Ex Parte Kick et al

Patent Trial and Appeal Board

Aug 12, 2013

11222498 (P.T.A.B. Aug. 12, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte GEORGE F. KICK, JAY LENKER, EDWARD J. NANCE,
JOSEPH BISHOP, and ONNIK TCHULLUIAN
____________

Appeal 2011-007778
Application 11/222,498
Technology Center 3700
____________

Before PHILLIP J. KAUFFMAN, BARRY L. GROSSMAN, and
BART A. GERSTENBLITH, Administrative Patent Judges.

GROSSMAN, Administrative Patent Judge.

DECISION ON APPEAL
Appeal 2011-007778
Application 11/222,498

2

STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from the Examiner’s
decision finally rejecting claims 9-17. We have jurisdiction over the appeal
under 35 U.S.C. § 6(b).
We affirm the decision of the Examiner.

CLAIMED SUBJECT MATTER
The claimed subject matter relates generally to medical devices and,
more particularly, to methods and devices for accessing the cardiovascular
system. Spec., para. [0001]. Claim 9, the sole independent claim, is
representative of the subject matter on appeal, and recites:
9. A method of instrumenting a left atrium of a
patient comprising the steps of:
routing a guidewire into the right atrium from a
peripheral vein;
inserting a sheath with a collapsed distal region and
a pre-inserted dilator into the patient over the guidewire;
advancing the sheath to a treatment or diagnostic
site within the right atrium of the heart;
performing a trans-septal puncture between the right
and left atrium and advancing the collapsed distal region
through the puncture into the left atrium;
dilating the distal region of the sheath so that the
distal region of the sheath is expanded;
collapsing the dilator;
removing the dilator from the sheath;
inserting instrumentation through the lumen of the
sheath into the left atrium;
performing therapy or diagnosis with the
instrumentation; and
removing the sheath from the patient.

Appeal 2010-007778
Application 11/222,498

3

REFERENCES
The Examiner relied upon the following prior art references:

REJECTION
The rejection before us for review is the rejection of claims 9-17
under 35 U.S.C. § 103(a) as unpatentable over Brock and Hayden. Ans. 3;
App. Br. 9.
ANALYSIS
Appellants argue claims 9-17 as a group. App. Br. 10, 12. Dependent
claims 10-17 are not argued separately. Accordingly, claims 10-17 stand or
fall with claim 9. 37 C.F.R. § 41.37(c)(1)(vii)(2011).
Appellants argue that:
(1) Brock does not disclose “expanding the shaft or inserting
instrumentation through the shaft while the shaft is positioned within a
patient” (App. Br. 10);
(2) Hayden does not disclose “advancing a sheath within the right or
left atriums of the heart, performing a trans-septal puncture, removing a
dilator from the catheter, or inserting instrumentation through the lumen of a
sheath into a patient, not to mention the left atrium of a patient’s heart” (id.);
and
(3) a person having ordinary skill in the art at the time of invention
“would not have been motivated to combine the disclosures of Brock and
Hayden to obtain the recited features of Claim 9” (id. at 11, 12).
Hayden US 2003/0212384 A1 Nov. 13, 2003
Brock US 7,090,683 B2 Aug. 15, 2006
Appeal 2010-007778
Application 11/222,498

4

The Examiner found that “Brock discloses the method of
instrumenting a left atrium of a patient substantially as claimed.” Ans. 3.
Relevant to Appellants’ arguments, the Examiner found that Brock discloses
an outer guide catheter and a coaxial inner (working) catheter that is used to
perform surgical or medical procedures. Id. (citing Brock, col. 17, ll. 32-58).
The cited passage from Brock discloses that the inner catheter can
immediately function at the operative site. However, if a second inner
catheter is required, the first inner catheter can be quickly withdrawn
through the outer guide catheter and the second inner, working catheter
inserted through the outer catheter.
Brock utilizes a tool 18 supported at the distal end of a shaft 30.
Brock, col. 10, ll. 65-67; fig. 6. Further, as the Examiner correctly points
out, Brock discloses exchange of tools, such a guide catheter housing an
inner catheter and a tool (5-degree-of-freedom tool and wrist). Ans. 5-6
(citing Brock, col. 29, l. 56 - col. 30, l. 9).
Thus, contrary to Appellants’ arguments (App. Br. 11), Brock
discloses inserting instrumentation through a shaft positioned within a
patient, and does not teach away from “tool exchanges.” See In re Fulton,
391 F.3d 1195, 1201 (Fed. Cir. 2004) (“The prior art’s mere disclosure of
more than one alternative does not constitute a teaching away from any of
these alternatives because such disclosure does not criticize, discredit, or
otherwise discourage the solution claimed in the '198 application.”).
Additionally, the Examiner found that Brock discloses guiding an
instrument with a catheter entering the right atrium and passing through a
septal wall of the heart to the left atrium. Ans. 3 (citing Brock, col. 25,
ll. 33-65). The Examiner also found that while Brock discloses all the other
Appeal 2010-007778
Application 11/222,498

