Howard Allen. Ketelson et al.

Patent Trials and Appeals Board

Aug 5, 2019

15398761 - (D) (P.T.A.B. Aug. 5, 2019)

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.
15/398,761 01/05/2017 Howard Allen Ketelson PAT903078-US-CNT02 1201
31781 7590 08/05/2019
ALCON RESEARCH, LTD.
PATENT DEPARTMENT
11460 JOHNS CREEK PARKWAY
JOHNS CREEK, GA 30097-1556
EXAMINER
MILLIGAN, ADAM C
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
08/05/2019 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 HOWARD ALLEN KETELSON and
NATHANIEL D. MCQUEEN1
__________

Appeal 2019-002322
Application 15/398,761
Technology Center 1600
__________

Before ERIC B. GRIMES, FRANCISCO C. PRATS, and
DEBORAH KATZ, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a contact
lens product, which have been rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
The Specification states that “[a] new family of contact lens materials,
silicone hydrogels (‘SiH’), is gradually replacing traditional hydrogels as the
material of choice for extended wear soft contact lenses.” Spec. 2:1–3.

1 Appellants identify the Real Party in Interest as Novartis AG. Appeal Br. 3.
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“Surfactants have been utilized in prior compositions for treating contact
lenses, for example poloxamers and poloxamines, such as the Pluronic® and
Tetronic® brands of surfactants, which are poly(oxyethylene) -
poly(oxypropylene) (‘PEO-PPO’) block copolymers.” Id. at 2:18–23.2
“However, such surfactants do not wet SiH lenses efficiently.” Id. at
2:23. “The present invention is directed to ophthalmic compositions
containing one or more block copolymers referred to as (polyoxyethylene)-
(polyoxybutylene) block copolymers (‘PEO-PBO’).” Id. at 1:6–8.3 The
“invention is particularly directed to the use of PEO-PBO copolymers in . . .
compositions for treating contact lenses, especially SiH lenses.” Id. at 3:14–
16. The compositions can be used “as packaging solutions for contact lenses,
i.e., solutions in which the contact lenses are stored from the time of
manufacture until a sale to a contact lens wearer.” Id. at 16:8–10.
Claims 21–30 are on appeal. Claim 21 is the only independent claim
and reads as follows:
21. A contact lens product, comprising a package; and a packaging
solution for storing a silicone hydrogel contact lens, wherein the
packaging solution comprises 0.001 w/v % to about 1 w/v % of at
least one poly(oxyethylene)-poly(oxybutylene) block copolymer
having a molecular weight in the range of 500 to 100,000 Daltons, and
having an osmolality of 200 to 400 milliosmoles/kilogram.

2 “Poly(oxyethylene)-poly(oxypropylene)” is abbreviated in different places
in the record as “PEO-PPO,” “EO-PO,” or “POP-POE.”
3 “Poly(oxyethylene)-poly(oxybutylene)” is abbreviated in different places
in the record as “PEO-PBO,” “EO-BO,” or “POB-POE.”
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DISCUSSION
The Examiner has rejected claims 21–30 under 35 U.S.C. § 103(a) as
obvious based on Ketelson4 and Nace.5 Ans. 3. The Examiner finds that
Ketelson teaches that “[b]lock copolymer surfactants . . . improv[e] the
surface wettability of soft contact lenses.” Ans. 3. “The block copolymers
used are in the form of PEO-PPO block copolymers . . . , with Tetronic ®
1304 being the most preferred.” Id. The Examiner finds that “Ketelson
teaches that soaking a contact lens in a EO/PO surfactant copolymer will
improve the wettability of the contact lens and will result in higher
comfortability of the contact lens for the user.” Id. at 4.
The Examiner finds that “Ketelson does not teach the use of PEO-
PBO block copolymers” but “Nace teaches a composition comprising 0.1%
of a polyoxyethylene-polyoxybutylene block copolymer.” Id.
The Examiner finds that “Nace does not teach that the composition is
suitable for ophthalmic use.” Id. at 5. The Examiner finds, however, that
“Nace teaches that POB/POE (i.e. EO-BO) copolymers wet surfaces more
efficiently than POP/POE (i.e EO-PO) copolymers,” and concludes that it
would have been obvious
to treat the contact lenses of Ketelson with the EO-BO
surfactant copolymers of Nace given that Nace teaches EO-BO
copolymers ha[ve] even better wettability than EO-PO
copolymers. As such, the skilled artisan would have an

