Smith & Nephew, Inc.v.Convatec Technologies, Inc.

Patent Trial and Appeal Board

May 29, 2014

10734784 (P.T.A.B. May. 29, 2014)

Trials@uspto.gov Paper 87
Tel: 571-272-7822 Entered: May 29, 2014
UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

SMITH & NEPHEW, INC.
Petitioner

v.

CONVATEC TECHNOLOGIES, INC.
Patent Owner
____________

Case IPR2013-00102
Patent 7,267,828 B2

Before LORA M. GREEN, RAE LYNN P. GUEST, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.
GUEST, Administrative Patent Judge.
SNEDDEN, Administrative Patent Judge, concurring-in-part.
FINAL WRITTEN DECISION
35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
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I. BACKGROUND
A. Introduction
On December 22, 2012, Smith & Nephew, Inc. (“Smith & Nephew”),
filed a Petition under 35 U.S.C. §§ 311-319, for inter partes review of
claims 1-5 and 7-14 of U.S. Patent No. 7,267,828 B2 (Ex. 1001, “the ’828
patent”). Paper 2 (“Pet.”). ConvaTec Technologies, Inc. (“ConvaTec”),
filed a Preliminary Response on April 3, 2013. Paper 8. On May 31, 2013,
we granted the Petition, and instituted an inter partes review of claims 1-5
and 7-14. Paper 9 (“Dec. on Inst.”).
After institution of this proceeding, ConvaTec filed its Patent Owner’s
Response (“PO Resp.”). Paper 26. ConvaTec also filed a Corrected Motion
to Amend (“Mot. Amend”), in which ConvaTec moved to substitute
proposed claim 15 for claim 1. Paper 25. Both ConvaTec and Smith &
Nephew filed Motions to Exclude. Papers 52; Paper 57. Oral hearing was
held on March 5, 2014.1
The Board has jurisdiction under 35 U.S.C. § 6(c). This final written
decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
For the reasons that follow, we determine that Smith & Nephew has
shown by a preponderance of the evidence that claims 1-5 and 7-14 of the
’828 patent are unpatentable. ConvaTec’s Motion to Amend is denied.
B. The ’828 patent
The ’828 patent describes methods of enhancing the photostability of
silver in antimicrobial materials for use in wound dressing and medical
devices. Ex. 1001, abstract; 1:13-15. Silver-containing materials are

1 A transcript of the oral hearing is included in the record as Paper 80.
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generally sensitive to light, and can cause uncontrolled discoloration of the
silver-containing material. Id. at 1:35-38. The silver-containing materials
made in accordance with the ’828 patent, however, are disclosed as being
substantially photostable, but will release silver when rehydrated. Id. at
3:28-30.
The ’828 patent discloses a method wherein antimicrobial materials
are prepared by subjecting a material containing hydrophilic, amphoteric, or
anionic polymers to a solution comprising an organic solvent and a source of
silver (“the silver solution”). Id. at 2:60-3:7. Examples of appropriate
organic solvents include ethanol, methanol, acetone, and isopropyl alcohol.
Id. at 4:24-27.
The polymer is subjected to the silver solution for a time that is
sufficient to incorporate the desired silver concentration into the polymer.
Id. at 3:18-20, 4:17-19. The ’828 patent also refers to a “silver-loading
step,” where “loading” is defined as “ionic exchange of the cation to the
polymer with silver ions.” Id. at 5:42-49.
In the next step, during the course of or following the period where
the polymer is subjected to the silver solution, the polymer is further
subjected to agent(s) that facilitate the binding of the silver and the polymer
together; “binding” is defined as “the formation of a photostable
compound.” Id. at 3:20-23, 5:53-54. Chlorides are examples of such
facilitating agents. Id. at 3:23-26.
C. Exemplary Claim
Claim 1 is the sole independent claim among the challenged claims of
the ’828 patent. All the claims are directed to methods of preparing a light
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stabilized antimicrobial material. The independent challenged claim, which
is illustrative of the claims at issue in this inter partes review, recites:
1. A method of preparing a light stabilized material
comprising a hydrophilic, amphoteric or anionic polymer, or a
mixture thereof, having antimicrobial activity comprising the
steps of
a) preparing a solution comprising an organic solvent and
a source of silver in a quantity sufficient to provide a desired
silver concentration in said light stabilized material;
b) subjecting a hydrophilic, amphoteric or anionic
polymer, or a mixture thereof, to said solution for a time
sufficient to incorporate the desired silver concentration into
said polymer; and
c) subjecting the hydrophilic, amphoteric or anionic
polymer, or a mixture thereof, during or after step (b), to one or
more agents which facilitate the binding of said silver into said
polymer, wherein the silver is substantially photostable in the
light stabilized material upon drying of said material, but will
dissociate from the light stabilized material upon hydration of
said material.
Claims 2-5 and 7-14 depend from claim 1, either directly or indirectly.
Dependent claims 2 and 3 specify the source of silver. Dependent
claims 4 and 5 specify the agents which facilitate the binding of said silver
into said polymer. Dependent claims 7 and 8 limit the polymer, and
dependent claim 9 limits the organic solvent. Dependent claims 10 and 11
specify the desired silver concentration. Dependent claims 12 and 13
specify the time to which the polymer is exposed to the silver solution, while
claim 14 specifies the time the polymer is exposed to the agents which
facilitate the binding of the silver into the polymer.
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D. Challenges to the Patentability of Claims
We instituted this inter partes review in connection with the following
challenges to the patentability of claims in the ’828 patent:
1. Claims 1-5, 7, 10, and 11 are anticipated, or rendered obvious, by
Kreidl.2
2. Claim 9 is rendered obvious by the combination of Kreidl and
Bahia.3
3. Claims 10-14 are rendered obvious by Kreidl, Walder,4 Ronan,5 and
Romans.6
4. Claims 8 and 9 are rendered obvious by the combination of Kreidl,
Bahia, and Ronan.
5. Claims 1-5, 7, 8, and 10-13 are anticipated or rendered obvious by
Ronan as evidenced by Kreidl and Romans.
6. Claim 9 is rendered obvious by the combination of Ronan and
Bahia.
7. Claims 1-5 and 7-9 are anticipated under 35 U.S.C. § 102(e) by
Gibbins ’751.7

2 Kreidl et al. (“Kreidl”), U.S. Patent No. 2,396,514 (issued Mar. 12, 1946)
(Ex. 1002).
3 Bahia et al. (“Bahia”), WO 94/16746, published August 4, 1994
(Ex. 1005).
4 Walder, U.S. Patent No. 5,848,995 (issued Dec. 15, 1998) (Ex. 1004).
5 Ronan et al. (“Ronan”), U.S. Patent No. 5,820,918 (issued Oct. 13, 1998)
(Ex. 1006).
6 Romans, U.S. Patent No. 3,092,552 (issued June 4, 1963) (Ex. 1003).
7 Gibbins et al. (“Gibbins ’751”), U.S. Patent No. 6,605,751 B1
(issued Aug. 12, 2003) (Ex. 1007).
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8. Claims 10-13 are rendered obvious by the combination of Gibbins
’751 as combined with Walder, Ronan, Romans, and Kreidl.
9. Claim 14 is rendered obvious by the combination of Gibbins ’751
and Kreidl.
II. ANALYSIS
A. Claim Interpretation
We interpret patent claim language in an inter partes review by
ascribing to that language its broadest reasonable meaning in light of the
specification of the patent. 37 C.F.R. § 42.100(b); Office Patent Trial
Practice Guide, 77 Fed. Reg. 48,756, 48,766 (Aug. 14, 2012). Under that
standard, we construe claim terms using “the broadest reasonable meaning
of the words in their ordinary usage as they would be understood by one of
ordinary skill in the art, taking into account whatever enlightenment by way
of definitions or otherwise that may be afforded by the written description
contained in the applicant’s specification.” In re Morris, 127 F.3d 1048,
1054 (Fed. Cir. 1997). We presume that claim terms have their ordinary and
customary meaning. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257
(Fed. Cir. 2007) (“The ordinary and customary meaning is the meaning that
the term would have to a person of ordinary skill in the art in question.”)
(internal quotation marks and citation omitted). A patentee may rebut that
presumption, however, by acting as his own lexicographer, providing a
definition of the term in the specification with “reasonable clarity,
deliberateness, and precision.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir.
1994).
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We expressly interpret below only those claim terms that require
analysis to resolve arguments related to the patentability of the challenged
claims in this proceeding.
1. “to incorporate the desired silver concentration into said
polymer”
ConvaTec contends that the above quoted phrase requires a chemical
interaction between silver ions solubilized from a silver salt and a polymer.
PO Resp. 6. ConvaTec contends also that the phrase “incorporate the
desired silver concentration into the polymer” is construed properly to
involve an ionic interaction. Id. To support that position, ConvaTec
contends that the specification of the ’828 patent associates the “incorporate
. . . into” step with “loading” of silver onto the polymer, where “loading” is
expressly defined in the ’828 patent to mean “ionic exchange of the cation to
the polymer with silver ions.” Id. at 6-7 (citing Ex. 1001 at 5:48-49).
We agree with ConvaTec that the claims encompass an ionic
interaction between free silver ions and a polymer; we do not agree,
however, that the claims are limited to that single type of interaction. The
claims do not recite the term “loading,” and we decline to construe the
claims to be limited to the express definition given to that term. Further, the
’828 patent provides a list of suitable polymers that includes substances
incapable of ionic interaction with silver ions including, for example,
unmodified polysaccharides (i.e., cotton) and polyurethane. Ex. 1001,
4:1-13; Ex. 1045, ¶ 52; Ex. 2029, ¶¶ 30, 58. Rather, we interpret the phrase
“incorporate . . . into” as requiring the silver to associate with the polymer in
a way, regardless of the type of interaction (e.g., ionic, Van der Waals, etc.),
such that it can interact with the polymer and the agent that facilitates the
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binding of silver into the polymer so as to form a substantially photostable
complex. Thus, in addition to ionic exchange, the term “incorporate . . .
into” includes other types of adsorptive interactions with the polymer that
result in a substantially photostable complex, such as adsorption of the silver
on the polymer, with the subsequent conversion of the silver cation to
insoluble silver chloride.
2. “a solution comprising an organic solvent”
The ’828 patent discloses that silver is dissolved in an organic solvent
to solubilize the source of silver such as a silver salt. Ex. 1001, 5:38-40.
The organic solvent also functions to prevent hydration of the polymer, and
as such should include less than 50% w/w water to alcohol so as to prevent
hydration of the polymer. Id. at 4:53-64. ConvaTec further relies on the
declaration of Dr. Kevin Edgar to establish that the presence of an organic
solvent creates an environment favorable for ion exchange. PO Resp. at 7-8;
see Ex. 2029 ¶¶ 17-18.
The express language of the claims, however, merely requires a
solution comprising an organic solvent, and does not recite expressly any
specific range as to the ratio of, for example, water to alcohol. The claims
may encompass a ratio of water to alcohol that favors the ionic exchange of
silver onto an ionized polymer, but are not so limited. The claims thus
broadly encompass any solution comprising an organic solvent in an amount
sufficient to prepare a silver solution, regardless of whether the amount of
organic solvent is sufficient to create an environment favorable for ionic
exchange.
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3. “binding of said silver into said polymer”
The ’828 patent expressly defines “binding” as “the formation of a
photostable compound.” Ex. 1001, 5:53-54. As with the
“incorporate . . . into” language discussed above, the term “binding” has not
been defined in the specification as being particularly limited to binding of
the silver to the polymer via ionic exchange. Accordingly, the term
“binding” can refer to any formation of a photostable compound on the
polymer.
4. “substantially photostable”
The ’828 patent defines “photostable” as “[c]ontrolled colour change
to a desired colour with minimal change thereafter.” See, e.g., Ex. 1001,
5:50-52. The ’828 patent does not define what is or is not a “desired color”
and does not exclude any particular color as a “desired color.”
ConvaTec seeks a definition of “desired color” that excludes any
colors other than a white and particularly excludes purple as a “desired
color.” PO Resp. 13-14 and 42-43. ConvaTec relies substantially on the
testimony of Dr. Tania Phillips8 (Ex. 2028) in support of that interpretation.
Id.
Smith & Nephew contends that the term “photostable” should be
interpreted broadly due to a lack of evidence to support what a skilled artisan

