Ex Parte LI

Board of Patent Appeals and Interferences

Aug 27, 2012

11978790 (B.P.A.I. Aug. 27, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
11/978,790 10/30/2007 Jianmin Li 02-396US2 (4010/112C1) 7472
27774 7590 08/27/2012
MAYER & WILLIAMS PC
251 NORTH AVENUE WEST
Suite 201
WESTFIELD, NJ 07090
EXAMINER
SCHALL, MATTHEWWAYNE
ART UNIT PAPER NUMBER
3738
MAIL DATE DELIVERY MODE
08/27/2012 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 JIANMIN LI
__________

Appeal 2011-007554
Application 11/978,790
Technology Center 3700
__________

Before TONI R. SCHEINER, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a stent for
simultaneous drug delivery and fluid passage. The Examiner rejected the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

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Statement of the Case
Background
The Specification teaches a stent “manufactured using a
biocompatible polymer and can include a passage for passing the bodily
fluids and at least one enclosed internal space. One or more therapeutic
agents are loaded into the at least one enclosed internal space” (Spec. 1-2 ¶
0005).
The Claims
Claims 1-12 and 14-25 are on appeal. Claim 1 is representative and
reads as follows:
1. A stent for passing one or more bodily fluids and
releasing at least one therapeutic agent into a body of a patient,
the device comprising:
an elongated member defining a passage for passing the
one or more bodily fluids, the passage extending at least
partially through the elongated member; and
an enclosed internal space defined by the elongated
member for holding at least one therapeutic agent, wherein the
elongated member comprises at least two portions, wherein at
least one portion comprises a first polymer having a first
durometer value and at least a second portion comprises a
second polymer having a second durometer value, wherein the
first and second durometer values are different.

The Issues

A. The Examiner rejected claims 1-3, 5-12, 14-19, and 22-25 under 35
U.S.C. § 103(a) as obvious over Herweck1 and St. Pierre2 (Ans. 3-10).

1 Herweck et al., US 5,411,550, issued May 2, 1995.
2 St. Pierre, E., US 6,719,804 B2, issued Apr. 13, 2004.
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B. The Examiner rejected claims 4 and 20 under 35 U.S.C. § 103(a) as
obvious over Herweck, St. Pierre, and Yan3 (Ans. 10).
C. The Examiner rejected claim 21 under 35 U.S.C. § 103(a) as obvious
over Herweck, St. Pierre, and Herweck ‘1004 (Ans. 10-11).
A. 35 U.S.C. § 103(a) over Herweck and St. Pierre
The Examiner finds that Herweck discloses a medical device
comprising an elongated member “defining a passage (12) for passing the
one or more bodily fluids, the passage extending at least partially through
the elongated member . . . ; and an enclosed internal space (12') defined by
the elongated member for holding at least one therapeutic agent” (Ans. 4).
The Examiner finds that “Herweck does disclose the elongated member
comprises a first polymer and a second polymer” (Ans. 4).
The Examiner finds that St. Pierre teaches a “stent made from
different polymers . . . wherein at least one portion comprises a first polymer
having a first durometer valve and at least a second portion comprises a
second polymer having a second durometer value, wherein the first and
second durometer values are different” (Ans. 4).
The Examiner finds it obvious “to alter the device of Herweck to have
the durometer values of St. Pierre, in order to alter the hardness of different
sections of the stent as described in St. Pierre” (Ans. 4).
Appellant contends that Herweck “does not describe a stent at all,
much less a ureteral stent. Nor does Herweck describe any pain or
discomfort associated with the devices (i.e., vascular grafts and shunts)

3 Yan, J., US 5,843,172, issued Dec. 1, 1998.
4 Herweck et al., US 5,320,100, issued Jun. 14, 1994.
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described therein, much less, intensified pain or discomfort associated with
certain positions along the length of the device” (App. Br. 6).
Appellant contends that St. Pierre “is confronted with a complex
situation in which various device attributes . . . are addressed through a
complex series of trade-offs resulting in a ureteral stent of varying hardness.
This combination of attributes, however, is irrelevant to the blood carrying,
non-stent devices . . . described in Herweck” (App. Br. 6).
Appellant contends that “there would have been no reason for one of
ordinary skill in the art to alter the medical device of Herweck to have the
durometer values of St. Pierre. The only reason to do so would be the
hindsight gleaned from Appellant’s disclosure” (App. Br. 6).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Herweck and St. Pierre render the
stent of claim 1 obvious?
Findings of Fact
1. Figure 1A of Herweck is reproduced below:

