Ex Parte Bouillot et al

Patent Trial and Appeal Board

Sep 25, 2018

13917730 (P.T.A.B. Sep. 25, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/917,730 06/14/2013 Philippe Michel Rene Bouillot
1095 7590 09/27/2018
NOVARTIS PHARMACEUTICAL CORPORATION
INTELLECTUAL PROPERTY DEPARTMENT
ONE HEAL TH PLAZA 433/2
EAST HANOVER, NJ 07936-1080
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
P AT054499-US-CIP 9743
EXAMINER
ROSENTHAL, ANDREWS
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
09/27/2018 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):
phip.patents@novartis.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PHILIPPE MICHEL RENE BOUILLOT and
EMERIC REYNAUD 1
Appeal 2016-006868
Application 13/917,730
Technology Center 1600
Before DEMETRA J. MILLS, TA WEN CHANG, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a solid
phase oral pharmaceutical composition, which have been rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
The Specification states that "SIP receptors belong to a family of
closely related, lipid activated G- protein coupled receptors" and that
" [ c] ertain S 1 P receptors are associated with diseases mediated by
1 Appellants identify the Real Party in Interest as Novartis AG. (Appeal Br.
2.)
Appeal2016-006868
Application 13/917,730
lymphocyte interactions, for example, in transplantation rejections,
autoimmune disease, inflammatory diseases, infectious diseases and cancer."
(Spec. 1.) According to the Specification, "[t]he present invention relates to
formulations of immunosuppressant compounds, and particularly to
formulations of S 1 P receptor modulators. More particularly the invention
relates to formulations of 1-{ 4-[ 1-( 4-cyclohexyl-3-trifluoromethyl-
benzyloxyimino )-ethyl]-2-ethyl-benzyl }-azetidine-3-carboxylic acid
["API"], pharmaceutically acceptable salts, and related compounds." (Id.)
Further according to the Specification, "[t]he present invention is predicated
at least in part on a finding that ... pharmaceutical compositions having
particular excipients are associated with reduced degradation of [ API] as
compared to alternative compositions of the same active pharmaceutical
ingredient." (Id. at 3.)
Claims 1, 4, 6, 7, and 9-13 are on appeal. Claim 1 is illustrative and
reproduced below:
1. A solid phase oral pharmaceutical composition
comprising glyceryl behenate, 1- { 4-[ 1-( 4-cyclohexyl-3-
trifluoromethyl-benzyloxyimino )-ethyl]-2-ethyl-benzyl }-
azetidine-3-carboxylic acid ("API") or a pharmacologically
acceptable salt, or hydrate thereof, wherein the API is not
exposed to a basic compound, with the exclusion of basic forms
of the API, itself.
(Appeal Br. 13 (Claims App.).)
2
Appeal2016-006868
Application 13/917,730
The Examiner rejects claims 1, 4, 6, 7, and 9-13 under 35 U.S.C.
§ 103 as being unpatentable over Ciszewski, 2 Reugger, 3 and Ando, 4 as
evidenced by Illinois Poison Center. 5 (Ans. 3.)
DISCUSSION
Issue
The Examiner finds that Ciszewski teaches a hemifumarate salt of 1-
{ 4-[1-( 4-cyclohexyl-3-trifluoromethyl-benzyloxyimino )-ethyl]-2-ethyl-
benzyl }-azetidine-3-carboxylic acid ("API"). (Ans. 4.) The Examiner finds
that the salt is "formulated in ... crystalline form and provided as a
pharmaceutical composition comprising said compound and a
pharmaceutically acceptable adjuvant, diluent or carrier." (Id.) The
Examiner finds that Ciszewski teaches that its invention can be prepared for
oral administration ( e.g., in tablet form) and "comprise excipients that do not
necessarily include basic compounds." (Id. at 4--5.) The Examiner finds
that Ciszewski teaches, as possible excipients, lubricants such as magnesium
stearate. (Id. at 6.)
