Ex Parte Tollini

Board of Patent Appeals and Interferences

May 6, 2010

11298806 (B.P.A.I. May. 6, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte DENNIS R. TOLLINI
____________

Appeal 2009-013304
Application 11/298,8061
Technology Center 3700
____________

Decided: May 7, 2010
____________

Before SCOTT R. BOALICK, JOHN C. KERINS, and KEN B. BARRETT,
Administrative Patent Judges.

BOALICK, Administrative Patent Judge.

DECISION ON APPEAL

1 Application filed December 9, 2005. The real party in interest is the
inventor, Dennis R. Tollini.
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2
This is an appeal under 35 U.S.C. § 134(a) from the final rejection of
claims 1, 3, 5, 11, 18 and 19. Claims 4, 6-10, 12-17 and 20-41 have been
withdrawn and claim 2 has been cancelled. We have jurisdiction under 35
U.S.C. § 6(b).
We affirm.

STATEMENT OF THE CASE
Appellant’s invention relates to a pre-formed support element for
controlling a cannulation angle for a fistula needle. (Abstract.)
Claims 1 and 18 are exemplary (with minor formatting added):
1. A device for controlling an angle of cannulation for a fistula
needle, comprising:
a pre-formed support element operatively arranged to support said
fistula needle and manipulatable to control said angle of cannulation,
wherein said support element is resilient,
wherein said support element is arranged to control said angle in
response to pressure upon said support element, and
wherein said support element pushes back against the pressure.

18. A combination for controlling an angle of cannulation,
comprising:
a pre-formed support element; and,
a fistula needle,
wherein said support element is arranged to support said fistula needle
and to move with respect to said fistula needle and
wherein an angle of cannulation for said fistula needle is controllable
via said movement of said support element to change a point of contact
between the needle and the support element.

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The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Schlesinger 3,702,612 Nov. 14, 1972
Rose 2004/0138623 A1 July 15, 2004
Claims 1, 3, 5 and 11 stand rejected under 35 U.S.C. § 102(b) as being
anticipated by Schlesinger.
Claims 18 and 19 stand rejected under 35 U.S.C. § 103(a) as being
obvious over Schlesinger and Rose.

ISSUES
§ 102 Rejection - Schlesinger
With respect to independent claim 1, Appellant argues that
Schlesinger does not teach “a pre-formed support element operatively
arranged to support said fistula needle and manipulatable to control said
angle of cannulation.” (App. Br. 4-11; see also Reply Br. 4-15.) In
particular, Appellant argues that the yoke 1 and resilient beam 2 of
Schlesinger cannot function properly to hold and control a fistula needle
(App. Br. 4-5; see also Reply Br. 4-8), the resilient beam 2 must be modified
to be able to perform the function of claim 1 (App. Br. 6-7; see also Reply
Br. 8-11) and the Examiner has not established that controlling an angle of
cannulation is inherent in Schlesinger (App. Br. 7-11; see also Reply
Br. 11-15).
Appellant’s arguments present the following issue:
Has the Examiner erred in finding that Schlesinger teaches “a pre-
formed support element operatively arranged to support said fistula needle
and manipulatable to control said angle of cannulation”?
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§ 103 Rejection – Schlesinger/Rose
With respect to independent claim 18, Appellant argues that the
combination of Schlesinger and Rose does not teach or suggest “wherein an
angle of cannulation for said fistula needle is controllable via said movement
of said support element to change a point of contact between the needle and
the support element.” (App. Br. 11-15; see also Reply Br. 15-25.)
In particular, Appellant argues that: Schlesinger does not teach
controlling an angle of a needle held by the yoke 1 and the resilient beam 2
(App. Br. 11; see also Reply Br. 15-16); Schlesinger teaches against
controlling an angle for a needle held by the yoke 1 and the resilient beam 2
(App. Br. 12; see also Reply Br. 16-17); modifying Schlesinger would
change its principle of operation (App. Br. 13; see also Reply Br. 17-19);
modifying Schlesinger would render it unusable for its intended purpose
(App. Br. 13-14; see also Reply Br. 19-20); no suggestion or motivation has
been provided to modify Schlesinger (App. Br. 14; see also Reply Br. 20-
21); and there is no reasonable expectation of success (App. Br. 14-15; see
also Reply Br. 21-24).
Appellant’s arguments present the following issue:
Has the Examiner erred in finding that the combination of Schlesinger
and Rose teaches or suggests “wherein an angle of cannulation for said
fistula needle is controllable via said movement of said support element to
change a point of contact between the needle and the support element”?

