Ex Parte Binyamin et al

Patent Trial and Appeal Board

Dec 12, 2013

11851643 (P.T.A.B. Dec. 12, 2013)

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.
11/851,643 09/07/2007 Gary Binyamin 32164-708.201 9684
21971 7590 12/12/2013
WILSON, SONSINI, GOODRICH & ROSATI
650 PAGE MILL ROAD
PALO ALTO, CA 94304-1050
EXAMINER
WOZNICKI, JACQUELINE
ART UNIT PAPER NUMBER
3774
MAIL DATE DELIVERY MODE
12/12/2013 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 GARY BINYAMIN and
EITAN KONSTANTINO1
__________

Appeal 2011-013714
Application 11/851,643
Technology Center 3700
__________

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

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a stent,
which have been rejected for obviousness. We have jurisdiction under 35
U.S.C. § 6(b).
We affirm.

1 Appellants identify the Real Party in Interest as TriReme Medical, Inc.
(Appeal Br. 3).
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STATEMENT OF THE CASE
Claims 1-5, 7, 27, and 28 are on appeal. Claim 1 is the only
independent claim and reads as follows:
1. A bifurcated stent comprising:
a main stent body adapted for placement in a body lumen adjacent to a
branch lumen, said main stent body having an abluminal surface and a
luminal surface; and
a first type of an anti-proliferative or anti-thrombogenic coating over
at least a portion of the luminal surface and a second type of coating to
promote healing or endothelialization over at least a portion of the abluminal
surface.

The Examiner has rejected claims 1-5, 7, and 27 under 35 U.S.C.
§ 103(a) as obvious based on Grotheim2 and Llanos3 (Answer 44). The
Examiner has rejected claim 28 as obvious based on Grotheim, Llanos, and
Vardi5 (Answer 6).
The Examiner finds that Grotheim discloses a bifurcated stent having
an anti-proliferative or anti-thrombogenic coating on a portion of its surface,
and a coating to promote healing or endothelialization on a portion of its
surface but does not disclose the coatings being on the luminal and
abluminal surfaces (id. at 4-5). The Examiner finds that “Llanos discloses it

