Corning Incorporated

Patent Trials and Appeals Board

Sep 3, 2020

2020000576 (P.T.A.B. Sep. 3, 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.
14/663,533 03/20/2015 Ronald Allen Faris SP14-070 3543
22928 7590 09/03/2020
CORNING INCORPORATED
SP-TI-3-1
CORNING, NY 14831
EXAMINER
DAVIS, RUTH A
ART UNIT PAPER NUMBER
1699
NOTIFICATION DATE DELIVERY MODE
09/03/2020 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):
usdocket@corning.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte RONALD ALLEN FARIS, ANN MEEJIN FERRIE,
VASILIY NIKOLAEVICH GORAL,
GREGORY ROGER MARTIN, and JIN LIU

Appeal 2020-000576
Application 14/663,533
Technology Center 1600
____________

Before RICHARD M. LEBOVITZ, DEBORAH KATZ, and
JOHN A. EVANS, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
The Examiner rejected claims 1–9 and 21–23 under 35 U.S.C. § 103
as obvious. Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject the claims. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM, but designate the affirmance a NEW GROUND OF
REJECTION under 37 C.F.R. § 41.50(b).

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as Corning
Incorporated. Appeal Br. 3.
Appeal 2020-000576
Application 14/663,533

2
STATEMENT OF THE CASE
Appellant appeals from the Examiner’s Final Rejection of claims 1–9
and 21–23 under 35 U.S.C. § 103 as obvious in view of Fike et al. (WO
2013/096858 A1, published June 27, 2013) “as cited by”2 US 9,410,118 B2,
issued Aug. 9, 2016) (“Fike”) and Jain et al. (US 2007/0128276 A1,
published June 7, 2007) (“Jain”). Final Act. 3.
Claim 1, the only independent claim on appeal, is reproduced below:
1. An ex vivo cell culture sustained release composition,
comprising:
a solid form mixture comprising:
a sustenant in an amount of from 60 to 96 wt%,
wherein the sustenant comprises a compound that maintains or
promotes the growth or proliferation of cells, or cellular
production of biologically active substances; and
a non-biodegradable binder in an amount of from 1
to 20 wt%; and
a non-biodegradable and water insoluble encapsulant coat
comprising at least one of cellulose ethers and cellulose esters
and that encapsulates the mixture, in an amount of from 1 to 20
wt%, based on 100 wt% of the total composition, the coat having
a weight as measured by relative weight increase of the solid
form mixture of between about 5 wt. % and about 15 wt.%.

REJECTION
Claim 1 is directed to an ex vivo cell culture sustained release
composition. The composition comprises: 1) a solid form mixture and 2) an
encapsulant coat that encapsulates the mixture. The coat, which is the
disputed element of the claim, comprises “at least one of cellulose ethers and
cellulose esters” in an amount of 1–20% of the composition. The

2 WO 2013/096858 A1 is the PCT publication on which the U.S. Patent is
based. The Examiner only cited to the U.S. Patent in the Final Office Action,
and not to the PCT.
Appeal 2020-000576
Application 14/663,533

3
encapsulant coat has “a weight as measured by relative weight increase of
the solid form mixture of between about 5 wt. % and about 15 wt.%. As
explained in the Specification, “[c]oating thickness was evaluated as a
percentage of tablet mass increase after the coating procedure.” Spec. ¶ 87.
The Examiner found that Fike describes a solid form mixture with a
sustenant and binder as claimed. Final Act. 3. The Examiner also found that
the mixture has an encapsulant coat, but not comprising “at least one of
cellulose ethers and cellulose esters” as required by the claim. Id. at 3–4.
However, the Examiner found that Jain describes ethylcellulose as an
encapsulant for a controlled release composition. Id. at 4. Ethylcellulose is a
cellulose ether. Spec. ¶ 82. The Examiner determined it would have been
obvious to use ethylcellulose as an encapsulant in Fike’s composition
because it is a “known standard, equivalent of a slow release encapsulant,
and with a reasonable expectation for successfully obtaining an effective
sustained release composition.” Id.
With respect to the amounts of the coating, the Examiner found that
Fike teaches that the coating amounts can be optimized to achieve the best
results to achieve the desired release profile. Final Act. 6.
Appellant contends that Fike is “silent with respect to the weight
percent of the encapsulant coat (or ‘percent amounts of coating’), and [does]
not recognize weight percent of a coating as being a result-effective variable
that achieves a particular result.” Reply Br. 3 (emphasis omitted). Appellant
argues that, instead, “Fike only discloses that the presence of the encapsulant
coat or capsular material can extend release of components. In fact,
regarding variables of the encapsulant itself, Fike focuses on the material or
Appeal 2020-000576
Application 14/663,533

