Novartis AG

Patent Trials and Appeals Board

Jun 18, 2020

2019005335 (P.T.A.B. Jun. 18, 2020)

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.
14/108,426 12/17/2013 Jinyu Huang PAT055389-US-NP 1211
31781 7590 06/18/2020
ALCON RESEARCH, LLC
PATENT DEPARTMENT
11460 JOHNS CREEK PARKWAY
JOHNS CREEK, GA 30097-1556
EXAMINER
KHARE, ATUL P
ART UNIT PAPER NUMBER
1742
NOTIFICATION DATE DELIVERY MODE
06/18/2020 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 JINYU HUANG, DAQING WU, UWE HAKEN,
HORNGYIH HUANG, and VENKAT SHANKAR
Appeal 2019-005335
Application 14/108,426
Technology Center 1700
Before JEFFREY B. ROBERTSON, JAMES C. HOUSEL, and
CHRISTOPHER C. KENNEDY, Administrative Patent Judges.
ROBERTSON, Administrative Patent Judge.
DECISION ON APPEAL1
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the
Examiner’s decision to reject claims 1, 3–5, and 7. Appeal Br. 2. We have
jurisdiction under 35 U.S.C. § 6(b).

1 This Decision includes citations to the following documents: Specification
filed December 17, 2013 (“Spec.”); Final Office Action mailed June 26,
2018 (“Final Act.”); Appeal Brief filed November 19, 2018 (“Appeal Br.”);
Examiner’s Answer mailed May 2, 2019 (“Ans.”); and Reply Brief filed July
2, 2019 (“Reply Br.”).
2 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real party in interest as Novartis AG.
Appeal Br. 2.
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We affirm.
CLAIMED SUBJECT MATTER
Appellant states the invention relates to a method for making contact
lenses using quaternary ammonium cationic group containing silicone
surfactants as mold releasing agents. Spec. 1. Claim 1, reproduced below,
is illustrative of the claimed subject matter (Appeal Br., Claims Appendix
11):
1. A method for producing silicone hydrogel contact lenses, the
method comprising the steps of:
(1) providing a mold for making soft contact lenses, wherein
the mold has a first mold half with a first molding surface
for defining an anterior surface of a contact lens and a
second mold half with a second molding surface for
defining an opposite posterior surface of the contact lens,
wherein said first and second mold halves are configured
to receive each other such that a cavity is formed between
said first and second molding surfaces;
(2) introducing a fluid polymerizable composition comprising
at least one actinically-crosslinkable water processable
siloxane-containing prepolymer and at least one water
soluble and/or dispersible quaternary ammonium cationic
group containing silicone surfactant into the cavity,
wherein the quaternary ammonium cationic group
containing silicone surfactant comprises a cationic
surfactant which is represented by formula (I)

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in which R1 is C1–C8 alkylene divalent radical, R2 is C1–C8
alkyl radical, X- is a Cl-, Br-, or I-, a is an integer of from
10 to 50, and b is an integer of from 2 to 8,
or a cationic surfactant which is represented by formula (II)

in which R1, R2, R3 and R4=, independently of each other, is a
C1–C8 alkyl radical, X- is Cl-, Br-, or I, and n is an integer of
from 10 to 50;
(3) curing the fluid polymerizable composition in the mold to
form a silicone hydrogel contact lens, wherein the formed
silicone hydrogel contact lens comprises the anterior surface
defined by the first molding surface and the opposite posterior
surface defined by the second molding surface; (4) separating
the mold from the formed lens; and
(5) repeating steps (1) to (4) at least three times;
wherein the water soluble/dispersible silicone surfactant is
present in the fluid polymerizable composition in an amount
sufficient to reduce an averaged mold separation force
between the mold and formed lens by at least about 30% in
comparison to a control composition comprising all
components of the fluid polymerizable composition with
exception of any mold releasing agent and wherein the
averaged mold separation force is obtained from an average
of the at least three instances of repetition.

