Ex Parte Krivoruchko

Patent Trial and Appeal Board

Nov 7, 2013

11733402 (P.T.A.B. Nov. 7, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MICHAEL KRIVORUCHKO
____________

Appeal 2012-002696
Application 11/733,402
Technology Center 3700
____________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

Opinion for the Board filed by Administrative Patent Judge ADAMS.

Opinion Dissenting filed by Administrative Patent Judge MILLS.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134 involves claims 1-16 (App. Br. 5).
Examiner entered rejections under 35 U.S.C. § 102(b) and 35 U.S.C.
§ 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

1 The Real Party in Interest is Medtronic Vascular, Inc. (App. Br. 3).
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STATEMENT OF THE CASE
The claims are directed to a method for manufacturing a balloon
catheter assembly. Claims 1 and 11 are representative and are reproduced in
the Claims Appendix of Appellant’s Brief.
Claims 1-4, 10-14, and 16 stand rejected under 35 U.S.C. § 102(b) as
being anticipated by Wang.2
Claims 5-9 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Wang and Mirzaee.3
Claim 15 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Wang.

Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Wang teaches Appellant’s claimed invention?
FACTUAL FINDINGS (FF)
FF 1. Wang suggests a balloon catheter assembly and method of making a
balloon catheter assembly (Ans. 4 and 5).
FF 2. Wang’s Figure 1 is reproduced below:

2 Wang et al., US 2004/0122464 A1, published June 24, 2004.
3 Mirzaee, US 6,585,926 B1, issued July 1, 2003.
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“FIG. 1 is an elevational view, partially in section, of a balloon catheter
which embodies features of the invention” (Wang 2: ¶ [0013]).
FF 3. Wang’s catheter assembly comprises a distal tip member 40, made of
polytetrafluoroethylene (ePTFE), a porous polymeric material (Wang 2: ¶¶
[0009] and [0019]).
FF 4. Wang teaches that
The microporous structure of the polymeric material
forming the distal tip is such that the material is typically gas
permeable. However, fluids such as body fluids in the patient’s
body lumen and contrast fluid in the catheter lumen preferably
do not permeate through the porous material absent significant
pressurization forcing the fluid therethrough. In one
embodiment, the microporous structure has a pore size
distribution of about 1.5 to about 30 micrometers.
(Id. at ¶ [0010].)
FF 5. Wang’s catheter assembly comprises a balloon 24 having “a first
layer 33 and a second layer 34,” wherein the “first layer 33 is formed of
ePTFE, and the second layer 34 is formed of a polymeric material preferably
different from the polymeric material of the first layer 33” (id. at 3: ¶ [0025];
see generally Ans. 4 and 5).
FF 6. Wang teaches that
Layer 34 limits or prevents leakage of inflation fluid through
the microporous ePTFE to allow for inflation of the balloon 24,
and expands elastically to facilitate deflation of the balloon 24
to a low profile deflated configuration. The layer 34 may
consist of a separate layer which neither fills the pores nor
disturbs the node and fibril structure of the ePTFE layer 33, or
it may at least partially fill the pores of the ePTFE layer.
(Id.)
FF 7. Wang teaches that “[i]n the embodiment in which the catheter
balloon has a porous polymeric layer (e.g., layer 33), the porous polymeric
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layer of the balloon is preferably formed of the same porous polymeric
material as the distal tip member 40, for improved bondability thereto” (id.
at ¶ [0026]; see Ans. 8).
ANALYSIS
Examiner reasons that since: (a) “fluids such as body fluids in the
patient’s body lumen and contrast fluid in the catheter lumen preferably do
not permeate through the porous material [of Wang’s distal tip member 40]
absent significant pressurization” and (b) Wang’s distal tip member and
balloon layer 33 can be made of the same polymeric material, ePTFE, then
fluids will not pass through Wang’s balloon layer 33 (see Ans. 8; FF 4-5 and
7). We are not persuaded.
Wang expressly teaches that the balloon has an additional layer, layer
34, to “limit[] or prevent[] leakage of inflation fluid through the microporous
ePTFE to allow for inflation of the balloon 24” (FF 6). Examiner failed to
establish an evidentiary basis on this record to support a finding that Wang’s
ePTFE polymeric layer 33 comprises pores that are sized and distributed to
prevent the fluid from passing through the balloon as is required by
Appellant’s claimed invention (see Reply Br. 2-3; FF 6).
Examiner also failed to establish an evidentiary basis on this record to
support a finding that a person of ordinary skill in this art would reasonably
consider Wang’s distal tip member 40 a balloon (see Ans. 8).
To be complete, we recognize, but are not persuaded by, the Dissent’s
reliance on In re Papesch, 315 F.2d 381, 391 (CCPA 1963) and In re Best,
562 F.2d 1252, 1255 (CCPA 1977). While it is true that “a compound and
all of its properties are inseparable,” the issue here is not whether ePTFE has
a particular property, but rather the issue is whether the evidence on this
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record supports a conclusion that two structurally distinct prior art structures
(Wang’s distal tip member and balloon) will necessarily have the same
properties if they are made of the same material. In this regard, we note that
steel has particular properties, yet if placed in water a steel brick will sink
while a steel boat will float. Similarly, notwithstanding Examiner and
Dissent’s assertions, the evidence on this record supports a conclusion that
Wang’s ePTFE polymeric layer leaks when inflated with fluid (FF 6) and
therefore, it cannot necessarily have “pores being sized and distributed to
prevent the fluid from passing through the balloon” as required by claim 1.
Accordingly, the evidence on this record satisfies the Best inquiry raised by
the Dissent. Wang expressly teaches that the ePTFE polymeric layer, as
relied upon by Examiner, leaks. There is no evidence on this record to
support a conclusion that this layer of Wang’s balloon is identical or
substantially identical to Appellant’s or produced by identical or
substantially identical processes. See, Best 562 F.2d at 1255. For the
foregoing reasons, the Dissent’s reliance on In re Woodruff, 919 F.2d 1575,
1577-78 (Fed. Cir. 1990) is equally inapplicable to the record before this
panel.
CONCLUSION OF LAW
The preponderance of evidence on this record fails to support
Examiner’s finding that Wang teaches Appellant’s claimed invention. The
rejection of claims 1-4, 10-14, and 16 under 35 U.S.C. § 102(b) as being
anticipated by Wang is reversed.

