Barry et al.v.Bates et al.

Patent Trial and Appeal Board

Feb 11, 2015

10618977 (P.T.A.B. Feb. 11, 2015)

BoxInterferences@uspto.gov
Tel: 571-272-4683 Entered: February 11, 2015

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

BRIAN L. BATES,
SCOTT E. BOATMAN, DAVID G. BURTON,
MICHAEL C. HOFFA,
DARIN G. SCHAEFFER, JASON S. STURGEON, and
ANTHONY O. RAGHEB
Junior Party
(Patent 7,803,149),

v.

JAMES J. BARRY,
and
MARIA PALASIS,
Senior Party
(Application No. 13/085,623),

Patent Interference No. 105,988
(Technology Center 1600)

Before RICHARD E. SCHAFER, SALLY GARDNER LANE, and
DEBORAH KATZ, Administrative Patent Judges.

LANE, Administrative Patent Judge.

Judgment – Bd. R. 127(a)

In view of the Decision on Motions (Decision, Paper 238), it is 1
ORDERED that judgment on priority as to Count 1 (Declaration (Paper 1) at 2
4), the sole count of the interference, is entered against senior party James J. Barry, 3
and Maria Palasis; 4
FURTHER ORDERED that claims 27, 29-31, and 34-36 of senior party Barry 5
application 13/085,623, which claims correspond to Count 1, are FINALLY 6
REFUSED; 35 U.S.C. § 135(a); 1 7
FURTHER ORDERED that the parties are directed to 35 U.S.C. § 135(c) and 8
to Bd. R. 205 regarding the filing of settlement agreements; 9
FURTHER ORDERED that a copy of this judgment shall be entered into the 10
administrative record of the involved junior party patent and the involved senior party 11
application; and 12
FURTHER ORDERED that, if a party seeks judicial review, the party must file 13
a notice with the Board within seven days of initiating judicial review. Bd. R. 41.8(b). 14
We direct the parties’ attention to Biogen Idec MA, Inc., v. Japanese Foundation for 15
Cancer Research, 2014 WL 2167677 (D.Mass. 2014). 16

1 Any reference to a statute in this Judgment is to the statute that was in effect on March
15, 2013 unless otherwise indicated. See Pub. L. 112-29, § 3(n), 125 Stat. 284, 293 (2011).

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cc (via electronic):

Attorney for Bates:

Christopher A. Brown
Kenneth A. Gandy
WOODARD, EMHARDT, MORIARTY,
McNETT & HENRY, LLP
cabrown@uspatent.com
kgandy@uspatent.com

Attorney for Barry:

Kristan L. Lansbery
David R. Marsh
ARNOLD & PORTER, LLP
kristan.lansbery@aporter.com
david.marsh@aporter.com
BoxInterferences@uspto.gov
Tel: 571-272-4683 Entered: February 11, 2015

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

BRIAN L. BATES,
SCOTT E. BOATMAN, DAVID G. BURTON,
MICHAEL C. HOFFA,
DARIN G. SCHAEFFER, JASON S. STURGEON, and
ANTHONY O. RAGHEB
Junior Party
(Patent 7,803,149),

v.

JAMES J. BARRY,
and
MARIA PALASIS,
Senior Party
(Application No. 13/085,623),

Patent Interference No. 105,988
(Technology Center 1600)

Before RICHARD E. SCHAFER, SALLY GARDNER LANE, and
DEBORAH KATZ, Administrative Patent Judges.

LANE, Administrative Patent Judge.

Decision – Motions - Bd. R. 121(a)

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I. Introduction 1
An interference was declared under 35 USC 135(a) 1 on 23 January 2014 2
between junior party Bates2 and senior party Barry.3 (Declaration, Paper 1). The 3
following motions are before us for decision. 4
Bates Motions 5
1. Bates Motion 2 for judgment on the basis that the Barry claims are 6
unpatentable for lack of sufficient support under the first paragraph of 35 U.S.C. 7
§ 112. (Bates Motion 2, Paper 93). 8
2. Bates Motion 3 challenging the benefit accorded to Barry in the declaration 9
of interference. (Bates Motion 3, Paper 89). 10
3. Bates Motion 4 seeking to substitute a Count for the current Count. (Bates 11
Motion 4, Paper 90). 12
Bates also filed Bates Motion 1 (Bates Motion 1, Paper 35) seeking 13
judgment on the basis that Barry lacked standing in the interference because its 14
claims are barred under 35 U.S.C. § 135(b)(1). We denied that Motion. (Decision 15
on Bates Motion 1, Paper 111 and Decision on Rehearing, Paper 121). 16
Barry Motions 17
1. Barry Motion 1 for judgment on the basis that the Bates claims are 18
unpatentable for lack of sufficient support under the first paragraph of 35 U.S.C. 19
§ 112. (Barry Motion 1, Paper 49). 20

1 Any reference to a statute in this Decision is to the statute that was in effect on March 15,
2013 unless otherwise indicated. See Pub. L. 112-29, § 3(n), 125 Stat. 284, 293 (2011).
2 The named Bates inventors are Brian L. Bates, Scott E. Boatman, David G. Burton,
Michael C. Hoffa, Darin G. Schaeffer, Jason S. Sturgeon, and Anthony O. Ragheb.
3 The named Barry inventors are James J. Barry, and Maria Palasis.

