Ex Parte Hamilton et al

Patent Trial and Appeal Board

Feb 21, 2017

13243730 (P.T.A.B. Feb. 21, 2017)

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.
13/243,730 09/23/2011 Bruce Hamilton 2001.1405106 1008
11050 7590 02/23/2017
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
WOOD, ELLEN SUZANNE
ART UNIT PAPER NUMBER
1782
NOTIFICATION DATE DELIVERY MODE
02/23/2017 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
BSC.USPTO@stwiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BRUCE HAMILTON and
RONALD A. SAHATJIAN
Appeal 2014-009936
Application 13/243,730
Technology Center 1700
Before PETER F. KRATZ, MICHAEL P. COLAIANNI, and
AVELYN M. ROSS, Administrative Patent Judges.
KRATZ, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on an appeal under 35U.S.C. § 134 from the
Examiner’s final rejection of claims 15—33, and 35. We have jurisdiction
pursuant to 35 U.S.C. § 6.
Appellants’ claimed invention is directed to a dilation balloon
including a multilayer balloon wall including a thermoplastic elastomer
coextruded with a non-compliant structural polymer wherein the non-
compliant structural polymer is employed in an inner layer and the
thermoplastic elastomer is employed as an outer layer. The outer layer is
thinner than the inner layer. The dilation balloon can be used in catheters
useful for procedures that take place in bodily conduits and which medical
Appeal 2014-009936
Application 13/243,730
treatments may involve widening constricted passages, such as takes place
with angioplasty, a procedure used to treat a stenosis in a blood vessel (Spec.
1,11. 16-28).
Appellants disclose that ‘“structural polymer’ or ‘structural polymer
material’, as used herein, is intended to mean any polymeric material
suitable for use in medical balloons and compatible with the TPE selected”
and “the term ‘non-compliant’, as used herein, is intended to mean
remaining at a preselected diameter as the internal pressure in the balloon is
increased above that required to fully inflate the balloon.” (Spec. 5,11. 15-
20). Polyethylene terephthalate (PET), Nylon, and other materials are
identified as “[sjuitable non-compliant structural polymeric materials”
(Spec. 5,11.21-23).
Appellants disclose that “‘thermoplastic elastomer’ or ‘TPE’, as used
herein, is intended to mean a polymeric material that combines the
mechanical properties of a thermoset rubber, i.e. resiliency, softness, and
toughness, with the production economics of a thermoplastic polymer”
(Spec. 6,11. 3-6). Appellants state that TPE’s include thermoplastic
polyurethanes (TPU’s) (Spec. 6,11. 6-9).
Claims 15, 30, and 35 are illustrative and reproduced below:
15. A dilatation balloon, the dilatation balloon
comprising a multilayer balloon wall, the multilayer balloon
wall having a thickness, wherein said multilayer balloon wall
comprises:
a thermoplastic elastomer coextruded with a non-
compliant structural polymer, said thermoplastic elastomer as
an outer layer and said non-compliant structural material is an
inner layer, the thermoplastic elastomer outer layer is thinner
than the non-compliant structural material inner layer, the
balloon having a total wall thickness of about 0.4 mil to about
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2.0 mil, said balloon having lower resistance to inflation and
deflation pressure than a balloon having only a non-compliant
structural layer at substantially the same wall thickness to the
thickness of the multilayer balloon wall.
30. A dilatation balloon, the dilatation balloon
comprising a multilayer balloon wall, the multilayer balloon
wall having a thickness, wherein said multilayer balloon wall
comprising:
a thermoplastic elastomer coextruded with a non-
compliant structural polymeric material, the thermoplastic
elastomer as both an inner thermoplastic elastomer layer and an
outer thermoplastic elastomer layer disposed upon an
intermediate structural layer of the non-compliant structural
polymeric material, said balloon having lower resistance to
inflation and deflation pressure than a balloon having only non-
compliant structural layer at a comparable balloon wall
thickness to the thickness of the multilayer balloon wall.