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Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 8. Examiner finds that Wang suggests Appellant’s claimed invention
with the exception of forming pores before or after the balloon is formed
(Ans. 6).
FF 9. Examiner relies on Mirzaee to suggest “a balloon catheter device
wherein forming … pores is completed before” or after the balloon is
formed (id.).
FF 10. Examiner finds that Wang fails to suggest an “assembly wherein the
balloon has a pore density of about 100 pores per cm2 to about 1,000,000
pores per cm2” (id. at 7).
ANALYSIS
The rejection over the combination of Wang and Mirzaee:
Based on the combination of Wang and Mirzaee, Examiner concludes
that, at the time Appellant’s invention was made, it would have been prima
facie obvious “to modify the device of Wang with the pore formation
mechanism of Mirzaee to create pores with a smaller diameter” (Ans. 6).
Appellant contends that Examiner failed to establish an evidentiary
basis on this record to support a conclusion that Mirzaee makes up for
Wang’s failure to suggest “balloon pores sized and distributed to prevent an
inflation fluid from passing through the balloon, as required by [A]ppellant’s
claims” (App. Br. 13). We agree.

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The rejection over Wang:
Based on the combination of Wang, Examiner concludes that, at the
time Appellant’s invention was made, it would have been prima facie
obvious to
[H]ave the balloon have a pore density of about 100 pores per
cm2 to about 1,000,000 pores per cm2, since it has been held
that where the general conditions of a claim are disclosed in the
prior art discovering the optimum or workable ranges involves
only routine skill in the art.
(Ans. 7; see also Ans. 9 (“Examiner maintains that the pore density would
have been an obvious design choice given the general conditions of the
claim”).) We are not persuaded. As Appellant explains, Wang fails to
“mention [the] porosity of a balloon,” therefore, notwithstanding Examiner’s
contention to the contrary, Wang fails to disclose the general conditions of
the claim (App. Br. 13; Cf. Ans. 7).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 5-9 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Wang and Mirzaee is reversed.
The rejection of claim 15 under 35 U.S.C. § 103(a) as unpatentable
over Wang is reversed.

REVERSED

cdc
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MILLS, Administrative Patent Judge, dissenting.
I respectfully dissent from the Decision of the majority and would
affirm the Examiner’s rejection.

