C.R. Bard, Inc.

Patent Trials and Appeals Board

Jun 11, 2021

2020003622 (P.T.A.B. Jun. 11, 2021)

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.
15/434,900 02/16/2017 Robert M. Hine BMD01-MN013 6005
159553 7590 06/11/2021
Dorton & Willis LLP c/o BD
10260 Alliance Road
Suite 210
Cincinnati, OH 45242
EXAMINER
HOPKINS, BRANDI N
ART UNIT PAPER NUMBER
2855
NOTIFICATION DATE DELIVERY MODE
06/11/2021 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
uspto@dortonwillis.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ROBERT M. HINE

Appeal 2020-003622
Application 15/434,900
Technology Center 2800
____________

Before KAREN M. HASTINGS, MICHAEL P. COLAIANNI, and
MERRELL C. CASHION, JR., Administrative Patent Judges.

COLAIANNI, Administrative Patent Judge.

DECISION ON APPEAL

Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–20, 32, and 33. We have jurisdiction
under 35 U.S.C. § 6(b).
We REVERSE.

1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant
identifies the real party in interest as Becton, Dickinson and Company.
Appeal Br. 3.
Appeal 2020-003622
Application 15/434,900

2
Appellant’s invention is directed to a system and method to determine
and compare insertion and withdrawal forces of various devices that may
include, without limitation, medical devices (Spec. ¶ 1; Claims 1 & 10).
Claims 1 and 10 are representative of the subject matter on appeal:
1. A force measuring system comprising:
a tortuous conduit having a predetermined path
operatively coupled to a transducer; and,
a computer communicatively coupled to the transducer,
the computer programmed to utilize signals output from the
transducer to calculate forces acting on the transducer, the
computer programmed to support a graphical user interface for
displaying the calculated forces

10. A process for comparing at least one of insertion and
withdrawal forces associated with at least two devices, the
process comprising:
inserting a first device into a tortuous conduit having a
predetermined path; recording insertion data indicative of
insertion forces applied by the first device traveling in a first
direction in the tortuous conduit;
withdrawing the first device from the tortuous conduit;
recording withdrawal data indicative of withdrawal forces
applied by the first device traveling in a second direction in the
tortuous conduit, where the second direction is generally
opposite the first direction;
repeating the foregoing steps by replacing the first device
with a second device; and,
comparing the insertion data and withdrawal data between
at least the first and second devices.

Appellant appeals the following rejection:
Claims 1–20, 32, and 33 are rejected under 35 U.S.C. § 103 as
unpatentable over Wallace (US 8,052,621 B2; Nov. 8, 2011) in view of
Zoarski (Gregg H. Zoarski et al., Performance Characteristics of
Appeal 2020-003622
Application 15/434,900

3
Microcatherter Systems in a Standardized Tortuous Pathway, 19 AJNR Am.
J. Neuroradiol, 1571–1576 (1998)).

FINDINGS OF FACT & ANALYSIS
The Examiner’s findings and conclusions regarding Wallace and
Zoarski with respect to claims 1 and 10 are located on pages 5–6, and 7 of
the Final Action. With regard to system claim 1, the Examiner finds that
Wallace teaches a force measuring system that includes conduit 4 (i.e., guide
instrument), which may be bent (Final Act. 5). The Examiner finds Wallace
does not explicitly disclose a tortuous conduit (Final Act. 5). The Examiner
construes “tortuous conduit” as meaning “a tube that is flexible.” (Ans. 4).
The Examiner finds Zoarski teaches a tortuous conduit (Final Act. 5). The
Examiner concludes that it would have been obvious to modify Wallace to
include a tortuous conduit, as taught by Zoarski, for the benefit of providing
a device to achieve a smooth and predictable advancement, which can
facilitate simulation of a circulation path for a catheter (Final Act. 5–6).
The Examiner explains that Wallace discloses a flexible tube (i.e.,
catheter 6 or 30) having a predetermined path directed by guide instrument 4
(Ans. 5). The Examiner interprets Wallace’s guide instrument 4 as a device
that directs or has an influence on the course of action or show or indicate
the way to (Ans. 5). The Examiner finds that, although Wallace does not use
the term “tortuous conduit,” Wallace states that guide instrument 4 along
with the catheter 30 is flexible and capable of bending (Ans. 5). The
Examiner finds that Zoarski would have motivated a person of ordinary skill
in the art to form the catheter as a tortuous conduit to facilitate simulation of
a circulation path for catheters as suggested by Zoarski (Ans. 6).
Appeal 2020-003622
Application 15/434,900

