Ex Parte Kim

Board of Patent Appeals and Interferences

Apr 26, 2011

11207126 (B.P.A.I. Apr. 26, 2011)

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.
11/207,126 08/17/2005 Cherng-Ju Kim 110.010US1 8195
66981 7590 04/26/2011
HUGH MCTAVISH
MCTAVISH PATENT FIRM
429 BIRCHWOOD COURTS
BIRCHWOOD, MN 55110
EXAMINER
ORWIG, KEVIN S
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
04/26/2011 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte CHERNG-JU KIM
__________

Appeal 2010-009244
Application 11/207,126
Technology Center 1600
__________

Before TONI R. SCHEINER, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a sustained
release pharmaceutical composition. The Examiner rejected the claims for
obviousness and new matter.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse the
Examiner‟s rejections, but enter a new ground of rejection for obviousness
under 37 C.F.R. § 41.50(b).

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STATEMENT OF THE CASE
Claims 13-17, 19, 20, and 40-45 are on appeal (App. Br. 3). Claim
13, the only independent claim, is representative and reads as follows:

13. A pharmaceutical composition comprising:
a sustained-release ionic complex containing (i) an ionic
small molecule pharmaceutically active agent having a
molecular weight of less than 2,000 and a solubility in water of
at least 2 mg/ml, complexed with (ii) an oppositely charged
ionic surfactant;
in combination with a pharmaceutically acceptable
diluent or carrier;
wherein the pharmaceutical composition releases the
ionic pharmaceutically active agent into solution with zero-
order kinetics in an aqueous solution containing salt;
wherein the sustained-release ionic complex is formed by
a process comprising contacting the ionic small molecule
pharmaceutically active agent with the oppositely charged ionic
surfactant in aqueous solution to form the sustained-release
ionic complex as a solid precipitate; and
wherein the pharmaceutical composition releases the
ionic pharmaceutically active agent into solution in aqueous
solution containing salt more slowly than does an otherwise
identical composition comprising, in place of the sustained-
release ionic complex, a salt of the active agent with a small
oppositely charged ion that is not a surfactant.

The following rejections are before us for review:
(1) Claims 13-17, 19, 20, and 40-45, under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description
requirement due to the introduction of new matter (Ans. 5-7); and
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(2) Claims 13-17, 19, 20, and 40-45, under 35 U.S.C. § 103(a) as
obvious over Pillay
1
and Penkler
2
(Ans. 7-9).

NEW MATTER
The Examiner contends that the response filed September 15, 2009
entered new matter into the claims (Ans. 5). Specifically, the Examiner
urges that the following recitation in claim 13 lacks adequate support in the
Specification:
wherein the pharmaceutical composition releases the ionic
pharmaceutically active agent into solution in aqueous solution
containing salt more slowly than does an otherwise identical
composition comprising, in place of the sustained-release ionic
complex, a salt of the active agent with a small oppositely
charged ion that is not a surfactant.

(Id.) The Examiner urges that the portions of the Specification cited by
Appellant as supporting this language do not describe the “concept of an
otherwise identical composition (as is currently claimed) which may include
other elements in addition to the complex” (id.).
Moreover, the Examiner urges, the Specification “only provides
support for the sustained-release ionic complex releasing the drug more
slowly than the corresponding conventional salt of the active agent, such as
chloride or sodium,” whereas the language at issue “is not limited to
conventional salts, but rather includes any small oppositely charged ion that

1
Viness Pillay and Reza Fassihi, Electrolyte-Induced Compositional
Heterogeneity: A Novel Approach for Rate-Controlled Oral Drug Delivery,
88 J. PHARM. SCI. 1140-1148 (1999).
2
U.S. Patent No. 6,255,502 B1 (issued July 3, 2001).

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is not a surfactant. There is also nothing in . . . the specification that
excludes a surfactant as the oppositely charged ion” (id. at 5-6).
Appellant contends that there is no legal requirement for claims to
have word-for-word support in the Specification (Reply Br. 17). Thus,
Appellant urges, a reading of the relevant portions of the Specification
shows that Appellant possessed an invention having the concepts in the
language at issue (id. at 17-19).
As stated in TurboCare Div. of Demag Delaval Turbomachinery
Corp. v. General Elec. Co., 264 F.3d 1111, 1118 (Fed. Cir. 2001):
The written description requirement and its corollary, the new
matter prohibition of 35 U.S.C. § 132, both serve to ensure that
the patent applicant was in full possession of the claimed
subject matter on the application filing date. When the applicant
adds a claim or otherwise amends his specification after the
original filing date . . ., the new claims or other added material
must find support in the original specification.

