Ex Parte Racz et al

Patent Trial and Appeal Board

Feb 19, 2015

10694235 (P.T.A.B. Feb. 19, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte N. SANDOR RACZ and CHRISTOPHER WILEY
__________

Appeal 2012-007537
Application 10/694,235
Technology Center 3700
__________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal
1
under 35 U.S.C. § 134 involving claims to a flexible
spinal needle catheter assembly. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1
Appellants identify the Real Parties in Interest as Custom Medical
Applications (see App. Br. 2).
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Statement of the Case
Background
“[C]ontinuous spinal anesthesia (‘CSA’) with an indwelling catheter
allows anesthesia of unlimited duration and the ability to carefully control
the level of the block by repeated small incremental doses of anesthetic”
(Spec. 2 ¶ 2). However, “the standard technique of inserting the spinal
catheter through the spinal needle, coupled with the difficulty of
manufacturing truly small needles and catheters, has meant large needles and
catheters were required, resulting in an unacceptably high incidence of post-
dural puncture headache (‘PDPH’)” (Spec. 2 ¶ 3). The Specification teaches
that “the conventional spinal catheter threading operation requires
considerable time and effort on the part of a clinician” (Spec. 3 ¶ 8).
The Claims
Claims 1, 3–6, 8, 9, 12, 14–18, 20, 21, 23, 25, 27–32, and 34–38 are
on appeal. Independent claim 1 is representative and reads as follows:
1. A flexible spinal needle catheter assembly
comprising:
a flexible needle catheter fabricated of plastic and
having a sufficiently high tensile strength to maintain
structural integrity during and after insertion into a patient’s
body and retraction therefrom, but also possesses sufficient
transverse flexibility to deform and accommodate patient
motion after insertion to reduce patient irritation therefrom,
said flexible needle catheter defining a hollow bore for
conveying medicating agent therethrough, said bore
extending through a length of said flexible needle catheter,
said flexible needle catheter having a proximal end which
defines a leading edge;
a support needle releaseably secured to said flexible
needle catheter, said support needle being removably
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disposed within said hollow bore of said flexible needle
catheter, said support needle having a first end which
defines a pencil point, non-cutting piercing point configured
for penetrating the dura mater of a patient, said support
needle having an outside diameter sized so that upon
withdrawal of the flexible spinal needle catheter assembly
from a dura mater of a spine of a patient, subsequent to an
insertion of said assembly through the dura mater, a
puncture opening produced by said insertion being of
dimensions which permit the dura mater substantially to
reseal said puncture opening formerly occupied by the
flexible spinal needle assembly within said dura mater, said
support needle defining a hollow lumen which extends along
a length of said support needle and an opening, defined
proximate said first end, which communicates the
environment with said lumen, said support needle being
positionable in two conditions relative to said flexible needle
catheter; in a first condition said support needle being
positioned with said first end of said support needle being
positioned outside of said bore of said flexible needle
catheter, said non-cutting piercing point and said opening
being positioned outside of said bore, the opening being
positioned contiguous to the leading edge of the flexible
needle catheter and in a second condition said support
needle being removed from within said hollow bore of said
flexible needle catheter, and
a solid stylet, releaseably secured within said lumen,
said stylet being positioned in a first condition to preclude
access from the environment to said lumen through said
opening.

