Ex Parte Cox et al

Patent Trial and Appeal Board

Nov 3, 2016

12426175 (P.T.A.B. Nov. 3, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/426,175 04/17/2009 Jeremy B. Cox
34284 7590 11/07/2016
Rutan & Tucker, LLP
611 ANTON BL VD
SUITE 1400
COST A MESA, CA 92626
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.
101672.0074P2 4292
EXAMINER
D ABREU, MICHAEL JOSEPH
ART UNIT PAPER NUMBER
3762
NOTIFICATION DATE DELIVERY MODE
11/07/2016 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):
patents@rutan.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JEREMY B. COX,
ANTHONY K. MISENER, CATHERINE C. BREITER,
BRET HAMATAKE, EDDIE K. BURNSIDE,
JASON R. STATS, and AMIR OROME
Appeal2015-002492
Application 12/426,175
Technology Center 3700
Before JAMES P. CAL VE, GEORGE R. HOSKINS, and
ARTHUR M. PESLAK, Administrative Patent Judges.
CAL VE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from the final rejection of
claims 1-21. Appeal Br. 4. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
Appeal2015-002492
Application 12/426,175
CLAIMED SUBJECT MATTER
Claim 1, the sole independent claim, is reproduced below.
1. A medical device placement system, comprising:
a medical device assembly including a medical device for
placement within a body of a patient and a sensing
component, the medical device assembly at least
partially disposed in a sterile field, a first connector
operably connected to the sensing component
including a first contact;
a data-receiving component at least partially disposed in
a non-sterile field, a second connector operably
connected to the data-receiving component including
a second contact; and
means for establishing a conductive pathway between the
sterile field and the non-sterile field after the sterile
field has been established by creating a perforation in
a drape separating the sterile field and the non-sterile
field with either the first connector or second
connector so as to operably connect the sensing
component to the data-receiving component without
compromising the sterile field.
REJECTION
Claims 1-21 are rejected under 35 U.S.C. § 103(a) as unpatentable
over Goldin (US 6,546,270 B 1, iss. Apr. 8, 2003), and either of Mackey
(US 5,423,877, iss. June 13, 1995) or Pyles (US 2005/0283216 Al, pub.
Dec. 22, 2005).
ANALYSIS
Claims 1-21 as unpatentable over Goldin and either Mackey or Pyles
The Examiner interpreted the "means for establishing a conductive
pathway" in claim 1 as invoking 35 U.S.C. § 112, sixth paragraph. Final
Act. 2. The Examiner found that Appellants disclose connector schemes as
structures to that claimed function. Id. at 3.
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Appeal2015-002492
Application 12/426,175
The Examiner found that Goldin teaches a medical device assembly
with catheter 20, sensing component (location sensor 28), a first conductor/
connector (wire 54) extending the length of the device to contact pin 40, and
a second connector (wire 52) connected to a data-receiving component. Id.
at 5. The Examiner also found that the first connector (wire 54 in Figure 3)
corresponds to the means for establishing a conductive pathway between the
sterile and the non-sterile fields. Id.; see Ans. 3.
The Examiner found that Golden does not teach creating a perforation
in a drape that separates sterile and non-sterile fields, but Mackey and Pyles
teach the use of sterile drapes at an insertion site for insertion of a catheter
into a patient. Final Act. 6. The Examiner determined that it would have
been obvious to use a sterile drape as taught by Mackey or Pyles and to
establish a conductive pathway between an internal sterile field of a patient
and a non-sterile field outside the patient by perforating the drape. Id.
Appellants argue that Goldin does not disclose a medical device with
a drape to define a sterile barrier and even if the sterile field is limited to the
patient's body, Goldin's catheter body traverses this boundary and Goldin
does not provide any connector along the catheter body in any area at or near
the patient boundary. Appeal Br. 13-14. Appellants argue that they define a
sterile field in their Specification as
A sterile drape that is positioned over the patient 70 during the
catheter insertion procedure defines the majority of the sterile
field: areas above the drape are sterile, while areas below
(excluding the insertion site and immediately surrounding
region) are non-sterile.
Id. at 14 (quoting Spec. i-f 84 with emphasis added by Appellants).
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Appeal2015-002492
Application 12/426,175
Appellants also argue that Mackey does not disclose any perforation
in a drape and Pyles discloses a sterile drape having an opening therein for
access to a site to be punctured, but neither reference teaches means to form
a perforation in a drape with a first or second connector. Appeal Br. 15-16.
Appellants further argue that elements 52 and 54 in Figure 3 of Goldin run
the entire length of the device and do not cause any perforation of a drape as
they are housed in the body of catheter 20. Id. at 16-17. We agree.
The Examiner has not established by a preponderance of evidence that
wires 52, 54 of Goldin provide a structure corresponding to the "means for
establishing a conductive pathway ... by creating a perforation in a drape
separating the sterile field and the non-sterile field." Appellants disclose
tether connector 132 with pin contact 170 that pierces drape 174 when tether
connector 132 connects to fin connector 156 and establishes a conductive
pathway with fin contact 168 as shown in Figure 15 below.
FIG, 15
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Appeal2015-002492
Application 12/426,175
Figure 15 of Appellants' disclosure is a cross-section of sty let tether,
fin connector, and tip location/navigation (TLS) sensor 50 with drape 174.
Pin contact 170 forms perforation 175 in drape 174 and passes through
centering hole 164 to contact fin contact 168. Spec. i-f 93. Pin contact 170
forms and occupies a small perforation 175, thus minimizing the size of the
perforation in sterile drape 174. Tether connector channel 172 encloses the
perforation 175 to preserve the sterility of drape 174. Id.
The Examiner's finding that Pyles creates a perforation in a drape by
disclosing a drape with an opening for access to an insertion site (Pyles i-f 24)
does not explain how Goldin' s wire 54, which the Examiner finds is the first
connector and the claimed "means" (Final Act. 5), creates a perforation in a
drape as claimed. Ans. 5. Wires 52, 54 extend from reference electrode 25
and location sensor 28, respectively, near catheter tip 26 and inside a body of
catheter 20 to catheter handle 30 and then via electrical connections to signal
processing circuits 40. Goldin, 12:28-32, Figs. 1, 3. Even if wires 52, 54
are considered to be connectors, they do not provide structure or equivalent
structure to create a perforation in a drape, as the Examiner admits. Ans. 6.
The Examiner's interpretation of the "means" in claim 1 as not requiring
structure to perforate a drape (id.) is not consistent with the plain language
of claim 1 interpreted in light of Appellants' Specification.
We do not sustain the rejection of claims 1-21.
DECISION
We reverse the rejection of claims 1-21.
REVERSED
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