Ex Parte Kopia et al

Board of Patent Appeals and Interferences

May 17, 2010

09575480 (B.P.A.I. May. 17, 2010)

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.
09/575,480 05/19/2000 Gregory A Kopia CRD-850USNP 1106
7590 05/17/2010
Philip S. Johnson
Johnson & Johnson
One Johnson & Johnson Plaza
New Brunswick, NJ 08933
EXAMINER
NGUYEN, CAMTU TRAN
ART UNIT PAPER NUMBER
3772
MAIL DATE DELIVERY MODE
05/17/2010 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 GREGORY A. KOPIA, GERALD H. LLANOS,
and ROBERT FALOTICO
__________

Appeal 2008-006026
Application 09/575,480
Technology Center 3700
__________

Decided: May 17, 2010
__________

Before TONI R. SCHEINER, FRANCISCO C. PRATS, and STEPHEN
WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for treating restenosis. The Patent Examiner rejected the claims on
the ground of anticipation and obviousness. We have jurisdiction under
35 U.S.C. § 6(b). We affirm-in-part.
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STATEMENT OF THE CASE
Claims 1, 3, 4, 6, 8 and 9, which are all the pending claims, are on
appeal. Claims 1 and 9 are illustrative and read as follows:
1. A method for treating restenosis comprising an intravascular infusion
or delivery by release from a surface of a stent of a combination of at
least two agents, including an anti-proliferative agent for inhibiting
smooth muscle cell growth comprising rapamycin or an analogue
thereof and an anti-inflammatory agent for inhibiting smooth muscle
growth, both said agents contained in therapeutic dosage amounts.

9. The method of claim 8 wherein the inhibitor of extracellular matrix
synthesis comprises halofuginone and the anti-proliferative agent is
taken from a group consisting of rapamycin, taxol, or vincristine.

The Examiner rejected the claims as follows:
• claims 1, 3, 4 and 6 under 35 U.S.C. § 102 (a and/or e) as being
anticipated by Kamath;1 and
• claims 8 and 9 under 35 U.S.C. § 103(a) as unpatentable over
Kamath and Nagler.2

ANTICIPATION and OBVIOUSNESS
The Issue
The Examiner’s position is that Kamath described a method of
treating restenosis via stent with the anti-proliferative agent TAXOL® and
an anti-inflammatory agent. (Ans. 4-5.) The Examiner interpreted the claim
term “analogue” to include a compound similar in function to another,
relying on the American Heritage Dictionary. (Id. at 6.) It is undisputed

1 Kalpana R. Kamath et al., US 6,335,029 B1, issued Jan. 1, 2002.
2 Arnon Nagler et al., US 6,159,488, issued Dec. 12, 2000.
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that TAXOL® and rapamycin function as anti-proliferative agents. Relying
on that functional similarity, the Examiner found that Kamath’s TAXOL® is
fairly treated as the rapamycin “analogue” recited in the claims, and that
Kamath’s method of delivering TAXOL® therefore anticipated Appellants’
method of delivering an anti-proliferative rapamycin analogue. The
obviousness rejection of claim 8 rested on the same interpretation of
“analogue.”
Appellants contend that treating TAXOL® as a rapamycin analogue
is “an improper characterization.” (App. Br. 5.) According to Appellants,
paclitaxel (the compound in TAXOL®) and rapamycin have different
structures and cannot be characterized as “analogues.” (Id. at 5-6.)
Appellants rely on a technical dictionary, and argue that “analogue” in the
pharmaceutical sense means “a chemical compound with a structure similar
to that of another but differing from it in respect to a certain component.”
(Id. at 7, citing Dorland’s Illustrated Medical Dictionary.) Appellants
contend that under that definition, TAXOL® is not a rapamycin analogue
and Kamath did not anticipate the claimed method (id.), nor could Kamath
and Nagler render the claimed invention obvious (id. at 8.)
The controlling issue in this appeal is the proper interpretation of the
term “analogue” in the claim phrase “rapamycin or an analogue thereof.”

