Ex Parte Farnan

Patent Trial and Appeal Board

Nov 22, 2016

12794847 (P.T.A.B. Nov. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
121794,847 06/07/2010
26875 7590 11/25/2016
WOOD, HERRON & EV ANS, LLP
2700 CAREW TOWER
441 VINE STREET
CINCINNATI, OH 45202
FIRST NAMED INVENTOR
Robert C. Farnan
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
CIRC-33US 9787
EXAMINER
DANG, ANH TIEU
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
11/25/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
usptodock@whe-law.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte ROBERT C. FARNAN
Appeal 2015-001071
Application 12/794,847
Technology Center 3700
Before JENNIFER D. BAHR, AMANDA F. WIEKER, and
ARTHUR M. PESLAK, Administrative Patent Judges.
PESLAK, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Robert C. Farnan ("Appellant") appeals under 35 U.S.C. § 134(a)
from the Examiner's decision rejecting claims 1-7, 10, 12-14, and 41--47. 1 2
We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Appellant submits the real party in interest is CircuLite, Inc. Appeal Br. 3.
2 Claim 11 is cancelled. Appeal Br. 14 (Claims App.).
Appeal2015-001071
Application 12/794,847
THE CLAIMED SUBJECT MATTER
Claim 1, reproduced below, is illustrative of the claimed subject
matter.
1. A coaxial transseptal device comprising:
a piercing device comprising a flexible shaft having
a proximal end, a distal end, and a sharpened portion on
the distal end, wherein a flexibility of the shaft of the
piercing device increases distally and the shaft of the
piercing device includes a helical cut section on a distal
end thereof for increasing flexibility of the shaft along the
distal end thereof; and
a coaxial guide-wire having a proximal portion, a
distal portion with a distal tip, a transition joint separating
the proximal portion from the distal portion, and a lumen
extending within the proximal and distal portions of the
guide-wire, the lumen of the guide-wire configured to
receive the piercing device and to move relative thereto,
the transition joint defining a location at which flexibility
increases from the proximal portion to the distal portion,
and the distal portion having a flexibility that further
increases from the transition joint in a direction toward
and to a location proximate the distal tip.
REJECTIONS
1) Claims 1---6, 10, 12, 13, and 41--45 are rejected under 35 U.S.C.
§ 103(a) as unpatentable over Kraus (US 6,641,564 Bl, iss. Nov.
4, 2003) and Peters (US 2002/0038129 Al, pub. Mar. 28, 2002).
2) Claims 7 and 46 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Kraus, Peters, and Murray III (US
2004/0092867 Al, pub. May 13, 2004).
2
Appeal2015-001071
Application 12/794,847
3) Claims 14 and 47 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Kraus, Peters, and Chin-Chen (US
2007/0185530 Al, pub. Aug. 9, 2007).
DISCUSSION
Rejection 1
Appellant argues claims 1-6, 10, 12, 13, and 41--45 as a group.
Appeal Br. 7-11. Pursuant to 37 C.F.R. § 41.37(c)(l)(iv), we select claim 1
as representative to decide this rejection. The other claims stand or fall with
claim 1.
The Examiner finds that Kraus discloses the limitations of claim 1
except that Kraus does not teach the flexibility of the guide-wire increases
distally and the flexibility of the piercing device increases distally due to a
helical cut. Final Act. 4; see also Ans. 3. The Examiner finds that Peters
discloses "a flexible inner tubular member having a proximal portion and a
distal portion with a distal tip and a transition joint separating the proximal
and distal portions and a lumen extending therebetween." Final Act. 4. The
Examiner also finds that Peters discloses "the transition joint defines a
location at which flexibility increases from the proximal portion to the distal
portion ... and the distal portion has a flexibility that further increases from
the transition joint in a direction toward the distal tip to a location proximate
the distal tip." Id. The Examiner reasons it would have been obvious to
modify Kraus's flexible inner tubular guidewire to
have a transition joint separating the proximal portion and the distal
portion of the guidewire wherein the flexibility of the distal portion
increases from the transition joint in a direction toward and to a
location proximate the distal tip of the distal portion using a helical
3
Appeal2015-001071
Application 12/794,847
Id.
cut section, as taught by Peters, in order to increase the flexibility
towards and at the distal end, as desired by Kraus, to allow more
bendability to navigate the guidewire further into a vessel through the
vasculature of a patient.
