Ex Parte 7,749,585 et al

Patent Trial and Appeal Board

Mar 3, 2016

95001484 (P.T.A.B. Mar. 3, 2016)

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.
95/001,484 11/12/2010 7,749,585 RI2601392 8239
40401 7590 03/04/2016
Hershkovitz and Associates, PLLC
2845 Duke Street
Alexandria, VA 22314
EXAMINER
TILL, TERRENCE R
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
03/04/2016 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 PATENT TRIAL AND APPEAL BOARD
____________

MEDTRONIC VASCULAR, INC.
Requester and Cross-Appellant

v.

MEDTECH CAPITAL VENTURES, LLC
Patent Owner and Appellant
____________

Appeal 2015-004356
Reexamination Control 95/001,484
Patent 7,749,585 B2
Technology Center 3900
____________

Before MARK NAGUMO, JEFFREY B. ROBERTSON, and
RAE LYNN P. GUEST, Administrative Patent Judges.

GUEST, Administrative Patent Judge.

DECISION ON APPEAL

Medtech Capital Ventures, LLC (hereinafter “Patent Owner”), appeals
from the Patent Examiner’s decision to reject pending claims 1–38 in an
inter partes reexamination of U.S. Patent 7,749,585 B2 (hereinafter “the
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’585 patent”).1 See Patent Owner’s Appeal Brief, filed April 3, 2014
(hereinafter “PO App. Br.”). Medtronic Vascular Inc. (hereinafter
“Requester”) filed a cross-appeal from the Patent Examiner’s decision not to
adopt proposed rejections of the claims. See Requester’s Cross-Appeal
Brief, filed April 21, 2014 (hereinafter “Req. App. Br.”). The Board’s
jurisdiction for this appeal is under 35 U.S.C. §§ 6(b), 134, and 315 (pre-
AIA). We AFFIRM.
I. BACKGROUND
The ’585 patent is directed to a medical dilation balloon, such as those
used in angioplasty dilation and the like, that is shrunk radially while
restraining axial shrinkage to exhibit a customizable linear or non-linear
compliance curve upon subsequent expansion, and a lower crosslinking
profile relative to the same balloon before shrinking. See ’585 patent,
Abstract, col. 1, ll. 25–45.
The technology described in the ’585 patent is related to a trade secret
litigation in New York State Supreme Court, styled Zylon, Corp. v.
Medtronic, Inc., Case Number 650523/08 (filed December 2008). PO App.
Br. 1.
Claims 1–38 are pending and stand rejected. An oral hearing was
held August 27, 2015. A transcript of the hearing was entered into the
record on February 24, 2016.

1 The ’585 patent issued July 6, 2010 to Alan Zamore and included original
claims 1–25. Claims 26–38 were added during this inter partes
reexamination.
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IA. Appeal by Patent Owner
Patent Owner appeals the following rejections maintained by the
Examiner:
1. Claims 1–27, 31–35, and 38 under 35 U.S.C. §102(b) as
anticipated by Muni2 (Ground 1, RAN 5);
2. Claims 26, 27, 31, 33, and 38 under 35 U.S.C. § 103(a) as
obvious over Muni in view of admitted prior art (APA) of
the ’585 Patent (Ground 11, RAN 20);
3. Claims 26–38 under 35 U.S.C. § 103(a) as obvious over
Muni (Ground 17; RAN 28).
Patent Owner expressly withdraws the appeal of the Examiner’s
rejection of claims 27, 30, 33, 35, and 36 under 35 U.S.C. § 112, first
paragraph, for failing to comply with the written description requirement
(Ground 14; RAN 23). See PO App. Br. 4. Accordingly, we summarily
affirm the Examiner’s rejection under 35 U.S.C. § 112, first paragraph.

IB. Appeal by Requester
Requester appeals the Examiner’s decision not to maintain additional
grounds of rejection as being “cumulative” of the rejections based on Muni
(Grounds 2–7), based on the additional prior art being “non-analogous” art
(Grounds 12–13), and based on the Examiner’s finding of no lack of written
descriptive support or indefiniteness under 35 U.S.C. § 112. Req. App. Br.
3. Patent Owner submits no response to Requester’s cross-appeal brief.

2 U.S. Patent 5,533,968, issued July 9, 1996, to Ketan P. Muni, et al.
(hereinafter “Muni”).
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IC. Claim 1
Claim 1 is an original patent claim, is representative of the claims
rejected on Ground 1, and reads as follows:
1. An axially restrained-shrunk catheter balloon comprising an
axially stretched polymer wherein the catheter balloon is
continuous and radially re-expandable.

Claim 26 is a new claim added during the appeal, is
representative of the claims rejected on Ground 11 and 17, and reads
as follows (indentation added for clarity):
26. An axially restrained-shrunk catheter balloon comprising
an axially stretched polymer
wherein the axially restrained-shrunk catheter balloon is
continuous and radially re-expandable and
wherein the axially restrained-shrunk catheter balloon is
made from a biaxially stretch oriented balloon.

