Ex Parte Wenchell et al

Patent Trial and Appeal Board

Mar 26, 2013

12266758 (P.T.A.B. Mar. 26, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte THOMAS WENCHELL and ROBERT C. SMITH
__________

Appeal 2011-009478
Application 12/266,758
Technology Center 3700
__________

Before LORA M. GREEN, FRANCISCO C. PRATS, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1-8 and 10-12. We have jurisdiction under
35 U.S.C. § 6(b).
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Application 12/266,758

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STATEMENT OF THE CASE
Claim 1 is the only independent claim on appeal, and reads as follows
(emphasis added):
1. A method of forming and enlarging a percutaneous penetration, the
method comprising the steps of:
providing a radially expandable dilation assembly having a needle
assembly removably inserted in a axial lumen thereof, the radially
expandable dilation assembly having a radially expandable sleeve body
defining a lumen and an introducer seal disposed across the lumen and
defining an opening formed therein, wherein the dilation assembly includes
at least one engaging member integrally formed with the handle portion and
projecting radially inward;
penetrating the radially expandable dilation assembly and needle
assembly through tissue to a target surgical site;
withdrawing the needle assembly from the radially expandable
dilation assembly; and
inserting an expansion assembly through the opening formed in the
introducer seal and into the axial lumen of the radially expandable dilation
assembly, wherein the expansion member includes at least one engaging
element formed in an outer surface thereof for co-operable engagement with
a respective one of the at least one engaging member of the dilation
assembly, wherein the at least one engaging member of the dilation
assembly cooperates with the at least one engaging element of the expansion
member to axially advance the expansion member through the dilation
assembly upon rotation of the expansion member relative to the dilation
assembly.

The following grounds of rejection are before us for review:
I. Claims 1-4, 6, 7, and 10-12 stand rejected under 35 U.S.C.
§ 103(a) as being rendered obvious by the combination of
Carlson,
1
DeLago,
2
and Edwards
3
(Ans. 3).

1
Carlson et al., US 5,827,319, issued Oct. 27, 1998.
2
DeLago, US 5,827,227, issued Oct. 27, 1998.
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II. Claim 5 stands rejected under 35 U.S.C. § 103(a) as being rendered
obvious by the combination of Carlson, DeLago, and Edwards as
further combined with Roth
4
(Ans. 9).
III. Claim 8 stands rejected under 35 U.S.C. § 103(a) as being rendered
obvious by the combination of Carlson, DeLago, and Edwards as
further combined with Hattler
5
(Ans. 10).
We reverse.

ISSUE
Does the preponderance of the evidence of record support the
Examiner’s conclusion that the combination of Carlson, DeLago, and
Edwards renders the method of claim 1 obvious?

FINDINGS OF FACT
FF1. The Specification teaches:
The present disclosure relates generally to apparatus and
methods for providing percutaneous access to an internal
operative site during a surgical procedure and, more
particularly, to apparatus and methods for creating a fluid-tight
seal around an outer surface of a surgical instrument inserted
therethrough, for reducing the amount of insertion force
required to insert a surgical instrument therein and for
delivering a medicament to the target delivery site.

(Spec. 1, ¶2).

3
Edwards et al., US 5,601,591, issued Feb. 11, 1997.
4
Roth et al., US 5,797,886, issued Aug. 25, 1998.
5
Hattler et al., US 4,846,791, issued Jul. 11, 1989.
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FF2. Figures 30 and 31 of the Specification are reproduced below:

Figure 30 shows a side elevational view of an elongated expansion
assembly, and Figure 31 shows a side elevational view of a radial
expandable dilation assembly (id. at 11, ¶¶ 55-56).
FF3. As taught by the Specification, “[e]xpansion member 406 is provided
with a pair of diametrically opposed helical grooves 460a, 460b formed into
an outer surface thereof and extending the entire length thereof” (id. at 31, ¶
111). The radially expandable dilation assembly 404 “includes a pair of
diametrically opposed bosses 422a, 422b extending radially inward from an
inner surface 424 thereof” (id. at 32, ¶ 112).
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FF4. According to the Specification:
Each boss 422a, 422b is configured and adapted to be
slidably received within and cooperate with a respective helical
groove 460a, 460b of handle assembly 20. Preferably, bosses
422a, 422b have a cross-sectional profile which substantially
conforms to a cross-sectional profile of helical grooves 460a,
460b…. [B]osses 422a, 422b and helical grooves 460a, 460b
screwingly cooperate with one another such that expansion
assembly 402 is axially advanced through expandable dilation
assembly 404 upon a rotation of expansion member 406.

