Ex Parte Christensen et al

Patent Trial and Appeal Board

Jan 29, 2015

12648533 (P.T.A.B. Jan. 29, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MARK A. CHRISTENSEN, STEVEN M. SMITH,
WALTER SHANG, and JAMES D. BEAL
____________

Appeal 2012-005442
Application 12/648,5331
Technology Center 3700
____________

Before MICHAEL C. ASTORINO, NINA L. MEDLOCK, and
BART A. GERSTENBLITH, Administrative Patent Judges.

GERSTENBLITH, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Mark A. Christensen et al. (“Appellants”) appeal under 35 U.S.C.
§ 134(a) from the Examiner’s decision rejecting claims 1–15. We have
jurisdiction under 35 U.S.C. § 6(b).

1 Appellants identify C. R. Bard, Inc. as the real party in interest. Appeal
Br. 3.
Appeal 2012-005442
Application 12/648,533

2
Claimed Subject Matter
Claims 1 and 14 are the independent claims on appeal. Claim 1 is
illustrative of the claimed subject matter and is reproduced below.
1. A method for assembling a valved sheath introducer,
comprising:
providing a valve including a slit, the valve comprising a
first anchoring member, a second anchoring member
unconnected to the first anchoring member, and a central
portion, the slit traversing through the central portion;
inserting the valve into a handle, the first and second
anchoring members positioned respectively in a first and
second receiving sections of the handle and the central portion
positioned in a bore of the handle, the central portion having a
diameter approximately equal to a diameter of the bore, the first
and second anchoring members and central portion extending
distally into the handle; and
attaching a cap to the handle under pressure, the cap
contacting a proximal most surface of the valve and
compressing the valve between the cap and the handle.
Appeal Br. 27, Claims App.
References
The Examiner relies upon the following prior art references:
Patterson US 5,613,956 Mar. 25, 1997
Dennis US 5,727,770 Mar. 17, 1998
Guo US 2002/0010425 A1 Jan. 24, 2002
Lui US 2003/0050604 A1 Mar. 13, 2003
Rejections
Appellants seek review of the following rejections, each of which was
made by the Examiner under 35 U.S.C. § 103(a):
I. Claims 1–9 and 13 are rejected as unpatentable over Patterson
and Guo;
Appeal 2012-005442
Application 12/648,533

3

II. Claims 10–12 are rejected as unpatentable over Patterson, Guo,
and Lui;
III. Claim 14 is rejected as unpatentable over Patterson and Dennis;
and
IV. Claim 15 is rejected as unpatentable over Patterson, Dennis,
and Guo.
SUMMARY OF DECISION
We REVERSE.
OPINION
Rejection I
The Examiner concludes that the combination of Patterson and Guo
would have rendered the subject matter of claims 1–9 and 13 obvious to one
of ordinary skill in the art at the time of the invention. Ans. 4–9. The
Examiner finds that Patterson discloses the elements of the claims, except
that “Patterson teaches a single anchoring member . . . rather than an
anchoring member which comprises of a first and second anchoring member
being received in a first and second receiving section of the handle.”
Id. at 5. The Examiner finds that Guo discloses an
anchoring member comprising . . . a first anchoring member
and a second anchoring member unconnected to the first
anchoring member (figure 5, element 32; page 4, paragraph 58),
and the inserting step further comprising positioning the first
and second anchoring members in a first and second receiving
section of the handle (figure 3, element[s] 32 and 54; page 4,
paragraph 58).
Id. at 6.
Appellants raise several arguments in response to this rejection,
including that the Examiner’s proposed combination of Patterson and Guo
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Appeal 2012-005442
Application 12/648,533

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Guo’s Figure 3 shows a “distal, perspective-view of the hemostasis
valve showing the proximal and distal valve gaskets joined together.” Guo,
para. 41.
The Examiner’s rejection is based upon the finding that Guo’s distal
valve gasket 40 is actually part of the handle, rather than part of hemostasis
valve 10. Ans. 5 (“Guo teaches . . . providing a valve (figures 2 and 5,
element 20; page 5, paragraph 62) . . . .”); id. at 5–6 (“Guo teaches . . .
providing a handle (figures 1 and 2, elements 90 and 40) . . . .”). Finding
that valve gasket 40 is part of the handle leads to the Examiner equating
protrusions 32 with the recited first and second anchoring members, and
equating positioning slots 54 with a first and second receiving sections of the
handle. Ans. 6.
The Examiner’s finding that Guo’s hemostasis valve does not include
distal valve gasket 40 is contrary to Guo’s disclosure that hemostasis
valve 10 includes primal valve gasket 20 and distal valve gasket 40. Guo,
para. 54. As such, the Examiner’s finding that distal valve gasket 40 is
actually part of Guo’s handle is not supported by a preponderance of the
evidence.
Accordingly, we do not sustain Rejection I.
Rejection II
Rejection II, directed to claims 10–12, which depend from claim 1,
relies upon the same findings discussed above with respect to Rejection I.
Ans. 9. Accordingly, for the reasons explained in the context of Rejection I,
we do not sustain Rejection II.
Appeal 2012-005442
Application 12/648,533