5

limitations in claim 9, “Brock does not disclose the distal end of the sheath is
inserted in a collapsed position and subsequently dilated in situ.” Ans. 3-4.
The Examiner cited Hayden for the one element missing from the
disclosure of Brock. Ans. 4. The Examiner found that “Hayden discloses a
catheter for insertion into the vasculature that is capable of being inserted
through a trans-septal puncture between the right and left atrium.” Id. The
Examiner also found that the catheter in Hayden “has a distal portion (30)
that is inserted through the vasculature in an unexpanded configuration (Figs
3, 8) and is subsequently expanded (Figs 4, 10) when it reaches the target
site.” Id.
Based on these findings, the Examiner concluded that it would have
been obvious to one having ordinary skill in the art at the time the invention
was made to modify the method of Brock such that the distal end of the
catheter included an expandable section. Ans. 4. The rationale for the
proposed modification was that it “would provide safer access to the left
atrium by introducing a smaller diameter guide sheath through the
vasculature and heart, while maintaining the function of introducing tools
through the regular diameter sheath upon expansion of the distal end to
perform treatment within the left atrium.” Id. at 5.
Appellants argue that there is no motivation to combine Brock and
Hayden. App. Br. 11, 12. Specifically, Appellants argue that Brock’s
device includes a tool supported at the distal end of a shaft, teaching away
from tool exchange procedures as claimed. App. Br. 11. Further, according
to Appellants, Brock is intentionally designed to be a relative small diameter
so that there is not motivation to expand the guide catheter as claimed. App.
Br. 11-12.
Appeal 2010-007778
Application 11/222,498

6

Whether a patent application claiming the combination of prior art
elements would have been obvious is determined by whether the claimed
improvement is more than the predictable use of prior art elements according
to their established functions. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
417 (2007).
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.
KSR, 550 U.S. at 417.
“Common sense teaches, however, that familiar items may have
obvious uses beyond their primary purposes, and in many cases a person of
ordinary skill will be able to fit the teachings of multiple patents together
like pieces of a puzzle.” Id. at 420. Regardless of the primary purpose of
Brock and Hayden, both references relate to surgical instruments inserted
through a lumen, such as an artery or vein, that provide surgical procedures
or other treatment at a site remote from the point of entry. The idea that a
person of ordinary skill in the relevant technology would ignore Hayden or
Brock because each may use this technology differently than the claimed
invention makes little sense. “A person of ordinary skill is also a person of
ordinary creativity, not an automaton.” Id.
We are not persuaded by Appellants’ argument that Brock’s guide
catheter is designed to be relatively small and therefore there is no
motivation to make it larger. The Examiner provided the rationale that the
Appeal 2010-007778
Application 11/222,498

7

proposed modification would provide safer access for the surgeon and
Appellants’ argument does not address the merits of that contention. The
Examiner provided articulated reasoning with rational underpinning to
support the legal conclusion of obviousness. Ans. 5.
In their Reply Brief, Appellants interpret claim 9 as requiring “the
expandable distal end of the device expands the puncture,” and assert that
“Brock and Hayden do not teach this feature.” Reply Br. 5. Appellants also
assert that “Hayden does not disclose or suggest any motivation to expand a
sheath for the purposes of dilating a puncture in the atrial septum of the
heart.” Id.; see also App. Br. 11-12 (e.g., “there is no need or motivation
disclosed in Brock to expand the instrument within a trans- septal opening.”)
(emphasis added). However, Appellants do not point to any language in
claim 9 that requires the expandable distal end of the sheath to expand the
puncture or to expand within the trans-septal opening. Appellants also do
not point to any language in claim 9 that requires the purpose of expanding
the sheath to be dilating the trans-septal puncture.
We determine the scope of the claims in patent applications not solely
on the basis of the claim language, but upon giving claims “their broadest
reasonable interpretation consistent with the specification” and “in light of
the specification as it would be interpreted by one of ordinary skill in the
art.” In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004)
(citations omitted).
Claim 9 calls for advancing the collapsed distal region of the sheath
“through the [trans-septal] puncture” and dilating the distal region “so that
the distal region of the sheath is expanded.” This is fully consistent with the
Specification. Spec., para. [0011] (“The collapsed distal region is advanced
Appeal 2010-007778
Application 11/222,498

8

through the puncture into the left atrium. The distal region of the sheath is
dilated so that the distal region of the sheath is expanded.”).
Contrary to Appellants’ arguments (Reply Br. 5), claim 9 does not
recite or require the expanded sheath to also expand the trans-septal
puncture.
Accordingly, Appellants’ arguments and evidence do not apprise us of
any error in the Examiner’s decision to reject claim 9.
Claims 10-17 fall with claim 9. 37 C.F.R. § 41.37(c)(1)(vii).

DECISION
Upon consideration of the record as a whole in light of Appellants’
contentions and the preponderance of relevant evidence we affirm the
Examiner’s decision rejecting claims 9-17.
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

mls