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The Issues
A. The Examiner rejected claims 1, 3–6, 8, 9, 12, 14–18, 20, 21, 23, 25,
27–32, and 35 under 35 U.S.C. § 103(a) as obvious over McWha
2
and
Smith
3
(Ans. 5–13).
B. The Examiner rejected claims 30 and 31 under 35 U.S.C. § 103(a) as
obvious over McWha, Smith, and Gribbons
4
(Ans. 13).
C. The Examiner rejected claims 34 and 36–38 under 35 U.S.C. § 103(a)
as obvious over McWha, Smith, and Klein
5
(Ans. 13–14).
A. 35 U.S.C. § 103(a) over McWha and Smith
The Examiner finds that McWha teaches a “a flexible needle catheter
(12) . . . defining a hollow bore (14) . . . [and] a support needle releasably
secured to said flexible needle catheter (22) . . . being disposed within said
hollow bore of said flexible needle catheter” (Ans. 5). The Examiner finds
that McWha teaches a “support needle having a first end which defines a
pencil point, non-cutting piercing point” (Ans. 5). The Examiner
acknowledges that “McWha does not teach that the flexible needle catheter
is comprised of a plastic” (Ans. 10). The Examiner finds that Smith teaches
“a spinal needle catheter for administration of anesthetics and/or analgesics
formed of a plastic” (Ans. 10). The Examiner finds it obvious to “form the
flexible needle catheter of McWha using the plastic (for example, Teflon) of
Smith et al to take advantage of the more lubricious properties thereof”
(Ans. 10).

2
McWha, K., US 5,871,470, issued Feb. 16, 1999.
3
Smith et al., US 5,250,035, issued Oct. 5, 1993.
4
Gribbons et al., US 2005/0070881 A1, published Mar. 31, 2005.
5
Klein, J., US 2004/0236307 A1, published Nov. 25, 2004.
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The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that McWha and Smith render the
claims obvious?

Findings of Fact
1. The Specification teaches that the “outermost layer of the
assembly 10 is the catheter 15 itself . . . Conventional plastic catheter
material may be used in its construction” (Spec. 9 ¶ 36).
2. The Specification teaches that the “central stylet 17 and support
needle 19, are typically made from a medically acceptable metal, such as
stainless steel or titanium” (Spec. 16 ¶ 54).
3. Figure 1 of the Specification is reproduced below:

“FIG. 1 is an exploded plan assembly view of one embodiment of a
catheterassembly” (Spec. 7 ¶ 24).
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4. Figure 1 of McWha is reproduced below:

“FIG. 1 is an exploded perspective view of the combined spinal epidural
needle” (McWha, col. 3, ll. 29–30).
5. McWha teaches
a combined spinal epidural needle set 10 includes an
epidural needle 12 with an overall length “I”, a hollow bore
14 defining an axis “A” therethrough having an inside
diameter “d”. Needle 12 has an open distal end 16, a
proximal end 18 and includes a hub 20. Needle set 10
includes a spinal needle 22 with an overall length “m”
greater than length “I” of epidural needle 12.

(McWha, col. 4, ll. 12–18.)
6. McWha teaches that “[s]pinal needle 22 has a hollow passage
24 therethrough, a pointed distal end 26, preferably a ‘pencil point’ 27”
(McWha, col. 4, ll. 20–22).
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7. Figures 2 and 3 of McWha are reproduced below:

As shown in FIG. 2, spinal needle 22 is slidably disposed for
movement within bore 14 of epidural needle 12 between a
position where distal point 26 of the spinal needle is
substantially coincident with open distal end 16 of epidural
needle 12 and at least one position, as shown in FIG. 3,
wherein distal point 26 of the spinal needle projects a
distance “x” beyond open distal end 16 of epidural needle
12.

(McWha, col. 4, ll. 25–32.)
8. McWha teaches that “[s]pinal needle 22 may also include a
stylet 25 sized to fit within and substantially occlude hollow passage 24.
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Stylet 25, when used, serves to stiffen spinal needle 22 and to substantially
prevent tissue from being forced into hollow passage 24” (McWha, col. 5, ll.
60–65).
9. McWha teaches that
The invention allows a practitioner to position the
needle set, with the point of the spinal needle substantially
coincident with the point of the epidural needle, within the
epidural space so that the distal point of the epidural needle
is adjacent the dura. The practitioner then advances the
spinal needle a preselected distance beyond the distal point
of the epidural needle, advances the needle set so that the
projecting point of the spinal needle penetrates the dura and
then may confirm the placement of the spinal needle in the
subarachnoid space with the presence of cerebrospinal fluid
at the hub of the spinal needle.

