Ex Parte Paul et al

Board of Patent Appeals and Interferences

Mar 21, 2007

10414939 (B.P.A.I. Mar. 21, 2007)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte RAM H. PAUL,
DANIEL J. SIROTA, and
PAUL D. AMARANT
__________

Appeal No. 2006-2037
Application No. 10/414,939
__________

ON BRIEF
__________

Before ADAMS, MILLS, and GREEN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on the appeal under 35 U.S.C. § 134 from the
examiner’s final rejection of claims 1-4, 6-11, 15-18, and 20-24. The examiner
objected to claims 12, 13, and 14, the only remaining pending claims, “as being
dependent upon a rejected base claim,” however, the examiner has indicated
that these claims would be “allowable if rewritten in independent form including
all of the limitations of the base claim and any intervening claims.” Brief, page 2.

Appeal No. 2006-2037 Page 2
Application No. 10/414,938
Accordingly, claims 1-4, 6-11, 15-18, and 20-24 are before us on appeal.
Claim 1 is illustrative of the subject matter on appeal and is reproduced below:
1. A medical device for at least partial implantation, comprising:
a main body having a first end, a second end, and a lumen
extending therebetween,
a first section proximal the first end of said main body and
having a first therapeutic agent, said first therapeutic agent comprising
one or more members selected from the group consisting of
antiproliferatives, anticoagulants, antithrombotics, thrombolytics, and
fibrinolytics; and
a second section proximal the second end of said main body
and having a second therapeutic agent, said second therapeutic agent
comprising an antimicrobial;
said main body having a length such that when said device is at
least partially implanted said first end accesses a body vessel and at
least a portion of said second section is disposed within a
subcutaneous space of a patient.

The references relied upon by the examiner are:
Ragheb et al. (Ragheb) 6,299,604 Oct. 9, 2001
Pacetti et al. (Pacetti) 6,663,662 Dec. 16, 2003
(102(e) date Dec. 28, 2000)

GROUNDS OF REJECTION
Claims 1, 2, 15, 18, and 20-24 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Ragheb.
Claims 1, 3, 4, 6, 7, 10, 11, 15, 16, and 20-241 stand rejected under
35 U.S.C. § 102(e) as anticipated by Pacetti.
Claims 8, 9, and 18 stand rejected under 35 U.S.C. § 103 as being
unpatentable over Pacetti.
We reverse.

1 The examiner included claim 5 in this rejection. However, as appellants emphasize (Reply
Brief, page 2), claim 5 was previously cancelled.

Appeal No. 2006-2037 Page 3
Application No. 10/414,938
DISCUSSION
Claim Construction:
For clarity, we refer to figures 1 and 12, reproduced below, to assist in our
construction of appellants’ claimed invention.

Claim 1 is drawn to a medical device. The device comprises three parts:
1. a main body 12;
2. a first section 24; and
3. a second section 26.
The main body has three parts:

1. a first end 20;

2. a second end 22; and

3. a lumen 14 extending between the first and second ends.

The main body 12 has a length such that when the device is at least partially
implanted the first end 20 accesses a body vessel 58 and at least a portion of the
second section 26 is disposed within a subcutaneous space 56 of a patient.

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Application No. 10/414,938
The first section 24 is proximal to the first end 20 of the main body 12 and
has a first therapeutic agent 28. The first therapeutic agent 28 comprises one or
more members selected from the group consisting of antiproliferatives,
anticoagulants, antithrombotics, thrombolytics, and fibrinolytics.
The second section 26 is proximal the second end 22 of the main body 12
and has a second therapeutic agent 30. The second therapeutic agent 30
comprises an antimicrobial.

Anticipation:
Ragheb:
Claims 1, 2, 15, 18, and 20-24 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Ragheb. The examiner directs attention to the Final Rejection,
mailed March 31, 2005, for a statement of the rejection. Given its brevity, we
reproduce the statement of the rejection in its entirety below:
Ragheb discloses a medical device comprising: a main body
having a first end, a second end, and a length extending from the
first end to the second end (12); a first section along the length
having a first therapeutic agent (figs. 1-5); a second section along
the length having a second therapeutic agent (figs. 1-5); as to
claim 2, (col. 6); as to claim 15, (see claim 2); as to claims 18 and
20-24, (figs. 1-5).

Final Rejection, page 3.
Ragheb is directed to a medical device with drugs or bioactive agents
incorporated onto it. Ragheb, column 1, lines 10-12. Ragheb discloses that it
has become common practice to “treat a variety of medical conditions by
introducing an implantable medical device partly or completely into” the patient,

Appeal No. 2006-2037 Page 5
Application No. 10/414,938
e.g., the patient’s vascular system. Ragheb, column 1, lines 15-19. Ragheb
discloses, “[h]owever, when such a device is introduced into and manipulated
through the vascular system, the blood vessel walls can be disturbed or injured.”
Ragheb, column 1, lines 22-24. Ragheb discloses that the problems associated
with the introduction and manipulation of a medical device in a patient can be
solved by providing the controlled release of an agent, drug or bioactive material
into the location in the body where the device is positioned. Ragheb, column 3,
lines 6-11. In this regard, Ragheb
discovered that the degradation of the agent, a drug or a bioactive
material that is applied to such a device can be avoided by positing
a coating layer on one surface of the device structure. The agent,
drug or bioactive material is posited over at least a portion of the
coating layer, wherein the coating layer provides for a controlled
release of the bioactive material posited thereon.

