Ex Parte Anand

Patent Trial and Appeal Board

Jan 29, 2015

12048871 (P.T.A.B. Jan. 29, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte PJ ANAND
__________

Appeal 2012-007374
Application 12/048,871
Technology Center 3700
__________

Before ERIC B. GRIMES, LORA M. GREEN, 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 multi-
lumen catheter device for hemodialysis. The Examiner rejected the claims
as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.

1 Appellant identifies the Real Party in Interest as C. R. Bard, Inc.
(see App. Br. 3).
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Application 12/048,871

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Statement of the Case
Background
“Multi-lumen catheters and, in particular split-tip catheters, are
desirable for various treatment applications such as hemodialysis where fluid
extraction and infusion occur simultaneously” (Spec. 1 ¶ 3). “[T]here
remains a need for a multi-lumen catheter that addresses the problems of
access recirculation yet retains the comparative ease of insertion of a single
lumen catheter” (Spec. 3 ¶ 10).
The Claims
Claims 1–25 are on appeal. Independent claim 1 is representative and
reads as follows (emphasis added):
1. A multi-lumen catheter device for hemodialysis,
comprising:

an elongate catheter body with at least a blood extraction
lumen and a blood return lumen extending
longitudinally therethrough, having a proximal end
adapted for coupling to a hemodialysis apparatus, and
having a distal end terminating in separable distal tip
portions adapted for insertion in a blood vessel, the
distal end further comprising:

a distal extraction tip portion for fluidic coupling of
the extraction lumen with the blood vessel,
a distal return tip portion for fluidic coupling of the
return lumen with the blood vessel, and
a bioresorbable adhesive joining the distal tip
portions together for insertion into the blood
vessel and facilitating separation of the distal
tip portions from each other following
insertion.

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The issues
A. The Examiner rejected claims 1, 2, 5, and 12–25 under 35 U.S.C.
§ 103(a) as obvious over Zawacki2 and Chastain3 (Ans. 5–14).
B. The Examiner rejected claims 3, 4, and 9 under 35 U.S.C. § 103(a) as
obvious over Zawacki, Chastain, and Kotzev4 (Ans. 14–17).
C. The Examiner rejected claims 6–8 under 35 U.S.C. § 103(a) as
obvious over Zawacki, Chastain, and Chevalier5 (Ans. 17–19).
D. The Examiner rejected claims 10 and 11 under 35 U.S.C. § 103(a) as
obvious over Zawacki, Chastain, and Tayot6 (Ans. 19–20).
A. 35 U.S.C. § 103(a) over Zawacki and Chastain
The Examiner finds that Zawacki teaches “a multi-lumen catheter
device for hemodialysis . . . comprising: an elongate catheter body 10 with at
least a blood extraction lumen 40 and a blood return lumen 50 . . . having a
proximal end 12 adapted for coupling to a hemodialysis apparatus, and
having a distal end 14 terminating in separable distal tip portions 40, 44, 50,
54 adapted for insertion in a blood vessel” (Ans. 5).
The Examiner finds that Zawacki teaches “the types of adhesives used
to join the distal tip potions together include epoxy and cyanoacrylates and
other comparable adhesives” (Ans. 6). The Examiner finds that the
Specification teaches that “epoxy and cyanoacrylates are disclosed as

