Ex Parte Rizq et al

Patent Trial and Appeal Board

Sep 26, 2016

11022585 (P.T.A.B. Sep. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111022,585 12/23/2004
11050 7590 09/28/2016
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
FIRST NAMED INVENTOR
Raed Rizq
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
2001.1365101 8944
EXAMINER
SZPIRA, TIJLIE ANN
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
09/28/2016 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 RAED RIZQ, JOHN J. CHEN, and STANLEY NORDIN
Appeal2014-007882
Application 11/022,585
Technology Center 3700
Before JILL D. HILL, LISA M. GUIJT, and ERIC C. JESCHKE
Administrative Patent Judges.
GUIJT, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants 1 appeal under 35 U.S.C. § 134(a) from the Examiner's
decision2 to reject claims 1-3, 6, 7, 9-12, and 24--35. We have jurisdiction
under 35 U.S.C. § 6(b).
We REVERSE.
1 Boston Scientific Scimed, Inc. is identified as the real party in interest.
App. Br. 3.
2 Appeal is taken from the Non-Final Office Action dated September 27,
2013 ("Non-Final Act.").
Appeal2014-007882
Application 11/022,585
THE CLAIMED SUBJECT MATTER
Claims 1, 3, 9, 10, and 24 are independent. Claim 1, reproduced
below, is illustrative of the subject matter on appeal.
1. An assembly comprising a catheter, a deflated
balloon mounted on the catheter and a stent mounted over
the balloon, wherein
the balloon comprises polymer material having a
fugitive plasticizer distributed therein, the polymer
material comprises a polymer that forms inter-chain
hydrogen bonds and the fugitive plasticizer comprises a
polar organic compound.
THE REJECTIONS
I. Claims 1-3, 6, 7, 9, 26-29, and 35 stand rejected under 35
U.S.C. § 103(a) as unpatentable over Gandhi (WO 98/36783; pub. Aug. 27,
1998) and Juman (US 2001/0014821 Al; pub. Aug. 16, 2001).
II. Claims 24, 25, and 33 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Amundson (US 5,484,449; iss. Jan. 16, 1996) and
Gandhi.
III. Claims 10-12 and 34 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Amundson and Zhong (US 5,869,127; iss. Feb. 9,
1999).
IV. Claims 30-32 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Gandhi, Juman, and Amundson.
ANALYSIS
Rejection I
Independent claims 1, 3, and 9 recite, in relevant part, "[a] balloon
compris[ing] polymer material having a fugitive plasticizer distributed
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Application 11/022,585
therein." App. Br. 23-24 (Claims App.). Regarding independent claims 1,
3, and 9, the Examiner finds, inter alia, that Gandhi teaches a balloon
including a polymer material having a fugitive plasticizer, and in particular,
that the phenols disclosed in Gandhi are fugitive plasticizers. Non-Final
Act. 3 (citing Gandhi, page 6, lines 9 to 25). The Examiner determines that
although Gandhi does not identify any of the disclosed plasticizers as
fugitive plasticizers, some of the compounds disclosed as plasticizers in
Gandhi are the same as the fugitive plasticizers identified in Appellants'
Specification and "function[] in the same manner;" therefore, Gandhi
discloses fugitive plasticizers as claimed. Ans. 3. The Examiner further
determines that the amount of plasticizer disclosed in Gandhi supports the
Examiner's characterization of Gandhi's plasticizers as the claimed fugitive
plasticizer, because both Gandhi's plasticizers and the claimed fugitive
plasticizer "have an effect on" the properties of the balloon, for example, "to
soften the balloon." Id. The Examiner also determines that claims 1, 3, and
9 are not method claims, and therefore, the capability of Gandhi's plasticizer
to be removed from the balloon is irrelevant. Id. at 4.
Appellants argue that Gandhi does not disclose or suggest that any of
the plasticizers "function as a fugitive plasticizer." App. Br. 12. In support,
Appellants submit that
[Gandhi] desires changing the physical properties of the balloon
material, i.e. by lowering the glass transition temperature, the
disclosure of which would lead one of ordinary skill in the art to
believe that these plasticizers are remaining in the balloon
material in amounts significant enough to alter the physical
properties of the balloon material.
