Ex Parte Stapf et al

Board of Patent Appeals and Interferences

Aug 4, 2009

10308681 (B.P.A.I. Aug. 4, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte DONALD STAPF,
SCOTT D. AUGUSTINE, and KEITH J. LELAND
__________

Appeal 2009-004903
Application 10/308,681
Technology Center 3700
__________

Decided:1 August 4, 2009
__________

Before LORA M. GREEN, RICHARD M. LEBOVITZ, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
medical device. The Patent Examiner rejected some claims as anticipated
and others as obvious. We have jurisdiction under 35 U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).
Appeal 2009-004903
Application 10/308,681

We affirm-in-part.

STATEMENT OF THE CASE
The invention is said to be “well suited to treating tissue on the hand
or a foot of a patient.” (Spec. 2:6-7.)2 “The invention is a non-contact tissue
treatment device having a cover formed as a bag, sac, or pouch, one or more
flexible attachment portions, and a support member supporting a portion of
the cover off of and out of contact with tissue to be treated.” (Id. at 2:10-
12.) Claims 21-24, 32, 35, 36, 42-48, 50, 55-57, and 59 are on appeal.3
Claims 21, 24, 28, 35, 42, 46, and 59 are representative or separately argued
and read as follows:
21. A tissue treatment device, comprising:
a bag-like cover with an open end;
an absorbent support member for being positioned within the cover to
support a portion of the cover out of contact with tissue to be treated;
and
means for attaching the cover to a patient’s extremity.

24. The tissue treatment device of claim 22, wherein the one or more
attachment portions each includes an adhesive material.

28. The tissue treatment device of claim 22, wherein the one or more
attachment portions each comprises a layer of foam material with an
adhesive material carried on a surface of the layer of foam material.

35. The tissue treatment device of claim 21, wherein the absorbent
support member includes an opening for enclosing tissue to be treated.

2 Page and line numbering according to the Preliminary Amendment filed
Dec. 2, 2002.
3 Claims 21-62 are pending. (App. Br. 2.) The Examiner objected to claims
25-31, 33, 34, 37-41, 49, 51-54, and 60-62. (Ans. 9.)
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42. The tissue treatment device of claim 21, wherein the cover is formed
from a single sheet of flexible material.

46. A tissue treatment device, comprising:
a bag-like cover with an open end;
an absorbent support member with an opening for enclosing tissue to
be treated, the support member positionable within the cover for
supporting a portion of the cover out of contact with the tissue to be
treated; and
one or more attachment portions disposed along the open end for
attaching the cover to an extremity of a person.

59. A method for treating tissue on a patient’s extremity with a tissue
treatment device, the tissue treatment device including:
a bag-like cover with an open end;
an absorbent support member for being positioned within
the cover for supporting a portion of the cover out of
contact with the tissue to be treated; and
one or more attachment portions disposed along the open
end;
the method comprising:
opening the open end of the cover;
placing the tissue treatment device over the patient’s extremity;
positioning the absorbent support member proximate the tissue to be
treated; and attaching the tissue treatment device to the patient’s
extremity.

The Examiner rejected the claims as follows:
• claims 21-23, 32, 35, 36, 43, 45-48, 50, 57, and 59 under 35 U.S.C.
§ 102(b) as anticipated by Baxter;4
• claims 24 and 55 under 35 U.S.C. § 103(a) as obvious over Baxter
in view of Kelly;5 and

4 U.S. Patent No. 4,178,924, issued to Samuel H. Baxter, Dec. 18, 1979.
5 U.S. Patent No. 5,407,419, issued to Joseph L. Kelly et al., Apr. 18, 1995.
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• claims 42, 44, 56, and 58 under 35 U.S.C. § 103(a) as obvious over
Baxter.

ANTICIPATION
The Anticipation Issues
A. Claim 21
The Examiner’s position is that Baxter’s cast protector has all the
structural elements in Appellants’ claims, and that Baxter’s device is a
“tissue treatment device” because it maintains a dry environment around the
broken limb. (Ans. 5-6.) According to the Examiner, Baxter’s device draws
moisture away from exposed tissue via absorbent bands and holes, “and thus
prevents bacteria and fungus from causing infections.” (Ans. 9.)
Appellants contend that (i) Baxter’s device is not a tissue treatment
device; (ii) Baxter’s outer tubular member 20 encloses an inner tubular
member, not tissue; and (iii) the function of Baxter’s absorbent band is to
keep tubular member 20 spaced outwardly of tubular member 18, not to
keep it out of contact with tissue. (App. Br. 5.)6
The issues with respect to the rejection of claim 21 are:
did Baxter disclose a tissue treatment device;
does claim 21’s absorbent support member perform a tissue enclosing
function that Baxter’s absorbent band does not;
does claim 21 require that the absorbent support member function to
separate a portion of the cover from tissue to be treated?