II. APPEAL BY PATENT OWNER
1. ANTICIPATION BY MUNI
Claims 1–27, 31–35, and 38 stand rejected as anticipated under
35 U.S.C. § 102(b) over Muni. The Examiner determined that Muni
describes that a preformed balloon is “attached to the catheter and then heat
shrunk. Thus, the ends are prevented from shrinking axially (axially
restrained).” RAN 5. Patent Owner disputes this finding.
Patent Owner contends that the term “axially restrained shrunk” in
claim 1 “means ‘controlled restraint,’ and that ‘controlled restraint’ has a
specific meaning” namely that “axial shrinkage is controlled (restrained) by
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restraining axial shrinkage during the radial shrinkage of the catheter balloon
prior to mounting of the balloon into the catheter.” PO App. Br. 6; PO Reb.
Br. 3. Accordingly, Patent Owner contends that Muni cannot anticipate the
claims because it radially shrinks the balloon while it is attached to the
balloon catheter. Id. at 6–7. We disagree with the Patent Owner’s
interpretation of the phrase “axially restrained shrunk.”
Claims 1 and 22 are directed to a catheter balloon product and not a
method of making a catheter balloon. As such, it is the patentability of the
product defined by the claim, rather than the process for making it that we
must gauge in light of the prior art. In re Wertheim, 541 F.2d 257, 271
(CCPA 1976); In re Brown, 459 F.2d 531, 535 (CCPA 1972); In re Thorpe,
777 F.2d 695, 697 (Fed. Cir. 1985) (“If the product in a product-by-process
claim is the same as or obvious from a product of the prior art, the claim is
unpatentable even though the prior product was made by a different
process.”); see also SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d
1312, 1317 (Fed. Cir. 2006). Thus, the claim does not preclude the balloon
axially restrained after being attached to a balloon, as opposed to before
attachment to the balloon, if the structure of the balloon produced by the two
methods is not distinguishable.
Patent Owner argues that the “restraining step . . . involves holding
the ends of the balloon in a fixed position” so that a “radially smaller balloon
is obtained with the axial dimension (length) remaining as it was prior to
heat application.” PO App. Br. 7. Accordingly, Patent Owner argues that a
balloon catheter is not sufficiently robust to oppose axial deformation forces
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experienced by a balloon mounted catheter and, thus, when radially shrunk
is, in fact, structurally different. Id. at 8.
Patent Owner has not provided sufficient factual evidence of record to
support such a finding. Because the claim is a product claim, the claim
necessarily does not include an implied “restraining step” as would a claim
that is directed to a method of manufacture. Further, as discussed above,
any process limitations in a product claim have little patentable weight if the
product is structurally indistinguishable.
Patent Owner relies on expert testimony to support this contention
(id.), such as the testimony of Dr. Shu,3 who testifies that in the design of
Muni, the balloon is attached to “a flexible, hollow, thin wall plastic inner
lumen [which] will bend, curve, or kink and thereby will offer no resistance
to any axial shortening stresses imparted by a shrinking balloon.” Shu Decl.
¶¶ 16 and 31; see also Johnson Decl.4 ¶ 36 (“the catheter would bend,
crumple or otherwise deform from the stress imparted.”); Levy Decl.5 ¶¶
50-51.
In response, Requester relies on the testimony of Dr. Meirowitz,6 who
states that
one of ordinary skill in the art setting out to build a catheter
described by Muni would understand that the inner lumen must
be specified to be of a strength to withstand the forces caused
by the heat and by the shrinkage of the outer tubular member,
The selection of such materials was well within the purview of
one of ordinary skill in the art at the time. Failure to properly

3 Declaration of Yan Ho Shun Ph.D, executed on Apr. 27, 2011.
4 Declaration of Michael R. Johnson, executed on Apr. 3, 2011.
5 Declaration of Stanley B. Levy Ph.D, executed on Sept. 5, 2012.
6 Declaration of Randy E. Meirowitz Ph.D, executed on June 1, 2011.
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spec the materials, would result in an in operable
[sic: inoperable] product, which one of ordinary skill in the art
would have clearly known. . . .
PVC is known in the industry to be more rigid than the PET
balloon material, and in dimensions suitable for an over-the-
wire lumen for angioplasty procedures, would be of sufficient
rigidity and strength to withstand the temperatures used to
shrink the balloon and to withstand the minimal forces that
would result from the shrinking operation.
Meirowitz Decl. ¶ 25 and ¶ 27 (citing Muni, col. 9, l. 40).
Patent Owner responds by challenging the qualifications of Dr.
Meirowitz for his testimony and by relying on the testimony of Dr. Levy.
PO App. Br. 10–12. In particular, Patent Owner contends that Dr.
Meirowitz is not an expert in the art of “angioplasty catheters and catheter
balloons” and thus, “does not have either the knowledge or experience to
determine what forces could exist or not exist in a balloon catheter
structure,” because he does not have knowledge of “the materials which can
be used to make such catheters so that serious injury does not occur to a
patient when the catheter is inserted into the patient.” PO App. Br. 11.
Patent Owner further contends that the testimony of Dr. Levy, who is an
expert in the area of angioplasty and catheter balloons, should outweigh that
of Dr. Meirowitz.
We are not persuaded of error in Dr. Meirowitz’s declaration or that
Dr. Meirowitz testified to information of which he would have insufficient
knowledge, such as to render his testimony unreliable. Dr. Meirowitz
reports 27 years of experience in the field of polymers and polymer
chemistry. Meirowitz Decl. ¶ 2. Accordingly, Dr. Meirowitz would be
considered adequately qualified to testify as to the properties of various
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polymers including PET and PVC. Furthermore, Dr. Meirowitz testifies to
having at least 4 years of experience between 1984 and 1988 “centered on
polymeric materials and encompassed various compositions and applications
including (but not limited to) fibers and films for medical applications.
Among the applications were cardiac sutures and balloon tipped catheters.”
Id. ¶ 4. Thus, while Dr. Meirowitz may not be an expert on the use of
balloon catheter procedures from a medical perspective, he has relevant
experience in the overall structure and materials used for the design of
balloon tipped catheters at least during the 1984–1988 time frame. Thus, we
find Dr. Meirowitz is qualified to testify as to the relative strengths of PET
and PVC for a balloon catheter and its inner lumen, respectively, as well as
the state of the art of balloon tipped catheters and the knowledge of those
skilled in the art at times prior to the claimed invention.
Dr. Meirowitz’s testimony that the skilled artisan would have known
to choose materials with sufficient strength to withstand the shrinking
process is also well supported by Muni’s teaching that the “catheters may be
made by conventional techniques well known to those skilled in the art” and
“can be formed from a wide variety of conventional materials.” Muni,
col. 9, ll. 32–37.
Moreover, we agree with Dr. Meirowitz that Muni is not directed to a
process that would render the balloon catheter distorted and, thus, unusable.
A reference is presumed to be enabling and therefore, once the examiner
establishes that the reference teaches each and every limitation of the
claimed invention, the burden shifts to the Patent Owner to prove the
reference is not enabling. Chester v. Miller, 906 F.2d 1574, 1578 (Fed. Cir.
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1990); In re Sasse, 629 F.2d 675, 681 (CCPA 1980). Patent Owner’s
testimonial evidence is not sufficiently supported to find that Muni’s
catheter would necessarily bend, curve, or kink and thus would have been
incapable of functioning as a suitable balloon catheter. To the contrary,
Muni can be relied upon as evidence that the skilled artisan can successfully
mount a balloon onto an inner lumen, specifically 100% circumferentially on
a distal end and up to 90% circumferentially on a proximal end (see Muni,
col. 4, ll. 23–26 and col. 5, ll. 62–65), and form a balloon dilation catheter
by heat shrinking the balloon thereafter.
Dr. Levy, in particular, testifies that Dr. Meirowitz disregards that
“small forces can distort the catheter” as demonstrated by references to
catheters deforming during an angioplasty procedure. See Levy Decl. ¶ 49.
Dr. Levy further provides an example situation with a “very long balloon
attached to a very slender catheter.” Id. ¶ 50. Finally, Dr. Levy testifies that
Muni only teaches that PVC materials can be used on the catheter shaft
“proximal to the expandable distal section” and thus only “the shaft portion
towards the adapter which of necessity excludes the shaft portion inside the
balloon.” Id. ¶ 53.
We do not find Dr. Levy’s testimony evidence of error. Dr. Levy fails
to explain how his testimony as to the forces applied to the catheter during a
balloon catheterization procedure are relevant to the forces between an inner
lumen and a balloon mounted thereon during heat shrinking. Also, Dr. Levy
has not shown that his example balloon catheter (long balloon, slender
catheter) is particularly exemplary of conventional catheters, as discussed in
Muni (see Muni, col. 9, ll. 49–61), or a particularly practical choice for a
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catheter designer. Finally, Muni describes preferred materials for a “catheter
shaft [10] proximal to the expandable distal section [17]” (Muni, col. 9,
ll. 37–38) and the “balloon [16] and the distal portion of the outer tubular
member [13] which forms the inflatable unbonded portion” (Muni, col. 9, ll.
42–44). Yet, “catheter shaft 10” is described as including both inner tubular
member 11 and outer tubular member 13. Muni, col. 5, ll. 54–60. Thus, to
the extent that the inner tubular member 11 is the same material along its
entire length, including where it is bonded to the balloon 16 and expandable
distal section 17, Dr. Meirowitz’s testimony is supported by the record.
Patent Owner further argues that a balloon that is “axially restrained
shrunk” is characterized by a lack of “undesirable change in axial length”
upon radial re-expansion of the balloon. PO App. Br. 6–7. We understand
Patent Owner to argue that the distinguishing structural feature, which is
indicative of the way the balloon was made, is whether or not the balloon
has an undesirable change in axial length when re-expanded. Id. Patent
Owner further argues that the Figures of Muni “confirm[] that the inflated
balloon shown in the outline view was not of the substantially same length
as the balloon in the un-inflated state.” Id. at 13–17.
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Figures 1 and 11 of Muni are reproduced below:

Figures 1 and 11 depict elevational views, partially in cross-section, of
different embodiments of a dilation catheter, illustrating a catheter balloon in
both a shrunken arrangement and after expansion (in phantom). See Muni,
col. 5, ll. 3–5 and 31–35.
According to Patent Owner, Figures 1 and 11 show that the dilation
balloon is not the same length in the un-inflated and inflated conditions.
Patent Owner relies on the testimony of Dr. Levy, which includes the
annotated portion of Figure 1 reproduced below.

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The figure from paragraph 34 of Dr. Levy’s Declaration depicts only
the distal most portion of Figure 1, annotated to show the relative lengths of
the “balloon body” before and after radial expansion, labelled B and C,
respectively, and the “overall balloon length” before and after radial
expansion, labelled A and D, respectively. The figure only shows the
balloon 16 of Muni and not the expandable distal portion 17, which is also
inflatable as described in Muni. See Levy Decl. ¶¶ 34–36.
Based on this figure, Patent Owner argues that the Figures show the
“balloon body” B and C is shorter after radial expansion and that the
“overall balloon length” A and D is shorter after radial expansion. PO App.
Br. 13. Patent Owner further contends that the “cones stretch in the
Figures.” Id. at 16. By “cones,” we understand Patent Owner to mean the
areas of the expandable portions that are not depicted as parallel to the inner
lumen.
We are not persuaded that the Figures of Muni adequately support
Patent Owner’s argument that Muni balloon is not axially restrained.
Initially, we note that drawings in patents, and applications for patent,
do not define the precise proportions of the elements and may not be relied
on to show particular sizes when the specification is completely silent on the
issue. Hockerson-Halberstadt Inc. v. Avia Group Int’l Inc., 222 F.3d 951,
956 (Fed. Cir. 2000); see also In re Wright, 569 F.2d 1124, 1127 (CCPA
1977) (“Absent any written description in the specification of quantitative
values, arguments based on measurement of a drawing are of little value.”).
As such, it would be error to rely solely on the specific lengths in the
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drawings without further express description in the Muni patent that the
drawings are to scale.
Further, the experts appear to agree that if a balloon is not axially
restrained during heat shrinking, the balloon will grow axially upon re-
inflation. See RAN 39–40; Meirowitz Decl. ¶ 14; Shu Decl. ¶ 18. Dr.
Meirowitz explains that the same compliance characteristic that allows the
balloon to be heat shrunk radially and then re-expand radially, would affect
the axial direction of the material in the same way if not axially restrained,
i.e., it would shrink axially when heated and then re-expand axially upon the
application of pressure. Meirowitz Decl. ¶¶ 14–16. Thus, Patent Owner has
not explained why the alleged axial shrinking of the balloon upon radial
expansion is an indication of a lack of axial restraint. Instead, Dr. Levy
merely states that it is so, without explaining the technical reasoning behind
his determination, in contrast to Dr. Meirowitz and Dr. Shu. See Levy Decl.
¶ 36.
Moreover, Patent Owner considers only axial changes to the
dimensions of the balloon 16, when both the balloon 16 and the expandable
distal portion 17 are radially heat shrunk and re-expanded. Thus, both
operate collectively as a “balloon.” A review of Figure 1 illustrates no axial
length change of the combined axial lengths of the expandable distal portion
17 and the balloon 16, where the endpoints overall do not change in the
shrunken or expanded position. Thus, we agree with the Examiner and the
Requester that the expandable portions of the catheter in Figure 1 does not
show any change in axial length. The Figures of Muni are not sufficient
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evidence to show that the axial length of the balloon has grown upon radial
expansion of the balloon.
Even if we only consider balloon 16 as the “balloon,” Figure 1 does
not show the full extent of the expandable distal portion 17 being bonded to
the inner lumen as described in Muni. Comparison of Figure 3 and Figure
3A illustrates that:
the outer tubular member 13 forming the distal section 17 takes
the shape of the inner tubular member 11 member [sic] and
where a substantial part of the inner periphery of the distal
section is also secured to the exterior of the inner tubular
member 11. The inflation lumen 20A is shown in this
embodiment as having a thin arcuate transverse shape in an
uninflated condition, but which, as shown in phantom, expands
to form a crescent shaped inflation lumen 20A upon inflation.
Muni, col. 6, ll. 20–30. Figure 3A of Muni is reproduced below.