8 Dr. Phillips testifies to having extensive experience in the field of wound
care, as both a practicing clinician and researcher, for almost 30 years, and
being very familiar with issues related to the wound care and management
field. Ex. 2028 ¶ 9. Dr. Phillips appears to be qualified to testify as to
wound care practices at the time of the invention described in the ’981
patent.
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would have considered to be a “desired color,” as required by the claims.
Paper 41 (Ex. 2047 (redacted version of Paper 41)), 7-10.
Dr. Phillips testifies that if she “were presented with an AQUACEL®
Ag dressing9 that was purple out of its package, or turned purple shortly
after exposure to light, [she] would assume that the dressing was expired and
not in optimal condition for clinical use.” Ex. 2028, ¶ 16. Dr. Phillips
further testifies that
It is my experience that the “desired color” of a silverised
antimicrobial material in the ‘981 patent and ‘828 patent is
white. . . . Instead, a color change from “white” to “purplish” is
in my opinion a discoloration, and does not equate with a
“substantially photostable” product, or a “photostable” product
that has minimal color change from the “desired color” of
white.
Ex. 2028 ¶ 21. Dr. Phillips also references a table in Gibbins ’751 which
lists “Ag Aquacel” when dry as “[w]hite, good, eventually purplish,” to
support her testimony that white is a desired color for a silverized
antimicrobial material. Ex. 2028 (citing Ex. 1007, 33:36), ¶ 18; Ex. 2041,
88:7-20.
We are not persuaded by Dr. Phillips’ testimony. Dr. Phillips only
testifies as to the “desired color” for the AQUACEL® Ag product, with
which she is familiar in clinical practice, and not to desired colors of wound
dressings in general. We note that the claims and specification of the ’828
patent are not limited to any particular product. The specification also does
not limit “desired color” to any particular desired colors for any particular
product. See, e.g., Ex. 1001, 5:46-48 (defining “photostable” as requiring a

9 AQUACEL® Ag dressing is a silverised wound dressing product marketed
by ConvaTec that is said to be covered by the ’981 patent. Ex. 2045, ¶ 2.
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“[c]ontrolled colour change to a desired colour,” without specifying a
desired color). Upon cross-examination, Dr. Phillips further states that there
was nothing inherently wrong with purple if the wound dressing did not
change further after turning purple.10
Dr. Phillips’ testimony is based on her experience11 as well as the
statements of the Gibbins ’751 patent. Dr. Phillips’ testimony does not
address what was recognized as a “desired color” in the art of wound
dressings as a whole. Dr. Phillips testifies that she has no knowledge of the
technical details of why color change may occur in a silverized wound
dressing12 on which to base her opinion as to what would be a “desired
color,” in the art of wound dressing as a whole.

10 Exhibit 2041, 88:21-89:14 (“I would say that in my experience, I have not
used a mauve tinted dressing as a silverized dressing. However, if there was
a new dressing introduced that was purple and it was exposed to the air and
it did not change color significantly during air exposure and it was as
effective as all the other silver containing antimicrobial dressings, then I
would have to see the data on it, but the color, per se, would not be an
objection.”); Exhibit 1046, 65:18-21 (“I think if the dressing had a purplish
tinge and it was exposed to light and it didn’t change color and didn’t look
any different, then it would be acceptable.”) (emphasis removed).

11 Ex. 1046, 65:7-10 (“Q. What about white with a purplish tinge to it, would
that also be a desired color? A. I haven’t seen that color in any of the
dressings I’m currently using.”); Exhibit 1046, 61:20-62:4 (“Q. You have
no understanding as to whether any other practitioners have a different
understanding as to the desired color of wound dressings? [] A. I can only
comment on my own experience. Q. Did you ask any other practitioners
whether they think purple is a desirable color for a wound dressing? A. I did
not.”) (objection omitted).
12 Exhibit 1046, 39:15-21(“I’m a clinician. I’m somebody who uses the
dressings in practice. I can see when they change color, but I could not give
you the scientific details why they change color.”).
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Moreover, Dr. Phillips’ testimony seems to suggest that any change of
color is undesirable,13 and reads Gibbins ’751’s color change of the dry
product from white to purple as being unacceptable.14 The claims recite,
however, that the material must be “substantially photostable . . . upon
drying” and the ’828 patent defines the term “photostable,” as having a
“[c]ontrolled colour change to a desired colour with minimal change
thereafter.” There is nothing to suggest that a controlled color change of a
dry product from white to purple would not be encompassed by the scope of
the definition of the ’828 patent.
Dr. Phillips also characterizes desirability based on whether the
material “was expired and not in optimal condition for clinical use.” Ex.
2028 ¶ 16. The ’828 patent defines photostability, however, not in terms of
suitability for use, antimicrobial activity, or chemical stability, but in terms
of controlled color change, with minimal change thereafter. Dr. Phillips’
testimony that a color change from white or greyish white would appear
“unsuitable for clinical use” or “expired” is also controverted by Gibbins
’751’s disclosure that, despite the purple color, Staph. aureus was
nonetheless inhibited. Ex. 1007, 34:42-54.

13 Exhibit 2028 ¶ 16; Exhibit 1046, 61:5-16 (“Well, I think in my experience
working with wound dressings, I know that most, in fact, all the silver
wound products that I’ve worked with are in the color spectrum between
white to gray. So if I open a packet with a wound dressing that’s a silverite
that I know is in this color spectrum and the color has changed to purple or
brown or green, I think that’s outside the normal color change that I would
expect to see within those dressings.”).