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REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Pruitt et al.
hereinafter
“Pruitt”
US 7,780,879 B2 August 24, 2010
Xie et al.
hereinafter
“Xie”
CN 102675538 A
English Translation
September 19, 2012
Siltech “Innovative Silicone Specialties” (Archived
from
www.siltech.com/index.php/siliconequaternary-
compounds-silquat to 2003, Retrieved on
December 7, 2016
2003
REJECTIONS
1. The Examiner rejected claims 1, 3–5, and 7 under pre-AIA 35
U.S.C. § 103(a) as unpatentable over Xie, Siltech, and Pruitt. Final
Act. 8–11.
2. The Examiner rejected 1, 3–5, and 7 under pre-AIA 35 U.S.C.
§ 103(a) as unpatentable over Pruitt and Siltech. Final Act. 12–14.

OPINION
In view of our disposition with respect to Rejection 2, discussed infra,
we find it unnecessary to reach a decision as to Rejection 1.

Rejection 2
Appellant states that claims 1, 3, and 7 and claims 4 and 5 are argued
as separate groups. See Appeal Br. 8. We select claims 1 and 4 as
representative for disposition of this rejection, with the patentability of the
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other claims standing or falling with claims 1 and 4. 37 C.F.R.
§ 41.37(c)(1)(iv).

The Examiner’s Rejection
Regarding claim 1, the Examiner found that Pruitt discloses providing
a contact lens mold, introducing a siloxane-containing prepolymer and an
alkyl quaternary ammonium cationic group containing surfactant as an
internal release agent into a mold, curing the lens-forming material, and
separating the mold with a reduction in mold separation force falling into the
claimed range. Final Act. 12–13, citing Pruitt, col. 2, ll. 60–67, col. 9, ll.
22–24, col. 16, Formula I, col. 17, ll. 25–31, col. 18, l. 55–col. 19, l. 14.
The Examiner found Pruitt’s alkyl quaternary ammonium cationic
surfactant lacks silicone backbone portions, and relied on Siltech for the
quaternary ammonium cationic group containing silicone surfactants having
the formulas recited in claim 1. Id. The Examiner found the surfactants
disclosed in Siltech are similar to the quaternary ammonium cationic group
containing phospholipids disclosed in Pruitt, because both contain
hydrophilic and hydrophobic groups (each are amphipathic), both are alkyl
quaternary ammonium cationic group-containing materials including
oxygen-containing substituents, and both are recognized as mold release
agents. Id. at 13, citing Siltech, 1, 2, 12–13.
The Examiner determined it would have been obvious to incorporate
the quaternary ammonium cationic group containing silicone surfactants
disclosed in Siltech having the formulas recited in claim 1 into Pruitt,
because they are interchangeable for or would improve the “remarkably
similar surfactant release agents already disclosed by Pruitt.” Id. at 13.
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As to the reduction in mold separation force recited in claim 1, as
discussed above, the Examiner found Pruitt discloses values falling within
the claimed range. Id., citing Pruitt, col. 17, ll. 25–31. The Examiner
determined that because the compounds disclosed in Siltech are similar to
Pruitt’s mold release agents, such would be expected to have the same or
similar mold separation-force-reducing effect. Id. The Examiner also
determined that because Pruitt discloses a correlation between release agent
amount and mold separation force (Pruitt, Table 1), one of ordinary skill in
the art would have optimized the amount of the surfactants disclosed in
Siltech in order to obtain the greatest possible reduction in mold separation
force without negatively impacting quality or utility of the resulting product.
Id. at 13–14.

Appellant’s contentions
Appellant argues the Examiner has failed to provide sufficient
reasoning as to why one of ordinary skill in the art, when faced with Pruitt’s
disclosure of a phospholipid internal mold releasing agent, would have
turned to Siltech and chosen the specific quaternary ammonium cationic
group containing silicone surfactants of Formulas I and II from among all
the silicone products disclosed therein. Appeal Br. 9. Appellant contends
not every mold release agent would result in the reduction of average mold
separation force recited in claim 1, such that employing the quaternary
ammonium cationic group containing silicone surfactants of Formulas I and
II led to unexpected results. Id. at 8, citing Spec., Table 1.
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Issue
Has Appellant identified reversible error in the Examiner’s position
that it would have been obvious to have incorporated the surfactants
disclosed in Siltech falling within Formulas I and II recited in claim 1 in the
method of making silicone hydrogel contact lenses disclosed in Pruitt, and
obtain the recited mold separation force reduction?

