Ex Parte Biewend et al

Board of Patent Appeals and Interferences

Nov 22, 2010

10745201 (B.P.A.I. Nov. 22, 2010)

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.
10/745,201 12/23/2003 Andre Biewend MEDG 64656 1322
29694 7590 11/22/2010
PIETRAGALLO GORDON ALFANO BOSICK & RASPANTI LLP
ONE OXFORD CENTRE, 38TH FLOOR
301 GRANT STREET
PITTSBURGH, PA 15219-6404
EXAMINER
LEWIS, KIM M
ART UNIT PAPER NUMBER
3772
MAIL DATE DELIVERY MODE
11/22/2010 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ANDRE BIEWEND and RONALD E. CAPONI
__________

Appeal 2009-014758
Application 10/745,201
Technology Center 3700
__________

Before TONI R. SCHEINER, ERIC GRIMES, and FRANCISCO C.
PRATS, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to a cover
for, among other things, an arm or leg cast. The Examiner has rejected the

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
Appeal 2009-014758
Application 10/745,201

2
claims as obvious based on the prior art. We have jurisdiction under 35
U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Claims 20-31, 33, and 34 are on appeal. Claims 20 and 31 are
representative and read as follows:
20. An adjustable cover system for a medical device or wound
comprising:
an elongated water resistant flexible bag adjustable to an extended
position and a folded position and having an opening on at least one end
capable of housing at least part of a patient’s appendage and a medical device
or wound in the interior of the flexible bag;
at least one first bag fastening element disposed on a surface of the
flexible bag;
at least one second bag fastening element separate from the first bag
fastening element disposed on a surface of the flexible bag, the second bag
fastening element capable of being releasably reengagable by the first bag
fastening element;
at least one sealing band anchor disposed on an exterior surface of the
flexible bag; and
an elongated water-resistant flexible substantially flat elastic sealing
band having sufficient length to be wrapped around the patient’s appendage
at least once, the sealing band comprising:
at least one substantially flat side having at least one portion
capable of engaging the sealing band anchor, and
a sealing band connector disposed on the substantially flat side
capable of attaching to an area on an opposing side of the sealing band or the
flexible bag to substantially seal the open end of the flexible bag against the
intrusion of moisture.

31. A method of using an adjustable cover for a medical device or
wound comprising:
providing an elongated water resistant flexible bag releasably
readjustable along a length of the flexible bag from an extended position to a
folded position along the length of the bag and having an open end on at least
one end;
Appeal 2009-014758
Application 10/745,201

3
inserting a patient’s appendage through the open end into the flexible
bag;
sealing the open end against the patient’s appendage with an elongated
water-resistant flexible substantially flat elastic sealing band; and
folding a portion of the flexible bag over another portion of the flexible
bag along the length of the flexible bag to adjust the flexible bag from the
extended position to the folded position.

Issues
The Examiner has rejected claims 20-31, 33, and 34 under 35 U.S.C.
§ 103(a) as obvious based on Caponi2 and Liman,3 with evidence provided by
Fasline,4 Jackson,5 Bauer,6 McRoberts,7 Nunes,8 and Gerhard9 (Answer 4).
The Examiner finds that Caponi discloses a protective cover for a cast that
includes all of the limitations of the claims on appeal except for “a first
fastening element . . . and a second fastening element . . . engageable with
first fastening element to adjust the length of the flexible bag from an
extended position to a folded position” (id. at 5).
The Examiner finds that Liman discloses “a length adjustable
(foldable) protective cover” for a cast that includes a fastener to decrease its
length (id.) and cites Fasline, Jackson, Bauer, McRoberts, Nunes, and
Gerhard as evidence that “it has been well established that adhesive/glue is a
common substitute for hook and loop material, and vice versa” (id.). The

2 Caponi, US 4,986,265, Jan. 22, 1991
3 Liman, US 3,741,203, June 26, 1973
4 Fasline et al., US 4,732,146, Mar. 22, 1988
5 Jackson, US 5,611,735, Mar. 18, 1997
6 Bauer, US 5,688,229, Nov. 18, 1997
7 McRoberts et al., US 5,807,299, Sept. 15, 1998
8 Nunes et al., US 5,833,639, Nov. 10, 1998
9 Gerhard, US 5,843,008, Dec. 1, 1998
Appeal 2009-014758
Application 10/745,201

