Ex Parte Klisch et al

Patent Trial and Appeal Board

Oct 14, 2014

10152426 (P.T.A.B. Oct. 14, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte LEO KLISCH and AUGUST POWELL
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Appeal 2012-011536
Application 10/152,426
Technology Center 3700
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Before TONI R. SCHEINER, DONALD E. ADAMS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a method
of attaching a hub to a catheter shaft. The Examiner rejected the claims as
failing to comply with the written description requirement and as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

1 Appellants identify the Real Party in Interest as Boston Scientific
Scimed, Inc. (see App. Br. 3).
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Statement of the Case
Background
“The use of intravascular catheters has become an effective method
for treating many types of vascular disease. In general, an intravascular
catheter is inserted into the vascular system of the patient and navigated
through the vasculature to a desired target site” (Spec. 1, ll.7–10). The
Specification notes that “[t]o facilitate manipulation of the proximal end of
the catheter . . . catheters commonly include a proximal hub or manifold”
(Spec. 2, ll. 15–17).
The Claims
Claims 17, 18, and 20–23 are on appeal. Claim 17 is representative
and reads as follows:
17. A method of attaching a hub to a catheter shaft,
comprising:
providing a strain relief;
inserting at least a portion of the strain relief into a
mold;
injecting a polymeric material into the mold to form a
hub having a distal end such that at least a portion of the
strain relief extends into the hub and such that no portion of
the strain relief proximal of the distal end of the hub is
outside the hub;
removing the hub from the mold to provide a hub
assembly comprising the hub and the strain relief;
providing a catheter shaft having a proximal end; and
subsequent to the step of removing the hub from the
mold to provide a hub assembly, bonding the strain relief of
the hub assembly to the proximal end of the shaft,
wherein the step of injecting a polymeric material into
the mold to form a hub includes the step of mechanically
interlocking the strain relief to the hub.

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The issues
A. The Examiner rejected claim 17 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement
(Final Rej. 5–6).
B. The Examiner rejected claims 17, 18, and 20–22 under 35 U.S.C.
§ 103(a) as obvious over Sater2 and Higgins3 (Final Rej. 7–8).
C. The Examiner rejected claim 23 under 35 U.S.C. § 103(a) as obvious
over Sater, Higgins, and Zadno-Azizi4 (Final Rej. 8–9).
A. 35 U.S.C. § 112, first paragraph – written description
The Examiner finds that “Claim 17 recites, ‘subsequent to the step of
removing the hub from the mold to provide a hub assembly, bonding the
strain relief of the hub assembly to the proximal end of the shaft’. There is
no disclosure of such a step in the originally filed specification” (Final Rej.
5–6). The Examiner finds that there “is no disclosure of a bonding the strain
relief of the hub assembly to the proximal end of the shaft after to the step of
removing the hub from the mold in ¶15 or in the entire originally filed
specification” (Final Rej. 6). The Examiner finds that:
There is no requirement that to bond the strain relief to the
proximal end that the hub must be removed from the mold.
Since there are multiple methods to bond the strain relief to
the hub assembly outside of the applicant’s claimed step,
and the applicant has only disclosed that the strain relief be
attached to the shaft, the applicant has not reasonably
conveyed to one skilled in the relevant art that the

2 Sater et al., US 6,068,622, issued May 30, 2000.
3 Higgins, S.W., US 4,875,481, issued Oct. 24, 1989.
4 Zadno-Azizi et al., US 5,997,562, issued Dec. 7, 1999.
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inventor(s), at the time the application was filed, had
possession of the claimed invention.

(Ans. 6.)
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that the phrase “subsequent to the step of
removing the hub from the mold to provide a hub assembly, bonding the
strain relief of the hub assembly to the proximal end of the shaft” in claim 17
lacks descriptive support in the originally filed Specification?
Findings of Fact
1. Originally filed claim 17 recites:
A method of attaching a hub to a catheter shaft,
comprising:
providing a strain relief;
inserting at least a portion of the strain relief into a
mold;
injecting a polymeric material into the mold to form a
hub;
removing the hub from the mold to provide a hub
assembly comprising the hub and the strain relief;
providing a catheter shaft having a proximal end; and
bonding the strain relief of the hub assembly to the
proximal end of the shaft.