14 Ex. 2028 ¶¶ 18-19; Ex. 2041, 88:7-20.
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Accordingly, we interpret the term “desired color” reasonably broadly
to encompass any color that may be desirable to one of ordinary skill in the
art for any purpose. On the testimony of record, we do not find any reason
to conclude that one of ordinary skill in the art would not consider purple as
a desired color.
There is no discussion in the ’828 patent as to whether or not a
“minimum color change” is a change of color to an undesirable color or
simply a change in the shade or spectrum of a single color. The broadest
reasonable meaning therefore includes both, and thus, we construe term
“photostable” to permit a minimal color change from a desired color, and
also to permit minimal discoloration to an undesired color.
As to “substantially,” the Federal Circuit has noted that “the term
‘substantially’ is capable of multiple interpretations.” Deering Precision
Instruments, L.L.C. v. Vector Distrib. Sys., Inc., 347 F.3d 1314, 1323 (Fed.
Cir. 2003) (citation omitted). “[S]ubstantially” can be interpreted as
“‘significantly’ or ‘considerably,’” or also “‘largely’ or ‘essentially.’” Id. at
1322-23 (citing Webster’s New 20th Century Dictionary 1817 (1983)). In
view of those possible meanings, the broadest reasonable interpretation of
“substantially,” when read in the context of the ’981 patent, is that the claim
is open to at least some degree of additional color change beyond that
described in the definition of the term “photostable.”
In view of the above discussion, we determine that the broadest
reasonable interpretation of the term “substantially photostable” is that the
material may undergo a controlled color change to desired color, some
minimal discoloration, even to an undesirable color, from the controlled
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color, and even some degree beyond a “minimal discoloration,” and still be
considered “substantially [i.e., essentially] photostable.”
B. Patentability of Original Claims
To prevail in its challenges to the patentability of claims, the
petitioner must establish facts supporting its challenges by a preponderance
of the evidence. 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). The Court of
Appeals for the Federal Circuit summarized the analytical framework for
determining whether prior art anticipates a claim as follows:
If the claimed invention was “described in a printed
publication” either before the date of invention, 35 U.S.C.
§ 102(a), or more than one year before the U.S. patent
application was filed, 35 U.S.C. § 102(b), then that prior art
anticipates the patent. Although § 102 refers to “the invention”
generally, the anticipation inquiry proceeds on a claim-by-claim
basis. See Hakim v. Cannon Avent Group, PLC, 479 F.3d 1313,
1319 (Fed. Cir. 2007). To anticipate a claim, a single prior art
reference must expressly or inherently disclose each claim
limitation. Celeritas Techs., Ltd. v. Rockwell Int’l Corp., 150
F.3d 1354, 1361 (Fed. Cir. 1998). But disclosure of each
element is not quite enough—this court has long held that
“[a]nticipation requires the presence in a single prior art
disclosure of all elements of a claimed invention arranged as in
the claim.” Connell v. Sears, Roebuck & Co., 722 F.2d 1542,
1548 (Fed. Cir. 1983) (citing Soundscriber Corp. v. United
States, 175 Ct.Cl. 644, 360 F.2d 954, 960 (1966) (emphasis
added)).
Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1334–35 (Fed. Cir.
2008). We must analyze prior art references as a skilled artisan would. See
Scripps Clinic & Res. Found. v. Genentech, Inc., 927 F.2d 1565, 1576 (Fed.
Cir. 1991) overruled on other grounds by Abbott Labs. v. Sandoz, Inc., 556
F.3d 1282 (Fed. Cir. 2009) (to anticipate, “[t]here must be no difference
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between the claimed invention and the reference disclosure, as viewed by a
person of ordinary skill in the field of the invention”).
A claim is unpatentable under 35 U.S.C. § 103(a) if the differences
between the claimed subject matter and the prior art are such that the subject
matter, as a whole, would have been obvious at the time the invention was
made to a person having ordinary skill in the art to which said subject matter
pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The
question of obviousness is resolved on the basis of underlying factual
determinations including: (1) the scope and content of the prior art; (2) any
differences between the claimed subject matter and the prior art; (3) the level
of skill in the art; and (4) where in evidence, so-called secondary
considerations. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966). The
level of ordinary skill in the art usually is evidenced by the references
themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir.
2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich,
579 F.2d 86, 91 (CCPA 1978).
For an obviousness analysis, prior art references must be “considered
together with the knowledge of one of ordinary skill in the pertinent art.” In
re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (quoting In re Samour, 571
F.2d 559, 562 (CCPA 1978)). Moreover, “it is proper to take into account
not only specific teachings of the reference but also the inferences which one
skilled in the art would reasonably be expected to draw therefrom.” In re
Preda, 401 F.2d 825, 826 (CCPA 1968). That is because an 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.”
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KSR, 550 U.S. at 418; see also In re Translogic Tech., Inc., 504 F.3d at
1259.
We analyze the instituted grounds of unpatentability in accordance
with the above-stated principles.
1. Claims 1-5, 7, 10, and 11 as anticipated and/or obvious
over Kreidl (Ex. 1002)
Kreidl discloses a disinfectant material being impregnated with light-
stabilized silver halide compositions. Ex. 1002, 1,1:2-5, 39-46. Kreidl
discloses a method in which bandage gauze is soaked in silver nitrate
solution, dried, and then placed in a sodium chloride solution. Id. at 3, 2:37-
46. In Example 5 of Kreidl, a bandage gauze is dipped into a solution of 1%
silver nitrate and dried. Id. at 6, 1:20-21. The bandage is then placed into a
20% sodium chloride solution for an hour, and washed. Id. at 6, 1:20-23.
According to Kreidl, the gauze bandage does not discolor when exposed to
light. Id. at 6, 1:23-24.
Example 6 is very similar to Example 5, except the bandage is
immersed in a 5% sodium chloride solution for 24 hours. Id. at 6, 1:25-29.
The time the gauze spends in the halide solution depends on the
concentration of the halide, such that using a 20% sodium chloride solution
only requires one hour, while a 5% solution requires 24 hours. Id. at 3, 2:57-
61.
Kreidl also teaches that wherever solutions are mentioned, the term
“is not to be limited to aqueous solutions but is meant to comprise other
suitable solvents such as alcohol, glycerine, carbon tetrachloride, and the
like.” Id. at 6, 2:20-26. While Kreidl states that aqueous solutions are
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preferred for silver halide preparations, it nonetheless discloses further that
mixed solvents, such as diluted alcohol, may be used. Id. at 6, 2:26-31.
a. Claim 1-5, and 7
ConvaTec contends that Kreidl does not anticipate claim 1, and
contends further that the claims are not rendered obvious by Kreidl, because
the bandage gauze of Kreidl is made from cotton fibers. PO Resp. 14-21.
According to ConvaTec, cotton—being made primarily of pure cellulose
containing no readily ionizable groups—is incapable of carrying out ion
exchange reactions and, thus Kreidl does not disclose a chemical association
of silver ions with the polymer. Id. at 16 (citing Ex. 2029, ¶ 30).
ConvaTec presents evidence that the process of Kreidl results in the
impregnation of precipitated and insoluble silver chloride into fibrous cotton
gauze in a process referred to as in situ incorporation. See, e.g., Ex. 1026,
¶¶ 14-15, 20, 26-27, 39. The insoluble silver chloride precipitate occurs
when the sodium chloride is added either before or at the same time as the
silver source, because the silver ions are more attracted to the chloride ions
than to any negative charges associated with the polymer. Id.; Ex. 2029,
¶ 23. Nonetheless, both parties agree that, due to the proximity of silver
chloride to the polymer, there necessarily will be adsorption of silver
chloride to the polymer. Ex. 1026 ¶ 26; see Ex. 2029 ¶ 32.
ConvaTec further argues that “Kreidl does not appreciate the use of
organic solvents for shifting the ion exchange equilibria, and ‘driv[ing] the
exchange of sodium for silver’ in the incorporation of silver into the
polymer.” PO Resp. 17 and 21.
ConvaTec’s arguments are substantially directed to an interpretation
of the phrase “incorporate . . . into” and “binding” as requiring an ionic
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exchange of the silver onto only anionic polymer fibers. We reject that
interpretation of the claim language as set forth above, and thus, we are not
persuaded by ConvaTec’s arguments. Although ConvaTec’s evidence
shows that ionic exchange is not possible for the cotton fibers and the lower
alcohol content described in Kreidl, the claims are not so limited, and
encompass any adsorption of the silver taught by Kreidl to the cotton, which
is an unmodified polysaccharide expressly recited in the claims. Both
parties agree that adsorption of silver chloride onto the cotton fiber occurs,
which is encompassed by the term “incorporate . . . into” and “binding”
recited in the claims. Ex. 1026 ¶ 26; Ex. 2029 ¶ 32.
Kreidl expressly states that the resulting silverized antimicrobial
materials do not discolor when exposed to light. Ex. 1002, 6, 1:23-24.
ConvaTec has not presented any persuasive evidence to undermine that
teaching.
ConvaTec further argues that Kreidl does not exemplify a solution
comprising an organic solvent, and the use thereof constitutes inappropriate
picking and choosing of embodiments for a finding of anticipation. PO
Resp. 17 (citing Ex. 2029 ¶ 31 (calling the use of an organic solvent an
“afterthought”)). Alternatively, ConvaTec argues that Kreidl’s preference
for aqueous solutions teaches away from the skilled artisan adding an
organic solvent. Id. at20-21.
Smith & Nephew contends that Kreidl expressly discloses the use of
an organic solvent, particularly diluted alcohol, with the silver source. Pet.
31-35, 39-42; Ex. 1002, 6, 2:20-31. As discussed above, the claims do not
require any particular concentration of an organic solvent.
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We are not persuaded that the use of an organic solvent in addition to
water is not taught expressly by Kreidl. The disclosure in Kreidl is not
limited to only the examples, and a disclosure that the described solutions
may comprise an organic solvent is sufficient. See Hewlett-Packard Co. v.
Mustek Sys., Inc., 340 F.3d 1314, 1324 n. 6 (Fed. Cir. 2003) (“The
anticipation analysis asks solely whether the prior art reference discloses and
enables the claimed invention, and not how the prior art characterizes that
disclosure or whether alternatives are also disclosed.”).
Moreover, it would have been obvious to one of ordinary skill in the
art to have selected an organic solvent as part of the silver nitrate solution
taught by Kreidl based on the explicit teaching in Kreidl. We are not
persuaded that the disclosure of an aqueous solution as preferred constitutes
a teaching away. Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807
(Fed. Cir. 1989) (“[A]ll disclosures of the prior art, including unpreferred
embodiments, must be considered.”) (quoting In re Lamberti, 545 F.2d 747,
750 (CCPA 1976)). Disclosed examples and preferred embodiments do not
constitute a teaching away from a broader disclosure of non-preferred
embodiments. In re Susi, 440 F.2d 442, 446 n.3CCPA 1971).
ConvaTec presents no additional arguments as to dependent claims 2-
5 and 7, other than those discussed above as to claim 1. Based on our
review of the evidence presented by Smith & Nephew we conclude that
Smith & Nephew has established by a preponderance of evidence that Kreidl
anticipates claim 1-5, and 7 under 35 U.S.C. §102(b). We conclude further
that, when weighed with the evidence of secondary considerations, discussed
below, Smith & Nephew has shown by a preponderance of the evidence that
claims 1-5, and 7 would have been obvious over Kreidl.
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b. Claims 10 and 11
Claim 10 is drawn to the method of claim 1, “wherein the desired
silver concentration is between 0.1 and 20 wt %,” and claim 11 recites that
“the desired silver concentration is between 1 and 20 wt %.” Kreidl teaches
that “[a]s a rule, for a standard bandage gauze not more than about 4% silver
nitrate should be retained on the fiber. . .” Ex. 1002, 3, 2:41-44. Stephen L.
Coulter (“Coulter Declaration,” Ex. 1026, ¶ 27) testifies that levels of silver
below 4% are within the ranges of silver claimed in claims 10 and 11.
ConvaTec argues that claims 10 and 11 are not anticipated by Kreidl,
as Kreidl does not disclose the level of silver in the finished product but
“merely discloses that a bandage gauze was ‘dipped into 1% AgNO3
solution.’” PO Resp. 24 (citing Ex. 1002, 6, 1:20-29).
ConvaTec does not challenge the Coulter Declaration in its Response,
nor does ConvaTec show why the Declaration is incorrect in its conclusions.
We thus credit the Declaration of Dr. Coulter.
For those reasons, we conclude that Smith & Nephew has established
by a preponderance of evidence that Kreidl renders claims 10 and 11
unpatentable as anticipating under 35 U.S.C. §102(b). We conclude further
that, when weighed with the evidence of secondary considerations, discussed
below, Smith & Nephew has shown by a preponderance of the evidence that
claims 10 and 11 would have been obvious over Kreidl.
2. Claim 9 as obvious over Kreidl (Ex. 1002) in view of
Bahia (Ex. 1005)
Claim 9 depends from claim 1 and further recites “wherein said
organic solvent is selected from the group consisting of industrial
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methylated spirit, denatured ethanol, methanol, acetone, isopropyl alcohol
and ethanol.”
Kreidl describes a solution comprising a “diluted alcohol” but does
not disclose any of the recited alcohols of claim 9. Ex. 1002, 6, 2:30-31.
Smith & Nephew contends:
Bahia discloses that industrial methylated spirits and industrial
alcohol (ethanol) are suitable solvents for use in processing
wound dressings, Bahia at 13:24-25, and that an antiseptic can
be added in alcohol containing wash compositions. Bahia at
13:10-18, 14:29-33. It would have been obvious to use
industrial methylated spirits or ethanol as the alcohol in the
process of Kreidl as these were well known forms of alcohol
used to wash wound dressings at the time of the invention as
demonstrated by Bahia.
Pet. 35.
ConvaTec’s arguments for patentability are similar to those discussed
above regarding the anticipation of claim 1, namely that, unlike Bahia,
Kreidl considers the use of an alcohol as an “afterthought,” while the
carboxymethylcellulose (CMC) described in Bahia would be capable of
ionic exchange with silver ions and would dissolve in an aqueous solution.
PO Resp. 22-23. According to ConvaTec, the teachings of Bahia cannot be
combined properly with the teachings of Kreidl because of the “vast
differences between the . . . processes disclosed in Bahia and Kreidl.” Id. at
23-24.
As above, ConvaTec’s arguments are presented as if the claims
require an ionic exchange between the silver and the polymer, which we
have determined they do not. Moreover, ConvaTec provides no persuasive
evidence that Smith & Nephew’s reasoning is in error. Thus, we agree with
Smith & Nephew that it would have been obvious to one of ordinary skill in
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the art to have used the ethanol of Bahia as the alcohol solvent described for
the bandage gauze in Kreidl, because Bahia is evidence that ethanol was a
known solvent for wound dressings. See KSR, 550 U.S. at 417 (The
question to be asked is “whether the improvement is more than the
predictable use of prior art elements according to their established
functions.”).
We conclude that, when weighed with the evidence of secondary
considerations, discussed below, Smith & Nephew has shown by a
preponderance of the evidence that claim 9 would have been obvious over
Kreidl in view of Bahia.
3. Claims 10-14 as obvious over Kreidl (Ex. 1002), Walder
(Ex. 1004), Ronan (Ex. 1006), and Romans (Ex. 1003)
a. Claims 10 and 11
As to claims 10 and 11, those claims have been discussed above in the
analysis of the challenge over Kreidl alone. Therefore, we need not address
those claims further.
b. Claims 12 and 13
Claims 12 and 13 specify the time during which the dressing material
is exposed to a silver nitrate solution. Smith & Nephew acknowledges that
Examples 5 and 6 of Kreidl do not disclose the duration in which the gauze
is exposed to the silver nitrate solution. Pet. 37. Smith & Nephew relies on
Walder, Ronan, and Romans, which each teach exposing a polymer to a
silver nitrate solution for a duration of time encompassed by the ranges set
forth in claims 12 and 13. Id. Smith & Nephew, therefore, contends that it
would have been within the level of skill of the ordinary artisan to “have
readily appreciated that the amount of time for which the polymer must be
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exposed to silver nitrate will depend on the type and dimensions of the
polymer subject to in situ silver chloride precipitation and the level of silver
chloride in the final product,” rendering claims 12 and 13 obvious. Id.
(citing Coulter Dec., Ex. 1026, ¶¶ 68, 70).
ConvaTec’s arguments that each of Walder, Ronan, and Romans fails
to teach ionic exchange of silver with a polymer (PO Resp. 25-28) are not
persuasive for the reasons discussed above.
ConvaTec further argues that Walder cannot properly be combined
with Kreidl, because Walder describes only an aqueous silver nitrate
solution. PO Resp. 25. ConvaTec also argues that Romans cannot properly
be combined with Kreidl because Romans is directed to “non-analogous
products, such as ointments and skin antiseptics,” and discloses a preferred
silver concentration outside of the claimed range. PO Resp. 28.
ConvaTec’s arguments are not persuasive. ConvaTec has not shown
why the aqueous solution of Walder or the differences described in Romans
are a basis for determining that the skilled artisan would not consider the
silver nitrate exposure times disclosed therein as being suitable for the
process described in Kreidl, as Smith & Nephew has shown that each of
Walder, Ronan, and Romans is directed to incorporating the antimicrobial
properties of silver into a polymer. Moreover, ConvaTec’s arguments fail to
direct us to any persuasive additional arguments regarding the teachings of
Ronan.
We thus conclude that, when weighed with the evidence of secondary
considerations, discussed below, Smith & Nephew has shown by a
preponderance of the evidence that claims 12 and 13 would have been
obvious over Kreidl, Walder, Ronan, and Romans.
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c. Claim 14
Claim 14 further recites the time during which the polymer is exposed
to the binding agents in step (c) of claim 1. Smith & Nephew notes that
Kreidl teaches exposing the gauze to a sodium chloride solution for one hour
when a 20% sodium chloride solution is used, and for 24 hours when a 5%
sodium chloride solution is used. Pet. 37-38. Smith & Nephew asserts that
Kreidl teaches that the amount of time the material is soaked in a sodium
chloride solution is a result-effective variable. Id. (citing Ex. 1002, 3, 2:44-
51). Smith & Nephew contends it would have been obvious to vary the time
the gauze of Kreidl is soaked in the sodium chloride solution, such as
soaking for 5 to 30 minutes, because Kreidl specifically teaches that it is a
result-effective variable. Id. (citing Coulter Dec., Ex. 1026, ¶ 70).
ConvaTec’s Response demonstrates no error in Smith & Nephew’s
challenge to patentability to claim 14 over those arguments discussed above.
PO Resp. 24-28. Namely, ConvaTec’s arguments do not respond to Smith
& Nephew’s evidence and argument that the amount of time the material is
exposed to an agent that facilitates the binding of silver is a result-effective
variable based on the teachings of Kreidl.
We thus conclude that, when weighed with the evidence of secondary
considerations, discussed below, Smith & Nephew has shown by a
preponderance of the evidence that claim 16 would have been obvious over
Kreidl, Walder, Ronan, and Romans.
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4. Claims 8 and 9 as obvious over Kreidl (Ex. 1002), Bahia
(Ex. 1005), and Ronan (Ex. 1006)
As to claim 9, we already determined that it is rendered obvious over
Kreidl and Bahia for the reasons discussed above. Therefore, we do not
address this claim further.
Claim 8 further recites that the polymer comprises “a
carboxymethylcellulose [CMC], an alginate or a mixture thereof.” Smith &
Nephew has presented a detailed argument that “it would have been obvious
to replace the cotton gauze of Kreidl with the gel fiber [CMC] dressing of
Bahia, or to apply the Kreidl process to provide the silver chloride as an
antiseptic in the gel fiber dressing of Bahia.” Pet. 51-53. ConvaTec’s
Response demonstrates no error in Smith & Nephew’s challenge to the
patentability of these dependent claims over those arguments discussed
above with respect to claim 1 and claim 9 above. Namely, ConvaTec argues
that Ronan’s aqueous solution would not allow for incorporation of silver
ions into the polymer by ionic exchange. PO Resp. 29-30. ConvaTec
further argues that, unlike Bahia, Kreidl considers the use of an alcohol as an
“afterthought,” while the CMC described in Bahia would be capable of ionic
exchange with silver ions and would dissolve in an aqueous solution. PO
Resp. 30.
As above, ConvaTec’s arguments are presented as if the claims
require an ionic exchange between the silver and the polymer, which we
have determined they do not. We agree with Smith & Nephew that it would
have been obvious to one of ordinary skill in the art to have used the CMC
polymer of Bahia for the bandage gauze in Kreidl, because the skilled artisan
would have been aware of the advantages of Bahia’s wound dressing,
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namely in promoting healing, ease of handling and translucency. Pet. 51-52.
See KSR, 550 U.S. at 417 (The question to be asked is “whether the
improvement is more than the predictable use of prior art elements according
to their established functions.”).
We thus conclude that, when weighed with the evidence of secondary
considerations, discussed below, Smith & Nephew has shown by a
preponderance of the evidence that claims 8 and 9 would have been obvious
over Kreidl, Bahia, and Ronan.
5. Claims 1-5, 7, 8, and 10-13 as anticipated or obvious over
Ronan (Ex. 1006), as evidenced by Kreidl (Ex. 1002) and
Romans (Ex. 1003)
Ronan discloses a method of making an antiseptic article, in which the
article is immersed in an infiltration solution comprising an aqueous solution
of silver acetate, and then immersed into a solution that contains an anion,
such as chloride. Ex. 1006, 4:40-56. The infiltration solution may contain
up to about 50% of a water miscible solvent such as an alcohol, glycol,
ether, or ester solvent. Id. at 5:20-25.
Ronan provides an example in which calcium alginate hydrogel
tubing is soaked for one hour in an aqueous 1% silver acetate solution, and
then soaked in an aqueous calcium chloride solution for an hour. Id. at 7,
Example 3.
ConvaTec contends that Ronan discloses insoluble alginate cross-
linked hydrogels that are not designed for ion-exchange, and thus, Ronan
does not disclose or suggest “incorporation” of silver onto anionic polymers
substrates. PO Resp. 32 (citing Ex. 2029, ¶¶ 37-38).
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As discussed above with respect to Kreidl, ConvaTec’s arguments are
substantially directed to an interpretation of the phrase “incorporate . . . into”
as requiring an ionic exchange of the silver onto only anionic polymer fibers.
We are not persuaded by ConvaTec’s arguments because we reject this
interpretation for the reasons discussed above. Although ConvaTec’s
evidence shows that Ronan’s alginate cross-linked hydrogels would likely be
destroyed by ion exchange, the claims are not so limited, and encompass
adsorption or other bonding of the silver taught by Ronan to the alginate
cross-linked hydrogels, which is a type of polymer expressly recited in claim
8. Both parties agree the silver chloride is provided in the alginate polymers
of Ronan, which is encompassed by the term “incorporated . . . into” recited
in the claims. Ex. 1026, ¶ 46; Ex. 2029, ¶ 39.
Ronan does not state expressly that the resulting silverized
antimicrobial materials do not discolor when exposed to light. Smith &
Nephew contends that, because Ronan discloses a process substantially
similar to the process taught by the ’828 patent, it would result inherently in
a material that is substantially photostable. Pet. 39 (citing Coulter Dec., Ex.
1026, ¶ 50). We agree with Smith & Nephew that Ronan describes a
process that is essentially the same as the claimed process. The realization
of a new benefit of an old process does not render that process patentable.
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377-78 (Fed. Cir.
2005); see also Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d
1368, 1376 (Fed. Cir. 2001) (stating in the context of a claimed process that
was drawn to the same use comprising the same steps of the prior art,
“[n]ewly discovered results of known processes directed to the same purpose
are not patentable because such results are inherent”). ConvaTec has not
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presented any persuasive evidence or argument to undermine this reasoning.
See, e.g., PO Resp. 33-34.
Smith & Nephew contends that Ronan expressly discloses the use of
organic solvents, particularly alcohols, glycols, ether, and ester solvents,
with the silver source. Pet. 39-40; Ex. 1006, 5:20-25.
ConvaTec argues that Ronan does not exemplify a solution
comprising an organic solvent. According to ConvaTec, the disclosure in
Ronan of “infiltration solutions” that may contain organic solvents “does not
constitute a disclosure of preparing a solution comprising an organic
solvent,” and the use thereof constitutes inappropriate picking and choosing
of embodiments for a finding of anticipation. PO Resp. 33. Alternatively,
ConvaTec argues that Ronan’s requirement for water soluble salts teaches
away from the skilled artisan adding an organic solvent. Id. at 35 (citing Ex.
1006, 3:59-64).
We disagree with ConvaTec that the use of an organic solvent in
addition to water is not taught by Ronan. The disclosure in Ronan is not
limited to the examples, and a disclosure that the described solutions may
comprise an organic solvent is sufficient. See Hewlett-Packard, 340 F.3d at
1324 n. 6.
Moreover, we agree with Smith & Nephew (Pet. 43) that it would
have been obvious to substitute the aqueous solvent with a solvent that
contained 50% alcohol as Ronan teaches that such a substitution may be
made. We are not persuaded that the disclosure of water soluble salts
constitutes a teaching away from including miscible organic solvents.
Merck, 874 F.2d at 807; In re Susi, 440 F.2d at 446 n.3.
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Smith & Nephew has presented a detailed argument that each of
claims 1-5, 7, 8, and 10-13 are anticipated by or, in the alternative, would
have been obvious over the teachings of Ronan. Pet. 33-43. ConvaTec’s
Response demonstrates no error in Smith & Nephew’s challenge to
patentability to any particular claim so challenged. PO Resp. 31-36. For
those reasons, we conclude that Smith & Nephew has established by a
preponderance of evidence that Ronan anticipates claims 1-5, 7, 8, and 10-
13 under 35 U.S.C. §102(b). We conclude further, that when weighed with
the evidence of secondary considerations, discussed below, Smith &
Nephew has shown by a preponderance of the evidence that claims 1-5, 7, 8,
and 10-13 would have been obvious over Ronan.
6. Claim 9 as obvious over Ronan (Ex. 1006) and Bahia (Ex.
1005)
Claim 9 depends from claim 1, and recites “wherein said organic
solvent is selected from the group consisting of industrial methylated spirit,
denatured ethanol, methanol, acetone, isopropyl alcohol and ethanol.”
Ronan describes a solution comprising an “alcohol” but does not
disclose any of the recited alcohols of claim 9. Smith & Nephew argues:
Bahia discloses that industrial methylated spirits is a suitable
solvent for use in processing wound dressings, Bahia at
13:24-25, and that an antiseptic can be added in alcohol
containing wash compositions. Bahia at 13:10-18, 14:29-33. It
would have been obvious to use industrial methylated spirits or
ethanol as the alcohol in the process of Ronan as these were
well known forms of alcohol used to wash wound dressings at
the time of the invention as demonstrated by Bahia.
Pet. 43-44.
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ConvaTec’s arguments that Ronan does not teach, but instead
discourages, the use of organic solvents (PO Resp. 36-37) are not persuasive
for the reasons discussed above with respect to anticipation based on Ronan.
ConvaTec argues further that, unlike the alginate fibers of Ronan, the
CMC described in Bahia would be capable of ionic exchange with silver
ions, and thus would dissolve in an aqueous solution. Id. at 37. According
to ConvaTec, the teachings of Bahia cannot be combined properly with the
teachings of Ronan, because the Bahia process does not contain silver, and
Ronan’s process is “very different,” and there are different “considerations
necessary in treating anionic polymers.” Id.
ConvaTec’s arguments directed to ionic exchange between the silver
and the polymer are not persuasive for the reasons discussed above. Further,
ConvaTec has shown no error in the reasoning that it would have been
obvious to one of ordinary skill in the art to have used the alginate material
described in Ronan for a wound dressing. Specifically, Bahia evidences that
the use of alginate hydrogels as wound dressings was known in the art, and
the skilled artisan would have used the ethanol of Bahia as the alcohol
solvent described in Ronan, because Bahia is evidence that ethanol was a
known solvent for such wound dressings. See KSR, 550 U.S. at 417.
We thus conclude that, when weighed with the evidence of secondary
considerations, discussed below, Smith & Nephew has shown by a
preponderance of the evidence that claim 9 would have been obvious over
Ronan and Bahia.
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7. Claims 1-5 and 7-9 are anticipated under 35 U.S.C.
§ 102(e) by Gibbins ’751 (Ex. 1007)
Gibbins ’751 discloses methods for incorporating silver chloride into
various substrates by nucleation of silver chloride into the matrix. See, e.g.,
Ex. 1007, 31:26 (Section heading “AGCL Colloid Nucleation in Solvent for
Aquacel”); Ex. 1026 ¶ 51.
Gibbins ’751 discloses a solution of a chloride salt, such as sodium
chloride that is made using water combined with an alcohol solvent, such as
ethanol or isopropyl alcohol, wherein the aqueous portion of the solution is
not greater than 50%. Ex. 1007, 18:13-17, 28-30. A polymeric material is
immersed into the chloride bath, and then immersed into a similar solution
of water and an alcohol solvent that contains silver ions. Id. at 18:20-25
Gibbins ’751 specifically teaches that the immersion sequence may also be
reversed without affecting the success of the method. Id. at 18:30-32.
Example 24D of Gibbins ’751 added silver to Aquacel® fibers.15 Id.
at 31, Example 24. In Example 24D of Gibbins ’751, the polymer was
added to a solution of sodium chloride comprising ethanol as the solvent, to
which was added, after “a few seconds,” a silver nitrate solution comprising
ethanol as the solvent. Id. at 32:61-67. Gibbins ’751 noted that, while the
silver Aquacel® eventually turned purplish, the material did not discolor
appreciably in light. Id. at 33:35-50.
Gibbins ’751 also provides Examples 25(a) through 25(n). Id. at
34:4-39. In each example, reagents were prepared and used to impregnate
CMC (Aquacel). Id. at 33:66 to 34:1. From those Examples, Gibbins ’751