Ragheb, column 3, lines 11-18.
For clarity, we reproduce Ragheb’s figure 1, which is a cross-sectional
view of one of Ragheb’s preferred embodiments2:

Accordingly, Ragheb discloses a device 10, which comprises a structure 12 that
is shaped and sized for introduction into a patient. Ragheb, column 6,

2 Ragheb, column 6, lines 3-4, “Fig. 1 is a cross-sectional view of a first preferred embodiment of
the present invention.”

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Application No. 10/414,938
lines 35-39. The structure 12 is composed of a base material 14 suitable for the
intended use of the structure 12. Ragheb, column 7, lines 15-16. At least one
layer 18 of a bioactive material is posited on one surface of the structure 12.
Ragheb, column 7, lines 62-65. According to Ragheb, the other surface of the
structure 12 “will either contain no bioactive material or one or more different
bioactive materials.” Ragheb, column 7, line 65 – column 8, line 1. Ragheb
discloses that this configuration allows for the delivery of one or more bioactive
materials or drugs to the blood stream from the lumen surface of the stent, while
a different treatment is delivered on the vessel surface of the stent. Ragheb,
column 8, lines 1-5. In addition, Ragheb discloses that the device 10 “also
comprises at least one porous layer 20 posited over the layer 18 of bioactive
material and the bioactive-material-free surface.” Ragheb, column 10,
lines 34-37. According to Ragheb, “[t]he purpose of the porous layer 20 is to
provide a controlled release of the bioactive material when the device 10 is
positioned in the vascular system of a patient.” Ragheb, column 10, lines 37-41.
Ragheb discloses that the device 10 “can further comprise at least one additional
coating layer 16 posited between the structure 12 and the at least one layer 18 of
bioactive material.” Ragheb, column 11, lines 5-8.
Therefore, Ragheb discloses a device 10 (for simplicity, a tube3) that has
a particular structure 12. As illustrated in Figure 1, a cross-sectional view of the

3 According to the examiner, many of Ragheb’s “devices are nothing more than mere tubes.”
Answer, page 6.

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Application No. 10/414,938
tube’s composition reveals that it is composed of several layers, which from the
inside (lumen surface) to the outside (vessel surface) are:
1. a porous layer 20;
2. a first bioactive layer 18, or no bioactive layer 18 if a first
bioactive layer 18 is present on the other surface of the device;

3. an optional coating layer 16;
4. a base material 14;
5. an optional coating layer 16;
6. a first bioactive layer 18, or no bioactive layer 18 if a first
bioactive layer 18 is present on the other surface of the device;

7. a porous layer 20.
There is no doubt that Ragheb’s device can read on a tube. Cf. Answer,
page 6. It is true that a tube generally has “a main body having a first end, a
second end and a length extending from the first end to the second end. . . .” Id.
It is also true that a tube is generally regarded as having a lumen extending
between the first and second ends. Cf. Answer, page 7.
However, we disagree with the examiner’s assertion that Ragheb
discloses “a first section that is disposed ‘proximal to the first end of the main
body’ . . .” as required by appellants’ claimed invention. Id. We also disagree
with the examiner’s assertion that Ragheb discloses a second section “disposed
‘proximal the second end of the main body . . .’” as required by appellants’
claimed invention. To the contrary, Ragheb, at best, discloses two sections on
either side (e.g., lumen surface and vessel surface) of the tube’s base
material 14.

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Application No. 10/414,938
As the examiner recognizes the first bioactive layer 18 extends from the
distal (e.g., first) end to the proximal (e.g., second) end of the tube. Answer,
page 8. Contrary to the examiner’s assertion, this is not what appellants’ have
claimed. Cf. Answer, page 9. As discussed above, appellants’ device comprises
three parts, which define separate sections located at different ends of the
device.4 In contrast, as the examiner recognizes Ragheb’s device defines
separate sections in terms of layers positioned on either side of the device’s base
material, which may run the full length of device. Therefore, it is our opinion that
Ragheb describes a different device than that set forth in appellants’ claims.
“Under 35 U.S.C. § 102, every limitation of a claim must identically appear
in a single prior art reference for it to anticipate the claim.” Gechter v. Davidson,
116 F.3d 1454, 1457, 43 USPQ2d 1030, 1032 (Fed. Cir. 1997). As discussed
above, Ragheb does not describe appellants’ invention. Accordingly, we reverse
the rejection of claims 1, 2, 15, 18, and 20-24 under 35 U.S.C. § 102(b) as
anticipated by Ragheb.

