Ex Parte Winterton et al

Patent Trial and Appeal Board

Feb 28, 2017

11416260 (P.T.A.B. Feb. 28, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/416,260 05/02/2006 Lynn Cook Winterton PAT034254-US-NP 6548
7590
ALCON RESEARCH, LTD.
PATENT DEPARTMENT
11460 JOHNS CREEK PARKWAY
JOHNS CREEK, GA 30097-1556
EXAMINER
RONEY, CELESTE A
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
03/02/2017 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 LYNN COOK WINTERTON, and JOHN MARTIN LALLY1
Appeal 2016-003144
Application 11/416,260
Technology Center 1600
Before JEFFREY N. FREDMAN, RACHEL H. TOWNSEND, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to ophthalmic
products such as contact lenses that release materials during wear. The
Examiner entered final rejections for obviousness. We have jurisdiction
under 35 U.S.C. § 6(b). We REVERSE.
STATEMENT OF THE CASE
Background
The present invention relates to ophthalmic devices, in
particular contact lenses, which are capable of gradually
releasing one or more guest materials during wear over at least
1 Appellants identify the Real Party in Interest as Novartis AG. App. Br. 3.
Appeal 2016-003144
Application 11/416,260
about 6 hours after storing in a packaging solution for at least
about one months. The present invention also provides
methods for making ophthalmic devices of the invention and
for time-controlled release of one or more guest materials for
treating eye problems.
Spec. 1:7-11.
The Claims
Claims 1—3, 5—16, 17—25, and 27 are pending. App. Br. 3. Claims 4
and 26 are cancelled and 5, 6, 17—25, and 27 have been withdrawn from
consideration. Id. Claims 1—3 and 7—16 were finally rejected in the Final
Action2 and were appealed.3 Id. In the Answer, the Examiner withdrew
grounds of rejection 3—8. See Answer 2—3. Accordingly, claims 12, 15 and
16 are no longer subject to any rejection, leaving claims 1—3, 7—11, and 13—
14 on appeal.
Claim 1 is illustrative and reads as follows:
1. An ophthalmic product, comprising:
a sealed package including a packaging solution and a soft
hydrogel contact lens, wherein the hydrogel contact lens
comprises a polymer matrix and a guest material which is not
covalently linked to the polymer matrix but distributed therein,
wherein the hydrogel contact lens has a capability of
gradually releasing the guest material during wear over at least
2 Examiner’s Final Action, mailed February 5, 2015.
3 Appellants state “[cjlaims 1 and 17—19 are on appeal.” App. Br. 3.
However, Appellants argue the rejection of additional appealed claims. See
App. Br. 6—14. We address only those claims subject to appeal following
Examiner’s withdrawal of grounds 3—8, which are claims 1—3, 7—11, and
13—14. See Ans. 2—3. We note that claims 17—19 were withdrawn and
claims 12, 15 and 16 are no longer subject to any rejection.
2
Appeal 2016-003144
Application 11/416,260
about 6 hours after storing in the packaging solution for at least
about one months,
wherein the hydrogel contact lens is produced by cast­
molding in a mold of a fluid prepolymer composition without
being subjected to any extraction processes,
wherein the prepolymer composition comprises the guest
material and an actinically-crosslinkable prepolymer from
which the polymer matrix is formed by polymerization,
wherein the guest material comprises a lubricant or a drug or
both thereof, and
wherein the guest material is free of any groups capable of
being actinically crosslinked with the actinically-crosslinkable
prepolymer and present in an amount sufficient to be released
from the contact lens over at least about 6 hours of wearing
time,
wherein the actinically-crosslinkable prepolymer is a
polyhydroxyl compound having a molecular weight of at least
about 2000 and comprising from about 0.5 to about 80%, based
on the number of hydroxyl groups in the poly(vinyl alcohol), of
units of the formula I, I and II, I and 111, or I and II and 111
\...
U5-i: UH
■o. \ j:>
X
X:
X..
