Ex Parte Brown et al

Patent Trial and Appeal Board

Sep 26, 2012

11824517 (P.T.A.B. Sep. 26, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte LAURA J. BROWN, MARY F. PANOZZO, JAMES J. WARD,
ANNA GOSIEWSKA, and DONALD CHRISTOPHER MARSDEN
__________

Appeal 2011-010398
Application 11/824,517
Technology Center 1600
__________

Before ERIC GRIMES, LORA M. GREEN, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner‟s rejection of claims 5 and 18-20. We have jurisdiction under 35
U.S.C. § 6(b).
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STATEMENT OF THE CASE
Claims 5 and 18 are the independent claims on appeal, and read as
follows:
5. A composite device for the treatment of chronic wounds comprising, a
tissue-engineering scaffold and a collagen/ORC coating, wherein said
scaffold is a nonwoven textile comprising a copolymer of glycolide and
lactide having a mole ratio of glycolide to lactide of about 90:10.

18. A method of treating a wound comprising,
a) contacting a chronic wound with one or more composite devices,
wherein said device(s) comprise a biocompatible, biodegradable tissue-
engineering scaffold which is a nonwoven textile comprising a copolymer of
glycolide and lactide having a collagen/ORC coating,
b) allowing said devices and said wound to remain in contact with
each other so as to increase the presence of activated macrophages in said
wound, and
c) covering or closing said wound, wherein said wound is treated.

The following grounds of rejection are before us for review:
I. Claims 5 and 18-20 stand rejected under 35 U.S.C. § 103(a) as
being rendered obvious by Cullen.
1

II. Claims 5 and 18-20 stand rejected under 35 U.S.C. § 103(a) as
being rendered obvious by the combination of Kihm
2
and
Schönfelder
3
(Ans. 5).

1
Cullen et al., WO 2004/024197 A1, published March 25, 2004.
2
Kihm et al., US 2005/0019865 A1, issued Jan. 27, 2005.
3
Schönfelder, et al. Influence of selected wound dressings on PMN elastase
in chronic wound fluid and their antioxidative potential in vitro, 26
BIOMATERIALS 6664-6673 (2005).
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We reverse Rejection I, but affirm Rejection II. But as reasoning
differs from that of the Examiner, we designate our affirmance as a new
ground of rejection.

ISSUE (Rejection I)
Has the Examiner established by a preponderance of the evidence that
Cullen renders the claimed device and method prima facie obvious?

FINDINGS OF FACT
FF1. The Specification teaches that “the invention relates to a composite
device comprising a tissue-engineering scaffold and an anionic
polysaccharide/ structural protein coating” (Spec. 1, ¶ 1).
FF2. The Specification teaches further that “[s]pecifically, the tissue-
engineering scaffold is a porous textile or foam comprising a biocompatible,
biodegradable polymer, and the anionic polysaccharide/structural protein
coating is 55/45 collagen/oxidized regenerated cellulose (collagen/ORC)
matrix” (id. at pp. 3-4, ¶ 10).
FF3. As to “coated,” the Specification teaches that “the scaffold is coated,
i.e. the scaffold‟s surface is covered completely or partially, with a layer or
film composition comprising an anionic polysaccharide/structural protein”
(id. at 4, ¶ 11).
FF4. Example 1 of the Specification describes preparation of composite
devices that comprise a 90/10 mole/mole percent poly(glycolic acid-co-
lactic acid) (PGA/PLA), which were the immersed in a slurry of 55/45 ratio
of collagen/ORC (id. at pp. 12-14; especially ¶¶ 30, 31, 33, and 35).
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FF5. The Examiner rejects claims 5 and 18-20 as being rendered obvious
by Cullen (Ans. 3-5).
FF6. The Examiner finds that Cullen discloses “a wound dressing material
for chronic wounds comprising collagen and oxidized regenerated cellulose
complexed with silver,” which may be in the form of a nonwoven fibrous
sheet (id. at 3).
FF7. The Examiner notes that “no one embodiment teaches that the
collagen/ORC coats polylactide/polyglycolide fibers” (id.).
FF8. The Examiner finds that Cullen teaches “that the wound dressing
materials may further comprise bioresorbable fibers such as
polylactide/polyglycolide fibers to provide reinforcement and dilution of the
polysaccharide” (id.).
FF9. The Examiner finds that “[a]s the fibers are added to provide
reinforcement, it is presumed that they are coated by the collagen/ORC” (id.
at 4).
FF10. Specifically, according to the Examiner, based on the teachings of
Cullen, “the dressing may be a nonwoven textile comprising
polylactide/polyglycolide and small amounts of ORC/silver and
collagen/silver that at least partially cover the polylactide/polyglycolide
fibers” (id. at 10).
FF11. Cullen is drawn to “wound dressing materials comprising complexes
formed between anionic polysaccharides, such as oxidized regenerated
cellulose (ORC), and silver, and to the uses thereof for the treatment of
wounds” (Cullen, p. 1, ll. 4-6).
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FF12. Cullen teaches that the “wound dressing materials … may further
comprise other medically acceptable materials besides polysaccharides,
including … bioresorbable fibers such as polylactide/polyglycolide
fibers” (id. at p. 5, ll. 15-19). The fibers are present in an “amount up to
about 90wt%, more preferably from about 25% to about 75wt% of the
wound dressing materials” (id. at 5, ll. 15-22).
FF13. Cullen teaches further that the materials also preferably comprise
collagen (id. at 5, ll. 24-28).
FF14. The wound dressing materials of Cullen were prepared by combining
all of the components in the desired proportions (see, e.g., Cullen, pp. 15-26,
Examples 2-7).