15 Aquacel® is a trade name for carboxymethoylcellulose (CMC).
Gibbins ’751, 33:67-34:1; Ex. 1045, ¶ 65.
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states that “[t]he stability of the material to light is controlled by the amount
of NaCl, and the location and concentration of Cu ions in the material.” Id.
at 33:62-65.
Examples 25(a)-25(h) use the following notation with X used to
describe amounts that vary between the different examples:
X g NaCl in 2 ml H2O, add to 50 g EtOH, add dressing, add X
mL AgNO3 sol., add X µl Cu.
Id. at 34:4-20. We interpret that notation as describing providing a sodium
chloride solution in 2 ml water, to which 40 g ethanol is added. The CMC
dressing is added. A silver nitrate solution then was added, followed
optionally with a copper solution in ethanol. See Ex. 1045 ¶ 6. These
examples systematically vary the sodium chloride concentration, the silver
nitrate concentration and the copper concentration.
Examples 25(i)-25(l) use the following notation with X used to
describe amounts that vary between the different examples:
X g AgNO3 to 100 µl H2O, add to 25 g EtOH/0.0888 g NaCl in
2 ml H2O, add X µ1 Cu, add to 25 g EtOH, add dressing, add
AgNO3 solution.
Id. at 34:21-33. We interpret that notation to describe first preparing a silver
nitrate solution in 100 µl of water, which is added to 25 g of ethanol. Then a
sodium chloride solution is prepared in 2 ml water, optionally adding
copper, and added to 25 g ethanol. The CMC dressing is then added to the
sodium chloride solution, followed by the silver nitrate solution. See Ex.
1045 ¶ 7. The concentration of silver nitrate and the copper concentration
are varied in these examples.
Examples 25(m) and 25(n) use the following notation with X used to
describe amounts that vary between the two examples:
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0.006795 g AgNO3 to 100 µl H2O, add to 25 g EtOH, add
dressing/X NaCl in 2 ml H2O, add 0 µl Cu, add to 25 g EtOH,
add to AgNO3 solution.
Id. at 34:34-39. What this notation means is at issue in this proceeding.
Based on a consistent reading of this notation with the other examples, we
agree with Smith & Nephew that this notation describes first preparing a
silver nitrate solution in 100 µl of water, to which is added to 25 g of
ethanol. The CMC dressing is then added to the silver nitrate solution. A
sodium chloride solution then is prepared in 2 ml water, without adding
copper, and added to 25 g ethanol. The sodium chloride solution is then
added to the silver nitrate solution. See Pet. 53-57; Paper 41 (Ex. 2047
(redacted version of Paper 41)), 6-7; see Ex. 1045 ¶¶ 8, 9, 20.
Gibbins ’751 at column 34, line 40, further states “[a]dd 10 g H2O to
25 g EtOH, add dressing.” That disclosure may be a control example, which
only adds water to ethanol, followed by adding a CMC dressing, and there is
no silver nitrate or sodium chloride added.
Each of the Examples was exposed to light and Staph. aureus to
determine antimicrobial activity. Ex. 1007, 34:42-44.
Gibbins ’751 states that:
Samples that contained higher concentrations of silver
discolored more quickly in light with most samples eventually
turning a purplish color. The exceptions were samples “n” and
“o” which remained white. With the exception of the sample
developed from the combination in “o”, the samples had an
acceptable feel and texture. Sample “o” was stiff following
processing. All samples produced the same size zone of
inhibition on the staph plate except for sample “o”, which had
no zone of inhibition.
Id. at 34:46-54. We note that there is no example “o” identified by
Gibbins ’751, but that Gibbins ’751 does include a possible additional
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control example, as discussed above. Id. at 34:40. The results would be
consistent with sample “o” being a control example with no expected
antimicrobial activity or color change in that no silver was added.
Smith & Nephew argues that Example 25(m), as well as the disclosure
in Gibbins ’751 that the steps of Example 24 can be prepared in the opposite
order without affecting the success of the method, anticipates claims 1-5 and
7-9 of the ’828 patent. Pet. 53-57.
ConvaTec argues that Gibbins ’751 intends the “immersion” or
“impregnation” of “an insoluble silver chloride precipitate,” which is not
“the incorporation of silver ions into polymers by ion exchange.” PO Resp.
39-40. According to ConvaTec, even though the CMC dressing of Gibbins
’751 is capable of ionic exchange with silver, only by immersing the
dressing in silver first, absence the presence of chloride ions, is the silver
allowed to ionically exchange with the dressing, and Gibbins ’751 “failed to
teach, disclose or appreciate that the order of addition . . . was important and
critical” to ionic exchange. Id. (citing Ex. 2029 ¶ 42); see Ex. 2029 ¶ 43. As
Dr. Edgar explains, “[t]he presence of soluble sodium ions from sodium
chloride will retard the exchange of sodium counterions on the anionic
polymer for soluble silver ions.” Ex. 2029 ¶ 43. Dr. Edgar concludes that
the sequence of addition of reagents, i.e., substrate in sodium chloride, then
addition of silver salt “is precisely the opposite of the sequence that would
promote the incorporation or loading of a desired silver salt concentration
into the polymer.” Id.
ConvaTec’s arguments are not persuasive. First, as discussed in detail
above, ConvaTec’s arguments are presented as if the claims required an
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ionic exchange between the silver and the polymer, which we have
determined they do not.
Second, the claims of the ’828 patent state that the addition of the
agent (e.g., chloride) in step (c) may be performed “during or after step (b),”
step (b) being the step of subjecting the polymer to the silver and organic
solvent solution. Thus, the claims of the ’828 patent are not limited to
separately subjecting the polymer to the silver first, followed by subjecting
the polymer to the chloride agent.
ConvaTec argues that step (b) requires “a time sufficient to
incorporate the desired silver concentration into said polymer” which
requires some ionic exchange of the silver prior to step (c), but that the ionic
exchange does not have to be complete before beginning step (c). PO Resp.
12 (citing Ex. 2029 ¶ 26).
ConvaTec’s argument is not persuasive because, as discussed above,
the “incorporation . . . into” step of step (b) is not limited to ionic exchange.
Moreover, as the claims specifically state that step (c) can take place “after
or during step (b),” as well as the evidence provided by Dr. Edgar, further
supports our interpretation of the “incorporating . . . into” language of claim
1 of the ’828 patent as including interactions in addition to ionic exchange.
Finally, because Gibbins ’751 discloses the same steps in the same
order recited in the claims of the ’828 patent, the silver ions would
necessarily ionically exchange with the CMC polymer prior to the addition
of the sodium chloride agent, based on the evidence provided by ConvaTec.
ConvaTec contends that neither Example 24, nor Example 25(m),
discloses the same process recited in the claims of the ’828 patent, but rather
should be understood to mean that the “dressing is in 0.0888 (presumably
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grams) of sodium chloride dissolved in 2 milliliters of water prior to mixing
with the silver nitrate solution.” PO Resp. 40-41; see Ex. 2029 ¶¶ 46-48.
ConvaTec argues that the “/” in the Examples means “in.” For example, the
stock silver aqueous solution is described in Gibbins ’751 as “0.11325 g
Ag/50 mL H2O,” which means “0.11325 grams of silver in 50 milliliters of
water.” PO Resp. 40 (citing Ex. 1007, 34:2); see also Ex. 2029 ¶ 48.
While we agree that the stock solutions are characterized by a “/”
which appears, in that instance to mean “in,” we are not persuaded that the
“/” means the same thing in the Examples. We find that it is the last step of
each Example that best explains the order. See Ex. 1045 ¶¶ 23-24.
Examples 25(a)-25(h) include no “/” designations and clearly state
that each of the components are additive. Examples 25(i)-25(l) recite
preparing the silver nitrate solution first, a “/,” then preparing the sodium
chloride solution, with the “add dressing” as an additive step of the sodium
chloride solution. What is most instructive, however, is that Examples 25(i)-
25(l) each recites “add AgNO3 solution” as the last additive step of the
sodium chloride solution, clarifying that, despite the fact that the silver
nitrate solution was prepared first, it was added to the sodium chloride
solution after the dressing. See Ex. 1045 ¶ 24.
Examples 25(m) and 25(n) are similar to these earlier examples in that
they recite preparing the silver nitrate solution first, a “/,” then preparing the
sodium chloride solution. They are distinguished, however, in that
Examples 25(m) and 25(n) recite adding the dressing before the “/” as an
additive step in preparing the silver nitrate solution, and finally recites “add
to AgNO3 solution” as the last step for preparing the sodium chloride
solution (emphasis added). Id.
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Smith & Nephew’s interpretation of the notation used in Gibbins ’751
is further supported by Example 24B, which previously concluded that “[i]t
was not appropriate to pre-mix separate solutions that are later combined to
form the bath for the immersion of hydrophilic matrix material for
impregnating with silver” because “a heavy rapidly forming precipitate
developed in the mixture.” Ex. 1007, 32:22-27. Thus, ConvaTec’s
interpretation would have Examples 25(i)-25(j) adding the dressing to a pre-
mixed solution in contravention of the earlier teaching in Gibbins ’751
against pre-mixing.
Further, Smith & Nephew’s interpretation is consistent with the
further disclosure in Gibbins ’751 that the order of immersion may be
reversed without consequence to the success of impregnation (Ex. 1007,
18:30-32). Example 25(m) and Example 25(k) recite the dressing being
immersed in the silver nitrate and sodium chloride solutions in the opposite
order and Gibbins ’751 reports no distinctions in the results for those
Examples. See Ex. 1007, 34:28-30, 34-36, 45-54; Ex. 1045, ¶ 28.
We credit the testimony of Dr. Coulter as to the interpretations of the
Examples 25(a)-25(n). Patent Owner states that “like all of the other
examples in Example 25, the Aquacel substrate in 25(m) is contacted to
sodium salt prior to admixing with soluble silver salt,” but does not address
the distinctions between the notations of Examples 25(a)-25(n). PO Resp.
41 (emphasis original).
Moreover, even if the steps of Example 25(m) are in the same order as
Example 24D, we find it persuasive that Gibbins’ 751 expressly teaches
reversing the order. The reverse order of Example 24D clearly reads on the
steps of claim 1. Thus, we agree with Smith & Nephew that the same
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process is recited in claim 1 and is described in the ’828 patent in the reverse
order of Example 24D and that the resulting material necessarily would be
“substantially photostable.”
ConvaTec further argues that, even if the steps of Example 25(m) are
in the same order as recited in the claims of the ’828 patent, Gibbins ’751
“failed to produce a substantially photostable product.” PO Resp. 41-42. In
addition to the testimony of Dr. Edgar, ConvaTec relies on the testimony of
Dr. Phillips in arguing that “that the ‘purplish’ or ‘purple’ color change from
white of Examples 24 and 25 [of Gibbins ’751] was not, in her experience,
‘substantially photostable.’” PO Resp. 42-43 (citing Ex. 2028 ¶¶ 16, 18-21,
Ex. 2029 ¶ 49).
As discussed above, the term “photostable” is defined in the ’828
patent as having a “[c]ontrolled colour change to a desired colour with a
minimal change thereafter.” As discussed above, we interpret the term
“desired colour” broadly to encompass any color that may be desirable to
one of ordinary skill in the art for any purpose, and do not find sufficient
evidence to particularly exclude purple as a “desired colour.” Further, as
also discussed above, with the definition allowing for “minimal change
thereafter,” and the qualifier “substantially” in the claim, we interpret the
phrase “substantially photostable” to mean that the material may undergo a
controlled colour change to desired color, some minimal discoloration, even
to an undesirable colour, from the controlled colour, and even some degree
beyond a “minimal discoloration,” and still be considered “substantially
photostable.”
Accordingly, we do not find ConvaTec’s arguments persuasive.
Gibbins ’751 states that “[s]amples that contained higher concentrations of
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silver discolored more quickly in light with most samples eventually turning
a purplish color. The exceptions were samples ‘n’ and ‘o’ which remained
white.” Ex. 1007, 34:46-49. Gibbins ’751 states also that its materials
“possess antimicrobial activity and do not appreciably discolor in the
presence of light.” Id. at 33:49-50. A controlled color change to “purplish”
would not be excluded from the phrase “substantially photostable” because
purple is not excluded as a “desirable color” within the meaning of the ’828
patent.
Even if purple were shown to be an undesirable color, Gibbins ’751
reports a change to “purplish” or having “[p]urple, specks.” Id. at 33:37-43,
34:46-49. Such a description indicates only a substantially minimal color
change to purple that is encompassed by the broad language recited in the
claims and the broad definition of “photostable” in the ’828 patent.
Smith & Nephew has presented a detailed argument that each of
claims 1-5 and 7-9 are anticipated by the teachings of Gibbins ’751. Pet. 53-
57. ConvaTec’s Response demonstrates no error in Smith & Nephew’s
challenge to the patentability to any particular claim so challenged. PO
Resp. 38-43. For those reasons, Smith & Nephew has established by a
preponderance of evidence that Gibbins ’751 anticipates claims 1-5 and 7-9
under 35 U.S.C. §102(e).
8. Claims 10-13 as obvious over Gibbins ’751 (Ex. 1007),
Walder (Ex. 1004), Ronan (Ex. 1006), Romans (Ex. 1003),
and Kreidl (Ex. 1002)
Claim 10 is drawn to the method of claim 1, “wherein the desired
silver concentration is between 0.1 and 20 wt %,” and claim 11 recites that
“the desired silver concentration is between 1 and 20 wt %.” Smith &
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Nephew argues that Walder, Ronan, and Romans teach “that the levels of
silver within the claimed ranges would have been considered desirable at the
time of the invention[,]” and that “silver concentrations within the claimed
ranges would have been desirable for antimicrobial effect[,] and a skilled
person would have sought to optimize these levels.” Pet. 57.
Claims 12 and 13 specify the time during which the material is
exposed to a silver nitrate solution. Smith & Nephew acknowledges that
Gibbins ’751 does not expressly disclose the duration in which the gauze is
exposed to the silver nitrate solution. Pet. 58. Smith & Nephew relies on
Walder, Ronan, and Romans, each of which teaches exposing a polymer to a
silver nitrate solution for a duration of time encompassed by the ranges set
forth in claims 12 and 13. Id. Smith & Nephew contends, therefore, that it
would have been within the level of skill of the ordinary artisan to “have
readily appreciated that the amount of time for which the polymer must be
exposed to silver nitrate will depend on the type and dimensions of the
polymer subject to in situ silver chloride precipitation and the level of silver
chloride in the final product,” rendering claims 12 and 13 obvious. Id.
(citing Coulter Dec., Ex. 1026 ¶¶ 68, 70).
ConvaTec argues that Walder, Ronan, and Romans cannot properly be
combined with Gibbins ’751 because (1) they each describe only an aqueous
silver solution; (2) “Walder relates to anti-infective urinary catheters” and
Romans is directed to “non-analogous products, such as ointments and skin
antiseptics,” and (3) Romans discloses a preferred silver concentration
outside of the claimed range. PO Resp. 44-45. According to ConvaTec,
because of
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the significant differences in the methods described in the
challenged claims of the ‘828 patent and the processes
described in Walder, Ronan, and Romans, a person of skill in
the art would have had no reasonable expectation of success in
the claimed processes over the cited combination.