The test for determining whether a specification is sufficient to
support a particular claim “is whether the disclosure of the application relied
upon „reasonably conveys to the artisan that the inventor had possession at
that time of the later claimed subject matter.‟” Ralston Purina Co. v. Far-
Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed.Cir.1985) (quoting In re Kaslow,
707 F.2d 1366, 1375 (Fed.Cir.1983)).
Thus, “[i]t is not necessary that the application describe the claim
limitations exactly, but only so clearly that persons of ordinary skill in the
art will recognize from the disclosure that appellants invented processes
including those limitations.” In re Wertheim, 541 F.2d 257, 262 (CCPA
1976) (citation omitted); see also Purdue Pharma L.P. v. Faulding, Inc., 230
F.3d 1320, 1323 (Fed. Cir. 2000) (“In order to satisfy the written description
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requirement, the disclosure as originally filed does not have to provide in
haec verba support for the claimed subject matter at issue.”).
We agree with Appellant that an ordinary artisan viewing the
Specification would have recognized that Appellant possessed the claimed
invention.
The language at issue requires the composition of claim 13 to release
the ionic pharmaceutically active agent into an aqueous salt-containing
solution more slowly than an otherwise identical composition that contains,
in place of the sustained-release ionic complex, a salt of the active agent
with a small oppositely charged ion that is not a surfactant.
The Specification summarizes Appellant‟s invention as follows:
The inventors have discovered that water-soluble ionic
pharmaceutical agents form complexes with oppositely charged
ionic surfactants, such as anionic bile surfactants. The
complexes dissociate slowly to release the pharmaceutical
agents in aqueous solutions containing salts. The release
kinetics are close to zero order. The release kinetics can be
made slower and even closer to pure zero order by formulating
the complexes with sustained-release polymers or fillers, such
as hyroxypropylmethylcellulose [sic]. Thus, complexes
between ionic pharmaceutical agents and oppositely charged
ionic surfactants are effective sustained-release formulations of
the pharmaceutical agents.

(Spec. 1.)
The Specification then defines the sustained release ionic complexes
of the invention:
The term “sustained release ionic complex” refers to an
ionic complex between a small molecule pharmaceutically
active agent and an oppositely charged ionic surfactant that in
aqueous solution releases the active agent into solution more
slowly than it is released from the corresponding conventional
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salt of the active agent with a small oppositely charged ion such
as chloride or sodium.