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2. Barry Motion 2 for judgment on the basis that the Barry claims are 1
unpatentable under 35 U.S.C. § 102 and/or § 103 over prior art. (Barry Motion 2, 2
Paper 88). 3
3. Barry Motion 3 seeking to add an additional Bates patent to the interference. 4
(Barry Motion 3, Paper 86). 5
4. Barry Miscellaneous Motion 5 seeking to exclude certain evidence. (Barry 6
Motion 5, Paper 221). 7
Barry also filed Barry Miscellaneous Motion 4 seeking the relief that one of 8
its witnesses not be required to answer certain questions on the basis that the 9
answers might reveal privileged material. (Barry Miscellaneous Motion 4, Paper 10
172). That Motion was dismissed. (Decision on Barry Miscellaneous Motion 4, 11
Paper 175). 12
We GRANT Bates Motion 2 and DISMISS the remaining motions before us. 13
14
Background 15
The Count of the interference is directed generally to a method of delivering 16
the drug paclitaxel to a patient’s blood vessel using a balloon catheter having the 17
drug on its surface. Paclitaxel is a known drug and is used as an anti-cancer and 18
anti-angiogenic agent. (Bates patent , Ex 2001, at 12:22-24). 19
Both parties describe balloon catheters for delivering the drug paclitaxel. In 20
each case the balloon catheters are coated with the drug to allow for its delivery. 21
In the balloon catheters of Barry the drug is placed in a containment polymer to 22
allow for controlled release of the drug. (Barry specification, Ex 2002, at, e.g., ¶ 23
0045). In the balloon catheters of Bates, however, the drug is not placed into a 24
containment polymer. (Bates patent at 5:45-50). According to the Bates 25

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specification, “[t]he specific improvement of the present invention entails attaining 1
a desired surface roughness, or texturing on the surface of the device…and 2
applying the bioactive material directly to that roughened or textured surface 3
without the need of any further overlying or containment layer or coating.” (Bates 4
patent at 5:19-24). 5
II. Findings of fact 6
The record supports the following findings of fact by a preponderance of the 7
evidence. 8
Bates 9
1. Junior party Bates is involved in the interference on the basis of patent 10
7,803,149, issued on 28 September 2010 from application 10/618,977, filed 14 11
July 2003. (Declaration at 3). 12
2. The Bates real-parties-in-interest are said to be Cook Medical Technologies 13
and William A. Cook Australia Pty Ltd. (Bates Notice of Real-Partes-in-14
Interest, Paper 4). 15
3. All of the claims of the Bates patent, claims 1-23, correspond to the Count. 16
(Declaration at 5). 17
4. Bates was accorded the following benefit as to Count 1. 18
US 60/395,434, filed 12 July 2002 19
(Declaration at 5). 20

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Barry 1
5. Senior party Barry is involved in the interference on the basis of application 2
13/085,623, filed 13 April 2011. (Declaration at 4). 3
6. The Barry real party-in-interest is said to be Boston Scientific Scimed, Inc. 4
(Barry Notice of Real-Party-in-Interest, Paper 10). 5
7. All of the claims of the Barry involved application, claims 27, 29-31, and 6
34-36, correspond to the Count. (Declaration at 5). 7
8. Barry was accorded the following benefit for Count 1: 8
US 11/833,717, filed 03 August 2007 9
US 11/188,850, filed 26 July 2005 10
US 09/978,763, filed 18 October 2001 11
US 09/172,026, filed 14 October 1998 12
(Declaration at 5 and Redeclaration, Paper 21, at 2) 13
The Count 14
9. The sole Count of the interference, Count 1, is: 15
Claim 1 of Bates or claim 27 of Barry. 16
(Declaration, Paper 1, at 4). 17
10. Claim 1 of Bates reads: 18
19
A method of delivering paclitaxel to an inner wall of a blood vessel of a patient 20
from an implantable medical device having an expandable balloon with the 21
paclitaxel on an outer surface of the balloon, the method comprising the steps 22
of: 23
24
(1) providing an angioplasty balloon having a dried layer containing the 25
paclitaxel on the outer surface of the balloon, the balloon being free of a coating 26