The Examiner finds that Ciszewski does not teach a composition
comprising glycerol behenate, as required by claim 1. (Id. at 5.) However,
the Examiner finds that Ruegger "teaches a composition comprising
sphingosine-1-phosphate (SIP) receptor modulators including, as a preferred
2 Ciszewski et al., WO 2010/080409 Al, published July 15, 2010.
3 Ruegger et al., WO 2009/048993 A2, published Apr. 16, 2009.
4 Howard Y. Ando et al., Property-Based Drug Design and Preformulation,
in REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY 720 (David B.
Troy et al., ed. 2005).
5 Silica Gel, ILLINOIS POISON CENTER, https://illinoispoisoncenter.org/my-
child-ate-Silica-Gel (last visited Mar. 24, 2015).
3
Appeal2016-006868
Application 13/917,730
species, [API described in claim 1] and salts thereof such as fumarate salts."
(Id.) The Examiner finds that Ruegger teaches combining the API of claim
1 with common excipients such as lubricants selected from the group
comprising magnesium stearate and glyceryl behenate. (Id.)
The Examiner concludes that a skilled artisan would have found it
prima facie obvious to use the glyceryl behanate taught in Ruegger in
Ciszewski' s composition to arrive at the invention of claim 1, with a
reasonable expectation of success, because Ciszewski teaches the API of
claim 1 "in an oral dosage form with non-basic excipients including
lubricants such as magnesium stearate," while Ruegger teaches a
composition comprising the same active agent as Ciszewski and also teaches
that "glyceryl behenate and magnesium stearate are both suitable alternative
lubricants." 6 (Id. at 6.)
Appellants contend that the cited references do not teach or suggest
the limitation, "wherein the API is not exposed to a basic compound," or the
use of glyceryl behenate with the API, as required by claim 1. (Appeal Br.
6-8, 11-12.) Appellants contend that they identified a previously unknown
problem associated with the stability and degradation of API and that the
subject matter of the claims exhibit unexpected results. (Id. at 6-9.)
Appellants contend that the Examiner's rejection is based on improper
hindsight. (Id. at 10-11.)
6 The Examiner cites Ando only to address certain limitations in dependent
claims 6 and 7 (Ans. 5, 7), which were not separately argued by Appellants.
Likewise, the Examiner cites Illinois Poison Center only to address a
limitation in dependent claim 13 (Ans. 5, 7), which Appellants do not
separately argue.
4
Appeal2016-006868
Application 13/917,730
Appellants do not separately argue the claims. We therefore limit our
analysis to claim 1. The issues with respect to this rejection are (1) whether
the cited prior art combination suggests a composition comprising API and
glyceryl behenate wherein "the API is not exposed to a basic compound"
other than basic forms of the API itself and, if so, (2) whether Appellants
have provided evidence of unexpected results that, when considered together
with evidence of obviousness, shows claim 1 to be non-obvious.
Findings of Fact
1. Ciszewski relates to
a hemifumarate salt of 1-(4-{l-[(E)-4-cyclohexyl-3-
trifluoromethyl-benzyloxyimino]ethyl}-2-ethyl-benzyl)-
azetidine-3-carboxylic acid[, i.e., API], ... pharmaceutical
compositions comprising this salt, . . . processes for
forming this salt and to its use in medical treatment[,] ...
new polymorphic forms of the hemifumarate salt form of
[ API], ... pharmaceutical compositions comprising these
polymorphic forms, ... processes for obtaining them, and
their use in medical treatment.
( Ciszewski Abstract.)
2. Ciszewski teaches that the hemifumarate salt of the API may be
administered orally. (Id. at 20.)
3. Ciszewski teaches that
[ s Jo lid dosage forms for oral administration include
capsules, tablets, pills, powders and granules. In such
solid dosage forms, the hemifumarate salt of [ API]
(including any one of its crystalline forms A to E) is
typically mixed with at least one inert, pharmaceutically
acceptable excipient or carrier such as sodium citrate or
dicalcium phosphate and/or one or more: a) fillers or
extenders . . . ; b) binders . . . ; c) humectants . . . ; d)
disintegrating agents . . . ; e) solution retarding agents
5
Appeal2016-006868
Application 13/917,730
. . . ; f) absorption accelerators . . . ; g) wetting agents
... ; h) absorbents ... and i) lubricants such as talc,
calcium stearate, magnesium stearate, solid polyethylene
glycols, sodium lauryl sulfate and mixtures thereof. In the
case of capsules, tablets and pills, the dosage form may
also comprise buffering agents.
