Ex Parte Pruitt et al

Patent Trial and Appeal Board

Jan 16, 2015

11978336 (P.T.A.B. Jan. 16, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte JOHN DALLAS PRUITT, LYNN COOK WINTERON,
SAI RAMAMURTHY KUMAR, and DAWN A. SMITH
____________

Appeal 2012-004850
Application 11/978,336
Technology Center 1600
____________

Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a method
of applying a hydrophilic coating onto a contact lens. The Examiner rejects
the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1 Appellants state that the Real Party in Interest is Novartis AG. (App.
Br. 1.)
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STATEMENT OF THE CASE
The Specification explains that
[S]ilicone hydrogel material typically has a surface or at least
some areas of its surface which is hydrophobic (non-
wettable). . . . The hydrophobic surface or surface areas of a
silicone hydrogel contact lens may cause it be adhered to the
eye. Thus, a silicone hydrogel contact lens will generally
require a surface modification to increase surface
hydrophilicity.
(Spec. 1.)
Claims 1–10 are on appeal, and can be found in the Claims Appendix
of the Appeal Brief (App. Br. 8–9). Claim 1 is representative of the claims
on appeal, and reads as follows:
1. A method for applying a hydrophilic coating onto a
silicone hydrogel contact lens, comprising the steps of:
(a) placing the contact lens in a lens package containing a
packaging solution, thereby forming an LbL coating on the
contact lens, wherein the packaging solution comprises a
polyionic material and at least one hydrolysable-at-autoclave
material, wherein the polyionic material includes (i) a polymer
having a hydrophobic backbone and multiple charged or
ionizable pendant groups, (ii) a chitosan, or (iii) a combination
thereof, wherein the packaging solution has an initial pH of less
than about 4.0, wherein the hydrolysable-at-autoclave material
is present in the packaging solution in an amount sufficient to
impart a final neutral pH to the packaging solution after the
package with the contact lens therein is autoclaved;
(b) sealing the lens package with the contact lens and the
packaging solution having the initial pH of less than about 4.0
therein; and
(c) autoclaving said sealed package with the contact lens
and the packaging solution therein, thereby hydrolyzing the
hydrolysable-at-autoclave material and imparting the final
neutral pH to the packaging solution in the sealed package,
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wherein the LbL coating has a hydrophilicity characterized by
an averaged water contact angle of about 80 degrees or less.

The Examiner rejects the claims as follows:
I. claims 1–6 and 9–10 under 35 U.S.C. § 103(a) as unpatentable
over Qiu2 in view of Chmelir3;
II. claims 7 and 8 under 35 U.S.C. § 103(a) as unpatentable
over Qiu in view of Chmelir and further in view of
Sherman4; and
III. claims 1–10 under 35 U.S.C. § 103(a) as unpatentable over
Muller5 in view of Qiu, Chmelir, and Sherman.

I. The Issue: Obviousness over Qiu and Chmelir
The Examiner’s position is that Qiu “teaches methods for making LbL
coated contact lenses. . . . [Specifically finding,] that polymers such as
polyacrylic acid can be added to the contact lens by placing the lens in a
solution of polyacrylic acid at a pH of 2.5.” (Ans. 6.) The Examiner
acknowledges that Qiu “does not teach the addition of urea to the contact
lens buffer before autoclaving to neutralize the polyacrylic acid lens coating
solution.” (Id.) The Examiner looks to Chmelir for providing this element.
Specifically, “Chmelir teaches that this neutralization can be performed
using urea hydrolysis, with the added benefit of forming hydrogels with
increase[d] water retention (hydrophilicity).” (Id.)