Id.
ConvaTec’s arguments are not persuasive. ConvaTec failed to show
the differences between the processes described in Walder, Ronan, and
Romans are a basis for determining that the skilled artisan would not
consider the silver concentrations or silver nitrate exposure times disclosed
therein as being suitable for the process described in Gibbins ’751, given
that each of Walder, Ronan, and Romans is directed to incorporating the
antimicrobial properties of silver into a polymer. Moreover, ConvaTec’s
arguments do not respond to Smith & Nephew’s evidence and argument that
the silver concentration and the amount of time for which the polymer must
be exposed to silver nitrate are result-effective variables based on the
teachings of Walder, Ronan, and Romans.
We thus conclude that, when weighed with the evidence of secondary
considerations, discussed below, Smith & Nephew has shown by a
preponderance of the evidence that claims 10-13 would have been obvious
over Gibbins ’751, Walder, Ronan, Romans, and Kreidl.
9. Claim 14 as obvious over Gibbins ’751 (Ex. 1007) and
Kreidl (Ex. 1002)
Claim 14 further recites the time during which the polymer is exposed
to the binding agents in step (c) of claim 1. Smith & Nephew notes that
Gibbins ’751 does not disclose the duration of exposure to sodium chloride
in its process. Pet. 58-59. Smith & Nephew asserts that Kreidl teaches that
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the amount of time the material is soaked in a sodium chloride solution is a
result-effective variable. Id. at 59 (citing Ex. 1002, 3, 2:44-51). Smith &
Nephew contends it would have been obvious to optimize the time the gauze
of Kreidl is soaked in the sodium chloride solution, such as soaking for 5 to
30 minutes, because Kreidl specifically teaches that it is a result-effective
variable. Id. (citing Coulter Dec., Ex. 1026 ¶ 70).
ConvaTec argues that Kreidl discloses exposure times are far outside
the claimed range: “For example, when having about 1% silver nitrate
retained on the fibers of such a bandage gauze a cold treatment in a 20%
sodium chloride solution for one hour or in a 5% solution for twenty-four
hours will give good results.” PO Resp. 46 (citing Ex. 1002, 3, 2:57-61).
ConvaTec’s arguments do not respond to Smith & Nephew’s evidence
and argument that the amount of time the material is exposed to an agent
that facilitates the binding of silver is a result-effective variable based on the
teachings of Kreidl. The time periods outside of the claimed range recited in
Kreidl are exemplary only, and do not overcome the suggestion in Kreidl
that the skilled artisan would have optimized the time the gauze is soaked in
the sodium chloride solution, depending on the temperature, concentration,
or desired completeness of the ensuing reaction.
We thus conclude that, when weighed with the evidence of secondary
considerations, discussed below, Smith & Nephew has shown by a
preponderance of the evidence that claim 14 would have been obvious over
Gibbins ’751 and Kreidl.
10. Secondary Considerations of Nonobviousness
Before we can determine that the obviousness determinations above
render the challenged claims unpatentable, we must consider the evidence of
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obviousness anew in light of any evidence of secondary considerations of
nonobviousness presented by ConvaTec. See Graham., 383 at 17-18 (“Such
secondary considerations as commercial success, long felt but unsolved
needs, failure of others, etc., might be utilized to give light to the
circumstances surrounding the origin of the subject matter sought to be
patented. As indicia of obviousness or nonobviousness, these inquiries may
have relevancy.”); Transocean Offshore Deepwater Drilling, Inc. v. Maersk
Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012) (“This objective
evidence must be ‘considered as part of all the evidence, not just when the
decisionmaker remains in doubt after reviewing the art.’”) (quoting
Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538-39 (Fed. Cir. 1983)).
ConvaTec presents the following evidence of commercial success,
industry acclaim, long-felt but unsolved need, and copying. PO Resp. 47-
58.
(1) Commercial Success
Commercial success involves establishing success in the marketplace
of a product encompassed by the claims, as well as a nexus between the
commercial product and the claimed invention. “Evidence of commercial
success, or other secondary considerations, is only significant if there is a
nexus between the claimed invention and the commercial success.” Ormco
Corp. v. Align Tech., Inc., 463 F.3d 1299, 1311-12 (Fed. Cir. 2006). “For
objective evidence to be accorded substantial weight, its proponent must
establish a nexus between the evidence and the merits of the claimed
invention.” In re GPAC Inc., 57 F.3d 1573, 1580 (Fed. Cir. 1995).
While objective evidence of nonobviousness lacks a nexus if it
exclusively relates to a feature that was “known in the prior art,” Ormco
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Corp., 463 F.3d at 1312, the obviousness inquiry centers on whether “‘the
claimed invention as a whole’ would have been obvious, 35 U.S.C. § 103,”
Rambus Inc. v. Rea, 731 F.3d. 1248, 1257-58 (Fed. Cir. 2013).
With regard to whether a nexus has been established between the
products upon which commercial success has been based and the claimed
invention, ConvaTec’s arguments are based on ConvaTec’s AQUACEL®
Ag product line. PO Resp. 48-49. Ms. Fiona Adams testified that she is
“aware of and familiar with the AQUACEL® Ag line,” which she
“understand[s] contain products manufactured using the methods claimed in
the ‘981 and ‘828 patents.” Ex. 2030 ¶¶ 3-4 (see Ex. 2045 (redacted version
of Ex. 2030)). Ms. Adams testifies as to the reason for success of
AQUACEL® Ag as follows:
ConvaTec’s success with AQUACEL® Ag products came
about because it created a new commercial opportunity that was
not realized previously in the wound dressing field. Although
silverised wound dressings, including Smith & Nephew’s
ACTICOAT product, were previously available, the market was
not established. It was only with the introduction of
AQUACEL Ag products and its unique features that customers
expanded the market and purchased these products.
AQUACEL Ag products created a commercially viable
opportunity for this segment, doubling the size of the market in
the US within just two years and taking dominant share in
under a year from launch.
Id. at ¶ 9.
The patent owner has the burden of showing that the commercial
success derives from a feature recited in the claims, in this case, for
example, the particular process steps or the resulting photostability. Tokai
Corp., v. Easton Enters. Inc., 632 F.3d 1358, 1369 (Fed. Cir. 2011). In
order to establish a proper nexus, the patent owner must offer proof that the
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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. See Microsoft v. Proxyconn,
Inc., IPR2012-00026, slip op. at 4 (PTAB Mar. 8, 2013) (Paper 32). We
have considered the testimony of Ms. Adams (Ex. 2045), which purports to
show that the AQUACEL® Ag product line includes the features of claim 1
of the ’828 patent. ConvaTec has not shown, however, that the sales of the
AQUACEL® Ag product line are a result of the claimed invention.
Ms. Adams provides no supporting evidence that the features recited
in the claims of the ’828 patent are responsible for the success of the
commercial AQUACEL® Ag products. Ms. Adams provides no details of
the manufacturing process for AQUACEL® Ag products as supporting
evidence that the products are manufactured using the steps recited in the
claims. Upon cross-examination, Ms. Adams testified that she has no
technical knowledge of the patents and could not confirm whether specific
products in the AQUACEL® Ag line were covered by the claims of the ’828
patent. Ex. 1049, 29:18-31:9; see Ex. 1048 (Ex. 2046 (redacted version of
Ex. 1048)), 105:14-20. Considering we have no evidence of the
manufacturing process for any of the products in the AQUACEL® Ag
product line, we have no means to assess whether any of the products are
covered by the claims of the ’828 patent.
We have considered ConvaTec’s evidence of commercial success, but
find it of insufficient weight and relevance to deem it persuasive as to the
merits of the claimed invention, particularly when we consider it within the
totality of the evidence before us.
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(2) Industrial Acclaim
ConvaTec presents evidence that the company has received praise for
“the development of innovative technologies that produce a major
improvement in business performance and/or patient benefit.” PO Resp. 49
(citing Ex. 2013). For example, ConvaTec presents evidence that “many
studies and publications have praised the Aquacel Ag line and demonstrated
its effectiveness in antimicrobial wound care,” namely due to “the reduction
of pain, dressing changes, and decreased length of hospital stays.” PO Resp.
49; see generally id. at 50-53 (citing Ex. 2045 ¶¶ 12-21 and supporting
documentation). ConvaTec also presents evidence of “the dramatic recovery
of patients treated with AQUACEL® Ag.” Id. at 53-54 (citing Ex. 2025).
As with commercial success, evidence of industrial acclaim is only
relevant to a determination of nonobviousness when it is directed to the
merits of the invention claimed. Secondary considerations may
presumptively be attributed to the claimed invention only where the product
being claimed “embodies the claimed features, and is coextensive with
them.” Ormco Corp., 463 F.3d at 1311-12 (quoting Brown & Williamson
Tobacco Corp. v. Philip Morris, Inc., 229 F.3d 1120, 1130 (Fed. Cir. 2000)).
Although ConvaTec cites comments lauding ConvaTec as an
innovator, as well as the effectiveness of the AQUACEL® Ag product line,
ConvaTec has not explained how such praise is directed to any particular
feature of the method recited in the claims. For example, ConvaTec has not
shown that the evidence of praise is directed to a particular step recited in
the claims or to the photostability of the product. We have thus considered
ConvaTec’s evidence of industrial acclaim, but find it of insufficient weight
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and relevance to deem it persuasive as to the merits of the claimed invention,
particularly when we consider it within the totality of the evidence before us.
(3) Long-felt but unmet need
The relevance of long-felt need and the failure of others to the issue of
obviousness depend on several factors. First, the need must have been a
persistent one that was recognized by those of ordinary skill in the art.
Orthopedic Equipment Co. v. All Orthopedic Appliances, Inc., 707 F.2d
1376, 1382 (Fed. Cir. 1983); see In re Gershon, 372 F.2d 535, 539 (CCPA
1967). Second, the long-felt need must not have been satisfied by another
before the invention by applicant. Newell Companies, Inc. v. Kenney Mfg.
Co., 864 F.2d 757, 768 (Fed. Cir. 1988) (“[O]nce another supplied the key
element, there was no long-felt need or, indeed, a problem to be solved.”).
Third, the invention must in fact satisfy the long felt need. In re Cavanagh,
436 F.2d 491, 496 (CCPA 1971) (“[I]t was still incumbent upon appellant, if
he wished by this method to rebut the inference of obviousness arising from
the similarity of his process to the prior art, to bring forward evidence of his
satisfaction of the need.”).
ConvaTec presents evidence of the need for “a less painful and
traumatic treatment of burn wounds” and that the AQUACEL® Ag product
line has “reduced number of required dressing changes, decreased pain, and
earlier patient discharge as compared with the traditional SSD [silver
sulfadiazine] treatment.” PO Resp. 55 (citing Ex. 2026, Ex. 2017, Ex.
2016). ConvaTec then argues that its evidence of “clinical and research
results,” “commercial success,” and dominant market share are additional
evidence of “a long-felt need in the field for an efficacious and cost-effective
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silverized wound dressing which reduced patient discomfort and decreased
hospital stays.” Id. at 55-56.
ConvaTec’s evidence of a long-felt but unmet need is not persuasive.
While ConvaTec describes advantages of the AQUACEL® Ag product line
over a traditional “silver sulfadiazine (SSD) ointment,” ConvaTec has not
demonstrated that advantages of the claimed invention are not met by
silverized hydrogels of the prior art, such as that taught by Gibbins ’751.
Moreover, ConvaTec has not shown that the evidence of long-felt and unmet
need is solved by the particular steps recited in the claims, or to the
photostability of the product, to the extent they are distinguishable from the
prior art of record.
We have considered ConvaTec’s evidence of long-felt but unmet
need, and find it of insufficient weight and relevance to deem it persuasive
as to the merits of the claimed invention particularly when we consider it
within the totality of the evidence before us.
(4) Copying
Although, “copying by a competitor may be a relevant consideration
in the secondary factor analysis[,]” “[n]ot every competing product that
arguably fails within the scope of a patent is evidence of copying.” Iron
Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1325 (Fed. Cir.
2004). Copying, as objective evidence of nonobviousness, requires evidence
of effort to replicate a specific product. Wyers v. Master Lock Co., 616 F.3d
1231, 1246 (Fed. Cir. 2010); Iron Grip, 392 F.3d at 1325.
ConvaTec argues that “[d]irect evidence of copying by Petitioner
Smith & Nephew also exists . . . .” PO Resp. 56. ConvaTec provides
evidence of an FDA statement that Smith & Nephew’s Durafiber Ag is
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“substantially equivalent” to ConvaTec’s Aquacel Ag product and has
“similar design, materials and manufacturing methods.” Id. (citing Ex.
2001). ConvaTec also produces evidence that “Smith & Nephew admitted
[in a submission against the European equivalent of the patent at issue in the
instant proceeding] that it has no other non-infringement argument in
relation to the process it uses to produce its silverised Durafiber wound
dressing” other than arguments based on amended claim language not
present in this proceeding. Id. at 57 (citing Ex. 2002).
ConvaTec’s evidence of copying is not persuasive. A statement of
“similar manufacturing methods” is not sufficient to demonstrate that Smith
& Nephew’s Durafiber product is identical to AQUACEL® Ag, is made
using the particular steps of the claimed invention, or even that it has the
recited photostability. Moreover, even if Smith & Nephew’s Durafiber Ag
is made using the exact same process as any of ConvaTec’s AQUACEL®
Ag products, ConvaTec has not shown that the AQUACEL® Ag product
line is manufactured according to the steps of the claims of the ’828 patent,
or has the claimed photostability. Further, ConvaTec has not produced any
evidence of the actual manufacturing process for Smith & Nephew’s
Durafiber Ag product, and we are not persuaded that a decision not to pursue
an alternative litigation strategy in its submission against the European
equivalent of the patent at issue in the instant proceeding is sufficient
evidence of a process that includes the steps and recited photostability of the
claims of the ’828 patent.
We have considered ConvaTec’s evidence of copying but find it of
insufficient weight and relevance to deem it persuasive as to the merits of
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the claimed invention, particularly when we consider it within the totality of
the evidence before us.
Determination with respect to obviousness
After weighing all the evidence of obviousness and nonobviousness of
record, on balance, we conclude that the strong evidence of obviousness
outweighs the weak evidence of nonobviousness. For the foregoing
reasons, we determine that Smith & Nephew has demonstrated by a
preponderance of the evidence that claims 1-5 and 7-14 are unpatentable
over the prior art of record.