(Id. at 23.)
4. Ruegger teaches a composition comprising a sphingosine 1
phosphate (SIP) receptor modulator. (Ruegger 1 :4--5.)
5. Ruegger teaches that preferred SIP receptor modulators include
"1-{ 4-[ 1-( 4-cyclohexyl-3-trifluoromethyl-benzyloxyimino )-ethyl]-2-ethyl-
benzyl }-azetidine-3-carboxylic acid, [i.e., API,] or a prodrug thereof." (Id.
at 11:22-23.)
6. Ruegger teaches oral formulations of its invention and further
teaches that "[t]he dosage form of a composition of [its] invention ... may
be a solid dosage form, e.g., a tablet." (Id. at 11 :29-32.)
7. Ruegger teaches that potentially feasible excipients for its
formulation include, e.g., fillers, binders, disintegrants, lubricants, flow
regulators, plasticizers, and matrix formers." (Id. at 12:26-28.) Ruegger
teaches that typical ranges found in a final formulation comprising a
compound described in its disclosure include lubricants from 0.5% to 2%.
(Id. at 12:29-34.)
8. Ruegger provides stability data for a formulation containing the
compound FTY720, i.e., 2-amino-2-[2-( 4-octylphenyl)ethyl]propane-1,3-
diol. (Id. at 17: 1-3.) In this context, Ruegger states that glycerylbehenat
(Compritol) is an example of a non-feasible excipient. (Id. at 20: 1-5.)
9. Ruegger claims a stable composition comprising API and one
or more excipients, wherein the recited excipients include "[l]ubricants
6
Appeal2016-006868
Application 13/917,730
selected from Hydrogenated castor oil, Glycerol behenate, magnesium
stearate, calcium stearate, zinc stearate, mineral oil, silicone fluid, sodium
lauryl sulfate, L-leucine, sodium stearyl fumarate." (Id. at 25: 1-26:4 ( claim
1 ), 26:29-33 (claim 4).)
Analysis
We agree with the Examiner that claim 1 is obvious over the
combination of Ciszewski, Ruegger, and Ando, as evidenced by Illinois
Poison Center.
In particular, Ciszewski teaches a pharmaceutical composition
comprising a hemifumarate salt of API in solid dosage forms for oral
administration. (FF1-FF3.) While Ciszewski does not explicitly teach
including glyceryl behenate in its composition, Ciszewski teaches that in
solid dosage forms the hemifumarate salt of API is typically mixed with at
least one inert, pharmaceutically acceptable excipient or carrier such as, e.g.,
lubricants such as magnesium stearate. (FF3.) Ruegger teaches that
magnesium stearate and glyceryl behenate are both lubricants that may be
used with APL (FF9.) Ruegger thus suggests magnesium stearate and
glyceryl behenate to be functional equivalents, and it would have been
obvious to substitute one equivalent (glyceryl behenate) for another
(magnesium stearate) in Ciszewski's composition. In re Fout, 675 F.2d 297,
301,213 USPQ 532,536 (CCPA 1982) (holding that "[e]xpress suggestion
to substitute one equivalent for another need not be present to render such
substitution obvious").
As for the negative limitation in claim 1, "wherein the API is not
exposed to a basic compound" other than the basic forms of the API itself,
Appellants concede that Ciszewski discloses excipients that are non-basic as
7
Appeal2016-006868
Application 13/917,730
well as excipients that are basic, and do not dispute that Ciszewski does not
require the inclusion of any particular basic compound in its composition.
(Appeal Br. 6-7.) Accordingly, Ciszewski suggests, and renders obvious,
compositions that meet this limitation, even if it also suggests compositions
that do not meet the limitation.
