Ex Parte Hartley et al

Patent Trial and Appeal Board

Mar 16, 2016

10726963 (P.T.A.B. Mar. 16, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
101726,963
48003 7590
EGL/Cook - Chicago
PO BOX 10395
CHICAGO, IL 60610
12/03/2003
03/16/2016
FIRST NAMED INVENTOR
David Ernest Hartley
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
127301705 4386
EXAMINER
SEVERSON, RYAN J
ART UNIT PAPER NUMBER
3731
MAILDATE DELIVERY MODE
03/16/2016 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte1 DAVID ERNEST HARTLEY, IAN NIXON, and
PETER JOHN MOSSOP
Appeal2012-004790
Application 10/726,963
Technology Center 3700
Before DONALD E. ADAMS, ERICA A. FRANKLIN, and
SUSAN L. C. MITCHELL, Administrative Patent Judges.
MITCHELL, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134 from the Examiner's
decision finally rejecting claims 6, 7, 9, and 24. We have jurisdiction over
the appeal under 35 U.S.C. § 6(b).
We reverse,
1 Appellants identify the Real Party in Interest as William A. Cook Australia
Pty, Ltd. and Cook Medical Technologies LLC. App. Br. 3.
Appeal2012-004790
Application 10/726,963
STATEMENT OF THE CASE
The Specification is directed to a method and a device for treating
aortic arch disease such as an aortic dissection. Spec. 1:6-8.
Claims 6, 7, 9, and 24 are on appeal, and are set forth in a
Claims Appendix to the Appeal Brief. App. Br. 20-21. Claim 24,
from which claims 6, 7, and 9 depend, is the sole independent claim at
issue, is illustrative and reads as follows (emphasis added):
24. An aortic dissection treatment prosthesis
comprising[:]
a proximal covered portion and a distal uncovered
portion, the distal uncovered portion being fastened to and
extending distally from the proximal covered portion;
the proximal covered portion comprising a tubular body
of a biocompatible graft material and at least three self
expanding stents within the tubular body and supporting
the tubular body to provide an outside sealing surface;
the distal uncovered portion comprising a plurality of self
expanding stents linked together by flexible links and defining
an elongate substantially cylindrical and flexible lumen wall
engaging surface, the flexible links comprising a thread or fiber
connected between adjacent stents in the uncovered stent
assembly,
wherein the stents of the uncovered stent assembly
comprise bends and the stents of the uncovered stent assembly
are linked to adjacent stents by the thread or fiber between
adjacent bends of the stents and wherein there are from eight to
ten uncovered stents of the plurality of stents in the uncovered
stent assembly each of the stents being of a zig-zag type and
being formed from stainless steel or nitinol;
2
Appeal2012-004790
Application 10/726,963
the proximal covered portion providing a cover for an
aortic dissection to close off the dissection so that blood can no
longer flow therethrough and the distal uncovered portion
providing gradual pressure to close a false lumen of the aortic
dissection and open up a true lumen with the flexible links
between adjacent bends of the stents enabling each stent to
expand separately as the false lumen is closed off.
The Examiner has rejected the claims as follows:
I. Claims 6, 9, and 24 under 35 U.S.C. § 103(a) as unpatentable
over Brightbill,2 and Cox3; and
II. Claim 7 under 35 U.S.C. § 103(a) as unpatentable over
Brightbill, Cox, and McNamara.4 Ans. 4--6.
I. Obviousness over Brightbill and Cox
Addressing independent claim 24, the Examiner asserts that Brightbill
teaches all the limitations except for "flexible liriks bet\'l/een the stents
comprising threads or fibers" but relies on Cox for this feature. Ans. 4--5.
The Examiner finds that Figure 7E of Cox teaches that "it is known to
connect stents together with threads or fibers ... to increase the flexibility of
the prosthesis." Id. at 5. The Examiner concludes that it would have been
obvious to the ordinary skilled artisan at the time the invention was made to
have substituted the links of Brightbill with the thread links of Cox to
increase the flexibility of Brightbill' s prosthesis. Id.
2 Jerry Brightbill, US 2003/0204245 Al, published Oct. 30, 2003.
3 Cox et al., US 5,824,040, issued Oct. 20, 1998 (hereinafter "Cox").
4 McNamara et al., US 6,004,347, issued Dec. 21, 1999 (hereinafter
"McNamara").
3
Appeal2012-004790
Application 10/726,963
The Examiner also finds that, although Brightbill discloses two
uncovered stents, the combination of Brightbill and Cox fails to disclose the
claimed number of "eight to ten uncovered stents." Id. However, the
Examiner determines that the claimed number of stents is "merely an
obvious matter of design choice" and that it would have been obvious "to
have created the prosthesis of Brightbill with 8-10 uncovered stents instead
of two for the purpose of creating a longer prosthesis that is capable of
treating a longer section of damaged vessel." Id.
Appellants counter that the Examiner has engaged in an improper
hindsight reconstruction of the claimed prosthesis, because the Examiner's
rejection does not properly set forth