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atop the dried layer, the balloon being free of a time-release layer, the balloon 1
being free of a containment material and the balloon being free of a 2
containment layer; and further wherein the balloon has folds, and portions 3
of the dried layer containing paclitaxel are positioned in the folds; 4
5
(2) advancing the balloon within the blood vessel to a treatment site 6
within the blood vessel; 7
8
(3) inflating the balloon at the treatment site to contact the balloon with 9
an inner wall of the blood vessel; 10
11
(4) maintaining the inflated balloon in contact with the inner wall of the 12
blood vessel so as to transfer paclitaxel to the inner wall of the blood vessel; 13
14
(5) deflating the balloon after said maintaining; and 15
16
(6) removing the deflated balloon from the blood vessel. 17
18
(Bates Clean Copy of Claims, Paper 6, numbering and indentations added). 19
20
11. Barry claim 27 reads: 21
A method of delivering paclitaxel to an inner wall of a blood vessel from a 22
balloon catheter having an expandable balloon with a coating on an outer 23
surface of the balloon, the method comprising: 24
25
(1) providing a balloon catheter including a balloon with a dried coating 26
consisting of paclitaxel or a mixture of paclitaxel with another bioactive 27
agent, the dried coating being free of any additional coating and solvent 28
atop the dried coating; 29
30
(2) advancing the balloon within the blood vessel to a treatment site; 31

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1
(3) inflating the balloon to directly contact the paclitaxel or mixture of 2
paclitaxel with another bioactive agent with an inner wall of the blood 3
vessel; and 4
5
(4) delivering the paclitaxel or mixture of paclitaxel with another 6
bioactive agent to the inner wall of the blood vessel while maintaining 7
the paclitaxel or mixture of paclitaxel with another bioactive agent in 8
direct contact with the inner wall of the blood vessel while the balloon is 9
inflated. 10
11
(Barry Clean Copy of Claims, Paper 9, numbering and indentations added). 12
12. The Barry involved claims were presented in the involved Barry application 13
after issuance of the Bates patent. (Barry published application, Ex 2002 and 14
application as filed, Ex 2003). 15
13. Thereafter Barry suggested the interference under Bd. R. 202(a), stating that 16
Bates claim 1 and Barry claim 27 “define substantially the same invention. 17
(Request for Interference, Ex 2004, at 16-18). 18
14. In the Request Barry stated that its claimed coating “excludes a release layer, 19
a containment material, and a containment layer” and that the coating is limited 20
to “paclitaxel or a mixture of paclitaxel with another bioactive agent” and 21
“excludes anything else from that layer.” (Request for interference at 13). 22
15. The parties agree that a “coating” is a substance placed on the surface of a 23
substrate such as a balloon surface. (Bates Motion 2, SMF4 1, admitted by 24
Barry, and Bates Motion 1 at 3:5-7). 25
16. The parties agree that a “bioactive agent” is a substance that produces a 26

4 Statement of Material Fact.

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desired biological or pharmaceutical result for a patient. (Bates Motion 2, SMF 1
2, admitted by Barry). 2
17. The parties agree that the Barry device has a polymer coating. (Bates 3
Motion 2, SMF 3, relevant portion admitted by Barry). 4
18. We understand that the polymer of Barry (which we also refer to herein as a 5
containment polymer) is used to provide a containment, i.e., controlled or time 6
release, feature to the balloon catheter. (Bates Motion 2, SMF 4, admitted by 7
Barry). 8
19. When speaking specifically of balloon catheters the Barry specification 9
states: 10
When an expandable catheter is chosen as the medical device of the 11
present invention, the expandable portion is preferably a balloon, in 12
which case the drug is placed in the polymer for controlled release of 13
the drug upon expansion of the balloon against a body lumen. 14
15
(Barry specification at ¶ 0045). 16
17
20. Bates on the other hand specifically excludes polymers and other materials 18
that might provide a containment function. ( Bates Motion 2, SMF 14 (denied 19
by Barry but on the basis that the lack of containment polymer is not novel)). 20
The testimony 21
21. Dr. Stephen R. Byrn provided testimony, further described in the Discussion 22
below, on behalf of party Bates regarding, inter alia, what the Bates and Barry 23
specifications would have conveyed to one skilled in the art. (Byrn Declaration, 24
Ex 2014). 25
22. Dr. Byrn testified that he is a Professor of Medicinal Chemistry 26
and that he has been the head of the Department of Medicinal Chemistry and 27

