Ex Parte Wang et al

Patent Trial and Appeal Board

Dec 18, 2017

14331758 (P.T.A.B. Dec. 18, 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.
14/331,758 07/15/2014 Lixiao Wang 2001.1360104 2116
11050 7590 12/20/2017
SEAGER, TUFTE & WICKHEM, LLP
100 South 5th Street
Suite 600
Minneapolis, MN 55402
EXAMINER
WEISBERG, AMY REGINA
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
12/20/2017 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 LIXIAO WANG, JEFFREY S. LINDQUIST, PAO NAO LEE,
JOHN JIANHUA CHEN, and DOUGLAS A. DEVENS
Appeal 2016-008248
Application 14/331,75 81,2
Technology Center 3700
Before JILL D. HILL, JEFFREY A. STEPHENS, and ERIC C. JESCHKE,
Administrative Patent Judges.
JESCHKE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant seeks review under 35 U.S.C. § 134(a) of the Examiner’s
decision, as set forth in the Final Office Action dated September 22, 2015
(“Final Act.”), and as further explained in the Advisory Actions dated
1 Boston Scientific Scimed, Inc. (“Appellant”) is the applicant as
provided in 37 C.F.R. § 1.46 and is identified as the real party in interest.
Appeal Br. 3.
2 Appellant identifies Application No. 13/593,756 as a related
application. Appeal Br. 3. The Patent Trial and Appeal Board rendered a
decision on appeal in the related Application on June 16, 2017. We have
reviewed that decision and, to the extent relevant to the issues in the present
appeal, have taken that decision into account in the analysis below.
Appeal 2016-008248
Application 14/331,758
December 3, 2015, and February 1, 2016, rejecting claims 1—15. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse.
BACKGROUND
The disclosed subject matter “is directed to methods of forming
balloons and parisons therefor.” Spec. 3,11. 9-10. Claim 1, the sole
independent claim, is reproduced below:
1. An expandable medical balloon, the
expandable medical balloon comprising:
a balloon wall comprising a thermoplastic
elastomer, the balloon having a calculated burst
strength of 32,000 psi or greater in a pre-sterilized
condition as defined by the following equation:
Strength = (P x D/2t)
where P = internal pressure when the balloon
bursts (kg/cm2) (1 kg/cm2 = 14.2 psi); D is the
exterior diameter (mm) of the balloon when a
pressure of 6 kg/cm2 (85.2 psi) is applied; and t is
the wall thickness (mm) of the portion of the
balloon with the larger exterior diameter.
REJECTIONS
1. Claim 15 stands rejected under 35 U.S.C. § 112, second
paragraph, as failing to particularly point out and distinctly claim the subject
matter regarded as the invention.
2. Claims 1—4, 8, and 13—15 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Anderson (US 5,500,180, issued Mar. 19,
1996).
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Application 14/331,758
3. Claim 5 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Anderson and Reinhardt (US 5,833,657, issued Nov. 10,
1998) .
4. Claims 6 and 7 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Anderson and Chin (US 7,947,059 B2, issued May 24,
2011).
5. Claim 9 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Anderson and Wang (US 5,951,941, issued Sept. 14,
1999) .
6. Claims 10 and 11 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Anderson and Lee (US 6,527,741 Bl, issued Mar. 4,
2003).
7. Claim 12 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Anderson and Nazarova (US 2001/0006700 Al, published
July 5, 2001).
DISCUSSION
Rejection 1 — The rejection of claim 15 under
35 U.S.C. § 112, second paragraph
Claim 15 recites: “The expandable medical balloon of claim 1
comprising improved resistance to repeat inflation bursts versus a control
utilizing the same thermoplastic elastomer extruded to keep a parison
elongation at break above 80% of the published elongation of the polymer.”
Appeal Br. 15 (Claims App.).
The Examiner rejected claim 15 as failing to particularly point out and
distinctly claim the subject matter regarded as the invention. The Examiner
highlighted the language prior to “extruded” in claim 15, and stated that
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Application 14/331,758
Appellant “has not defined the control nor the ‘same thermoplastic
elastomer’ thus it is indefinite what properties App[ellant] is claiming are
different from the prior art.” Final Act. 3 (| 5). The Examiner stated that
“[f]or the purpose of examination, the Examiner is interpreting that
App[ellant] is referring the improved burst strengths claimed in claims 1—4.”
Id. In addition, the Examiner stated that the phrase “same thermoplastic
elastomer” lacks sufficient antecedent basis. Id. (1 6).
Appellant argues (1) “that those of ordinary skill in the art are familiar
with the calculation of burst strengths/wall tensile strengths from an
observed balloon burst strength and nominal dimensions of the balloon prior
to inflation”; (2) “that such persons are aware of desirability of improved
resistance to repeat inflation bursts (for example, col. 1, lines 23—30 of
Anderson); and (3) “that such persons are well aware of the use of ‘controls’
to evaluate changes in performance, a technique used by Anderson in the
Examples provided.” Appeal Br. 5. We determine that, in response to this
Rejection, Appellant has provided a “persuasive explanation for the record
of why the language at issue is not actually unclear.” In re Packard, 751
F.3d 1307, 1311 (Fed. Cir. 2014).
