Ex Parte Schmitz et al

Patent Trial and Appeal Board

Sep 18, 2014

12251173 (P.T.A.B. Sep. 18, 2014)

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.
12/251,173 10/14/2008 Klaus-Peter Schmitz TEPH 113 CIP (2) 5107
23579 7590 09/18/2014
Pabst Patent Group LLP
1545 PEACHTREE STREET NE
SUITE 320
ATLANTA, GA 30309
EXAMINER
SCHALL, MATTHEW WAYNE
ART UNIT PAPER NUMBER
3738
MAIL DATE DELIVERY MODE
09/18/2014 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 parte KLAUS-PETER SCHMITZ, DETLEF BEHREND,
KATRIN STERNBERG, NEILS GRABOW,
DAVID P. MARTIN, and SIMON F. WILLIAMS
__________

Appeal 2012-007478
Application 12/251,173
Technology Center 3700
__________

Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to an
absorbable biocompatible stent. The Examiner rejected the claims as
anticipated and as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1 Appellants identify the Real Party in Interest as Tepha, Inc. (see
App. Br. 2).
Appeal 2012-007478
Application 12/251,173

2
Statement of the Case
Background
“Stents are currently used in a range of medical applications normally
to prevent re-occlusion of a vessel after a procedure to dilate the vessel”
(Spec. 1, ll. 15-16). “To address the disadvantages associated with the use
of permanent materials in stents and stent coatings, there have been several
reports describing the use of absorbable materials to make stents and stent
coatings” (Spec. 2, ll. 26-28).
The Specification teaches “[a]bsorbable stents and stents coated with
absorbable materials have been developed that have improved properties”
(Spec. 9, ll. 26-27).
The Claims
Claims 1-30 are on appeal. Claim 1 is representative and reads as
follows:
1. A biocompatible stent comprising a base coat and
optionally a top coat, wherein the base coat comprises a
blend of poly(4-hydroxybutyrate) (P(4HB)), and
poly(lactide) (PLA), and one or more therapeutic, diagnostic
or prophylactic agents.

The issues
A. The Examiner rejected claims 1, 2, 9-16, 19-24, and 26-30 under 35
U.S.C. § 102(e) as anticipated by Hossainy2 (Ans. 4-5).
B. The Examiner rejected claims 6 and 7 under 35 U.S.C. § 103(a) as
obvious over Hossainy (Ans. 5).

2 Hossainy et al., US 2006/0147412 A1, published Jul. 6, 2006.
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Application 12/251,173

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C. The Examiner rejected claims 3-5, 8, 17, and 18 under 35 U.S.C.
§ 103(a) as obvious over Hossainy and Levenberg3 (Ans. 6).
D. The Examiner rejected claim 25 under 35 U.S.C. § 103(a) as obvious
over Hossainy and Williams4 (Ans. 6-7).
A. 35 U.S.C. § 102(e) over Hossainy
The Examiner finds that
Hossainy discloses an absorbable biocompatible stent or
stent coatings comprising a blend of PLLA and P4HB
(paragraphs [0010], [0021], [0031], [0088] and [0095]).
Hossainy further discloses the stent optionally comprises
tacrolimus or rapamycin (paragraph [0062]). Hossainy
further discloses coating a stent as described above with a
base coat and optionally a top coat, comprising a blend of
P4HB and PLLA and a therapeutic agent (paragraphs
[0199]-[0205]). Hossainy further discloses concentrations
of the agent that include about 2 µg/mm2 (paragraph
[0086]). Hossainy further discloses triethylcitrate in a
concentration between 0.01 and 10% (paragraphs [0066],
[0070] and [0075]). Hossainy further discloses the stent is
metallic (paragraph [0018]). Hossainy further discloses
balloon expanding the stent (paragraphs [0005] and [0200]).

(Ans. 4-5).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Hossainy anticipates the
claims?