FINDINGS OF FACT
1. According to the Spec. 5 ¶ [0025], the material of the balloon
includes, “ethylenetetrafluoroethylene, perfluoroalkoxy copolymer, and
polytetrafluoroethylene. Polymer derivatives of these materials may also be
used.”
2. According to the Spec. 6 ¶ [0029],
For example, the pores may be optimized for the specific
inflation fluid used, balloon material, and operating pressure, so
that the resulting catheter has improved flexibility and can
accommodate the inflation pressure needed for the targeted
application (e.g., angioplasty or stent delivery), but does not
allow the inflation fluid to leak out of the balloon during
inflation. For example, the average diameter of the pores may
be less than about 500 μm (microns), preferably between about
0.1 micron and about 400 microns, and more preferably
between about 1 micron and about 100 microns.

3. In one embodiment, the balloon may be made of a tetrafluoroethylene
polymer with a node and fibril microstructure. Spec. 7 ¶ [0032].
4. Spec. 7 ¶ [0032] states that
In another embodiment, the pores may be created as the
balloon preform is stretched into the shape of the balloon. For
example, U.S. Patent No. 4,187,390 discloses a method for
creating porous structures out of tetrafluoroethylene polymers.
Similar methods may be used to create porous structures out of
polyamides, polyether block amides, polyethylene, and
polyethylene terephthalate in accordance with embodiments of
the present invention. Specifically, once the balloon preform
has been created, the preform may be reheated to a suitable
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temperature and stretched at a suitable strain rate, for the
specific polymer being used, to create a node and fibril
microstructure of the type described by U.S. Patent No.
4,187,390. As would be appreciated by one of ordinary skill in
the art, the size and distribution of the nodes and fibrils, and
resulting pores, will depend on the temperature and strain rate
used to stretch the balloon preform.

5. U.S. Patent No. 4,187,3904 describes porous, amorphous micro-
structure of tetrafluoroethylene characterized by nodes interconnected by
fibrils. (Abstract.)
6. U.S. Patent No. 4,187,390 states
In comparison, expanded, amorphous-locked films of this
invention have permeabilities to nitrogen from about 1 x 10-8 to
1 x 10-1 metric units. These higher permeabilities are consistent
with the lower densities and higher porosities of the expanded,
amorphous-locked films, compared with conventional films.
Furthermore, by controlling the degree of expansion and the
amorphous-locking conditions used, it is possible to make
tetrafluoroethylene polymeric materials having any desired
permeability within the range listed above. These permeability
differences are due primarily to differences in pore sizes within
the materials.
Also, permeabilities to liquids of the expanded, amorphous-
locked materials described herein are higher, in an analogous
way, than corresponding permeabilities to liquids of the
conventional materials.
As a result of the ability of the expanded, amorphous-locked
materials described herein to transmit fluids are described,
these materials are useful as filtering membranes to separate
solid materials from gases and from liquids. For optimum
filtering rates, relatively low-permeability, small-pore size
membranes are used to filter out small solid particles, and high-
permeability, large-pore size membranes are used to filter out
large solid particles.

4 Gore, US 4,187,390, issued Feb. 5, 1980.
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Also, the expanded, amorphous-locked materials described
herein are useful as semi-permeable membranes for separating
wetting fluids from non-wetting fluids.

(Col. 4, l. 66 – col. 5, l. 25.)

7. Wang indicates that the balloon is microporous. “In a presently
preferred embodiment, the balloon 24 first layer 33 comprises a porous
polymeric material, and preferably microporous polymeric material having a
node and fibril microstructure, such as ePTFE.” Wang 3 ¶ [0025].
(Emphasis added.)
8. Wang 3 ¶ [0026] states that,
In the embodiment in which the catheter balloon has a porous
polymeric layer (e.g., layer 33), the porous polymeric layer
of the balloon is preferably formed of the same porous
polymeric material as the distal tip member 40, for improved
bondability thereto.

9. The polymeric material of distal tip is the same polymeric material as
the balloon. Wang 2 ¶ [0010]. In one embodiment, the microporous
structure of the distal tip has “a pore size distribution of about 1.5 to about
30 micrometers, preferably about 3 to about 15 micrometers.” Id.

PRINCIPLES OF LAW
In order for a prior art reference to serve as an anticipatory reference,
it must disclose every limitation of the claimed invention, either explicitly or
inherently. See In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). To
anticipate, every element and limitation of the claimed invention must be
found in a single prior art reference, arranged as in the claim. Karsten Mfg.
Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001).
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Where . . . the claimed and prior art products are
identical or substantially identical, or are produced by identical
or substantially identical processes, 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
…. 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.