Discussion
We are not persuaded by Appellant’s contention that the Examiner has
failed to provide sufficient reasoning to support the position that one having
ordinary skill in the art would have looked to the specific surfactants
disclosed in Siltech and having the formulas recited in claim 1 in order to
modify Pruitt’s phospholipid mold releasing agent.
Although Appellant argues Siltech discloses a number of silicone
products and Pruitt’s mold releasing agent “has a totally different property
and structure” from the quaternary ammonium cationic group containing
silicone surfactants (Appeal Br. 9–10), Appellant does not address to any
particular extent, the Examiner’s findings with respect to the chemical
similarities between the two structures. Specifically, Appellant does not
address the presence of alkyl quaternary ammonium cationic groups and
oxygen-containing substituents in the surfactants of both Pruitt and Siltech,
as well as the identification of both as mold releasing agents. Final Act. 13;
Ans. 8–9, 13–14; Pruitt, col. 15, ll. 50–52; col. 16, ll. 40–54, Formula I;
Siltech, 1, 2, 12–13.
As the Examiner explains, such similarities in structure and function
between the quaternary ammonium cationic group containing silicone
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surfactants in Siltech and the phospholipid mold release agent in Pruitt
provide support for the position that one of ordinary skill in the art would
have employed the alkyl quaternary ammonium surfactants in Siltech in
Pruitt, including those having Formulas I and II recited in claim 1, with a
reasonable expectation of success. Ans. 14–15. Appellant’s general
arguments that Pruitt’s phospholipids have a different structure and property
do not sufficiently address the Examiner’s rationale.
We are also not persuaded by Appellant’s argument that not every
mold releasing agent would yield the mold separation force reduction recited
in the claim. Although Appellant points to Table 1 of the Specification for
support (Appeal Br. 8), we agree with the Examiner (Ans. 11–13) that Table
1 is insufficient to outweigh the evidence applied in the Examiner’s
rejection. In particular, we observe that the Examiner found that Pruitt
suggests a correlation between the amount of mold release agent and
separation force (Final Act. 13, citing Pruitt, Table 1), and as a result one of
ordinary skill in the art would have optimized the amount of releasing agent
to achieve the greatest possible reduction in separation force without
negatively impacting quality of utility of the resulting product. Final Act.
13–14.
We agree with the Examiner that Pruitt appears to show a decrease in
mold separation force (MSF) as the amount of mold release additive is
increased. See Pruitt, Table 1, Exs. 4 (additive amount 2.5% by weight,
MSF 13 N), 5 (additive amount 2.0% by weight, MSF 21 N) as compared to
control Ex. 6 (additive amount 0% by weight, MSF 131 N). Appellant does
not address the Examiner’s position in this regard. Given Pruitt’s disclosure
that the mold separation force is reduced by at least 40% (col. 17, ll. 25–31)
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along with the Examiner’s findings of the similarity between quaternary
ammonium cationic group containing silicone surfactants in Siltech and the
phospholipid mold release agent in Pruitt discussed above, we are not
persuaded by Appellant’s argument.
Regarding the data in Table 1, we agree with the Examiner that
Table 1 is insufficient to establish unexpected results in reducing mold
separation force by at least about 30%. Ans. 11–13. As the Examiner points
out, a number of other surfactants also appear to meet the claimed reduction
in mold separation force. Id.; see Table 1, where the mold release agent
(MRA) is PVP-PVAc-45KDa, PVP-40kDa, H2N-PDMS-NH2. In addition,
in order to prove unexpected results, the invention must be compared with
the closest prior art. In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed.
Cir. 1991). Table 1 does not compare the closest prior art, which are
compositions in Pruitt where the mold release agent is a phospholipid.
Claim 4
Although Appellant lists claim 4, which recites the mold is “a reusable
mold,” under a separate heading, Appellant does not contest the Examiner’s
finding that Pruitt discloses a reusable mold. Appeal Br. 9–10; Final Act.
12, citing Pruitt col. 18, l. 55 –col. 19, l. 10. Rather, Appellant again argues
the Examiner’s rationale in combining Pruitt and Siltech as addressed above.
In view of the above discussion, we affirm the Examiner’s rejection of
claims 1, 3–5, and 7 as obvious over Pruitt and Siltech.

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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3–5, 7 103 Xie, Siltech, Pruitt3
1, 3–5, 7 103 Pruitt, Siltech 1, 3–5, 7
Overall
Outcome
1, 3–5, 7
3 As explained above, because we affirm the Examiner’s rejections of all
the claims based on Rejection 2, we do not reach this rejection.
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). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED