Ex Parte Robinson et al

Patent Trial and Appeal Board

Mar 28, 2016

12786188 (P.T.A.B. Mar. 28, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
121786, 188 05/24/2010 Timothy Mark Robinson
60402 7590 03/30/2016
KINETIC CONCEPTS, INC
c/o Harness Dickey & Pierce
5445 Corporate Drive
Suite 200
Troy, MI 48098
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
VAC.0916US 2309
EXAMINER
TOWNSEND, GUY K
ART UNIT PAPER NUMBER
3761
NOTIFICATION DATE DELIVERY MODE
03/30/2016 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):
docket@hdp.com
dgodzisz@hdp.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TIMOTHY MARK ROBINSON and
CHRISTOPHER BRIAN LOCKE
Appeal2014-000971
Application 12/786, 188
Technology Center 3700
Before ERIC B. GRIMES, ULRIKE W. JENKS, and
ROBERT A. POLLOCK, Administrative Patent Judges.
PERCURIAM
DECISION ON APPEAL
This is a decision on appeal 1 under 35 U.S.C. § 134(a) from the
Examiner's rejection of claims 1---6, 11-20, and 40. We have jurisdiction
under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
The Specification discloses improvements "to existing wound care
systems" (Spec. i-f 4). "Tissue that is exposed to moisture for extended
periods of time runs the risk of maceration and other issues .... Negative
1 Appellants identify the Real Party in Interest as KCI Licensing, Inc. (App.
Br. 5).
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Application 12/786, 188
pressure wound therapy may be used to remove fluids from the tissue site"
(id. at i-f 3). The Specification discloses "a reduced-pressure treatment
system for treating a tissue site on a patient [that] includes a manifold pad
... and a reduced-pressure subsystem for delivering reduced pressure to the
manifold pad" (id. at i-f 4). "The manifold pad includes ... a hydrogel
reservoir member" (id.). "The hydro gel reservoir member is adapted to
receive and store a fluid from the tissue site at a first pressure and adapted to
release at least a portion of the fluid at a second pressure, wherein the first
pressure is greater than the second pressure" (id.).
Claim 1 is representative of the claims on appeal:
1. A reduced-pressure treatment system for treating a
tissue site on a patient, the reduced-pressure treatment system
compnsmg:
a manifold pad for disposing proximate the tissue site,
the manifold pad comprising:
a manifold member, and
a hydrogel reservoir member impregnated within the
manifold member, the hydrogel reservoir member adapted to
receive and store a fluid from the tissue site at a first pressure
and adapted to release at least a portion of the fluid at a second
pressure,
wherein the first pressure is greater than the second
pressure on an absolute pressure scale;
a sealing drape for placing over the tissue site and the
manifold pad, the sealing drape adapted to form a fluid seal;
and
a reduced-pressure subsystem for delivering reduced
pressure to the manifold pad.
Independent claim 12 similarly recites the limitation of "a hydrogel
reservoir member impregnated within the manifold member." Independent
claim 40 recites a manifold member comprising interconnected struts and "a
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hydrogel reservoir member comprising a second material coating at least a
portion of the interconnected struts within the manifold member."
Issue
The Examiner has rejected claims 1-3, 5, 12, 13, and 40 under
35 U.S.C. § 102(b) as anticipated by Ambrosio2 (Ans. 4--7). 3 The Examiner
has also rejected claims 4, 6, 11, and 14--20 under 35 U.S.C. § 103(a) as
obvious over Ambrosio (claims 4 and 15; Ans. 8), and over Ambrosio and
Watt4 (claims 6, 11, 14, and 16-20; Ans. 9-13). Because the same issue is
dispositive for all claims, we will consider these rejections together.
The issue presented is: Does the evidence of record support the
Examiner's finding that Ambrosio discloses a reduced-pressure treatment
system for treating a patient tissue site that comprises a manifold pad having
"a hydrogel reservoir member impregnated within the manifold member," as
required by claims 1 and 12, or a "a hydrogel reservoir member comprising
a second material coating at least a portion of the interconnected struts
within the manifold member" as required by claim 40 (emphasis added)?
2 Ambrosio et al., US 2007/0185426 Al, Aug. 9, 2007.
3 The Examiner's statement of the rejection also includes claim 41, but claim
41 is not on appeal (App. Br. 6).
4 Watt et al., WO 2005/123170 Al, Dec. 29, 2005.
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Application 12/786, 188
Findings ofFact
1. Ambrosio discloses
a reduced pressure delivery system . . . for applying reduced
pressure tissue treatment to a tissue site ... [which] includes a
multi-layer reduced pressure delivery apparatus having a tissue
contact layer, a release layer, and a manifold layer. The tissue
contact layer includes a scaffold adapted to contact the tissue site.