Figure 3A is a transverse cross-sectional view of an alternative
catheter construction, similar to the catheter shown in Figure 1 and taken
essentially along the lines 3–3 in Figure 1, i.e., showing that a “substantial
part” of the expandable distal portion 17 is bonded to the inner tubular
member 11 and not re-expanded. Muni, col. 5, ll. 10–13 and col. 6, ll. 20–
30.
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According to Muni, up to 90% of the area of the inner surface of the
outer tubular member takes the shape of and is secured to the inner tubular
member. Id., col. 4, ll. 23–26. Thus, the skilled artisan would have
understood that with 90% bonding, the proximal end of balloon 16 would
appear much like the proximal end of the expandable distal section 17 in
Figure 1, which also has a substantial portion of the outer tubular member
bonded to the inner tubular member and which does not show any axial
length change in the radially expanded condition. See Figure 1. Patent
Owner has not demonstrated that a 90% bonded balloon does not have a
substantially identical structure to one that is “axially restrained” as claimed.
Patent Owner’s arguments with respect to Figure 13, showing only a small
portion (roughly 30% or more) of the expandable distal portion bonded, are
not germane to an embodiment in which 90% is bonded. See PO Reb. Br.
5–6; see Muni, Figure 13.
Additionally, Patent Owner has not persuasively explained why a
balloon would not be axially restrained during shrinking if only 10% of its
proximal end was unbound to the inner lumen. Id. at 4–6. Patent Owner has
not directed us to any requirement in the claims or the ’585 Patent that the
entire circumference of the claimed balloon must be axially restrained
during shrinkage.
Patent Owner further relies on a statement in Muni’s related U.S.
Application Publication 2003/0229307 A1, published December 11, 2003
(the “’307 Publication”) indicating that “a differential develops between the
length of the inflated inflatable section and the underlying portion of the
inner tubular member . . . causing the inflated inflatable section to become
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deformed.” PO App. Br. 14 (citing the ’307 Publication, ¶ 40). However,
we find Patent Owner’s reliance on this teaching fails to address the next
sentence, which is not quoted by Patent Owner, which discloses that
[t]o minimize or eliminate the differential, the inflatable section
of the outer tubular member 14 is first formed into a balloon by
subjecting this section to an internal pressure at elevated
temperatures, e.g. from about 250° F., in a conventional manner
and cooling the balloon while it is inflated, e.g. to room
temperature, to impart heat shrinking characteristics. After
cooling, the inflated inflatable portion 12 is deflated. The outer
tubular member 14 is then assembled with the inner tubular
member 15 and then the treated inflatable section 12 is heat
shrunk onto an inner member such as the inner tubular member
15 or a mandrel (not shown) thereby eliminating or minimizing
differential elongations upon the inflation of the inflatable
section. Heat shrinking is effected by heating to a temperature
of about 50° to about 80° C., preferably about 55° to about 65°
C. for at least about 5 seconds and generally not longer than
about 1 hour. The heating for first forming the balloon prior to
the heat shrinking thereof can be heat treatment to provide the
expansion characteristics of the invention which is generally
within the range of 50° C. above or below the crystalline
melting point of the polymer.
’307 Publication, ¶ 40. This procedure is substantially identical to the
procedure described in Muni, which states that
[t]he expandable portion of the outer tubular member is formed
from a heat shrinkable thermoplastic polymer material,
particularly an irradiated cross-linked polymer material, which
has been thermally treated to a temperature of not more than
about 75° C., preferably not more than about 50° C., above or
below the crystalline melting point of the polymer to provide
the desired expansion. It is preferred to expand the expandable
distal section at the thermal treatment temperature, cool and
then heat shrink the expanded distal section at a temperature
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within about 45° C. to about 80° C. to a diameter much smaller
than the expanded diameter.
See Muni, col. 3, ll. 38–48; see also col. 10, ll. 30–55. Thus, we are
persuaded that the teachings of Muni do not have the deformation to which
Patent Owner alleges.
We are also not persuaded by Patent Owner’s discussion of Figure 1
of the ’585 patent, which shows no change in the balloon body length upon
heat shrinkage (PO App. Br. 15–16). Muni describes substantially identical
heat shrinking with the balloon being axially bound. Patent Owner has not
shown persuasively that Muni’s heat shrinking step is not substantially
identically to that shown in Figure 1 of the ’585 patent. Specifically, Patent
Owner has not shown persuasively that there is a change in Muni’s balloon
length during heat shrinking. Muni’s figures, which as discussed above
cannot be relied on as being to scale, only demonstrate balloon re-expansion
after heat shrinking.
The fact that there is some give and movement of the cones and the
balloon upon re-expansion does not sufficiently demonstrate a lack of axial
restraint when the balloon’s overall length (i.e., between two points where
the balloon is bonded to the inner tubular member 11) has not changed, and
certainly has not grown. Thus, we are not persuaded that the figures of
Muni illustrate that the balloon is not an “axially restrained-shrunk catheter
balloon,” as recited in the claims.
Patent Owner further contends that Muni fails to teach a catheter
balloon that comprises an “axially stretched polymer.” PO App. Br. 9–10,
17–18, and 20–22; see PO Reb. Br. 8. The Examiner relies on the teaching
in Muni that the distal portion of the tubular member that is to become the
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expandable distal portion “was subjected to a thermal treatment at about
250° F. for a period of about 20 seconds while applying tension in the
longitudinal direction in order to develop a significant level of longitudinal
orientation in the inflatable portion.” Muni, col. 10, ll. 7–11; see RAN 5.
Patent Owner argues that 250°F is roughly 70° higher than the melting
point (192° F–196° F for Surlyn) of the polymer tubing used to make the
balloon.7 PO App. Br. 20; PO Reb. Br. 8. According to Patent Owner, a
temperature of 250°F is too high for axial stretching because, at
temperatures above the melting point, “the polymer chain loses its tensile
strength, yield point, and crystallinity, all of which are required for stretch
orientation.” PO Reb. Br. 8; PO App. Br. 20–21. Patent Owner further
contends that “tension” described in Muni is not the type of “axial
stretching” that would lead to an axially oriented polymer, as one of ordinary
skill in the art would have understood. Id.
Requester responds that Patent Owner has not shown that, if only
exposed to a temperature of 250°F for 20 seconds, the polymer itself reaches
250° F and, thus, would melt. Req. Res. Br. 10. Requester additionally
contends that a temperature of 250° F is an appropriate temperature for
longitudinal orientation of a crosslinked polymer, which would have a
higher glass transition temperature and melting temperature than a non-

