Ex Parte Qiu et al

Patent Trial and Appeal Board

Nov 22, 2016

13847112 (P.T.A.B. Nov. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/847, 112 03/19/2013
31781 7590 11/25/2016
ALCON RESEARCH, LTD,
PA TENT DEPARTMENT
11460 JOHNS CREEK PARKWAY
JOHNS CREEK, GA 30097-1556
FIRST NAMED INVENTOR
Y ongxing Qiu
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
PAT033229-US-DIV 5720
EXAMINER
ALAWADI, SARAH
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
11/25/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
patent. docketing@alcon.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YONGXING QIU, JOHN MARTIN LALLY,
MANAL M. GABRIEL, and XINMING QIAN 1
Appeal2015-005013
Application 13/847,112
Technology Center 1600
Before DEMETRA J. MILLS, ULRIKE W. JENKS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for making an antimicrobial device from a polymerizable dispersion that
includes a siloxane-containing macromere and stabilized-silver nanoparticles
that were obtained by reducing silver ions or silver salts in a solution in the
presence of a stabilizer and lyophilized, which have been rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as Novartis AG. (Appeal Br.
3.)
Appeal2015-005013
Application 13/847,112
STATEMENT OF THE CASE
"Contact lenses are often exposed to one or more microorganisms
during wear, storage and handling." (Spec. 1.) "Many attempts have been
made to develop antimicrobial" contact lenses including by "incorporat[ing]
antimicrobial compounds into a polymeric composition for molding a
contact lens" or coating the contact lenses with antimicrobial coatings.
(Spec. 1-2.) Appellants' invention is directed to making "an antimicrobial
ophthalmic device which has a relatively high antimicrobial activity over a
long period of time." (Spec. 2.)
Claims 24, 25, and 27-32 are on appeal. 2 Claim 24 is representative
and reads as follows:
24. A method for making an antimicrobial medical device,
comprising the steps of:
obtaining lyophilized stabilized-silver nano-particles,
wherein the stabilized-silver nano-particles are obtained by
reducing silver ions or silver salts in a solution in the presence
of a stabilizer by means of heating;
directly dispersing a desired amount of the lyophilized
stabilized-silver nano-particles in a polymerizable fluid
composition comprising a siloxane-containing macromer to
form a polymerizable dispersion;
introducing an amount of the polymerizable dispersion in
a mold for making a medical device; and
polymerizing the polymerizable dispersion in the mold to
form the antimicrobial medical device containing silver
nanoparticles.
2 Claims 14--23 are also on appeal, but stand withdrawn from consideration.
(Appeal Br. 3.)
2
Appeal2015-005013
Application 13/847,112
(Appeal Br. 14 (formatting changes added).)
The following ground of rejection by the Examiner is before us on
review:
Claims 24, 25, and 27-32 under 35 U.S.C. § 103(a) as being
unpatentable over Andersson, 3 Guillet, 4 Tan, 5 Markowitz, 6 Yarborough, 7
and Chan. 8
DISCUSSION
The Examiner finds that Andersson teaches making contact lenses by
incorporating nanosized silver salt particles into the lens formulation that
includes the siloxane monomer TRIS, and the vinylic and hydrophilic
monomer DMA in a diluent that has been put into a mold and then curing
the composition to effect polymerization. (Final Action 4; Ans. 4.) The
Examiner notes that Andersson does not "expressly teach that the
nanonarticles are lvonhilized and stabilized with nolvacrvlic acid nrior to
_._ el _._ _._ el el _._
addition with the polymerizable fluid." (Final Action 5; Ans. 4.)
The Examiner finds that Guillet teaches preparation of stable silver
colloids by "reducing metallic silver [through radiation, e.g., laser radiation,]
and surrounding the silver particles with polyacrylic acid" and that these
3 Andersson et al., US 2004/0150788 Al, published Aug. 5, 2004. The
Examiner and Appellants refer to this publication as Anderson.
4 Guillet, US 2003/0177868 Al, published Sept. 25, 2003.
5 Tan et al., Preparation of gold, platinum, palladium and silver
nanoparticles by the reduction of their salts with a weak reductant-
potassium bitartrate, 13 J. Mater. Chem. 1069-75 (2003).