Appellants contend that the cited references do not teach or suggest
the limitation, "wherein the API is not exposed to a basic compound," as
recited in claim 1 and that "Ciszewski simply does not provide any
motivation, teaching or suggestion to only utilize non-basic excipients."
(Appeal Br. 6-8; see also Reply Br. 2-3.) We are not persuaded for the
reasons already discussed above: Ciszewski teaches compositions wherein
API is mixed with one or more excipient from a list of excipients, which
Appellants concede include non-basic ingredients. Thus, Ciszewski teaches
compositions consisting of API and a single, non-basic ingredient, which
meets the limitation regarding API not being exposed to a basic compound,
even if Ciszewski also teaches compositions that might include basic
excipients. Put another way, in order to render claim 1 obvious it is not
necessary for the prior art to teach forbidding basic excipients, as Appellants
contend-the prior art merely needs to teach or suggest a composition that
does not contain basic excipients.
Likewise, while Ciszewski may not have disclosed combining the
hemifumarate salt of the API with non-basic ingredients for the reasons
disclosed in the Specification (i.e., to improve the stability of the API in a
pharmaceutical composition) (Spec. 12), "neither the particular motivation
nor the avowed purpose of the patentee controls" in an obviousness analysis.
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,419 (2007). Instead, "any need
8
Appeal2016-006868
Application 13/917,730
or problem known in the field of endeavor at the time of invention and
addressed by the patent can provide a reason for combining the elements in
the manner claimed." Id. at 420.
Appellants also contend that "the Examiner has failed to consider the
claimed invention as a whole," in that Appellants have "discovered the
source of a problem associated with the stability and degradation of certain
APis," which may result in a patentable invention "even though the remedy
may be obvious once the source of the problem is identified." (Appeal Br.
8-9.) We are not persuaded. This is not a situation where a composition
containing API and non-basic excipients is non-obvious until Appellants'
alleged discovery of the problem associated with the stability and
degradation of certain APis. Thus, Appellants have at most discovered a
new property of a composition suggested in the prior art, 7 namely greater
stability of the API in the composition, but a "newly-discovered property of
the prior art cannot support a patent on that same art." Abbott Labs. v.
Baxter Pharm. Products, Inc., 471 F.3d 1363, 1368 (Fed. Cir. 2006).
Appellants further argue that the Examiner's rejection is based on
improper hindsight. (Appeal Br. 10-11.) In particular, Appellants contend
7 Appellants contend that MPEP 2145 (II), which the Examiner cites to
support the principle that "discovery of an additional advantage that would
flow naturally from following the suggestions of the prior art is not a basis
for patentability," is inapplicable, because "there is no suggestion in the
prior art that only non-basic excipients ... should be utilized in a
formulation with the APL" (Appeal Br. 3.) As we have already discussed
above, however, because Ciszewski teaches that API may be combined with
non-basic (as well as basic) excipients, and does not teach any basic
excipient to be required, Ciszewski does teach compositions consisting of
API and non-basic excipient(s), even if it doesn't explicitly teach excluding
basic excipients.
9
Appeal2016-006868
Application 13/917,730
that "Ciszewski teaches no less than 30 different types of excipients suitable
for solid oral formulations" but the Examiner's rejection cites only non-basic
agents. (Id. at 10.) Appellants contend that, because "Ciszewski ... does
not provide any motivation, teaching or suggestion to only utilize non-basic
excipients," "the use of non-basic excipients is absent from the cited art and
is only present in Applicant's specification." (Id. at 10-11.) Appellants
conclude that, given the above, "[i]t logically follows that utilizing only non-
basic excipients has been improperly gleaned from Applicant's own
specification and ... the Examiner's analysis is an exercise of impermissible
hindsight." (Id. at 11.)
