Ex Parte Sowinski et al

Board of Patent Appeals and Interferences

Jun 14, 2012

11430334 (B.P.A.I. Jun. 14, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte KRZYSZTOF SOWINSKI and RONALD RAKOS
__________

Appeal 2011-005883
Application 11/430,334
Technology Center 3700
__________

Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims directed to an elastomerically recoverable PTFE material, and an
implantable tubular stent graft. The Patent Examiner rejected the claims for
containing new matter and for obviousness. We have jurisdiction under
35 U.S.C. § 6(b). We reverse the new matter rejection and affirm the
obviousness rejections.
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STATEMENT OF THE CASE
Claims 105 and 22 are on appeal. Claim 1 is representative and reads
as follows:
1. An elastomerically recoverable PTFE material comprising:
(a) an ePTFE material defined by nodes and fibrils, said fibrils
being in longitudinally compressed state and defining pores; and
(b) an elastomeric matrix; said elastomeric matrix impregnated
within said pores, said elastomeric matrix impregnated throughout said
ePTFE material, said compressed fibrils and elastomeric matrix
cooperatively permitting longitudinal expansion and elastomeric recovery
without plastic deformation of said ePTFE material,
wherein said elastomeric matrix is a polycarbonate urethane material
having a shore hardness rating between 70A and 75 D,
and wherein said elastomeric matrix includes said polycarbonate
urethane material in a compressed form and said polycarbonate urethane
material in an uncompressed form.

The Examiner rejected the claims as follows:
 claims 1-5 and 22 under 35 U.S.C. § 112, first paragraph, as failing to
comply with the written description requirement because they contain
new matter;
 claims 1-5 under 35 U.S.C. § 103(a) as unpatentable over Della
Corna,1 Phaneuf,2 Thompson;3 and
 claim 22 under 35 U.S.C. § 103(a) as unpatentable over Della Corna
and Thompson.

1 Linda V. Della Corna et al., US 4,955,899, Sept. 11, 1990.
2 Matthew D. Phaneuf et al., US 6,743,253 B2, June 1, 2004.
3 Paul J. Thompson, US 6,165,211, Dec. 26, 2000.
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NEW MATTER
The Issue
The Examiner’s position is that the limitation “said elastomeric matrix
includes said polycarbonate urethane material in a compressed form and said
polycarbonate urethane material in an uncompressed form” in claims 1 and
5, and the limitation “said elastomeric matrix includes compressed
elastomeric material and uncompressed elastomeric material” in claim 22,
were not in the original disclosure and are therefore prohibited new matter.
(Ans. 3-4.)
Appellants contend “[t]he specification is sufficient to convey to a
person of ordinary skill that the invention was possessed by the Applicants
at the time of filing.” (App. Br. 10.) In particular, Specification paragraphs
30 and 31 are said to describe producing various properties of the final
product by performing a compression step prior to, between, and/or after the
application of elastomeric material. The process described is said to
“allow[] both compressed and uncompressed elastomer to occupy the graft
pores.” (Id. at 11.)
“The test for determining compliance with the written description
requirement is whether the disclosure of the application as originally filed
reasonably conveys to the artisan that the inventor had possession at that
time of the later claimed subject matter, rather than the presence or absence
of literal support in the specification for the claim language.” In re Kaslow,
707 F.2d 1366, 1375 (Fed. Cir. 1983).
The Specification describes applying elastomeric material to a
compressed ePTFE tube. (Spec. 7, ¶¶ 27-28.) However, the Specification
also states that “the compression step and the application steps were
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interchangeable to produce an elastomerically recoverable PTFE material
with various properties, such as different expansion ratios.” (Id. at ¶ 29.)
“The various properties of the final product were produced by performing
the compression step prior to, between, and/or after the application of the
elastomeric material.” (Id., emphasis added.)
Appellants explain an example as follows:
For example, the elastomer can be applied to the graft, which is
then compressed. The compression force will not only compress some
of the elastomer, but will also drive some of the elastomer out of the
pores, leaving areas of the pore without elastomer. The evaporation of
the solvent carrying the elastomer can also leave areas of void space
in the pores. The subsequent decompression of the graft and
application of elastomer deposits an uncompressed elastomer in the
void space within the pores. This process allows both compressed and
uncompressed elastomer to occupy the graft pores.

(App. Br. 11.) The example embodiment is consistent with the
Specification’s disclosure that compression can be done “between”
elastomer applications. Appellants’ evidence is sufficient to show that a
person of ordinary skill in the art would have appreciated that the
Specification described producing an elastomeric matrix that includes
compressed and uncompressed elastomeric material in the matrix. The new
matter rejection is reversed.

