Ex Parte Fischell et al

Board of Patent Appeals and Interferences

Nov 1, 2010

10449162 (B.P.A.I. Nov. 1, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/449,162 05/30/2003 Robert E. Fischell APJOHN-07799 6715
7590 11/01/2010
MEDLEN & CARROLL, LLP
Suite 350
101 Howard Street
San Francisco, CA 94105
EXAMINER
WANG, SHENGJUN
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
11/01/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ROBERT E. FISCHELL, DAVID R. FISCHELL, and
TIM A. FISCHELL
__________

Appeal 2010-001576
Application 10/449,162
Technology Center 1600
__________

Before ERIC GRIMES, DONALD E. ADAMS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to a surgical
method. The Examiner rejected the claims as obvious. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.

1 The two-month time period for filing an appeal or commencing a
civil action, as recited in 37 C.F.R. § 1.304, or for filing a request
for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from
the “MAIL DATE” (paper delivery mode) or the
“NOTIFICATION DATE” (electronic delivery mode) shown on
the PTOL-90A cover letter attached to this decision.
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Application 10/449,162

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Statement of the Case
The invention relates to “devices and methods used to prevent the
formation of scar tissue that often occurs as a result of a surgical procedure”
(Spec. 1).
The Claims
Claims 1, 3, 6-13, 16-21, and 31 are on appeal.2 Claims 1, 3, 9, 12, 13,
and 19 are separately argued. The remaining claims have not been argued
separately and therefore stand or fall together. 37 C.F.R. § 41.37(c)(1)(vii).
Claims 1, 3, and 9 are representative and are reproduced below:
1. A method, comprising:
a) providing;
i) a patient undergoing a surgical procedure,
wherein said procedure comprises creating an
anastomosis; and
ii) a suture, wherein at least one cytostatic,
antiproliferative agent is attached to said suture;
and,
b) joining at least two vessels with said suture thereby
creating said anastomosis.

3. The method of Claim 1, wherein said agent is selected
from the group consisting of sirolimus, tacrolimus,
everolimus, CCI-779, 7-epi-rapamycin, 7-thiomethyl-
rapamycin, 7-epi-trimethoxyphenyl-rapamycin, 7-epi-
thiomethyl-rapamycin, 7- demethoxy-rapamycin, 32-
demethoxy-rapamycin and 2-desmethyl-rapamycin.

9. The method of Claim 1, further comprising suturing a
sheet of material to said anastomosis with said suture.

2 Appellants’ argument relating to third party influence relates to
petitionable, not appealable, issues, which we decline to address.
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The issue
The Examiner rejected claims 1, 3, 6-13, 16-21, and 31 under 35
U.S.C. § 103(a) as obvious over Morris,3 Fischell,4 Goldstein,5 and Wright6
(Ans. 3-5).
The Examiner finds that:
A person of ordinary skill in the art would have been
motivated to incorporate the cytostatic, antiproliferative
agents herein, such as rapamycin and other known
pharmaceutical agents into known biodegradable suture and
sheet, and use them for joining vascular vessels in surgical
procedure because rapamycin and other antiproliferative
agents are known to be useful for treating hyperproliferative
vascular conditions particularly, those mechanically
induced. One of ordinary skill in the art would have
reasonably expected the employment of the rapamycin
locally would reduce the hyperproliferation of the vessels
caused by the mechanical injury (surgical procedure).

(Ans. 5.)
Appellants contend that the Examiner has “not provided any explicit
analyses providing ‘interrelated teachings of multiple patents’ to show a
teaching of an antiproliferative coated suture used to create an anastomosis.
Instead, the Examiner points, in hindsight and piecemeal fashion, to the cited
references to create a completely conclusory argument that all the elements
are found” (App. Br. 10). Appellants contend that
The Examiner merely cites Morris et al. for the suggestion
that rapamycin may be useful for treating hyperproliferative

3 Morris et al., US 5,516,781, issued May 14, 1996.
4 Fischell et al., US 5,795,286, issued Aug. 18, 1998.
5 Goldstein et al., US 6,143,037, issued Nov. 7, 2000.
6 Wright et al., US 6,273,913 B1, issued Aug. 14, 2001.
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vascular disease. Morris et al. therefore does not contribute
to a rationale explicit analysis that a suture coated with an
anti-proliferative would provide a successful anastomosis
using sutures.
Further, Goldstein et al. teaches away from Morris's
systemic delivery.