6 Citations are to “Applicants’ Corrected Supplemental Brief On Appeal,”
dated Nov. 21, 2007.
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B. Claims 35, 36 and 46
The Examiner found that Baxter’s absorbent band 28 had an opening
to receive and enclose the extremity of a user, meeting the claim limitation
“an opening for enclosing a tissue to be treated.” (Ans. 6.)
Appellants contend that Baxter’s “encircling bands 28 encircle an
inner tubular member, not tissue to be treated.” (App. Br. 9.) According to
Appellants, the Examiner’s finding cannot be supported without extrinsic
evidence “to establish that the encircling rings are inherently capable of
‘enclosing tissue to be treated.’” (Id.)
The issue for this rejection is whether Baxter’s band 28 had “an
opening for enclosing a tissue to be treated.”

C. Claim 59
Claim 59 is a method of treating tissue and comprises a step
“positioning the absorbent support member proximate the tissue to be
treated.” The Examiner found that Baxter inherently taught the method of
claim 59. (Ans. 6.) Appellants argue that Baxter’s absorbent bands
“encircle the inner tubular member; they are not positioned ‘proximate tissue
to be treated.’” (App. Br. 10.)
The issue for this rejection is whether the evidence supports the
Examiner’s finding that Baxter inherently taught positioning the absorbent
band proximate tissue to be treated.

Findings of Fact
Baxter
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1. Baxter disclosed an “elongated tubular protective cover for a cast
enclosed body limb.” (Abstract.)
2. Baxter’s cover 16 had inner and outer members 18 and 20. (Col. 2, ll.
33-35.)
3. Outer members 18 and 20 had open ends. (Figs. 1 and 2.)
4. Spacing band 28 was secured to the outer surface of the tubular
member 18 by adhesive. (Col. 2, ll. 48-59.)
5. Baxter disclosed that “any body moisture developing within the inner
tubular member 18 is at least to some degree purged therefrom and
absorbed by the absorbent bands 28, 32 and 34.” (Col. 3, ll. 50-53.)
6. Baxter’s cover had an elongated flexible strip 40 that attached the
cover to a patient’s extremity. (Col. 3, ll. 30-38.)
7. The Examiner found that because “the protector keeps fluid from
penetrating the cast covering the broken limb, the protector is treating
the limb by maintaining a dry broken limb (tissue) and cast
environment.” (Ans. 5-6.)
8. Baxter’s outer member 20 is “a portion of the cover out of contact
with tissue to be treated.” (Figs. 1 and 2.)

Principles of Law Relating to Anticipation
To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or
inherently. Anticipation is an issue of fact, and the question of
whether a claim limitation is inherent in a prior art reference is
a factual issue.

In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (citations omitted).
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“The preamble of a claim does not limit the scope of the claim when it
merely states a purpose or intended use of the invention. . . . [R]eview of a
patent in its entirety should be made to determine whether the inventors
intended such language to represent an additional structural limitation or
mere introductory language.” In re Paulsen, 30 F.3d 1475, 1479 (Fed. Cir.
1994). “[W]hile it is true that claims are to be interpreted in light of the
specification . . . , it does not follow that limitations from the specification
may be read into the claims. . . . It is the claims that measure the invention.”
Sjolund v. Musland, 847 F.2d 1573, 1581-82 (Fed. Cir. 1988) (emphasis in
original, citation omitted).