We agree with Appellant that “[t]he production, testing, and test
results of a control versus an article of the invention is described in the
[Specification in a manner which would be readily understood by one of
ordinary skill in the art.” Appeal Br. 5 (citing Spec. 7—8 (discussion of
“Table 1 — Control” and “Table 2 — High Draw Down”)). As noted by
Appellant (Appeal Br. 5), in Example 5, the Specification discloses that
“[pjarisons, extruded to keep the parison elongation at break above 80 % of
the published elongation of the polymer, were used as controls” and that
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Application 14/331,758
“[pjarisons, extruded to provide a parison elongation at break of about 50%
or less of the published elongation of the polymer, were prepared as
invention examples.” Spec. 8,1. 24 —9,1. 1. The Specification further
discloses that “[t]he balloons were inflated to 211 psi and deflated
repeatedly” and that “[t]he control balloon group [of four balloons], on
average, failed at about 80 repeats” whereas “[a]ll of the balloons of the
invention group survived 235 repeats without failure.” Id. at 9,11. 1^4.
Moreover, the Specification indicates certain relationships between
the draw down ratio (“DDR”)3 used in processing and both (1) the burst
strength4 of the sample and (2) the elongation at break5 of the sample. For
example, the Specification indicates that the use of a higher DDR during
processing can (1) increase the burst strength and (2) decrease the elongation
at break. Compare Spec. 7,11. 27—30 (“Table 1 — Control”), with id. at 7,
1. 31 — 8,1. 20 (“Table 2 — High Draw Down” and “Table 3 — Parison
Modifications”); see also id. at 5,11. 5—26 (stating that “Parison elongation
may be controlled by varying one or more of the following extrusion
parameters” including “Draw down ratio”); id. at 7,11. 31—33 (“Table 2 gives
the results of the same balloon wall thickness made in accordance with the
invention by increasing the DDR. The increased draw down ratio reduced
3 The Specification defines DDR as: “Draw down ratio of the cross-
sectional area from extrusion head opening to final tube dimensions. DDR =
[(Die ID)2 - (Tip OD)2]/[(Tubing OD)2 - (Tubing ID)2].” Spec. 6,11. 17-19.
4 The Specification defines “Burst Strength” using the equation recited
in claim 1. See Spec. 6,11. 36-41.
5 The Specification states that elongation at break is “[g]iven as
percentage elongation determined on a 3" long extruded tube which is
stretched to break.” Spec. 6,11. 21—22.
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Application 14/331,758
the elongation of this tube to about 48% of the published elongation
value.”).
Based on these disclosures, we agree with Appellant that the language
of claim 15:
indicates to [a person of ordinary skill in the art] that the control
parison in question is to be formed from the thermoplastic
elastomer polymer used to form the balloon having the
unexpected burst strength and that a control parison is subjected
to the same balloon formation and testing conditions as a parison
having an elongation at break equal to or below 80% of the
published elongation of the thermoplastic elastomer polymer
used to form both the Control and the High Draw Down balloon.
Appeal Br. 5. As such, the “same thermoplastic elastomer” recited in claim
15 finds antecedent basis in the “thermoplastic elastomer” of claim 1. We
also agree with Appellant that, in light of the Specification here, the “recited
relative difference in elongation properties” in claim 15 adequately defines
the scope of the recited “control.” Id. at 6.
As to the Examiner’s position that “the features upon which Appellant
relies (i.e., said improved resistance vs a control) are not recited in the
rejected claim(s)” (Ans. 3), as noted by Appellant, claim 15 recites the
property of “improved resistance to repeat inflation bursts versus a control”
as further defined in the claim. See Reply Br. 2. For the reasons above, we
determine that claim 15 sets forth this property with sufficient clarity.
We do not agree with the Examiner’s position (to the extent relied
upon to support this Rejection) that the term “published” in claim 15 renders
the claim indefinite. See Ans. 4 (“Specifically, where are the elongation
values for the polymer published? The me[te]s and bounds of this claim
cannot be determined from this claim.”). Instead, we agree with Appellant
that “where the information is published is immaterial to the definiteness of
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the claim” and that, in light of Anderson, one of ordinary skill in the art
would understand the scope and meaning of the claim language at issue. See
Reply Br. 3 (citing column 8, lines 43—50 and stating that Anderson “had no
apparent difficulty locating the manufacture’s literature (The Dow Chemical
Company) value for elongation (250%) for the PELLETHANE 2363-75D
used in the examples of Anderson”).
As to the Examiner’s discussion of MPEP § 608.01 (i), claim 15 is not
written in the format provided for in 37 C.F.R. § 1.75(e) (the so-called
Jepson format). See Ans. 3. Thus, that claim 15 may not satisfy each
requirement of that format does not support this Rejection.