2 Yongxing Qiu et al., US 6,896,926 B2, issued May 24, 2005.
3 Miroslav Chmelir, US 5,856,370, issued Jan. 5, 1999.
4 Guy J. Sherman, US 4,560,491, issued Dec. 24, 1985.
5 Achim Müller et al., US 6,156,244, issued Dec. 5, 2000.
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Does the preponderance of evidence of record support the Examiner’s
conclusion that it would have been obvious to combine the teachings of Qiu
and Chmelir because each uses the “same active steps of neutralizing the
acidic polymers and heating them to high temperatures in both methods”?
Findings of Fact (FF)
1. Qiu disclosed a method of applying a layer-by-layer (LbL)
coating onto a contact lens (Qiu, col. 2, ll. 55–60). “[T]he concentration of
the charged polymeric material in a solution for forming the innermost layer
of an LbL coating is at least three folder higher than the concentration of a
coating material in a coating solution for forming subsequent layers of the
LbL coating.” (Qiu, col. 12, ll. 13–17; Ans. 6.)
2. Qiu’s Example 3 disclosed a LbL coating made of layers
comprising polyacrylic acid (PAA) and poly (allylamine hydrochloride)
(PAH). The contact lens, in Example 3, is sequentially dipped in either PAA
or PAH solution followed by a water rinse in-between each dip. (see Qiu
col. 15, l. 34 to col. 16, l. 39 (Example 3); Ans. 6.) The first coating on the
lens applies “PAA solution (0.001M, pH 2.5) for 30 min to form the inner
most layer of the coating. . . . [The lens is] then dipped manually in a PAH
solution (0.0001M, pH 2.5).” (Qiu col. 16, ll. 14–19.)
3. Qiu disclosed that PAA coating has a direct impact on the
hydrophilicity of the lens.
It is discovered unexpectedly that the concentration of 1st
dip solution (i.e., the first PAA solution) appears to have a
direct impact on the hydrophilicity of the lens coating. The
LbL coated lenses with the 1st dipping in the 0.001M PAA
solution have an average contact angle of from about 42
degrees. The LbL coated lenses with the 1st dipping in the
0.0001M PAA have an average contact angle of from about 87
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degrees.
(Qiu col. 16, ll. 14–19.)
4. Chmelir disclosed the use of blowing agents for the formation
of structures in hydrogels.
Ammonium salts of inorganic or organic acids and urea are
mentioned as blowing agents, ammonium carbonate being
preferred. . . . [A]mmonium and alkali carbonates used as
blowing agents which are added to the monomer solution prior
to polymerization. Owing to the carbonate decomposition
during polymerization, carbon dioxide is formed and causes the
formation of a “microcellular structure” in the hydrogel. This
may explain the improved absorption rate for liquids of the
final product.
(Chmelir col. 1, ll. 54–63; Ans. 6.)
5. Chmelir disclosed the use of hydrolysable-at-autoclave
materials to neutralize the hydrogel product.
[A]n N-containing blowing agent decomposing to ammonia and
carbon dioxide at 80° to 250° C is added to acrylic acid, either
before or after the polymerization. The acrylic acid is
neutralized to the extent of 60-100% with NaOH, KOH or NH3,
and the added quantity of N-containing blowing agent
corresponds to an increase in the neutralization degree to 102 to
140%. Ammonium salts of inorganic or organic acids and urea
are mentioned as blowing agents, ammonium carbonate being
preferred.
(Chmelir col. 1, ll. 47–56; Ans. 6.)
Principles of Law
To support an obviousness rejection, all claim limitations must be
taught or suggested by the prior art. See In re Royka, 490 F.2d 981, 984–85
(CCPA 1974). “A rejection based on section 103 clearly must rest on a
factual basis, and these facts must be interpreted without hindsight
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reconstruction of the invention from the prior art.” In re Warner, 379 F.2d
1011, 1017 (CCPA 1967). “The Patent Office has the initial duty of
supplying the factual basis for its rejection. It may not, because it may doubt
that the invention is patentable, resort to speculation, unfounded assumptions
or hindsight reconstruction to supply deficiencies in its factual basis.” Id.
Analysis
Qiu disclosed a method of applying a coating agent onto a contact
lens. (FF 1–3.) As recognized by the Examiner, “Qui [sic] does not teach
the addition of urea to the contact lens buffer before autoclaving to
neutralize the polyacrylic acid lens coating solution.” (Ans. 6.) The
Examiner looks to Chmelir for this limitation.
Chmelir teaches adding a urea-containing blowing agent to an acrylic
acid polymer mixture. (FF 5.) Specifically, Chmelir discloses a two-step
process to neutralize the acrylic acid composition. Initially, “[t]he acrylic
acid is neutralized to the extent of 60-100% with NaOH, KOH or NH3, and
the added quantity of N-containing blowing agent corresponds to an increase
in the neutralization degree to 102 to 140%” (FF 5). As explained by
Chmelir, blowing agents produce gas that allows the formation of
microcellular structures during the polymerization of the acrylic acid
polymer. (FF 4.) In addition to the carbon dioxide gas formation, the
blowing agent also functions to neutralize the solution of the acrylic acid
composition. (FF 5.)
Appellants argue that a prima facie case of obviousness has not been
established based on Qiu and Chmelir (App. Br. 2–5). Specifically,
Appellants contend that “(Qiu) is totally silent about an in-situ coating
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process (i.e., applying a coating onto a lens surface directly in the lens
package).” (App. Br. 3.)
We have considered the cited references and the Examiner’s response
to Appellants’ arguments, but find that based on the facts presented,
Appellants have the better position with respect to the combination of Qiu
and Chmelir. We agree with the Appellants that the Examiner has not
provided a clearly articulated rationale to add the blowing agent from
Chmelir to the polyacrylic acid coating agent of Qiu. In particular we find
that the Examiner’s assertion that it would have been obvious to add the
blowing agent to the contact lens coating solution of Qiu because the
ordinary artisan “would have preferred to heat the composition once rather
than twice, thereby saving time and energy and thus would have sealed the
packaging material before the neutralization step, thus avoiding a second
unnecessary sterilizing step” (Ans. 9) is not factually supported by the
record. What is missing from the Examiner’s analysis is some reason to
look to Chmelir’s blowing agent, an agent that produces gas, for the purpose
of arriving at a one-step sterilization / neutralization process for a contact
lens. The Examiner has not articulated a reason, based on facts in the
record, for adding a neutralizing agent, specifically, a hydrolysable-at-
autoclave material to the coating solution of Qiu.
Accordingly, we reverse the obviousness rejection of claim 1 and
rejected dependent claims based on the combination of Qiu and Chmelir.