In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (emphasis added.) “From the
standpoint of patent law, a compound and all of its properties are
inseparable; they are one and the same thing.” In re Papesch, 315 F.2d 381,
391 (CCPA 1963).
Additionally, where the Patent Office has reason to believe that
a functional limitation asserted to be critical for establishing
novelty in the claimed subject matter may, in fact, be an
inherent characteristic of the prior art, it possesses the
authority to require the applicant to prove that the subject
matter shown to be in the prior art does not possess the
characteristic relied on.

In re Best, 562 F.2d at 1254-55 (emphasis added) (quoting In re Swinehart,
439 F.2d 210, 212-13 (CCPA 1971)). It is well-recognized that “merely
discovering and claiming a new benefit of an old process cannot render the
process again patentable.” In re Woodruff, 919 F.2d 1575, 1577-78 (Fed.
Cir. 1990).
“It is also an elementary principle of patent law that when, as by a
recitation of ranges or otherwise, a claim covers several compositions, the
claim is ‘anticipated’ if one of them is in the prior art.” Titanium Metals
Corp. of America v. Banner, 778 F.2d 775, 782 (Fed. Cir. 1985)
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Anticipation has been found even when a prior art range “does not
exactly correspond to [the] claimed range,” but the prior art “range entirely
encompasses, and does not significantly deviate from, [the] claimed ranges.”
See Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir.
2005) (court found that a claimed range of 0.025 to 5% did not significantly
deviate from a prior art range of 0.01 to 20%).
“Products of identical chemical composition cannot have mutually
exclusive properties.” A chemical composition and its properties are
inseparable. Therefore, if the prior art teaches the identical chemical
structure, the properties applicant discloses and/or claims are necessarily
present. In re Spada, 911 F.2d 705, 709 (Fed. Cir. 1990) (Applicant argued
that the claimed composition was a pressure sensitive adhesive containing a
tacky polymer while the product of the reference was hard and abrasion
resistant. “The Board correctly found that the virtual identity of monomers
and procedures sufficed to support a prima facie case of unpatentability of
Spada’s polymer latexes for lack of novelty.”).

Claim Interpretation
With respect to claim interpretation, method of manufacturing claim 1
does not require the balloon to be inflated. The catheter assembly claim 11
does not indicate the level of inflation of the balloon, and uses “comprising”
claim language so claim 11 is open to addition claim elements such as a
second balloon layer. In addition, claim 15 is dependent upon claim 11 and
adds a specific pore density. Thus, under the doctrine of claim
differentiation, claim 11 is not limited to a specific pore density. Both the
method and catheter assembly claims require “a polymer having a plurality
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of pores.” A plurality of pores is at least two pores. The claims do not
specify a level of inflation of the balloon and therefore the claims encompass
both low and high levels of balloon inflation.

ANALYSIS
Same material and Pore Size
Both the balloon of Wang and the claimed balloon can be made of the
same material with the same pore size. In particular, Wang indicates that the
balloon is microporous. Wang 3 ¶ [0025]. “In a presently preferred
embodiment, the balloon 24 first layer 33 comprises a porous polymeric
material, and preferably microporous polymeric material having a node and
fibril microstructure, such as ePTFE.” Wang 3 ¶ [0025].
Wang 3 ¶ [0026] states that,
In the embodiment in which the catheter balloon has a
porous polymeric layer (e.g., layer 33), the porous polymeric
layer of the balloon is preferably formed of the same porous
polymeric material as the distal tip member 40, for improved
bondability thereto.

Thus, in Wang, the polymeric material of the balloon is the same
polymeric material as the distal tip. Wang 2 ¶ [0010.] In one embodiment,
the microporous structure of the distal tip of Wang (imputed to the balloon
as the balloon is made of the same material as the distal tip)5 has “a pore size