4
formulation of the encapsulant, not the weight percent of the encapsulant.”
Id. (emphasis omitted).
DISCUSSION
The issue in this rejection is the obviousness of using ethylcellulose as
the seed coating in Fike in the claimed amount of “a weight as measured by
relative weight increase of the solid form mixture of between about 5 wt. %
and about 15 wt.%.”
Fike discloses a coating comprised of PLGA (poly-lactic-co-glycolic
acid) which delays the release of the cell culture media it encapsulates. Fike
1:39–49; 12:55–59; 13:31–38. Example 4 of Fike, cited by the Examiner,
describes coating a bead with PLGA. Id. at 22:18–38. The example
discloses:
Several parameters like coating component concentration, bead
size, % alginate, protocols for coating, drying conditions and
level of dryness, solvents for pre-coating, etc. had to be
optimized in order to achieve the best results.
Fike 22:35–38.
This disclosure from Fike, as discussed by the Examiner, indicates
that coating parameters can be optimized to achieve a desired result.
Fike does not disclose a coat comprising the recited “cellulose ethers
and cellulose esters.” The Examiner found that ethylcellulose is a cellulose
ether derivative. Final Act. 4. Ethylcellulose, as found by the Examiner, is a
well-known coating for pharmaceuticals. The Examiner cited Jain as
evidence of this fact, which Appellant does not dispute. In addition to Jain,
Appeal 2020-000576
Application 14/663,533

5
Muschert3 is newly cited as evidence that ethylcellulose was widely used at
the time of the invention in pharmaceutical coatings for controlled release.4
Muschert discloses a coating comprising ethylcellulose to which
“small amounts of poly(vinyl acetate)-poly(ethylene glycol)-graft-copolymer
(PVA–PEG-graft-copolymer)” have been added. Muschert 138 (Abstract).
The claimed coat comprises at least one of a cellulose ester or cellulose
ether, but does not exclude other components, such as the added polymer in
Muschert.
Muschert further teaches:
Potentially too rapid drug release can effectively be slowed down
by increasing the coating level. Thus, adapting the polymer blend
ratio and coating thickness desired and long term stable drug
release profiles (even under stress conditions and open storage)
can be provided for very different types of drugs and starter cores
by the addition of small amounts of PVA–PEG-graft-copolymer
to aqueous ethylcellulose dispersion.
Muschert 138 (Abstract) (emphasis added).
Thus, as indicated in the disclosure reproduced above, Muschert
teaches that “coating level” or “coating thickness” is varied to achieve the
desired drug release profile. A thicker coating would mean that more coating
is present, adding more weight to the total composition. Muschert therefore

3 S. Muschert et al., “Improved long term stability of aqueous ethylcellulose
film coatings: Importance of the type of drug and starter core,” Int’l J.
Pharmaceutics, 2009, 368:138–145.
4 “Ethylcellulose is a highly suitable polymer for film coating (Wallace, 1990;
Iyer et al., 1993; Ye et al., 2007). It is nontoxic, nonallergenic, nonirritant and
a good film former (Wade and Weller, 1994; Naelpäa et al., 2007). For many
years this polymer has been widely used in oral pharmaceutical formulations
for various purposes, including moisture protection, taste masking (DeMerlis
et al., 2005) and controlled release.” Muschert 138.
Appeal 2020-000576
Application 14/663,533