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FINDINGS OF FACT
The record supports the following findings of fact (FF) by a
preponderance of the evidence.

Schlesinger
1. Schlesinger relates to “a catheter support which can accommodate
limited motion of the catheter without slippage and without pulling on
the patient.” (Col. 1, ll. 5-8.) The catheter support prevents the
involuntary removal of the catheter from the patient’s body. (Col. 1,
ll. 13-16). The catheter support includes a yoke 1 attached to a base
plate 4 with a resilient beam 2. (Col. 2, ll. 14-16; fig.1.) The base
plate 4 includes an adhesive layer 6 (col. 2, ll. 18-19) for mounting the
catheter support to a patient’s body (col. 1, ll. 65-67). The yoke 1 is
sufficiently sized to accommodate a catheter (unreferenced). (Col. 2,
ll. 50-52; fig. 1.) Figure 4 illustrates that the yoke 1 has a U-shaped
front face (see also, e.g., figs. 2, 3) opposite a U-shaped back face
(hidden from view).

2. “The beam 2 is formed from a resilient material, conveniently a
plastic, which is capable of bending to accommodate a limited
movement of the catheter while snugly retaining the catheter in the
yoke.” (Col. 2, ll. 29-32.) The catheter can be fixed in place to the
patient’s body via the adhesive layer 6. (Col. 2, ll. 46-50.) However,
“limited motion of the catheter is allowed by the support.” (Col. 2,
ll. 54-55.)

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Rose
3. Rose relates to a “device for securing intravenous needles, cannulas
and tubing to treatment sites including arterial-venous fistula sites.”
(¶ [0003].) Needle assemblies 9 and 10 include needles 5 and 6
attached to tubes 9 and 10, respectively. (¶ [0020]; fig.1.) Such
needles 5 and 6 include arterial-venous (AV) fistula needles
(¶ [0020]), which can be inserted into a suitable vein (¶ [0004]).

PRINCIPLES OF LAW
Anticipation is established when a single prior art reference discloses,
expressly or under the principles of inherency, each and every limitation of
the claimed invention. Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342,
1347 (Fed. Cir. 1999); In re Paulsen, 30 F.3d 1475, 1478-79
(Fed. Cir. 1994). Inherency may not be established by probabilities or
possibilities, and “[t]he mere fact that a certain thing may result from a given
set of circumstances is not sufficient.” Continental Can Co. v. Monsanto
Co., 948 F.2d 1264, 1269 (Fed. Cir. 1991).
“Section 103 forbids issuance of a patent when ‘the differences
between the subject matter sought to be patented and the prior art are such
that the subject matter as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said
subject matter pertains.’” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 406
(2007). In KSR, the Supreme Court emphasized that “[t]he combination of
familiar elements according to known methods is likely to be obvious when
it does no more than yield predictable results.” Id. at 416. The Court
explained:
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When a work is available in one field of endeavor, design
incentives and other market forces can prompt variations of it,
either in the same field or a different one. If a person of
ordinary skill can implement a predictable variation, § 103
likely bars its patentability. For the same reason, if a technique
has been used to improve one device, and a person of ordinary
skill in the art would recognize that it would improve similar
devices in the same way, using the technique is obvious unless
its actual application is beyond his or her skill.
Id. at 417.
A patent applicant is free to recite features of an apparatus either
structurally or functionally, i.e., by what it does. Where the Patent Office
has reason to believe that a functional limitation asserted to be critical may
in fact be an inherent characteristic of the prior art, it possesses the authority
to require the applicant to prove that the subject matter in the prior art does
not possess the characteristic relied on. In re Schreiber, 128 F.3d 1473,
1478 (Fed. Cir. 1997).