4 Ketelson et al., Dynamic wettability properties of a soft contact lens
hydrogel, 40 Colloids and Surfaces B: Biointerfaces 1−9 (2005).
5 V.M. Nace, Contrasts in the Surface Activity of Polyoxypropylene
and Polyoxybutylene-Based Block Copolymer Surfactants, 73 JAOCS1–8
(1996).
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expectation that soaking the contact lenses of Ketelson in EO-
BO copolymer solution of Nace prior to use would provide the
user with even more comfortability than that taught by Ketelson
because the contact lenses would have even more wettability.
Id. at 4–5.
Appellants argue, among other things, that “[a]t most, the Nace[]
article teaches cotton wetting performance of POP/POE copolymer or
POB/POE materials.” Appeal Br. 5. Appellants argue that “[t]he Examiner
has . . . failed to provide sufficient reasoning to support his rationale as to
why a person skilled in the art to replace Tetronic® surfactants[,] with
tetrafunctional block copolymers based on ethylene oxide (EO) and
propylene oxide (PO)[,] taught by Ketelson with PEO-PBO block
copolymers taught by Nace.” Id. at 7.
We agree with Appellants that the Examiner has not persuasively
shown that a person of ordinary skill in the art would have found it obvious
to modify Ketelson’s composition to include the PEO-PBO copolymer
taught by Nace. “In rejecting claims under 35 U.S.C. § 103, the examiner
bears the initial burden of presenting a prima facie case of obviousness.” In
re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993). “In rejecting an
application, factual determinations by the PTO must be based on a
preponderance of the evidence.” In re Oetiker, 977 F.2d 1443, 1449 (Fed.
Cir. 1992) (J. Plager, concurring). “Motivation to combine is
a factual determination.” Arctic Cat, Inc. v. Bombardier Recreational
Prods., Inc., 876 F.3d 1350, 1359 (Fed. Cir. 2017).
Ketelson investigated “[t]he wettability of poly[2-hydroxyethyl
methacrylate-co-methacrylic acid] (pHEMA-MAA) soft contact lenses . . .
in the absence and presence of block copolymer surfactants.” Ketelson 1,
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abstract. The block copolymers “consisted of four polyethylene oxide
(PEO)-polypropylene oxide (PPO) chains attached to the nitrogen atoms of
[a] central ethylene diamine functionality.” Id. at 2, right col. Ketelson
concludes that “the use of block copolymer surfactants with particular
physico-chemical properties appears to be a viable approach towards
improving the surface wettability properties of soft contact lenses.” Id. at 8,
right col.
Nace states that “[b]lock copolymer nonionic surfactants, made from
1,2-butylene oxide (BO), propylene oxide (PO), and ethylene oxide (EO),
are an interesting class of materials.” Nace 1, left col. Nace “presents a
detailed comparison of POB/POE and POP/POE block copolymer
surfactants in terms of several key interfacial performance parameters, such
as . . . wetting.” Id. at 2, left col. Nace reports that “POB/POE copolymers
wet cotton more efficiently than POP/POE analogues because of the oillike
nature of the POB hydrophobe and its ease of interface formation with
hydrophobic cotton fibers.” Id. at 3, left col.
Thus, as the Examiner has found (Ans. 4), Ketelson teaches contact
lens solutions, but not ones that contain the PEO-PBO copolymer required by
claim 21. And, while Nace discloses a composition containing a PEO-PBO
copolymer, it “does not teach that the composition is suitable for ophthalmic
use” (Ans. 5), like the compositions of Ketelson and claim 21.
The Examiner has not identified a common thread shared by Ketelson
and Nace that would provide a reason to combine their teachings. The
Examiner points to Nace’s teachings regarding the wetting properties of
PEO-PBO copolymers (Ans. 4) but, while Nace teaches that PEO-PBO
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copolymers are more efficient in wetting cotton than PEO-PPO copolymers,
the Examiner has not provided evidence or sound reasoning to show that a
surfactant that is efficient in wetting cotton would also be expected to be
efficient in wetting a contact lens, whether it be the pHEMA-MAA contact
lens of Ketelson or the silicone hydrogel contact lens referred to in claim 21.
In summary, we conclude that the Examiner has not cited evidence
sufficient to show that a person of ordinary skill in the art would have had a
reason, based on Ketelson and Nace, to replace the PEO-PPO copolymer in
Ketelson’s composition with Nace’s PEO-PBO copolymer. Because the
rejection of claims 21–30 under 35 U.S.C. § 103(a) based on Ketelson and
Nace is not supported by a preponderance of the evidence, we reverse it.

REVERSED