“FIG. 1A is a schematic perspective view of a biluminal vascular prosthesis”
(Herweck, col. 4, ll. 36-37).
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2. Herweck teaches “a multi-lumenal prosthetic device for
implantation into a patient. The invention can be utilized, for example, as a
vascular graft providing sustained release of a selected bioactive agent or
diagnostic material directly into a blood or other fluid flow pathway”
(Herweck, col. 5, ll. 4-9).
3. Herweck teaches that the “device has at least two lumina which
are separated by a porous, semi-permeable wall” (Herweck, col. 5, ll. 9-11).
4. Herweck teaches that “the prosthesis 10 can be used for
distribution of chemotherapy agents which are often very toxic and often
cause arterial and venous blood vessel destruction at the needle catheter
entry site” (Herweck, col. 7, ll. 42-46).
5. Herweck teaches that “device 10 eliminates such needle and
catheter injury to the blood vessel and large bolus chemical exposure to the
native vessel with these highly toxic chemotherapy agents. . . . Similar
problems and corresponding solutions also exist for hemodialysis patients
whose native veins are consumed by repetitive needle penetration and
permanent blood vessel wall injury” (Herweck, col. 7, ll. 55-65).
6. St. Pierre teaches “a medical stent . . . The stent body itself
includes a first section, a second section, and a third section defining a
lumen and located between the first and second sections. The first section
includes a first material having a first durometer value while the second
section includes a second material having a second durometer value. The
second durometer value is greater than the first durometer value” (St. Pierre,
col. 1, ll. 48-58).
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7. St. Pierre teaches “stents according to the invention have a
‘softer’ end and a ‘harder’ end. The harder end generally resides in the
patient’s kidney while the softer end generally resides in the patient’s
bladder” (St. Pierre, col. 1, ll. 34-37).
8. St. Pierre teaches that this “construction is desirable because the
harder end is suited for placing the stent in the patient’s kidney and/or to
retain the stent in the patient’s kidney while the softer end is suited to
increase patient comfort and/or, to a degree, retain the stent in the patient’s
bladder” (St. Pierre, col. 3, ll. 61-65).
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.
Analysis
St. Pierre teaches a stent for passing bodily fluids comprising an
elongated member defining a passage for passing a bodily fluid (FF 6) where
the stent has a first section which “includes a first material having a first
durometer value while the second section includes a second material having
a second durometer value. The second durometer value is greater than the
first durometer value” (St. Pierre, col. 1, ll. 48-58; FF 6).
Herweck teaches “a multi-lumenal prosthetic device for implantation
into a patient. The invention can be utilized, for example, as a vascular graft
providing sustained release of a selected bioactive agent or diagnostic
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material directly into a blood or other fluid flow pathway” (Herweck, col. 5,
ll. 4-9; FF 2). Herweck teaches that “the prosthesis 10 can be used for
distribution of chemotherapy agents which are often very toxic and often
cause arterial and venous blood vessel destruction at the needle catheter
entry site” (Herweck, col. 7, ll. 42-46; FF 4). Herweck further teaches that
“device 10 eliminates such needle and catheter injury to the blood vessel and
large bolus chemical exposure to the native vessel with these highly toxic
chemotherapy agents. . . . Similar problems and corresponding solutions also
exist for hemodialysis patients whose native veins are consumed by
repetitive needle penetration and permanent blood vessel wall injury”
(Herweck, col. 7, ll. 55-65; FF 5).
Applying the KSR standard of obviousness to the findings of fact, we
conclude that an ordinary artisan would have reasonably found it obvious to
incorporate the multiple lumens of Herweck into the kidney stent of St.
Pierre since Herweck teaches that the use of multiple lumens permits
delivery of bioactive agents including chemotherapeutic agents for use in
patients including hemodialysis patients (FF 1-8). Such a combination is
merely a “predictable use of prior art elements according to their established
functions.” KSR, 550 U.S. at 417.
Appellant contends that Herweck “does not describe a stent at all,
much less a ureteral stent. Nor does Herweck describe any pain or
discomfort associated with the devices (i.e., vascular grafts and shunts)
described therein, much less, intensified pain or discomfort associated with
certain positions along the length of the device” (App. Br. 6). Appellant
contends that St. Pierre “is confronted with a complex situation in which
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various device attributes . . . are addressed through a complex series of
trade-offs resulting in a ureteral stent of varying hardness. This combination
of attributes, however, is irrelevant to the blood carrying, non-stent devices .