7 We note that 250°F is actually only 58° higher than Patent Owner’s lower
reported melting temperature of 192° F. Further, 250°F (i.e., 121°C) is only
about 32°C higher than Patent Owner’s lowest reported melting point 192°F
(i.e., about 89°C), which is consistent with the “preferably not more than
about 50° C., above or below the crystalline melting point of the polymer”
described in Muni. Muni, col. 3, ll. 38–48.
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crosslinked polymer. Id. at 11 (citing the Second Meirowitz Declaration,
executed October 8, 2012, ¶ 19–20).8 Requester further contends that Patent
Owner’s contention that the product was heated above the melting point
“under tension” is not reasonable because the polymer would soften and sag
“like pulling taffy,” which would unreasonably distort a formed product. Id.
at 10–11.
We find Requester’s contentions persuasive, particularly in light of
Patent Owner failure to respond thereto. See PO Reb. Br. 8. Again, a
reference is presumed to be enabling and Patent Owner has the burden to
prove the reference would not function as described. Chester, 906 F.2d at
1578; Sasse, 629 F.2d at 681. We are unpersuaded by Patent Owner’s
argument that Muni’s described application of “tension in the longitudinal
direction in order to develop a significant level of longitudinal orientation”
does not describe an axially stretched and oriented polymer. See Muni, col.
10, ll. 6–11. We agree with the Requester that Muni expressly describes that
the polymer has “longitudinal orientation.” Req. Res. Br. 11–12. We are
not persuaded that Muni’s “longitudinal orientation” means something other
than molecular orientation merely because Muni does not use the word
“stretch.” Patent Owner’s interpretation of the phrase “under tension” as not
equivalent to “stretching” is not supported by persuasive evidence. That is,

8 Requester also cites ¶¶ 14–20 of the Second Meirowitz Declaration, but it
appears that copies of pages 2–4 of this declaration, which includes ¶¶ 14–
18, were not submitted into the record, either on October 9, 2012 before the
Examiner or on May 1, 2014 with the appeal brief. We therefore are unable
to consider these paragraphs. See 37 C.F.R. § 41.63(c).
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the phrase “under tension,” may reasonably be interpreted as “stretching.”9
If the polymer material is oriented, as one skilled in the art would have
understood the term, the polymer material under tension is necessarily
“stretched.” See PO App. Br. 7 (defining “[a]xially stretched polymer” to
mean an “axially oriented polymer”); Meirowitz Declaration ¶¶ 29–31
(describing that the term “orientation” is “a very well known term in the
field of polymer chemistry and has a very specific meaning,” namely
“alignment of the polymeric chains,” and relying on substantial evidentiary
support for this interpretation).10
Moreover, while Muni teaches an oven temperature of 250°F, Muni
describes that the heating is only for about 20 seconds (col. 10, ll. 8–9) and
that the material is “thermally treated to a temperature of not more than
about 75° C., preferably not more than about 50° C., above or below the
crystalline melting point of the polymer to provide the desired expansion.”
Muni, col. 3, ll. 38–45. The lower end of this range includes temperatures
above the glass transition but below the melting point, which is consistent
with Dr. Levy’s testimony of the range in which polymers are oriented by
stretching. PO App. Br. 24 (citing Levy Decl. ¶¶ 69–74); PO Reb. Br. 8.
Moreover, we find the discussion in Muni of providing a non-
compliant balloon (see Muni, Abstract, col. 2, l. 66 to col. 3, l. 1; col. 10, ll.
16–26; col. 10, l. 66 to col. 11, l. 2) consistent with the description in the

9 We note that Merriam-Webster also defines “tension” as “the act or action
of stretching or the condition or degree of being stretched to stiffness.” See
http://www.merriam-webster.com/dictionary/tension.
10 As discussed above, Dr. Meirowitz is qualified to testify as an expert to
well-known terms in the field of polymer chemistry.
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’585 Patent that such noncompliance is produced by highly oriented
polymers. ’585 Patent, col. 5, ll. 43–67.
Thus, we are persuaded that Muni describes a balloon made from an
axially stretched polymer, as recited in the claims.11