(App. Br. 11.)
Appellants contend that “Goldstein et al., Morris et al., Wright et al.,
and Fischell et al., when combined, do not teach the following claim
elements of Claim 1: i) an anastomosis; and ii) joining at least two vessels
with a suture” (id. at 13). Appellants appear to make a similar contention for
independent claim 12 (see id. at 15).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that using a suture with an attached
cytostatic, antiproliferative agent in a surgical procedure creating an
anastomosis would have been obvious?
Findings of Fact
1. Morris teaches a “method of preventing or treating
hyperproliferative vascular disease in a mammal by administering an
antiproliferative effective amount of rapamycin alone or in combination with
mycophenolic acid” (Morris abstract).
2. Morris teaches that “[v]ascular injury causing intimal
thickening can be broadly categorized as being either biologically or
mechanically induced. . . . Mechanical injuries leading to intimal thickening
result following balloon angioplasty, vascular surgery, transplantation
surgery, and other similar invasive processes that disrupt vascular integrity”
(Morris, col. 1, ll. 45-64).
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3. Morris teaches “treating hyperproliferative vascular disease in a
mammal . . . by administering an antiproliferative effective amount of
rapamycin . . . via a vascular stent impregnated with rapamycin” (Morris,
col. 3, ll. 45-50).
4. Morris teaches that “[r]apamycin, alone or in combination with
mycophenolic acid can be administered intravascularly or via a vascular
stent impregnated with rapamycin, alone or in combination with
mycophenolic acid, during balloon catheterization to provide localized
effects immediately following injury” (Morris, col. 11, ll. 41-45).
5. Fischell teaches a “radioisotope impregnated material sheet or
mesh designed to be placed between internal body tissues to prevent the
formation of post-operative adhesions, which adhesions are really scar tissue
formation” (Fischell abstract).
6. Goldstein teaches the
desirability of coating medical devices such as, inter alia,
surgical implants, sutures and wound dressings with
pharmaceutical agents is well documented in the art. Such
coated devices could theoretically provide a means for
locally delivering pharmaceutical or therapeutic agents at the
site of medical intervention to treat a variety of diseases. For
example, surgical implants or sutures coated with antibiotics
can provide local delivery of antibiotic directly at an
implantation or suture site, thereby decreasing the onset of
infection following the surgical intervention.

(Goldstein, col. 1, ll. 14-22.)
7. Goldstein teaches that “[c]oated sutures would not only enable
mechanical juxtaposition of tissue . . . such sutures would essentially ‘spot
weld’ the tissue together” (Goldstein, col. 5, ll. 1-5).
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8. Wright teaches “[d]elivery of rapamycin locally, particularly
from an intravascular stent, directly from micropores in the stent body . . . to
inhibit neointimal tissue proliferation and thereby prevent restenosis”
(Wright abstract).
9. Wright teaches that “[p]olymeric Sheet Rapamycin is combined
at concentration range previously highlighted, with a degradable polymer
such as poly(caprolactone-gylcolide [sic]) or non-degradable polymer, e.g.,
polydimethylsiloxane, and mixture cast as a thin sheet. . . . The resulting
sheet can be wrapped perivascularly on the target vessel” (Wright, col. 7, ll.
2-8).
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417. Moreover, an “[e]xpress suggestion to substitute
one equivalent for another need not be present to render such substitution
obvious.” In re Fout, 675 F.2d 297, 301 (CCPA 1982). As noted by the
Court in KSR, “[a] person of ordinary skill is also a person of ordinary
creativity, not an automaton.” 550 U.S. at 421.