For these reasons, we do not sustain the rejection of claim 15 under
35 U.S.C. § 112, second paragraph.
Rejection 2 — The rejection of claims 1—4, 8,
and 13—15 under 35 U.S.C. § 103(a)
For claim 1, the Examiner found that Anderson teaches “a balloon
wall comprising thermoplastic elastomer (column 8 lines 20-42), the balloon
having a calculated burst strength of 32,000 psi (column 7 lines 27—38) or
greater in a pre-sterilized condition” as defined by the recited equation.
Final Act. 4. The Examiner stated that Appellant “recites PELLETHANE as
an exemplary thermoplastic elastomer material (page 4 of [Specification)
and Anderson lists the same (column 8 lines 43—45).” Id. at 4—5.
Appellant argues that column 7, lines 27 to 38 in Anderson, cited as
disclosing the recited “calculated burst strength,” “states desirable ranges of
properties of medical balloons of the ‘compliant’ type” but “does not teach
that the full extent of each of the desirable ranges have been achieved in a
thermoplastic elastomer medical balloon,” as recited in claim 1. Appeal Br.
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7. According to Appellant, “Anderson may be asserted to teach the
existence of medical balloons having a thermoplastic elastomer wall and
may be asserted to teach the existence of (noncompliant) medical balloon
walls having calculated burst strengths of 32,000 or greater” but “Anderson
does not expressly teach ... a thermoplastic elastomer balloon wall having a
calculated burst strength of 32,000 psi or greater.” Id. at 8. Appellant
contends that the Examiner “errs in asserting that PELLETHANE 2363-75D
polyurethane in part is necessarily capable of providing the full range of
properties described as desirable or preferred when formed into a medical
balloon of Anderson.” Id. at 11. We agree with Appellant’s understanding
of the relied-upon aspects of Anderson.
In column 8, Anderson discloses: (1) “block copolymers” as one
example of polymeric materials that “may be used in forming the balloons
and balloon catheters of this invention” (col. 8,11. 20—24); (2) that
“polyurethane block copolymers” are the preferred “block copolymer” (col.
8,11. 24—31); and (3) PELLETHANE is the “most preferred polyurethane”
(col. 8,11. 43—45). In column 7, Anderson discloses that “[t]he present
invention” provides balloons with “wall tensile strength of at least about
14,000 psi, preferably in the range of about 15,000 to about 40,000 psi and
most preferably in the range of about 16,000 to about 30,000 psi.”
Anderson, col. 7,11. 26—38.
Although the Examiner is correct that Anderson teaches the use of
various materials in the invention, and also teaches a range of wall tensile
strengths6 in balloons made from the disclosed materials, the Examiner has
6 Appellant acknowledges that the term “wall tensile strength” as used
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Application 14/331,758
not provided an adequate basis—based on evidence or scientific reasoning—
to support the finding that Anderson discloses a balloon made of
PELLETHANE (or any other “thermoplastic elastomer”) that necessarily
possesses a “calculated burst strength of 32,000 psi or greater,” as required
by claim 1. Cf. Ans. 5 (“Anderson teaches a plethora of materials which
may be used and that the balloon may have a tensile strength [of] 15,000—
40,000 psi (column 7 lines 27^40).”); see also Reply Br. 4 (arguing that
“Anderson fails to disclose any expandable thermoplastic elastomer medical
balloon ‘having a calculated burst strength of 32,000 psi or greater in a pre­
sterilized condition’ as defined within claim 1”).
For these reasons, we do not sustain the rejection of independent
claim 1, and also do not sustain the rejection of claims 2—4, 8, and 13—15
(which depend from claim 1) under 35 U.S.C. § 103(a).* * * * 7
Rejections 3 through 8 — The rejection of claims
5—7 and 9—12 under 35 U.S.C. § 103(a)
Claims 5—7 and 9-12 depend from claim 1. Appeal Br. 14—15
(Claims App.). The Examiner’s added reliance on Reinhardt (for Rejection
3), Chin (for Rejection 4), Wang (for Rejection 5), Lee (for Rejection 6), and
Nazarova (for Rejection 7) does not remedy the deficiencies in Anderson
in Anderson (see, e.g., col. 7,1. 35) is equivalent to the recited “calculated
burst strength.” See Appeal Br. 7 (stating that these “terms are to be treated
as equivalent as evidenced by the use of the same formula to calculate those
values”).
7 In the event of further prosecution, the Examiner may consider
whether any claims in this Application are rendered unpatentable under the
judicially created doctrine of obviousness-type double patenting based on
one or more of the claims from related Application No. 13/593,756, which
issued in U.S. Patent No. 9,801,981 B2. See supra n.2.
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discussed above (see supra Rejection 1). Thus, for the same reasons
discussed above, we do not sustain the rejection of claims 5—7 and 9-12
under 35 U.S.C. § 103(a).
DECISION
We reverse the decision to reject claim 15 under 35 U.S.C. § 112,
second paragraph, and we reverse the decision to reject claims 1—15 under
35 U.S.C. § 103(a).
REVERSED
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