C. Motion to Amend
ConvaTec filed a Motion to Amend. Paper 25. For the reasons set
forth below, ConvaTec’s Motion to Amend is denied.
As the moving party, ConvaTec bears the burden of proof to establish
that it is entitled to the relief requested. 37 C.F.R. § 42.20(c). Entry of the
proposed amendment, therefore, is not automatic, but only upon ConvaTec’s
having demonstrated the patentability of the proposed substitute claims.
ConvaTec requests cancellation of claim 1, to be replaced with
proposed substitute claim 15, reproduced below, with underlined text
indicating material inserted relative to original claim 1, and bracketed text
indicating material deleted relative to original claim 1:
15. A method of preparing a light stabilized material
comprising a gel-forming fiber selected from the group
consisting of a hydrophilic, amphoteric or anionic polymer, or a
mixture thereof, having antimicrobial activity comprising the
steps of
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a) preparing a solution comprising an organic solvent and
a source of silver in a quantity sufficient to provide a desired
silver concentration in said light stabilized material;
b) subjecting the gel-forming fiber [a hydrophilic,
amphoteric or anionic polymer, or a mixture thereof,] to said
solution for a time sufficient to [incorporate] load the desired
silver concentration into said [polymer] gel-forming fiber; and
c) subjecting the gel-forming fiber [a hydrophilic,
amphoteric or anionic polymer, or a mixture thereof,] during or
after step (b), to one or more agents which facilitate the binding
of said silver into said [polymer] gel-forming fiber, wherein the
silver is [substantially] photostable in the light stabilized
material upon drying of said material, but will dissociate from
the light stabilized material upon hydration of said material.