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Pharmacology, and the head of the Department of Industrial and Physical 1
Pharmacy, at Purdue University. (Bryn Declaration at 2). 2
23. Dr. Byrn testified that he has been engaged in study, research and teaching 3
in the field of physical, organic and pharmaceutical chemistry for more than 40 4
years and has particular experience with solid state chemistry of drugs, 5
including pharmaceutical coatings applied to intravascular medical devices. 6
24. Based on his education, professional experience and other accomplishments 7
set forth in his Declaration and attached curriculum vitae (Exhibit A to the Byrn 8
Declaration), we determine that Dr. Bryn is qualified to testify about issues 9
relevant to this interference. 10
25. Dr. Steve Kangas provided testimony, further described in the Discussion 11
below, on behalf of Barry regarding, inter alia, his opinions about what the 12
Barry specification would have conveyed to one skilled in the art based on 13
testing performed under his supervision seeking to replicate Example 9 of the 14
Barry specification. (Kangas Declaration, Ex 1066). 15
26. Dr. Kangas testified that he has a Ph.D. in Polymer Chemistry and has been 16
working at Boston Scientific Scimed, Inc., the Barry real-party-in-interest, since 17
2001. 18
27. Dr. Kangas testified that he is a Fellow at the Interventional Cardiology 19
Research and Development Department at Boston Scientific Corporation. 20
28. Dr. Kangas testified that from 1996 to 2001 he worked as a Chemist in the 21
areas of formulation and characterization of photoreactive imageable coatings. 22
29. Based on his education, professional experience and other accomplishments 23
set forth in his Declaration and attached curriculum vitae (Appendix A to the 24
Kangas Declaration), we determine that Dr. Kangas is qualified to testify about 25

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issues relevant to this interference. 1
30. Dr. W. Mark Saltzman has presented testimony, further described in the 2
Discussion below, on behalf of Barry regarding, inter alia, what the Barry 3
specification would have conveyed to one skilled in the art. (Saltzman 4
Declaration, Ex 1006). 5
31. Dr. Saltzman has a Ph.D. in medical engineering, has extensive teaching 6
experience in chemical and biomedical engineering and extensive research 7
experience in drug delivery. (Saltzman Declaration at ¶¶1-12). 8
32. Based on his education, professional experience and other accomplishments 9
set forth in his Declaration we determine that Dr. Saltzman is qualified to testify 10
about issues relevant to this interference. 11
III. Discussion 12
Bates Motion 2 (based on lack of written description and/or enablement) 13
We turn first to Bates Motion 2 as it presents a threshold issue that, if 14
resolved in Bates’ favor, might deprive Barry of standing in the inference. In 15
particular such a threshold issue is presented where, e.g., an applicant suggests an 16
interference under Bd. R. 202(a), as Barry did here, yet its claims are found to lack 17
written description support. Bd. R. 201. 18
As the moving party, Bates has the burden of proof to show that it is entitled 19
to the request relief. Bd. R. 121(b). 20
Written Description 21
In its Motion 2, Bates argues that the Barry specification does not provide 22
written description support for certain features found in the Barry claims such that 23
the Barry claims are not patentable to Barry. (Bates Motion 2 at 1). 24

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“To satisfy [the written description] requirement, the specification must 1
describe the invention in sufficient detail so ‘that one skilled in the art can clearly 2
conclude that the inventor invented the claimed invention as of the filing date 3
sought.’” In re Alonzo, 545 F.3d, 1015, 1019 (Fed. Cir. 2008), citing Lockwood v. 4
Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed.Cir.1997). We thus consider what the 5
specification reasonably would have conveyed to one of ordinary skill in the art in 6
evaluating whether the specification provides sufficient written description for the 7
claimed invention. Bilstad v. Wakalopulos, 386 F.3d 1116, 1125 (Fed. Cir. 2004). 8
9
Bates argues that, as the Barry claims were substantially copied from the 10
claims of the involved Bates patent, the claim construction principle set forth in 11
Agilent Techs. Inc. v. Affymetrix, Inc., 567 F.3d 1366 (Fed. Cir. 2009) is applicable. 12
Accordingly, argues Bates, we must look to see if the Barry specification describes 13
the subject matter that was substantially copied, construing that subject matter in 14
the context of the Bates specification. (Bates Motion 2 at 1:6-13). Barry does not 15
disagree that Agilent applies and argues that its specification provides description 16
for all the claimed features when its claims are construed in accordance with Bates’ 17
construction. (Barry Opposition 2 at 1:4-8). 18
We agree with the parties and construe the Barry claims in the context of the 19
Bates specification for purposes of evaluating whether the Barry specification 20
provides written description support. (Agilent at 1375 (“To be clear, as the court 21
explained in Rowe, when a party challenges written description support for an 22
interference count or the copied claim in an interference, the originating disclosure 23