2. The Specification5 teaches that:
Hub assembly 14 is designed, for example, to make it
possible to manufacture different portions of catheter 10 in
separate locations. According to this embodiment, hub
assembly 14 may be manufactured in a molding shop or

5 For consistency with the Examiner and Appellants, we will
identify locations in the Specification using the paragraphs in US
2003/0220628 A1, the pre-grant publication of US 10/152,426.
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other suitable location and then be moved to a clean room
where catheter 10 is being manufactured. Inside the clean
room, hub assembly 14 may be attached to shaft 12.
Because of this feature, an assembler no longer needs to
remove the entire catheter 10 (including shaft 12 that may be
150 cm or more in length) into a “non-clean” environment
for attachment to the hub by insert-molding. Moreover, by
eliminating the need to move the shaft 12 from room to
room, the probability of damaging catheter 10 during
manufacturing is reduced.

(Spec. 1–2 ¶ 15.)
Principles of Law
“[I]t is the specification itself that must demonstrate possession. And
while the description requirement does not demand any particular form of
disclosure, . . . or that the specification recite the claimed invention in haec
verba, a description that merely renders the invention obvious does not
satisfy the requirement.” Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d
1336, 1352 (Fed. Cir. 2010).
Analysis
The Examiner finds that “there is more than one way to attach the
strain relief to the hub assembly and proximal end of the catheter shaft.
There is no requirement that to bond the strain relief to the proximal end that
the hub must be removed from the mold” (Ans. 4).
Appellants contend that:
The hub assembly that is claimed is formed by removing the
hub from the mold: “removing the hub from the mold to
provide a hub assembly comprising the hub and the strain
relief.” This is where the term “hub assembly” is first
introduced into claim 17 and the term, as it is written, means
in this process claim something more than the conjoined
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result of the injection molding process of a previously
recited step. The claim language requires the removal of the
hub from the mold to form the hub assembly.

(Reply Br. 4.)
We find that Appellants have the better position. We agree that
original claim 17 does not provide a “hub assembly” until after the hub is
removed from the mold, because the “hub assembly,” as a claim element,
does not exist until that point in the original claim 17 (FF 1). Therefore, the
“bonding” step of the strain relief to the “hub assembly” necessarily occurs
subsequent to the formation of the “hub assembly,” consistent with the
language of original claim 17. We therefore find that the new “subsequent”
limitation in the instant claim 17 simply expressly states what was implicitly
required by originally filed claim 17, that the bonding step occurs after
removal of the hub from the mold (FF 1).
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that the phrase “subsequent to the step of removing the hub from the mold to
provide a hub assembly, bonding the strain relief of the hub assembly to the
proximal end of the shaft” in claim 17 lacks descriptive support in the
originally filed Specification.
B. 35 U.S.C. § 103(a) over Sater and Higgins
The Examiner finds that “Sater discloses a method of attaching a hub
to a catheter shaft . . . . However, Sater does not disclose having a hub
having a distal end such that at least a portion of the strain relief extends into
the hub or mechanically interlocking the strain relief to the hub by
mechanical interlocking grooves to the hub” (Final Rej. 7–8). The Examiner
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finds that “Higgins teaches that it is known to have a hub having a distal end
such that at least a portion of the strain relief extends into the hub or
mechanically interlocking the strain relief to the hub by mechanical
interlocking grooves” (Final Rej. 8).
The Examiner finds it obvious to “modify the method as taught by
Sater with the method and strain relief extending into the hub as taught by
Higgins for the purpose of providing a firm, strong, bonding of the strain
relief and hub members, both adhesively and mechanically” (Final Rej. 8).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Sater and Higgins render the claims
obvious?
Findings of Fact
3. Sater teaches that “many of the performance advantages of the
unitary catheter hub and strain relief 60 can also be achieved by injection
molding the unitary catheter hub and strain relief 60 [as] a separate piece and
attaching it to the proximal portion of the catheter body” (Sater, col. 12, ll.
12–15).
4. Sater teaches that:
In this manufacturing method, a straight mandrel of slightly
larger diameter can be substituted for the catheter body 15
within the mold cavity 165 while the molten material is
injected. The straight mandrel can then be withdrawn after
the molded unitary catheter hub and strain relief 60 is
ejected resulting in the strain relief coil lumen 85 and a
lumen extending proximally through the length of the
catheter/hub body junction 70.

