and 30 as anticipated by
Palmaz (Ans. 5-6).
The Examiner finds that Figure 10 of Palmaz depicts a stent which
“meets the claim language where the annular elements as claimed are met by
the prostheses or grafts (70) . . . and the connectors as claimed are the
connectors (100) or spiral members (102)” (Ans. 5-6). In particular, the
Examiner finds that “each of the . . . prostheses (70) of Palmaz has a
[serpentine] structure” (id. at 11).
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The Examiner finds that Palmaz anticipates claim 17 based on “[t]he
same rationale used in the interpretation of Pinchasik” (Ans. 6).
Figure 10 of Palmaz is reproduced below:
Figure 10 depicts Palmaz‟s “expandable intraluminal vascular graft,
or prosthesis, 70'” in its “expanded, and deformed configuration” (Palmaz,
col. 11, ll. 35-36; col. 12, ll. 65). “[G]raft, or prosthesis, 70' generally
includes a plurality of prostheses, or grafts 70” (id. at col. 11, ll. 48-49).
“Disposed between . . . adjacent grafts, or prostheses, 70, is at least one
connector member 100 to flexibly connect adjacent . . . grafts, or prostheses,
70” (id. at col. 11, ll. 55-58).
Appellants contend that “Palmaz does not disclose a stent wherein
„each cell of the stent defined by two of the connecting members and
portions of two different serpentine bands” with a plurality of peaks and
valleys, as required by claim 17, “for reasons similar to those discussed
above with respect to Pinchasik” (App. Br. 17).
Palmaz is essentially cumulative to Pinchasik in all relevant respects,
and like Pinchasik, does not disclose a stent with cells defined by, or
bounded by, two connecting members and a portion of a serpentine band
comprising a plurality of peaks, and a portion of an adjacent serpentine band
comprising a plurality of valleys, as required by claim 17.
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The rejection of claims 17, 20, 29, and 30 as anticipated by Palmaz is
reversed.
OBVIOUSNESS
III.
The Examiner rejected claims 18 and 19 as unpatentable over Palmaz
or Pinchasik, each in view of Lau (Ans. 9-10).
The Examiner relies on Palmaz and Pinchasik as above, and cites Lau
as evidence that “it was known to make similar stents out of Nitinol . . . or
shape memory material as an alternative to balloon expandable stents” (id.).
The Examiner concludes that “it would have been obvious to make the stents
of Palmaz or Pinchasik out of Nitinol or shape memory material” (id. at 10).
Claims 18 and 19 depend from claim 17. Appellants contend that Lau
does not address “the deficiencies of Palmaz or Pinchasik, respectively,
discussed above with respect to independent claim 17” (App. Br. 25).
We agree. The rejection of claims 18 and 19 as unpatentable over
Palmaz or Pinchasik, each in view of Lau, is reversed.
IV.
The Examiner rejected independent claim 16, and dependent claims
25, 26, and 28 as unpatentable over Pinchasik and Kleshinski (Ans. 6-7).
Independent claim 16 is similar to claim 17 in that it is directed to a
stent with an expandable framework having a plurality of cells, where the
framework comprises “a plurality of annular elements . . . formed in a
generally serpentine wave pattern having a plurality of peaks and troughs,”
“a plurality of connecting members connecting adjacent annular elements
from peak to trough,” and where “each cell of the stent is bounded . . . by a
portion of one annular element . . . [and] a portion of another annular
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element, and by two of the connecting members which extend between the
one annular element and the other annular element.”
The Examiner relies on Pinchasik as above, and cites Kleshinski as
evidence that “it was known to put fingers on end cells in order to make
them less compression resistant than other cells” (id. at 7).
Appellants contend that the rejection of claim 16 “fails for reasons
similar to those discussed above with respect to claim 17, and Kleshinski
does not remedy the deficiencies of Pinchasik” (App. Br. 18). In particular,
Appellants contend that Pinchasik fails to disclose „serpentine bands,
wherein each band . . . comprises alternating peaks and valleys . . . .‟” (id. at
15).
We agree with Appellants. Claim 16 requires “annular elements . . .
formed in a generally serpentine wave pattern having a plurality of peaks
and troughs.” Given the Specification‟s distinction between a closed
diamond pattern in the prior art, and the undulating flexible pattern of the
present invention (Spec. 2: 18-19, 28-30); the Specification‟s figures,
depicting “an undulating flexible pattern of . . . struts 18” (id. at 4: 1-3); and
even the Examiner‟s dictionary definition of “serpentine”(Ans. 11)
2
we find
that one of skill in the art would not consider Pinchasik‟s diamond mesh
segments to be serpentine bands, as that term is used in claim 16.
The rejection of claims 16, 25, 26, and 28 as unpatentable over
Pinchasik and Kleshinski is reversed.
2
The Examiner cites Merriam-Webster OnLine, which defines “serpentine”
as “1 : of or resembling a serpent (as in form or movement) . . . 3a : winding
or turning one way and another
” (definition located at
http://www.merriam-webster.com/dictionary/serpentine).
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V.
The Examiner also rejected claims 16, 25, 26, and 28 as unpatentable
over Palmaz and Kleshinski (Ans. 7-8).
The Examiner relies on Palmaz as above, and on Kleshinski as above,
thus, this rejection is essentially cumulative to rejection IV, and is reversed
for the same reasons discussed above in connection with rejection IV.
VI.
The Examiner rejected claims 9, 10, 13-15, 21, 22, and 24 as
unpatentable over Israel, Pinchasik, and Kleshinski (Ans. 8-9).
Claim 9 is similar to claim 16, and requires, in relevant part,
a plurality of cells which are bounded at a first end by a
portion of one annular element, at a second end by a portion of
another annular element and two connecting members which
extend between the one annular element and the other annular
element, the first end offset in a circumferential direction from
the second end relative to the circumference of the body . . .
(Claim 9).
The Examiner finds that “Israel discloses a flexible expandable stent
that has annular elements called meander patterns . . . and connecting
members called loops” (Ans. 8), but “it is not clear that the first end can be
circumferentially offset from the second end” (id.). However, the Examiner
finds that “Pinchasik teaches that circumferentially offset connectors were
known where similar meander pattern stents were made and as an alternative
to circumferentially aligned cell ends” (id.).
3
The Examiner concludes that it
would have been obvious “to circumferentially offset the cell ends of Israel
3
The Examiner points to Figures 2C and 3C in support of this finding (Ans.
8), but their relevance to meander-patterned stents is not clear.
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for the same reasons that Pinchasik does . . . or in order to provide better
coverage between stent segments” (id.).
Appellants contend that Pinchasik‟s helical connectors are similar to
Palmaz‟s (App. Br. 22), and “Israel specifically teaches away from the use
of [the] helical connectors” disclosed in Palmaz (id. at 21), thus, “the
Examiner‟s proposed modification would not be carried out” (id. at 22).
Israel specifically states that the flexible “helical connectors” in
Palmaz‟s stent twist when the stent expands radially and shrinks
longitudinally, and that “[t]he twisting motion is most probably harmful to
the blood vessel” (Israel, col. 1, ll. 33-44). Israel‟s solution to this problem
is to avoid helical connectors like Palmaz‟s by fabricating a stent with
intertwined “even and odd meander patterns [which] are 180° out of phase
with each other” (id. at col. 1, ll. 55-64). Therefore, we agree with
Appellants that “one of ordinary skill in the art would not be motivated to
use the [similar] helical connectors of Pinchasik with the stent of Israel”
(App. Br. 22).
SUMMARY
Anticipation rejections I and II are reversed, as are obviousness
rejections III-VI.
REVERSED
alw