6 Markowitz et al., US 6,054,495, issued Apr. 25, 2000.
7 Yarborough et al., US 2004/0009609 Al, published Jan. 15, 2004.
8 Chan et al., US 2005/0038471 Al, published Feb. 17, 2005.
3
Appeal2015-005013
Application 13/847,112
particles can be used in drug delivery. (Final Action 5; Ans. 4--5.) The
Examiner finds that Tan teaches that chemical reduction of silver
nanoparticles with a stabilizer "protects [the] smaller nanoparticles from
aggregating and helps control [the] particle size and shape." (Final Action 5;
Ans. 5.) The Examiner further finds that Chan teaches radiation is a heat
source, and thus the laser radiation used in Guillet reduces the silver by
heating. (Final Action 5; Ans. 4--5.) The Examiner finds that it would have
been obvious to one of ordinary skill in the art at the time the invention was
made to substitute the silver particles of Andersson with the Guillet reduced
silver particles that are stabilized with polyacrylic acid for the benefit of
having stabilized non- aggregated silver particles. (Final Action 5; Ans. 5.)
The Examiner notes that while Guillet does not teach lyophilization of
the reduced nanoparticles, it would have been obvious to do so with the
Guillet particles in light of Markowitz and Yarborough and use such
particles in the Andersson method. (Final Action 6; Ans. 5.) The Examiner
finds that Markowitz teaches lyophilization of metal nanoparticles and that
Yarborough teaches that lyophilization enables storage of particles without
refrigeration but allows for "excellent resolubility." (Final Action 6; Ans.
5.)
We agree with the Examiner's factual findings and conclusion that it
would have been obvious to substitute the reduced silver nanoparticles of
Guillet that had been lyophilized as taught by Markowitz in the Andersson
method.
Appellants argument that one of ordinary skill in the art would not
have substituted the silver salt particles of Andersson "for silver particles
4
Appeal2015-005013
Application 13/847,112
that have been reduced and stabilized with polyacrylic acid as disclosed by
Guillet because silver ion, not the reduced silver ion, is responsible for the
effect of antimicrobial property" (Appeal Br. 6) is not persuasive. In light of
the knowledge in the prior art as evidenced by Guggenbichler, 9 a reference
cited by Appellants (Appeal Br. 6), it is irrelevant to a determination of
obviousness that Guillet does not specifically mention that the reduced
stabilized silver nano-particles are antimicrobial, cf Abbott Labs. v. Baxter
Pharm. Prod., Inc., 471 F.3d 1363, 1367---68 (Fed. Cir. 2006) (holding that
discovery of a property inherent to a prior art process does not render that
process patentable, even if the prior art did not appreciate the property), as
that would be an inherent property of the Guillet stabilized and reduced
nano-particles as used in the Andersson method.
The Examiner finds that even if prior art teaches that for silver to have
antimicrobial properties, it must be in its ionized form (Appeal Br. 6; Reply
Br. 3), Andersson as modified with the reduced stabilized nano-particles of
Guillet would be antimicrobial to the same extent as Appellants claimed
reduced, stabilized silver nano-particles (Ans. 8-9; Claim 24).
Guggenbichler supports the Examiner's finding. In particular,
Guggenbichler teaches that a sufficient concentration of free, unbound silver
ions can result from metallic silver nano-particles in a polymer matrix.
(S20-S21). Guggenbichler notes that when "[a] substantial enlargement of
the surface of metallic silver" is present in a polymer matrix, such as is
9 Guggenbichler et al., A New Technology of Microdispersed Silver in
Polyurethane Induces Antimicrobial Activity in Central Venous Catheters,
27 (Suppl. 1) Infection, S 16-S23 (1999).
5
Appeal2015-005013
Application 13/847,112
provided by provision of nano-particles to the matrix, it can result "in the
liberation of antimicrobially-active concentration[ s] of silver" through the
reaction "with NaCl, KCl and other salts in electrolyte solutions or in
interstitial fluids." (Id.) In the modified Andersson method, the reduced and
stabilized nano-particles would be mixed with the polymerizable fluid, thus
creating a matrix filled with silver nano-particles that would give rise to a
large reactive surface of silver particles. These silver nano-particles would
then be available for liberation of silver ion in the contact lens produced
therefrom, when placed in contact with the tears that moisten the outer
surface of the eyeball. Thus, we do not agree with Appellants that Guillet's
teaching of reduced stabilized metallic silver nano-particles would have
dissuaded one of ordinary skill in the art from using those particles in
Andersson (Appeal Br. 5---6). Moreover, we disagree with Appellants that
"the basic principle of operation of [Andersson] is changed" (Appeal Br. 4--
6; Reply Br. 3--4) by the substitution with Guillet's reduced, stabilized silver
nano-particles.
