Ex Parte Pacetti

Board of Patent Appeals and Interferences

Jul 27, 2010

09406473 (B.P.A.I. Jul. 27, 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.
09/406,473 09/27/1999 STEPHEN D. PACETTI 50623-00008 1646
7590 07/27/2010
CAMERON KERRIGAN
SQUIRE, SANDERS & DEMPSEY LLP
ONE MARTINE PLAZA
SUITE 300
SAN FRANCISO, CA 94111-3492
EXAMINER
KOHARSKI, CHRISTOPHER
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
07/27/2010 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 STEPHEN D. PACETTI
____________

Appeal 2009-013353
Application 09/406,473
Technology Center 3700
____________

Before JENNIFER D. BAHR, MICHAEL W. O’NEILL, and KEN B.
BARRETT, Administrative Patent Judges.

O’NEILL, Administrative Patent Judge.

DECISION ON APPEAL1
STATEMENT OF THE CASE
Stephen D. Pacetti (Appellant) appeals under 35 U.S.C. § 134 from
the Examiner’s Non-Final Office Action mailed September 7, 2006 rejecting
claims 142, 143, and 147 under 35 U.S.C. § 103(a) as obvious. Appellant

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown in the PTOL-90A cover letter attached to this decision.
Appeal 2009-013353
Application 09/406,473

2
has cancelled claims 1-141, 144-146, and 148-154. We have jurisdiction
under 35 U.S.C. § 6(b).
The Invention
The claims on appeal relate to a sheath adapted to removably cover at
least part of an implantable medical device in the form of a balloon which
carries a therapeutic substance and which is integrated with a catheter. The
sheath has a hollow body and is made of a material capable of preventing the
therapeutic substance from significantly absorbing into the sheath. The
sheath material is a polymeric material having specific ranges of oxygen
transmission rates and water vapor transmission rates at certain parameters
(i.e., 0-200 cc/100 in2 for 1 mil per 24 hours at 73°F, 75% relative humidity
and 1 atmosphere and 0-20 gm/100 in2 for 1 mil per 24 hours at 100°F, 90%
relative humidity and 1 atmosphere, respectively).
Claims 142, 143, and 147, reproduced below in pertinent part,
represent the subject matter on appeal.
142. A sheath comprising
. . .
wherein the polymeric material comprises a polyurethane
having a glass transition temperature above a storage
temperature.

143. A sheath comprising
. . .
wherein the polymeric material comprises a polyurethane
having a non-polar soft segment wherein the non-polar soft
segment is selected from hydrocarbons, silicones,
fluorosilicones, or their mixtures.

147. A sheath comprising
. . .
Appeal 2009-013353
Application 09/406,473

3
wherein the balloon material, sheath material, or both
comprise a therapeutic substance contacting surface,
wherein the therapeutic substance contacting surface
contacts a coating comprising a main-group-element oxide.

The Rejection
The following Examiner’s rejection is before us for review:
Claims 142, 143, and 147 are rejected under 35 U.S.C. § 103(a) as
obvious over Sahatjian2 (U.S. Patent No. 5,674,192, issued Oct. 7, 1997).

SUMMARY OF THE DECISION
We AFFIRM-IN-PART.

OPINION
Issues
The determinative issues in this appeal are:
1) Did the Examiner err in finding it is inherent that polyurethane has
a glass transition temperature (Tg) above its storage temperature?
2) Did the Examiner err in concluding that based upon the Examiner’s
finding of common knowledge, one of ordinary skill in the art would modify
the non-polar segment of the polyurethane of Sahatjian to be selected from
one of the materials recited in claim 143?

2 Appellant’s June 7, 2007 Appeal Brief and December 5, 2007 Reply Brief
both refer to “Sanhatjian” and “Sanhatjiam,” but we are assuming that these
are typographical errors and that Appellant meant to refer to the correct
reference name of “Sahatjian.”

Appeal 2009-013353
Application 09/406,473

4
3) Did the Examiner err in finding that the sheath material comprises a
therapeutic substance contacting surface which is capable of contacting a
coating comprising a main-group-element oxide?
Analysis
Issue (1) -- Inherency with respect to Claim 142
Appellant contends that it is not inherent that polyurethane has a glass
transition temperature (Tg) above its storage temperature. App. Br. 3.
Appellant argues that the Examiner’s interpretation that the storage
temperature can be any temperature is not reasonable because what one of
ordinary skill in the art would understand with respect to the storage
temperature should be considered when the Specification fails to specify the
storage temperature. App. Br. 3. Appellant also argues that even if the glass
transition temperature (Tg) of the sheath material is below the storage
temperature, the Examiner’s supposition that the sheath would then be liquid
or in an unstable form during storage does not necessarily follow. App. Br.
3.
The Examiner’s position is that it is inherent that polyurethane has a
glass transition temperature (Tg) above its storage temperature. Ans. 3. In
an attempt to support that position, the Examiner reasons that since the
storage temperature has not been specified in the Specification, “the
[storage] temperature can be any temperature.” Ans. 4. The Examiner also
alleges that if the glass transition temperature (Tg) were above the storage
temperature, the sheath would be a solid structure, but if the glass transition
Appeal 2009-013353
Application 09/406,473