. . described in Herweck” (App. Br. 6).
We are not persuaded. As noted by the Examiner, Herweck
exemplifies a vascular graft (Ans. 11; FF 2). However, Herweck discloses
“a multi-lumenal prosthetic device . . . providing sustained release of a
selected bioactive agent or diagnostic material directly into a blood or other
fluid flow pathway” (FF 2 (emphasis added)). The incorporation of the
additional lumen of Herweck into the kidney stent of St. Pierre permits
delivery of drugs or chemotherapeutic agents using the stent of St. Pierre
without the risks of catheter injury to the patient discussed by Herweck (FF
5). A “person of ordinary skill is also a person of ordinary creativity, not an
automaton.” KSR, 550 U.S. at 421, and the person of ordinary creativity
would reasonably recognize that incorporation of Herweck’s lumen would
permit treatment of the bladder with agents using the kidney stent of St.
Pierre.
Appellant contends that “it also appears that the Examiner is using
alleged similarities between Appellant’s specification and Herweck as a
reason to combine St. Pierre with Herweck, which is clearly improper
hindsight” (Reply Br. 4).
We are not persuaded. While we are fully aware that hindsight bias
often plagues determinations of obviousness, Graham v. John Deere Co.,
383 U.S. 1, 36 (1966), we are also mindful that the Supreme Court has
clearly stated that “if a technique has been used to improve one device, and a
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person of ordinary skill in the art would recognize that it would improve
similar devices in the same way, using the technique is obvious unless its
actual application is beyond his or her skill.” KSR, 550 U.S. at 417. In this
case, we conclude that the person of ordinary skill would have recognized
the ability to treat the bladder in the stent of St. Pierre with drugs or
chemotherapeutic agents using the additional lumen of Herweck would have
improved the stent of St. Pierre.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Herweck and St. Pierre render the method of claim 1 obvious.
B. 35 U.S.C. § 103(a) over Herweck, St. Pierre, and Yan
The Examiner relies upon Herweck and St. Pierre as discussed above,
and finds that “Yan teaches a stent with pores and at least one plug disposed
within the pore, wherein the plug comprises a biodegradable barrier, in the
same field of endeavor, for the purpose of altering the delivery of therapeutic
agents” (Ans. 10). The Examiner finds it obvious to “modify the micropores
of the combined references with the biodegradable seal of Van in order to
allow for a controlled release of the therapeutic agent as described in Van”
(Ans. 10).
The Examiner provides sound fact-based reasoning for combining
Yan with Herweck and St. Pierre. We adopt the fact finding and analysis of
the Examiner as our own. Appellant argues the underlying obviousness
rejection over Herweck and St. Pierre, but Appellant does not identify any
material defect in the Examiner’s reasoning for combining Yan with
Herweck and St. Pierre. Since Appellant only argues the underlying
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rejection of Herweck and St. Pierre, which we affirmed above, we affirm
this rejection for the reasons stated by the Examiner.
C. 35 U.S.C. § 103(a) over Herweck, St. Pierre, and Herweck ‘100
The Examiner relies upon Herweck and St. Pierre as discussed above,
and finds that “Herweck (‘100) teaches a stent with a radiopaque material
placed into a secondary lumen . . . which can be placed only in certain parts
of that lumen . . . in the same field of endeavor, for the purpose of increasing
the visibility of the stent” (Ans. 11). The Examiner finds it obvious to “place
the radiopaque material in only the ends of the lumen and to modify the
sealed opening of the combined references with the radiopaque material of
Herweck (‘100), in order to increase the visibility of the elongated member”
(Ans. 11).
The Examiner provides sound fact-based reasoning for combining
Herweck ‘100 with Herweck and St. Pierre. We adopt the fact finding and
analysis of the Examiner as our own. Appellant argues the underlying
obviousness rejection over Herweck and St. Pierre, but Appellant does not
identify any material defect in the Examiner’s reasoning for combining
Herweck ‘100 with Herweck and St. Pierre. Since Appellant only argues the
underlying rejection of Herweck and St. Pierre, which we affirmed above,
we affirm this rejection for the reasons stated by the Examiner.
SUMMARY
In summary, we affirm the rejection of claims 1 under 35 U.S.C. §
103(a) as obvious over Herweck and St. Pierre. Pursuant to 37 C.F.R. §
41.37(c)(1), we also affirm the rejection of claims 2, 3, 5-12, 14-19, and 22-
25 as these claims were not argued separately.
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We affirm the rejection of claims 4 and 20 under 35 U.S.C. § 103(a)
as obvious over Herweck, St. Pierre, and Yan.
We affirm the rejection of claim 21 under 35 U.S.C. § 103(a) as
obvious over Herweck, St. Pierre, and Herweck ‘100.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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