Matthew Scholz et al.

Patent Trials and Appeals Board

Aug 4, 2020

11908237 - (D) (P.T.A.B. Aug. 4, 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.
11/908,237 05/19/2008 Matthew T. Scholz 60650US006 1770
32692 7590 08/04/2020
3M INNOVATIVE PROPERTIES COMPANY
PO BOX 33427
ST. PAUL, MN 55133-3427
EXAMINER
YU, HONG
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
08/04/2020 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):
LegalUSDocketing@mmm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MATTHEW T. SCHOLZ, TERRY R. HOBBS, and
DANLI WANG
____________

Appeal 2019-006337
Application 11/908,237
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, TAWEN CHANG, and
MICHAEL A. VALEK, Administrative Patent Judges.

VALEK, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 submits this appeal under 35 U.S.C. § 134(a) involving
claims to methods for delaying the onset of infection within an internal
cavity of a subject. 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(a). Appellant identifies 3M Company and 3M Innovative
Properties Company as the real parties in interest. Appeal Br. 2. Herein, we
refer to the Final Action mailed September 21, 2018 (“Final Act.”);
Appellant’s Appeal Brief filed January 31, 2019 (“Appeal Br.”); and
Examiner’s Answer mailed April 19, 2019 (“Ans.”).
Appeal 2019-006337
Application 11/908,237
2
STATEMENT OF THE CASE
The Specification explains that
[a]lthough certain cavities are typically low in bacteria count
and are classified as infection free, the instillation of
conventional instrumentation, including tubes and catheters,
into these cavities is often accompanied by a large number of
infections or high incidence of elevated bacteria count such as
bacteriuria (that is, a relatively high bacteria count in the urine
with no clinical signs of infection). These infections often
result in a cavity remote from the external opening leading to
the cavity. For example, many bladder infections are believed
to be a result of bacteria introduced from insertion of the
catheter through the meatus and urethra into the bladder. . . .
Infections resulting from urinary catheters have been
responsible for excess mortality as well as morbidity among the
catheterized population and have been the subject of numerous,
and most often at least partly unsuccessful, attempts to control
or prevent same.
Spec. 1–2.
According to the Specification, “[t]he standard practice today
advocated by many advisory groups is to apply povidone iodine solutions
such as are marketed under the name BETADINE to the external meatus.”
Id. at 4. In contrast, “the present invention” involves “contacting at least a
portion of the interior surface of an opening leading to the internal cavity
with an antimicrobial composition; and subsequently . . . inserting an
instrument into the opening.” Id. at 6. According to the Specification,
contacting the internal surface of the urethra is much more
effective than merely contacting the outer surface of the
urethral opening, which is known as the meatus, since the
meatus is typically closed in a normal state and would not allow
antimicrobial solutions to enter and kill the microorganism that
reside on the interior surface. Thus, with conventional therapy
where the microorganisms on the interior surface are not killed
Appeal 2019-006337
Application 11/908,237
3
they remain viable and when an instrument is inserted they are
free to adhere or otherwise move along with the instrument into
cavities that are normally essentially sterile. Even if the
instrument is precoated with an antimicrobial lubricant most of
that lubricant will be wiped off as it is inserted into an
opening, such as a urethra, that seals around an instrument, such
as a catheter.
Id.
Claims 1, 3, 7, 10, 42, 57, 58, and 60–69 are on appeal and can be
found in the Claims Appendix of the Appeal Brief. Claim 1 is illustrative of
the claims on appeal. It reads as follows:
1. A method of delaying the onset of an infection caused by
a microbial organism in an internal cavity of a subject, the
method comprising:
contacting at least a portion of the interior surface of an
opening leading to the internal cavity with an antimicrobial
composition; and subsequently at least partially inserting an
instrument into the opening, wherein the antimicrobial
composition comprises:
an effective amount of an antimicrobial component
comprising an antiseptic present in an amount of at least 0.1
weight percent based on the total weight of the composition;
and
a surfactant component distinct from the antimicrobial
component, wherein the surfactant component is present in an
amount of at least 0.1 wt-% based on the total weight of the
composition, and the surfactant component comprises an
anionic surfactant, zwitterionic surfactant, poloxamer
surfactant, amine oxide surfactant, or combinations thereof;
wherein the opening is a urethra, and the cavity is a
bladder;
wherein a surfactant incorporated into an iodophor is not
considered the surfactant component, but is part of the
antimicrobial component; and
wherein the antimicrobial composition is placed on at
Appeal 2019-006337
Application 11/908,237
4
least 1 cm deep of the interior surface of the opening leading to
the internal cavity.
Appeal Br. 13.
The following rejections are before us for review:
I. Claims 1, 3, 10, 42, 57, 58, 61–63, and 65–69 under 35 U.S.C. § 103
as unpatentable over Dyer2, Surgical Skin Preparation,3 Woodhead,4
Rhodes,5 and Eggimann;6
II. Claims 7 and 64 under 35 U.S.C. § 103 as unpatentable over Dyer,
Surgical Skin Preparation, Woodhead, Rhodes, Eggimann, and
Buckles;7 and
III. Claim 60 under 35 U.S.C. § 103 as unpatentable over Dyer, Surgical
Skin Preparation, Woodhead, Rhodes, Eggimann, Cioanta,8 and
McAnalley.9
Appeal Br. 4.