5
temperature (Tg) were below the storage temperature, “the sheath would be
unstable form during storage.”3 Ans. 5.
When relying on the theory of inherency, the examiner has the initial
burden of providing a basis in fact and/or technical reasoning to reasonably
support the determination that the allegedly inherent characteristic
reasonably flows from the teachings of the applied prior art. See In re King,
801 F.2d 1324, 1327 (Fed. Cir. 1986). This is the case whether the rejection
is based on inherency under 35 U.S.C. § 102, prima facie obviousness under
35 U.S.C. § 103, or both jointly or alternatively. See In re Best, 562 F.2d
1252, 1255 (CCPA 1977); see also In re Napier, 55 F.3d 610, 613 (Fed. Cir.
1995) (“The inherent teaching of a prior art reference, a question of fact,
arises both in the context of anticipation and obviousness.”) “In relying
upon the theory of inherency, the examiner must provide a basis in fact
and/or technical reasoning to reasonably support the determination that the
allegedly inherent characteristic necessarily flows from the teachings of the
applied prior art.” Ex parte Levy, 17 USPQ2d 1461, 1464 (BPAI 1990).
We find that the Examiner has not met the initial burden because the
Examiner failed to provide a basis in fact and/or technical reasoning to
reasonably support the determination that polyurethane inherently has a
glass transition temperature (Tg) which is above the storage temperature.
Moreover, the allegedly inherent characteristic of polyurethane having a
glass transition temperature (Tg) above the storage temperature does not
necessarily flow from the teachings of Sahatjian.

3 It is noted that the September 7, 2006 Office Action stated on the bottom of
page 2 that “the sheath would be a liquid or unstable form during storage,”
and this language was changed to the above-quoted language in the Grounds
of Rejection section of the Examiner’s Answer.
Appeal 2009-013353
Application 09/406,473

6
Indeed, the Examiner has not provided sufficient evidence to show
that one of ordinary skill in the art would understand the claim terminology
of “storage temperature” to be any temperature in order to support the
Examiner’s broad interpretation. The scope of the claims in patent
applications is determined not solely on the basis of the claim language, but
upon giving claims “their broadest reasonable interpretation consistent with
the specification” and “in light of the specification as it would be interpreted
by one of ordinary skill in the art.” In re Am. Acad. of Sci. Tech. Ctr., 367
F.3d 1359, 1364 (Fed. Cir. 2004). Thus, even though the storage
temperature is not specified in the Specification, it was not reasonable for
the Examiner to find that any temperature would suffice. Rather, the
Examiner should have considered how the ordinary skilled artisan would
have interpreted the claim terminology of “storage temperature.” The
Examiner has not justified the broad interpretation of the storage
temperature being any temperature and the Examiner’s broad interpretation
would effectively read the “storage temperature” limitation out of the claim
as being superfluous. See Stumbo v. Eastman Outdoors, Inc., 508 F.3d
1358, 1362 (Fed. Cir, 2007) (denouncing claim constructions which render
phrases in claims superfluous). On the record before us, we cannot conclude
that the Examiner applied a correct construction of “storage temperature.”
Additionally, the Examiner’s findings that if the glass transition
temperature (Tg) were above the storage temperature, the sheath would be a
solid structure, and if the glass transition temperature (Tg) were below the
storage temperature, the sheath would be a liquid or unstable form during
storage, fail to provide a basis in fact and/or technical reasoning to
reasonably support the determination that polyurethane inherently has a
Appeal 2009-013353
Application 09/406,473

7
glass transition temperature (Tg) which is above the storage temperature.
Indeed, the Examiner’s findings show an incorrect understanding of the term
“glass transition temperature (Tg)” which is not a melting point marking the
change from a solid state to a liquid state as occurs in crystalline polymers,
but rather is the temperature where amorphous polymers change from being
hard and brittle to being soft and pliable. Thus, it does not necessarily
follow that if the glass transition temperature (Tg) were below the storage
temperature, the sheath material would not be solid or would be unstable.
In view of the foregoing, the Examiner’s decision to reject claim 142
under 35 U.S.C. § 103(a) as being obvious over Sahatjian cannot be
sustained.
Issue (2) -- Official Notice with respect to Claim 143
The Examiner’s position is that “[i]t is common knowledge in the
chemical art to modify the non-polar segments in order to provide properties
such as flexibility and bendability which are desired in the medical arts.
Ans. 5. From this finding of common knowledge, the Examiner concluded
that “it would have been obvious to modify any medically acceptable
material to the essential properties, which are desired.” Ans. 5.
Appellant contends that even accepting the Examiner’s finding of
what is common knowledge in the art, one of ordinary skill in the art would
not be lead to modify the non-polar segment of the polyurethane of Sahatjian
to be selected from the particular materials of hydrocarbons, silicones,
fluorosilicones, and mixtures thereof as recited in claim 143. App. Br. 6.
We agree with Appellant that even accepting the Examiner’s finding
that “[i]t is common knowledge in the chemical art to modify the non-polar
segments in order to provide properties such as flexibility and bendability
Appeal 2009-013353
Application 09/406,473