3 Levenberg et al., US 2005/0031598 A1, published Feb. 10, 2005.
4 Williams et al., US 6,548,569 B1, issued Apr. 15, 2003.
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Application 12/251,173

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Findings of Fact
1. The Specification teaches that “the stent is a metallic stent
coated with a base coating containing a blend of poly(4-hydroxybutyrate)
(P(4HB)) and poly(L-lactide) (PLLA)” (Spec. 6, ll. 21-23).
2. Figure 1 of the Specification shows the structure of poly(4-
hydroxybutyrate) as reproduced below:

“Figure 1 is the chemical structure of poly(4-hydroxybutyrate) (P(4HB)”
(Spec. 8, l. 14).
3. The Specification teaches that “‘Poly( 4-hydroxybutyrate)’ as
generally used herein means a homopolymer comprising 4-hydroxybutyrate
units. It may be referred to herein as P(4HB)” (Spec. 9, l. 29 to 10, l. 1).
4. Hossainy teaches “polymers containing poly
(hydroxyalkanoates) and agents such as diagnostic, prophylactic,
therapeutic, ameliorative, and other agents, for use with medical articles.
The polymers can be used in medical articles such as, for example, stents”
(Hossainy 1 ¶ 10).
Appeal 2012-007478
Application 12/251,173

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5. Hossainy teaches that:
The PHA compositions of the present invention
include any combination of polymers, copolymers and
agents, wherein the combination comprises a
hydroxyalkanoate moiety. Polymers comprising
hydroxyalkanoate moieties can be biodegradable due to the
labile nature of the ester groups that can be present between
at least the hydroxyalkanoate moieties.

(Hossainy 2 ¶ 20).
6. Hossainy teaches that “[e]xamples of other polymers that can
be combined with the PHAs of the present invention include . . . poly(L-
lactide)” (Hossainy 3 ¶ 31).
7. Hossainy teaches that the “term ‘PHA’ refers to a polymeric
composition that contains a hydroxyalkanoate, which is a hydroxyacid
moiety that contains an alkane with hydroxyl and carboxyl functionality”
(Hossainy 10 ¶ 88).
8. Hossainy teaches that a “polymer of the present invention can
comprise a polymeric carrier having an A-moiety (A), a B-moiety (B), and
an optional linkage (L1) connecting A to B” (Hossainy 10 ¶ 91).
9. Hossainy teaches a formula I as shown below

where the “the A:B ratio can be less than, greater than, or equal to one; both
A and B can be independently selected, and comprise any combination of
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Application 12/251,173

