Ex Parte Tan

Board of Patent Appeals and Interferences

Apr 23, 2009

10690436 (B.P.A.I. Apr. 23, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte SHARON MI LYN TAN
____________

Appeal 2009-0508
Application 10/690,436
Technology Center 3700
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Decided1: April 23, 2009
____________

Before JAMESON LEE, SALLY GARDNER LANE and SALLY C.
MEDLEY, Administrative Patent Judges.

MEDLEY, Administrative Patent Judge.

DECISION ON APPEAL

1 The two month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

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A. STATEMENT OF THE CASE
Boston Scientific Scimed Inc. (“Boston Scientific”), the real party in
interest, seeks review under 35 U.S.C. § 134(a) of a Final Rejection of
claims 1-26. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
References Relied on by the Examiner
Fields et al. (“Fields”) 5,357,961 Oct. 25, 1994
Fischell et al. (“Fischell”) 5,413,561 May 9, 1995
Davidson 5,588,443 Dec. 31, 1996
Liu et al. (“Liu”) 6,371,944 Apr. 16, 2002

The Rejections on Appeal
The Examiner rejected claims 1-26 under 35 U.S.C. § 103(e) as
unpatentable over Liu, Davidson, and Fischell or Fields.
Claims 1-26 stand or fall together. (App. Br. 4).
The Invention
Referring to figure 2, [numbers from figure 2 inserted], Boston Scientific
discloses an infection management system. The system includes a catheter
[8], a side arm tube [13], a one way valve [14], and an antimicrobial
intervention device [15] (i.e., rod) with a cap [16] located at its proximal
end. (Spec. 3-6).
Boston Scientific’s figure 2 is reproduced below:

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Figure 2 depicts a catheter with a side arm and rod.
Claim 1, reproduced from the Claim Appendix of the Appeal Brief, is as
follows:
An infection management system, comprising:
a catheter with a lumen extending therethrough;
a side-arm tube extending laterally from a side of the
catheter, wherein
the side-arm tube is located in a region of the catheter which
remains outside a patient's body, and
a lumen through the side-arm tube communicates with the
catheter lumen;
a one-way valve which prevents fluid flow from the catheter
lumen through the side-arm tube lumen without preventing
fluid flow through the catheter lumen;
an antimicrobial agent-bearing intervention device
configured to be inserted through the side-arm tube lumen and
the one-way valve into the catheter lumen; and
a cap coupled to the antimicrobial agent-bearing intervention
device, the cap being configured so that a user can handle the
antimicrobial agent-bearing intervention device without directly
contacting the antimicrobial agent-bearing intervention device.

B. ISSUES
1. Has Boston Scientific demonstrated that Liu does not describe a
catheter?
2. Has Boston Scientific demonstrated that the Examiner erred in
determining that the claimed invention would have been obvious based on
the rationale provided by the Examiner for combining the references?
C. FINDINGS OF FACT
1. A catheter is defined as “[a] tubular instrument to allow passage of
fluid from or into a body cavity or blood vessel.” Stedman’s Medical
Dictionary (Lippincott, Williams &Wilkins) (27th ed. 2004).
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2. One of ordinary skill in the art at the time the invention was made
would have recognized the benefit of providing an additional seal to
prevent blood loss for redundancy should the first seal unexpectedly
fail.
Boston Scientific’s Disclosure
3. Referring to figure 2 above, [numbers from figure 2 inserted], Boston
Scientific describes that catheter body [9] may alternatively be
removably coupled at its distal end to a catheter previously implanted
in the patient. (P. 5, l. 30-p. 6, l.1)
Liu
4. Referring to figure 1B, [numbers from figure 1B inserted], Liu
describes an apparatus that includes a receptacle portion [1] such as a
syringe, a connecting portion [2] having a common passage [10] from
a first conduit to the receptacle portion, a first entry [3] for attachment
to the receptacle, a second entry [4] into a second conduit [9] and a
third entry [8] which opens to the first conduit such as a needle3 that is
inserted into a blood vessel. (Col. 3, ll. 6-19).
Liu’s Figure 1B, is reproduced below:

Figure 1B depicts a needle, a connecting portion and a syringe.

3 Although not shown in Liu’s Figure 1B, the needle is referred to as
element 7, as is shown in the Liu prior art Figure 1A. Col. 2, ll. 47-50.
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5. A flexible linear object such as a guide wire [18] can be inserted into
and through the second entry [4] and into the lumen of a conduit such
as a needle. (Col. 3, ll. 12-15).
6. Second entry [4] has a one-way valve [5], such as a flap valve which
prevents backup and escape of fluids such as blood through the
second entry. (Col. 2, ll. 50-59, col. 3, ll. 15-17).
7. Referring to figure 2B, [numbers from figure 2B inserted], Liu
describes that it is possible to use the invention by means of a separate
adapter having three entries [11], [12], [13]. (Col. 4, ll. 10-15).
Liu’s Figure 2B, is reproduced below:

