Ex Parte Cull

Patent Trial and Appeal Board

Nov 7, 2016

12681731 (P.T.A.B. Nov. 7, 2016)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/681,731 11/03/2010 David L. Cull CDL-8-PCT-US 6408
22827 7590 11/07/2016
DORITY & MANNING, P.A.
POST OFFICE BOX 1449
GREENVILLE, SC 29602-1449
EXAMINER
BERDICHEVSKY, AARTI
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
11/07/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID L. CULL1
Appeal 2014-006694
Application 12/681,731
Technology Center 3700
Before GEORGE R. HOSKINS, LEE L. STEPINA, and
AMANDA F. WIEKER, Administrative Patent Judges.
WIEKER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
David L. Cull (“Appellant”) appeals under 35 U.S.C. § 134(a) from
the Examiner’s final rejection of claims 1—20. We have jurisdiction over the
appeal under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellant, the Real Party in Interest is CreatiVasc Medical,
LLC. Br. 1.
Appeal 2014-006694
Application 12/681,731
CLAIMED SUBJECT MATTER
The claimed invention concerns “devices and methods to facilitate
cannulation and prevent needle puncture bleeding of an arteriovenous
fistula.” Spec. 3:4—6. Claim 1 is illustrative of the subject matter on appeal,
and recites:
1. A device for locating an arteriovenous fistula and
occluding an arteriovenous fistula needle puncture site, the
device comprising:
a body, the body formed from a self-sealing biocompatible
material, the body having a semi-curved shape with two edges
that extend along the length of the body, the body configured to
conform to a contour of a portion of an arteriovenous fistula with
the edges configured to be generally parallel to the length of an
arteriovenous fistula, the edges providing a tactile clue when
focal pressure is applied to skin above an arteriovenous fistula,
the body providing a barrier to limit bleeding from a posterior
portion of an arteriovenous fistula.
Br. 8 (Claims App.). Independent claim 11 is a method claim and contains
similar limitations. Id. at 9 (Claims App.).
REJECTIONS
The claims stand rejected as follows:
I. Claims 1—12 and 15—20 under 35 U.S.C. § 103(a) as
unpatentable over Vertenstein (US 5,167,629, iss. Dec. 1, 1992)
and House (US 2006/0118236 Al, pub. June 8, 2006).
II. Claims 13 and 14 under 35 U.S.C. § 103(a) as unpatentable
over Vertenstein, House, and Berry (US 5,306,240, iss. Apr. 26,
1994).
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Application 12/681,731
ANALYSIS
Rejection I— Claims 1—12 and 15—20
Appellant argues claims 1 and 11 as a group. Br. 3—6. We treat claim
1 as representative, and claim 11 stands or falls with claim 1. 37 C.F.R.
§41.37(c)(l)(iv).
The Examiner finds that Vertenstein teaches a device substantially as
recited in claim 1 but fails to teach that the device’s body is formed from a
self-sealing material. Final Act. 2—3; Ans. 2. The Examiner finds that
House teaches an implantable device formed from a self-sealing
biocompatible material with reinforcement. Final Act. 3. In light of these
teachings, the Examiner concludes it would have been obvious to an
ordinarily skilled artisan to replace the body material disclosed by
Vertenstein with the self-sealing and reinforced material taught by House
because “this material would provide a body that would be more resistant to
fluid leakage following puncturing with a needle, and would be more
flexible than simply metal alone” such as disclosed in Vertenstein. Id. at 3—
4 (citation omitted).
Appellant contends that Vertenstein teaches away from the proposed
combination because Vertenstein’s device is “designed strictly as a vein
locator with metal walls designed to ‘protect[] any surrounding vital organs
from injury during placement of an intravenous access catheter’ . . . and to
prevent disassembly.” Br. 4—5 (citing Vertenstein 4:34—36, 4:53—54). In
Appellant’s view, an ordinarily skilled artisan would not have substituted
House’s self-sealing material for Vertenstein’s metal body “since such a
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Application 12/681,731
material would potentially allow the needle penetration that Vertenstein . . .
aims to avoid.” Id. at 5.
We are not persuaded by Appellant’s argument. Vertenstein discloses
a vein locator that includes a U-shaped sleeve (10), adapted to surround a
patient’s vein (7). Vertenstein 3:20—22, Figs. 4—5. Vertenstein specifies that
the sleeve is formed from “a biocompatible metal,” but contemplates
expressly that “other materials could be used.” Id. at 3:43—45. Therefore,
we are not persuaded that a skilled artisan would have been discouraged or