(Id. at 4.)
The Specification then provides an example in which 5% w/v
solutions of the drug salt diltiazem-HCl and the bile salt surfactant sodium
deoxycholate were combined to yield a diltiazem-deoxycholate complex that
precipitated from the solution (id. at 12 (Example 1)). After the precipitate
was separated from the solution, it was formed into tablets, and the drug
release properties over time were assessed (id. (“At the first time point, all
diltiazem from the diltiazem-HCl was released. Diltiazem from diltiazem-
deoxycholate released slowly over a time period of over 1500 minutes with
kinetics close to zero-order.”)). Example 1 also describes a comparison of
the release properties of tablets containing hydroxypropylmethylcellulose
(HPMC) and diltiazem-deoxycholate and otherwise identical tablets, except
that the drug salt was diltiazem-HCl (id.).
Thus, the Specification explains that Appellant‟s invention is directed
to forming complexes of charged drug compounds with oppositely charged
ionic surfactants, such as anionic bile surfactants (id. at 1). The
Specification then explains that those complexes have a significantly slower
drug release rate than conventional drug salts, such as sodium or chloride
(id. at 4), and goes on to exemplify a drug release rate comparison between a
composition containing a drug-bile salt complex, diltiazem-deoxycholate,
and an identical composition that contains a drug-conventional salt complex,
diltiazem-HCl, rather than the drug-bile salt complex (id. at 12).
Given these disclosures, we are not persuaded that Appellant‟s
Specification would have failed to convey to an ordinary artisan that
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Appellant possessed a composition having the properties recited in the
language at issue in claim 13. We therefore reverse the Examiner‟s new
matter rejection of claim 13 and its dependents.
OBVIOUSNESS – PILLAY AND PENKLER
The Examiner finds that “Pillay teaches each element of instant claim
13 except for an explicit teaching of precipitating the drug and surfactant
together prior to their inclusion in the matrix” (Ans. 8). The Examiner
reasons, however, that “the only active step required by the instant claims
for forming a precipitate is contacting the ionic active agent with the ionic
surfactant in aqueous solution,” and finds that “Pillay teaches this step . . .
wherein the induced intragel pH and release characteristics were measured
from tablets swollen in aqueous solution” (id.).
Moreover, the Examiner reasons, “precipitation of bile acid/basic drug
complexes was recognized in the art, and doing so would actually
complement Pillay‟s method and is no more than an obvious variation
thereof” (id.). The Examiner cites Penkler to support this assertion, and
based on the two references‟ teachings concludes that an ordinary artisan
would have considered it obvious to “form a complex of a cationic drug (e.g.
diltiazem) and anionic bile acid surfactant (e.g. deoxycholate) for use in
Pillay‟s dosage forms” (id. at 8-9).
Appellant argues, among other things, that Penkler is directed to
compositions for transmucosal or transdermal absorption, whereas “Pillay
concerns tablets and formulations for oral delivery. These dissolve in the
stomach or intestine, a route that Penkler indicates is not applicable to the
Penkler invention” (Reply Br. 7). Thus, Appellant argues, since “the
motivation to combine cited by the Examiner does not make sense in the
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context of both references, there is no prima facie case of obviousness” (id.
at 8).
“In proceedings before the Patent and Trademark Office, the
Examiner bears the burden of establishing a prima facie case of obviousness
based upon the prior art.” In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir.
1992).
In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), the
Supreme Court emphasized “an expansive and flexible approach” to the
obviousness question, but also reaffirmed the importance of determining
“whether there was an apparent reason to combine the known elements in
the fashion claimed by the patent at issue.” Id. at 418 (emphasis added).
Ultimately, therefore, “[i]n determining whether obviousness is
established by combining the teachings of the prior art, the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir.
1995) (internal quotations omitted).
We agree with Appellant that the Examiner has not made a prima
facie case of obviousness based on the asserted combination of references.
Pillay describes the results of a study that investigated techniques for
improving the sustained release properties of orally administered tablets (see
Pillay 1141 (“The aim of this work was to provide and expand on a means to
design, formulate, and develop a novel oral monolithic, controlled-release
tablet dosage form for drugs of various solubility that may be tailored to
provide zero- order or quasi-steady-state drug release over a 24-h period.”)).
Pillay found that including certain “electrolytes,” such as sodium
bicarbonate, in tablets containing hydrophilic polymer and a model drug,
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diltiazem, “enabled control of diltiazem hydrochloride release in a zero-
order manner in different pH environments over a 24-h period” (id. at 1140
(abstract)). Pillay discloses that sodium deoxycholate was among the
electrolytes tested (id. at 1143-44).
In contrast, Penkler is directed to preparing a pharmaceutical
composition which contains “an acid addition salt of a basic drug and a fatty
acid or bile acid. The acid addition salts thus formed exhibit enhanced
transmucosal and transdermal penetration of the basic drug” (Penkler,
abstract). Thus, Penkler discloses:
The compositions of this invention may be utilized in delivering
the pharmaceutically active agent to the following target areas:
(1) the sublingual surface or floor of mouth, (2) the buccal
cavity, (3) the gums, (4) the nasal passages, (5) the rectum or
colon, (6) the vagina, (7) the ocular cavity or cul-de-sac of the
eye, and (8) the skin.
The preferred pharmaceutical forms are sublingual
tablets, nasal sprays, buccal tablets, suppositories (rectal and
vaginal), transdermal patches and topical gels.

(Id. at col. 13, ll. 3-12.)
We agree with Appellant that the Examiner has not adequately
explained why an ordinary artisan would have been prompted to include
Penkler‟s drug-bile acid addition salt in Pillay‟s oral dosage forms.
Specifically, while the Examiner asserts that an ordinary artisan would
have viewed the permeation-enhancing properties of Penkler‟s compositions
as useful in Pillay‟s oral dosage forms (Ans. 9), as Appellant points out,
Penkler‟s orally administered formulations are intended to be absorbed
quickly through the oral mucosae (see e.g., Penkler, col. 1, ll. 27-29 (“The
mucosal route of drug delivery is a useful alternative to parenteral delivery
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where rapid therapeutic effect is desired.”)), which is the opposite objective
of Pillay‟s oral dosage forms having sustained drug release for 24 hours.
Thus, because the teachings advanced by the Examiner as supporting
the references‟ combination appear to be at odds in their ultimate objectives,
we are not persuaded that an ordinary artisan would have been prompted to
combine the references in the manner advanced by the Examiner to arrive at
the combination of ingredients recited in claim 13. We therefore reverse the
Examiner‟s obviousness rejection of that claim, and its dependents, as
obvious over Pillay and Penkler.
NEW GROUND OF REJECTION
Under the provisions of 37 C.F.R. § 41.50(b), we enter the following
new ground of rejection:
Claim 13 is rejected under 35 U.S.C. § 103(a) as obvious over
Penkler.
Claim 13 recites a pharmaceutical composition. Claim 13 specifies
two components that must be present in the composition:
(1) a sustained-release ionic complex that contains (i) an ionic
pharmaceutically active agent having a molecular weight of less than 2,000
and a solubility in water of at least 2 mg/ml, complexed with (ii) an
oppositely charged ionic surfactant; and
(2) a pharmaceutically acceptable diluent or carrier.
As the Specification explains, diltiazem, the elected species
3
of
pharmaceutical agent, is a cationic drug compound that has the properties
required by claim 13 (Spec. 9). As the Specification also explains, a number