4
Appellant argues Wallace and Zoarski fail to teach a tortuous conduit
having a predetermined path operatively coupled to a transducer (Appeal Br.
26). Appellant argues Wallace teaches a catheter moving within a conduit
that is operatively coupled to a force sensor (Appeal Br. 26). Appellant
contends that the catheter itself cannot be considered a tortuous conduit
within the meaning of the claim because the catheter is not operatively
coupled to a transducer and comprises a tortuous predetermined path
(Appeal Br. 26). Appellant contends that each catheter in Wallace and
Zoarski are resilient and do not have a predetermined path (Appeal Br. 26).
We begin our analysis by construing “tortuous conduit.” Although
Appellant uses the phrase throughout the Specification, Appellant does not
provide a formal definition of tortuous conduit (Spec. generally). Appellant
describes, however, test conduit 240 in Figure 2 as a tortuous, hollow
pathway that may be shaped to replicate or resemble a patient body channel
(Spec. ¶ 24). Test conduit 240 in Figure 2 is shown as a curved, tubular
structure having three bends in the tube. The Examiner cites Merriam-
Webster’s Dictionary for the definition of “tortuous” as “marked by repeated
twists, bends or turns.” (Ans. 4). Appellant does not dispute this definition
(Reply Br. generally). We construe tortuous conduit as a conduit having at
least two bends or twists (i.e., repeated bends or twists).
The claim further requires that the tortuous conduit having a
predetermined path that is operatively coupled to a transducer. Merriam-
Webster Dictionary defines “predetermine” as “to determine beforehand.”2
Accordingly, a “predetermined path” is one that is set beforehand.

2 https://www.merriam-webster.com/dictionary/predetermine last accessed June 4, 2021.
Appeal 2020-003622
Application 15/434,900

5
Therefore a “tortuous conduit having a predetermined path” is a conduit
having at least two bends or twists with a path determined beforehand.
With this proper claim construction in mind, we agree with Appellant
that the Examiner has not shown where Wallace and Zoarski teaches a
conduit having at least two bends that is set beforehand. The Examiner’s
construction of tortuous conduit as including a flexible tube is unreasonably
broad in that it fails to account for the disclosure in the Specification and the
plain meaning of tortuous that includes multiple bends or turns. The
Examiner finds that Wallace teaches the conduit (i.e., guide instrument) 4 is
bent (Final Act. 5). Although the Examiner finds that Wallace does not
teach a tortuous conduit, the Examiner appears to find that Wallace’s
bendable catheters constitute a tortuous conduit (Final Act. 5; Ans. 5).
Wallace may teach that the working lumen may be bent, but a single bend in
the lumen is not sufficient to constitute a tortuous conduit as that phrase is
properly construed (Wallace, col. 7, ll. 15–27; Fig. 1a).
The Examiner relies on Zoarski to teach using a tortuous conduit
(Final Act. 5). Zoarski teaches using a tortuous conduit in an experimental
setting to determine load forces required to propel hydrophilically coated
microcatheters through a standardized tortuous pathway constructed of
polytetrafluoroethylene tubing that models the intracranial vascular system
(Zoarski 1571). Zoarski’s tube is used as a model to test microcatheters.
Although Zoarksi’s tubing has multiple bends so as to constitute a tortuous
conduit when the tubing is affixed in a holding device, Appellant
persuasively argues that substituting Zoarski’s tortuous conduit for
Wallace’s guide instrument 4 would have led to attempting to maneuver the
fixed tortuous shape through a complicated bodily conduit (Reply Br. 9).
Appeal 2020-003622
Application 15/434,900

6
We agree. Wallace uses a flexible catheter and guide instrument 4 to
maneuver the working catheter 6, 30 into a body lumen (col. 2, ll. 13-16).
The Examiner’s apparent proposal to substitute Zoarski’s fixed, tortuous
conduit for Wallace’s flexibly movable guide instrument 4 would have
frustrated Wallace’s purpose by making the insertion of Wallace’s catheter
into a body lumen more difficult (Final Act. 5–6; Ans. 6). In essence,
Wallace’s guide instrument 4 or catheter 6, 30 would have been made into a
tortuous structure based primarily on hindsight. The Examiner does not
provide a meaningful reason why a person of ordinary skill in the art would
have modified Wallace’s catheter to include a fixed, tortuous conduit as the
guide instrument.
Thus, on this record, we reverse the Examiner’s § 103 rejection of
claims 1–20, 32, and 33 over Wallace and Zoarski.

DECISION
In summary:

Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–20, 32, 33 103 Wallace, Zoarski 1–20, 32,
33

REVERSED