Analysis
Claims 1 and 12
Morris teaches that “[m]echanical injuries leading to intimal
thickening result following balloon angioplasty, vascular surgery,
transplantation surgery, and other similar invasive processes that disrupt
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vascular integrity” (Morris, col. 1, ll. 45-64; FF 2). Morris teaches a
“method of preventing or treating hyperproliferative vascular disease in a
mammal by administering an antiproliferative effective amount of
rapamycin alone or in combination with mycophenolic acid” (Morris
abstract; FF 1).
Goldstein teaches that the “desirability of coating medical devices
such as . . . sutures . . . with pharmaceutical agents is well documented in the
art” (Goldstein, col. 1, ll. 14-16; FF6).
We agree with the Examiner that the ordinary artisan, familiar with
the teachings of Morris and Goldstein, would have reasonably coated sutures
with rapamycin to prevent intimal thickening after vascular surgery,
including transplantation surgery, which is reasonably understood to
necessarily require joining blood vessels in an anastomosis (FF 1-4, 6).
Such a combination is merely a “predictable use of prior art elements
according to their established functions.” KSR, 550 U.S. at 417.
Appellants contend that the “Goldstein et al., Morris et al., Wright et
al., and Fischell et al., when combined, do not teach the following claim
elements of Claim 1: i) an anastomosis; and ii) joining at least two vessels
with a suture” (App. Br. 13).
We are not persuaded. While Morris does not use the word
“anastomosis,” when Morris teaches mechanical injury repair such as
vascular surgery and particularly transplantation surgery, the ordinary artisan
would reasonably interpret these surgeries to include the step of joining
arteries to form an anastomosis or the transplant would not be connected to
the patient’s blood supply. The Examiner properly relies upon Goldstein to
teach that “[c]oated sutures would not only enable mechanical juxtaposition
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of tissue . . . such sutures would essentially ‘spot weld’ the tissue together”
(Goldstein, col. 5, ll. 1-5; FF 7).
Claims 3 and 13
Appellants contend that “[n]either Goldstein et al., Morris et al.,
Wright et al., nor Fischell et al. teach that a suture may be attached to a
cytostatic, antiproliferative drug including sirolimus” (App. Br. 14).
The Examiner finds that rapamycin is sirolimus (see Ans. 4).
We conclude that the Examiner has the better position, since having
found the use of rapamycin obvious for the reasons given above, and since
sirolimus is simply an alternative name for rapamycin (see Spec. 2: 4), the
use of sirolimus would have been obvious for the same reasons.
Claims 9 and 19
Appellants contend that “[n]either Fischell et al., Wright et al.,
Goldstein et al., nor Morris et al., teach that a suture may be used to suture a
sheet of material to an anastomosis” (App. Br. 14).
The Examiner finds that using “a sheet as carrier for local delivery
would have been obvious to one of ordinary skill in the art since they are
know to be used as carrier for local delivery” (Ans. 5).
We conclude that the Examiner has the better position. Claims 9 and
19 are directed to the method of claim 1, which creates an anastomosis using
sutures, further comprising suturing a sheet of material to the anastomosis.
Wright teaches that a polymeric sheet with rapamycin can be wrapped
around a target vessel (FF 9) and that rapamycin inhibits neointimal tissue
proliferation (FF 8), which Morris teaches can result from vascular surgery
(FF 2). The Examiner finds obvious the “employment of those materials
[i.e, sutures and sheets with antiproliferative agents] in vascular surgery for
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suppressing proliferation” (Ans. 7). We agree with the Examiner, that it
would have been obvious to the ordinary artisan, who is a person of ordinary
creativity, based on these teachings, to wrap a sheet with rapamycin around
a newly-made anastomosis to prevent proliferation, such as intimal
thickening and suture it in place.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that using
a suture with an attached cytostatic, antiproliferative agent in a surgical
procedure creating an anastomosis would have been obvious for claims 1, 3,
12, and 13.
The evidence of record supports the Examiner’s conclusion that
suturing a sheet to the anastomosis would have been obvious for claims 9
and 19.
SUMMARY
In summary, we affirm the rejection of claims 1, 3, 12, and 13 under
35 U.S.C. § 103(a) as obvious over Morris, Fischell, Goldstein, and Wright.
Pursuant to 37 C.F.R. § 41.37(c)(1)(vii)(2006), we also affirm the rejection
of claims 6-8, 11, 13, 16-18, 21 and 31, as these claims were not argued
separately.
We affirm the rejection of claims 9, 10, 19, and 20 under 35 U.S.C. §
103(a) as obvious over Morris, Fischell, Goldstein, and Wright.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).

AFFIRMED

Appeal 2010-001576
Application 10/449,162

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