Ex Parte Colburn et al

Patent Trial and Appeal Board

Mar 11, 2013

11473285 (P.T.A.B. Mar. 11, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JOEL COLBURN and ROGER CALUYA
__________

Appeal 2011-006663
Application 11/473,285
Technology Center 3700
__________

Before DONALD E. ADAMS, ERICA A. FRANKLIN, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

SNEDDEN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of manufacturing an inflatable cuff. The Examiner has rejected the claims as
anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.

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STATEMENT OF THE CASE
Appellants‟ invention relates to
method of manufacturing an inflatable cuff is provided. The
method includes the acts of stretching a tube, creating a positive
pressure within the tube, changing the amount the tube is
stretched, heating the tube, and increasing the positive pressure
within the tube such that a portion of the tube in blown outward
to form a cuff.

(Specification, Abstract.) Figures 3A – 3D of the Specification are
reproduced below.

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“Fig. 3A depicts an exemplary cuff 12A having an inverted cone
shape when inflated” (id. at 11). “Fig. 3B depicts an exemplary cuff 12B
having a generally hourglass shape, i.e., two cones generally connected at
their apexes, when inflated” (id.). “Fig. 3C depicts an exemplary cuff 12C
wider at the middle than at the proximate and distal ends 20 and 22, but with
generally straight walls connecting the middle and ends, i.e., two cones
generally connected at their bases” (id. at 11-12). “Fig. 3D depicts an
exemplary cuff 12D wider at the middle than at the proximate and distal
ends 20 and 22, but with generally straight or slightly curved walls
throughout the middle of the cuff body 26” (id. at 12).
Claims 1-10, 12-14, 21-28, and 30-36 are on appeal. Claims 1 and 21
are representative of the appealed subject matter and reads as follows
(emphasis added):
1. A method of manufacturing an inflatable cuff,
comprising:
pre-heating a tube to a first temperature;
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stretching the tube;
creating a positive pressure within the tube such that a
portion of the tube is blown outward against an inner surface of
a mold to form a generally conical cuff; and
heating the generally conical cuff to a second
temperature that is greater than the first temperature.

21. A method of manufacturing an inflatable cuff,
comprising:
stretching a tube comprising a composition;
creating a positive pressure within the tube such that a
portion of the tube is blown outward against an inner surface of
a mold to form a cuff comprising the composition; and
heating the cuff;
wherein the tensile strength of the composition is greater
in the cuff than in the tube.

The claims stand rejected as follows:
I. Claims 1, 3, 4, 6, 7, 13, 14, 21, 22, 24, 25, 31, 32, 34, and 35 under
35 U.S.C. § 102(b) as being anticipated by Wang et al. (WO
95/22367 A1, published Aug. 24, 1995).
II. Claims 2, 9, 27 and 33 under 35 U.S.C. § 103(a) as being
unpatentable over the combination of Wang and Wallace (US
4,130,617, issued Dec. 19, 1978).
III. Claims 5 and 23 under 35 U.S.C. § 103(a) as being unpatentable
over Wang.
IV. Claims 8 and 26 under 35 U.S.C. § 103(a) as being unpatentable
over the combination of Wang and Wilkins (US 2002/0150707 A1,
published Oct. 17, 2002).
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V. Claims 10, 28, and 36 under 35 U.S.C. § 103(a) as being
unpatentable over the combination of Wang and Pagan (EP 1 005
877 A2, published Jun. 7, 2000).
VI. Claims 12 and 30 under 35 U.S.C. § 103(a) as being unpatentable
over the combination of Wang and Schjeldahl et al. (US 4,456,000,
issued Jun. 26, 1984).
The same issue is dispositive for each of the rejections.
Issue
The Examiner finds that
Wang discloses a method of manufacturing an inflatable cuff 14
(“balloon”, Fig. 1), comprising: pre-heating a tube 12/13 (Fig.
2a-c) to a first temperature (“90°C”, pg. 7, ln. 15-26); stretching
the tube 12/13 (pg. 7, ln. 15-26); creating a positive pressure
within the tube 12/13 such that a portion of the tube is blown
outward against an inner surface of a mold 28 to form a
generally conical cuff (pg. 8, ln. 9-30); and heating the
generally conical cuff to a second temperature (“95°C”) that is
greater than the first temperature (pg. 9, ln. 27-33).