(Id. at 32, ¶ 113.)
FF5. The Examiner rejects method claim 1 as being obvious over the
combination of Carlson, DeLago, and Edwards (Ans. 3).
FF6. The Examiner notes that neither Carlson or DeLago teach
wherein the dilation assembly includes at least one engaging
member integrally formed with the handle portion and
projecting radially inward; and wherein the expansion member
includes at least one engaging element formed in an outer
surface thereof for co-operable engagement with a respective
one of the at least one engaging member of the dilation
assembly, wherein the at least one engaging member of the
dilation assembly cooperates with the at least one engaging
element of the expansion member to axially advance the
expansion member through the dilation assembly upon rotation
of the expansion member relative to the dilation assembly.

(Id. at 5 (emphasis removed).)
FF7. The Examiner finds that Edwards teaches that limitation (id. (citing
Edwards Figs. 3 and 8; col. 5, ll. 10-41)).
FF8. Edwards provides a “biocompatible stent for placement in the
prostatic urethra” (Edwards, col. 1, ll. 25-27).
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FF9. In the portion of Edwards relied upon by the Examiner, Edwards
discusses releasing the stent from the placement device (id. at col. 5, ll. 10-
11).
FF10. As taught by Edwards, the release means “includes means for rotating
sleeve 96 and mandrel 106 in opposite directions about the longitudinal axis
of tubular assembly 92 so as to cause stent body 22 to expand to its first
position” (id. at col. 5, ll. 26-29).
FF11. Edwards teaches:
In this regard, a spring driver 176 mounted within housing 142
has a spindle 177 which extends longitudinally from the spring
driver in the distal direction. A first elongate drive gear 178 is
mounted to spindle 177 between ribs 148 and 156 and engages
sleeve gear 149. A second drive gear 181 is mounted to spindle
177 between first drive gear 178 and spring driver 176 and
engages an idler gear 182 mounted on a spindle 183 connected
to housing 142 and extending in a direction parallel with
spindle 177. Idler gear 182 in turn engages mandrel gear 158.

(Id. at col. 5, ll. 28-38.)

ANALYSIS
Appellants argue that Edwards is drawn to a “placement device
having two tubular members that rotate relative to each other to cause the
radial expansion of a stent” (App. Br. 13). According to Appellants, the
Examiner has not explained which portion of the placement device of
Edwards corresponds to the dilation assembly of the claim, and which
portion corresponds to the expansion assembly (id.). Appellants urge that it
is unclear “how the rotatable tubular members of the placement device of
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Edwards would be combined with the expansion and dilator assemblies of
Carlson/DeLago to cause the expansion of the expandable sleeves” (id.).
We agree with Appellants that the Examiner has not established a
prima facie case that the combination of Carlson, DeLago, and Edwards
renders independent claim 1 obvious. While we agree in principle with the
Examiner that “it is not necessary that the inventions of reference be
physically combinable to render obvious the invention under review and
combining the teaching of references does not involve an ability to combine
their specific structures” (Ans. 12), “there must be some articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), cited with
approval in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417-18 (2007).
Here, the Examiner states that Edwards teaches
an apparatus and placement device wherein the dilation
assembly (placement device 91, Fig.3) includes at least one
engaging member integrally formed with the handle portion and
projecting radially inward (Col.5, lines 10-12, Fig.8); and
wherein the expansion member includes at least one engaging
element formed in an outer surface thereof for co-operable
engagement with a respective one of the at least one engaging
member of the dilation assembly, wherein the at least one
engaging member of the dilation assembly cooperates with the
at least one engaging element of the expansion member to
axially advance the expansion member through the dilation
assembly upon rotation of the expansion member relative to the
dilation assembly (Col.5, lines 10-41).

(Ans. 5 (emphasis removed)). The Examiner does not explain, however,
which portions of the placement device and its handle as taught by Edwards
read on the limitations of an expansion member that includes at least one
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engaging element formed in an outer surface thereof, or a dilation assembly
having an engaging member for co-operable engagement with the engaging
element of the expansion member. The Examiner’s rejection is thus too
cursory to pass the Kahn test, and is thus reversed.
As the remainder of the rejected claims depend from claim 1, and the
Examiner does not rely on either Roth or Hattler to remedy the above
deficiencies of the combination of Carlson, DeLago, and Edwards (see, e.g.
Ans. 9-11), we reverse the rejection as to claims 2-8 and 10-12 as well.

REVERSED

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