PRINCIPLES OF LAW
During prosecution before the Office, claims are to be given their
broadest reasonable interpretation consistent with the Specification as it
would be interpreted by one of ordinary skill in the art. In re American
Academy Of Science Tech Center, 367 F.3d 1359, 1364 (Fed. Cir. 2004).
Claim language, however, “should not [be] treated as meaningless.” Bicon,
Inc. v. Straumann Co., 441 F.3d 945, 951 (Fed. Cir. 2006).

ANALYSIS
Appellants argue that Cullen does not “disclose or suggest that the
PGL fibers thereof should be spun, woven, knitted or crimped and entangled
to form a nonwoven textile” (App. Br. 6-7). Appellants further assert that
the Examiner‟s interpretation of the term “„coating‟” is not consistent with
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the Specification, and as used in the Specification, the term “„coating‟” is
consistent as to how the term would be interpreted by the ordinary artisan
(Reply Br. 4-5).
We agree with Appellants. Claim 5 requires “a tissue-engineering
scaffold and a collagen/ORC coating,” and claim 18 requires “biodegradable
tissue engineering scaffold which is a nonwoven textile comprising a
copolymer of glycolide and lactide having a collagen/ORC coating.” The
collagen and ORC are incorporated into the mixture that makes up the
scaffold of Cullen, and thus the Examiner‟s interpretation of the claims as
reading on “small amounts of ORC/silver and collagen/silver that at least
partially cover the polylactide/polyglycolide fibers” (FF10) essentially reads
the term “coating” out of the claims. We thus reverse the rejection.

CONCLUSION OF LAW
We conclude that the Examiner has not established by a
preponderance of the evidence that Cullen renders the claimed device and
method prima facie obvious. We thus reverse the rejection of claims 5 and
18-20 under 35 U.S.C. § 103(a) as being rendered obvious by Cullen.

ISSUES (Rejection II)
Has the Examiner established by a preponderance of the evidence that
the combination of Kihm and Schönfelder renders the claimed device and
method prima facie obvious?
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And if yes, have Appellants provided evidence of unexpected results,
that, when weighed with the evidence of obviousness, is sufficient to support
a conclusion of nonobviousness?