5 Even if, as the majority argues and which argument I do not agree, that no
specific pore size can be imputed from the distal tip material to the balloon,
Wang indicates that the balloon is microporous. Neither claim 1 nor claim
11 is directed to a specific number of pores or pore size, and thus the
microporous structure of the balloon of Wang reads on the plurality of pores
of the pending claims. A microporous material is defined as “a material
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distribution of about 1.5 to about 30 micrometers, preferably about 3 to
about 15 micrometers.” Id.
Permeability Attributed to Pore Size
In two locations in the Specification, balloon permeability is attributed
to balloon pore size. (FF 2, 6.) The claimed pore size and that of Wang are
the same or overlap, thus the permeability or lack of permeability is the
same in Wang’s and the claimed balloon, and therefore the claimed balloon
permeability is anticipated by Wang’s balloon. Titanium Metals Corp. of
America v. Banner, 778 F.2d 775, 782 (Fed. Cir. 1985). Furthermore, if the
claimed pore size and that of Wang are the same, and the pores of the
claimed balloon do not leak, then the balloon of Wang having the same pore
size does not leak. The pores of Wang may be distributed in any manner, as
the pore size has been selected not to leak. Thus I do not agree with the
majority’s conclusion that Wang’s statement that a second balloon layer
“prevents leaks,” is sufficient comparative evidence under In re Best to show
that the claimed balloon made of the same material and microporous pore
size (or in the low end of Wang’s pore size range) do not have the same
permeability property. (Compare, In re Spada, 911 F.2d 705, 709 (Fed. Cir.
1990) (Applicant argued that the claimed composition was a pressure
sensitive adhesive containing a tacky polymer while the product of the
reference was hard and abrasion resistant. “The Board correctly found that
the virtual identity of monomers and procedures sufficed to support a prima
facie case of unpatentability of Spada’s polymer latexes for lack of
novelty.”).

containing pores with diameters less than 2 nm.”
http://en.wikipedia.org/wiki/Microporous_material
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According to the Specification, page 5 ¶ [0025], the material of the
balloon includes, “ethylenetetrafluoroethylene, perfluoroalkoxy copolymer,
and polytetrafluoroethylene. Polymer derivatives of these materials may
also be used.” According to the Specification page 6 ¶ [0029], “[f]or
example, the average diameter of the pores may be less than about 500 μm
(microns), preferably between about 0.1 micron and about 400 microns, and
more preferably between about 1 micron and about 100 microns.” In one
embodiment, the balloon may be made of a tetrafluoroethylene polymer with
a node and fibril microstructure. Spec. 7 ¶ [0032]. If one followed the
procedure set forth in U.S. Patent No. 4,187,390 (’390) mentioned in ¶
[0032] of the Specification, one would have a material permeable to liquid.
(’390, col. 5, l. 5.) In addition, U.S. Patent No. 4,187,390 also attributes
fluoroethylene polymer permeability to pore size (’390, col. 5, l. 32-39),
which pore size is overlapping in the present case with Wang. Appellant’s
process claims do not include a specific temperature or strain rate or other
process limitation to distinguish the claimed process from the disclosure of
Wang.
No Evidence of Leakage in Wang
Thus, Wang’s first layer balloon materials are the same material and
the same pore size, with the same node and fibril structure, as set forth in the
Specification. Wang ¶ [0025.] Moreover, the first layer of the balloon of
Wang does not leak except at significantly high pressure levels. Wang 2 ¶
[0010]. Moreover, contrary to the majority’s assertion, Wang does not
expressly teach that the ePTFE polymeric layer, as relied upon by Examiner,
leaks. Wang states that “Layer 34 limits or prevents leakage of inflation
fluid through the microporous ePTFE to allow for inflation of the balloon
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24.” The prevention of leakage is not the same as leakage. One can have
high pressure braiding cover around a toilet fill hose to prevent future leaks
that may or may not occur, but that does not mean that the underlying hose
is leaking, especially at low fill pressures. Likewise, the prevention of
leakage in the present context does not necessarily mean that the underlying
porous material is actively leaking. Unlike the majority’s steel brick
example, both balloons, claimed and prior art, are made of the same material
and pore size for the same use.
More particularly, Wang states, “fluids such as body fluids in the
patient’s body lumen and contrast fluid in the catheter lumen preferably do
not permeate through the porous material absent significant pressurization
forcing the fluid therethrough.” Wang 2 ¶ [0010]. Therefore, Wang
specifically states that, in a preferred embodiment, the porous polymer
material does not leak. For this reason, I find that the claimed balloon and
the prior art balloon are identical or substantially identical.
Burden of Proof on Appellant
Where . . . the claimed and prior art products are
identical or substantially identical, or are produced by identical
or substantially identical processes, 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
…. 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.