2 Zawacki et al., US 7,393,339 B2, issued Jul. 1, 2008.
3 Chastain et al., US 6,178,356 B1, issued Jan. 23, 2001.
4 Kotzev, D., US 6,224,622 B1, issued May 1, 2001.
5 Chevalier et al., US 5,049,138, issued Sep. 17, 1991.
6 Tayot et al., US 6,730,299 B1, issued May 4, 2004.
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suitable embodiments of the instant claimed bioresorbable adhesives” (Ans.
6). The Examiner finds that Zawacki teaches “methods for providing
increasing and decreasing separation forces between tip sections along the
length of a split tip catheter such that the tips are easier to separate at their
terminal ends by utilizing different adhesives or solvents for different zones”
(Ans. 7).
The Examiner finds that “Chastain teaches biodegradable adhesive 32
and resorbable polymer adhesive 36 . . . to join the tip portions 32, 34 to the
lead 12 for insertion into the blood vessel and facilitating separation of the
distal 16 tip portions 32, 34 from each other following insertion” (Ans. 8–9).
The Examiner finds it obvious
to join the tips of the catheter of Zawacki together for
insertion into a blood vessel and facilitate separation of the
tip portions from each other following insertion as taught by
[Chastain] since Chastain states . . . that the benefits of
providing distal tip portions with this design is that they
permit the lead device to provide a low profile during
insertion through the vasculature or any catheters that may
be employed during deployment to a target site and for the
tips to separate after deployment, which are objects of
Zawacki, when released by the action of body fluids
following placement at the desired site.

(Ans. 9).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Zawacki and Chastain render
obvious a “bioresorbable adhesive joining the distal tip portions together for
insertion into the blood vessel and facilitating separation of the distal tip
portions from each other following insertion” as required by claim 1?
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Findings of Fact
1. Zawacki teaches that “[m]ulti-lumen catheters are used for the
purpose of creating two or more separate fluid pathways, such as in
hemodialysis applications” (Zawacki, col. 1, ll. 12–14).
2. Figure 1 of Zawacki is reproduced below:

Referring now to FIG. 1, a split-tip catheter 10 is shown
having a proximal end 12 and a distal end 14. The proximal
end of the catheter 12 is attached to a Y-connector 60 . . .
The Y-connector 60 and extension tubing 62 fluidly connect
the lumens to a blood treatment unit or dialysis machine . . .
The distal end 14 of the catheter 10 is separated into tip
sections 40 and 50 distal to a dividing point 30.

(Zawacki, col. 6, ll. 1–15).
3. Zawacki teaches that as “is standard for dialysis catheters, tip
section 40 is used to aspirate blood from the patient, while tip section 50 is
used to infuse treated blood from a dialysis machine” (Zawacki, col. 6, l. 67
to col. 7, l. 2).

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4. Figure 21C of Zawacki is reproduced below:

Figure 21C shows
an improvement to prior art split-tip catheters that are
releasably joined or ‘splittable’ distal to the dividing point
. . ., wherein increasing separation force is required to
separate the tip sections from one another. An increasing
separation force as used herein means that the bond strength
between the tip sections of the catheter will be greater as
measured from a distal end toward the dividing point.

(Zawacki, col. 15, ll. 31–38).
5. Zawacki teaches that “the discussion with respect to the
separation of splittable tip sections herein encompasses both permanent and
temporary (i.e., releasably joined) separation” (Zawacki, col. 15, ll. 57–59).
6. Zawacki teaches that “[t]ypes of adhesive which could be used
include epoxy and cyanoacrylates, although certainly other comparable
adhesives would also be suitable” (Zawacki, col. 18, ll. 2–4).
7. Chastain teaches that the retention
structure can be temporarily adhered to the lead body in part
or in total. Partial adhesion allows parts of the retention
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structure to be fixed to lead body for a short period of time
to, for example, provide a low profile during lead insertion.
The biodegradable adhesive is used to temporarily constrain
the retention structure to lie against the lead body until
released by the action of body fluids on the biodegradable
adhesive following placement of the electrode at the desired
site. Total adhesion with a resorbable adhesive allows the
lead body to be separated from the retention structure