FINDINGS OF FACT
FF15. The Examiner rejects claims 5 and 18-20 as being rendered obvious
by the combination of Kihm and Schönfelder (Ans. 5-7).
FF16. The Examiner finds that Kihm teaches “a scaffold used in the
treatment of bone and cartilage conditions (abstract)” (id. at 5).
FF17. The Examiner finds further than Kihm teaches that “the scafford [sic]
may be a nonwoven mat formed using fibers comprised of a synthetic
absorbable copolymer of glycolic and lactic acids, sold under the tradename
VICRYL, a 90:10 copolymer (para. 0264)” (id.).
FF18. The Examiner finds that Kihm teaches “[i]n a preferred embodiment,
the scaffold is coated with collagen (para. 0265)” (id.).
FF19. Specifically, Kihm teaches (emphasis added):
Examples of scaffolds which may be used in the present
invention include nonwoven mats, porous foams, or self
assembling peptides. Nonwoven mats may, for example, be
formed using fibers comprised of a synthetic absorbable
copolymer of glycolic and lactic acids (PGA/PLA), sold under
the tradename VICRYL (Ethicon, Inc., Somerville, N.J.).
Foams, composed of, for example, poly(epsilon-
caprolactone)/poly(glycolic acid) (PCL/PGA) copolymer,
formed by processes such as freeze-drying, or lyophilized, as
discussed in U.S. Pat. No. 6,355,699, are also possible
scaffolds. Hydrogels such as self-assembling peptides (e.g.,
RAD16) may also be used. These materials are frequently used
as supports for growth of tissue.
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The three-dimensional framework may be made of
ceramic materials including, but not limited to: mono-, di-, tri-,
alpha-tri-, beta-tri-, and tetra-calcium phosphate,
hydroxyapatite, fluoroapatites, calcium sulfates, calcium
fluorides, calcium oxides, calcium carbonates, magnesium
calcium phosphates, biologically active glasses such as
BIOGLASS (University of Florida, Gainesville, Fla.), and
mixtures thereof. There are a number of suitable porous
biocompatible ceramic materials currently available on the
commercial market such as SURGIBON (Unilab Surgibone,
Inc., Canada), ENDOBON (Merck Biomaterial France, France),
CEROS (Mathys, A. G., Bettlach, Switzerland), and
INTERPORE (Interpore, Irvine, Calif., United States), and
mineralized collagen bone grafting products such as HEALOS
(Orquest, Inc., Mountain View, Calif.) and VITOSS,
RHAKOSS, and CORTOSS (Orthovita, Malvern, Pa.). The
framework may be a mixture, blend or composite of natural
and/or synthetic materials. In some embodiments, the scaffold
is in the form of a cage. In a preferred embodiment, the
scaffold is coated with collagen.

(Kihm, p. 20, ¶¶ 264-265.)
FF20. Thus, Kihm clearly suggests a nonwoven mat scaffold of PGA/PLA,
coated with collagen.
FF21. The Examiner notes that Kihm fails “to teach that the scaffold is
coated with a collagen/oxidized regenerated cellulose (ORC) mixture” (Ans.
5).
FF22. The Examiner finds that Schönfelder teaches “that a collagen/ORC
mixture is superior to collagen by itself in terms of superoxide scavenging
(p. 6667-6671)” (id. at 6).
FF23. The Examiner finds that Schönfelder teaches that “[c]hronic wounds
have an overproduction of superoxides, resulting in a persistent inflamed
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phase (p. 6665),” and that “[r]educing the superoxides stops the circle of
inflammation and supports the normal healing process (p. 6665)” (id.).
FF24. The Examiner concludes it would have been obvious to substitute a
collagen/ORC mixture for the collagen coating of Kihm because
Schönfelder teaches that ORC “scavenges inflammation phase causing
superoxides and promotes the natural wound healing cycle” (id.).
FF25. Example 1 of the Specification describes preparation of a 90/10
mole/mole percent poly(glycolic acid co-lactic acid) nonwoven scaffold
(PGA/PLA nonwoven scaffold) and a 35/65 mole/mole percent poly
(epsilon-caprolactone-co-glycolic acid) (PCL/PGA) copolymer foam
scaffold (PCL/PGA foam scaffold) (Spec. 12).
FF26. For the composite scaffolds, each of the above scaffolds were
immersed in a slurry of a 55/45 ratio of collagen/ORC solids, to form a
nonwoven composite scaffold and a foam composite device (id. at 13-14).
FF27. A collagen/ORC foam was also formed from the collagen/ORC slurry
(id.).
FF28. In Example 3 of the Specification:
Wound healing is measured by calculating the total
amount of new tissue ingrowth into the wound area. This tissue
ingrowth extends both above and below the area of the native
tissue. Greatest granulation tissue height above native tissue is
defined as repair in the wound bed, which extends above the
area of native tissue. The greatest granulation tissue height is
calculated by drawing a line across the surface of a wound to
“recreate” the normal skin architecture making certain to follow
the native tissue contour. Next, a perpendicular line is drawn
from this line to the greatest granulation tissue height. The
greatest granulation tissue height measurements are shown in
Table 1.
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(Id. at 15, ¶40.)
FF29. Table 1 from Example 3 is reproduced below:

FF30. According to the Specification:
Histological sections evaluated at day 7 post implantation
demonstrated that Collagen/ORC was not detected in the
wound bed whereas both the foam and nonwoven scaffolds
were present. The nonwoven composite device demonstrated a
statistically significant increase in “greatest granulation tissue
height above native tissue” when compared to the nonwoven
scaffold control group (p= 0.0049, T-test). This response
resulted in an elevated wound surface. Histological assessment
showed the presence of activated macrophages associated with
the scaffold. Although the foam composite device did not
demonstrate a statistical difference in greatest granulation tissue
height when compared to the foam scaffold control, histological
evaluation showed an increased presence of activated
macrophages over the controls, which initiate and potentiate the
wound healing cascade by enhancing cell migration,
angiogenesis, extracellular matrix deposition and
epithelialization. By contrast to both composite scaffolds, the
Collagen/ORC alone did not contain increased activated
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macrophages. The composite device provides both a stimulus
for cell ingrowth and sustained structural support for cell
migration and proliferation without the use of allogeneic cells
or the risk of blood borne pathogens.
(Id. at 16, ¶ 41.)

PRINCIPLES OF LAW
The Supreme Court has emphasized that “the [obviousness] analysis
need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” KSR
Int’l v. Teleflex Inc., 550 U.S. 398, 418 (2007). “If a person of ordinary skill
can implement a predictable variation, § 103 likely bars its patentability.”
(Id. at 417.) Under the correct obviousness analysis, “any need or problem
known in the field of endeavor at the time of invention and addressed by the
patent can provide a reason for combining the elements in the manner
claimed.” Id. at 420.
Moreover,
The test for obviousness is not whether the features of a
secondary reference may be bodily incorporated into the
structure of the primary reference; nor is it that the claimed
invention must be expressly suggested in any one or all of the
references. Rather, the test is what the combined teachings of
the references would have suggested to those of ordinary skill
in the art.

See In re Keller, 642 F.2d 413, 425 (CCPA 1981).
The burden of demonstrating unexpected results rests on the party
asserting them. In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972). In
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addition, “when unexpected results are used as evidence of nonobviousness,
the results must be shown to be unexpected compared with the closest prior
art.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). A
showing of unexpected results must also be commensurate in scope with the
breadth of the claims. In re Grasselli, 713 F.2d 731, 743 (Fed. Cir. 1983).