35. A dilatation balloon, the dilatation balloon
comprising a multilayer balloon wall, the multilayer balloon
wall having a thickness, wherein said multilayer balloon wall
comprises:
a thermoplastic elastomer coextruded with a non-
compliant structural polymer, said thermoplastic elastomer as
an outer layer and said non-compliant structural material is an
inner layer, the thermoplastic elastomer outer layer is thinner
than the non-compliant structural material inner layer, the
balloon having a total wall thickness of about 0.4 mil to about
2.0 mil, said balloon having lower resistance to inflation and
deflation pressure than a balloon having only a non-compliant
structural layer of equal wall thickness to the thickness of the
multilayer balloon wall.
The Examiner maintains the following grounds of rejection:
Claims 15—33 stand rejected under 35 U.S.C. § 112, second paragraph
as being indefinite for failing to particularly point out and distinctly claim
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Application 13/243,730
the subject matter which applicant regards as the invention. Claims 15—20,
22—27, 30—33, and 35 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Trotta.1 Claim 21 stands rejected under 35 U.S.C. §
103(a) as being unpatentable over Trotta in view of Mark2. Claims 28 and
29 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Trotta
in view of Boer3.
We affirm the stated rejections. Our reasoning follows.
Indefiniteness Rejection
Section 112 as in effect at the time of filing of the present application
requires that “[t]he specification . . . conclude with one or more claims
particularly pointing out and distinctly claiming the subject matter which the
applicant regards as his invention.” 35 U.S.C. § 112, second paragraph. See
In re Warmerdam, 33 F.3d 1354, 1361 (Fed. Cir. 1994) (“The legal standard
for definiteness is whether a claim reasonably apprises those of skill in the
art of its scope.”). In addition, our reviewing court stated that “[i]t is the
applicants’ burden to precisely define the invention, not the PTO’s.” In re
Morris, 127 F.3d 1048, 1056 (Fed. Cir. 1997).
Thus, claims are definite under Section 112, second paragraph if one
of ordinary skill in this art would have been reasonably apprised of the scope
of the claims, when the claim language is read in light of the specification.
See In re Warmerdam, 33 F.3d 1354, 1361 (Fed. Cir. 1994).
1 U.S. Patent No. 5,290,306 (Mar. 1, 1994).
2 “POLYESTERS, ELASTOMERIC”, Encyclopedia of Polymer Science
and Engineering, ed., Mark et al., John Wiley & Sons, New York, 1988, v.
12, pp. 75-117.
3 U.S. Patent No. 6,355358 B1 (Mar. 12, 2002).
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“As the statutory language of ‘particularity]’ and ‘distinct [ness]’
indicates, claims are required to be cast in clear—as opposed to ambiguous,
vague, indefinite—terms.” In re Packard, 751 F.3d 1307, 1313 (Fed. Cir.
2014).
The Examiner maintains claims 15 and 30, and the claims,
respectively, dependent thereon, are indefinite because the limitation “said
balloon having lower resistance to inflation and deflation pressure than a
balloon having only a non-compliant structural layer at substantially the
same wall thickness to the thickness of the multilayer balloon wall” (claim
15) and the corresponding limitation “said balloon having lower resistance
to inflation and deflation pressure than a balloon having only non-compliant
structural layer at a comparable balloon wall thickness to the thickness of the
multilayer balloon wall” (claim 30) each include relative terminology for the
wall thickness for the comparative balloon for which a standard of measure
is not provided in the Specification and for which claimed subject matter one
of ordinary skill in the art would not be reasonably apprised of the scope of
the claims (Ans. 2—3; Final Office Act. 2—3). The Examiner maintains that
the clarity of the limitations in question is further weakened by the lack of
identification of the make-up of the non-compliant structural material of the
only layer of the comparison balloon wall [as compared to the non-
compliant structural inner layer of the claimed multilayer dilation balloon
wall] (Ans. 3; Final Office Act. 2—3).