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Rejection III
The Examiner concludes that the combination of Patterson and Dennis
would have rendered the subject matter of claim 14 obvious to one of
ordinary skill in the art at the time of the invention. Ans. 11–12. In
particular, the Examiner finds that Patterson discloses the elements of the
claim, except a valve including a central portion extending distally into a
handle. Id. at 12. The Examiner finds that Dennis discloses a central
portion of a valve extending distally into a handle. Id. The Examiner
concludes that it would have been obvious to “form a valved sheath
introducer with a central portion, as taught by Patterson, such that the central
portion extends distally into a handle, as taught by Dennis, because Dennis
teaches that such a central portion acts to seal the housing before a catheter
is inserted (column 2, lines 44 – 53).” Id.
Appellants raise several arguments in response to this rejection,
including that one of ordinary skill would not have sought to combine the
teachings of Dennis and Patterson for the reason offered by the Examiner
because Patterson’s valve is described as self-sealing and, thus, already
maintains a seal when no instrument is inserted through the introducer.
Appeal Br. 5.
In response, the Examiner asserts that because Patterson’s central
portion includes a slit, the bore of the housing is not sealed when a catheter
is not inserted. Ans. 14.
Appellants assert, in their Reply Brief, that simply because Patterson
discloses a slit in its gasket does not mean that the slit cannot be sealed by
pressure between its opposite sides. Reply Br. 5. Appellants further assert
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Application 12/648,533

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that Dennis also discloses that its gasket includes slit 33, which extends
through the gasket, yet Dennis’s gasket provides a seal. Id.
Patterson discloses a catheter introducer including a housing that
“contains and supports one or more self-sealing hemostasis gaskets that
close to prevent blood leakage when no instrument is present in the
introducer.” Patterson, 1:22–34; id. at 3:46 (“The housing contains a self-
sealing hemostasis gasket 8 . . . .” (emphasis omitted)). Patterson
specifically explains that the slits are of a relatively small diameter (as
compared to a prior art device) to avoid the possibility that the gasket might
leak with or without an instrument inserted therethrough. Id. at 4:57–61.
We are not persuaded that the Examiner’s reasoning, i.e., that one of
ordinary skill in the art would have sought to modify Patterson’s central
portion in light of Dennis to enable sealing of the housing before a catheter
is inserted, because Patterson already discloses a housing that is self-sealing
when no instrument is present in the introducer. Thus, Patterson already
provides the benefit sought by the Examiner through the modification.
Additionally, the Examiner’s finding that Patterson’s slits result in an
unsealed housing when a catheter is not inserted is contradicted by the
above-cited disclosures of Patterson, which specifically indicate that the slits
do not defeat the self-sealing nature of the gasket.
Further, even though we recognize that the structure of Dennis’s
device is different, we agree with Appellants that Dennis’s disclosure
supports their argument that the presence of a slit alone does not indicate
necessarily the lack of a seal. For example, Dennis discloses an elastomeric
double valve sealing device for a cannula wherein one of the valves is a
“generally conical member divided into two symmetrical halves by a slit.”
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Application 12/648,533

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Dennis, 2:35–36, 44–50. Yet, Dennis also discloses that the conical valve
member “seals the cannula when no instrument is present.” Id. at 2:52–53.
Accordingly, we do not sustain Rejection III.
Rejection IV
Rejection IV, directed to claim 15, which depends from claim 14,
relies upon the same findings discussed above with respect to Rejection III.
Ans. 12. Accordingly, for the reasons explained in the context of
Rejection III, we do not sustain Rejection IV.
DECISION
We REVERSE the Examiner’s decision rejecting claims 1–15.

REVERSED
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