(Chastain, col. 2, ll. 14–24).
8. Chastain teaches that the “free ends of the retention structure 30
may be adhesively bonded to the lead body 12, using a biodegradable
adhesive 32 . . . The adhesive is such that when exposed to body fluids, it
will release within a matter of minutes, allowing the resilient retention
structures to deploy” (Chastain, col. 3, ll. 21–27).
9. The Freasier7 Declaration states that “cyanoacrylates are not
generally accepted as being bioresorbable to a person of ordinary skill in the
art” (Freasier Dec 2 ¶ 6).
10. The Specification teaches that
bioresorbable adhesives have bonding elements and
degradable elements. The degradable elements can have the
components of polylactide, polyglycolide and polylactones
(polycaprolactone). The bonding elements can have
hydrogen bonding strength (polyvinyl alcohol,
polysaccharides) or can be able to polymerize as a single
component (cyanoacrylates) or as two compone[n]ts (epoxy
compound plus amino compounds, or radical(light) initiators
of acrylate compounds).

(Spec. 10 ¶ 0050).

7 Declaration of James Freasier, filed Oct. 14, 2011.
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11. Claim 5 of Kotzev, drawn to “bioabsorbable tissue adhesives
made by the method of claim 3” requires the claim 3 combination of “the
copolymer of claim 1 into a cyanoacrylate monomer” where the copolymer
of claim 1 further includes a cyanoacrylate monomer and another monomer
which “is selected from the group consisting of glycolide, lactide, ϵ-
caprolactone, dioxanone and trimethylene carbonate” (Kotzev, col. 10, l. 64
to col. 11, l. 38).
Principles of Law
A prima facie case for obviousness “requires a suggestion of all
limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and “a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Analysis
Appellant contends that “Zawacki does not describe a bioresorbable
adhesive, as cyanoacrylates are not bioresorbable as proffered by the
Examiner” (App. Br. 8). Appellant contends that “cyanoacrylate only
provides the bonding portion of a bioresorbable adhesive. Without the
degradable elements, the cyanoacrylate is not a bioresorbable adhesive, as
claimed” (App. Br. 9).
The Examiner finds that “the features upon which Appellant relies
(i.e., the cyanoacrylates are not degradable elements) are not recited in the
rejected claim(s)” (Ans. 23). The Examiner is not persuaded by the Freasier
Declaration because “this declaration is in direct opposition to patented
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claim 5 of Kotzev; claim 5 specifically claims, ‘A bioabsorbable tissue
adhesive’, thus a simple declaration is insufficient to overcome the
presumption of validity which an issued patent is accorded” (Ans. 25).
We find that Appellant has the better position. The Specification
clearly explains that “bioresorbable adhesives have bonding elements and
degradable elements. The degradable elements can have the components of
polylactide, polyglycolide and polylactones (polycaprolactone). The
bonding elements can . . . polymerize as a single component
(cyanoacrylates)” (Spec. 10 ¶ 0050; FF 10). Thus, the Specification teaches
that cyanoacrylate alone is not a bioresorbable adhesive, but requires
degradable elements such as polylactide, polyglycolide and polylactones
(polycaprolactone) (FF 10). This position is also evidenced by the Freasier
Declaration (FF 9).
The Examiner’s reliance on Kotzev’s claim 5 is misplaced, because
claim 5 of Kotzev depends on claims 1 and 3, and claim 1 clearly requires
that the bioresorbable adhesive be composed of a copolymer of
cyanoacrylate monomer and another monomer “selected from the group
consisting of glycolide, lactide, ϵ-caprolactone, dioxanone and trimethylene
carbonate” (Kotzev, col. 11, ll. 4–6; FF 11). Therefore, even in Kotzev, the
bioresorbable adhesive is not solely composed of cyanoacrylate monomers,
but also includes other “degradable element” monomers, the first three listed
in claim 1 of Kotzev being identical to the three degradable elements taught
in the Specification (FF 10–11).
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We therefore agree with Appellant that Zawacki does not teach the
use of a bioresorbable adhesive in the releasably joined catheter, and the
rejection requires the combination with Chastain for this element.
Appellant next contends that “Zawacki teaches away from using a
bioresorbable adhesive of Chastain. . . . if bioresorbable adhesive were used
in Zawacki, the practitioner would no longer be able to select various
dividing points with a single catheter; instead, all the adhesive would
biodegrade leaving the tips fully divided” (Reply Br. 8–9).
The Examiner finds that “nothing in the disclosure of Zawacki
precludes the separation of the tips after insertion into a patient; Zawacki
provides motivation for various other catheter tip embodiments wherein the
tips are joined during insertion by guidewires and sheaths and separated after
insertion by manipulating the guidewires and sheaths” (Ans. 25).
Appellant responds that “[e]ven assuming arguendo a practitioner
could divide the tips after insertion, which Appellant disputes, if the
remaining adhesive is bioresorbable, then the selected dividing point would
still change beyond what the practitioner selected, thereby defeating the
purpose of the Zawacki invention” (Reply Br. 9). Appellant contends that:
Zawacki specifically states that ‘[i]n each of these
embodiments, . . . it should be appreciated that said dividing
point is a fixed point beyond which separation can not take
place without use of excessive separation force. In other
words, the invention of Zawacki excludes any use of
bioresorbable adhesive that might separate the tips (as in the
instant specification), and maintains that separation is only
accomplished by applying separation force.