6
provides evidence that the weight of the coating affects the drug release
characteristics of the drug, making it a “result-effective variable.” “[W]here
the general conditions of a claim are disclosed in the prior art, it is not
inventive to discover the optimum or workable ranges by routine
experimentation.” In re Aller, 220 F.2d 454, 456 (1955) (citations omitted).
As explained In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir.
2012), “[t]his rule is limited to cases in which the optimized variable is a
‘result-effective variable.’ In re Antonie, 559 F.2d 618, 620 (CCPA 1977);
see [In re] Boesch, 617 F.2d [272, 276 CCPA 1980)] (‘[D]iscovery of an
optimum value of a result effective variable . . . is ordinarily within the skill
of the art.’).” Thus, because coating weight percent is a “result-effective
variable,” it would be routine optimization, as found by the Examiner, to
determine the weight percent of the encapsulant coating to achieve the
desired drug release profile. Jain also describes varying the release
controlling material in the coating from 0.1% to 99% w/w of the
composition (Jain ¶ 9), which would necessarily change the weight percent
of the coating in the sustained release composition.
Muschert also discloses:
In addition to the variation of the PVA–PEG-graft-
copolymer content[,] also the variation of the coating level is an
efficient tool to adjust desired release patterns from the
investigated systems (Fig. 3). An increase in the coating level
from 5% to 15% (w/w) resulted in a significant decrease in the
absolute and relative release rates, irrespective of the type of
release medium.
Muschert 143 (paragraph spanning columns 1–2) (emphasis added).
Appeal 2020-000576
Application 14/663,533

7
Muschert teaches that the “w/w” is determined by the weight gain of
the composition after coating,5 which is the same way the coat weight
increase is measured in the rejected claims and in the Specification (Spec. ¶
87). Muschert describes a coat weight percent gain of 5–15% that is
substantially the same and overlaps with the claimed “relative weight
increase of the solid form mixture of between about 5 wt. % and about 15
wt.%.” It is well established that, when there is a range disclosed in the prior
art, and the range recited in the claim overlaps or falls within that range,
there is a presumption of obviousness. In re Peterson, 315 F.3d 1325, 1329
(Fed. Cir. 2003); Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317,
1322 (Fed. Cir. 2004).
[The] law is replete with cases in which the difference between
the claimed invention and the prior art is some range or other
variable within the claims . . . in such a situation, the applicant
must show that the particular range is critical, generally by
showing that the claimed range achieves unexpected results
relative to the prior art range.
In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) (citation omitted).
Here, Appellant has not provided objective evidence that the recited
range of “between about 5 wt. % and about 15 wt.%” is critical in view of
the teachings of Fike, Jain, and Muschert.
Appellant did not provide separate arguments for dependent claims 2–
9 and 21–23. These claims therefore fall with claim 1. 37 C.F.R.
§ 41.37(c)(1)(iv).

5 “The coating dispersions were sprayed onto the diltiazem HCl-layered
sugar cores until a weight gain of 5–30% (w/w) was achieved (as
indicated).” Muschert 140.
Appeal 2020-000576
Application 14/663,533

8
Although we affirm the rejection for the reasons set forth by the
Examiner, Muschert is newly cited as evidence that ethylcellulose is a result-
effective variable. For this reason, the affirmance is cited as a new ground of
rejection pursuant to 37 C.F.R. § 41.50(b). The new ground of rejection is as
follows:
Claims 1–9 and 21–23 are rejected under 35 U.S.C. § 103 as obvious
in view of Fike, Jain, and Muschert.

CONCLUSION
In summary:
Claims
Rejected
35
U.S.C.
§
Reference(s)/Basis Affirmed Reversed New
Ground
1–9, 21–
23
103 Fike, Jain,
Muschert
1–9, 21–
23
1–9, 21–
23

TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
Section 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
Appeal 2020-000576
Application 14/663,533

9
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under §41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.

Further guidance on responding to a new ground of rejection can be
found in the MPEP § 1214.01.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1). See 37 C.F.R.
§§ 41.50(f), 41.52(b).

AFFIRMED; 37 C.F.R. § 41.50(b)