Analysis of the Anticipation Issues
A. Claim 21
Claim 21’s preamble recites “a treatment device,” but none of the
claim elements are defined to perform treatment. Because the body of the
claim does not indicate how the preamble limits the claim, we review the
Specification “to determine whether the inventors intended such language to
represent an additional structural limitation or mere introductory language.”
Paulsen, 30 F.3d at 1479. The Specification describes the device as a “non-
contact tissue treatment device” having a “support member” (Spec. 2), the
same structural element recited in the claim. It therefore does not appear
that the preamble adds additional structure which is not already recited in the
claim.
The Examiner found that Baxter’s device treated tissue by absorbing
moisture, which “prevents bacteria and fungus from causing infections.”
(Ans. 9.) We find that explanation reasonable. The Examiner’s explanation
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is also consistent with an interpretation limiting the claim to a non-contact
device. Appellants argue that Baxter’s device didn’t work for the treatment
the Examiner found because “[i]f maintained for a long enough time,” high
humidity would result. (Reply Br. 3.) Baxter explicitly taught that the
absorbent would absorb moisture. (FF5.) Appellants’ claim does not recite
a time period. The length of time the device is used is not the issue. We
find that Baxter’s device was a tissue treatment device, and that claim 21 is
not distinguished on that point.
Appellants dispute the Examiner’s finding that Baxter’s absorbent
band 28 is “an absorbent support member for being positioned within the
cover to support a portion of the cover out of contact with tissue to be
treated” as recited in Appellants’ claim 21. We agree with the Examiner’s
finding that the claim language describes Baxter’s band 28, see Ans. 9-10.
Appellants’ claim language describes the position of Baxter’s absorbent
band 28. (See Baxter’s Fig. 2.) Baxter’s absorbent band 28 supports cover
member 20 as it is positioned on inner member 18 (FF2-3), which makes
cover member 20 “a portion of the cover out of contact with tissue to be
treated.” (FF8.) Baxter’s band 28 is positioned as claimed and it performs
the support function as claimed.
Appellants argue as if the claim required that the absorbent member
be positioned between tissue and cover. The claim does not require that
positioning. The Specification says the invention has “a support member
supporting a portion of the cover off of and out of contact with tissue to be
treated.” (Spec. at 2:10-12; emphasis added.) However, the claim does not
require the support member to keep the cover “off” the wound. We do not
read those additional descriptive words into the claim. Sjolund, 847 F.2d at
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1581-82. Nor does the claim require the support member to be the element
which keeps the cover “out of contact” with the tissue to be treated. Rather,
we interpret the “support member” to support “a portion of the cover,”
where that cover portion is itself “out of contact with the tissue to be
treated.”
As claims 22, 23, 32, 43, and 45 were not separately argued and fall
with claim 21. 37 C.F.R. § 41.37(c)(1)(vii).

B. Claims 35, 36 and 46
The issue for this rejection is whether Baxter’s band 28 had “an
opening for enclosing a tissue to be treated.” Baxter’s device enclosed
tissue, as illustrated in Fig. 2. Inner tubular member 18, outer tubular
member 20, and absorbent band 28 functioned as parts of the enclosing
device. We agree with the Examiner as a matter of fact that Baxter’s
absorbent band 28 was ring shaped, and that tissue was enclosed by it, along
with the other illustrated parts.
Appellants ask “[h]ow can Baxter’s ‘encircling bands’ be deployed
‘for enclosing tissue to be treated.’” (App. Br. 8.) Baxter’s Fig. 2 shows
absorbent band 28 as a ring around a broken leg. Appellants argue that the
issue is one of capability, i.e., whether Baxter’s band 28 was “inherently
capable of ‘enclosing tissue to be treated.’” (Id. at 9.) To the contrary, we
find that Baxter explicitly taught that band 28 surrounded tissue to be
treated. Appellants argue that Baxter’s cast 12 is the only element that
“encircles the ‘tissue to be treated.’” (Reply Br. 4.) We disagree. In
addition to cast 12, Baxter’s concentric elements 18, 20 and 28 encircle the
tissue to be treated.
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Claims 47, 48, 50, and 57 were not separately argued and fall with
claims 35, 36 and 46. 37 C.F.R. § 41.37(c)(1)(vii).

C. Claim 59
The Examiner’s position is that “Baxter discloses a cast protector . . .
thereby inherently teaching a method of . . . tissue treatment.” (Ans. 6.) The
Examiner did not explain how Baxter disclosed the claimed step of
positioning the absorbent support member “proximate the tissue to be
treated.” Baxter taught absorbent support members between inner and outer
tubular members (see Fig. 2), and it is not evident that Baxter’s absorbent
supports could be positioned proximate tissue to be treated. Because the
Examiner did not explain this finding, and did not point to evidence
supporting it, we reverse this rejection.

OBVIOUSNESS
The Obviousness Issues
A. Claims 24 and 55
The Examiner found that Baxter’s device differed from those claimed
by being “silent as to the means by which the sealing strip is secured to the
protector.” (Ans. 8.) Kelly taught it was “conventional in the art to provide
sealing strips with adhesive, and a release layer to protect the adhesive prior
to use.” (Id.) The Examiner concluded it would have been obvious in view
of Kelly to use adhesive on Baxter’s sealing strip, and to provide a release
layer to protect the adhesive prior to use. (Id.)
Appellants contend that “Baxter’s flexible seal band is complete in
itself and requires no further elements for it to operate as described by
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Baxter. . . . there is no advantage gained in modifying Baxter by addition of
an adhesive material to Baxter’s flexible strip.” (App. Br. 11.)
The issue with respect to this rejection is whether the Examiner
presented a reason to use adhesive on Baxter’s seal band.