any reasoned rationale as to, given the teachings of Brightbill (a
drug coated stent) and Cox (a modular prosthesis for variable
lumens ), [why] one of ordinary skill would,
first, take the mere suggestion in Brightbill that the drug coated
stent may have a sheath to carry the drug and selectively cover
at least three stents at the proximal end as claimed while
leaving 8-10 stents uncovered;
second, arrange the covered region proximal of the uncovered
region as claimed;
third, select from the various ways of connecting the
connectors to the ring frames as shown in Cox,
fourth, determine that only part of the single body stent of
Brightbill should be broken apart and reconnected with flexible
links, and
4
Appeal2012-004790
Application 10/726,963
fifth, determine that the part of Brightbill where the welds are
connected with flexible links is only the uncovered portion.
App. Br. 14.
The Examiner responds that "it must be recognized that any judgment
on obviousness is in a sense necessarily a reconstruction based upon
hindsight reasoning" and emphasizes that as "long as it takes into account
only knowledge which was within the level of ordinary skill at the time the
claimed invention was made, and does not include knowledge gleaned only
from the applicant's disclosure, such a reconstruction is proper." Ans. 7.
Appellants respond that "[t]here [is] simply no disclosure [in
Brightbill] of a covered proximal portion and an uncovered distal portion as
claimed and the Examiner offers no explanation why one of skill would
select precisely what Appellants[] have claimed, without resort to
Appellants' specification." Reply Br. 3. Appellants further contend that
Cox fails to disclose the claimed arrangement; and argue that the Examiner
has failed to provide "any real rational analysis of why one of skill in the art
would take the stenosis treating urinary stent body of Brightbill, break it
apart into pieces and apply the covered links of Cox to only those parts of
Brightbill that are uncovered." Id. at 4.
\Ve agree with Appellants that the obviousness rejection should be
reversed. "[T]he examiner bears the initial burden, on review of the prior art
or on any other ground, of presenting aprimaf(1cie case ofunpatentability."
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). In satisfying this initial
burden, "[i]t is impe1missible to use the claimed invention as an instruction
manual or 'template' to piece together the teachings of the prior art so that
the claimed invention is rendered obvious." In re Fritch, 972 F.2d 1260,
5
Appeal2012-004790
Application 10/726,963
1266 (Fed. Cir. 1992). Stated difforently, to establish obviousness, there
must be "an apparent reason to combine the known elements in the fashion"
recited in the claims. KSR. Intl Co. v. Teleflex Inc., 550 U.S. 398, 418
(2007).
On this record, the Examiner fails to establish an evidentiary basis that
supports a conclusion that a person of ordinary skill would have had such a
reason to take the elements disclosed in BrightbilI and Cox and arrange thern
in the claimed fashion .. As observed by Appellants, the claimed subject
matter "requires a very specific aiTangement to treat a very specific
condition." Reply Br. 3. The Examiner's proffered rationale for replacing
the Brightbill prosthesis weld links with Cox's threads or fibers, i.e.,
increasing the flexibility of Brightbill's prosthesis, does not adequately
support a conclusion of obviousness. See Ans. 5. As stated by AppeHants,
"BrightbilI never once expresses any need, desire or preference for axial[]
flexibility in its stent," and "even if one of skill would find some motivation
to combine the links of Cox with Brightbill, the Examiner offers no
explanation as to why one of skill would select only those regions of
BrightbiH that are uncovered." Id. at 5.
Therefore, for the reasons expressed above, we do not sustain the
Examiner's rejection of independent claim 24 as obvious over Brightbill and
Cox. For the same reasons, we also do not sustain the Examiner's rejection
of dependent claims 6 and 9. "[D]ependent claims are nonobvious if the
independent claims from which they depend are nonobvious." Fritch, 972
F.2d at 1266.
6
Appeal2012-004790
Application 10/726,963
II. Obviousness over Brightbill, Cox, and McNamara
Addressing claim 7, the Examiner finds that Brightbill and Cox fail to
teach "barbs extending from the stent through the graft." Ans. 6. To address
this deficiency, the Examiner relies on the McNamara reference. Id. The
Examiner, however, does not provide any teaching in the rejection of
dependent claim 7 to address what we find lacking in the Examiner's
rejection of claim independent 24, as discussed above.
Accordingly, for the reasons expressed above in our discussion of the
rejection of independent claim 24, we also reverse the Examiner's rejection
of dependent claim 7.
SUMMARY
We reverse the rejection of claims 6, 9, and 24 under 35 U.S.C.
§ 103(a) as unpatentable over Brightbill and Cox.
We reverse the rejection of claim 7 under 35 U.S.C. § 103(a) as
unpatentable over Brightbill, Cox, and McNamara.
REVERSED
7