(Ans. 4.) Regarding claim 1, the Examiner finds that Wang discloses
“applying heat and also applying internal pressure to the balloon to blow the
cuff” (id. at 10). The Examiner also finds that “Fig. 1 of Wang clearly
shows that the two waist portions of the cuff 14 are tapered toward the ends
of the cuff in resemblance to a cone” and “that this shape can be
characterized as being „generally conical‟” (id. at 11).
Regarding claim 21, the Examiner finds that “it is inherent that the
process disclosed by Wang would cause the tensile strength in the balloon
cuff to be greater than the tensile strength in the rest of the tube” (id. at 5).
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Here, “Kinslow is relied upon as supporting evidence that an increase in
tensile strength occurs in the blow molding process with many polymers”
(id. at 11).
The issue presented is:
Does the evidence of record support the Examiner‟s findings that
Wang teaches an inflatable cuff having each element of claims 1 and 21?
Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
FF1. Figure 1 of Wang is reproduced below.

“Fig 1 is a perspective view of an angioplasty catheter having a
balloon of the invention mounted thereon” (Wang 4, ll. 6-7).
The cone regions of the balloon (C)(D)(E)(F) and waist regions
of the balloon (B)(C)(F)(G) are formed having a reduced
thickness because the axial tension and blowing pressure is
selectively varied as a mold (28) containing the balloon (14),
and is gradually dipped into a heating medium (70) so as to
sequentially blow a first waist (B)(C), a body (D)(E) and a
second waist (F)(G).

(id. at Abstract).

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FF2. Wang discloses as follows:
Once the prestretch is complete, the stretched tubing 13 is
radially expanded into the form of a balloon 14, using a
molding process. The molding process comprises placing the
stretched tubing 13 in a mold, heating the mold and expanding
the stretched tubing radially by means of internal pressure.
After sufficient time has passed for the balloon to form, the
mold is cooled and the balloon 14 is removed.
(Id. at 5.)
FF3. Wang discloses as follows:
After cooling, the stretched tubing 13 is removed from
the water bath and expanded radially using internal pressure.
The dimensions to which it is stretched are preferably
controlled by performing the radial stretching while the tubing
13 is in a mold having the shape of the desired balloon. ...
Heating the stretched tubing 13 while radially expanding it may
best be accomplished by dipping the mold 28 into hot water
while internal pressure is applied.
(Id. at 8.)
FF4. Kinslow discloses as follows:
It is a well-known fact that many polymers which are
particularly suitable for blow molding such as the olefin
polymers, undergo the phenomenon known as orientation when
stretched in the solid state at a temperature below the crystalline
melt point. Since this orientation can result in as much as a 20-
fold increase in tensile strength, it was only natural that
attempts should be made to utilize this phenomenon in the
production of blow molded hollow articles such as bottles.
(Kinslow, col. 1, ll. 21-28.)
FF5. Kinslow discloses that olefins include “ethylene, propylene,
butane and mixtures thereof, more particularly polypropylene” (Kinslow,
col. 2, ll. 46-49) (emphasis added).
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FF6. Wang discloses that “[i]t is possible to make balloons from a
variety of materials that are generally of the thermoplastic polymeric type.
Such materials may include: ... polypropylene” (Wang 2, ll. 1-8) (emphasis
added).
Principles of Law
“[U]nless a reference discloses within the four corners of the
document not only all of the limitations claimed but also all of the
limitations arranged or combined in the same way as recited in the claim, it
cannot be said to prove prior invention of the thing claimed and, thus, cannot
anticipate under 35 U.S.C. § 102. “ Net MoneyIN, Inc. v. VeriSign, Inc.,
545 F.3d 1359, 1371 (Fed. Cir. 2008).
The Examiner has the burden of providing reasonable proof that a
claim limitation is an inherent characteristic of the prior art. In re Best, 562
F.2d 1252, 1254–55 (CCPA 1977) (“Whether the rejection is based on
„inherency‟ under 35 U.S.C. § 102, on „prima facie obviousness‟ under 35
U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its
fairness is evidenced by the PTO‟s inability to manufacture products or to
obtain and compare prior art products.”); see also Crown Operations Int'l,
Ltd. v. Solutia Inc., 289 F.3d 1367, 1377 (Fed. Cir. 2002). The Examiner
meets this “burden of production by „adequately explaining the
shortcomings it perceives so that the applicant is properly notified and able
to respond.‟” In re Jung, 637 F.3d 1356, 1362 (Fed. Cir. 2011) (quoting
Hyatt v. Dudas, 492 F.3d 1365, 1370 (Fed. Cir. 2007)). The burden of proof
then shifts to the applicant “to prove that the subject matter shown to be in
the prior art does not possess the characteristic relied on.” Best, 562 F.2d at
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1255 (“Where … the claimed and prior art products are identical or
substantially identical, … the PTO can require an applicant to prove that the
prior art products do not necessarily or inherently possess the characteristics
of his claimed product.”); In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990)
(“[W]hen the PTO shows sound basis for believing that the products of the
applicant and the prior art are the same, the applicant has the burden of
showing that they are not.”).
Analysis
Appellants contend that Wang fails to disclose formation of a
generally conical cuff, but rather discloses a conventional barrel-shaped
angioplasty balloon. We are not persuaded. Because the Specification does
not define the terms “generally conical,” we interpret the phrase according to
the ordinary meaning of the terms as they would be interpreted by the
ordinary artisan. Figures 3A, 3B and 3C of the Specification show various
conical forms that may form the design of the cuff. We find the cuff of
Wang to comprise two conical portions that can reasonably be described as
having a generally conical shape (FF1), especially when compared to
Figures 3B and 3C of the Specification. That is, we do not find the use of
the terms “generally conical” to distinguish from the shape used by Wang.
Appellants further contend that Wang fails to disclose “„creating a
positive pressure within [a] tube such that a portion of the tube is blown
outward against an inner surface of a mold to form a generally conical cuff‟”
as required by independent claims 1 and 21 (App. Br. 10). Rather, Wang

