Ex Parte Lao et al

Board of Patent Appeals and Interferences

Jan 8, 2009

11172280 (B.P.A.I. Jan. 8, 2009)

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.
10/769,019 02/02/2004 Samir Roy 13587.348 8006
23702 7590 12/02/2009
Bausch & Lomb Incorporated
One Bausch & Lomb Place
Rochester, NY 14604-2701
EXAMINER
CHANNAVAJJALA, LAKSHMI SARADA
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
12/02/2009 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 SAMIR ROY, SANTOSH KUMAR CHANDRASEKARAN,
KATSUMI IMAMORI, TAKEMITSU ASAOKA,
AKIHIRO SHIBATA, MASAMI TAKAHASHI,
and LYLE M. BOWMAN
__________

Appeal 2009-009792
Application 10/769,019
Technology Center 1600
__________

Decided: December 1, 2009
__________

Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN,
and STEHEN WALSH, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 involving claims to a topical
ophthalmic composition. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.
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Statement of the Case
Background
“Treatment of ocular-and periocular infections can be effected by the
application of ointments or the instillation of topical antibiotic suspensions
to the eye” (Spec. 1, ll. 16-17). According to the Specification,
“[c]ompositions such as: CHIBOXIN™ (Merck and Co., West Point,
Pennsylvania), CILOXAN™ (Alcon Laboratories, Fort Worth, Texas) and
OCUFLOX™ (Allergan Inc., Irvine, California) employ quinolone
antimicrobials in aqueous solution or aqueous suspension” (Spec. 1, ll. 24-
26).
The Claims
Claims 50-77 are on appeal. Claims 50, 57, and 62 are representative
and read as follows:
50. A topical ophthalmic composition comprising:
a quinolone carboxylic acid derivative of formula (I),

wherein R1 is a hydrogen atom, an alkyl group, an
aralkyl group, an ester residual group which can be
hydrolyzed in vivo, R2 is a hydrogen atom or an amino group
which may be substituted by one or two lower alkyl groups,
X is a hydrogen atom or a halogen atom, Y is CH2, O, S,
SO, SO2, or N-R3, wherein R3 is a hydrogen atom or a lower
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alkyl group, and Z is an oxygen atom or two hydrogen
atoms;
a carboxy containing polymer;
a chelating agent; and
a block copolymer of ethylene oxide and propylene
oxide.

57. The composition of claim 50, wherein said quinolone
carboxylic acid derivative of formula (I) comprises particles
prepared by micronization.

62. The composition of [claim 50, further comprising a
solubilizer], wherein said solubilizer is hydroxypropyl-β-
cyclodextrin.

The prior art

The Examiner relies on the following prior art references to show
unpatentability:
Ryde et al. US 3,868,445 Feb. 25, 1975
Konno et al. US 5,385,900 Jan. 31, 1995
Dawson et al. US 6,239,113 B1 May 29, 2001

Nigel M. Davies et al., Biopharmaceutical considerations in topical ocular
drug delivery, 27 CLINICAL EXPERIMENTAL PHARMACOLOGY PHYSIOLOGY
558-562 (2000).

The issues
A. The Examiner rejected claims 50-56, 58-61, 63-69, 71-74, and 76
under 35 U.S.C. § 103(a) as obvious over Dawson and Konno (Ans. 3-7).
B. The Examiner rejected claims 62 and 75 under 35 U.S.C. § 103(a) as
obvious over Dawson, Konno, and Davies (Ans. 7-8).
C. The Examiner rejected claims 57, 70, and 77 under 35 U.S.C. § 103(a)
as obvious over Dawson, Konno, and Ryde (Ans. 3-7).
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A. 35 U.S.C. § 103(a) over Dawson and Konno
The Examiner finds that “Konno teaches quinolone carboxylic acid
derivatives of the instant invention” (Ans. 4). The Examiner finds that
“Dawson specifically mentions fluorquinolones and suggests that the
combination of antibiotics advantageously treat[s] multiple conditions
simultaneously, in particular topical application to treat eye infections” (Ans.
4). The Examiner concludes that it would have been obvious to use the
“quinolone carboxy derivatives of Konno in place of the conventional
fluorquinolones, such as norfloxacin, ofloxacin etc., in the composition of
Dawson comprising combination antibiotics, because Konno teaches that the
quinolone carboxy derivatives are effective against a variety of Gram-
positive and Gram-negative bacteria and much stronger the conventionally
known fluoroquinolones” (Ans. 5).
Appellants argue that “a person of ordinary skill like Dawson
recognizes that not all known antibiotics may be formulated into a safe and
pharmacologically effective ophthalmic composition. In other words, the
success is not predictable” (App. Br. 7). Appellants also argue that
“different fluoroquinolones do not yield the same pharmacokinetic efficacy
in ophthalmic testing. See; e.g., Figure 5 . . . These data further show the
unpredictability of the pharmacokinetics of drugs, which influences their
therapeutic potential” (App. Br. 8).
In view of these conflicting positions, we frame the obviousness issue
before us as follows:
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Have Appellants demonstrated that the Examiner erred in finding it
obvious to combine the fluoroquinolone of formula 1 of Konno with the
topical ophthalmic composition of Dawson?
Findings of Fact (FF)
1. Konno teaches
a quinolone carboxylic acid derivative having the
following formula (1),

wherein R1 is a hydrogen atom, an alkyl group, an
aralkyl group, an ester residual group which can be
hydrolyzed in living bodies, R2 is a hydrogen atom or an
amino group which may be substituted by one or two lower
alkyl groups, X is a hydrogen atom or a halogen atom, Y is
CH2, O, S, SO, SO2, or N-R3, wherein R3 is a hydrogen atom
or a lower alkyl group, and Z is an oxygen atom or two
hydrogen atoms; or a salt thereof.

