Bard Access Systems, Inc.

Patent Trials and Appeals Board

Nov 3, 2020

2020002759 (P.T.A.B. Nov. 3, 2020)

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.
14/394,204 10/13/2014 Ghassan S. Kassab 101672.0205P 3429
158673 7590 11/03/2020
BD/Rutan & Tucker, LLP
18575 Jamboree Road
9th Floor
Irvin, CA 92612
EXAMINER
HENSON, DEVIN B
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
11/03/2020 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):
ip.docket@bd.com
patents@rutan.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GHASSAN S. KASSAB, WILLIAM COMBS, MARK
SVENDSEN, and H. TOBY MARKOWITZ
Appeal 2020-002759
Application 14/394,204
Technology Center 3700
Before JILL D. HILL, LEE L. STEPINA, and ARTHUR M. PESLAK,
Administrative Patent Judges.
HILL, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 82–102. See Final Act. 1. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real party in interest as 3DT Holdings, LLC.
Appeal Br. 4.
Appeal 2020-002759
Application 14/394,204

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BACKGROUND
Appellant’s invention relates to methods for navigating and
positioning a central venous catheter within a patient. Claims 82 and 98 are
independent. Claim 82, reproduced below with emphasis added, is
illustrative of the claimed subject matter:
82. A method, comprising the steps of:
puncturing a patient's skin to access a blood vessel of the
patient;
advancing at least part of a device into the blood vessel,
the device comprising:
a first pole and a second pole, each of the first pole and
the second pole configured with excitation and
detection functionality to generate an electric field
within a mammalian body sufficient to obtain a
plurality of field measurements therein; and
an elongated body having a lumen extending distally
therethrough and configured as a unipolar stylet for
at least partial insertion into the blood vessel of the
patient and advancement through a vasculature of
the patient, the advancement dependent upon the
plurality of field measurements indicating one or
more locations of a portion of the elongated body
within the vasculature,
wherein the first pole is associated with the elongated
body and the second pole is positioned on an
external surface of the patient,
wherein the indicating is based on a detected cross-
sectional area change determined through
conductance corresponding to the plurality of field
measurements,
wherein the step of advancing is performed while
obtaining the plurality of field measurements,
transmitting the field measurements to a console,
and displaying the conductance or conductance-
based images to assist a clinician in the
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Application 14/394,204

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advancement through the vasculature without X-
ray, fluoroscopy, or ultrasound.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Kondrosky US 2008/0255475 A1 Oct. 16, 2008
Rothenberg US 2009/0259124 A1 Oct. 15, 2009
Markowitz US 2009/0262992 A1 Oct. 22, 2009
Kassab US 2010/0010355 A1 Jan. 14, 2010
Cox US 2011/0015533 A1 Jan. 20, 2011
Vollkron US 2012/0078342 A1 Mar. 29, 2012
He US 2012/0108950 A1 May 3, 2012

REJECTIONS
I. Claims 82–84 and 86–89 stand rejected under 35 U.S.C. § 103
as unpatentable over Kassab, Rothenberg, Cox, and Markowitz.
II. Claim 85 stands rejected under 35 U.S.C. § 103 as unpatentable
over Kassab, Rothenberg, Cox, Markowitz, and Vollkron.
III. Claims 90, 91, 93–95, and 98–1022 stand rejected under 35
U.S.C. § 103 as unpatentable over Kassab, Rothenberg, Cox, Markowitz,
and He.
IV. Claims 92, 96, and 97 stand rejected under 35 U.S.C. § 103 as
unpatentable over Kassab, Rothenberg, Cox, Markowitz, He, and
Kondrosky.

