Ex Parte Harris et al

Board of Patent Appeals and Interferences

Aug 9, 2010

10773121 - (D) (B.P.A.I. Aug. 9, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte CHARMAINE K. HARRIS and JOSEPH J. KLEIN
____________________

Appeal 2009-005351
Application 10/773,121
Technology Center 3700
____________________

Before: WILLIAM F. PATE III, STEFAN STAICOVICI, and
KEN B. BARRETT, Administrative Patent Judges.

PATE III, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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Application 10/773,121
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STATEMENT OF CASE
Appellants appeal under 35 U.S.C. § 134 from a rejection of claims 1-
5, 7-40 and 42-50. App. Br. 3. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.

The claims are directed to a percutaneous flat lead introducer. Claim
1, reproduced below, is illustrative of the claimed subject matter:
1. A stimulation lead introducer comprising:
an elongated dilator defining a dilator lumen sized to
advance over a guidewire, the dilator having a substantially
conical distal tip, wherein at least a portion of the conical distal
tip has a substantially oblong cross-section; and
an elongated sheath defining a sheath lumen sized to
accommodate the dilator or a stimulation lead, wherein the
sheath comprises a sheath material that is substantially
deformable.

REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Otten
DeWindt
Mamo
US 5,255,691
US 6,146,371
US 6,847,849 B2
Oct. 26, 1993
Nov. 14, 2000
Jan. 25, 2005

REJECTIONS
Claims 1-5, 7-22, 24-40, and 42-50 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Mamo and DeWindt.2 Ans. 3.

2 The Answer includes claims 6 and 41 in this ground of rejection.
However, claims 6 and 41 have been cancelled and are therefore not
addressed in this decision. App. Br. 3.

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Claim 23 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Mamo, DeWindt, and Otten. Ans. 5.
The provisional statutory double-patenting rejection of claims 1-5, 7-
40 and 42-50 is not present in the Answer and has apparently been
withdrawn by the Examiner due to the abandonment of the copending
application. App. Br. 15.

OPINION
Appellants first argue that the Examiner erred by finding that since
Mamo’s dilator, read by the Examiner as including the claimed “sheath,” can
be constructed from plastic, Mamo thereby discloses a sheath that is
“substantially deformable” as required by independent claims 1 and 46. App.
Br. 8-10, 13. Appellants repeat this argument regarding claim 49, but claim
49 does not contain this limitation. App. Br. 14. Since plastics, including
polyethylenes, can be manufactured to have a variety of stiffnesses, a
material is not necessarily “substantially deformable” solely by virtue of
being a plastic or polyethylene. See, e.g., Elizabeth Benham & Max
McDaniel, Ethylene Polymers, HDPE, Encyclopedia of Polymer Science
and Technology (2010), available at
http://mrw.interscience.wiley.com/emrw/9780471440260/epst/
article/pst408/current/html. Accordingly, we reverse the Examiner’s
rejection of independent claims 1 and 46 and dependent claims 2-5, 7-15, 44,
45, 47 and 48.
The next issue raised by Appellants relates to the Examiner’s
proposed modification of Mamo with the cross-sectional shape taught by
DeWindt to teach the claimed “conical distal tip” having a “substantially
oblong cross-section”. App. Br. 10-14. This limitation is present in claims 1,
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16, 38, 46 and 49. The Examiner’s findings that Mamo discloses a dilator
lacking an oblong cross section and that DeWindt discloses an oval-shaped
cannula are not disputed by Appellants. Ans. 4. We adopt these findings as
our own. The fact that the Examiner does not rely on a single reference that
discloses a dilator having a conical distal tip having an oblong cross section
does not establish that the Examiner erred in determining the claimed subject
matter would have been obvious under 35 U.S.C. § 103(a). Contra App. Br.
10-11. While, as Appellants point out, DeWindt’s cannula may be intended
for a purpose different from Appellants’ and Mamo’s, we disagree with
Appellants’ contention that one of ordinary skill in the art would not have
recognized DeWindt’s teachings as relevant to Mamo’s dilator. App. Br. 11.
One of ordinary skill in the art would recognize that minimizing
invasiveness to the patient by using the cross sectional shape disclosed by
DeWindt would be a predictable advantageous feature of a variety of
surgical instruments, including Mamo’s dilator. Thus, we find Appellants’
argument that the Examiner’s proposed combination would have failed to
render obvious a dilator tip having a “substantially oblong cross-section” is
unpersuasive.
The next issue raised by Appellants is whether the Examiner failed to
make a prima facie case of obviousness regarding claim 16 because the
Examiner never articulated how the combination of Mamo and DeWindt
would have rendered obvious the step of “inserting a stimulation lead
introducer to a target site within an epidural region proximate a spine of a
patient via a guidewire.” Since the Examiner has not mentioned this step in
the rejection, nor has the Examiner responded to Appellants’ allegation that
it is missing from the references, and it is not apparent in Mamo or
DeWindt, we agree with Appellants that the Examiner failed to establish a
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prima facie case of obviousness regarding claim 16. The key to supporting
any prima facie conclusion of obviousness under 35 U.S.C. § 103 is the clear
articulation of the reason (or reasons) why the claimed invention would have
been obvious. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). The
Examiner has not carried this burden. Thus, we find that the rejection of
claim 16 and dependent claims 17-22 and 24-37 must be reversed. Since, as
applied by the Examiner, Otten is not relied upon to cure this deficiency, we
are constrained to reverse the rejection of claim 23 also.
The next issue raised by Appellants is whether the Examiner failed to
make a prima facie case of obviousness regarding claim 38 because the
Examiner never asserted that the combination of Mamo and DeWindt would
have rendered obvious a dilator for widening a path for a stimulation lead to
travel through an epidural region proximate the spine of a patient. App. Br.
13. This preamble limitation relates to the intended use of the device. Since
the claim defines a complete structure without the preamble, the preamble
does not breathe life and meaning into the claim and is therefore afforded
little patentable weight. Although Mamo does not specify widening a path at
the location specified in the preamble, if Mamo’s device would be capable
of performing the recited intended use, then it meets the claim. Where the
limitation relied upon for patentability is functional in nature the burden
shifts to Appellants to establish that the prior art relied upon could not
perform the claimed function. In re Swinehart, 439 F.2d 210, 213 (CCPA
1971). Appellants do not provide any further arguments or factual support
for this allegation and have therefore failed to carry this burden.
Accordingly, the rejection of claim 38 and dependent claims 39, 40, 42, and
43 is sustained.
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The final issue raised by Appellants is whether the Examiner failed to
make a prima facie case of obviousness regarding claim 49 because the
Examiner never asserted that the combination of Mamo and DeWindt would
have rendered obvious an oblong cross section on the distal end of the
stimulation lead. App. Br. 16. Since the Examiner has not addressed this
limitation, nor has the Examiner respond to Appellants’ arguments, and it is
not apparent in the references, we find that the Examiner has failed to
articulate a reason why the claimed subject matter would have been obvious.
KSR, 550 U.S. at 418. Thus, we find that the Examiner’s rejection of claim
49 and dependent claim 50 must be reversed.

DECISION
For the above reasons, the Examiner’s rejection of claims 1-5, 7-37,
44-50 is reversed. The Examiner’s rejection of claims 38-40, 42, and 43 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). See 37 C.F.R.
§ 1.136(a)(1)(iv) (2007).

AFFIRMED-IN-PART

nlk

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