C.R. BARD, INC.

Patent Trials and Appeals Board

Sep 2, 2020

2020001051 (P.T.A.B. Sep. 2, 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.
15/479,833 04/05/2017 Paul Anthony Zani 249492WOUS02_492605-67 3987
120023 7590 09/02/2020
Dorsey & Whitney / BECTON, DICKINSON & CO
111 South Main Street
21st Floor
Salt Lake City, UT 84111-2176
EXAMINER
PERREAULT, ANDREW D
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
09/02/2020 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
ip.docketing.slc@dorsey.com
ip.patent.sl@dorsey.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte PAUL ANTHONY ZANI, JOHN CHRISTIAN GOHDE,
ALLAN JON CETRONE, and URIYAH DUCHUN ROBINSON

Appeal 2020-001051
Application 15/479,833
Technology Center 3700
____________

Before MICHAEL C. ASTORINO, NINA L. MEDLOCK, and
TARA L. HUTCHINGS, Administrative Patent Judges.

ASTORINO, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the
Examiner’s decision to reject claims 1, 2, 5, 7, 9–11, and 24–27.2 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. The Appellant identifies the real party in interest as
C.R. Bard, Inc. Appeal Br. 4.
2 Claims 12–23 are withdrawn. Appeal Br. 4. Claims 3, 4, 6, and 8 are
cancelled. Id. at 29–30.
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Application 15/479,833

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STATEMENT OF THE CASE
Claimed Subject Matter
Claims 1 and 11 are the independent claims on appeal. Claim 1,
reproduced below, is illustrative of the claimed subject matter.
1. A patient care protocol package configured to
improve performance and standardization of one or more
catheter pre-insertion and/or post-insertion patient care
protocols, the patient care protocol package comprising:
a container;
one or more wipes disposed in the container, the one or
more wipes for use in performing the one or more catheter pre-
insertion and/or post-insertion patient care protocols; and
at least one labeling provided on the container, the at
least one labeling including:
a first labeling configured to improve performance
and standardization of the one or more catheter pre-
insertion and/or post-insertion patient care protocols, the
first labeling including a first column and a second
column, each of the first and second columns including at
least one picture;
wherein the first column of the first labeling
facilitates correct usage of the one or more wipes and
facilitates correct performance of the one or more
catheter pre-insertion and/or post-insertion patient care
protocols with regards to female anatomy;
wherein the second column of the first labeling
facilitates correct usage of the one or more wipes and
facilitates correct performance of the one or more
catheter pre-insertion and/or post-insertion patient care
protocols with regards to male anatomy;
a second labeling spaced from the first labeling
that includes substantially only words; and
at least one token disposed in or on the container, the at
least one token configured to be removed from the container,
wherein the at least one token at least one of performs, verifies,
or assists with the one or more catheter pre-insertion and/or
post-insertion patient care protocols.
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Rejections
Claims 24 and 25 are rejected under 35 U.S.C. § 112(a) as failing to
comply with the written description requirement.
Claims 1, 2, 5, 7, 9–11, and 24–27 are rejected under 35 U.S.C. § 103
as unpatentable over Morelli et al. (US 2010/0274205 A1, pub. Oct. 28,
2010) (“Morelli”) in view of Monroe (US 2009/0128330 A1, pub. May 21,
2009).
Claims 1, 2, 5, 7, 9–11, and 24–27 are rejected under 35 U.S.C. § 103
as unpatentable over Morelli in view of Mazel et al. (US 2001/0044427 A1,
pub. Nov. 22, 2001) (“Mazel”).

ANALYSIS
Written Description
The Examiner finds that claim 24, which recites, “[t]he patient care
protocol package of claim 1, wherein the container includes only the one or
more wipes disposed therein,” fails to comply with the written description
requirement. Final Act. 5. The Examiner explains that claim 24 requires the
container to include “only wipes,” yet the Specification fails to limit the
contents of the container to be only wipes. See id.; Ans. 8. Additionally, the
Examiner finds that the container may include syringes and gloves. Final
Act. 5.
The Appellant argues that the subject matter of claim 24 is adequately
supported by the original Specification. Appeal Br. 12–13; Reply Br. 4–5.
The Appellant points out that the Specification discloses wipes and gloves as
alternative elements that can be included the container. Id. (citing Spec.
¶¶ 44, 52). And, as alternative elements, only wipes disposed in the
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container may be claimed. Id. (Manual of Patent Examining Procedure
(“MPEP”) § 2173.05(i), Negative Limitations (9th ed., rev. 10.2019, last rev.
June 2020) (“[i]f alternative elements are positively recited in the
specification, they may be explicitly excluded in the claims.”). We agree
with the Appellant’s argument.

