Ex Parte Cullen et al

Patent Trial and Appeal Board

Jan 22, 2013

10527421 (P.T.A.B. Jan. 22, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte BREDA M. CULLEN, DEBORAH ADDISON,
DAVID GREENHALGH, ALICIA ESSLER and
SARAH-JAYNE GREGORY
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Appeal 2011-001281
Application 10/527,421
Technology Center 3700
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Before CHARLES N. GREENHUT, MICHAEL L. HOELTER and
BARRY L. GROSSMAN, Administrative Patent Judges.

HOELTER, Administrative Patent Judge.

DECISION ON APPEAL
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STATEMENT OF THE CASE
This is a decision on appeal, under 35 U.S.C. § 134(a), from a final
rejection of claims 1, 5, 6, 10, 11, 13 and 16-18. Br. 3. Claims 2-4, 7-9, 12,
14 and 15 have been cancelled. Clms. App’x. 8-9. We have jurisdiction
under 35 U.S.C. § 6(b). Appellants' representative presented oral argument
on January 15, 2013. We AFFIRM.

CLAIMED SUBJECT MATTER
The disclosed subject matter “relates to wound dressing materials
comprising complexes formed between anionic polysaccharides, such as
oxidized regenerated cellulose (ORC), and silver.” Spec. 1:4-6.
Independent apparatus claim 1 and independent method claim 13 are
illustrative of the claims on appeal and are reproduced below:
1. A wound dressing material comprising a complex of an
oxidized regenerated cellulose with silver, wherein the the [sic]
amount of silver in the wound dressing material comprises from
about 0.1 wt. % to about 0.3 wt% silver.

13. A method for treating venous ulcers, decubitis ulcers or
diabetic ulcers, comprising applying a wound dressing material
directly to the surface of the wound; wherein the wound
dressing material comprises a complex of oxidized regenerated
cellulose with silver, wherein the amount of silver in the wound
dressing material comprises from about 0.1 wt. % to about 0.3
wt % silver.

REFERENCES RELIED ON BY THE EXAMINER

Bechtold US 3,032,182 May 1, 1962
Jaschinski US 6,409,881 B1 Jun. 25, 2002
Watt GB 2314842 A Jan. 14, 1998

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THE REJECTIONS ON APPEAL
1. Claims 1, 5, 6, 10, 13 and 16-18 are rejected under 35 U.S.C. § 103(a)
as being unpatentable over Watt and Jaschinski. Ans. 5.
2. Claim 11 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Watt, Jaschinski and Bechtold. Ans. 7.

ANALYSIS
The rejection of claims 1, 5, 6, 10, 13 and 16-18
as being unpatentable over Watt and Jaschinski
Appellants argue claims 1, 5, 6, 10, 13 and 16-18 as a group. Br. 4-6.
We select independent claims 1 and 13 for review with dependent claims 5,
6, 10 and 16-18 standing or falling with these independent claims. See 37
C.F.R. § 41.37(c)(1)(vii) (2011).
The Examiner finds that Watt substantially discloses Appellants’
invention but that Watt fails to disclose the use of silver or the claimed range
specified for silver. Ans. 5. The Examiner relies on Jaschinski for teaching
“that it is known to treat oxidized cellulose with a silver based antibacterial
agent in an amount of 0.1 wt. % to 25 wt. % (col. 24, lines 37-51) in order to
confer antibacterial properties to medical products for the inherent purpose
of preventing bacterial growth.” Ans. 5. This same section of Jaschinski
also teaches that the range is “particularly 0.1 to 0.5 wt. %.” Jaschinski
24:45-47. As a result, the Examiner “contends that the claimed range lies
inside the disclosed range” and further that it would have been obvious “to
treat the wound dressing material of Watt et al. with a silver based
antibacterial agent, in order to prevent bacterial growth.” Ans. 5.
Appellants do not dispute Jaschinski’s disclosure of treating cellulose-
containing material (i.e., a bandage) with silver in a range that encompasses
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Appellants’ claimed range (see Jaschinski 24:37-51). Instead Appellants’
contend that “the present inventors have found that such a low silver
concentration range is needed in order to achieve the proliferative effect on
wound healing cells” and that “[e]ven at slightly higher silver contents,
e.g.[,] 0.5 wt[.]% (as disclosed by Jaschinski, see below), the silver has been
demonstrated to have an antiproliferative effect on wound healing cells.”1
Br. 4. Appellants distinguish between the proliferative effect of silver and
the known2 antibacterial or antimicrobial effect of silver and contend that
“[t]he proliferative effect of silver at the low concentration range from 0.1 to
0.3 weight % is a completely new discovery, supported by the above cited
data.” Br. 5.
Since the disclosed range shares the lowermost end point and is only
slightly larger than the range recited in the claims, the Examiner correctly
concluded that a prima facie case of obviousness exists. See In re Peterson,
315 F. 3d 1325, 1329-30 (Fed. Cir. 2003). “[A]n applicant may overcome a
prima facie case of obviousness by establishing ‘that the [claimed] range is