2 The Examiner’s inclusion of claim 108 in the heading of Rejection III (see
Final Act. 7) appears to be a typographical error in that claim 108 was
cancelled. See Final Act. 1; see also Appeal Br. 27 (App. A).
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ANALYSIS
Rejection I; Claims 82–84 and 86–89
The Examiner finds that Kassab discloses many of the steps of claim
82, including advancing a device having a first pole associated with an
elongated body and a second pole. Final Act. 2–3. The Examiner finds,
however, that the second pole of Kassab is not positioned on an external
surface of the patient. Id. at 3. The Examiner finds that both Rothenberg
and Cox disclose a first pole associated with an elongate body and a second
pole positioned on an external surface of the patient. Id. at 4. The Examiner
concludes that it would have been obvious to modify the method of Kassab
to position the second pole on an external surface of the patient to “locate[] a
tip of a central venous catheter relative to the superior vena cava, sino-atrial
node, right atrium, and/or right ventricle using electrocardiogram data.” Id.
at 5 (citing Rothenberg, Abstract). The Examiner also relies on Markowitz
to reject independent claim 82, but for limitations unrelated to the positions
of the first and second poles. See Final Act. 4–5.
Appellant asserts that the Examiner’s rationale for the combination is
insufficient based on the disclosure of the references. Appeal Br. 15.
Appellant contends that a skilled artisan would not have made the proposed
modification based on underlying technical differences in detection, namely,
Rothenberg detects electrical signals generated by the heart whereas Kassab
detects electrical signals generated by the catheter. Id.
The Examiner responds that the motivation to make the combination
is reasonable because each of the references positions a catheter tip within
the heart using electric field measurements. Ans. 6. According to the
Examiner, one of ordinary skill could have easily modified the method of
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Kassab, as suggested, and the substitution of one arrangement for the other
would yield predictable results with respect to positioning a catheter tip with
a high expectation of success. Ans. 7. The Examiner asserts that “in the
proposed combination, each element merely performs the same function as it
does separately.” Id. The Examiner notes that, although Rothenberg detects
electrical signals generated by the heart, which is different from Kassab’s
detection of electrical signals generated by a catheter, “both types of
electrical signals are still within the scope of the broadly recited ‘plurality of
field measurements’ recited in the claims.” Id.
Appellant replies that the difference in detection affects the proposed
modification not only based on the type of signal (Rothenberg’s electrodes
detect electrical signals generated by the heart whereas Kassab’s electrodes
generate signals and detect signals), but also based on the function of the
electrodes. Reply Br. 10. Appellant asserts that claim 82 requires more than
just a plurality of field measurements, and recites “each [pole] of the first
pole and the second pole [is] configured with excitation and detection
functionality to generate an electric field within a mammalian body
sufficient to obtain a plurality of field measurements therein.” Id.
Appellant has the better position. As Appellant notes, claim 82
requires that each pole is “configured with excitation and detection
functionality to generate an electric field.” Appeal Br. 23 (App. A).
Although Kassab’s electrodes serve both an excitation and detection
function, the Examiner has not established adequately that Rothenberg’s
electrodes also perform both functions. Nor has the Examiner established
adequately that Cox’s electrodes also perform both functions. Thus, in
substituting one arrangement for another, the Examiner’s assertion that
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“each element merely performs the same function as it does separately”
(Ans. 7), is not supported by a preponderance of the evidence.
In addition, given that the Examiner notes that Rothenberg’s detection
of electrical signals generated by the heart differs from Kassab’s detection of
electrical signals generated by a catheter (see Ans. 7), the Examiner does not
provide sufficient evidence or technical explanation as to why one of
ordinary skill in the art would consider the signals to be compatible with
each other. The Examiner’s reasoning, that a person of ordinary skill in the
art would have been motivated to modify Kassab’s elongated body to have a
first pole on the body and a second pole external to a patient to locate a tip
using electrocardiogram data, is therefore not supported by a preponderance
of the evidence. For these reasons, we do not sustain the rejection of claim
82, and claims 83, 84, and 86–89, which depend from claim 82.

Rejections II–IV
Rejections II–IV rely on the same proposed combination of Kassab,
Rothenberg, Cox, and Markowitz, with additional disclosure of Vollkron,
He, or Kondrosky. The Examiner does not rely on the additional disclosure
of Vollkron, He, or Kondrosky in any manner that would remedy the
conclusion set forth in the rejection based on Kassab, Rothenberg, Cox, and
Markowitz. We do not sustain Rejections II–IV for the same reasons set
forth above.
CONCLUSION
The Examiner’s rejections are reversed.
More specifically,
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DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
82–84, 86–89 103 Kassab,
Rothenberg, Cox,
Markowitz
82–84, 86–89
85 103 Kassab,
Rothenberg, Cox,
Markowitz,
Vollkron
85
90, 91, 93–95,
98–102
103 Kassab,
Rothenberg, Cox,
Markowitz, He
90, 91, 93–95,
98–102
92, 96, 97 103 Kassab,
Rothenberg, Cox,
Markowitz, He,
Kondrosky
92, 96, 97
Overall
Outcome:
82–102
REVERSED