B. Claims 42, 44, 56, and 58
The Examiner acknowledged that Baxter did not teach a cover formed
from a single sheet of flexible material. However, the Examiner concluded
that “[a]bsent a critical teaching [and/or] a showing of unexpected results
derived from constructing the cover from a single sheet . . . the selection of
the number of sheets, which form the cover is an obvious design.” (Ans. 8.)
Appellants contend that “the [E]xaminer’s mere allegation that the
claimed invention is an obvious design choice . . . does not satisfy the ‘all
elements’ requirement of prima facie obviousness.” (App. Br. 12.)
The issue for this rejection is whether the Examiner’s explanation
satisfied the requirements for stating a prima facie obviousness case for
claim 42.

Findings of Fact
Kelly
9. Kelly described “[a]n enclosure for covering extremities.” (Abstract.)
10. Kelly taught that “[w]hen enclosing or covering an extremity, the
enclosure protects a bandage or cast portion of the extremity from
water.” (Id.)
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11. Kelly’s enclosure was “sack-like,” and had an adhesive strip with a
removable covering along the length of a lip extending above the
opening. (Id.)

Principles of Law Relating to Obviousness
A rejection for obviousness must include “articulated reasoning with
some rational underpinning to support the legal conclusion.” KSR Int’l Co.
v. Teleflex Inc., 550 U.S. 398, 418 (2007), quoting In re Kahn, 441 F.3d 977,
988 (Fed. Cir. 2006). The proper question to ask is whether a person of
ordinary skill in the art, facing the wide range of needs created by
developments in the field of endeavor, would have seen a benefit to
combining the prior art teachings. KSR, 550 U.S. at 424; see also In re
Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (the desirability of the
combination may arise from nature of the problem, teachings of references,
or the ordinary knowledge of those skilled in the art).
[A] combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield
predictable results. . . . [I]f a technique has been used to
improve one device, and a person of ordinary skill in the art
would recognize that it would improve similar devices in the
same way, using the technique is obvious unless its actual
application is beyond that person’s skill.

KSR, 550 U.S. at 401.

Analysis of the Obviousness Issues
A. Claims 24 and 55
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Appellants’ argument that there would have been no advantage to
using Kelly’s adhesive on Baxter’s device is unpersuasive. Adhesive was
used on Kelly’s similar device to good effect. “[I]f a technique has been
used to improve one device, and a person of ordinary skill in the art would
recognize that it would improve similar devices in the same way, using the
technique is obvious unless its actual application is beyond that person’s
skill.” KSR, 550 U.S. at 401.

B. Claims 42, 44, 56 and 58
We agree with Appellants’ contention that the Examiner did not
establish a prima facie case of obviousness with respect to claims 42, 44, 56,
and 58. Baxter disclosed a device having a cover comprising perforated
inner tubular member and an unperforated outer tubular member, the two
held in position by absorbent support members (see Fig. 2). The Examiner
did not provide a reason why one of ordinary skill in the art would have
found it obvious to replace the two different tubular members with only one,
presumably discarding the absorbent support members. A rejection for
obviousness must “articulate[] reasoning with some rational underpinning.”
KSR, 550 U.S. at 418. The Examiner’s conclusion lacks that kind of support
and we reverse this rejection. Claims 44, 56 and 58 stand with claim 42.
37 C.F.R. § 41.37(c)(1)(vii).

CONCLUSIONS OF LAW
Anticipation
Baxter disclosed a tissue treatment device.
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Baxter’s absorbent band performed the function recited for Claim 21’s
absorbent support member.
Claim 21 does not require that the absorbent support member function
to separate a portion of the cover from tissue to be treated.
Baxter’s band 28 had “an opening for enclosing a tissue to be treated.”
The evidence does not support the Examiner’s finding that Baxter
inherently taught positioning the absorbent band proximate tissue to be
treated.

Obviousness
The Examiner presented a reason to use adhesive on Baxter’s seal
band.
The Examiner did not establish a prima facie case of obviousness for
claim 42.

SUMMARY
We affirm the rejection of claims 21-23, 32, 35, 36, 43, 45-48, 50 and
57 under 35 U.S.C. § 102(b) as anticipated by Baxter; and
We reverse the rejection of claim 59 under 35 U.S.C. § 102(b) as
anticipated by Baxter.
We affirm the rejection of claims 24 and 55 under 35 U.S.C. § 103(a)
as obvious over Baxter in view of Kelly; and
We reverse the rejection of claims 42, 44, 56 and 58 under 35 U.S.C.
§ 103(a) as obvious over Baxter.

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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-IN-PART

cdc

Terrance A. Meador
INCAPLAW
1050 Rosecrans Street, Suite K
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