(Reply Br. 9).
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We find that Appellant has the better position. We agree with
Appellant that there would not have been a reason to combine Zawacki with
Chastain’s bioresorbable adhesive because Chastain teaches that when
exposed to body fluids, the adhesive will “release within a matter of
minutes” (Chastain, col. 3, ll. 26–27; FF 8). While Zawacki’s tip sections
are releasably joined (FF 5), Zawacki requires a change in separation force
over the tip sections (FF 4). If Chastain’s rapidly releasing bioresorbable
adhesive were substituted for Zawacki’s adhesives, the split-tips of
Zawacki’s catheter would either separate prematurely or lose the property of
allowing selection of the predetermined distance of the catheter split based
on the increase in separation force used by the surgeon. In either case, the
ordinary artisan would have lacked a reason to combine Zawacki’s catheter
with Chastain’s rapidly releasing bioresorbable adhesive.
Therefore, we are not persuaded by the Examiner’s reasoning that it
would have been obvious to substitute Chastain’s adhesive into Zawacki’s
catheter in order “for the tips to separate after deployment, which are objects
of Zawacki, when released by the action of body fluids following placement
at the desired site” (Ans. 9). Indeed, Zawacki teaches that for the tips to
separate after deployment, a differential level of force by the surgeon should
be applied (FF 4), not release by the body fluid itself. The adhesive of
Zawacki and the bioresorbable adhesive of Chastain are not obvious
equivalents and the Examiner has not provided a persuasive reason to
substitute Chastain’s bioresorbable adhesive for the adhesive of Zawacki.
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Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Zawacki and Chastain render obvious a “bioresorbable adhesive joining
the distal tip portions together for insertion into the blood vessel and
facilitating separation of the distal tip portions from each other following
insertion” as required by claim 1.
B–D. 35 U.S.C. § 103(a)
These rejections rely upon the underlying obviousness rejection over
Zawacki and Chastain. Having reversed this rejection, we also necessarily
reverse the further obviousness rejections because Kotzev, Chevalier, and
Tayot are not relied upon to provide a reason to substitute a bioresorbable
adhesive for the adhesive of Zawacki.
SUMMARY
In summary, we reverse the rejection of claims 1, 2, 5, and 12–25
under 35 U.S.C. § 103(a) as obvious over Zawacki and Chastain.
We reverse the rejection of claims 3, 4, and 9 under 35 U.S.C.
§ 103(a) as obvious over Zawacki, Chastain, and Kotzev.
We reverse the rejection of claims 6–8 under 35 U.S.C. § 103(a) as
obvious over Zawacki, Chastain, and Chevalier.
We reverse the rejection of claims 10 and 11 under 35 U.S.C. § 103(a)
as obvious over Zawacki, Chastain, and Tayot.

REVERSED
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