OBVIOUSNESS
The Issue
The Examiner’s position is that Della Corna described “the device
substantially as claimed, however does not disclose 1) the particular
elastomer and 2) a stent on the graft.” (Ans. 5.)
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As to the first difference, although Della Corna taught using
segmented polyurethanes with the claimed hardness in its elastomeric
matrix, Della Corna did not disclose using polycarbonate urethane, recited in
claim 1. (Id.) The Examiner found that (i) Phaneuf taught using
polycarbonate urethane on porous graft structures to provide improved
sealing properties and compliance (id.); and (ii) Phaneuf disclosed that
polycarbonate urethane is an example of the segmented polyurethanes Della
Coran used, and an alternate material to other materials Della Corna used
(id. at 6). The Examiner concluded it would have been obvious to use
Phaneuf’s polycarbonate urethane in Della Corna’s devices “in order to
provide a prosthesis with optimal sealing and compliance properties.” (Id.)
As to the second difference, the Examiner found that Thompson
taught (i) “the use of a stent in combination with a graft, such that as the
graft provides biocompatibility and reduced cell growth, the stent provides
support for improved flow (col.1, lines 14-35), thus the two
compl[e]menting each other;” and (ii) “that stent graft combinations are well
known in the art and provide[d] many examples (col.1, lines 16-18, 34-48).”
(Id.) The Examiner concluded that it would have been obvious “to combine
Della Corna in view of Phaneuf’s graft prosthesis with Thompson’s teaching
and evidence that stents are known to be used in combination with grafts in
order to provide support for the graft and vessel thus improved flow there
through.” (Id.)
The Examiner found that as a stent radially expands, “the graft
attached to it also radially expands and longitudinally contracts.” (Id.) The
Examiner explained that, when placed in a blood vessel, the stent graft
suggested in the rejection would have had an elastomeric matrix that
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included polycarbonate urethane material in a compressed form and in an
uncompressed form: “When the stent graft is expanded in the vessel,
elastomer in the longitudinally extending pores is compressed, while
elastomer in other pores such as those extending circumferentially or
laterally are not compressed (thus the expanded stent graft contains
compressed and non-compressed elastomer).” (Id.)
Appellants contend that in Della Corna’s method, “[t]he elastomer
itself is never actually compressed; rather, the elastomer is just applied to a
graft surface that has already been compressed. Therefore, the combination
of compressed and uncompressed elastomer (polycarbonate urethane) is not
present.” (App. Br. 12, citing Della Corna at col. 5 – col. 6.)
The Examiner agrees that, prior to deployment in a blood vessel, the
elastomer in the suggested stent would not be compressed, but contends that
after placement in a blood vessel, some of the elastomer will be compressed:
Although yes, all elastomer in Della Corna is disclosed to be applied
after the compression step, forming what applicant refers to as
‘uncompressed elastomer’, when the graft of Della Corna is expanded
and placed in the body in use-at this point in time will contain both
compressed and uncompressed elastomer. . . . when the stent graft of
Della Corna (in view of Phaneuf and Thompson) expands into the
vessel, it circumferentially expands causing it to longitudinally
compress/shorten. When this happens, the circumferential expansion
will expand or flatten the laterally directed pores (remaining
uncompressed elastomer) and the longitudinal compression will
further compress the longitudinally directed fibrils/pores (creating
compressed elastomer).

(Ans. 10.)
Appellants reply:
While there may be less compressive force during expansion,
the Examiner has not established that there will be no compression
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(i.e., uncompressed). Moreover, the Examiner stated that the
circumferential expansion will flatten the laterally directed pores, and
the elastomer previously applied to these areas would be
uncompressed. However, flattening something implies compression.
Thus, the Examiner has not shown that Della Corna teaches or
suggests an elastomer matrix comprising an elastomer in a
compressed form and an uncompressed form to one of ordinary skill
in the art.
There is no teaching or suggestion in any of the cited references
that an elastomeric matrix comprises both an uncompressed elastomer
and a compressed elastomer.

(Reply Br. 4.)
The only issue presented for review is whether the elastomerically
recoverable PTFE material suggested by the references includes
polycarbonate urethane in both compressed form and uncompressed form.

Discussion
The broadest reasonable interpretation of “compressed form” must be
applied, as the plain language of claim 1 does not define the term, and
Appellants have not established a Specification-limited definition. See, e.g.,
In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004) (“Absent claim language
carrying a narrow meaning, the PTO should only limit the claim based on
the specification or prosecution history when those sources expressly
disclaim the broader definition.”).
Claim 1 must also be interpreted broadly because as a product claim,
it covers the defined device at any time or place, whether deployed in a
blood vessel or not. It appears that the Examiner agrees with Appellants that
the stent suggested by the prior art, after removal from the mandrel and
before placement in a blood vessel, may not include urethane in both
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compressed and uncompressed forms. The rejection is based on the
compression state of the device in a blood vessel. The question then is
whether the Examiner’s explanation of expansion and compression
occurring after the suggested stent is placed in a blood vessel is reasonably
correct.
The Examiner states that when the stent is placed in a blood vessel, it
will expand circumferentially, and “the circumferential expansion will
expand or flatten the laterally directed pores (remaining uncompressed
elastomer).” (Ans. 10.) Appellants don’t dispute that flattening will occur,
but argue that because “flattening something implies compression,” the
rejection fails to show that Della Corna taught or suggested a matrix
comprising an elastomer in a compressed form. (Reply Br. 4.) Appellants
provide no evidence to support the argument that flattening implies
compression. In this context, the Examiner’s explanation looks more
reasonable. When the stent expands circumferentially, expansion (the
opposite of compression) causes the elastomer under tension to flatten
because the matrix is stretched by expansion. There is no dispute that some
compressed elastomer remains. Thus, we find the Examiner’s explanation
more reasonable.
Claims 2-5 have not been argued separately and therefore stand or fall
with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). As Appellants rely on the same
arguments against the rejection of claim 22, claim 22 also falls with claim 1.

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Application 11/430,334

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SUMMARY
We reverse the rejection of claims 1-5 and 22 under 35 U.S.C. § 112,
first paragraph.
We affirm the rejection of claims 1-5 under 35 U.S.C. § 103(a) as
unpatentable over Della Corna, Phaneuf, Thompson.
We affirm the rejection of claim 22 under 35 U.S.C. § 103(a) as
unpatentable over Della Corna and Thompson.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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