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In re Best, 562 F.2d at 1255 (emphasis added.) “From the standpoint of
patent law, a compound and all of its properties are inseparable; they are one
and the same thing.” In re Papesch, 315 F.2d at 391.
Appellant appears to argue that the functional claim limitation, “the
pores being constructed and arranged to block fluid from passing
therethrough when the balloon is inflated by the fluid,” distinguishes their
balloon from that of Wang.
However,
[W]here the Patent Office has reason to believe that a
functional limitation asserted to be critical for establishing
novelty in the claimed subject matter may, in fact, be an
inherent characteristic of the prior art, it possesses the
authority to require the applicant to prove that the subject
matter shown to be in the prior art does not possess the
characteristic relied on.

In re Best, 562 F.2d at 1254-55 (quoting In re Swinehart, 439 F.2d at 212-
13). A similar argument can be made for method claim 1. It is well-
recognized that “merely discovering and claiming a new benefit of an old
process cannot render the process again patentable.” In re Woodruff, 919
F.2d at 1577-78. Moreover, it has been long held that
[E]ven though applicant’s modification results in …
improvement and utility over the prior art, it may still not be
patentable if the modification was within the capabilities of one
skilled in the art, unless the claimed ranges “produce a new and
unexpected result which is different in kind and not merely in
degree from the results of the prior art.”

In re Huang, 100 F.3d 135, 139 (Fed. Cir. 1996) (quoting In re Aller, 220
F.2d 454, 456 (1955), and citing In re Woodruff, 919 F.2d at 1578. There is
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no evidence of record that the claimed pore size provides a different result
from the same pore size of Wang.
The Examiner has established an evidentiary basis on this record to
shift the burden of proof to Appellant to show that Wang’s ePTFE polymeric
layer 33 comprises pores which are size and distributed to allow fluid to pass
through the balloon. There is no evidence of record provided by Appellant
of the permeability of Wang’s balloon structure (having the same pore size
as claimed), to fluid at low pressures which are encompassed by the claim.
Furthermore, “the patentability of apparatus or composition claims
depends on the claimed structure, not on the use or purpose of that
structure.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d
801, 809 (Fed. Cir. 2002). In other words, the claim language “when the
balloon is inflated by fluid” is irrelevant to the patentability of the balloon
structure, if there are no other indicated differences in structure from the
prior art structural material, pore size, or node and fibril structure of the
balloon material.
Finally, Wang provides that,
Layer 34 limits or prevents leakage of inflation fluid through
the microporous ePTFE to allow for inflation of the balloon 24,
and expands elastically to facilitate deflation of the balloon 24
to a low profile deflated configuration. The layer 34 may
consist of a separate layer which neither fills the pores nor
disturbs the node and fibril structure of the ePTFE layer 33, or
it may at least partially fill the pores of the ePTFE layer.

Wang 3 ¶ [0025].
When this paragraph of Wang is read in conjunction with the
embodiment in which the catheter balloon has a microporous polymeric
layer (e.g., layer 33) of node and fibril structure, and the porous polymeric
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layer of the balloon is preferably formed of the same porous polymeric
material as the distal tip member 40, it suggests that Wang’s structure reads
on the claimed balloon and/or is the same as the claimed balloon structure.
Wang indicates that the distal tip material (the same as the balloon material)
is not permeable to fluid at low pressures, and the claims encompass balloon
inflation both at low and high pressures. Thus, there is no distinction
between the structure of the claimed balloon and that of Wang and Appellant
has provided no evidence that Wang’s balloon material is permeable to fluid
at low fluid pressures.
Therefore, I agree with the Examiner and find that the burden of proof
has shifted to Appellant to show that the balloon of Wang, made of the same
material of the same pore size and same node and fibril structure, and does
not leak at low pressures, does not have the same fluid permeability as the
claimed balloon. This is particularly relevant to the method of manufacture
claim which does not require the balloon to be inflated.
Neither Appellant nor the majority has accounted for a difference
between the balloon materials of Wang and the claimed balloon materials.
Nor has Appellant claimed a different process step accountable for the
performance difference in the balloon. There is no evidence that Wang’s
minimally inflated balloon leaks, and, in fact, Wang’s balloon does not leak
at pressures which are not significant. The independent claims do not recite
a level of pressurization, thus encompass low levels of balloon
inflation/pressurization disclosed in Wang would anticipate the claim.
Therefore, I would affirm the rejection of the Examiner.