We are not persuaded for reasons already discussed. As Appellants
acknowledge (id. at 10), "[a]ny judgment on obviousness is in a sense
necessarily a reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level of ordinary
skill at the time the claimed invention was made and does not include
knowledge gleaned only from applicant's disclosure, such a reconstruction is
proper." In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209,212
(CCP A 1971 ). In this case, Ciszewski teaches that API may be used with
one or more excipients, including excipients that are non-basic, even if it
also teaches excipients that are basic. Thus, the obviousness rejection is
based, not on Appellants' disclosure that using non-basic ingredients with
API improves API stability, but on Ciszewski's teaching that API may be
used with particular non-basic excipients.
Appellants next contend that the cited references do not teach the use
of glyceryl behenate with API, as required by claim 1. (Appeal Br. 11-12;
Reply 3--4.) In particular, Appellants contend that Reugger teaches glyceryl
10
Appeal2016-006868
Application 13/917,730
behenate to be a non-feasible excipient. (Appeal Br. 11.) We are not
persuaded. As the Examiner points out, Reugger's statement that glyceryl
behenate is a non-feasible excipient occurs in the context of another
compound (FTY720, i.e., 2-amino-2-[2-( 4-octylphenyl)ethyl]propane-1,3
diol in free form or in a pharmaceutically acceptable salt form) rather than
the API of claim 1. (Ans. 15, FF8.)
Appellants contend that Reugger makes it clear that the mechanism of
"the degradation of compounds ( and by extension what makes [glyceryl
behenate] non-feasible)" in the FTY720/glyceryl behenate composition is
nucleophilic attack, and the API contains several functional groups that are
nucleophiles and thus also subject to nucleophilic attack. (Appeal Br. 12;
Reply Br. 4--5.) Accordingly, Appellants contend that "[i]t is entirely
plausible ... that Reugger' s teaching of glyceryl behenate as an unfeasible
excipient applies to the APL" (Appeal Br. 12.) Appellants' attorney
arguments regarding whether a skilled artisan would understand Reugger's
disclosure of glyceryl behenate as a non-feasible excipient to apply to API,
however, cannot substitute for evidence. Johnston v. IVAC Corp., 885 F.2d
1574, 1581 (Fed. Cir. 1989) ("Attorneys' argument is no substitute for
evidence."). Given Reugger's suggestion that its invention may comprise
glycerol behenate as a lubricant and given the differences between API and
FTY720, we find that the Examiner has established a prima facie case that
the prior art combination suggests a composition comprising API and
glyceryl behenate and further agree with the Examiner that Appellants have
not sufficiently shown that glyceryl behenate would be viewed by the skilled
artisan as infeasible for the claimed APL (FF8, FF9, Ans. 15.)
11
Appeal2016-006868
Application 13/917,730
Appellants also argue that the Specification8 shows that magnesium
stearate and glyceryl behenate are not substitutable for each other and that
"the use of glyceryl behenate was 400% more effective than that of
magnesium stearate." (Appeal Br. 12; Reply Br. 5---6.) We are not
persuaded. As an initial matter, the question relevant to obviousness is
whether a skilled artisan would have understood magnesium stearate and
glyceryl behenate to be functional substitutes at the time of the invention.
Appellants have not shown that a skilled artisan would have been aware of,
at the time of the invention, the data presented in the Specification and relied
on by Appellants to show that magnesium stearate and glyceryl behenate are
not functional substitutes. Furthermore, to the extent Appellants' argument
is that a skilled artisan would have known that glyceryl behenate is more
effective than magnesium stearate, such knowledge would have, in fact,
provided another motivation to substitute glyceryl behenate for magnesium
stearate in Ciszewski' s composition. 9
Finally, Appellants appear to contend that the subject matter of claim
1 exhibits unexpected results, arguing that "one of the important elements of
[their] invention is the surprising discovery that using particular excipients
are associated with reduced degradation of the APL" (Appeal Br. 6; see also
id. at 9, Reply Br. 5---6.) In the Reply Brief, Appellants specifically point to
"the marked differences between the use of magnesium stearate and glyceryl
8 In the Appeal Brief, Appellants cite to Bouillot et al., US2013027316I Al
("the '161 Publication"), which is the published version of the patent
application at issue in this appeal. (Appeal Br. 12.)