Figure 2B depicts an adapter.
8. Third entry [13] is used for connection to a conduit. (Col. 4, ll. 10-
15).
9. Liu further describes that “[u]sing the separate adapter, the method of
the invention can be practiced using standard equipment such as
needles, catheters and wires found in most health care facilities.”
(Col. 5, ll. 15-18).
Davidson
10. Davidson describes a guidewire [40] which can be coated with
antibiotic, anticoagulants, for reducing platelet adhesion, or reducing
other adverse cellular or tissue responses to surfaces in contact with
blood. (Col. 4, ll. 25-35).
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Fischell
11. Referring to figure 7 below, [numbers from figure 7 inserted],
Fischell describes a catheter [20], [70] with a sealing cap [80] having
a hemostasis valve [85] for coupling with a guidewire. (Col. 3, ll. 1-
44, col. 4, ll. 38-43, 55-57).
Fishell’s figure 7 is below:

Figure 7 depicts a catheter with a sealing cap.
Fields
12. Referring to figure 1 below, [numbers from figure 1 inserted], Fields
describes a three-way connector [15] including an insertion port [18],
a flushing port [24] and an outlet port [21] which is connected to a
catheter [30]. (Col. 4, ll. 38-60).
Fields’ figure 1 is below:

Figure 1 depicts a catheter and three-way connector.

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13. A reclosable septum [41] is disposed on the insertion port [18], but
enables a guidewire [35] to pass through the septum [41]. (Col. 4, ll.
59-60, col. 5, ll. 7-33).
14. Guidewire [35] includes a handle [38] at its end which provides a
gripping surface that is larger than the guidewire and makes guidewire
handling easier. (Col. 4, l. 66-col. 5, l. 4).
15. The handle [38] also acts as a stop to fix the position of the guidewire
[35] in relation to the tip of a catheter. (Col. 5, ll. 4-6, 12-19).
D. PRINCIPLES OF LAW
In KSR, the Supreme Court rejected the rigid application of the “teaching
suggestion or motivation” (TSM) test, instead favoring the “expansive and
flexible approach” used by the Court. KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398, 415 (2007). Based on its precedent, the Court reaffirmed the
longstanding principle 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.
In KSR, the Court instructed that in an obviousness analysis, it is not
necessary to find precise teachings in the prior art directed to the specific
subject matter claimed because inferences and creative steps that a person of
ordinary skill in the art would employ can be taken into account. Id. at 418.
The Court also explained that “[a] person of ordinary skill is also a person of
ordinary creativity, not an automaton.” Id. at 421.
E. ANALYSIS
Independent claim 1 is representative and recites a “system
comprising: a catheter . . . a sidearm extending laterally from a side of a
catheter . . .”. (App. Br. 9).
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The Examiner finds that Liu’s needle [7] is a catheter. (Final
Rejection 2; Ans. 4; FF4 4). The Examiner also relies on Liu’s connecting
portion [2] for its second conduit [9], and one-way valve [5] to meet the
claim limitations of the side-arm tube, side-arm tube lumen and one-way
valve. (Final Rejection 2; Ans. 4; FF 4).
Boston Scientific argues that one skilled in the art would understand
that Liu’s needle is not a catheter. (App. Br. 5; Reply Br. 1). The argument
is plausible. However, we need not determine whether one of ordinary skill
in the art would have considered a needle to be a catheter. A prior art
reference is available for all that it teaches. EWP Corp. v. Reliance
Universal Inc., 755 F.2d 898, 907 (Fed. Cir. 1985). In addition to the
Examiner’s findings, Liu describes an additional embodiment in which an
adapter, i.e., a catheter, is separable and therefore not attached or necessarily
integrated with a needle.
Liu’s separate adapter, shown in figure 2B, has similar features to the
connecting portion [2] of the embodiment relied upon by the Examiner
except that it is separate from and not integral with a needle. (FFs 4, 7-9).
The adapter of figure 2B, like connecting portion [2], has one-way valve and
a second conduit and therefore meets the claim limitations of a side-arm
tube, side-arm tube lumen and one-way valve. The separable adapter body
is a tubular instrument that allows passage of fluid from or into a body
cavity or blood vessel and is therefore a “catheter” as defined. (FF 1). The
structure of the stand alone adapter of figure 2B does not necessarily depend
on the integration with a needle. Therefore, Boston Scientific’s argument