(Konno, col. 1, l. 50 to col. 2, l. 3).
2. Konno teaches that quinolones of “formula (1) and their salts
exhibited antimicrobial activities against Gram positive microorganisms
much stronger than conventional quinolone carboxylic acid derivatives,
while maintaining their strong antimicrobial activities against Gram negative
microorganisms as well as excellent absorptivity” (Konno, col. 1, ll. 41-47).
3. Konno teaches that “[c]ompound (1) can be formed into various
antimicrobial preparations, such as tablets, granules, powders, capsules,
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suspensions, injections, suppositories, or the like, according to conventional
methods” (Konno, col. 3, ll. 65-68).
4. The Examiner finds that Konno “fails to explicitly teach their
[compound (1)’s] use for preventing or treating microbial infections of eye
tissues” (Ans. 5).
5. Dawson teaches “a process for treating an eye that comprises
topically applying an azalide antibiotic to an eye in an amount effective to
treat or prevent infection” (Dawson, col. 2, ll. 33-35).
6. Dawson teaches “the . . . use of additional medicaments in
combination with the azalide antibiotics . . . . Typically, the additional
medicaments include other antibiotics . . . . Examples of suitable
medicaments include . . . fluoroquinolones such as ciprofloxacin,
norfloxacin, ofloxacin, trovafloxacin, lomefloxacin, levofloxacin, and
enoxacin” (Dawson, col. 6, ll. 16-35).
7. Dawson teaches that the antibiotic is suspended in polymeric
suspending agents and that a “preferred polymeric suspending agent is a
water swellable, water insoluble polymer, especially a crosslinked carboxy-
containing polymer” (Dawson, col. 9, ll. 3-6).
8. The Specification teaches that “[a]dditional excipients may
include, for example, without limitation, chelating agents (e.g. ETDA [sic
EDTA] etc), surfactants and additional polymeric agents (e.g., block
copolymer of ethylene oxide and propylene oxide, such as Poloxamer™
polymers)” (Spec. 20, ll. 4-6).
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9. Dawson teaches that the “ophthalmic compositions may contain
. . . . EDTA (disodium edetate)” which is a chelating agent (Dawson, col. 6,
ll. 7-12).
10. Dawson teaches the use of Poloxamer 407 in ophthalmic
compositions (see Dawson, col. 12, l. 20).
11. Dawson teaches that “for a variety of reasons, many antibiotics
are not amenable or suitable for topical application to the eye” (Dawson, col.
1, ll. 33-35).
12. Dawson teaches that “[e]xamples of antibiotics that are reported
to be useful in ocular topical administration include . . . fluoroquinolone
derivatives including norfloxacin, ofloxacin, and ciprofloxacin” (Dawson,
col. 2, ll. 13-17).
Principles of Law
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) the level of ordinary skill in the art; (3) the differences between the
claimed invention and the prior art; and (4) secondary considerations of
nonobviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
The Supreme Court has emphasized that “the [obviousness] analysis need
not seek out precise teachings directed to the specific subject matter of the
challenged claim, for a court can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ.” KSR Int'l v.
Teleflex Inc., 550 U.S. 398, 418 (2007).
In Kubin, the court commented that “[r]esponding to concerns about
uncertainty in the prior art influencing the purported success of the claimed
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combination, this court [in O'Farrell] stated: ‘[o]bviousness does not require
absolute predictability of success … all that is required is a reasonable
expectation of success.”’ In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009)
(citing In re O'Farrell, 853 F.2d 894, 903-904 (Fed. Cir. 1988)).
Analysis
Dawson teaches ophthalmic antibiotic compositions which comprise
fluoroquinolone antibiotics (FF 6), carboxy containing polymers (FF 7),
chelating agents (FF 9), and block copolymers of ethylene oxide and
propylene oxide (FF 10). While Dawson does not teach the fluoroquinolone
of formula (1), Konno teaches that quinolones of “formula (1) and their salts
exhibited antimicrobial activities against Gram positive microorganisms
much stronger than conventional quinolone carboxylic acid derivatives,
while maintaining their strong antimicrobial activities against Gram negative
microorganisms as well as excellent absorptivity” (Konno, col. 1, ll. 41-47;
FF 2).
We agree with the Examiner that a preponderance of the evidence
supports a determination that the claimed invention would have been
obvious over the prior art. In KSR, the Supreme Court stated that an
invention may be found obvious if it would have been obvious to a person
having ordinary skill to try a course of conduct:
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When there is a design need or market pressure to solve a
problem and there are a finite number of identified,
predictable solutions, a person of ordinary skill has good
reason to pursue the known options within his or her
technical grasp. If this leads to the anticipated success, it is
likely the product not of innovation but of ordinary skill and
common sense. In that instance the fact that a combination
was obvious to try might show that it was obvious under
§ 103.