9 To the extent Appellants are arguing unexpected results rather than lack of
reason to substitute magnesium stearate with glyceryl behenate, we address
Appellants' arguments below.
12
Appeal2016-006868
Application 13/917,730
behenate in conjunction with the API," arguing that Example 5 of the
Specification shows that "the compound is 400% more stable when utilizing
glyceryl behenate as opposed to magnesium stearate." (Reply Br. 5.)
Appellants contend that, since "the prior art does not disclose at all the
[effect of excipients on the] relevant property (i.e., the stability of the API),"
"there can be no expectation of any difference in the properties when
comparing the prior art and the claimed invention." (Id. at 6.)
We are not persuaded. While we agree that "[ o ]ne way for a patent
applicant to rebut a prima facie case of obviousness is to make a showing of
'unexpected results,' i.e., to show that the claimed invention exhibits some
superior property or advantage that a person of ordinary skill in the relevant
art would have found surprising or unexpected," In re Soni, 54 F.3d 746, 750
(Fed. Cir. 1995), "by definition, any superior property must be unexpected to
be considered evidence of non-obviousness." Pfizer, Inc. v. Apotex, Inc.,
480 F.3d 1348, 1371 (Fed. Cir. 2007). Furthermore, "it is well settled that
unexpected results must be established by factual evidence. 'Mere argument
or conclusory statements in the specification does not suffice."' In re
Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (quoting In re De Blauwe,
736 F.2d 699, 705 (Fed. Cir. 1984)).
Here, the evidence cited by Appellants, at most, shows that a
composition consisting of API and glyceryl behenate possesses superior
stability when compared to a composition consisting of API and magnesium
stearate. The record contains insufficient persuasive evidence, however, that
such difference in stability is not merely unknown but unexpected. While
the Federal Circuit has held that "when an applicant demonstrates
substantially improved results ... and states that the results were
13
Appeal2016-006868
Application 13/917,730
unexpected, this should suffice to establish unexpected results in the absence
of evidence to the contrary," In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995), in
this case the only assertion that the invention exhibits unexpected results
appear in attorney arguments in the brief. Such attorney arguments,
however, cannot take the place of evidence. In re Pearson, 494 F.2d 1399,
1405 (CCPA 1974). 10
Accordingly, we affirm the Examiner's rejection of claim 1. Claims
4, 6, 7, and 9-13, which are not separately argued, fall with claim 1. 37
C.F.R. § 4I.37(c)(l)(iv).
10 We also note that the glyceryl behenate and magnesium stearate
compositions compared in Example 5 contain differences other than the
identity of the lubricant. For instance, the glyceryl behenate composition
contains 5.950 mg glyceryl behenate per 0.25 mg hemifumarate salt of API,
while the magnesium stearate composition contains only 0.850 mg
magnesium stearate per 0.25 mg hemifumarate salt of APL (Spec. 32, Table
3.) Likewise, the tablet containing glyceryl behenate was not coated in
contrast to the coated tablet containing magnesium stearate. (Id.) While the
Specification states that the tablet made with glyceryl behenate "were not
coated with the moisture protective film coated opadry AMB in order to
better demonstrate the stability benefit" (Spec. 31 ), Appellants have not
sufficiently explained why the alleged different stability performance was
not due to these differences rather than the identity of the lubricant. We also
note that "[t]he evidence presented to rebut aprimafacie case of
obviousness must be commensurate in scope with the claims to which it
pertains." In re Dill, 604 F.2d 1356, 1361 (CCPA 1979). Here, Example 5
compares only the effect of glyceryl benehate and magnesium stearate on a
composition of hemifumarate salt of API, even though the claim also
encompasses compositions comprising glyceryl benehate and API itself,
other pharmacologically acceptable salts, or hydrates thereof. (Appeal Br.
13 (Claims App.).)
14
Appeal2016-006868
Application 13/917,730
SUMMARY
For the reasons above, we affirm the Examiner's decision rejecting
claims 1, 4, 6, 7, and 9-13 as obvious in view of the cited prior art for the
reasons herein and of record.
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).
AFFIRMED
15