Claim 8
Patent Owner presents arguments under separate headings for claim 8.
Claim 8 depends from claim 1 and further recites that the catheter balloon
has “a wall thickness that is less than a wall thickness of a polymer tube
from which the catheter balloon is formed.”
Claim 8 recites a product-by-process limitation in that it requires the
resulting product to have been made from a tube having a larger wall
thickness. Accordingly, we subscribe little weight to the process for
preparing the balloon because of our findings above that the balloon is
structurally similar to the claimed balloon, whether made from a polymer
tube having a larger wall thickness or not.
Nonetheless, the Examiner finds that axially stretching a polymer tube
and blow molding a polymer tube, both of which are described by Muni, will
necessarily reduce the wall thickness. RAN 7.

11 Moreover, for the reasons discussed below with respect to the separate
rejections of claims 27–38, axially stretching would have been obvious to
one of ordinary skill in the art based on the teachings of Muni and/or the
admission in the ’585 Patent that it was known in the art to stretch-orient
polymers to impart strength and changes in a catheter balloon’s compliance
characteristics.
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Patent Owner initially argues that Muni does not teach axially
stretching (PO App. Br. 17), an argument which is deemed unpersuasive for
the reasons discussed above. Patent Owner further relies on the thicknesses
of the balloon walls shown in Figures 1 and 11 of Muni as evidence that the
wall thickness is consistent. Id. We find this argument unpersuasive for two
reasons. First, as discussed above, it is error to rely on particular sizes in the
figures unless there is a suggestion that the drawing are to scale. See
Hockerson-Halberstadt, 222 F.3d at 956. Second, Figures 1 and 11 of Muni
illustrate a catheter balloon in a deflated condition and in an inflated
condition, in phantom. Muni, col. 6, ll. 11–13. Patent Owner has not
persuasively demonstrated how these figures are descriptive of “a wall
thickness of a polymer tube from which the catheter balloon is made.”
Patent Owner further contends that the process of heat shrinking the
balloon “to a diameter the same or slightly larger than its original diameter,”
as described in Muni (col. 10, ll. 47–51), would result in a recoiled balloon
having the same thickness as the tube from which it is made. PO App. Br.
17. We are not persuaded by this argument. Patent Owner has not pointed
to persuasive evidence to support a finding that the wall thickness of the
balloon upon heat shrinking is not less than a wall thickness of a polymer
tube from which the catheter balloon is formed after axially stretching and/or
blow molding an extruded polymer tube, as found by the Examiner.

Claim 21
Patent Owner presents arguments under separate headings for claim
21. Claim 21 depends from claim 1 or claim 19 and further recites that “the
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balloon comprises a stretch-oriented polymer.” Patent Owner’s arguments
with respect to claim 21 are substantially similar to those discussed above
for claim 1, namely that Muni fails to describe “stretching.” PO App. Br.
17–18. For the reasons discussed above, we do not find these arguments
persuasive, particularly in light of the express teaching in Muni of
“longitudinal orientation.” Muni, col. 10, l. 11.

Claim 22
Patent Owner presents arguments under separate headings for
independent claim 22. Claim 22 is a product-by-process claim which recites
A shrunk continuous catheter balloon produced by a
process comprising: providing a polymer material formed into a
tube; axially stretching the tube; forming a continuous balloon
from the polymer material, and heating the balloon while
restraining axial contraction in a controlled manner and thereby
radially shrinking the axially stretched balloon.
Patent Owner presents many of the same unpersuasive arguments
addressed above with respect to claim 1, namely that Muni does not describe
axial “stretching” and that the figures of Muni illustrate axially shrinkage
upon inflation. PO App. Br. 18–19. Patent Owner further argues that Muni
does not teach “restraining axial contraction in a controlled manner.” Id.
We understand Patent Owner to be arguing that “in a controlled manner”
means that “the balloon maker . . . [can] choose to lengthen or shorten the
balloon to a predetermined size or hold the balloon axial dimensions
constant.” Id. at 18. Patent Owner’s interpretation is supported in the ’585
patent, which describes “restraining alternatives” including maintaining the
length, extending the length, or, least preferably, shortening the length of the
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tube upon heat shrinking. ’585 patent, col. 10, l. 25 to col. 11, l. 2.
However, we note again that claim 22 is a product-by-process claim. The
structure dictated by claim 22 includes a continuous balloon of an axially
oriented polymer that is radially heat-shrunk “while restraining axial
contraction.” Claim 22 reads on a heat shrunk balloon in which the length of
the balloon is maintained during radial heat shrinkage. Accordingly, if the
catheter balloon of Muni has the same structure as an axially retrained
balloon in which the length of the balloon is maintained during heat
shrinkage, then the product is anticipated by the claims, even if the method
of forming the balloon of Muni does not disclose axial restraint by a method
in which the balloon length can alternatively be lengthen or shortened during
heat shrinkage.
As discussed above, we are persuaded that Muni’s catheter balloon is
axially restrained during heat shrinkage. Accordingly, Patent Owner has not
shown that Muni’s catheter balloon is structurally different than one formed
during a controlled restraint method in which the ends are “restrained so as
to maintain the same original overall length that the tube exhibited with the
formed balloon still in place.” ’585 patent, col. 10, ll. 49–54. Thus, the fact
that Muni’s method does not allow for extending or shortening the length of
the balloon during heat shrinkage is of no moment because the process step
of restraining “in a controlled manner” does not distinguish Muni’s catheter
balloon structure from an identical structure made by a method that could
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have extended or shorted the balloon length, but did not, and instead held the
balloon ends in place.12
Patent Owner further argues that Muni does not describe how balloon
16 was formed. PO App. Br. 18. According to the Patent Owner all of
Muni’s disclosure directed to forming the “expandable portion” of the outer
tubular member applies only to the “distal expandable section 17” of the
Muni catheter, which is distinct from the balloon 16. Id. (citing Muni, col.
3, ll. 31–49). Patent Owner’s interpretation of the teaching of Muni is not
persuasive.
As discussed above, Muni describes a process for the formation of the
“expandable portion of the outer tubular member” that is substantially
identical to that described in the ’307 Publication for the “inflatable section
12,” i.e., the balloon.13 See Muni, col. 3, ll. 39–49 (quoted supra). Muni
further states that “[t]he balloon and the distal portion of the outer tubular
member which forms the inflatable unbonded portion may be made . . . as