3
See Response to Election/Restriction entered June 9, 2008, at page 2.
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of anionic bile salt surfactants, including the elected species deoxycholate,
4

as well as glycodeoxycholate, are suitable for complexation with cationic
drugs (see id. at 5-7).
Claim 13 requires the sustained release ionic complex to be formed by
contacting the ionic pharmaceutically active agent with the oppositely
charged ionic surfactant in aqueous solution to form the complex as a solid
precipitate.
Claim 13 also requires the composition to release the ionic
pharmaceutically active agent into an aqueous salt-containing solution with
zero-order kinetics. Claim 13 further requires the composition to release the
ionic pharmaceutically active agent into an aqueous salt-containing solution
more slowly than an otherwise identical composition that contains, in place
of the sustained-release ionic complex, a salt of the active agent with a small
oppositely charged ion that is not a surfactant.
As seen in Appellant‟s Example 1, these functional properties are
attained by forming the precipitated complex between an ionic drug, such as
diltiazem, and a bile acid, such as deoxycholate (id. at 12-13; see also
Specification, generally).
Like claim 13, Penkler describes a “pharmaceutical composition
[which] contains an acid addition salt of a basic drug and a fatty acid or bile
acid. The acid addition salts thus formed exhibit enhanced transmucosal and
transdermal penetration of the basic drug” (Penkler, abstract).

4
See Response to Election/Restriction entered June 9, 2008, at page 2.
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As required by claim 13, Penkler‟s compositions can contain a variety
of pharmaceutical excipients, including those consistent with orally
administered sustained release compositions:
The acid addition salt present in part or completely as a
cyclodextrin inclusion complex may be formulated together
with conventional pharmaceutical excipients into sustained
release buccal tablets or patches with uni-directional release
according to methods known in the art. Preferred excipients for
sustained release buccal tablets or patches are muco-adhesive
polymers such as cross-linked polyacrylic acids (carbomers,
polycarbophils).

(Id. at col. 12, ll. 9-15 (emphasis added).)
As also required by claim 13, Penkler‟s drug-bile acid addition salt is
a complex that is produced by mixing solutions of the drug and bile acid to
form a precipitate:
[T]he sodium salt of the fatty acid or bile acid is dissolved in
water at elevated temperature. A solution of the commercially
available salt of the drug (e.g hydrochloride, sulphate,
succinate, phosphate, etc) is added slowly with stirring at
elevated temperature. The resulting solution is cooled to room
temperature and the addition salt precipitate collected on a
filter, washed with cold water and dried in vacuo.

(Id. at col. 11, ll. 29-36.) Thus, Example 7 of Penkler describes the
preparation of a drug-bile acid addition complex by combining solutions of
the drug salt loperamide-HCl and sodium deoxycholate to form a precipitate
(id. at col. 15, ll. 1-16).
While Penkler does not exemplify the elected species of drug
(diltiazem) or surfactant (deoxycholate),
5
Penkler discloses that diltiazem is

5
See Response to Election/Restriction entered June 9, 2008, at page 2.
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among the drugs suitable for formulation according to its teachings (id. at
col. 8, ll. 54-55), and that deoxycholate is among suitable bile acids (id. at
col. 10, l. 66, through col. 11, l. 2).
Thus, in view of the teachings of Penkler discussed above, we find
that an ordinary artisan would have been prompted to prepare a composition
containing (1) a sustained release pharmaceutical excipient and (2) a
drug-bile acid addition complex produced by combining solutions of
diltiazem and deoxycholate to form the precipitated complex, as required by
claim 13.
With respect to the functional properties required by claim 13, as
noted above, Appellant‟s Specification discloses that the claimed zero-order
and slower release kinetics are achieved by forming the same drug-bile acid
precipitated complex as Penkler, in essentially the same fashion as taught in
Penkler. Thus, as stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977)
(citations omitted):
Where . . . the claimed and prior art products are identical or
substantially identical, or are produced by identical or
substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed product.
. . . Whether the rejection is based on „inherency‟ under 35
U.S.C. § 102, on „prima facie obviousness‟ under 35 U.S.C. §
103, jointly or alternatively,

the burden of proof is the same,
and its fairness is evidenced by the PTO‟s inability to
manufacture products or to obtain and compare prior art
products.