Our reviewing court has held that when the USPTO has initially
issued a well-grounded rejection that identifies ways in which the language
in a claim is ambiguous, vague, incoherent, opaque, or otherwise unclear in
describing and defining the claimed invention, and thereafter, the applicant
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fails to provide a satisfactory response, the USPTO can properly reject the
claim as failing to meet the statutory requirement that the claims be definite.
In re Packard, 751 F.3d at 1313—1314. The court explained a satisfactory
response can take the form of modification of the language identified as
unclear, a separate definition of the unclear language, or, in appropriate
circumstances, “persuasive explanation for the record of why the language at
issue is not actually unclear.” Id. at 1311.
Appellants do not dispute the Examiner’s determination that the
subject Specification fails to furnish a standard for measuring the scope of
the claim terms ‘“substantially the same’ wall thickness” and/or “a
comparable balloon wall thickness.” However, Appellants argue that “one
of ordinary skill in the art would understand what is intended by a
‘substantially similar’ wall thickness or a ‘comparable’ wall thickness”
(App. Br. 14) and that “what is found in the prior art is very relevant as to
how one of ordinary skill in the art would determine ‘substantially the same’
wall thickness” (App. Br. 15).4
However, Appellants have not articulated how the comparisons
identified in Durcan (U.S. Patent No. 8,535,596 issued September 17, 2013,
U.S. Patent No. 8,294,055 issued March 12, 2013, and U.S. Patent No.
8,388,575 issued March 05, 2013) represents supporting evidence as to what
is found in the prior art with respect to the meaning of the contested claim
terms particularly given that Appellants claim priority benefits for their
claimed invention back to the filing date (October 01, 1993) of prior
Application No. 08/130,283 through a chain of prior filed Applications,
4 Appellants do not identify different standards for determining the scope of
substantially the same wall thickness and a comparable wall thickness.
6
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which claimed earlier effective filing date precedes the prior art status of
any of the Durcan documents identified by Appellants in the Appeal Brief
(App. Br. 12; see Spec. 1). Hence, Appellants’ reliance on the cited Durcan
patents as showing a prior art comparison technique is undercut by
Appellants’ priority claim to an earlier effective filing date for the claimed
subject matter. Nor have Appellants otherwise persuasively articulated how
any of the cited documents furnish evidence as to the meaning one of
ordinary skill in the art would ascribe to the relative claim terms employed
by Appellants in a seemingly equivalent way in Appellants’ claims 15 and
30 when read in light of Appellants’ description of their invention furnished
in the subject Specification (Reply Br. 2; see generally App. Br.).
Appellants urge that the claim term “substantially” would have been
understood by an ordinarily skilled artisan as a commonly used term and as
recognizing that for conducting a comparison the wall thickness of a
comparison balloon “may not be exact or perfect” in terms of matching the
thickness of a balloon made in accordance with the claimed invention (App.
Br. 12). But also, Appellants essentially contend that the claim term
substantially may embrace any comparison wall thickness that one of
ordinary skill in the art may consider to be a thickness that is approximately
the same as a wall thickness made according to the claimed invention; that
is, any wall thickness that is sufficiently comparable in thickness or
adequately similar in thickness for conducting a balloon property
comparison. (App. Br. 11—17; Reply Br. 2—13).
These arguments are not persuasive of harmful error in the
Examiner’s rejection of claims 15—33 under 35U.S.C. § 112, second
paragraph. Appellants acknowledge that a range of wall thicknesses are
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Application 13/243,730
suitable for the claimed multilayer dilation balloon but do not venture to say
how close a comparison balloon wall thickness should be to a particular
multilayer wall thickness of an inventive sample balloon for purposes of
being sufficiently similar in thickness for comparing resistances to inflation
and deflation pressures and so as to be substantially the same and/or
comparable in thickness (App. Br. 11; see generally App. Br. and Reply
Br.).
In particular, Appellants disclose that the relevant balloon properties
of lower resistance to inflation and deflation pressure are just some of
several balloon properties that are principally influenced by the inclusion of
TPE as part of the balloon wall material whether by use of a blend of
material in a single layer balloon wall or in a multilayer balloon wall that
may or may not include a blend of materials, including TPE (thermoplastic
elastomer), in one or more layers of the balloon wall (Spec. 13,11. 2—18; see
also Spec. 3,11. 5-15; 4,11. 5-14; 7,11. 7-11; 9,1. 17- 10,1. 11).