2 US 5,994,383, issued November 30, 1999 (“Dyer”).
3 “Surgical Skin Preparation and Foley Catherization & Quick Check,”
https://quizlet.com/45137717/surgical-skin-preparation-and-foley-
catherization-quick-check-flash-cards/) (“Surgical Skin Preparation”).
4 K. Woodhead et al., Behaviors and Rituals in the Operating Theatre, 51 J.
of Hospital Infection 241–255 (2002) (“Woodhead”).
5 Melba Rhodes, The ABCs of Infection Control, Infection Control Today,
http://www.infectioncontroltoday.com/articles/2003/05/the-abcs-of-
infection-control.aspx (2003) (“Rhodes”).
6 P. Eggimann et al., Overview of Catheter-related Infections With Special
Emphasis on Prevention Based on Educational Programs, 8 Clin. Microbial
Infect. 295–309 (2002) (“Eggimann”).
7 US 3,817,248, issued June 18, 1974 (“Buckles”).
8 US 6,758,857 B2, issued July 6, 2004 (“Cioanta”).
9 US 5,284,833, issued February 8, 1994 (“McAnalley”).
Appeal 2019-006337
Application 11/908,237
5
Analysis
All of the rejections turn on common issues relating to the teachings
in Dyer, Surgical Skin Preparation, Woodhead, Rhodes, and Eggimann, and
Examiner’s conclusion of obviousness based on the same. See Final Act. 10,
13 (relying on the combination of these references “as applied” to the claims
in Examiner’s first rejection). Accordingly, we consider the rejections
together, focusing on claim 1 as illustrative. The same analysis, discussed
below within the context of claim 1, also applies to the other rejected claims.
The issue before us is whether a preponderance of the evidence supports
Examiner’s conclusion that the method of claim 1 would have been obvious
over the teachings in these references.
Examiner finds Dyer discloses antimicrobial compositions comprising
the ingredients and amounts recited in claim 1 and teaches that such
compositions are useful for preventing infection in the context of indwelling
urinary catheters. Final Act. 5. Examiner acknowledges that Dyer does not
teach:
i) the exact steps of contacting at least a portion of the interior
surface of urethra leading to a bladder, and the external tissue
surrounding the opening with an antimicrobial compound; and
ii) contacting at least a portion of the interior surface of an
opening leading to the internal cavity comprising filling the
urethral passage with the composition; placing the antimicrobial
composition at least 1 cm deep into the urethra.
Id. at 6. Examiner determines “[t]he 1st deficiency is cured” by certain
teachings in Surgical Skin Preparation, Woodhead, Rhodes, and Eggimann
concerning “[s]urgical skin preparation . . . to prepare the operative site . . .
as free as possible from bacteria” and the fact that “normal flora become
pathogens when introduced into normally sterile areas” like the bladder. Id.
Appeal 2019-006337
Application 11/908,237
6
at 6–7. Based on these teachings, Examiner finds that “preparing the
insertion site (at least a portion of the interior surface of urethra leading to a
bladder) and the periphery (the external tissue surrounding the opening)
were well known to a person of ordinary skill in the art at the time of the
invention.” Id. at 8. According to Examiner, “[t]he 2nd deficiency is cured
by the rational[e] that it would have been prima facie obvious at the time of
the invention to a person of ordinary skill in the art [to] come up with the
depth of application of the antimicrobial composition into [the] urethra.” Id.
at 7.
Appellant argues that read “as a whole” the cited references “do not
teach ‘contacting at least a portion of the interior surface of an [urethra]
opening leading to the [bladder] internal cavity with an antimicrobial
composition; and subsequently at least partially inserting an instrument into
the opening [urethra].” See Appeal Br. 6–10 (modifications in original). In
particular, Appellant urges that
even assuming that the Examiner has perfectly characterized
[the cited references] for the proposition that one should keep
insertion surfaces as free as possible from bacteria . . . the
Examiner still has not shown that contacting the interior surface
of the urethra with an antimicrobial composition would be