Obviousness
Independent claim 1 recites “one or more wipes disposed in the
container, the one or more wipes for use in performing the one or more
catheter pre-insertion and/or post-insertion patient care protocols.” Appeal
Br., Claims App. Similarly, independent claim 11 recites, “one or more
wipes disposed in the container, the one or more wipes for use in performing
the one or more catheter post-insertion patient care protocols.” Id.
For the rejections of claims 1 and 11, as unpatentable over Morelli in
view of Monroe and Morelli in view of Mazel, the Examiner finds that
Morelli’s protective barrier wipe 16 corresponds to the claimed “one or more
wipes.” Final Act. 6, 7, 9; see Morelli ¶ 19. The Examiner finds that
Morelli describes “wiping the healthy skin with the barrier wipe” and that
protective barrier wipe 16 is “fully capable of performing some protocol
related to catheter insertion such as but not limited to wiping skin either
before or after catheter insertion.” Ans. 9; see Morelli ¶ 32.
The Appellant argues that the Examiner’s finding lacks adequate
support because the Examiner fails to explain on the record how Morelli’s
protective barrier wipe 16 is “capable of ‘performing the one or more
catheter pre-insertion and/or post-insertion patient care protocols,’ as recited
in independent claim 1.” Appeal Br. 14–15; see Reply Br. 6. The Appellant
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points out that Morelli’s protective barrier wipe 16 is a specific type of wipe,
namely a wipe that creates a protective barrier. See Appeal Br. 14–15 (citing
Morelli ¶ 32). The Appellant contends that “the Examiner did not
demonstrate how the barrier formed by the barrier wipe affects a catheter,
perineal region of an individual, the odds of developing a catheter-associated
urinary tract infection, etc.” Id. at 15. The Appellant’s argument is
persuasive.
As discussed above, the Examiner finds that Morelli’s protective
barrier wipe 16 corresponds to “one or more wipes” as recited in claims 1
and 11. For this finding to be adequately supported, the Examiner needs to
explain how Morelli’s protective barrier wipe 16 is able to perform at least
one catheter pre-insertion and/or post-insertion patient care protocol. The
Examiner may do so by either: identifying a catheter pre-insertion and/or
post-insertion patient care protocol and explaining how Morelli has the
ability of performing it; or explaining how Morelli’s wipe is the same type
of wipe as described in the Appellant’s Specification.
The Examiner does not identify a catheter pre-insertion and/or post-
insertion patient care protocol that Morelli’s protective barrier wipe 16 has
the ability of performing. Some examples of the one or more catheter pre-
insertion and/or post-insertion patient care protocols are identified in the
Specification. For instance, “[i]n some embodiments, the post-insertion
patient care protocol may require that five different portions of the patient’s
periurethral region, the patient’s perineal region, and the drainage bag
system 100 be washed using, for example, non-antiseptic wipes.” Spec.
¶ 52. The Specification also instructs that the wipes “may be used to clean
the genitalia of the male (e.g., wipe the foreskin and the meatus, foreskin,
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the periphery thereabout) and/or female (wipe the meatus),” “may be use[d]
to clean the inner thigh of the patient,” and may be “used to clean a portion
of the catheter 114.” Id. ¶ 53, Figs. 1C, 1D. The Examiner does not
adequately explain –– using evidence or technical reasoning –– how
Morelli’s protective barrier wipe 16 has the ability of performing any of
these protocols. Additionally, there is no support in the record for the
assumption that wiping the healthy skin with a protective barrier wipe 16
corresponds to a catheter pre-insertion and/or post-insertion patient care
protocol.
The Examiner also does not show that Morelli’s wipe is the same type
of wipe as described in the Appellant’s Specification. In this regard, we note
that the Specification provides “[a]n example of wipes that may be included
in the package 124 include Provon® products available from GOJO.com.”
Id. ¶ 53. Morelli describes that “protective barrier wipe 16 can be item
number MSC 1505, Sureprep® No-Sting, manufactured by Medline
Industries, Inc. (Mundelein, Ill.)” Morelli ¶ 19. Moreover, Morelli appears
to distinguish protective barrier wipe 16 from “[o]ther wound and skin
preparation materials,” for example, “wound cleansers, such as hydrogen
peroxide and saline.” Id. Accordingly, the example product described in the
Specification appears to be a different type of product than the example
protective barrier wipe product described in Morelli.
In view of the foregoing, we determine that the Examiner’s finding
Morelli’s protective barrier wipe 16 corresponds to “one or more wipes
disposed in the container, the one or more wipes for use in performing the
one or more catheter pre-insertion and/or post-insertion patient care
protocols,” as recited in claim 1, as well as the similar recitation of claim 11,
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lacks adequate support. Further, we note that the Examiner fails to rely on
Monroe or Mazel in any manner that would remedy the deficiency in the
Examiner’s finding as discussed above. Thus, we do not sustain the
Examiner’s rejections of independent claims 1 and 11, and the claims that
depend therefrom, as unpatentable Morelli in view of Monroe or Mazel.

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § References/Basis  Affirmed Reversed
24, 25 112(a) Written Description

24, 25
1, 2, 5, 7,
9–11,
24–27
103 Morelli, Monroe 1, 2, 5, 7,
9–11,
24–27
1, 2, 5, 7,
9–11,
24–27
103 Morelli, Mazel 1, 2, 5, 7,
9–11,
24–27
Overall
Outcome
1, 2, 5, 7,
9–11,
24–27

REVERSED