6
monomers such that the polymer has at least one hydroxyalkanoate
group . . . and z is an integer not equal to zero” (Hossainy 10 ¶¶ 91-92).
10. Hossainy teaches that in “some embodiments, the composition
can comprise . . . 4-hydroxybutyrate” (Hossainy 10 ¶ 95).
11. Hossainy teaches that “B . . . can include a polyol, a
polycarboxylic acid, an amino acid, or a combination thereof” (Hossainy 12
¶ 107).
Principles of Law
The Examiner bears the initial burden of establishing a prima facie
case of anticipation. In re King, 801 F.2d 1324, 1326-27 (Fed. Cir. 1986).
Anticipation under 35 U.S.C. § 102 requires that “each and every element as
set forth in the claim is found, either expressly or inherently described, in a
single prior art reference.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir.
1999).
Analysis
Claim Interpretation
We begin with claim interpretation since it is a necessary prerequisite
for comparing the claim to the prior art. Claim 1 requires the use of a blend
of poly(4-hydroxybutyrate) (also called P(4HB)) and poly(lactide) (also
called (PLA)) on the stent. The issue presented here is whether poly(4-
hydroxybutyrate) is a homopolymer.
The Examiner finds that “Appellant has not claimed a homopolymer.
Claim 1 requires multiple monomers of P(4HB) and multiple monomers of
PLA” (Ans. 8).
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Appellants contend that “[p]oly(4-hydroxybutyrate) (P(4HB)) is a
polymer made of repeating units of the same monomer, 4-
hydroxybutyrate. . . . Thus, P4HB is a homopolymer” (Reply Br. 4).
We find that Appellants have the better position. The Specification
explicitly defines “Poly( 4-hydroxybutyrate)” to mean “a homopolymer
comprising 4-hydroxybutyrate units” and further states that it may be
referred to herein as P(4HB) (FF 3). This express definition in the
Specification controls the meaning of poly(4-hydroxybutyrate). See Phillips
v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (“[O]ur cases
recognize that the specification may reveal a special definition given to a
claim term by the patentee that differs from the meaning it would otherwise
possess. In such cases, the inventor’s lexicography governs.”)
Hossainy
The Examiner finds that “[e]ven if the claim language was viewed to
require a homopolymer of P(4HB), the disclosure of Hossainy rejects this as
well. Even considering the embodiments of paragraphs [0091]-[0094], the
polymer is comprised of monomers (see paragraph [0092], line 3) of any
combination of the list of paragraph [0095], which includes P(4HB)” (Ans.
8-9).
We agree with Appellants that Hossainy does not teach a
homopolymer comprising 4-hydroxybutyrate units (see, e.g., Reply Br. 4).
While Hossainy teaches stents with polymer blends (FF 4-5), where one of
the polymers may be PLA (FF 6), and where one of the polymers may
comprise 4-hydroxybutyrate (FF 10), there is no teaching in Hossainy to
form homopolymers that comprises repeat units of only 4-hydroxybutyrate.
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The Examiner’s reliance on paragraphs [91]-[95] of Hossainy is not
persuasive. In those paragraphs, Hossainy teaches hydroxyalkanoate
polymers composed of two moieties, an “A” and a “B” moiety (FF 8) which
is necessarily a copolymer that requires the presence of both the “A” and
“B” moieties, since z cannot equal zero (FF 9). While Hossainy teaches that
the “A” moiety can be composed of 4-hydroxybutyrate (FF 10), Hossainy
further teaches that “B . . . can include a polyol, a polycarboxylic acid, an
amino acid, or a combination thereof” (Hossainy 12 ¶ 107; FF 11). The
Examiner has not identified any teaching in Hossiany that both the “A” and
“B” moieties may be 4-hydroxybutyrate, thereby forming a homopolymer.
Rather, the Examiner selectively picked a single moiety identified for the
copolymer taught by Hossiany in order to assert that the claimed stent
comprising a homopolymer coating is anticipated.
To the extent that there may be some suggestion in Hossainy,
unidentified by the Examiner, to select 4-hydroxybutyrate as both the “A”
and “B” moieties, the Court has stated that an anticipatory reference under
35 U.S.C. § 102 “must clearly and unequivocally disclose the claimed
compound or direct those skilled in the art to the compound without any
need for picking, choosing, and combining various disclosures not directly
related to each other by the teachings of the cited reference.” In re Arkley,
455 F.2d 586, 587-588 (CCPA 1972).
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Hossainy anticipates the claims.
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Application 12/251,173

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B.-D. 35 U.S.C. § 103(a)
These rejections rely upon the underlying anticipation rejection over
Hossainy. Having reversed the rejection of claim 1, we also necessarily
reverse these obviousness rejections because none of the additionally cited
prior art is relied upon to teach the poly(4-hydroxybutyrate) homopolymer
as required by independent claim 1, upon which all of the rejected claims
depend.
SUMMARY
In summary, we reverse the rejection of claims 1, 2, 9-16, 19-24, and
26-30 under 35 U.S.C. § 102(e) as anticipated by Hossainy.
We reverse the rejection of claims 6 and 7 under 35 U.S.C. § 103(a)
as obvious over Hossainy.
We reverse the rejection of claims 3-5, 8, 17, and 18 under 35 U.S.C.
§ 103(a) as obvious over Hossainy and Levenberg.
We reverse the rejection of claim 25 under 35 U.S.C. § 103(a) as
obvious over Hossainy and Williams.

REVERSED
tc