4 FF denotes Finding of Fact.
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that Liu’s needle [7] is not a catheter is of no moment, since Liu describes
other embodiments where a needle is not integral with the “catheter” body.
Moreover, Liu’s separable adapter is similar to Boston Scientific’s
catheter body [9], which may be removably coupled to a further catheter.
(FF 3). One of ordinary skill in the art at the time of the invention would
have recognized that Liu’s adapter could have been connected to a further
tubular structure or another catheter body and not necessarily connected to a
needle, similar to Boston Scientific’s disclosed embodiment. Liu suggests
as much when it describes that the adapter’s third entry [13] is for
connecting to a first conduit and that “[u]sing the separate adapter, the
method of the invention may be practiced using standard equipment such as
needles, syringes, catheters and wires found in most health care facilities.”
(FFs 8-9, emphasis added). The Fischell and Fields references relied on by
the Examiner provide additional evidence to demonstrate that one of
ordinary skill in the art would have known that Liu’s adapter could have
been connected to a further tubular structure or catheter. Both references
show a further tubular structure or catheter attached to an adapter similar to
Liu’s. (See Fischell fig. 6A, col. 4, ll. 18-22; and FF 12).
For all these reasons, Boston Scientific has not demonstrated that Liu
does not describe a catheter.
Claim 1 further recites “an antimicrobial agent-bearing intervention
device . . . and a cap coupled to the antimicrobial agent-bearing intervention
device . . .”. (App. Br. 9).
The Examiner finds that the combination of Liu and Davidson
describes an antimicrobial agent-bearing intervention device; but not a cap
coupled to the intervention device. (Final Rejection 2-3; Ans. 4; see FFs 4-
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5, 10). The Examiner finds that Fischell teaches a cap [80] coupled to a
guidewire in order to provide a handle or seal at the port end. (Final
Rejection 3; Ans. 4; FF 11). Alternatively, the Examiner finds that Fields
teaches an intervention device or guidewire [35] having a cap [38] for
manipulation of the intervention device and for sealing against the port and
for stopping the guidewire at a fixed location relative to the catheter. (Final
Rejection 4; Ans. 5-6; FFs 14-15). The Examiner determined that the
combination of Liu, Davidson and Fischell and the combination of Liu,
Davidson and Fields would have been obvious to one of ordinary skill in the
art at the time the invention was made. (Final Rejection 3-4; Ans. 4, 6).
Boston Scientific cites several sections of the Liu reference and
concludes that one skilled in the art would not have been motivated to
modify Liu to add a cap to the second entry [4] to prevent contamination or
leaking of fluids at the proximal end. (App. Br. 5-6, emphasis added).
Boston Scientific also argues that (1) it is not apparent that adding a cap to
Liu’s device would actually be desirable for further reducing leaks and/or
contamination since Liu already has a device for preventing leaks (i.e., valve
[5]); (2) there is no support in the record to explain why one skilled in the art
would have been motivated to go through the additional cost and complexity
associated with adding a cap to Liu’s device; and (3) there is no evidence of
record that indicates that Liu’s approach to preventing leaks does not work.
(Reply Br. 2).
Although Boston Scientific indicates that all claims stand or fall
together, Boston Scientific’s “cap” arguments seem directed to the
limitations of dependent claims 7 and 16. Independent claims 1, 10 and 19
do not require a cap on the second entry (i.e., the proximal end of the side-
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arm tube [4]). However, dependent claims 7 and 16 do. Claims 7 and 16
each recite “the cap is adapted to seal a proximal end of the side-arm tube . .
.”. (App. Br. 10, 12). In any event, we address the argument with respect to
dependent claims 7 and 16.
The Examiner finds that Fischell describes a cap [80] for sealing the
system to reduce blood loss when inserting guiding catheters/rods/wires i.e.,
intervention devices. (Final Rejection 3; Ans. 4, citing figs. 1-3 and 7).
Fields describes a similar arrangement of a cap [41] for sealing. (FFs 12-
13). The Examiner determined that it would have been obvious to one with
ordinary skill in the art at the time the invention was made to modify the
device of Liu and Davidson with a cap for the side arm in order to reduce
blood loss when inserting the wire into the side arm. (Final Rejection 3;
Ans. 4).
Boston Scientific does not present objective evidence to support its
argument that one skilled in the art would not have been motivated to
modify the combination of Liu and Davidson to add a cap to the second
entry [4] to prevent contamination or leaking of fluids at the proximal end.
Equally unpersuasive are Boston Scientific’s arguments that (1) there is no
motivation or apparent desirability to add a cap to Liu’s device, and (2) no
evidence has been presented to show that Liu’s approach to preventing leaks
does not work. In determining obviousness, it is not necessary to find
precise teachings in the prior art directed to the specific subject matter
claimed because inferences and creative steps that a person of ordinary skill
in the art would employ can be taken into account. In this case, one with
ordinary skill in the art at the time the invention was made would have
recognized the benefits of providing an additional seal to prevent blood loss
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for redundancy should the first seal unexpectedly fail. (FF 2). “A person of
ordinary skill is also a person of ordinary creativity, not an automaton.”
KSR at 1742. Furthermore, modifying the combination of Liu and Davidson
to include a cap for the side arm would have been obvious to one with
ordinary skill in the art because the combination of familiar elements
according to known methods is obvious when it does no more than yield
predictable results. Boston Scientific does not present evidence to
demonstrate that the combination yields unpredictable results.
For these additional reasons, Boston Scientific does not demonstrate that
the Examiner erred in determining that claims 1-26 would have been
obvious.
F. CONCLUSION
1. Boston Scientific has not demonstrated that Liu does not describe a
catheter.
2. Boston Scientific has not demonstrated that the Examiner erred in
determining that the claimed invention would have been obvious based on
the rationale provided by the Examiner for combining the references.
G. ORDER
The decision of the Examiner rejecting claims 1-26 under 35 U.S.C. §
103(e) as unpatentable over Liu, Davidson, and Fischell or Fields is
affirmed.
No time period for taking any subsequent action in connection with
the appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED
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MAT

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Minneapolis, MN 55440-1022