(McWha, col. 3, ll. 11–21.)
10. McWha teaches that the “cannula of epidural needle 12 and
spinal needle 22 preferably are formed from stainless steel” (McWha, col. 7,
l. 67 to col. 8, l. 2).
11. McWha teaches that the “hubs of the epidural needle and the
spinal needle each include an adjustable engagement for preselecting and
releasably maintaining the position of the distal point of the spinal needle
with respect to the open distal end of the epidural needle” (McWha, col. 3,
ll. 6–10).

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12. Figure 4a of McWha is reproduced below:

“FIG. 4a illustrates open distal end 16 with “Touhy” type point 36. The
“Tuohy” type point is formed by a gentle bend 37 of needle 12 away from
axis A and a bevel 38 extending from axis A to the tubing edge 39. Both of
the preferred configurations are well accepted for epidural needles”
(McWha, col. 4, ll. 61–66).
13. Smith teaches a needle system “characterized by a cannula,
preferably formed of a plastic such as Teflon, which has a non-pointed but
beveled distal end and a clear-plastic hub on its proximal end” (Smith, col.
1, ll. 36–39).
14. Smith teaches that “[p]referably, the elongated member 28 is
formed of a smooth, inert thermoplastic, such as Teflon, which has a greater
self-lubricating property than a material, such as steel, upon insertion of the
elongated member 28 into a previously formed elongated puncture-like
epidural passage 36” (Smith, col. 3, ll. 19–24).
15. Smith teaches “a plastic cannula having a beveled distal end
with a bored hub on its proximal end and a stainless steel stylet having a
cone-shaped or pencil-point distal end” (Smith, col. 2, ll. 1–3).
16. Smith teaches that “the pencil-point end 72 of the stylet 26 and
the beveled end 30 of the cannula 24 forming a minimal size opening 74 in
the dura 76 . . . by spreading apart the fiber of the dura 76” (Smith, col. 4, ll.
65-68).
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Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.
Analysis
Claim 1
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 4–14; FF 1–16) and agree that the
claims are rendered obvious by McWha and Smith. We address Appellants’
arguments below.
Appellants contend that “McWha does not describe a plastic flexible
needle catheter” (App. Br. 14). Appellants contend that:
While Smith describes a cannula that comprises a plastic
“elongated member” with “a greater self-lubricating
property” than steel (Smith, at col. 3, lines 12-22), the
cannula of Smith’s system is in all other ways unlike, and
incompatible with, the presently claimed flexible needle
catheters. For example, the cannula of Smith is inserted into
a previously formed puncture in a patient’s back (Id., at col.
3, lines 22-25), and then used to position a spinal catheter in
the patient, after which the cannula is subsequently
removed.