In sum, for the reasons discussed, we find that an ordinary artisan
would have been prompted by Penkler to combine the ingredients required
by claim 13, in the manner required by the claim. As following Penkler‟s
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teachings would result in a composition having the required functional
properties, we conclude that claim 13 would have been prima facie obvious
to an ordinary artisan.
We have carefully considered Appellant‟s arguments as they pertain
to this new ground of rejection, but are not persuaded that the new rejection
is unsupported by the evidence of record.
We acknowledge that it is improper to base an obviousness rejection
on an unknown inherent property present in the prior art. See In re
Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993) (“„That which may be inherent
is not necessarily known. Obviousness cannot be predicated on what is
unknown.‟ Such a retrospective view of inherency is not a substitute for
some teaching or suggestion supporting an obviousness rejection.”) (quoting
In re Spormann, 363 F.2d 444, 448 (CCPA 1966)).
In the instant case, however, the rationale for combining the claimed
components, including the preparation of a drug-bile acid
precipitate/complex comes from Penkler‟s explicit teachings, and is not
derived from any knowledge unavailable to an ordinary artisan.
We acknowledge Penkler‟s disclosure that its drug-bile acid
complexes can be used in compositions that deliver the complexed drug
quickly (see e.g., Penkler, col. 1, ll. 27-29 (“The mucosal route of drug
delivery is a useful alternative to parenteral delivery where rapid therapeutic
effect is desired.”); see also id. at col. 11, ll. 52-56).
However, as noted above, Penkler also discloses that its drug-bile acid
complexes are useful in orally administered dosage forms that provide
sustained release:
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The acid addition salt present in part or completely as a
cyclodextrin inclusion complex may be formulated together
with conventional pharmaceutical excipients into sustained
release buccal tablets or patches with uni-directional release
according to methods known in the art. Preferred excipients for
sustained release buccal tablets or patches are muco-adhesive
polymers such as cross-linked polyacrylic acids (carbomers,
polycarbophils).

(Id. at col. 12, ll. 9-15 (emphasis added); see also id. at col. 1, ll. 29-30
(“The transermal [sic, transdermal] route is advantageous for sustained
release of active agents.”))
Thus, we are not persuaded that an ordinary artisan following
Penkler‟s teachings lacked a reasonable expectation in producing a
composition having claim 13‟s functional properties, nor are we persuaded
that the claimed properties of zero-order kinetics and slower release
compared to conventional salts would have been considered unexpected
when viewed alongside the relevant teachings in Penkler, absent evidence to
the contrary.
Moreover, the fact that Appellant‟s purpose in formulating the
claimed composition -- producing a composition with zero-order kinetics --
might have been different than Penkler‟s purpose does not demonstrate that
claim 13 would have been unobvious to an ordinary artisan viewing
Penkler‟s teachings. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 419
(2007) “(“In determining whether the subject matter of a patent claim is
obvious, neither the particular motivation nor the avowed purpose of the
patentee controls. What matters is the objective reach of the claim. If the
claim extends to what is obvious, it is invalid under § 103.”).
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In sum, for the reasons discussed, we conclude that claim 13 would
have been obvious to an ordinary artisan in view of Penkler. While we have
only included claim 13 in this rejection, should prosecution resume in this
case, the Examiner should consider whether any of its dependent claims
should be subject to this rejection.

SUMMARY
We reverse the Examiner‟s new matter rejection of claims 13-17, 19,
20, and 40-45, under 35 U.S.C. § 112, first paragraph.
We also reverse the Examiner‟s obviousness rejection of claims
13-17, 19, 20, and 40-45 over Pillay and Penkler.
We enter a new ground of rejection of claim 13 under 35 U.S.C. §
103(a) as being obvious over Penkler.

TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37
C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review.
37 C.F.R. § 41.50(b) also provides that 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
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reconsidered by the examiner, in which event the proceeding
will be remanded to the examiner . . . .

(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record . . . .

REVERSED, 37 C.F.R. § 41.50(b)

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