The amount of fugitive plasticizer remammg in
Appellants' balloon material, on the other hand is small enough
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Application 11/022,585
so as to have no effect on the properties of the balloon material
other than to soften it enough initially for the stent to stick to the
balloon.
Id. (citing Spec., p. 2, 11. 19-20 ("the fugitive plasticizer may be removed by
evaporation"), p. 10, 11. 5-7 ("a balloon burst property was not affected by a
plasticization process."). Appellants maintain that "[ n Jot all plasticizers
have the properties that allow removal from a polymer material, hence the
term 'fugitive plasticizer.'" Id. at 16; see also Reply Br. 5.
The Specification discloses that
[a] s used herein the concept of a fugitive plasticizer is a
compound that can penetrate the balloon material to soften it,
without dissolving the balloon material, in the manner of a
traditional plasticizer, but that subsequently can be removed
without melting or dissolving the balloon material or damaging
an attached stent.
Spec., p. 3, 11. 3---6 (emphasis added). For example, the Specification
discloses that"[ fJollowing crimping [of the stent to the balloon material], the
fugitive plasticizer may be removed by evaporation, optionally under
vacuum, again with little or no heating." Id. at p. 2, 11. 18-19; see also id. at
p. 3, 1. 11 ("Removal of the fugitive plasticizer is typically accomplished by
volatilization.").
We are not apprised of error in the Examiner's finding that the prior
art discloses compounds as "traditional plasticizers" that are also identified
by Appellants' Specification as "fugitive plasticizers." For example,
Godaire discloses that
[t]he balloon optionally further comprises a plasticizer.
Plasticizer is used herein to mean any material that can decrease
the flexural modulus of a polymer. The plasticizer may influence
the morphology of the polymer and may affect the melting
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Application 11/022,585
temperature and glass transition temperature. Examples of
plasticizers include ... ethylene glycol.
Godaire i-f 21 (emphasis added); cf Spec. p. 5, 1. 26-p. 6, 1. 3 ("[f]ugitive
plasticizers for coating, films, floor polishes, polymer emulsions and
molding compositions are well known[;] ... [t]ypical compounds include
polyhydric alcohols, e.g., ethylene glycol.") (emphasis added)).
However, we agree with Appellants that the similarity of the
compounds is not enough. The definition of the claim term "fugitive
plasticizer," as set forth in the Specification, requires a traditional plasticizer
(which softens), to be further capable of removal from the balloon material,
for example, by evaporation or volatilization, without melting or dissolving
the balloon material. 3 Spec., p. 2, 11. 18-19, p. 3, 11. 3---6, 11, p. 7, 11. 4---6.
We understand that both traditional and fugitive plasticizers function to
soften the balloon material, and thus, the Examiner's conclusion that
Gandhi's traditional plasticizers "function in the same manner" as the
claimed fugitive plasticizers is partly correct. However, we also understand
that a difference between a traditional plasticizer and a fugitive plasticizer is
that a fugitive plasticizer may be removed from the balloon material after
formation, for example, by evaporation or volatilization, without melting or
dissolving the balloon material. Thus, the Examiner's conclusion that
because Gandhi's plasticizers soften the balloon material, Gandhi's
plasticizers are also fugitive plasticizers is in error.
3 During patent examination, claims are to be given their broadest reasonable
interpretation consistent with the specification, with claim language being
read in light of the specification as it would be interpreted by one of ordinary
skill in the art. In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed.
Cir. 2004).
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The Examiner has not provided support that Gandhi's plasticizer
functions as a fugitive plasticizer, as defined by the Specification, in the
context of the device disclosed in Gandhi. The Examiner also does not
address Appellants' argument that the amount of plasticizer remaining in the
balloon material after formation is evidence as to whether a plasticizer is a
fugitive plasticizer, in that if the amount of plasticizer that remains in the
balloon material after formation is such that a physical property of the
balloon (excluding softening) is altered, such as the glass transition property,
the plasticizer is unable to be removed from the balloon material without
melting or dissolving the balloon material. Gandhi discloses using an
amount of plasticizer such that the glass transition property of the balloon
material is changed. See, e.g., Gandhi, p. 5, 11. 7-9 ("A plasticized
polyamide or polyester is a polyamide or polyester with a plasticizer added
to control the glass transition temperature of the material."). Thus, a
preponderance of the evidence does not support the Examiner's finding that
Gandhi expressly discloses a plasticizer that functions as a fugitive
p las ti cizer.