II. The Issue: Obviousness over Qiu, Chmelir, and Sherman
With respect to this rejection, Appellants rely on the same arguments
relied upon with respect to claim 1 (App. Br. 6). For the reasons discussed
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above, we find that the Examiner has not established a prima facie showing
of obviousness with respect to claims 7 and 8. Accordingly, we also reverse
the rejection of these claims.

III. The Issue: Obviousness over Muller, Qiu, Chmelir, and Sherman
The Examiner takes the position that “Muller teaches the idea of
combining a buffer with a hydrolysable component in a sealed container,
and neutralizing the buffer by heating the hydrolysable component thereby
forming a hydrophilic coating on a contact lens.” (Ans. 13.) The Examiner
acknowledges that “Muller does not teach that the contact lens could be
coated with a hydrophilic polymer by neutralizing an acidic solution with a
base, instead of neutralizing a basic solution with an acid” (id. at 14). The
Examiner looks to Qiu for applying LbL coatings onto contact lenses with
polyionic material “such as polyac[r]ylic acid (which reads on a polyanionic
material) or carboxymethyl chitosan (which reads on a chitosan and contains
carboxyl groups)” (id.). The Examiner looks to Chmelir for teaching a
hydrolysable-at-autoclave material and finds “Chmelir teaches that adding
the blowing agent not only neutralizes the acrylic acid but also forms a
microcellular structure which increases the hydrogels absorption rate of
liquids (hydrophilicity) of the hydrogel” (id. at 15).
Does the preponderance of the evidence of record support the
Examiner’s conclusion that combination of references renders the step of
“autoclaving said sealed package with the contact lens and the packaging
solution” with the hydrolysable-at-autoclave material to arrive at a final
neutral pH obvious?
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Findings of Fact
6. Muller disclosed a process for making storage stable contact
lens by use of hydrogel moldings.
[The Process] comprises the following steps:
a) transferring a hydrogel moulding that contains
hydrolytically removable side groups to a container,
b) filling up the container containing the hydrogel
moulding with a basic buffer solution,
c) closing the container, and
e) autoclaving the container containing the hydrogel
moulding and the basic buffer solution at a temperature of at
least 100ºC, wherein, during the autoclaving, the hydrolytically
removable side groups are essentially completely removed, the
container contents are sterilized, and the basic buffer solution is
converted into a physiologically acceptable aqueous solution
that is substantially isotonic and pH-compatible with the
lacrimal fluid of the human eye.
(Muller, col. 2, ll. 19–39.)
7. Muller disclosed
During the autoclaving the hydrogel is generally sterilised, and
the side groups are generally completely hydrolysed. The acid
freed during the hydrolysis, which typically is produced by
removal of a side group, forms with the preferably basic
hydrolysis solution a buffer mixture of which the pH value,
osmolarity and composition are preferably within a
physiologically acceptable range.
(Muller, col. 3, ll. 15–22.)
8. Muller disclosed that “[a]ccording to ISO [International
Organization of Standardization] standard, the . . . physiological range for
storage solutions is from pH 6.8 to 7.8 and from 280 to 400 mosmol/kg”
(Muller, col. 13, ll. 66–67).