4
Examiner concludes that it would have been obvious to modify Caponi’s
device to be length-adjustable, as taught by Liman, and to substitute a hook-
and-loop fastening system for the adhesive strip taught by Liman (id. at 6).
Appellants contend that adhesives and hook-and-loop fasteners are not
equivalents (Appeal Br. 5-6) and that they have provided secondary evidence
of “commercial success of the invention, and unsolved needs addressed by
the invention” that rebuts the Examiner’s rejection (id. at 6).
The issues presented in this appeal are:
Does the evidence of record support the Examiner’s conclusion that it
would have been obvious to modify Caponi’s cast cover to include a hook-
and-loop fastener system to adjust its length? and, if so,
Have Appellants provided evidence of unobviousness that, when
weighed with the evidence supporting the Examiner’s rejection, shows that
the claimed invention would not have been obvious?
Findings of Fact
1. The Examiner finds that Caponi discloses a protective cover for a
cast that includes all of the limitations of claims 20 and 31 except for “a first
fastening element . . . and a second fastening element . . . engageable with
first fastening element to adjust the length of the flexible bag from an
extended position to a folded position” (Answer 5). Appellants do not
dispute this finding.
2. Liman discloses a protective cover for a cast that includes “a means
whereby the closed end of the covering may be adjustably shortened so that
the covering can accommodate different lengths of limbs” (Liman, col. 3, ll.
54-57).
Appeal 2009-014758
Application 10/745,201

5
3. Liman discloses that the “means for shortening the covering
includes an adhesive strip mounted on a surface of the covering adjacent the
bottom end. The exposed adhesive face may be secured to a portion of the
protective covering distant from the bottom end with the surplus length of the
covering folded over and thus the effective length of the covering is
shortened.” (Id. at col. 3, ll. 57-63.)
4. Fasline discloses a wound dressing retention apparatus that includes
straps affixed to a framework (Fasline, col. 2, l. to col. 3, l. 24).
5. Fasline discloses that “[a]ny number of releasable fasteners may be
employed to secure [the straps to the framework], including snaps, buttons or
releasable adhesives; however, it has been found to be most desirable to use a
suitable hook and loop fastener” (id. at col. 3, ll. 31-35).
Principles of Law
“If a person of ordinary skill can implement a predictable variation [of
a known work], § 103 likely bars its patentability.” KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 417 (2007).
“When there is a design need or market pressure to solve a problem
and there are a finite number of identified, predictable solutions, a person of
ordinary skill has good reason to pursue the known options within his or her
technical grasp. If this leads to the anticipated success, it is likely the product
not of innovation but of ordinary skill and common sense.” Id. at 421.
Analysis
Caponi discloses a protective cover for a cast that meets the limitations
of claims 20 and 31 except that it does not include a two-element fastening
Appeal 2009-014758
Application 10/745,201

6
system to adjust its length (claim 20), or that is “releasably readjustable”
from an extended to a folded position (claim 31). Liman discloses that a
protective cover for a cast that includes a means for adjusting its length can
accommodate different lengths of limbs. Liman specifically discloses using
an adhesive strip as the means for shortening, but Fasline provides evidence
that releasable adhesives and hook-and-loop fasteners are both known types
of releasable fasteners. In view of these disclosures, we agree with the
Examiner that it would have been obvious to modify Caponi’s cast cover to
include a two-element, readjustable hook-and-loop fastener system to allow
its length to be adjusted in order to accommodate different lengths of limbs.
Appellants argue that, of the references that the Examiner cited as
showing interchangeability of adhesives and hook-and-loop fasteners, “none
of these patents address a situation where a fastener is exposed to water and
must be capable of being releasably reengagable” (Appeal Br. 5). Appellants
also argue that “it is not a simple substitution to apply a fastener such as a
hook and loop combination or a button to these protective covers” and that it
was only “[a]fter much development and expense [that] a heat weld process
was developed for attaching the fasteners, namely hook and loop material, to
the bag” (id. at 6).
These arguments are not persuasive. The Examiner has provided
evidence showing that hook-and-loop fasteners were recognized as releasable
fasteners conventionally used in medical devices, among other things.
Appellants’ arguments – that hook-and-loop fasteners would not be used
where they would be exposed to water, and that adding a hook-and-loop
Appeal 2009-014758
Application 10/745,201