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discloses “that a balloon is formed not when positive pressure is generated,
as presently recited, but when the tubing is heated” (id. at 11). That is,
[i]f applied internal pressure were the cause of the balloon walls
being blown outward, the balloon of the Wang reference would
be formed in its entirety upon the initial application of the
higher pressure when the first waist was formed, and thus could
not have different portions that were separately and sequentially
formed

(Reply Br. 3-4).
We are not persuaded. As explained by the Examiner, heat and
pressure are applied simultaneously during the molding process to form the
waist and cone portions of the balloon disclosed in Wang (FF1 – FF3; see
also, Ans. 10). The language of the claims does not distinguish from a
method where a balloon is sequentially formed and a method where the
balloon is formed entirely with an initial application of pressure. Claim 1
merely requires that a portion of the tube is blown outward against an inner
surface of a mold. We agree with the Examiner that this feature is disclosed
by Wang (id.).
Finally, we are also not persuaded by Appellants‟ arguments that,
Wang does not disclose that the tensile strength of the composition is greater
in the cuff than in the tube after the act of stretching or heating, as required
by claim 21 (see, e.g., App. Br. 19-20). Here, the Examiner relies on
Kinslow (Ans. 11), which discloses that the blow molding process naturally
increases the tensile strength of olefin polymers (FF4) such as polypropylene
(FF5), and the balloons in Wang may be made from polypropylene (FF6).
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We find that the Examiner presented a sound rationale for believing
that the cuff formed by the process of Wang would inherently have a higher
tensile strength than the original tube material (Ans. 11; see also Final
Office Action 9). Having done so, Appellants have the burden of showing
that they are not. Best, 562 F.2d at 1254–55.
Appellants have not met this burden. Appellants merely argue that
[t]he fact that the feature may be present (i.e., “many polymers
... undergo the phenomenon known as orientation”) is
insufficient. Id. Further, the Examiner has failed to provide any
basis in fact or technical reasoning to demonstrate that blow
molding always and without exception, i.e., necessarily,
increases the strength of the molded material, even when
different pressure and/or temperature ranges are employed.
(App. Br. 20.) This is insufficient because the argument does not address
the use of olefin polymers such as polypropylene as described by Wang.
Appellants have not demonstrated that Wang‟s use of polypropylene would
not produce a cuff made from a tube comprising a composition wherein the
tensile strength of the composition is greater in the cuff than in the tube as
required by claim 21.

Conclusion of Law
The preponderance of evidence on this record supports the
Examiner‟s findings that Wang anticipates claims 1 and 21. Claims 3, 4, 6,
7, 13, 14, 22, 24, 25, 31, 32, 34, and 35 fall with claims 1 and 21. 37 C.F.R.
§ 41.37(c)(1)(vii).
Regarding the obviousness rejections of dependent claims 2, 5, 8, 9,
10, 12, 23, 26, 27, 28, 30, 33 and 36, Appellants argue that “the references
cited by the Examiner in combination with the Wang reference do not
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appear to obviate the deficiencies of the Wang reference noted with respect
to the respective independent claims” without providing additional argument
or evidence (App. Br. 21). “It is well settled that „anticipation is the epitome
of obviousness.‟” In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002)
(quoting In re Fracalossi, 681 F.2d 792, 794 (CCPA 1982). Thus, for the
same reasons discussed above, we affirm each of the obviousness rejections.

SUMMARY
We affirm all rejections on appeal.

AFFIRMED

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