Appellants’ disclosures appears to suggest that the materials
(especially the amount of TPE) used in each of the multilayers of a balloon
wall and the particular materials employed in any comparison example
balloon having a single layer wall (including any TPE employed in a non-
compliant structural polymer layer of a balloon wall) would have a
significant impact on the resistance to inflation and deflation properties of
the balloon (Spec. 13,11. 1—18; 9,1. 17— 10,1. 11). Yet and as observed by
the Examiner, independent claims 15 and 30 do not limit the comparison
balloon to a particular non-compliant structural layer material composition,
much more to a noncompliant structural layer material that is made of the
same material(s) as the non-compliant structural material inner layer of the
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Application 13/243,730
claimed balloon having a multi-layer wall by Applicants’ use of the
indefinite article “a” or no referencing term in describing the comparison
balloon’s “non-compliant structural layer” (Ans. 3; claims 15, 30), which
provides no definitive reference back to the non-compliant structural
material inner layer of the claimed balloon so as to provide for the
comparison balloon’s non-compliant structural layer to have an identical
composition as the non-complaint structural material inner layer of
Appellants’ claimed dilation balloon (Ans. 3; claims 15, 30). Appellants’
arguments do not address this latter aspect of the Examiner’s indefmiteness
rejection with sufficient specificity to indicate reversible error therein
(“[t]his limitation also fails to specify what the comparative balloon non-
compliant structural layer is made of’) (Final Act.2).
Accordingly, Appellants’ arguments do not reasonably indicate the
existence of a well-known non-ambiguous criteria that one of ordinary skill
in the art would have used in assessing reasonable limits for the workable
difference in balloon wall thickness between a comparison balloon and an a
multi-layer walled balloon according to Appellants’ claims with respect to
resistance to inflation and deflation pressure comparisons. As indicated
above, Appellants do not disclose, suggest or argue any values for a
thickness difference or deviation that would be considered significant and/or
any values of a difference or deviation in thickness of a balloon wall that
would be considered insignificant. Hence, Appellants' disclosure fails to set
forth an adequate definition or guidelines as to what is meant by the relative
claim terminology employed by Appellants in claims 15 and 30. Appellants
have not otherwise established that an art recognized standard exists for the
recited relative claim terms in the context of the presently claimed subject
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matter that would have been understood by one of ordinary skill in the art as
being the measure for construing the contested claim terms when read in
light of the Specification from the perspective of one of ordinary skill in the
art while giving either claim 15 or claim 30 its broadest reasonable
construction.
While the burden of persuasion rests with the Examiner, it is our view
that the Examiner has met this burden of presenting a prima facie case of
indefiniteness so as to shift the burden of producing sufficient claim
amendment, evidence, and/or argument to Appellants to refute the
Examiner’s underlying factual bases for the indefmiteness rejection, the
resolution of which ultimately entails a question of law. In particular,
Appellants have not established by way of argument and/or
evidence/amendment that the Examiner is ultimately wrong in asserting that
the questioned relative claim terms have an unclear meaning to one of
ordinary skill in the art. After all, the language of a claim satisfies § 112,12
only if “one skilled in the art would understand the bounds of the claim
when read in light of the specification.” Exxon Research & Eng ’g Co. v.
United States, 265 F.3d 1371, 1375 (Fed. Cir. 2001).
The crux of the issue before us is not whether the above-identified
relative claim terms are terms that have been employed in a reasonably
definite way under some circumstances in describing balloon wall
thicknesses for other purposes and/or in describing dimensions of other
devices and/or in some other discussion pertaining to balloon wall
thicknesses or dimensions of other items.5 Rather, the question is whether
5 “It is well established that when the term ‘substantially’ serves reasonably
to describe the subject matter so that its scope would be understood by
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the relative terms as used by Appellants in the rejected claims for delimiting
Appellants’ invention have a reasonably definite meaning to one of ordinary
skill in the art for specifying balloon wall thickness dimensions (whether the
thicknesses are averaged or not over a particular balloon wall’s other
dimensions) for balloon property comparisons.