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provides the meaning of the pertinent claim language.”)5; See also Tobinick v. 1
Olmarker, 753 F.3d 1220, 1224 (Fed. Cir. 2014), citing Robertson v. Timmermans, 2
603 F.3d 1309, 1312 (Fed. Cir. 2010) (“In interference proceedings, a disputed 3
claim is construed in the context of its originating disclosure rather than the 4
interfering application”.) While the Barry claims are not verbatim copies of the 5
Bates claims, in suggesting the interference, Barry represented that its claims 6
define the same or substantially the same invention as the claims of Bates. (See 7
Suggestion of Interference at, e.g., 16-17, including chart comparing Bates claim 1 8
to claim 27 and representation that “claims define substantially the same 9
invention.”). We believe it is correct to construe the claims in dispute in view of 10
the Bates specification for the reason set forth in Agilent, i.e., because we are 11
evaluating whether Barry has sufficient basis, i.e., sufficient written description, to 12
challenge Bates’ priority of invention as to the substantially copied subject matter. 13
(See Agilent at 1375)(“Stated more directly, does Besemer have adequate basis to 14
copy Schembri’s claim and thereby challenge Schembri’s priority of invention?”); 15
See also Ex parte Smart, 16
http://www.uspto.gov/ip/boards/bpai/decisions/inform/fd09-015036.pdf (PTAB 17
2010) (applying Agilent after Applicant suggested an Interference representing its 18
added claims to be “the same or substantially the same subject matter” as published 19
claims). 20
Bates argues that the claimed balloon catheters exclude a containment 21
polymer as part of the coating. In suggesting the interference, Barry seemed to 22

5 For purposes of evaluating other challenges to patentability, e.g., prior art under 35
U.S.C. § 102 or § 103, it is appropriate to construe the claims in view of the specification in
which they appear. See Agilent at 1375).

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agree stating that, because of the “closed language” of its claims, the coating 1
“excludes a release layer, a containment material, and a containment layer” and 2
that the coating is limited to “paclitaxel or a mixture of paclitaxel with another 3
bioactive agent” and “excludes anything else from that layer.” (Request for 4
interference at 13). Bates argues that the claimed balloon catheters are not 5
described in the Barry specification because the coatings described in the Barry 6
specification require a containment polymer in addition to the paclitaxel and any 7
additional bioactive agent. (Bates Motion 2 at 8:3-18). 8
We construe the Barry claims, as viewed in the context of the Bates 9
application, as limited to a “coating” that does not have within it a containment 10
polymer.6 In this regard we credit Dr. Byrn’s testimony that the Bates description 11
is directed to “application of a paclitaxel layer by itself to a device, including a 12
balloon catheter” and “without layers or materials designed to extend release of the 13
paclitaxel”. (Bryn Declaration at ¶ 21). Dr. Byrn’s testimony is consistent with the 14
language of the Bates specification, including the Bates claims, indicating a device 15
that is not coated with any containment polymer material. (See, e.g., Bates patent 16
at 3:9-19, 14:5-13, and claim 1). Moreover, Barry agrees that the Bates’ 17
specification describes devices that exclude any containment polymer coating. 18
(Bates Motion 2, SMF 14 (denied by Bates but on basis that the lack of 19
containment polymer is not novel). 20
Even though Barry concedes that the coatings described by its specification 21
include a polymer, Barry takes the position that it nevertheless describes the 22

6 Construing the Barry claims in view of the Barry specification may raise a question of
whether an interference-in-fact exists. See Bd. R. 203(a). Since this issue has not been raised in
the briefing though we do not consider it.

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claimed coatings. In particular, Barry argues that it describes balloon catheters that 1
have a polymer coating and then a separate and distinct paclitaxel coating such that 2
a coating “consisting of” paclitaxel is present. (Barry Opposition 2 (Paper 139) at 3
2, citing to, e.g., Example 9 of its specification as well as ¶¶ 39-41, 72 and 73). 4
We are not persuaded by Barry’s argument because we conclude that the 5
Barry claims, as construed in the context of the Bates specification, are directed to 6
a balloon catheter that is not coated with any containment polymer material. Such 7
a balloon catheter is not described by Barry and thus, we find that Bates has shown 8
a lack of written description for the claimed subject matter. 9
Further, even if we were to construe the Barry claims in such a way that the 10
balloon catheter may have a coating of containment polymer that is separate from 11
the coating consisting of paclitaxel, we are not persuaded by Barry’s argument that 12
its specification describes such a device. 13
The medical devices of Barry contain paclitaxel that is “[i]ncorporated into” 14
the polymer coatings (Barry specification at ¶ 0009) to form a “drug-impregnated 15
polymer coating.” (Barry specification at ¶ 0032). 16
Barry, in arguing that the paclitaxel need not be within the containment 17
polymer, urges that the Barry specification “never states or implies that the reason 18
for the polymer layer on a balloon is to contain or control the paclitaxel.” (Barry 19
Opposition 2 at 3:10-11). Barry is incorrect. As Bates has pointed out, the Barry 20
specification states: 21
When an expandable catheter is chosen as the medical device of the 22
present invention, the expandable portion is preferably a balloon, in 23
which case the drug is placed in the polymer for controlled release of 24
the drug upon expansion of the balloon against a body lumen. 25
26