- \
n
3
Appeal 2016-003144
Application 11/416,260
CH >
4-----
in which
the molecular weight refers to a weight average molecular
weight, Mw, determined by gel permeation chromatography,
R is linear or branched alkylene having up to 12 carbon
atoms,
Ri is hydrogen or lower alkyl having up to seven,
R2 is an ethylenically unsaturated, electron-withdrawing,
crosslinkable radical having up to 25 carbon atoms,
R3 is hydrogen, a C1-C6 alkyl group or a cycloalkyl group,
R7 is a primary, secondary, tertiary amino group, or a
quaternary amino group of the formula NC/R’FX", in which
each R’, independently of the others, is hydrogen or a C1-C4
alkyl radical and X is a counterion,
Rs is the radical of a monobasic, di basic or tribasic,
saturated or unsaturated, aliphatic or aromatic organic acid or
sulfonic acid.
App. Br. 15—16 (Claims Appendix).
The Issues
Claims 1—3 and 7—11 are rejected under 35 U.S.C. § 103(a) as obvious
over Andino et al.* 4 Final Act. 2.
4 US 2004/0046287 Al, published March 11, 2004 (“Andino”)
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Appeal 2016-003144
Application 11/416,260
Claims 13—14 are rejected under 35 U.S.C. § 103(a) as obvious over
Andino in view of Bothe et al.* 5 Final Act. 5.
I
The Examiner has rejected claims 1—3 and 7—11 under 35 U.S.C. §
103(a) as obvious over Andino. The Examiner finds that Andino
discloses a method for producing an ophthalmic device . . .
[that] comprises a solution of device forming material into a
container, wherein said device forming material is crosslinkable
or polymerizable by actinic radiation. . . . Ideally, the contact
lens is comfortable to wear for extended periods of time ... its
packaging system compris[es] a hydrophilic polymeric material
(e.g. acrylamides, methacrylamides and vinyl-lactams []), and a
water soluble polymer component; said water soluble polymer
including polyvinyl alcohol.
Final Act. 2—3. The Examiner finds Andino further discloses “a hydrogel
contact lens and its packaging system comprising a hydrophilic polymeric
material and a water soluble polymer component [that includes] polyvinyl
alcohol.” Id. at 3. The Examiner finds “the formulas of the prior art are the
same as those of the instant claim 1” and concludes
[t]he molecular weight of the prepolymers of the invention is at
least about 2000, and comprises from about 0.5 to about 80 %,
based on the number of hydroxyl groups in the poly(vinyl
alcohol), of units of the formula I, I and II, I and III, or I and II
and 111.
Id.
The Examiner finds
Andino does not specifically disclose release over six hours, as
recited in claim 1; However, it appears that the composition of
5 US 5,712,356, issued January 27, 1998 (“Bothe”)
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Appeal 2016-003144
Application 11/416,260
the prior art would reasonably be expected to release the active
over six hours, since Andino discloses release over an extended
period of time, and since Andino uses the same polymer (e.g.
polyvinyl alcohol) as is instantly recited and disclosed.
Id. The Examiner concludes that Andino discloses all the individual
elements of the claimed combination, but not “in an anticipatory fashion.”
Id. at 3^4. The Examiner further concludes
it would have been obvious to have made this combination to
include the water soluble polymer components present in the
composition taught by Andino . . . because water soluble
polymers are taught to form contact lens[es and] this
modification of the prior art represents nothing more than “the
predictable use of prior art elements according to their
established functions” a prima facie case of obviousness exists.
Id. at 4 (citing KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007)).
Appellants argue that Andino
does not disclose or suggest anything about a) “wherein the
hydrogel contact lens comprises a polymer matrix and a guest
material which is not covalently linked to the polymer matrix
but distributed therein” and b) “wherein the guest material is
free of any groups capable of being actinically crosslinked
with the actinically-crosslinkable prepolymer” as recited in
the claim 1.