In this regard, we further observe that claims 15 and/or 30 are not
limited to a uniformly thick multilayer wall for the balloon. Appellants have
not otherwise identified what represents sufficient
correspondence/comparability in balloon wall thicknesses for the claimed
property comparison and what deviation in thickness measurements for a
comparison balloon disqualify it as a balloon having a comparable wall
thickness. Nor have Appellants adequately articulated why only a particular
narrow meaning (e.g., a comparison balloon having a wall as perfect or
nearly perfect in thickness dimension identity to an inventive sample balloon
wall as manufacture would permit) would have been attached to the relative
persons in the field of the invention, and to distinguish the claimed subject
matter from the prior art, it is not indefinite.” Verve, LLC v. Crane Cams,
Inc., 311 F.3d 1116, 1120 (Fed. Cir. 2002); see also Liquid Dynamics Corp.
v. Vaughan Co., Inc., 355 F.3d 1361, 1368 (Fed. Cir. 2004) (the term
“substantial” implies “approximate” rather than “perfect”). For reasons
advanced infra and by the Examiner in the Final Office Action and in the
Answer, Appellants have not established that Appellants’ use of the terms
“substantially” and “comparable” for describing the comparison balloon
wall thickness relative to the thickness of a multilayer wall balloon for
purposes of identifying a relatively lower resistance to inflation and
deflation pressures for Appellants’ pending claims includes underling factual
circumstances indicating that the relative terms “substantially” and
“comparable” are employed in a manner such that the bounds of the claimed
subject matter herein would have been reasonably ascertainable by those of
ordinary skill in the art.
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claim terms in an examination context from the viewpoint of an ordinarily
skilled artisan wherein the claims are subject to their broadest reasonable
interpretation when read in light of the Specification as would be understood
by one of ordinary skill in the art.6 After all, a significant purpose of the
definiteness requirement is to furnish others “who would endeavor, in future
enterprise, to approach the area circumscribed by the claims of a patent, with
the adequate notice demanded by due process of law, so that they may more
readily and accurately determine the boundaries of protection involved and
evaluate the possibility of infringement and dominance.” In re Hammack,
427 F.2d 1378, 1382 (CCPA 1970).
Upon due consideration of the record before us, Appellants have not
shown that they met their production burden to overcome/refute the factual
bases underlying the Examiner’s determination as to the lack of reasonable
clarity of the pending claims for reasons relied upon by the Examiner such
as by way of clarifying amendment presented by Appellants during the
iterative examination process culminating in this appeal. Nor have
Appellants otherwise identified reversible legal error in the Examiner’s
maintained indefmiteness determination by way of argument set forth in the
Briefs before us.
Thus, we affirm the Examiner's rejection of claims 15—33 under 35
U.S.C. § 112, second paragraph, for indefmiteness.
6 During patent examination, the pending claims are interpreted as broadly
as their terms reasonably allow. The reason is that during patent prosecution
when claims can be amended, ambiguities should be recognized, scope and
breadth of language explored, and clarification imposed. In re Zletz, 893
F.2d 319, 321 (Fed. Cir. 1989).
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Rejections under 35 U.S.C. § 103
After review of the opposing positions articulated by Appellants and
the Examiner, the applied references, and Appellants’ claims and
Specification disclosures, we determine that the Appellants’ arguments are
insufficient to identify reversible error in the Examiner’s obviousness
rejections. In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011).
Accordingly, we affirm the stated obviousness rejections for
substantially the fact findings and the reasons set forth by the Examiner in
the Examiner’s Answer and the Final Office Action. We offer the following
for emphasis only.