The release layer includes a hydrogel-forming material and a
plurality of flow channels, and the manifold layer includes a
distribution manifold. The release layer is positioned between
the tissue contact layer and the manifold layer, and the hydrogel-
forming material of the release layer binds to at least one of the
tissue contact layer and the manifold layer.
(Ambrosio 2, i-f 13; see Ans. 4.)
2. Figure 3 of Ambrosio is shown below:
Figure 3 illustrates a cross-sectional side view of "a reduced pressure
delivery apparatus having a tissue contact layer [223], a release layer [225],
and a manifold layer [227]" (id. at 3, i-f 26).
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Application 12/786, 188
3. Ambrosio discloses that
The reduced pressure delivery apparatus 213 . . . [has] a first
layer, or tissue contact layer 223, a second layer, or release layer
225, and a third layer, or manifold layer 227. The first layer 223
includes a scaffold 233 and ... flow channels 234. The second
layer 225 includes a release material 235 such as a hydrogel-
forming material or a water-soluble polymer ... [and] flow
channels 236. The third layer 227 includes a distribution
manifold 237 and ... flow channels 238. The three layers are
arranged such that the second layer 225 is positioned between the
first layer 223 and the third layer 227.
(Id. at 5, i-f 51; see Ans. 4.)
4. Ambrosio also discloses that a "scaffold is typically a three
dimensional porous structure that provides a template for cell growth. The
scaffold may be infused with, coated with, or comprised of cells, growth
factors, extracellular matrix components, nutrients, integrins, or other
substances to promote cell growth" (id. at 3, i-f 36). "A scaffold may be used
as a manifold in accordance \'l1ith the embodiments described herein to
administer reduced pressure tissue treatment to a tissue site" (id.).
Analysis
Appellants argue that Ambrosio does not disclose a "hydrogel
reservoir member impregnated within a manifold member," as recited in
claim 1 (App. Br. 9). Appellants argue that because "Ambrosio['s] scaffold
(233) cannot be impregnated within itself, the scaffold (233) cannot provide
a hydrogel reservoir member impregnated within a manifold member" (id. at
10). Appellants argue that the Examiner relies on Ambrosio's "paragraph
[0036] to support the proposition that the scaffold (233) may be 'infused or
coated ... with other material,' but this passage does not mention hydro gel
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Application 12/786, 188
at all" (id.). Appellants argue that this Ambrosio passage only states "that a
scaffold may be infused or coated with 'cells, growth factors, extracellular
matrix components, nutrients, integrins, or other substances.'" (Id.)
In response to Appellants' arguments, the Examiner provides the
following annotated version of Ambrosio's Figure 2:
(Ans. 16.) The Examiner finds that Ambrosio discloses "a manifold pad
[layers (233)(235)(237) ... ] for disposing proximate ... the tissue site
(221 )" (id. (citing Ambrosio, i-f 51 )). The Examiner finds that the manifold
pad comprises
(i) a manifold member [(223)/(225)[]"first tissue
contact layer"; "release layer"], and
(ii) a hydrogel reservoir member [(233)/(235)
"scaffold", "release material"] [within (223)]; [comprising a
pad] impregnated [infused or coated] within the manifold
member (223) [(233) within (223)].
(Id. (citing Ambrosio, i-fi-136, 51, 54, and 56) (citations to Ambrosio
removed).)
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Ambrosio discloses a multi-layer reduced pressure delivery apparatus
having a first tissue contact layer 223, a second release layer 225, and a third
manifold layer 227 (FF 3). The first tissue contact layer 223 includes a
scaffold 233 and the second release layer 225 includes a hydrogel forming
release material 235 (FF 3). As shown in Ambrosio's Figure 3 (FF 2) and
the Examiner's annotated version of Ambrosio's Figure 2 (shown above),
the release layer 225 lies between the tissue contact layer 223 and the
manifold layer 227. Accordingly, we agree with Appellants that the
Examiner has not adequately explained how Ambrosio discloses "a manifold
pad for disposing proximate the tissue site, the manifold pad comprising: a
manifold member, and a hydrogel reservoir member impregnated within the
manifold member," as recited in claim 1.