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(Bates Reply 2 referring to Barry specification at ¶ 0045, emphasis added). 1
2
Barry argues though that it is the “one or more additional layers” of a 3
“preferred embodiment” that modulates release of the drug. (Barry Opposition 2 at 4
3:10-16, referring to Ex 2002 at ¶ 43). The embodiment referred to by Barry is one 5
where the medical device has been “previously coated with a polymer/drug agent 6
in accordance with the present invention” and an additional release rate-modifying 7
or modulating layer may be applied in a subsequent coating step. However, Barry 8
has not explained why the optional addition of second polymeric coat to control or 9
modulate release of the drug means that the required polymeric coat does not also 10
work to control release of the drug. Indeed, as we have noted, the specification 11
states that, specifically in the case of a balloon catheter, “the drug is placed in the 12
polymer for controlled release.” (Barry specification at ¶ 0045). 13
As Barry has not pointed to express support for a separate paclitaxel coating, 14
we understand Barry’s argument to be that the specification inherently describes 15
such a separate coating. “To establish inherency, the extrinsic evidence ‘must 16
make clear that the missing descriptive matter is necessarily present in the thing 17
described in the reference, and that it would be so recognized by persons of 18
ordinary skill. ‘Inherency, however, may not be established by probabilities or 19
possibilities. The mere fact that a certain thing may result from a given set of 20
circumstances is not sufficient.’” In re Robertson, 169 F.3d 743, 745, (Fed. Cir. 21
1999) (citations omitted). 22
Barry argues that replication of Example 9 of its specification demonstrates 23
that the paclitaxel forms a “discrete layer” on the balloon catheter. (Barry 24
Opposition 2 at 2:16-20, referring to Kangas Declaration at ¶¶ 12-15). In his 25

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testimony, Dr. Kangas describes preparation and testing of balloons said to have 1
been performed under his supervision and in accordance with the “drip method” of 2
Example 9 of the Barry specification. Dr. Kangas testified that, based upon his 3
review of data obtained from analysis of the “drip method” balloons, he concluded 4
that these balloons have “a discrete layer of paclitaxel residing on the polyurethane 5
[polymer] coating.” (Kangas Declaration at ¶ 15). 6
Because Example 9 is lacking in details of how to form the balloon catheter 7
it discusses, Dr. Kangas testified that it was necessary for him to “fill in the gaps” 8
to make what is said to be a balloon catheter according to Example 9. (Deposition 9
Transcript of Kangas (Ex 2056) at 131:21-24). Dr. Kangas conceded that he had to 10
choose such details as the type of polyurethane polymer, dip speed and time, and 11
ethanol grade. (Deposition Transcript of Kangas at e.g., 131:21-24; 40:5-42:19; 12
52:8-54: 25; 58:9-12; 59:12-20; 61:1-24; 65:17- 66:10; 67: 15-25; 68:1-23;111:9-13
112:1; 113:1-115:17;133:3-135: 25.) Dr. Kangas stated that he did not know what 14
Barry meant by the “dripping” method of Example 9 so he opted to use a method 15
that resulted in the spreading of the drug solution. (Deposition Transcript of 16
Kangas at 134:22-135:9; 113:1-115:17). Dr. Kangas testified that he spun the 17
balloons at a high speed to form a layer of the solution even though spinning is not 18
called for in Example 9. (Deposition Transcript of Kangas at 67:15-25 and 68:1-19
11). Despite the need to fill in the gaps, Dr. Kangas conceded that he did not read 20
the entire Barry specification and that “[he] reviewed Example 9, and….kind of 21
read through some of the other examples” and the claims but “didn’t go into detail 22
on the specification.”7 (Deposition Transcript of Kangas at 31:17-32:1). 23

7 In his testimony Dr. Kangas referred to the ’166 patent which we understand to be Barry
patent 6,306,166 (Ex 1008) which issued from Barry benefit application 09/172,026 and which