Concerning the Examiner’s first stated obviousness rejection,
Appellants argue claims 15—20, 22—27, 30-33, and 35 together as a group
and present substantially the same arguments for independent claims 15, 30,
and 35 (App. Br. 17, 23). Appellants do not present separate arguments for
any of the dependent claims, including claims 21, 28, and 29, which are
subject to separate grounds of rejection over Trotta as used in the base
rejection, and an additional applied reference (App. Br. 23—25).7
Accordingly, we select claim 35 as the representative claim on which we
7 Because Appellants argue the separate grounds of rejection of dependent
claims 21, 28, and 29 on the basis of the arguments made for the base
rejection of the independent claims including the claims on which the
separately rejected dependent claims depend from, we need not review the
additional reference(s) applied against dependent claims 21, 28, and 29.
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primarily focus in deciding this appeal as to the Examiner’s obviousness
rejections.
Representative claim 35 requires, inter alia, that the multilayer wall of
the dilation balloon having a total wall thickness of about 0.4 mil to about
2.0 mil and which balloon wall includes an outer layer made with a
thermoplastic elastomer and an inner layer comprising a non-complaint
structural material wherein the outer layer is thinner than the inner layer.
Appellants do not dispute the Examiner’s determination that Trotta
teaches or suggests a dilation balloon having a multi-layer wall that includes
an inner (balloon) wall made of a non-compliant structural material (biaxial
oriented PET or polyamide) and an outer layer (balloon elastomeric sleeve)
that includes a thermoplastic elastomer (polyurethanes, polyester-ether
copolymers, or polyetheresteramide terpolymers) (Ans. 4—6; Final Act. 3—7;
Trotta, col. 2,11. 32—34; col. 4,11. 26—39).8 Nor do Appellants contend that
the Examiner erred in determining that Trotta teaches or suggests a total
dilation balloon wall thickness (balloon (inner) layer and sleeve (outer)
layer) corresponding to the total wall thickness specified in representative
claim 35 (Final Act. 5; Ans. 5; Trotta, col. 4,11. 19-21, 34—35). Rather,
Appellants focus their principal arguments on the representative claim 35
limitation requiring the balloon wall outer layer to be thinner than the inner
layer and on the required balloon property of lower resistance to inflation
and deflation pressure as compared to the resistance to inflation and
8 Trotta’s sleeve 20 corresponds to the outer layer of the claimed balloon
wall and Trotta’s balloon 10 corresponds to the inner layer of the claimed
balloon wall (Trotta, col. 4,11. 26—33; Fig. 1).
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deflation pressure of a balloon having only a non-compliant structural layer
of equal wall thickness to the claimed balloon having a multi-layer wall.9
Appellants argue that Trotta teaches that the balloon wall outer layer
(sleeve) is of the same thickness or thicker than the balloon wall inner layer
in column four of Trotta and, based thereon, contend that Trotta provides no
suggestion of forming the outer elastomer layer to be thinner than the inner
structural layer (App. Br. 18; Trotta, col. 4,11. 19-54).
Appellants contend that “Trotta et al. is completely silent as to the
balloon having lower resistance to inflation characteristics whatsoever”
(App. Br. 23). Appellants argue that Trotta does not suggest that “providing
for an equally thick or thicker outer layer would lower resistance to inflation
as well as deflation” (id.; see also App. Br. 19-24; Reply Br. 13—21).
Moreover, Appellants argue that the Examiner’s proposed modification of
Trotta to include a thinner outer layer relative to a thicker inner layer lacks
merit because “one of ordinary skill in the art would not be lead [sic.] to
believe by the disclosure of Trotta et al. that by providing a thinner outer
layer, one of ordinary skill would still be able to attain compression to the
9 Commonly rejected and argued independent claims 15 and 30, as discussed
above, are drawn to a balloon having somewhat similar limitations as to the
balloon wall structure of claim 35 albeit claim 30 does not specify that a
balloon outer layer is thinner than the interior non-compliant structural
polymeric layer, which is a principal feature argued by Appellants as a non­
ob vious distinction. Claim 30 requires an inner thermoplastic elastomer
layer in addition to an outer thermoplastic elastomer layer. However,
Appellants have waived any separate argument as to claim 30 and the inner
thermoplastic layer feature of claim 30 that they may have made by arguing
the rejected claims together with respect to the Examiner’s obviousness
rejection in the Appeal Brief.