Godaire discloses that "[i]t is desirable to improve the flexibility and
trackability of dilatation balloons while limiting the use of plasticizers,
which can migrate out of the balloon, and while maintaining a high degree
of strength in the balloon." Godaire i-f 10. Godaire suggests that "[i]n order
to improve the flexibility of standard balloons without the use of plasticizers,
or alternatively, with the limited use of plasticizers, a softer and more
flexible material is blended into the balloon base material." Id. However,
the Examiner does not rely on Godaire for disclosing a plasticizer that
functions as a fugitive plasticizer, and we determine that Godaire stops short
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Application 11/022,585
of expressly disclosing that such migration is removal of the plasticizer from
the balloon material, for example, by evaporation or volatilization, without
melting or dissolving the balloon material. Rather, as stated supra (and
similar to Gandhi), Godaire teaches using the plasticizer in an amount to
influence the morphology of the polymer and/or affect the melting and glass
transition temperatures of the balloon material. See, e.g., Godaire i-f 21.
Accordingly, we do not sustain the Examiner's rejection of
independent claims 1, 3, and 9, and claims 2, 6, 7, 26-29, and 35, which
depend therefrom.
Rejection II
Independent claim 24 recites, in relevant part, "a deflated balloon
mounted on the catheter ... wherein the assembly was formed by crimping
the stent on the balloon ... to produce a pillowing of the balloon material
between sidewall openings in the stent." App. Br. 24 (Claims App.). The
Examiner finds that Amundson discloses this limitation because
Amundson's "balloon was not inflated or pressured in a way that would
'harden' the balloon, and thus the balloon was in a softened state when the
stent crimping occurred." Non-Final Act. 5 (citing Amundson, col. 3, 11. 46-
53, Fig. 2).
Appellants argue that Amundson does not disclose or suggest that "the
balloon will pillow between the sidewall openings of the stent." App. Br.
17. The Examiner responds that "[a] deflated balloon will have flexibility
and be able to pillow into openings, but when the balloon is inflated, the
balloon will not pillow in the same manner due to the rigidity that is
imparted through a change in volume." Ans. 4.
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Application 11/022,585
The Examiner's citations to Amundson do not support the Examiner's
finding that, in a deflated state, the balloon pillows between sidewall
openings in the stent, a structural limitation required by claim 24.
Amundson' s Figure 2, which is "a side elevation showing an overall view of
a stent prosthesis ... fitted over a deflated balloon," does not depict
pillowing of the balloon between sidewall openings in the stent. Amundson,
col. 2, 11. 50-52. Although Figure 5 depicts pillowing of the balloon
between sidewall openings in the stent, Figure 5 "show[ s] the balloon being
inflated." Id. at col. 5, 11. 57-58. Column 3, lines 46 to 53 of Amundson
also does not expressly support the Examiner's finding regarding pillowing,
but simply discloses "squeezing the stent over the balloon."
Accordingly, we do not sustain the Examiner's rejection of
independent claim 24, and claims 25 and 33 depending therefrom.
Rejection III
Similar to independent claim 24, independent claim 10 recites, in
relevant part, "a deflated balloon mounted on the catheter ... wherein the
stent has been crimped on the balloon ... to produce a pillowing of the
balloon material between sidewall openings in the stent." App. Br. 24
(Claims App.). The Examiner relies on the same deficient findings from
Amundson to support the rejection of claim 24, and for the same reasons as
stated supra with respect to claim 24, we also do not sustain the Examiner's
rejection of claim 10, and claims 11, 12, and 34 depending therefrom. Non-
Final Act. 6.
Rejection IV
Claims 30-32 depend from independent claim 1. The Examiner's
reliance on Amundson does not cure the deficiency in the Examiner's
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finding with respect to Gandhi as applied to claim 1. Therefore, we do not
sustain the Examiner's rejection of claims 30-32 for the reasons discussed
supra.
DECISION
The Examiner's rejections of claims 1-3, 6, 7, 9-12, and 24--35 are
REVERSED.
REVERSED
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