Findings of Fact
1. The Specification states: “[a]ntiproliferative action on SMC in vitro
has been demonstrated for many of these agents including heparin and
heparin conjugates, taxol, tranilast, colchicine, ACE inhibitors, fusion
toxins, antisense oligonucleotides, rapamycin an ionizing radiation.
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Thus, agents with diverse mechanisms of SMC inhibition may have
therapeutic utility in reducing intimal hyperplasia.” (Spec. 5:17-21.)
2. The Specification does not use or define the term “analogue,” nor did
the original claims use it.
3. Kamath described methods for the controlled, localized delivery of
bioactive agents to target location within a body. (Kamath, col. 3, ll.
27-29.)
4. Kamath described a method using a stent. (Id. at col. 3, ll. 57-67.)
5. Kamath described stent delivery of an anti-proliferative agent such as
paclitaxel (commercially available as TAXOL®) in combination with
an anti-inflammatory agent. (Id. at col. 6, ll. 6-24.)
6. We find that a person of ordinary skill in the art has a medical
background.

Principles of Law
[T]he PTO applies to the verbiage of the proposed claims the
broadest reasonable meaning of the words in their ordinary
usage as they would be understood by one of ordinary skill in
the art, taking into account whatever enlightenment by way of
definitions or otherwise that may be afforded by the written
description contained in the applicant’s specification.

In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997) (emphasis added).

Because dictionaries, and especially technical dictionaries,
endeavor to collect the accepted meanings of terms used in
various fields of science and technology, those resources have
been properly recognized as among the many tools that can
assist the court in determining the meaning of particular
terminology to those of skill in the art of the invention.

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Phillips v. AWH Corp., 415 F.3d 1303, 1318 (Fed. Cir. 2005) (emphasis
added).
“To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or inherently.” In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (citations omitted).
When determining whether a claim is obvious, an Examiner must
make “a searching comparison of the claimed invention – including all its
limitations – with the teaching of the prior art.” In re Ochiai, 71 F.3d 1565,
1572 (Fed. Cir. 1995).

Analysis
The main issue in this appeal is the proper interpretation of the claim
term “analogue.” Intrinsic evidence is little help in interpreting the meaning
of “analogue” because the word did not appear in the Specification as it was
originally filed. Looking to the extrinsic evidence, the Examiner and
Appellants provide dueling dictionary definitions, the Examiner’s definition
referencing only functional similarity, the Appellants’ definition referencing
structural similarity.
The claim is to be interpreted “as [it] would be understood by one of
ordinary skill in the art.” Morris, 127 F.3d at 1054. We find Dorland’s
Illustrated Medical Dictionary more pertinent to the art than the more
general American Heritage Dictionary. We find it likely that a person of
ordinary skill in this art, having a medical background (FF 6), would
interpret a claim to medical treatment in light of how terms are used in the
medical field. See Phillips, 415 F.3d at 1318. That is, “analogue” of
rapamycin means a compound with a structure similar to rapamycin. The
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Examiner has not shown that paclitaxel has a structure similar to rapamycin.
Accordingly, we will reverse the rejection under § 102. As the rejection of
claim 8 under § 103(a) was based on the same claim interpretation, we will
reverse it as well.
The method defined by claim 9 includes delivering an “anti-
proliferative agent [] taken from a group consisting of rapamycin, taxol, or
vincristine.” As Kamath taught delivering paclitaxel, commercially
available as TAXOL®, the evidence supports the rejection of claim 9 under
§ 103(a). Appellants’ only argument against the rejection of claim 9 is that
because Kamath “falls short” as an anticipating reference, it also “falls
short” as a § 103 reference. That general argument overlooks claim 9’s
particular terms.

CONCLUSION
We interpret “analogue” to mean a compound with a structure similar
to that of another. Given that interpretation, paclitaxel is not an analogue of
rapamycin.

SUMMARY
We reverse the rejection of claims 1, 3, 4 and 6 under 35 U.S.C. § 102
(a and/or e) as being anticipated by Kamath.
We reverse the rejection of claim 8 under 35 U.S.C. § 103(a) as
unpatentable over Kamath and Nagler.
We affirm the rejection of claim 9 under 35 U.S.C. § 103(a) as
unpatentable over Kamath and Nagler.

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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-IN-PART

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PHILIP S. JOHNSON
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK NJ 08933