2 Grotheim et al., US 2007/0208415 A1, Sept. 6, 2007.
3 Llanos et al., US 2005/0004663 A1, Jan. 6, 2005.
4 The Examiner did not rely on Llanos in the Office Action mailed Aug. 2,
2010. Appellants treated the rejection in the Answer as a new ground of
rejection and addressed it on the merits in their Reply Brief. Appellants also
argued that the Examiner entered a new ground without complying with the
MPEP, but that is an issue that can be reviewed only by way of petition, not
appeal.
5 Vardi et al., US 6,599,316 B2, July 29, 2003.
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is known that drug combinations are used on both surfaces to treat and
effectively control cellular responses” (id. at 5). The Examiner interprets the
claims as “not requir[ing] different coatings on the luminal and abluminal
surfaces;” i.e., “the claims do not prevent layers of coatings . . . or one
coating with both an anti-thrombogenic and an endothelialization agent
present in at least two layers” (id. at 8).
Appellants contend that “a plain reading of the claim language is that
the coating on the abluminal surface is indeed different than the coating on
the luminal surface. This is supported by the specification at paras [0014],
and [0041]” (Reply Br. 8). Appellants contend that “[n]owhere does
Grotheim teach or suggest different coatings on abluminal and luminal
surfaces” (Appeal Br. 6) and that Llanos does not make up for that
deficiency (Reply Br. 7).
The issue presented is whether the claim language requires a stent
having different coatings on the luminal and abluminal surfaces.
Findings of Fact
1. The Specification describes “various methods for coating the struts
of the stent” (Spec. 13, ¶ 42).
2. The Specification states that “the abluminal surface 42 of strut 40
may have at least two layers 46 and 48 applied thereto. . . . [B]oth layers 46
and 48 may be active and/or may contain a desired therapeutic or other
agent.” (id. at 13, ¶ 43.)
3. The Specification states that “a polymeric carrier or therapeutic
agent 50 may be deposited in a well 52 or other reservoir formed in a strut
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56. Optionally, . . . the well 52 may be covered with a membrane or layer 58
which controls release of therapeutic agent from the well.” (Id. at 13, ¶ 44.)
4. Grotheim discloses “a medical device such as a stent for use in a
bifurcated body lumen having a main branch and a side branch” (Grotheim 1,
¶ 13).
5. Grotheim discloses that “[t]he medical device further includes a
coating including at least one therapeutic agent. The coating may be
selectively disposed on the medical device surface.” (Id. at 1, ¶ 16.)
6. Grotheim discloses that “therapeutic agents include, but are not
limited to, anti-thrombogenic agents, anti-proliferative agents, . . . [and]
vascular cell growth promoters” (id. at 4, ¶ 66).
7. Grotheim discloses that “coating layers of different coating
mixtures may be applied to the stent surface” (id. at 4, ¶ 88).
8. Llanos discloses “[t]he use of a heparin barrier coating for
controlling drug release in drug eluting medical devices” (Llanos 4, ¶ 36).
9. Llanos discloses that “the entire inner and outer surface of the stent
100 may be coated with drug/drug combinations in therapeutic dosage
amounts” (id. at 11, ¶ 144).
10. Llanos discloses that “a heparin coating may be utilized as a
barrier for controlling the elution rate of a therapeutic agent . . . from a
medical device, such as a stent” (id. at 50, ¶ 467).
11. Llanos discloses that “heparin may be affixed to one or both
surfaces of a stent (luminal and abluminal) as a therapeutic agent to act as
both an anti-coagulant and an anti-proliferative. In this exemplary
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embodiment; however, heparin . . . also act[s] as a diffusion barrier for other
therapeutic agents formulated in the coating.” (Id.)
12. Llanos discloses that “any number of medical devices with any
number of therapeutic agents may be treated with a heparin coating to
function as a barrier or diffusion coating to control the elution of another
therapeutic agent” (id.).
Principles of Law
During proceedings at the USPTO, “claims are given their broadest
reasonable interpretation consistent with the specification.” In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000). See also In re Zletz, 893 F.2d 319, 321
(Fed. Cir. 1989) (“[D]uring patent prosecution when claims can be amended,
ambiguities should be recognized, scope and breadth of language explored,
and clarification imposed.”).
Analysis
The claims are directed to a stent having “a first type of an anti-
proliferative or anti-thrombogenic coating over at least a portion of the
luminal surface and a second type of coating to promote healing or
endothelialization over at least a portion of the abluminal surface” (claim 1).
The claim does not require the coatings on the luminal and abluminal
surfaces to be different, and does not require the luminal and abluminal
surfaces to have only a single coating layer or a coating containing a single
active agent.
The Specification states that “methods of coating the struts of the
stent” (FF 1) include providing it with “at least two layers . . . contain[ing] a
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desired therapeutic” (FF 2) or depositing a therapeutic agent “covered with a
membrane or layer 58 which controls release of therapeutic agent” (FF 3).
We agree with the Examiner that the broadest reasonable interpretation of
the claims, in light of the Specification, includes a stent having the same
coating on the luminal and abluminal surfaces; specifically, a coating having
two layers, one containing an anti-proliferative or anti-thrombogenic agent
and one containing an agent that promotes healing or endothelialization.
Grotheim discloses a bifurcated stent that includes a coating that
includes at least one therapeutic agent, such as an anti-thrombogenic agent,
an anti-proliferative agent, and/or a vascular cell growth promoter (FFs 5, 6).
Llanos discloses a heparin barrier coating for controlling release of a
therapeutic agent from a stent (FFs 8, 9). Llano discloses that heparin is an
anti-coagulant (i.e., anti-thrombogenic) and anti-proliferative agent and also
acts as a diffusion barrier (FF 11) for “any number of other therapeutic
agents” (FF 12). We agree with the Examiner that it would have been
obvious to modify Grotheim’s stent – which Grotheim suggests coating with
a vascular cell growth promoter – by adding an outer heparin coating to act
as an anti-coagulant and to provide controlled release of the vascular cell
growth promoter.
Appellants argue that Grotheim alone does not provide a reason to
make the claimed stent without the use of hindsight (App. Br. 4-7, Reply Br.
5-6) but this argument does not address what would have been obvious to a
person of ordinary skill in the art based on the collective disclosures of
Grotheim and Llanos.
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Appellants also argue that the claims require a different coating on the
abluminal and luminal surfaces (Reply Br. 8) and that Llanos does not teach
or suggest different coatings on the two surfaces of Grotheim’s stent (id. at
7). Appellants point to the Specification’s paragraphs 14 and 41 as support
for their interpretation of the claim language (id. at 8).
This argument is also unpersuasive because, as discussed above, the
Specification’s paragraphs 42-44 support interpreting claim 1 to read on a
stent having the same coating on both surfaces, where the coating includes a
first layer of an anti-thrombogenic or anti-proliferative agent and a second
layer of an agent that promotes healing or endothelialization. Paragraphs 14
and 41 of the Specification do not support a narrower interpretation of the
claim language because those paragraphs refer to a stent having different
therapeutic agents on the main body of the stent and on the crown of the
stent (the part that extends into a branching blood vessel; Spec. 12, ¶ 40), not
to different coatings on the luminal and abluminal surfaces.
Conclusion of Law
The claim language does not require a stent having different coatings
on the luminal and abluminal surfaces. The rejection of claim 1 as obvious
based on Grotheim and Llanos is affirmed. Claims 2-5, 7, and 27 have not
been argued separately and therefore fall with claim 1. 37 C.F.R.
§ 41.37(c)(1)(vii).
Appellants have waived any arguments directed specifically to the
rejection of claim 28 as obvious based on Grotheim, Llanos, and Vardi (see
App. Br. 7, Reply Br. 8). Therefore, we also affirm the rejection of claim
28. See Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008).
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SUMMARY
We affirm both of the rejections on appeal.
TIME PERIOD FOR RESPONSE
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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