(App. Br. 15.) Appellants contend that “[f]abricating the spinal or epidural
needle cannula of McWha from flexible plastic would render this reference
unsuitable for its intended purpose and produce an inoperable needle set”
(App. Br. 16).
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We are not persuaded. In the Specification, in McWha, and in Smith,
the stylet is composed of steel (FF 2, 10, 15), and the Specification and
McWha also teach that the support needle is composed of steel (FF 2, 10).
Smith teaches that the steel stylet functions to support the plastic cannula
and allow penetration of the dura, specifically teaching that “the pencil-point
end 72 of the stylet 26 and the beveled end 30 of the cannula 24 forming a
minimal size opening 74 in the dura 76 . . . by spreading apart the fiber of
the dura 76” (Smith, col. 4, ll. 65-68; FF 16).
This teaching by Smith that the plastic needle, supported by the steel
stylet, is capable of penetrating the tough dura (FF 16) supports the
Examiner’s finding that the ordinary artisan would have appreciated that a
plastic catheter “would be capable of penetration through the skin of the
patient” (Ans. 16). We therefore agree with the Examiner that applying
Smith’s suggestion to form the epidural needle of McWha from plastic
would retain the capacity of McWha’s epidural needle, when combined with
the supporting steel spinal needle 22 and steel stylet 25, to penetrate skin and
penetrate the dura (see FF 16).
Appellants contend that “McWha does not describe a spinal needle
(asserted by the Examiner to correspond to the claimed support needle) that
has an opening positioned contiguous to the leading edge of the flexible
needle catheter” (App. Br. 17). Appellants contend that “Smith does not
supply this element of claim 1 that is missing from McWha. Smith
describes a stylet having a pointed end that appears to block access to the
bore of the cannula, because spinal fluid is aspirated through the cannula
only after removal of the stylet from the cannula” (App. Br. 18).
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We are not persuaded. The instant claims are drawn to a specific
catheter assembly apparatus, not to a method of using the catheter. Thus, the
limitation recited in claim 1 for a “support needle being positionable in two
conditions . . . the opening being positioned contiguous to the leading edge
of the flexible needle catheter” represents an intended use of the apparatus.
However, “apparatus claims cover what a device is, not what a device does.”
Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed.
Cir. 1990). Merely stating an intended use for an apparatus is not sufficient
to distinguish the apparatus from the prior art. That is, all that is reasonably
required by claim 1 is the capacity for McWha’s support needle to be
positioned contiguous to the leading edge of the epidural needle.
McWha teaches that the spinal needle may be positioned relative to
the epidural needle at any desired location, beginning “substantially
coincident with the point of the epidural needle” and advancing the point
“beyond the distal point of the epidural needle” (McWha, col. 3, ll. 11–19;
FF 9). McWha depicts an embodiment where the spinal needle is located
within leading edge of the epidural needle in Figure 2 and advances beyond
the leading edge of the epidural needle in Figure 3 (FF 7), reasonably
disclosing that the needle may be positioned at any intermediate point
including contiguous to the leading edge of the epidural needle (FF 9, 11).
Appellants contend that
one of skill in the art would not have been motivated to
manufacture the epidural needle of McWha from plastic.
Without any indication that McWha’s epidural needle could
be manufactured from plastic, or some other flexible
material, one of ordinary skill would have thought that steel
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is preferred precisely because it is inflexible; i.e., steel
makes an excellent cutting tool.

(App. Br. 19).
We are not persuaded. If there are tradeoffs involved regarding
selection of plastic versus steel, these tradeoffs do not teach away from
proposed combination. See Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157,
1165 (Fed. Cir. 2006) (“a given course of action often has simultaneous
advantages and disadvantages, and this does not necessarily obviate
motivation to combine.”); Winner Intl Royalty Corp. v. Wang, 202 F.3d
1340, 1349 n.8 (Fed. Cir. 2000) (“The fact that the motivating benefit comes
at the expense of another benefit, however, should not nullify its use as a
basis to modify the disclosure of one reference with the teachings of another.
Instead, the benefits, both lost and gained, should be weighed against one
another.”). Here, Smith provides a specific reason to use plastic in the place
of steel, teaching that “[p]referably, the elongated member 28 is formed of a
smooth, inert thermoplastic, such as Teflon, which has a greater self-
lubricating property than a material, such as steel, upon insertion of the
elongated member 28 into a previously formed elongated puncture-like
epidural passage 36” (Smith, col. 3, ll. 19–24; FF 14). Thus, in situations
where lubrication is important, such as the insertion of catheters into spinal
tissue, the ordinary artisan would be motivated by Smith to modify the
epidural needle of McWha from steel to plastic.
Claims 16, 25, 27, 28, and 35
Appellants reiterate the same arguments addressed to claim 1 above
regarding the flexibility of the needle cannula of McWha in view of Smith
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(App. Br. 24, 29. 32–33, 36); the ability of the combined needle to penetrate
the skin (App. Br. 29, 33) and the relative positioning of the epidural needle
and spinal needle of McWha (App. Br. 24–25, 30, 34, 39–40).
We are not persuaded for the reasons given above.
Claim 29
Appellants contend that “McWha does not describe a catheter that is
tapered to blend smoothly into the outer surface of the support needle” (App.
Br. 38).
The Examiner finds that “Figure 4A of McWha clearly shows a
curved distal tip of the flexible needle catheter, which directly interfaces
with the outer surface of the support catheter where it exits the opening, and
as such the interior surface of the flexible needle catheter blends smoothly
with the exterior surface of the support catheter” (Ans. 17-18).
We find that the Examiner has the better position. As the Examiner
notes, Figure 4a of McWha shows a catheter with a curved distal tip (FF 12)
and teaches that this configuration is “well accepted for epidural needles”
(McWha, col. 4, l. 66; FF 12). Appellants provide no rebuttal argument in
the Reply Brief for this claim.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
McWha and Smith render the claims obvious.