Appellant contends that the Examiner's finding that Kraus' dilator
120 is capable of functioning as a coaxial guide-wire is erroneous because it
is well known in the art that "dilators and guide-wires have mutually
exclusive purposes and functions." Appeal Br. 8. Appellant argues that the
Examiner's finding that Kraus' dilator is capable of use as a guide-wire is
inconsistent with In re Giannelli, 739 F.3d 1375 (Fed. Cir. 2014), because
one of ordinary skill in the art would know that a dilator device is not a
guide-wire and using a dilator as a guide-wire could have "negative
consequences for a patient." Appeal Br. 8. Appellant also argues that Kraus
teaches away from the use of a guide-wire because Kraus discloses an
improvement to the prior art Seldinger technique (or method) for inserting a
needle into the vasculature, wherein the Seldinger technique includes the use
of a guide-wire. Id. at 7. By contrast, Appellant contends that Kraus
discloses in several places that Kraus' improvement does not require a
guide-wire. Id. at 7-8. Appellant also contends that the Examiner's finding
that Peters discloses flexibility increasing from the transition joint toward
the distal end is erroneous because although Peters discloses increased
flexibility in the central portion, the flexibility decreases at the distal end.
Id. at 10.
The Examiner responds that Appellant has not provided a proposed
construction of the term "guide-wire" that would distinguish Kraus's dilator
120. Ans. 10. The Examiner submits that one of ordinary skill in the art
4
Appeal2015-001071
Application 12/794,847
would understand that the term "guide-wire" "encompasses a long flexible
device used to guide placement and positioning for a larger device or
prosthesis, such as an intravascular ... stent." Id. The Examiner asserts that
Kraus' dilator 120 meets the structural and functional limitations of a guide-
wire as so construed, and that Kraus' s reference to an improvement over the
Seldinger technique as not requiring a guide-wire means that "Kraus does
not require an additional guidewire because structure 120 in combination
with structure 300, functions as the guidewire." Id. at 11. With respect to
the flexibility of Peters' tube decreasing at the distal end, the Examiner
responds that claim 1 does not require that the flexibility of the guide-wire
increase to the very distal end but only "to a location proximate to the distal
tip." Id. at 12. The Examiner submits that Appellant's Figure 3 discloses
that Appellant's claimed invention also exhibits decreased flexibility near its
distal end in the area denoted by element 58 where spiral cuts in tube 74 and
piercing device 44 are not present. Id. at 13.
For the following reasons, we sustain the rejection. We initially note
that Appellant does not provide any evidence or persuasive technical
reasoning to support the argument that one of ordinary skill in the art would
understand that a dilator is not a coaxial guide-wire or otherwise offer
evidence of relevant differences between a dilator and a coaxial guide-wire.
Nor does Appellant provide any evidence or persuasive technical reasoning
to support the argument that using a dilator as a coaxial guide-wire could
have negative consequences for a patient. See Appeal Br. 8.
The Specification describes "radial tip 80 [of coaxial guide-wire 46]
can be used to dilate the puncture created by the piercing device 44 through
intra-atrial septum 22 to a diameter that is similar to the outer diameter of
5
Appeal2015-001071
Application 12/794,847
the coaxial guide-wire 46." Spec. il 46 (emphasis added); see also Fig. 7C.
Therefore, Appellant's argument that Kraus's dilator 120 cannot be used as a
coaxial guide-wire is not consistent with the description in the Specification
that the tip of Appellant's coaxial guide-wire dilates a puncture created by
the piercing device. Appellant's argument that the Examiner's finding that
Kraus's dilator 120 is capable of acting as a coaxial guide-wire is
insufficient in view of In re Giannelli is also unavailing. In Giannelli, the
Court of Appeals for the Federal Circuit determined the meaning of "an
input assembly ... adapted to be moved ... by a pulling force." Giannelli,
739 F.3d at 1376 (emphasis added). The Federal Circuit noted that "adapted
to" can be construed to mean "configured to" or alternatively "capable of."