Pacetti:
Claims 1, 3-7, 10, 11, 15, 16, and 20-24 stand rejected under 35 U.S.C.
§ 102(e) as anticipated by Pacetti. The examiner directs attention to the Final
Rejection, mailed March 31, 2005, for a statement of the rejection.

4 See e.g., Brief, page 11. While the examiner asserts (Answer, page 8) that this spatial
relationship is not required for appellants’ claim 1, the examiner has not explained how the claim
can be constructed to avoid this spatial relationship of different sections at different ends of the
device. Accordingly, we are not persuaded by the examiner’s assertion.

Appeal No. 2006-2037 Page 9
Application No. 10/414,938
According to the examiner “Pacetti discloses a medical device comprising:
a main body having a first end, a second end, and lumen extending
there[ ]between . . .; a first section proximal the first end of said main body and a
second section having proximal the second end of said main body. . . .” Final
Rejection, page 2. The examiner finds that Pacetti teaches that the first section
has a “first therapeutic agent comprising one or more members selected from the
group consisting of antiproliferatives . . ., anticoagulants, antithrombotics,
thcombolytics, and fibrinolytics. . . .” Id. In addition, the examiner finds that
Pacetti teaches that the second section has a “second therapeutic agent
comprising an antimicrobial. . . .” Id. According to the examiner, Pacetti’s device
is fully capable of being positioned in the manner required by appellants’ claimed
invention.
Pacetti is directed to “a coating disposed on an implantable device, . . .
[e.g.,] a stent, for inhibiting the release rate of an active ingredient carried by the
device.” Pacetti, column 1, lines 7-12. For clarity, we reproduce Figure 2A5.

Pacetti discloses a stent 20 having a surface 22. Pacetti, column 18,
lines 2-3. Pacetti’s “[s]tent 20 includes cavities or micro-pores 24 formed in the
body for releasably containing an active ingredient 26 . . . .” Pacetti, column 18,

5 Figure 2A illustrates a diffusion barrier layer deposited over a stent in accordance with one
embodiment of Pacetti’s invention. Pacetti, column 4, lines 12-14.

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Application No. 10/414,938
lines 3-5. In addition, “[a] diffusion barrier layer 28 is disposed on surface 22 of
stent 20 covering cavities 24.” Pacetti, column 18, lines 5-7. The “[d]iffusion
barrier layer 28 contains particles 30 for reducing the rate of release of active
ingredient 26.”
In response appellants assert that “Pacetti does not teach or suggest the
very specific and sequential arrangement of agents as specified in claim 1.”
Brief, page 7. We agree. As discussed above, appellants’ device comprises
three parts, which define separate sections located at different ends of the
device.6 Contrary to the examiner’s assertion7 (Answer, page 4), we find not
teaching in Pacetti that describes a device with the arrangement of parts set forth
in appellants’ claimed invention. While we agree with the examiner in that the
devices described by appellants and Pacetti can be tubes, we find no evidence in
Pacetti and the examiner failed to identify any specific teaching in Pacetti that
describes a device that is the same as those required by appellants’ claimed
invention.
“Under 35 U.S.C. § 102, every limitation of a claim must identically appear
in a single prior art reference for it to anticipate the claim.” Gechter v. Davidson,
116 F.3d 1454, 1457, 43 USPQ2d 1030, 1032 (Fed. Cir. 1997). As discussed
above, Ragheb does not describe appellants’ invention. Accordingly, we reverse

6 We disagree with the examiner that “there is nothing in applicant’s claim 1 that teaches or
suggests a very specific and sequential arrangement of agents.” Answer, page 3. The examiner
has not explained how the claim can be constructed to avoid the defined spatial relationship of
different sections at different ends of the device as set forth in appellants’ claimed invention.
Accordingly, we are not persuaded by the examiner’s assertion.

7 According to the examiner (Answer, page 4), appellants’ device and Pacetti’s device appear to
be identical in structure.

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Application No. 10/414,938
the rejection of claims 1, 3-7, 10, 11, 15, 16, and 20-24 under 35 U.S.C. § 102(e)
as anticipated by Pacetti.

Obviousness:
Claims 8, 9, and 18 stand rejected under 35 U.S.C. § 103 as being
unpatentable over Pacetti. The examiner directs attention to the Final Rejection,
mailed March 31, 2005, for a statement of the rejection. The examiner offers
nothing more than an assertion that the discussion of Pacetti set forth in the
rejection under 35 U.S.C. § 102(e) leads to a finding that claims 8, 9 and 18
would have been prima facie obvious to a person of ordinary skill in the art at the
time the invention was made. Final Rejection, pages 11-12. We disagree for the
reasons set forth above.
Accordingly, we reverse the rejection of claims 8, 9 and 18 stand rejected
under 35 U.S.C. § 103 as being unpatentable over Pacetti.
REVERSED

)
Donald E. Adams )
Administrative Patent Judge )
)
) BOARD OF PATENT
)
Demetra J. Mills ) APPEALS AND
Administrative Patent Judge )
) INTERFERENCES
)
)
Lora M. Green )
Administrative Patent Judge )

Appeal No. 2006-2037 Page 12
Application No. 10/414,938
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