ANALYSIS
§ 102 Rejection
We are not convinced by Appellant’s arguments (App. Br. 4-11; see
also Reply Br. 4-15) that Schlesinger does not teach the limitation “a pre-
formed support element operatively arranged to support said fistula needle
and manipulatable to control said angle of cannulation,” as recited in
claim 1.
The Examiner found that the yoke 1 and the resilient beam 2 of
Schlesinger correspond to “a pre-formed support element.” (Ans. 3.) The
Examiner interpreted the feature “operatively arranged to support said fistula
needle and manipulatable to control said angle of cannulation” as a
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functional limitation and found that the yoke 1 and the resilient beam 2 of
Schlesinger were capable of performing the claimed function. (Ans. 3-4.)
We agree with the Examiner that “a pre-formed support element
operatively arranged to support said fistula needle and manipulatable to
control said angle of cannulation” is a functional limitation and defines the
“pre-formed support element” by what it does, rather than structurally. See
Schreiber, 128 F.3d at 1478. Thus, the “pre-formed support element” must
have the ability to support the fistula needle, in which the angle of
cannulation is controlled by manipulating the support element.
Schlesinger teaches a catheter that enters a patient’s body. (FF 1.)
This teaching of Schlesinger implicitly teaches that the catheter enters the
patient’s body at an angle relative to the patient’s body and that this angle
can change due to patient movement (i.e., Schlesinger teaches an angle of
cannulation that is controlled by manipulating the support element).
Schlesinger also teaches a catheter support including a yoke 1 for
accommodating the catheter. (FF 1.) The yoke 1 is operatively arranged to
support the fistula needle when a catheter with a fistula needle attached to its
end is placed directly in the yoke 1 because the yoke 1 is indirectly attached
to the fistula needle via the catheter, which holds the needle in place.
Claim 1 does not require either a fistula needle or direct placement of a
fistula needle inside the yoke 1. Instead, claim 1 only requires that the
yoke 1 have the ability to support a fistula needle. The yoke 1 of
Schlesinger has the ability to support a fistula needle, as claimed.
Schlesinger teaches that the yoke 1 is attached to a base plate 4 by a
resilient beam 2. (FF 1.) The base plate 4 includes an adhesive layer 6 for
mounting the catheter support to the patient’s body. (FF 1.) The resilient
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beam 2 can accommodate limited patient movement when the catheter is
inserted in the patient’s body. (FF 2.) Schlesinger also teaches that the
resilient beam 2 is “capable of bending” as a result of “limited movement of
the catheter.” (FF 2.) In other words, the resilient beam 2 limits the “angle
of cannulation” of the catheter from patient movement. Therefore, the
resilient beam 2 of Schlesinger has the ability of being “manipulatable to
control said angle of cannulation.”
Appellant argues that the catheter support of Schlesinger cannot
support and control a fistula needle because “a needle placed in the device
[of Schlesinger] will be horizontal to base 4 . . . [and] the angle of the needle
precludes the needle from even coming in contact with the patient.”
(App. Br. 5.) However, these arguments are unconvincing because claim 1
does not require direct placement of the fistula needle in the support
element. Rather, claim 1 recites that the fistula needle is “supported” by the
support element. As discussed previously, the yoke 1 supports the fistula
needle because the yoke 1 is indirectly attached to the fistula needle via the
catheter, which holds the needle in place.
Next, Appellant argues that the catheter support of Schlesinger must
be modified to be capable of performing the function of claim 1 because “to
possibly control the angle of a fistula needle, beam 2 of Schlesinger’s device
would have to be bent and placed under constant strain.” (App. Br. 6.)
However, this argument is not convincing because, as discussed previously,
claim 1 does not require direct placement of the fistula needle in the support
element.
Finally, Appellant argues that: controlling the angle of cannulation is
not inherent because “Schlesinger teaches against using his support device to
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control an angle of cannulation” (App. Br. 8); “[u]sing Schlesinger’s device
as suggested by the Examiner would change the principle of operation for
the device” (App. Br. 9); and “[u]sing Schlesinger’s device as suggested by
the Examiner would render the device unusable for its intended purpose”
(App. Br. 10). However, such arguments are not germane to the issue of
anticipation. See Celeritas Techs., Ltd. v. Rockwell Int’l Corp.,
150 F.3d 1354, 1361 (Fed. Cir. 1998) (whether a reference teaches away
from claimed subject matter is inapplicable to anticipation analysis).
Therefore, the Examiner has not erred in finding that Schlesinger
teaches “a pre-formed support element operatively arranged to support said
fistula needle and manipulatable to control said angle of cannulation,” as
recited in claim 1.
We conclude that the Examiner has not erred in rejecting claim 1
under 35 U.S.C. § 102(b). Because Appellant has not presented separate
arguments regarding dependent claims 3, 5 and 11, we affirm the rejection
of these claims for the same reasons as for claim 1, from which they depend.