B. 35 U.S.C. § 103(a) over McWha, Smith, and Gribbons
Appellants contend that “Gribbons does not provide the knowledge or
motivation for one of ordinary skill in the art at the time of the invention to
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supply the elements otherwise missing from the combination of McWha and
Smith” (App. Br. 41–42).
We are not persuaded for the reasons given above, because we
conclude that McWha and Smith render obvious a spinal needle catheter
assembly comprising a plastic, flexible needle catheter that contains a
support needle in the hollow bore of the plastic, flexible needle catheter,
wherein the support needle comprises an opening that is positioned
contiguous to the leading edge of the plastic, flexible needle catheter as
required by claim 30 (FF 4–16).
C. 35 U.S.C. § 103(a) over McWha, Smith, and Klein
Appellants reiterate the arguments regarding McWha and Smith,
addressed above (see App. Br. 43–44). Appellants contend that:
Forming the epidural needle of McWha such that the plane
containing the leading edge is perpendicular to a
longitudinal axis of the epidural needle would render the
epidural needle unsatisfactory for its intended purpose of
cutting through the skin of a patient to introduce the spinal
epidural needle set into the epidural space, because such a
modification would render the epidural needle blunt.

(App. Br. 44).
The Examiner finds that “the insertion apparatus would still be
capable of performing its intended functions should the leading edge be
made perpendicular because it would still be capable of guiding the support
catheter to its intended destination through a preformed puncture as
described by Klein” (Ans. 18–19). The Examiner finds that “blunt tips are
capable of penetrating tissue should enough force be provided” (Ans. 19).
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We find that the Examiner has the better position. Klein teaches that
the “the metal stylet 46 can be either blunt-tipped (requiring a skin incision
to permit insertion into the subcutaneous space), or sharp-tipped (permitting
the cannula to be inserted directly through the skin and into the
subcutaneous space without requiring a preparatory skin incision” (Klein 3
¶ 37).
Thus, the difference identified by Appellants is based upon different
intended modes of use of the device. As the Examiner points out, consistent
with Klein, when the catheter rendered obvious by McWha, Smith, and
Klein is inserted into a preexisting incision, one reason to use Klein’s blunt
tip may be to “prevent additional tissue damage from a sharp point veering
off course” (Ans. 14). Appellants’ claims are not drawn to a specific method
of spinal treatment, but rather to a product which is, in part, the combination
of a flexible needle with a lumen into which a smaller needle with a non-
piercing point and a lumen may be inserted and a style which may be
inserted into the smaller needle. McWha, Smith, and Klein render this
product configuration obvious for the reasons given by the Examiner (FF 1–
16; Ans. 4–20). As already noted, claims directed to an apparatus must be
distinguished from the prior art on structural grounds
SUMMARY
In summary, we affirm the rejection of claims 1, 16, 25, 27, 28, 29,
and 35 under 35 U.S.C. § 103(a) over McWha and Smith. Pursuant to 37
C.F.R. § 41.37(c), claims 3–6, 8, 9, 12, 14, 15, 17, 18, 20, 21, 23, and 30–32,
fall with claims 1, 16, 25, 27, 28, 29, and 35, as these claims were not argued
separately.
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We affirm the rejection of claims 30 and 31 under 35 U.S.C. § 103(a)
as obvious over McWha, Smith, and Gribbons.
We affirm the rejection of claims 34 and 36–38 under 35 U.S.C.
§ 103(a) as obvious over McWha, Smith, and Klein.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED
JRG