ANALYSIS
Appellants argue that Schönfelder teaches an ORC/collagen matrix
“in the form of a freeze-dried matrix, and not in the form of a coating” (App.
Br. 9). Appellants assert that Kihm discloses a laundry list of scaffolds,
“which may be „coated with collagen‟” (App. Br. 10 (citing Kihm, ¶¶ 264-
265)). Thus, Appellants assert, the Examiner‟s choice of the PGA/PLA
nonwoven mat as a scaffold “from among the many possible three-
dimensional constructs disclosed in Kihm . . . constitutes an impermissible
hindsight reconstruction of the present claims” (App. Br. 10; see also Reply
Br. 6-7). Appellants assert further that the references “fail to disclose how
the skilled artisan should incorporate the freeze-dried … matrices disclosed
by Schoenfelder [sic] [ ] into the Kihm [ ] scaffolds” (App. Br. 10).
According to Appellants, there would be “a plethora of possibilities in such
proposed combination, with no preference disclosed for making a slurry of
the ORC/collagen freeze-dried matrix of Schoenfelder [sic] [ ] and
depositing a coating onto the Kihm et al. scaffolds,” the method disclosed in
the instant Specification at ¶ 33 (id.).
Appellants‟ arguments are not convincing. Kihm suggests a
nonwoven mat scaffold of PGA/PLA, coated with collagen (FF20).
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Schönfelder suggests a reason as to why the ordinary artisan would have
added ORC to the collagen coating of Kihm. We thus agree with the
Examiner that the combination of Kim and Schönfelder renders the claimed
device and method prima facie obvious.
We do not find persuasive Appellants‟ argument that the combination
is based on impermissible hindsight because of the number of possible
scaffolds taught by Kihm. The fact that a nonwoven mat scaffold of
PGA/PLA is one of a number of obvious scaffolds does not make it any less
obvious. KSR, 550 U.S. at 419 (“What matters is the objective reach of the
claim. If the claim extends to what is obvious, it is invalid under § 103.”).
See, e.g., Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir.
1989) (“That the [prior art] patent discloses a multitude of effective
combinations does not render any particular formulation less obvious.”); In
re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985) (affirming obviousness
rejection of claims in light of prior art teaching that “hydrated zeolites will
work” in detergent formulations, even though “the inventors selected the
zeolites of the claims from among „thousands‟ of compounds”).
In addition, the references need not specifically teach how one would
use the collagen/ORC combination taught by Schönfelder for the collagen
coating taught by Kihm, as Kihm teaches a collagen coating, and there is no
evidence that it would beyond the level of skill of the ordinary artisan to
incorporate ORC in that coating as well. Note that attorney argument cannot
take the place of evidence lacking in the record. Estee Lauder Inc. v.
L’Oreal, S.A., 129 F.3d 588, 595 (Fed. Cir. 1997).
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Citing Example 3 of the Specification, Appellants argue further that
the claimed invention demonstrates unexpected results (App. Br. 11).
Appellants assert that, as can be seen from Table 1, the nonwoven composite
scaffold “provides a significant increase in mean tissue height (i.e. healing)
of wounds, as compared to a PGA/PLA scaffold (item 1) alone,” which
corresponds to the PGA/PLA scaffold exemplified by Kihm (id. at 11-12
(citing Kihm, ¶¶ 623-644)). Appellants further assert that the nonwoven
composite scaffold demonstrates unexpected results over the collagen/ORC
freeze-dried matrix of Schönfelder (App. Br. 12).
Appellants further assert that they should only be required to compare
the claimed invention against the closest prior art example (Reply Br. 9), and
that Kihm does not exemplify collagen coated onto the PGA/PLA scaffold
(App. Br. 12-13). Specifically, Appellants assert that the Examiner suggests
“that Appellants create non-existent examples, by suggesting that the
PGA/PLA scaffold should be coated with collagen according to Kihm”
(Reply Br. 9).
We agree with the Examiner (Ans. 12) that Appellants have not
compared the nonwoven composite device to the closest prior art. Although
not specifically exemplified by Kihm, Kihm clearly suggests a PGA/PLA
scaffold coated with collagen as a preferred embodiment. Such a
comparison does not require comparing the claimed invention with itself, but
is a comparison of the claimed product with a product clearly suggested by
the prior art. See, e.g., In re Fracalossi, 681 F.2d 792, 795 n. 1 (CCPA
1982) (Miller, concurring) (noting that the disclosure of a reference is not
limited to its examples, and that a reference is not prior art for the teachings
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of specific embodiments, but also for what it fairly suggests to the skilled
artisan). Notably, Schönfelder discloses that both collagen alone and a
collagen/ORC mixture have antioxidant capacity and the property of
reducing the concentration and activity of PMN elastase (Schönfelder,
abstract), both of which are described as relevant to treating chronic wounds
(id.).
Moreover, the purported showing of unexpected results is not
commensurate in scope with the claimed invention. The results are drawn to
an ORC/collagen coating consisting of a 55/45 ratio of collagen to ORC
solids (FF26). Independent claims 5 and 18 encompass a device having a
coating having any ratio of collagen to ORC solids. That is, a device having
a coating consisting of 99% collagen and 1% ORC would read on the
claimed device and method, but would be very close to the device coated
with collagen suggested by Kihm. Appellants have not shown that the
results observed for the tested ratio of collagen to ORC would also be
expected for any other ratio of collagen to ORC.

CONCLUSION
We conclude that the Examiner has established by a preponderance of
the evidence that the combination of Kihm and Schönfelder renders the
claimed device and method prima facie obvious. We conclude further that
Appellants have not provided evidence of unexpected results, that when
weighed with the evidence of obviousness, that is sufficient to support a
conclusion of nonobviousness.
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We thus affirm the rejection of claims 5 and 18-20 under 35 U.S.C.
§ 103(a) as being rendered obvious by the combination of Kihm and
Schönfelder.

This decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that the Appellants, WITHIN
TWO MONTHS FROM THE DATE OF THE DECISION, must exercise
one of the following two options with respect to the new grounds of
rejection to avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of the claims so
rejected or new evidence relating to the claims so rejected, or both, and have
the matter reconsidered by the examiner, in which event the proceeding will
be remanded to the examiner….
(2) Request rehearing. Request that the proceeding be reheard under § 41.52
by the Board upon the same record….

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; 37 C.F.R. § 41.50(b)

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