Paper 25 at 2-3 (emphasis removed, alterations).
1. Written Description Support
Pursuant to 37 C.F.R. § 42.121(b)(1), a motion to amend in an inter
partes review must set forth “[t]he support in the original disclosure of the
patent for each claim that is added or amended.”
In our Order dated July 3, 2013, we pointed ConvaTec’s attention to
Nichia Corp. v. Emcore Corp., IPR2012-00005, slip op. at 4 (PTAB June
13, 2013) (Paper 27), for a discussion of the burden for identifying written
descriptive support for the proposed substitute claims. Paper 15 at 4.
As set forth in Nichia, “37 C.F.R. § 42.121(b)(1) requires the patent
owner to set forth the support in the original disclosure of the patent for
each proposed substitute claim.” Nichia, Paper 27 at 3. Specifically,
[T]he Board noted that the written description test is whether
the original disclosure of the application relied upon reasonably
conveys to a person of ordinary skill[ ] in the art that the
inventor had possession of the claimed subject matter as of the
filing date. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d
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52
1336, 1351 (Fed. Cir. 2010) (en banc). Therefore, the written
description support must be shown in the original disclosure of
the application . . . that issued as the . . . patent, unless [patent
owner] indicates, in its motion, that there was no change to the
original disclosure when the patent issued.

Id.
ConvaTec, in its Motion to Amend, points to issued claim 1, as well
as sections of the issued ’828 patent, as support for proposed substitute claim
15. Mot. Amend 4-5. As noted above, however, that is not sufficient, as
ConvaTec did not state where support could be found in the disclosure as
originally filed for the substitute claims, nor did ConvaTec state in its
Motion that the specification of the issued patent was identical to the
specification originally filed in Application Number 10/734,784 (“the ’784
application”). ConvaTec’s Motion to Amend, therefore, fails on that point
alone.
Moreover, proposed substitute claim 15 adds that the “hydrophilic,
amphoteric or anionic polymer, or a mixture thereof,” is “a gel forming
fiber.” ConvaTec states that the “’828 patent includes various examples of
gel-forming fibers, including hydrophilic, amphoteric and anionic polymers
such as AQUACEL®, or those and other polymer fibers.” Mot. Amend 4
(citing Ex. 1001, 3:47-64).
The section of the ’828 patent relied upon by ConvaTec states:
Accordingly, the invention provides methods of
preparing a material which contains one or more hydrophilic,
amphoteric or anionic polymers, wherein the polymers have
antimicrobial activity. Preferably, the material containing the
polymer(s) is used in a medical device, a wound dressing, or an
ostomy device. Materials which are particularly adapted for the
inventive method include gel-forming fibers such as AquacelTM
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(WO 93/12275, WO 94/16746, WO 99/64079, and U.S. Pat.
No. 5,731,083), or those described in WO 00/01425 or PCT/GB
01/03147; wound dressings containing similar gel-forming
fibers behind or overlying a non-continuous or perforated skin-
contact layer such as VersivaTM (U.S. Pat. No. 5,681,579, WO
97/07758 and WO 00/41661); DuoDermTM (U.S. Pat. No.
4,538,603), DuoDerm CGFTM (U.S. Pat. No. 4,551,490 and EP
92 999), or a blend of two or more fibres such as CarboflexTM
(WO 95/19795). The present invention well-suited for other
materials which contain carboxymethylcellulose.