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inner surface of the balloon while lowering the resistance to inflation” (App.
Br. 23).
Appellants’ arguments are not persuasive of harmful error in the
Examiner’s obviousness rejections of the appealed claims. At the outset, we
observe that Appellants predicate much of the argument on an incorrect
reading of the cited column 4 teachings of Trotta as specifying that the
polyurethane elastomer outer layer is at least as thick as the balloon wall
structural inner layer. In fact, Trotta teaches that the inner layer balloon wall
thickness “may be about 0.0005 inch” when made of biaxially oriented PET
and the outer polyurethane layer 20 “may have a thickness of, typically,
0.0005 to 0.002 inch” (col. 4,11. 19—20, 33—35). Appellants do not
persuasively explain how Trotta’s employment of the permissive term
“may” in furnishing some examples of what each of the layer thicknesses
may be is a teaching that restricts the layers to a thickness relationship as
Appellants argue to be the case.
As determined by the Examiner, one of ordinary skill in the art would
not have construed Trotta’s teachings so narrowly. Rather, one of ordinary
skill in the art would have found at least an implicit suggestion in Trotta to
employ layers of other thickness dimensions than those Trotta explicitly
teaches may be employed, including using a relatively thicker inner layer
and thinner outer layer in determining the workable thickness limits and
depending on the overall stiffness desired for the dilation balloon, one of
ordinary skill in the art would have direction from Trotta to employ a
somewhat thicker inner layer as compared to the outer layer as determined
by the Examiner (Final Act. 5—6, 15; Ans. 6, 14—17). In this regard, Trotta
teaches that providing an elastomeric sleeve (outer layer) assists balloon
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deflation without requiring that the outer layer must be at least as thick as
the inner layer to provide this functionality (Trotta, col. 2,11. 6—21), as
contended by Appellants.
Moreover, we concur with the Examiner that Appellants’
Specification requires no linkage between employing a thinner outer layer
than the inner layer and a lowered resistance to balloon deflation, as required
by claim 35 (Ans. 16). Appellants simply disclose that typically, the
elastomeric layer is significantly thinner than the structural layer without a
showing of the effect that a particular thickness relationship between a
structural inner layer and an elastomeric outer layer has on particular balloon
resistance to inflation properties (Spec. 8,11. 3^4).
Hence, Appellants’ argument to the effect that the Examiner is
engaging in impermissible hindsight by employing Appellants’ teachings
lacks traction. In particular, we further observe that representative claim 35
requires no particular amount of lowered resistance to inflation and deflation
pressure as compared with a balloon with a wall made of only a non-
compliant structural polymer layer of equal wall thickness (App. Br. 20—23).
Appellants’ disclosure suggests this latter balloon property is primarily due
to the incorporation of TPE in the balloon wall and Appellants have not
argued that representative claim 35 is non-obviously distinguished from the
balloon wall taught or suggested by Trotta based on the TPE content of
Appellants’ claimed balloon wall (Spec. 13,11. 1—18; see generally App.
Br.). Indeed, Appellants have not specifically disputed the Examiner’s
determination that Trotta incorporates TPE in the balloon wall outer layer
(sleeve 20) (Final Act. 4—5; Ans. 4—6). Thus, the Examiner has furnished a
sufficient evidentiary basis to reasonably expect that a balloon made in
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accordance with the teachings of Trotta and including TPE would have
decreased resistance to inflation and deflation pressures as compared to a
balloon of an equal wall thickness that only comprised a non-complaint
structural polymer layer.
Consequently, we determine that Appellants’ arguments do not show
harmful error in the Examiner’s obviousness determination.
It follows that we shall sustain the Examiner’s obviousness rejections
of the appealed claims.
CONCLUSION/ORDER
The Examiner’s decision to reject the appealed claims is affirmed.
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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