dissuaded from modifying Vertenstein’s device body to be formed from a
different material, i.e., a self-sealing material as taught by House. See In re
Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Additionally, we are
unpersuaded that use of a self-sealing material may permit injury to vital
organs, which Vertenstein aims to avoid. Br. 5. Vertenstein attributes the
avoidance of injury to the “configuration of the sleeve’s walls 15,” not to the
material employed. Vertenstein 4:34—38; see also Ans. 2. Appellant
provides no persuasive evidence or technical reasoning to establish that
organs would be injured if the material of Vertenstein’s device were
changed, but its configuration remained the same. Indeed, Vertenstein
discloses that it is the arrangement of protuberances (21) atop the sleeve,
which may be felt through the patient’s skin to identify the vein’s location
within the sidewalls (15) of the sleeve, which allows needle insertion into
the vein and protects surrounding organs from injury. See Vertenstein 3:23—
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Application 12/681,731
30, 4:34—38. Vertenstein does not suggest that the metal material of the
sleeve is necessary for performance of this function.2
Appellant also contends that House teaches away from the claimed
invention because House’s device replaces an arteriovenous fistula, whereas
the claimed device surrounds an arteriovenous fistula. Br. 5—6.
We are unpersuaded by this argument, which attacks the references
individually. See In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir.
1986). The Examiner’s rejection does not rely on House as teaching any
structural features of the device. Final Act. 2—4. Rather, the rejection relies
on Vertenstein’s disclosure of a device structure and House’s teaching of a
self-sealing material. Id.', Ans. 3. Appellant’s argument does not address
the combination of references as relied upon by the Examiner. Br. 5—6.
Unpersuaded of error in the Examiner’s rejection of claim 1, we
sustain the rejection of claim 1 and claim 11, which was grouped with claim
1. Appellant does not provide separate argument for claims 2—10, 12, or 15—
20, which depend from independent claims 1 or 11. Appeal Br. 6.
Accordingly, we also sustain the rejection of those claims.
Rejection II— Claims 13 and 14
The Examiner finds that Vertenstein and House render obvious the
method of claim 11, but do not teach a tunneler as recited in claims 13 and
14. Final Act. 6. The Examiner finds that Berry teaches a tunneler and a
method for implanting a subcutaneous vascular access graft, and concludes
2 Appellant’s argument that Vertenstein’s device is designed to “prevent
disassembly” is also unpersuasive. Br. 5. This function is attributed to
locking clip 30, not the material of the sleeve. Vertenstein 4:53—54.
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Application 12/681,731
that it would have been obvious to an ordinarily skilled artisan “to use a
tunneler as taught by Berry to at least partially position the vein locating
device of Vertenstein and House” with less trauma. Id.
Appellant contends that Vertenstein teaches away from use of a
tunneler as required by claims 13 and 14 because Vertenstein “requires a
surgeon to squeeze the side walls of the device to nest the device to the
ring,” which is “counter to the purpose of a tunneler, which seeks to avoid a
larger surgical opening.” Br. 6—7.
We are unpersuaded by this argument. Although the procedure
disclosed by Vertenstein involves “squeezing] the side walls of the device,”
(Vertenstein 4:40-42), Appellant does not identify any disclosure in
Vertenstein that would discourage or discredit the modification proposed by
the Examiner, in light of Berry’s teachings. See In re Gurley, 27 F.3d at 553
(“A reference may be said to teach away when a person of ordinary skill,
upon reading the reference, would be discouraged from following the path
set out in the reference, or would be led in a direction divergent from the
path that was taken by the applicant.”). Further, the reasoning articulated by
the Examiner for the proposed modification—to avoid trauma—is supported
by rational underpinnings. See Berry 2:28—32.
Unpersuaded of error in the Examiner’s rejection of claims 13 and 14,
we sustain the rejection.
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Application 12/681,731
DECISION
The rejection of claims 1—20 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).
AFFIRMED
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