12 Although not argued separately, the same reasoning applies to claim 38.
Claim 38 is another independent product-by-process claim in which the
process includes a step of “applying a suitable temperature and time to
radially shrink the balloon while applying in a controlled manner suitable
devices to the ends of the balloon to maintain the overall length of the
shrunken balloon to be constant, elongated or contracted relative to the
original formed length of the bi-axially stretch oriented balloon.” Patent
Owner has not shown a structural difference between Muni’s balloon
catheter and a balloon formed in the claimed process wherein “the overall
length of the shrunken balloon [is] to be constant . . . relative to the original
formed length of the bi-axially stretch oriented balloon.”
13 We note that the ’307 Publication does not have the additional
“expandable distal section 17” of Muni, which was added in the later (Muni)
application.
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described in the aforementioned application Ser. No, 07/758,630.” Muni,
col. 9, ll. 42–47. Muni’s U.S. Application 07/758,630, filed September 12,
1991 (now abandoned), is a parent application for both the ’307 Publication
and Muni. Accordingly, we interpret the description in Muni of the
formation of the “expandable portion of the outer tubular member” to refer
to both the “expandable distal section 17” and the “inflatable member or
balloon 16,” because both sections are expandable portions of the outer
tubular member.
Moreover, we find that this description of a process for forming a
balloon to be within the scope of the steps recited in claim 22, such that
claim 22 is anticipated by the teachings of Muni.
Accordingly, for the reasons discussed above, we affirm the
Examiner’s rejection of claims 1–27, 31–35, and 38 under 35 U.S.C.
§ 102(b) as anticipated by Muni.