§ 103 Rejection
We are not convinced by Appellant’s arguments (App. Br. 11-15; see
also Reply Br. 15-25) that the combination of Schlesinger and Rose does not
teach or suggest “wherein an angle of cannulation for said fistula needle is
controllable via said movement of said support element to change a point of
contact between the needle and the support element,” as recited in claim 18.
The Examiner acknowledged that Schlesinger does not teach or
suggest “a fistula needle” and cited Rose for the disclosure of a fistula
needle attached to a tube. (Ans. 5-6.) The Examiner interpreted the feature
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“controllable via said movement of said support element to change a point of
contact between the needle and the support element” as a functional
limitation and found that the yoke 1 and the resilient beam 2 of Schlesinger
were capable of performing the claimed function. (Ans. 5.)
We agree with the Examiner that the “support element to change a
point of contact between the needle and the support element” is a functional
limitation and defines the “support element” by what it does, rather than
structurally. See Schreiber, 128 F.3d at 1478. Thus, the “support element”
must have the ability to change the point of contact between the needle and
the support element.
Rose teaches inserting a fistula needle into a suitable vein, where the
needle is attached to a tube (i.e., a catheter). (FF 3.) Similar to the previous
discussion with respect to claim 1, Rose implicitly teaches that the fistula
needle enters the patient’s body at an angle relative to the patient’s body and
that this angle can change due to patient movement (i.e., Rose teaches an
“angle of cannulation”). As also discussed previously with respect to
claim 1, the yoke 1 has the ability to support the fistula needle even when
the catheter is placed directly in the yoke 1 with a fistula needle attached to
the end of the catheter.
Further, as discussed previously, Schlesinger teaches a catheter
support including a base plate 4 with an adhesive layer 6 for mounting the
catheter support to the patient’s body. (FF 1.) Thus, the base plate 4 of the
catheter support is capable of being moved at different distances relative to
the point of entry of the catheter into the patient’s body. (See FF 2.) When
the catheter is placed in the yoke 1 such that the end of the catheter attached
the fistula needle is aligned with the U-shaped front face of the yoke 1 (see
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FF 1), the fistula needle contacts the yoke 1. Therefore, the combination of
Schlesinger and Rose teaches or suggests a “point of contact.” When the
base plate 4 of the catheter support is moved so that the catheter is
positioned in the yoke 1 such that the end of the catheter attached the fistula
needle is aligned with the U-shaped back face of the yoke 1 (see FF 1), the
fistula needle contacts the yoke 1 at a different “point of contact.” In other
words, the catheter support of Schlesinger is capable of movement “to
change a point of contact between the needle and the support element” when
the end of the catheter attached the fistula needle is placed directly in the
yoke 1.
Appellant argues: that Schlesinger does not teach controlling the
angle of the needle held by the yoke 1 and the resilient beam 2 (App. Br. 11;
see also Reply Br. 15-16); Schlesinger teaches against controlling an angle
for a needle held by the yoke 1 and the resilient beam 2 (App. Br. 12; see
also Reply Br. 16-17); modifying Schlesinger would change its principle of
operation (App. Br. 13; see also Reply Br. 17-19); modifying Schlesinger
would render it unusable for its intended purpose (App. Br. 13-14; see also
Reply Br. 19-20); no suggestion or motivation has been provided to modify
Schlesinger (App. Br. 14; see also Reply Br. 20-21); and there is no
reasonable expectation of success (App. Br. 14-15; see also Reply Br. 21-
24). However, these arguments are not convincing because, similar to the
previous discussion of claim 1, claim 18 does not require direct placement of
the fistula needle in the yoke 1 of the support element. It is sufficient that
the yoke 1 supports the fistula needle by supporting the catheter, which
holds the needle in place.
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Therefore, the Examiner has not erred in finding that the combination
of Schlesinger and Rose teaches or suggests “wherein an angle of
cannulation for said fistula needle is controllable via said movement of said
support element to change a point of contact between the needle and the
support element,” as recited in claim 18.
We conclude that the Examiner has not erred in rejecting claim 18
under 35 U.S.C. § 103(a). Because Appellant has not presented separate
arguments regarding dependent claim 19, we affirm the rejection of this
claim for the same reasons as for claim 18, from which claim 19 depends.

CONCLUSION
Based on the findings of fact and analysis above, we conclude that:
(1) the Examiner has not erred in rejecting claims 1, 3, 5 and 11
under 35 U.S.C. § 102(b); and
(2) the Examiner has not erred in rejecting claims 18 and 19 under
35 U.S.C. § 103(a).

DECISION
The rejection of claims 1, 3, 5 and 11 under 35 U.S.C. § 102(b) is
affirmed.
The rejection of claims 18 and 19 under 35 U.S.C. § 103(a) 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)(1)(iv).

AFFIRMED
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