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The need for Dr. Kangas to “fill in the gaps” as he did signifies that Example 1
9 does not provide enough information for us to find that a separate paclitaxel layer 2
is inherently described by the Example. Further weighing against such a finding is 3
the express language of Example 9 (and elsewhere in the specification) that 4
paclitaxel is “loaded” into the polymer. (Example 9 at ¶ 0071 and ¶ 0045). 5
Barry urges that Dr. Kangas simply chose parameters and techniques that 6
one of ordinary skill in the art would have used to replicate the example. (Barry 7
Response to Additional Material Facts, Paper 218, in response to SMF 38 and 39). 8
Accepting that Dr. Kangas made choices within the options that were known to 9
those skilled in the art, we have not been directed to evidence sufficient to show 10
that one skilled in the art necessarily would have made the particular choices that 11
Dr. Kangas made. Further, as Dr. Kangas conceded, he did not read the entire 12
Barry specification and thus his choices were not informed by what the Barry 13
specification as a whole would have directed to one skilled in the art. 14
Barry further argues that other data in its specification shows “immediate 15
and sustained release of paclitaxel from a paclitaxel coated balloon” which, 16
according to Barry, “would indicate to one of skill in the art that a layer of drug is 17
present at the outer surface of the balloon.” (Barry Opposition 2 at 2:16-3:3, 18
referring to Barry specification at Figs. 3a, 3b, 9 and Table II (Example 6) and 19
Fifth Declaration of Saltzman (Ex 1067) at ¶¶ 18 and 19, original emphasis). 20
Dr. Saltzman testified: 21
It is my opinion that a person of ordinary skill as of October 1998 22
would have understood such immediate release to indicate that a layer 23
of paclitaxel is present at the outer surface of the balloon. Such data 24
also demonstrate that the polymer layer underneath the drug layer is 25

we understand has the same specification as the involved Barry application.

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not a “release rate-modifying layer. 1
2
(Saltzman Declaration at ¶ 18, referring to the Barry specification at Figures 3
3a, 3b, and 9, Table II, and ¶0043). 4
Dr. Saltzman also testified that: 5
In order to allow extended release of paclitaxel from a balloon, the 6
blood vessel of a patent would be occluded for a period of days, 7
causing complications such as ischemia of the surrounding tissues. 8
Accordingly, as of October 1998, one of ordinary skill in the art 9
would have recognized that prolonged implantation of an inflated 10
angioplasty balloon would be undesirable and that Barry teaches 11
balloon embodiments capable of immediate release of paclitaxel. 12
13
(Saltzman Declaration at ¶ 19). 14
15
Dr. Saltzman refers to figures and tables in the Barry specification but fails 16
to provide much explanation of how he reached his conclusions based on the 17
figures and tables. For example, at Table II “[t]he amount of paclitaxel released in 18
the pig bloodstream, as calculated from the amount of paclitaxel loaded into the 19
[polyacrylic acid-based] coating minus that extracted from the coating after 20
delivery” is reported. Table II reports that after 1 minute 63% of the loaded 21
paclitaxel is released in the bloodstream and that after five minutes 68% of the 22
drug is released. (Barry specification at Example 6 at ¶ 0062 and Table II, 23
emphasis added). 24
Lacking from Dr. Saltzman’s testimony is sufficient explanation of why the 25
release rate of the drug indicates that a separate layer of paclitaxel is formed, 26
particularly when the example itself states that the paclitaxel is “loaded into” the 27
polymer and is “extracted from” the polymer. Elsewhere in the specification, 28
Barry explains that in the balloon catheter “the drug-impregnated polymer coating” 29

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contacts the lumen wall and then “[t]he drug is released from the polymer as it 1
slowly dissolves” which serves to limit drug exposure to the rest of the body. 2
(Barry specification at ¶32). Further, Bates points to evidence that it was known in 3
the art that drug/polymer coated medical devices were known to, at times, have a 4
rapid burst release of the drug. (Bates Reply 2 at 3:7-12, referring to Ex 1055 at 5
124-125, Ex 2051 at 248, Ex 1067 at ¶11, and Ex 2052 at ¶7). 6
Bates further argues that the Barry specification does not provide sufficient 7
description for the claim limitation “wherein the balloon has folds, and [wherein] 8
portions of the dried layer are positioned in the folds.” (Bates Motion 2 at 9-11). 9
Bates also argues that the Barry specification does not provide sufficient 10
description for the limitations of the claims directed to the absence of solvent in the 11
coating, i.e., “dried coating being free of…solvent atop the dried coating,” “dried 12
coating without solvent,” and “substantially free of solvent”. (Bates Motion 2 at 8-13
9). None of these other limitations is argued by Bates to result in unpatentability 14
of all the Barry involved claims. We already determined that all of the Barry 15
involved claims are unpatentable for reasons stated above. Accordingly, we 16
exercise our discretion to not consider the arguments regarding these other 17
limitations. 18
Enablement 19
Bates argues that the Barry application could not have taught how to 20
perform or use the claimed methods or the items recited in those methods since the 21
Barry specification does not show that the inventors had in mind the claims now at 22
issue. (Bates Motion 2 at 16:10-16). 23
The written description requirement is separate and distinct from the 24
enablement requirement. Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 25