8
which are desired in the medical arts,” the Examiner has not established that
one of ordinary skill in the art would have been lead to modify the non-polar
segment of the polyurethane of Sahatjian to be selected from any one of
hydrocarbons, silicones, fluorosilicones, or their mixtures as recited in claim
143. This is because the Examiner’s finding of common knowledge is
directed to properties such as flexibility and bendability, but is not directed
to the materials which would have been recognized by a person of ordinary
skill in the art as having such properties. In other words, the Examiner has
not made any finding that materials such as hydrocarbons, silicones,
fluorosilicones, or mixtures thereof, would have been recognized by persons
of ordinary skill in the art as having properties rendering them suitable for
use as the non-polar segment of the polyurethane of Sahatjian.
Based on the foregoing, the Examiner’s decision to reject claim 143
under 35 U.S.C. § 103(a) as being obvious over Sahatjian cannot be
sustained.
Issue (3) -- Obviousness of Claim 147
Appellant contends that Sahatjian fails to disclose the claim
recitations of “wherein the balloon material, sheath material, or both
comprise a therapeutic substance contacting surface,” and “wherein the
therapeutic substance contacting surface contacts a coating comprising a
main-group-element oxide.” App. Br. 8.
The Examiner’s position is as follows:
The Examiner is considering the limitation of the
main group element oxide to not be positively
claimed. The sheath material has a contacting
surface which is considered by the Examiner to be
the inner/internal surface of the sheath. The
Appeal 2009-013353
Application 09/406,473

9
Examiner is considering the coating to be on the
balloon which is not being positively recited. Thus,
it is the Examiner's position that the sheath has a
contacting surface which is capable of contacting a
balloon which could have a main-group-element
oxide.

Ans. 9.
Although the Appellant filed a Reply Brief, Appellant’s Reply
Brief does not refute the Examiner’s above-quoted clarification of the
Examiner’s position.
We note that Appellant has the burden on appeal to the Board to
demonstrate error in the Examiner’s position. See In re Kahn, 441 F.3d 977,
985-86 (Fed. Cir. 2006) (“On appeal to the Board, an applicant can
overcome a rejection [under § 103] by showing insufficient evidence of
prima facie obviousness or by rebutting the prima facie case with evidence
of secondary indicia of nonobviousness.”) (quoting In re Rouffet, 149 F.3d
1350, 1355 (Fed. Cir. 1998)).
More particularly, the Appellant has made arguments with respect to
these claims which simply state, in whole or in part, that the references do
not disclose or suggest certain claimed features – without responding to the
Examiner’s reasoning in establishing a prima facie case of obviousness. A
general allegation that the art does not teach any of the claim limitations is
no more than merely pointing out the claim limitations. A statement which
merely points out what a claim recites will not be considered an argument
for separate patentability of the claim. 37 C.F.R. § 41.37(c)(1)(vii).
Appellant’s statements in the Appeal Brief that Sahatjian fails to teach
or suggest the limitations of claim 147 are a general allegation that the art
Appeal 2009-013353
Application 09/406,473

10
does not teach the claim limitations. We do not find the general allegation to
be a convincing argument for separate patentability of the claim.
Based on the foregoing, the Examiner’s rejection of claim 147 under
35 U.S.C. §103(a) as being obvious over Sahatjian is sustained.

CONCLUSIONS
The Examiner erred in finding that it is inherent that polyurethane has
a glass transition temperature (Tg) above its storage temperature.
The Examiner erred in concluding that one of ordinary skill in the art
would have modified the non-polar segment of the polyurethane of Sahatjian
to be selected from any one of hydrocarbons, silicones, fluorosilicones, and
mixtures thereof in view of the Examiner’s finding of common knowledge.
The Examiner did not err in finding that the sheath material comprises
a therapeutic substance contacting surface which is capable of contacting a
coating comprising a main-group-element oxide.

DECISION
We reverse the Examiner’s decision to reject claims 142 and 143 as
being obvious under 35 U.S.C. §103(a) over Sahatjian. We affirm the
Examiner’s rejection of claim 147 as being obvious under 35 U.S.C. §103(a)
over Sahatjian.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv) (2007).

AFFIRMED-IN-PART
Appeal 2009-013353
Application 09/406,473

11

mls

CAMERON KERRIGAN
SQUIRE, SANDERS & DEMPSEY LLP
ONE MARTINE PLAZA
SUITE 300
SAN FRANCISCO, CA 94111-3492