We also disagree with Appellants that Guillet' s teaching that the
reduced and stabilized silver nano-particles may be "potentially useful in
imaging applications such as ink jet printers" (Appeal Br. 6) would have
dissuaded one of ordinary skill in the art from using those particles in
Andersson (Appeal Br. 6). As Appellants note, Guillet teaches finely
divided silver metal particles (Reply Br. 3) that are protected from
aggregating (Appeal Br. 6). We agree with the Examiner that Guillet's
teachings, which also include that the metal nanoparticle composition can be
used in drug delivery applications (Ans. 6 (citing Guillet i-fi-1 6, 27, 3 0, and
6
Appeal2015-005013
Application 13/847,112
45--46)), besides for imaging applications (Appeal Br. 6; Reply Br. 3), are
sufficient to render Guillet' s teachings relevant to Andersson, which
concerns making a medical device (contact lens) for delivering a drug
(antimicrobial silver ions) to the eye. (Ans. 6.)
Appellants argue that there would not have been a reasonable
expectation of success to obtain lyophilized silver particles because
Markowitz teaches that lipid A and lipid B are essential elements for
Markowitz's application and that Andersson does not teach lipid A and lipid
B like Markowitz. (Appeal Br. 7-8.) We disagree. As the Examiner notes,
Markowitz was not relied upon for the method of making vesicles that
include metallic ions, but rather for teaching that lyophilization of
unagglomerated metallic nano-particles was well within the knowledge of
one of ordinary skill in the art and that such particles are readily able to be
dispersed again upon reconstitution. (Ans. 9; Markowitz 1 :59---60.) Even if
it were true that Markowitz teaches the necessity of lipid A and lipid B in
making size controlled unagglomerated metal nano-particles using
unpolymerized vesicles, which we take no position on, that would not
change our conclusion that there is sufficient evidence to establish a
reasonable expectation of success of lyophilizing the Guillet stabilized and
reduced silver nano-particles. Regardless of what steps Markowitz indicates
were used "for the formation of size controlled unagglomerated [metallic]
nanoparticles" (Markowitz 1 :49---60), Markowitz does not teach that any
peculiar methodology was necessary for lyophilization of the nano-particles
made by the disclosed process. (Markowitz 8:9-10.) As the Examiner
explained
7
Appeal2015-005013
Application 13/847,112
the test for obviousness is not whether the features of a
secondary reference may be bodily incorporated into the
structure of the primary reference; nor is it that the claimed
invention must be expressly suggested in any one or all of the
references. Rather, the test is what the combined teachings of
the references would have suggested to those of ordinary skill
in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871
(CCPA 1981).
(Ans. 10.) Moreover, for a prima facie case of obviousness to be
established, the references need not recognize the problem solved by
Appellants (Appeal Br. 7). See In re Kemps, 97 F.3d 1427, 1430 (Fed. Cir.
1996) ("[T]he motivation in the prior art to combine the references does not
have to be identical to that of the applicant to establish obviousness."); In re
Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992). We agree with the Examiner
that in light of Markowitz's teaching that it was known how to lyophilize
metallic nanoparticles that can readily redisperse upon hydration, and
Yarborough' s teaching that "lyophilization increases storage stability by
providing compounds with longer shelf lives with excellent resolubility
characteristics" (Final Action 6), it would have been obvious to lyophilize
Guillet's silver nano-particles to obtain a shelf-stable product with good
reconstitution (Ans. 9) and use such particles in Andersson's method.
For the foregoing reasons, Appellants do no persuade us that the
Examiner erred in rejecting claim 24 for obviousness over 24, 25, and 27-32
under 35 U.S.C. § 103(a) as being unpatentable over Andersson, Guillet,
Tan, Markowitz, Yarborough, and Chan.
Claims 25 and 27-32 have not been argued separately and therefore
fall with claim 24. 37 C.F.R. § 41.37(c)(l)(iv).
8
Appeal2015-005013
Application 13/847,112
SUMMARY
We affirm the rejection of claims 24, 25, and 27-32 under 35 U.S.C.
§ 103(a) as being unpatentable over Andersson, Guillet, Tan, Markowitz,
Yarborough, and Chan.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
9