7
fastener to Caponi’s device required more than routine experimentation – are
unsupported by evidence and therefore unpersuasive.
Appellants also argue that Caponi and Liman do not suggest a device
that includes a “releasably reengagable” fastening system because Caponi’s
device does not include a fastening system and Liman’s device includes an
adhesive fastening system (Reply Br. 3-7). This argument, however, ignores
the Examiner’s evidence showing that those skilled in the art recognized
hook-and-loop fasteners as conventional fastening systems. As such,
substituting a hook-and-loop fastener for Liman’s adhesive is simply the use
of a known element for its known purpose and therefore obvious. See KSR,
550 U.S. at 416 (“The combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predictable
results.”).
Finally, Appellants argue that they have presented evidence of
secondary considerations that overcomes any prima facie case of obviousness
(Appeal Br. 6). Appellants rely on declarations submitted under 37 C.F.R.
§ 1.132 by Ron Hudenich (signed Jan. 29, 2008) and Andre Biewend (signed
Jan. 18, 2008).
Both Dr. Hudenich and Mr. Biewend declared: “In my considered
opinion, the first and second fastening elements, e.g. a hook and loop
material, as recited in claims 1 and 20 of the captioned application is not an
obvious substitution of for [sic] the adhesive shown in U.S. Patent No.
3,741,203 to Liman” (Hudenich Declaration, ¶ 4; Biewend Declaration, ¶ 9
(second occurrence)).
Appeal 2009-014758
Application 10/745,201

8
Neither Dr. Hudenich nor Mr. Biewend, however, provided any
evidence or reasoned explanation why such a substitution would not have
been obvious to a hypothetical person of ordinary skill in the art. Their
unsupported opinions therefore do not persuade us that the claimed invention
would not have been obvious under 35 U.S.C. § 103(a).
Mr. Biewend declared that sales of BathGuard products, which are
“covered by the captioned patent application” (Biewend Declaration, ¶ 3),
“have more than doubled since we incorporated the invention as claimed” (id.
at ¶ 4) and “have increased in market share since we introduced product
according to the present invention” (id. at ¶ 5). These statements, however,
do not show any nexus between the claimed invention and the commercial
success of BathGuard products. See In re Huang, 100 F.3d 135, 140 (Fed.
Cir. 1996) (Commercial success “is relevant in the obviousness context only
if there is proof that the sales were a direct result of the unique characteristics
of the claimed invention – as opposed to other economic and commercial
factors unrelated to the quality of the patented subject matter. . . . In other
words, a nexus is required between the sales and the merits of the claimed
invention.”).
Mr. Biewend declared that “[a]mong other reasons customers prefer
our product because it is easily applied by a patient without assistance, it can
be reused and it is easily adjustable” (Biewend Declaration, ¶ 7). Mr.
Biewend also declared that the “ability to reuse the products and the
adjustability of the products allows [sic] inventories to be keep [sic] low
compared to competing products . . . . Resellers of BATHGuard products
appreciate the need to stock lower levels [of] product.” (Id. at ¶ 8.)
Appeal 2009-014758
Application 10/745,201

9
These statements fail to provide the required nexus between the
characteristics of the claimed invention and the commercial success of
BathGuard products. Mr. Biewend does not provide any evidence to support
his statements regarding the motivation of customers or resellers who buy
BathGuard products. Mr. Biewend’s unsupported statements regarding the
reasons that people prefer BathGuard products over competing products are
not adequate to establish that the commercial success of BathGuard products
is based on the characteristics of the claimed invention rather than unrelated
factors, such as a superior advertising campaign. See Huang, 100 F.3d at 140
(“[T]he inventor’s opinion as to the purchaser’s reason for buying the product
. . . is insufficient. Instead, the applicant must submit some factual evidence
that demonstrates the nexus between the sales and the claimed invention – for
example, an affidavit from the purchaser explaining that the product was
purchased due to the claimed features.”).
Conclusions of Law
The evidence of record supports the Examiner’s conclusion that it
would have been obvious to modify Caponi’s cast cover to include a hook-
and-loop fastener system to adjust its length. Appellants have not provided
evidence of unobviousness that, when weighed with the evidence supporting
the Examiner’s rejection, shows that the claimed invention would not have
been obvious.
SUMMARY
We affirm the rejection of claims 20 and 31 under 35 U.S.C. § 103(a)
as obvious based on Caponi and Liman, with evidence provided by Fasline,
Appeal 2009-014758
Application 10/745,201

10
Jackson, Bauer, McRoberts, Nunes, and Gerhard. Claims 21-30, 33, and 34
fall with claims 20 and 31 because they were not argued separately. 37
C.F.R. § 41.37(c)(1)(vii).
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

lp

PIETRAGALLO GORDON ALFANO BOSICK & RASPANTI LLP
ONE OXFORD CENTRE, 38TH FLOOR
301 GRANT STREET
PITTSBURGH PA 15219-6404