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Analysis
Appellants contend that Muller does not teach sealing a contact lens
into a package with a solution having an initial pH of “less than about 4.0”
(App. Br. 6). Appellants further contend that the neither Qiu nor Chmelir
suggests “the limitation of sealing the lens package with the contact lens and
the packaging solution having the initial pH of less than about 4.0 therein”
(id. at 7 (emphasis removed)).
The Examiner is relying on the combination of Muller, Qiu, and
Chmelir to arrive at the claim limitation of “autoclaving said sealed package
with the contact lens and the packaging solution therein, thereby hydrolyzing
the hydrolysable-at-autoclave material and imparting the final neutral pH to
the packaging solution in the sealed package.”
The Examiner finds that Muller disclosed “combining a buffer with a
hydrolysable component in a sealed container, and neutralizing the buffer by
heating the hydrolysable component” (Ans. 13). Appellants do not dispute
that Muller discloses neutralizing the storage solution of a contact lens
during the autoclaving step (App. Br. 6 (“What Muller teaches is a process
in which the hydrolytically removable side groups of a hydrogel moulding
(i.e., the side groups along the polymer chains with the polymer matrix of
the moulding) are essentially completely removed during autoclaving while
neutralizing the basic buffer solution in the package”).) Accordingly, Muller
provides the rationale for the ordinary artisan to consider placing a contact
lens and a hydrolysable-at-autoclave material into a sealed package (FF 6–
8).
Qiu teaches that the addition of the first PAA coating has a direct
impact on the hydrophilicity of the lens (FF 1, 3; see also Ans. 14). The
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PAA coating solution has a pH of 2.5 (FF 2; see also Ans. 14), “Qui [sic]
then teaches neutralizing the contact by placing it in PBS buffer at a pH of
7.2 and autoclaving the lens” (Ans. 14). Qiu disclosed washing off the
acidic coating solution and then “[e]ach of the coated lenses is placed and
sealed in one glass vial filled with a phosphate buffered saline (PBS) (ca. pH
7.2) and autoclaved” (Qiu, col. 16, 27–30). Muller acknowledges that the
physiological range of a solution is pH 6.8 to 7.8 (FF 8). Thus, both Qiu and
Muller teach storing a contact lens in a physiologically acceptable buffer.
As explained by the Examiner, Muller’s contact lens in the initial
packaging solution is at a pH that is too high and requires a lowering to
arrive at a physiological pH (see Ans. 13). Qiu’s coating solutions have a
pH that is too low and would require an elevation of pH to arrive at
physiologically acceptable pH value (see Ans. 14). The Examiner concludes
that it is obvious to add “the blowing agent urea to the solutions with the
methods of forming polyacrylic acid hydrogel coatings taught by Qui [sic] in
order to neutralize the contact lenses without the need for PBS buffer and
[simultaneously] provide a more hydrophilic coating on the lens.” (Ans.
16.)
We agree with Appellant that the Examiner has not shown that the
cited references disclose or would have made obvious the use of Qiu’s
coating solutions as a suitable lens packaging solution even if the pH is
brought up into a physiologically acceptable range as suggested by the
Examiner. What is missing from the Examiner’s analysis is some reason to
replace the PBS storage buffer with a neutral buffer containing the
polyacrylic acid (PAA) or poly (allylamine hydrochloride) (PAH) coating
materials. “In proceedings before the Patent and Trademark Office, the
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Examiner bears the burden of establishing a prima facie case of obviousness
based upon the prior art.” In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir.
1992). That burden has not been carried here. Because the Examiner has
not provided sufficient evidence-based reasoning to show that these coating
materials would also be suitable packaging materials for a contact lens, we
are constrained to reverse the rejection of claim 1 based on 35 U.S.C.
§ 103(a). For the same reason, we reverse the § 103(a) rejection of
dependent claims 2–10.
We conclude that the evidence cited by the Examiner does not support
a prima facie case of obviousness based on the combination of Muller, Qiu,
Chmelir, and Sherman.

SUMMARY
We reverse the rejection of claims 1–6 and 9–10 under 35 U.S.C.
§ 103(a) as unpatentable over Qiu in view of Chmelir.
We reverse the rejection of claims 7 and 8 under 35 U.S.C. § 103(a)
as unpatentable over Qiu in view of Chmelir and further in view of Sherman.
We reverse the rejection of claims 1–10 under 35 U.S.C. § 103(a) as
unpatentable over Muller in view of Qiu, Chmelir, and Sherman.

REVERSED

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