Ex. 1001 3:47-64.
As set forth above, the ’828 patent states that the polymer may be a
hydrophilic, amphoteric, or anionic polymer. The patent goes on to state
that materials that are particularly suited are gel forming fibers, and other
than listing specific brand names, only lists carboxymethylcellulose as gel
forming fiber. Notably, ConvaTec does not explain how that section of the
’828 patent provides support for a gel forming fiber that is each of a
hydrophilic, amphoteric, or an anionic gel forming polymer.
It was ConvaTec’s burden to demonstrate that substitute claim 15 had
written descriptive support in the original disclosure of the application that
issued as the ’828 patent. ConvaTec does not point us to support in the
application, and in addition, has not explained how the section of the ’828
patent it relies upon to support proposed substitute claim 15 provides support
for the added claim limitation that the gel-forming fiber is selected from the
group consisting of a hydrophilic, amphoteric, or anionic polymer, or a
mixture thereof.
As we conclude that ConvaTec has not established that the disclosure
of the issued ’828 patent provided written descriptive support for proposed
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substitute claim 15, we do not address the patentability of proposed
substitute claim 15 over the prior art.16
D. Motion to Exclude Evidence
1. Smith & Nephew’s Motion to Exclude Evidence
A party wishing to challenge the admissibility of evidence must
identify the grounds of the objection and explain why the evidence is not
admissible. 37 C.F.R. § 42.64(c). Here, Smith & Nephew seeks to exclude
testimony of Ms. Fiona Adams (Ex. 2045) and Ex. 2012 related to the
commercial success of ConvaTec’s Aquacel Ag line of products without
identifying any rule of evidence or other authority to support its position that
the testimonial evidence in question is inadmissible. Paper 52. Rather,
Smith & Nephew’s rationale for excluding Ms. Adams’ testimony is that
ConvaTec has never established that any of the Aquacel Ag products are
covered by any of the claims of the ’828 patent. Id. Contending that the
evidence is inadequate for a determination of nexus, however, is not
sufficient to establish the impropriety of the evidence, much less the
inadmissibility of the evidence under the Federal Rules of Evidence. See
Office Patent Trial Practice Guide, 77 Fed. Reg. 48,758 (August 14, 2012)
(A motion to exclude may not be used to challenge the sufficiency of the
evidence to prove a particular fact.).
Accordingly, Smith & Nephew’s Motion to Exclude is denied.

16 As discussed above in the analysis of the patentability challenges of the
original claims, Patent Owner’s argument as to proposed substitute claim 15
also fails on the basis that Gibbins ’751 teaches a substantially identical
process, and thus would inherently produce a light stabilized antimicrobial
material as required by proposed substitute claim 15.
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2. ConvaTec’s Motion to Exclude Evidence
ConvaTec seeks to exclude the following: (1) testimony of Dr.
Stephen Coulter (Ex. 1045); (2) Ex. 1037; and (3) Ex. 1038. Paper 57 (“PO
Mot. Exclude”). As the movant, ConvaTec has the burden of proof to
establish that it is entitled to the requested relief. 37 C.F.R. § 42.20(c).
ConvaTec argues that the declaration testimony of Dr. Stephen
Coulter should be excluded because he is not qualified to testify as an expert
with respect to the claimed subject matter of the ’828 patent, specifically
with regards to the photostability of a wound dressing. Id. at 2-4. ConvaTec
points to paragraph 30 of the Coulter Declaration (Exhibit 1045) as being the
inadmissible portion of Dr. Coulter’s testimony. ConvaTec further argues
that Dr. Coulter’s testimony reveals that he does not understand what a
person of ordinary skill in the art would consider to be a “desired color” for
a silverized wound dressing. Id.
We are not persuaded by ConvaTec’s arguments. Initially,
ConvaTec’s objections to Dr. Coulter’s testimony go to the weight and
sufficiency of his testimonial evidence, rather than its admissibility. See
Liquid Dynamics Corp. v. Vaughan Co., 449 F.3d 1209, 1221 (Fed. Cir.
2006) (citing Quiet Tech. DC-8, Inc. v. Hurel-Dubois UK Ltd., 326 F.3d
1333, 1344-45 (11th Cir. 2003)); In re TMI Litig., 193 F.3d 613, 692 (3d
Cir. 1999) (“So long as the expert’s testimony rests upon ‘good grounds,’ it
should be tested by the adversary process—competing expert testimony and
active cross-examination . . .” (quoting Ruiz–Troche v. Pepsi Cola of Puerto
Rico Bottling Co., 161 F.3d 77, 85 (1st Cir.1998))); Wilmington v. J.I. Case
Co., 793 F.2d 909, 920 (8th Cir.1986) (“Virtually all the inadequacies in the
expert’s testimony urged here by [the defendant] were brought out forcefully
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56
at trial . . . . These matters go to the weight of the expert’s testimony rather
than to its admissibility.”). It is within our discretion to assign the
appropriate weight to be accorded to Dr. Coulter’s testimonial evidence.
Moreover, we have reviewed Dr. Coulter’s testimony and note that the
testimony in question is not relied upon in our claim construction of the term
“photostable” or in our determination of what would be considered a
“desired color” for a silverized wound dressing to a person of ordinary skill
in the art. Thus, the objection to paragraph 30 of Dr. Coulter’s testimony is
moot.
Smith & Nephew relies on Exhibits. 1037 and 1038, in its opposition
to ConvaTec’s Motion to Amend claims, as evidence to support its
conclusion that Example 25(m) of Gibbins ’751 discloses the same order of
addition of silver source (silver nitrate) and agent (sodium chloride) as
claimed in the ’828 patent. Paper 45, 9. ConvaTec argues that the
Petitioner’s Exhibits. 1037 and 1038 should be excluded because they are
inadmissible hearsay, are not properly authenticated, or are otherwise
improper under Federal Rule of Evidence 901. Paper 57, 4-6.
We find it unnecessary to consider the objections to the admissibility
of Exhibits 1037 and 1038. Exhibits 1037 and 1038 were not relied upon in
our determination as to the meaning of Example 25(m) of Gibbins ’751.
Even excluding Smith & Nephew’s evidence, we have determined that
Smith & Nephew has demonstrated, by a preponderance of the evidence,
that the challenged claims of the ’828 patent are unpatentable.
Accordingly, ConvaTec’s Motion to Exclude is dismissed as moot.

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57
III. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that claims 1-5 and 7-14 of the ’828 patent are
unpatentable;
FURTHER ORDERED that ConvaTec’s Motion to Amend is denied,
FURTHER ORDERED that Smith & Nephew’s Motion to Exclude is
denied;
FURTHER ORDERED that ConvaTec’s Motion to Exclude is
dismissed as moot; and
FURTHER ORDERED that because this is a final decision, parties to
the proceeding seeking judicial review of the decision must comply with the
notice and service requirements of 37 C.F.R. § 90.2.

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59
Such discoloration is undesirable for silverized medical devices meant for
coming into contact with skin.
ConvaTec also presents evidence that purple is not a “desired colour”
within the meaning of “photostable.” Ex. 2028 ¶ 16; Ex. 1046, 61:5-16. Dr.
Phillips, for example, testified that a silverized wound dressing that was
purple out of its package, or turned purple shortly after exposure to light,
would be considered expired or not in optimal condition for clinical use.17
Ex. 2028 ¶ 16. Dr. Phillips testified that the “desired colour” of a silverized
wound dressing is white to a “grayish white.” See, e.g., Ex. 2028 ¶ 21. See
also, Ex. 1046 64:24–65:6, 86:13–87:3. Smith & Nephew presents no
evidence as to what color(s) would be desirable or undesirable to a person of
ordinary skill in the art. Thus, the weight of the evidence on the present
record suggests that, to a person of ordinary skill in the art, the “desired
colour” of a silverized wound dressing for purposes of photostablility is
white to a grayish white, and that purple, specifically, is not a desirable
color.

17 Although the majority finds Dr. Phillips’ testimony to be controverted by
the disclosure in Gibbins ’751 that a purplish color did not render the
product ineffective for inhibiting the growth of Staph. aureus, there is
insufficient evidence on this record suggesting that the clinical effectiveness
of a product with regard to its antimicrobial properties is a surrogate for
photostability. Rather, Gibbins ’751 suggests that the problem with
silverized products related to photostability is discoloration because
discoloration in the product causes discoloration of skin touching the
product. Ex. 1007, 4:28-31. Thus, a purple dressing is “unsuitable for
clinical use” because of its discoloration, not solely because the
antimicrobial effectiveness of the products may be reduced to some
unknown but less than optimal degree.
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Further, I disagree with the majority’s determination that “minimal
change,” as referenced within the meaning of “photostable,” may refer to a
change of color from a desirable color to an undesirable color. ConvaTec
provides testimonial evidence that a color change from the “desired colour”
(e.g., white) to purple would not be understood to be a “minimal change” to
a person of ordinary skill in the art. Pet. 13 and 53. Ex. 2028 ¶ 16-21 (Dr.
Phillips concluding that “a color change from ‘white’ to ‘purplish’ is in my
opinion a discoloration, and does not equate with a ‘substantially
photostable’ product …that has minimal color change from the ‘desired
color’ of white.”); Ex. 2029 ¶ 50 (Dr. Edgar stating “I fully agree with Dr.
Phillips’ statements from a scientific point of view that a change in color of
the product from ‘white’ to ‘purple’ would not be considered ‘substantially
photostable’ or ‘photostable.’”); see Ex. 1050, 19-20. Smith & Nephew
presents no evidence as to what would be considered a “minimal change” to
a person of ordinary skill in the art. Thus, the weight of the evidence
suggests that a change of color from a desirable color to an undesirable color
would not be considered a “minimal change.”
The claims, however, simply do not require silver to be photostable,
but require the silver to be “substantially photostable.” Here, I agree with
the majority that “substantially,” in the context of the ’828 patent, means
“largely” or “essentially.” Under the broadest reasonable interpretation of
“substantially photostable,” silver may undergo some minimal discoloration
to an undesirable color and still be considered “substantially [i.e.,
essentially] photostable.”
Using the above claim construction, I disagree with the majority’s
reliance on Example 25 of Gibbins ’751, but agree with the outcome because
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61
Example 24 of Gibbins ’751 discloses the results of an experiment
producing a product that is substantially photostable. Specifically, Example
24 describes an experiment in which the prepared product produced purple
specks when subjected to a light-stability test. Ex. 1007, 33:37-43. A
person of ordinary skill in the art would understand a “speck” to represent a
color change within the meaning of the terms “substantially photostable.”
This disclosure in Example 24, combined with other teachings in
Gibbins ’751 suggesting that the order of steps used in Example 24 may be
reversed (id. at col. 18, ll. 30-32), reaches the “substantially photostable”
element of the claims.
The results of Example 25 of Gibbins ’751, however, describe an
experiment in which the prepared products eventually turned “purplish.” Id.
at 34:46-54. There is insufficient evidence presented on this record to
support a finding that a disclosure of a product “eventually turning a
purplish color” would be considered a minimal color change. See, id.
With regard to the Motion to Amend, although substitute claim 15
deletes the term “substantially,” potentially addressing the problem of
finding a product producing only purple specks to be within the scope of the
claim, I agree with the majority’s opinion that ConvaTec’s Motion to
Amend remains deficient. Accordingly, I join the majority with regard to
the denial of the Motion to Amend.

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Petitioner:

Jeff B. Vockrodt
Rodger L. Tate
Christopher H. Yaen
Hunton & Williams, LLP
jvockrodt@hunton.com
rtate@hunton.com
cyaen@hunton.com

Patent Owner:

Jeffrey Guise
Peter R. Munson
Lorelei P. Westin
Wilson Sonsini Goodrich & Rosati, PC
jguise@wsgr.com
pmunson@wsgr.com
lwestin@wsgr.com