2. OBVIOUSNESS OVER MUNI AND ADMITTED PRIOR ART
Claims 27–38 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Muni. Claims 26, 27, 31, 33, and 38 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Muni in view of admitted prior art (APA).
Claim 26 and claim 31 are independent claims to products which are
substantially similar to claims 1 and 22 above, but further recite that the
“balloon is made from a biaxially stretch oriented balloon” (claim 26) or the
product-by-process step of “forming a continuous biaxially stretch oriented
balloon from the tube” (claim 31).
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Although Patent Owner presents arguments for the rejections of claim
26 and claims 31 and 38, as a group, separately from the argument made for
all of claims 26-38, the arguments are substantially identical to those made
for all of the claims as a group. See PO App. Br. 26. Accordingly, all the
rejected claims stand or fall based on the same reasoning.
The Examiner determines that, because Muni describes both
“longitudinal orientation” and inflation while heat treating, “it would have
been obvious to a person of ordinary skill in the art at the time the invention
was made to recognize that the balloon of Muni et al. is biaxially stretched
(stretched axially and radially).” RAN 28–29. The Examiner also found
that “assuming, arguendo, that Muni fails to explicitly teach axially
stretched and/or biaxial orientation, this is admitted as prior art by the ’585
patent.” RAN 20. In particular, the Examiner finds that the ’585 patent
“admits that stretch orientation and biaxial orientation was known in the
prior art” as producing balloons with higher tensile strength. Id. (citing the
’585 patent, col. 5, ll. 43–67). Thus, the Examiner determines that it would
have been obvious to make the balloon of Muni using a biaxially stretch
oriented polymer “to arrive at a balloon that has higher strength.” Id.
Patent Owner presents many of the same unpersuasive arguments
addressed above with respect to claims 1 and 22. Patent Owner further
contends that Muni does not teach or suggest “biaxially oriented stretch
molding of balloons.” PO App. Br. 20–21 (emphasis omitted). We note that
no claims specifically require a step where a blow molding process is used to
impart biaxial orientation. The “biaxially stretch oriented balloon” recited in
the claims does not preclude a balloon that achieves biaxial orientation by
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stretching in first one of the axial or radial direction and then by stretching in
the other direction. Accordingly, Patent Owner’s argument that blow
molding a balloon, as described by Dr. Meirowitz with respect to U.S. Patent
4,093,484, issued June 6, 1978, to Harrison et al. (hereinafter “Harrison”), is
not a biaxial orienting process (id.), i.e., that the balloon is not biaxially
oriented in the same blow molding process, is not persuasive. The Examiner
indicates that Muni teaches two separate steps: blow molding a balloon (i.e.,
providing polymer orientation in a radial direction) and providing
longitudinal orientation “while applying tension” (i.e., providing orientation
in an axial direction). RAN 28–29.
Patent Owner contends that the temperature of the thermal treatment
described in Muni is too high for orienting the polymer, and, thus, Muni
does not describe or suggest a biaxially stretch oriented balloon, nor would it
be obvious to combine known methods of biaxially stretch orienting a
balloon with the high temperature method of Muni. See PO App. Br. 20–25.
We discuss above why this reasoning is not persuasive. In particular, Patent
Owner has not shown that heating Surlyn in a 250°F oven for only 20
seconds would cause the temperature of the gamma-irradiated cross-linked
material to reach its melting point. Additionally, Muni teaches a broader
range for the thermal treatment of preferably 50° C above or below the
crystalline melting point, which encompasses Dr. Levy’s description of a
suitable range for achieving polymer orientation. Accordingly, preparing a
balloon made from an oriented polymer would have been within the skill of
the ordinary artisan at the time of the invention based on both the description
provided in Muni and the known process for achieving biaxial orientation of
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balloons admitted in the ’585 Patent for improving the balloon strength and
non-compliance characteristics.
Patent Owner further contends that Muni does not disclose a biaxially
stretched balloon because it does not describe an embodiment in which a
balloon is both stretched axially and radially. PO App. Br. 20–21 and 23-25.
In particular, Patent Owner argues that the first exemplary embodiment of
Muni is not directed to the formation of a balloon, but rather describes only
“longitudinal orientation” of a tube. Id. at 23. In other words, Patent Owner
argues that the first example does not include a blow molding step which
would have been necessary to provide the radial orientation of the polymer.
Patent Owner further argues that the second exemplary embodiment
describes blow molding a balloon, but fails to describe providing a
longitudinal orientation, and there is no suggestion in Muni to combine the
exemplary embodiments. Id.
We agree with Patent Owner that the second exemplary embodiment
does not appear to describe a longitudinally oriented balloon. See, e.g., Fig.
16 (showing that the second exemplary embodiment is more compliant that
the first exemplary embodiment). However, we do not agree with Patent
Owner that Muni’s first exemplary embodiment does not describe a balloon
that has been formed by radial expansion, which imparts radial orientation to
the polymer balloon.
Muni describes that, for the first exemplary embodiment, “[a]n outer
tubular member for a [dilation] catheter was prepared having a structure
essentially as shown in FIGS. 1–3.” Muni, col. 9, ll. 64–66. Figures 1 to 3
show that the outer tubular member includes both the inflatable portion 16
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and the expandable distal portion 17. See Muni, Figures 1–3, col. 5, l. 53 to
col. 6, l. 32. Moreover, as discussed above, Muni provides a general
description of the formation of the “expandable portion of the outer tubular
member,” which, as also discussed above, is consistent with the teachings in
prior Muni patents for the formation of a balloon from the outer tubular
member, namely expanding the balloon during a thermal treatment at about
50° C above or below the crystalline melting point of the polymer. See id.,
col. 3, ll. 38–48, col. 9, ll. 43–47, and col. 10, ll. 40–55; Meirowitz Decl. ¶¶
10–13 and 15 (describing blow molding balloons); Johnson Decl. ¶ 31 (“[I]t
is standard practice among heat shrink manufacturers to allow expansion or
blowing of the heat shrink tubing only in the radial direction.”); Levy Decl.
¶¶ 19–25 (discussing that the blow molding process does not include axial
stretching).
We agree with the Requester (see Req. Res. Br. 20) that the first
exemplary embodiment includes a balloon formed as shown in Figures 1–3,
with the additional processing step of providing “longitudinal orientation” to
“[t]he distal portion of the polymerized tubular member which was to
become the expandable distal portion,” i.e., axial orientation is provided
before the balloon is blow molded to provide radial orientation. Muni, col.
10, ll. 6–11 (emphasis added). Moreover, we further agree with the
Requester (Req. Res. Br. 20) that the skilled artisan would have been
capable of applying the longitudinal orientation to the blow molded balloon
otherwise described in Muni, even if not described in the same embodiment,
to achieve the compliance characteristics of the longitudinally oriented
balloon shown in Figure 16.
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Thus, a polymer balloon catheter, where the polymer material has
been stretched both axially and radially while being heated, would have been
obvious to one of ordinary skill in the art having the teaching of Muni, either
alone or with the admitted prior art of the ’585 Patent.
Claims 28 and 32 further require that the balloon is axially restrained
“by clamping the ends of the biaxially stretch oriented balloon.” We
interpret the “clamping” step to be an additional process limitation. Patent
Owner has not shown that a clamping process for axially restraining during
heat shrinking causes a structurally different balloon catheter from one in
which the balloon is bonded as described in Muni. See PO App. Br. 25.
Accordingly, for the reasons discussed above, we affirm the
Examiner’s rejection of claims 26–38 under 35 U.S.C. § 103(a) as
unpatentable over Muni either alone or further in view of admitted prior art
in the ’585 Patent.

III. APPEAL BY REQUESTER
In addressing all of claims 1–38 on appeal as unpatentable on other
grounds, we decline to address the merits of additional proposed, but non-
adopted, grounds of rejection appealed by the Requester. See Beloit Corp. v.
Valmet Oy, 742 F.2d 1421, 1423 (Fed. Cir. 1984) (having decided a single
dispositive issue, the ITC was not required to review other matters decided
by the presiding officer); see also Tempo Lighting, Inc. v. Tivoli LLC, 742
F.3d 973, 979 (Fed. Cir. 2014).

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TIME PERIOD FOR RESPONSE
In accordance with 37 C.F.R. § 41.79(a)(1), the “[p]arties to the
appeal may file a request for rehearing of the decision within one month of
the date of: . . . [t]he original decision of the Board under § 41.77(a).” A
request for rehearing must be in compliance with 37 C.F.R. § 41.79(b).
Comments in opposition to the request and additional requests for rehearing
must be in accordance with 37 C.F.R. § 41.79(c) & (d), respectively. Under
37 C.F.R. § 41.79(e), the times for requesting rehearing under paragraph (a)
of this section, for requesting further rehearing under paragraph (d) of this
section, and for submitting comments under paragraph (c) of this section
may not be extended.
An appeal to the United States Court of Appeals for the Federal
Circuit under 35 U.S.C. §§ 141–144 and 315 and 37 C.F.R. § 1.983 for an
inter partes reexamination proceeding “commenced” on or after November
2, 2002 may not be taken “until all parties' rights to request rehearing have
been exhausted, at which time the decision of the Board is final and
appealable by any party to the appeal to the Board.” 37 C.F.R. § 41.81. See
also MPEP § 2682 (8th ed., Rev. 7, July 2008).

AFFIRMED

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PATENT OWNER:

HERSHKOVITZ & ASSOCIATES, PLLC
2845 Duke Street
Alexandria, VA 22314

THIRD-PARTY REQUESTER:

SHEPPARD, MULLIN, RICHTER & HAMPTON LLP
12275 El Camino Real
Suite 200
San Diego, CA 92130