-20-
1341(Fed. Cir. 2010). To satisfy the enablement requirement, the specification 1
must teach those skilled in the art how to make and use the full scope of the 2
claimed invention without requiring “undue experimentation”. In re Wright, 999 3
F.2d 1557, 1561, (Fed. Cir. 1993). “The determination of what level of 4
experimentation is ‘undue,’ so as to render a disclosure non-enabling, is made from 5
the viewpoint of persons experienced in the field of the invention.” Elan 6
Pharmaceutical, Inc. v. Mayo Foundation, 346 F.3d 1051, 1055 (Fed Cir. 2003), 7
citing Enzo Biochem, 188 F.3d at 1373–74 as discussing evidence of enablement 8
and nonenablement in an unpredictable field of biotechnology. Thus, as with 9
written description, we consider the viewpoint of persons skilled in the art in 10
determining whether the disclosure is sufficiently enabling of the claimed 11
invention. Factors that are considered in the enablement inquiry include (1) the 12
quantity of experimentation necessary, (2) the amount of direction or guidance 13
presented, (3) the presence or absence of working examples, (4) the nature of the 14
invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) 15
the predictability or unpredictability of the art, and (8) the breadth of the claims. In 16
re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). 17
Enablement is evaluated as of the application filing date. In re Brana, 51 18
F.3d 1560, 1567 n.19 (Fed. Cir. 1995). We therefore evaluate Barry’s enablement 19
from the view point of one skilled as of 13 April 2011, the filing date of the Barry 20
application. Bates’ argument addresses what the Barry specification expressly 21
discloses and does not provide a sufficient discussion of the state of the prior art 22
including what one skilled in the art would have known at the time that would have 23
contributed to the enablement of the Barry claims. For example, the Bates patent 24
issued prior to the Barry filing date and so its teachings were available to one 25

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skilled in the art. 1
Bates did not direct us to sufficient evidence to establish that the claims were 2
not enabled as of the filing date of the involved Barry specification. Bates did not 3
meet its burden of proof as to the enablement issue. Bd. R. 121(b). 4
We GRANT Bates Motion 2 for judgment on the basis that the Barry claims 5
are unpatentable for lack of sufficient support under the first paragraph of 35 6
U.S.C. § 112. 7
Barry Miscellaneous Motion 5 seeking to exclude certain evidence. 8
Barry moves to exclude certain evidence on the basis that the evidence is 9
“inadmissible as hearsay, being made by an unqualified expert witness, and/or 10
lacking proper foundation or authentication.” (Barry Miscellaneous Motion 5 at 11
1). In particular, Barry seeks to exclude portions of Exhibits 2033 and 2034. 12
Exhibit 2033 is a Response filed on 30 June 2014 in European Application 13
No. 10 728 079.4. Exhibit 2034 is the second declaration of Dr. Byrn. (Bates 14
Exhibit List, Paper 233). 15
In deciding Bates Motion 2, we did not rely on either the testimony of Dr. 16
Byrn that was provided in this second declaration or the Response in the European 17
Application. Accordingly, we need not and do not decide whether the evidence 18
should be excluded. 19
Barry Miscellaneous Motion 5 is DISMISSED as moot. 20

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Summary 1
We grant Bates Motion 2 as Bates has shown that the involved Barry claims, 2
lack sufficient written description. As Barry does not have standing in the 3
interference (Bd.R. 201), we do not consider the other motions before us. 4
5
IV. Order 6
It is 7
ORDERED that Bates Motion 2 is GRANTED, 8
FURTHER ORDERED that Bates Motions 3 and 4 and Barry Motions 1, 2, 9
3 and Barry Miscellaneous Motion 5 are DISMISSED; and 10
FURTHER ORDERED that judgment will be entered against Barry in a 11
separate paper. 12

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cc (via electronic):

Attorney for Bates:

Christopher A. Brown
Kenneth A. Gandy
WOODARD, EMHARDT, MORIARTY,
McNETT & HENRY, LLP
cabrown@uspatent.com
kgandy@uspatent.com

Attorney for Barry:

Kristan L. Lansbery
David R. Marsh
ARNOLD & PORTER, LLP
kristan.lansbery@aporter.com
david.marsh@aporter.com