1 Appellants’ Specification, when describing the tested examples regarding
the proliferative effect of silver (i.e., Spec. 19:9 to 20:26 and Fig. 4), seems
to bear this out while other portions of Appellants’ Specification seems to
indicate that a different, larger range of silver is preferable for proliferative
effect.
The amount of silver in the wound dressing material is from
about 0.1wt[.]% to about 3wt.%, preferably from more than
about 0.1wt[.]% to about 1wt.%, and for example from about
0.2wt.% to about 0.6wt.%, typically about 0.3wt.%. Lesser
amounts of silver could give insufficient antimicrobial effect.
Greater amounts of silver could give rise to anti- proliferative
effects on wound healing cells
(Spec. 4:23-28).
2 e.g., Jaschinski 24:37-51, Spec. 3:14-16.
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critical, generally by showing that the claimed range achieves unexpected
results relative to the prior art range.’” Id. (citations omitted). Critical
ranges generally produce a new and unexpected result which is different in
kind and not merely in degree from the results of the prior art. In re Aller,
220 F. 2d 454, 456 (CCPA 1955). Appellant has the burden of proving such
criticality. Id.
While the particular range recited may result in a beneficial effect not
discussed in the prior art, Appellants do not offer persuasive evidence or
argument to show that a decrease in the proliferative effects at a particular
concentration of an antimicrobial agent would have been unexpected or
unpredictable. Appellants have not established that in addition to affecting
microbial activity one skilled in the art would not also expect such agents to
affect cellular proliferation, thereby rendering the claimed subject matter the
product of routine optimization. Considering all of the evidence and
arguments before us, the evidence of obviousness outweighs the evidence
against.
Regarding Appellants’ method claim 13 directed to applying a wound
dressing, our reviewing court has provided instruction that while new uses of
known processes may be patentable, newly discovered results of known
processes directed to the same purpose are not patentable because such
results are inherent. Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc. 246
F.3d 1368, 1376-77 (Fed. Cir. 2001) (“However, the claimed process here is
not directed to a new use; it is the same use, and it consists of the same steps
as described by [the cited art]. Newly discovered results of known processes
directed to the same purpose are not patentable because such results are
inherent.”) (citing In re May, 574 F.2d 1082, 1090 (CCPA 1978); Verdegaal
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Bros., Inc. v. Union Oil Co., 814 F.2d 628, 633 (Fed. Cir. 1987);
MEHL/Biophile Int'l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir.
1999)). Here, Watt, Jaschinski and Appellants’ claimed invention all have
the same purpose of being applied to wounds to further their healing, i.e., the
same use.
We also note, as does the Examiner at Answer 9, that the claims recite
a wound dressing having a certain concentration of silver and that the claims
do not recite any proliferative effect which Appellants rely on to distinguish
their invention from the Examiner’s combination of Watt and Jaschinski.
Further, Appellants do not persuade us of error in the Examiner’s finding
that “the addition of silver to the sponge of Watt et al. in the particular
amount of anywhere between 0.1 to 0.5 wt. % [would] have been prima
facie obvious in light of the teachings of Jaschinski in order to achieve the
desired effect.” Ans. 9.
Appellants further contend that “there is no suggestion nor disclosure
that an oxidized regenerated cellulose-silver complex first be formed and
then incorporated as part of a wound dressing.” Br. 5. We agree with the
Examiner that “the claims do not recite that an oxidized regenerated
cellulose-silver complex first be formed and then incorporated as part of a
wound dressing.” Ans. 9. Further, Appellants contend that there is no
suggestion in the cited documents that the claimed range “would achieve the
proliferative and anti-inflammatory effects identified by the present
inventors.” Br. 6. Again, as stated by the Examiner, “such effects are not
presented in the claims of the instant invention, and are therefore irrelevant.”
Ans. 9, see also 10.
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In view of the record presented, we are not persuaded by Appellants’
arguments and accordingly, we sustain the Examiner’s rejection of claims 1,
5, 6, 10, 13 and 16-18.

The rejection of claim 11
as being unpatentable over Watt, Jaschinski and Bechtold
Claim 11 depends from claim 10 which depends from claim 1
discussed supra. Appellants incorporate the arguments above with respect
to claims 1 and 13 and further state that “Bachtold [sic] adds nothing further
in view of the Examiner’s rejection of Watt and Jaschinski to correct the
deficiencies previously identified by Appellant [sic].” Br. 7. We are not
persuaded that any deficiencies have been identified by Appellants regarding
the Examiner’s combination of Watt and Jaschinski and accordingly, we
sustain the Examiner’s rejection of claim 11.

DECISION
The rejections of claims 1, 5, 6, 10, 11, 13 and 16-18 are affirmed.
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

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