The Examiner points to the combination of the tissue contact layer
223 and the release layer 225, and therefore, the combination of the scaffold
material 233 and the hydro gel forming release material 235 of those layers,
as corresponding to the manifold member of claim 1. The Examiner also
points to the release layer 225, which comprises a hydrogel forming release
material 235, as corresponding to the claim 1 "hydrogel reservoir member
impregnated within the manifold member." Thus, the Examiner points to
the release layer 225 comprised of hydro gel forming release material 235 as
corresponding to both the manifold member and the "hydrogel reservoir
member impregnated within the manifold member" of claim 1. However,
consistent with the principle that all limitations in a claim must be
considered to be meaningfuli it is improper to rely on the same stmcture in
Ambrosio as conesponding to two different elements of clairn 1, i.e. the
manifold member and the hydro gel reservoir member impregnated within
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the manifold member. \Vhen a claim requires two separate elements, one
element construed as having two separate functions does not meet the
claim's terms. See Lantech, Inc. v. Keip Mack Co., 32 F.3d 542, 547 (Fed.
Cir. 1994); see also Jn re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999)
(claims requiring three separate means not anticipated by structure
containing only two means using one element twice).
Additionally, the Examiner points to the scaffold material 233 of the
tissue contact layer 223 and the disclosure in Ambrosio's paragraph 36 that
the scaffold may be infused or coated with various substances (see FF 4 and
the Examiner's annotated version of Ambrosio's Fig. 2 reproduced above).
However, as pointed out by Appellants, Ambrosio's paragraph 36 does not
disclose or suggest coating or infusing the scaffold with a hydrogel, but only
discloses that the "scaffold may be infused with, coated with, or comprised
of cells, growth factors, extracellular matrix components, nutrients,
integrins, or other substances to promote cell growth" (FF 4). The Examiner
has not explained the link between these substances and the hydrogel. In
other words, the Examiner has not explained that the hydrogel materials (see
Ambrosio 6, i-f 60) are art recognized or known cell growth promoting
materials. Thus, we agree with Appellants that the Examiner has not
adequately explained how Ambrosio discloses the manifold pad of claim 1.
Accordingly, we reverse the anticipation rejection of independent claim 1
and dependent claims 2, 3, and 5.
Independent claim 12 is directed to a manifold pad which, like
claim 1, comprises a manifold member and "a hydrogel reservoir member
impregnated within the manifold member." Thus, we also reverse the
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anticipation rejection of independent 12 and dependent claim 13 for the
reasons discussed above.
Independent claim 40 is directed to a manifold pad that comprises,
among other things, "a manifold member comprising a first material of
interconnected struts within the manifold member forming a plurality of
interconnected cells through the manifold member; [and] a hydrogel
reservoir member comprising a second material coating at least a portion of
the interconnected struts within the manifold member" (emphasis added).
Appellants argue that "the Examiner again relies on paragraph [i-f 3 6]
of Ambrosio for the proposition that the scaffold (233), acting as a manifold
with interconnected struts, may be coated or infused with a second material
in the form of a hydrogel" (App. Br. 13-14). Appellants argue that
"Ambrosio does not teach infusing a hydrogel or super-absorbent polymer
into the scaffold (233)" (id. at 14).
We also reverse the anticipation rejection of independent claim 40 as
anticipated by Ambrosio because, as discussed above, the Examiner has not
pointed to any disclosure of Ambrosio as showing that the scaffold 233 of
the tissue contact layer 235 is infused or coated with a hydrogel.
The Examiner has also rejected claims 4 and 15 under 35 U.S.C.
§ 103(a) as obvious in view of Ambrosio (Ans. 8). Claims 4 and 15 depend
from independent claims 1 and 12, respectively. For this rejection, the
Examiner relies on the reasoning discussed above for claims 1 and 12. We
find that the Examiner has not met the burden of establishing that the
limitations of claims 1 and 12 are disclosed in Ambrosio, we reverse this
rejection for the reasons discussed above.
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The Examiner has also rejected claims 6, 11, 14, and 16-20 under
35 U.S.C. § 103(a) as obvious in view of Ambrosio and Watt (Ans. 9-13).
For this rejection, the Examiner relies Ambrosio as discussed above for
independent claims 1 and 12 and relies on Watt only to supply dependent
claim limitations. We find that the Examiner has not met the burden of
establishing that the limitations of claims 1 and 12 are disclosed in
Ambrosio, we reverse the obviousness rejection of claims 6, 11, 14, and 16-
20.
SUMMARY
We reverse the rejection of claims 1-3, 5, 12, 13, and 40 under
35 U.S.C. § 102(b).
We also reverse the rejection of claims 4, 6, 11, and 14--20 under
35 U.S.C. § 103(a).
REVERSED
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