apparent to a person of ordinary skill in the art.
Id. at 9.
Based on the present record, we determine that Appellant has the
better position. None of the references Examiner cites teach contacting the
“interior surface” of the urethra with an antimicrobial composition prior to
inserting an instrument into the opening, as recited in claim 1. Rhodes and
Eggimann teach that catheter-related infections may be caused by
microorganisms migrating along the catheter into “normally sterile areas
Appeal 2019-006337
Application 11/908,237
7
(like the bladder . . . .” Rhodes, 3; see also Eggimann, 299 (explaining
within the context of central venous catheters that “infection may start with
the colonization of the skin insertion site by microorganisms of the skin flora
that may move [along] the catheter”). Consequently, these and other of the
references Examiner cites explain that “sterile technique” should be
observed when inserting a urinary catheter. Rhodes, 3; Surgical Skin
Preparation, 3. However, what is missing from these references is a
suggestion to apply an antimicrobial composition to the interior surface of
the opening, i.e., the urethra, leading to the bladder.
Examiner’s attempts to fill this gap by citing teachings concerning the
preparation of skin for surgery are unpersuasive. See Final Act. 6–7; Ans.
4–5. The statements Examiner relies upon in Surgical Skin Preparation and
Woodhead describe the application of antiseptic compositions to the skin
around a surgical site to “render[] the area as free as possible from bacteria.”
Surgical Skin Preparation 4; Woodhead 246 (“Gross contamination at the
site of incision should be removed before antiseptic skin preparation.”).
Similarly, Eggimann describes “cleansing and disinfection” of the site where
a central venous catheter is inserted through the skin. Eggimann 302. None
of these references describe the sterilization of skin before insertion of an
instrument into the urethra and bladder, as recited in claim 1.
Even if the cited references could be read more generally to support
the proposition that it would have been obvious to apply an antimicrobial
composition to the skin before inserting a urinary catheter, the record does
not support Examiner’s conclusion that it, therefore, would have been
obvious to apply an antimicrobial composition to the interior surface of the
urethra. Indeed, the cited references describe the application of an
antimicrobial composition to the skin, i.e., the exterior surface of the
Appeal 2019-006337
Application 11/908,237
8
location where the procedure is performed. Thus, the combined teachings of
the references in the rejection are no closer to Appellant’s claims then what
the Specification describes as the prior art, “standard practice” of applying
an antiseptic solution to the “external meatus” before inserting a catheter
into the bladder. Spec. 4. Because Examiner has not sufficiently shown that
it would have been obvious to modify that standard practice by applying an
antimicrobial composition to the interior surface as well, the record does not
support Examiner’s determination that it would have been “prima facie
obvious” to “come up with the depth of application of the antimicrobial
composition into [the] urethra, the amount of the antimicrobial composition,
and the length of time between injection of gel and insertion of catheter”
(Final Act. 7).
For these reasons, the rejection of claim 1 is not supported by a
preponderance of the evidence. Examiner’s rejections of Appellant’s other
claims are deficient for the same reasons. Accordingly, we reverse.

DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3, 10,
42, 57, 58,
61–63,
65–69
103 Dyer, Surgical Skin
Preparation,
Woodhead, Rhodes,
Eggimann
1, 3, 10,
42, 57,
58, 61–
63, 65–69
7, 64 103 Dyer, Surgical Skin
Preparation,
Woodhead, Rhodes,
Eggimann
7, 64
Appeal 2019-006337
Application 11/908,237
9
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
60 103 Dyer, Surgical Skin
Preparation,
Woodhead, Rhodes,
Eggimann
60
Overall
Outcome
1, 3, 7,
10, 42,
47, 57,
58, 60–69

REVERSED