(Sater, col. 12, ll. 16–23.)
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5. Sater teaches that the “catheter body proximal end 55 is inserted
into that lumen and adhesive or heat may be applied to retain it therein”
(Sater, col. 12, ll. 23–25).
6. Sater teaches that “the present invention may be practiced and
implemented to provide such a strain relief coil in substitution for the stain
reliefs incorporated in the above-described prior art catheters although not
all of the benefits of the preferred embodiment may be realized” (Sater, col.
12, ll. 38–42).
7. Higgins teaches that:
[A] tubular strain relief member 28 is provided, to which the
proximal end 14 of catheter body 12 may be secured by an
appropriate adhesive or the like. A portion of coil 26 is
tightly secured within tubular strain relief 28 . . . . Strain
relief 28 and coil 26, in the process of manufacturing and
attaching of hub 18, may be placed into an appropriate jig,
with the plastic hub 18 being insert molded into position
about coil 26 and tubular strain relief 28, to provide firm,
strong bonding of the members together, both adhesively
and mechanically. Specifically, the melted molding
compound can penetrate in small amounts between the coils
of wire coil 26, and can also enter into intimate, bonding and
adhering contact with strain relief tube 28, to accomplish
this purpose.

(Higgins, col. 3, ll. 8–22.)
Principles of Law
“Although the PTO must give claims their broadest reasonable
interpretation, this interpretation must be consistent with the one that those
skilled in the art would reach.” In re Cortright, 165 F.3d 1353, 1358 (Fed.
Cir. 1999).
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Analysis
Appellants contend that the “coil 26 of Higgins is not the strain relief,
and because the coil does not extend distally out from the proximal end of
the hub, the coil cannot function as a strain relief” (App. Br. 7). Appellants
contend that the “strain relief member 28 is a smooth tubular member that,
when the hub is inject[ion] mold[ed] about the proximal portion thereof,
does not permit ‘the step of mechanically interlocking the strain relief to the
hub’ recited in claim 1, nor does Higgins teach such a step” (App. Br. 7–8).
The Examiner responds that “as recited in claim 20, ‘a proximal
portion’ could include another element, not the strain relief itself, such as
coil (26) in Higgins which is ‘tightly secured’ within strain relief (28)” (Ans.
7). The Examiner finds that at “no point in claim 17 or claim 20 does the
appellant require by a claim recitation that the mechanical interlocking
occurs between a proximal portion of the strain relief and the hub” (Ans. 7).
We find that Appellants have the better position. At best, both Sater
and Higgins show connection of the strain relief to the hub using a slip-fit
connection. However, the Specification teaches that “[s]train relief 18 also
includes a proximal region 24 having a mechanically interlockable
geometry, such as one or more retaining grooves 26” (Spec. 2 ¶ 18).
Therefore, even under the broadest reasonable interpretation rubric a “slip-
fit” connection cannot reasonably be interpreted as “mechanically
interlocked” since there are no elements which are physically
interconnected.
We recognize, but are not persuaded by, the Examiner’s argument that
because Higgins shows coil 26 and strain relief 28 as secured together,
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molding compound penetrating between the coils of coil 26 results in
mechanical interlocking strain relief 28 (FF 7). However, as Appellants
correctly point out (Reply Br. 5), claim 17 specifically requires
“mechanically interlocking the strain relief to the hub.” In Higgins, at best it
is coil 26 which is mechanically interlocked, not strain relief 28, since the
Examiner has not identified any portion of strain relief 28 itself which is
mechanically interlocked (FF 7).
We also find unpersuasive the Examiner’s argument that the language
in claim 20 of “a proximal portion” broadens claim 17 to allow the coil to
serve as the proximal portion which is mechanically interlocked. While
claim 20 recites “a proximal portion,” that phrase is most reasonably
interpreted as referring to “a proximal portion” of the strain relief, and
requiring the strain relief itself to have some type of mechanical interlock,
not simply a slip fit or attachment to another component, particularly in light
of the requirement in claim 17 for “mechanically interlocking the strain
relief to the hub.”
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Sater and Higgins render the claims obvious.
C. 35 U.S.C. § 103(a) over Sater, Higgins, and Zadno-Azizi
This rejection relies upon the underlying obviousness rejection over
Sater and Higgins. Having reversed the rejection of claim 17, we also
necessarily reverse this obviousness rejection because Zadno-Azizi is not
relied upon to teach “mechanically interlocking the strain relief to the hub”
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as required by independent claim 17, upon which all of the rejected claims
depend.
SUMMARY
In summary, we reverse the rejection of claim 17 under 35 U.S.C.
§ 112, first paragraph, as failing to comply with the written description
requirement.
We reverse the rejection of claims 17, 18, and 20–22 under 35 U.S.C.
§ 103(a) as obvious over Sater and Higgins.
We reverse the rejection of claim 23 under 35 U.S.C. § 103(a) as
obvious over Sater, Higgins, and Zadno-Azizi.

REVERSED

cdc