App. Br. 7 (emphasis original). Appellants argue that although Andino
discloses a hydrogel contact lens made of hydrophilic polymers like those
disclosed in their Specification, “these hydrophilic polymeric material are
used to prepare prepolymers for further irradiating to obtain a cured
layer of crosslinked device-forming material. Therefore, the actinically
crosslinkable groups in the hydrophilic polymeric material disclosed in
Andino have been consumed and become a part of prepolymer.” Id. at 7
(emphasis original).
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Application 11/416,260
The Examiner responds that the device forming material identified in
Andino “comprises a hydrophilic polymeric material (e.g. acrylamides,
methyacrylamides and vinyl-lactams . . .). The hydrophilic polymers are the
guest material (e.g. the hydrophilic polymers of Andino are lubricants). The
device forming material is formed by the cross-linkable water soluble
polymer (e.g. polyvinyl alcohol.” The Examiner concludes:
the polyvinyl alcohol of Andino’s formula I is a pre-polymer
(Andino at section 0037); however, it appears that the final
product is the actinic cross-linkable polyvinyl alcohol polymers.
Further, Andino states in the abstract that the composition is
cross-linkable by actinic radiation. As such, it appears that the
prior art and the instant claims are directed to the same final
product. Regarding whether or not polyvinyl alcohol is cross-
linkable, the Examiner maintains that polyvinyl alcohol is a
cross-linkable polymer based on the hydroxyl groups.
Ans. 4—5.
Appellants acknowledge that the claimed prepolymer for the lens
formation is identical to that of Andino, but argue “the difference is that
prepolymer composition in the present patent application also comprises the
guest material” of claim 1, which must be “free of any groups capable of
being actinically crosslinked with the actinically-crosslinkable prepolymer”
of claim 1. Reply Br. 3. Appellants argue Andino does not identify guest
material or guest material that is free of any groups capable of being
actinically crosslinked with the actinically-crosslinkable prepolymer. Id. at
3^4.
We agree with Appellants that the evidence does not support the
Examiner’s finding that Andino teaches all of the limitations of claim 1.
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Application 11/416,260
Although the Examiner has identified that hydrophilic polymers such as
acrylamides, methyacrylamides and vinyl-lactams may comprise the guest
material, it is not necessarily true that all of these polymers meet the
limitation of the claim 1 that the guest material is “free of any groups
capable of being actinically crosslinked with the actinically-crosslinkable
prepolymer.” “Inherency . . . may not be established by probabilities or
possibilities. The mere fact that a certain thing may result from a given set
of circumstances is not sufficient.” MEHL/Biophile Int 7 Corp. v. Milgraum,
192 F.3d 1362, 1365 (Fed. Cir. 1999).
The Examiner does not point to any specific teaching in Andino that
the hydrophilic polymers are not separately crosslinkable, or show that no
crosslinking of the hydrophilic polymer with the prepolymer is occurring in
Andino’s composition. Nor has the Examiner demonstrated materials that
are identical in structure to specific examples disclosed in the Specification.
If the Examiner had shown the materials were identical in any of these
manners, the burden to prove otherwise would have shifted to Appellants.
See In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Absent this showing,
however, we are constrained to reverse because the Examiner has not
provided evidence sufficient to support a prima facie case of obviousness.
See In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (“In rejecting claims
under 35 U.S.C. § 103, the examiner bears the initial burden of presenting a
prima facie case of obviousness. Only if that burden is met, does the burden
of coming forward with evidence or argument shift to the applicant.”).
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II
The Examiner has rejected claims 13—14 under 35 U.S.C. § 103(a) as
obvious over Andino in view of Bothe. As discussed above, however, the
Examiner has not shown that Andino teaches all of the limitations of
independent claim 1.
The Examiner relies on Bothe’s teachings regarding the molecular
weight range of hydrophilic copolymers (Final Act. 6), but does not point to
any teaching in Bothe that the hydrophilic copolymers are not separately
crosslinkable, or otherwise identify a lack of crosslinking. Because Bothe
does not cure the deficiency of the teachings of Andino, we therefore reverse
the rejection under 35 U.S.C. § 103(b).
SUMMARY
We reverse both of the rejections on appeal.
REVERSED
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