Id. at 1379. Nonetheless, the Federal Circuit held that "adapted to," in that
case, should be construed as designed or constructed to be moved by a
pulling force, not merely capable of being moved by a pulling force, because
the specification disclosed moving the input assembly by a pulling force
only. Id. at 1379. Here, unlike Giannelli, the Specification discloses the tip
of the coaxial guide-wire dilates the opening in the intra-atrial septum
created by the piercing device, and, thus, is consistent with Kraus' dilator
120. Finally, Appellant's argument that Kraus teaches away from the use of
a guide-wire is premised on the unsupported argument that one of ordinary
skill in the art "would not conclude that dilator 120 is a coaxial guide wire."
Appeal Br. 7. The teaching away argument is not persuasive because of the
description in Appellant's Specification that the tip of Appellant's coaxial
guide-wire dilates the puncture. Spec. i-f 46. For the foregoing reasons,
Appellant's contention that the recited "coaxial guide-wire" does not read on
Kraus' dilator 120 is not persuasive.
6
Appeal2015-001071
Application 12/794,847
Peters discloses tube 34 having a central region 66 beginning at a
transition zone near uncut portion 34 wherein central region 66 contains cut
segments 40 that increase the flexibility of tube 34 toward its distal end in
the direction of cutting member 36. See Peters i-f 38, Fig. 4. Appellant
attempts to distinguish Peters by arguing that Peters discloses decreased
flexibility toward the distal end beginning in the region noted by reference
numeral 67 in Figure 4 where the pitch of helical cuts 40 is decreased.
Appeal Br. 1 O; see Peters, Fig. 4. The Specification describes that spiral cuts
7 6 in tube 7 4 "provide a flexibility that increases distally." Spec. i-f 3 7.
Appellant's piercing device 44 contains spiral cuts 82 to increase flexibility
in the distal direction. Id. f 38. Appellant's Figures 3 and 4 illustrate that
spiral cuts 7 6 in tube 7 4 and spiral cuts 82 in piercing device 44 end prior to
the distal tip 80 in the area denoted by reference numeral 58 indicating
decreased flexibility near the distal end as in Peters. Id., Figs. 3, 4.
Appellant's argument is not persuasive in light of this disclosure in the
Specification and because claim 1 does not preclude the distal portion from
having decreased flexibility near the distal end but rather recites that the
flexibility of the distal portion of the guide wire "further increases from the
transition joint ... to a location proximate the distal tip."
Appellant, thus, fails to persuasively apprise us of error in the
Examiner's factual findings or rationale, quoted above, for the combination
of Kraus and Peters, which we determine to be reasonable and supported by
rational underpinnings. See KSR Int 'l Co. v Teleflex Inc., 550 US 398, 416
(2007) ("The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.").
7
Appeal2015-001071
Application 12/794,847
We, thus, sustain the rejection of claims 1---6, 10, 12-13, and 41--45 under 35
U.S.C. § 103(a).
Re} ections 2 and 3
Claims 7 and 46 are dependent on claim 1 and claim 42 respectively.
Appeal Br. 13, 16 (Claims App.). The Examiner rejects claims 7 and 46 as
unpatentable over Kraus, Peters, and Murray III. Final Act. 9. Appellant
relies on the same arguments for patentability set forth above for claim 1.
Appeal Br. 11. We sustain the rejection of claims 7 and 46 for the same
reasons set forth above with respect to claim 1.
Claims 14 and 47 are dependent on claim 1 and claim 42 respectively.
Appeal Br. 15, 16 (Claims App.). The Examiner rejects claims 14 and 47 as
unpatentable over Kraus, Peters, and Chin-Chen. Final Act. 10. Appellant
relies on the same arguments for patentability set forth above for claim 1.
Appeal Br. 11. We sustain the rejection of claims 14 and 4 7 for the same
reasons set forth above with respect to claim 1.
DECISION
The Examiner's decision rejecting claims 1-7, 10, 12-14, and 41--47
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). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
8