KSR, 550 U.S. at 421. We agree with the Examiner that the ordinary
practitioner, familiar with the prior art of Dawson and Konno, would
recognize that it would have been obvious to use Konno’s superior
fluoroquinolones in Dawson’s ophthalmic antibiotic composition (see Ans.
5; FF 1-7, 9-12).
Appellants argue that Dawson “recognizes that not all known
antibiotics may be formulated into a safe and pharmacologically effective
ophthalmic composition. In other words, the success is not predictable”
(App. Br. 7). We are not persuaded. O'Farrell states that “[o]bviousness
does not require absolute predictability of success.” In re O'Farrell, 853
F.2d 894, 903 (Fed.Cir.1988). O'Farrell identifies
two kinds of error. In some cases, what would have been
“obvious to try” would have been to vary all parameters or
try each of numerous possible choices until one possibly
arrived at a successful result, where the prior art gave either
no indication of which parameters were critical or no
direction as to which of many possible choices is likely to be
successful. . . . In others, what was “obvious to try” was to
explore a new technology or general approach that seemed
to be a promising field of experimentation, where the prior
art gave only general guidance as to the particular form of
the claimed invention or how to achieve it.
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O'Farrell, 853 F.2d at 903. The instant facts do not fit O'Farrell’s first kind
of error, since the prior art of Dawson specifically points the practitioner to
ophthalmic compositions with fluoroquinolone antibiotics and the prior art
of Konno specifically identifies formula (1) as a superior fluoroquinolone
antibiotic, which suggests a likelihood of success in using Konno’s
fluoroquinolone antibiotic in Dawson’s ophthalmic composition.
The instant fact pattern also does not represent a situation where the
prior art only provides a “general approach”, since the prior art provides the
very specific teaching of Konno’s specific fluoroquinolone of formula (1)
which has superior antibiotic activity and absorptivity (FF 1-3) and
Dawson’s specific ophthalmic antibiotic compositions which may include
fluoroquinolones (FF 5-7, 9-12). See In re Kubin, 561 F.3d 1351, 1359
(Fed. Cir. 2009).
We are not persuaded by Appellants’ argument that the
“unpredictability of properties even within the fluoroquinolones is clearly
demonstrated by Thompson Franzco1” (App. Br. 7). In fact, we find that the
Thompson Franzco supports the Examiner’s position, since Thompson
Franzco concludes that the “published literature indicates that, although not
free of complications, fluoroquinolones are generally safe when used to treat
ocular infections” (Thompson Franzco, 573, col. 2). Thus, while Thompson
Franzco expressed concerns over adverse effects, the fundamental
conclusion he reached was that fluoroquinolones are generally safe when

1 Thompson Franzco, Ocular Toxicity of fluoroquinones, 35
CLINICAL EXPERIMENTAL OPHTHALMOLOGY 566-577 (2007).
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used to treat ocular infection, which supports the finding of a “reasonable
expectation of success” in using Konno’s fluoroquinolone of formula (1) in
Dawson’s ophthalmic composition.
Appellants argue that “different fluoroquinolones do not yield the
same pharmacokinetic efficacy in ophthalmic testing. See; e.g, Figure 5,
which shows the comparison of the bioavailability of Compound I versus
ciproflaxacin in the conjunctiva” (App. Br. 8). Appellants further argue that
“[s]uch claimed formulation produces the exemplary advantageous
pharmacokinetic results over the prior-art compounds and formulations,
which advantageous results are not limited to any particular concentration of
Compound 1” (App. Br. 10).
We are uncertain if these arguments are intended to raise the issue of
unexpected results or simply “expectation of success”. As we have already
discussed, in order to demonstrate obviousness, the Examiner does not have
to show that every compound yields the same result, only that there is a
“reasonable expectation of success”. See In re O'Farrell, 853 F.2d 894, 903
(Fed.Cir.1988) (“Obviousness does not require absolute predictability of
success. Indeed, for many inventions that seem quite obvious, there is no
absolute predictability of success until the invention is reduced to practice.”)
We also do not find Appellants’ evidence sufficient to demonstrate an
unexpected result relative to the prior art of Konno and Dawson.
Appellants’ demonstration in Figure 5 that Compound I has superior
bioavailability would have been expected by Konno, who teaches that
quinolones of “formula (1) and their salts exhibited . . . excellent
absorptivity” (Konno, col. 1, ll. 41-47; FF 2). Appellants have therefore, not
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established that the results were unexpected relative to the prior art. “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 De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984). Further,
“[A]rguments of counsel cannot take the place of evidence lacking in the
record.” Estee Lauder Inc. v. L'Oreal, S.A., 129 F.3d 588, 595 (Fed. Cir.
1997) quoting Knorr v. Pearson, 671 F.2d 1368, 1373 (CCPA 1982).
Further, there is no evidence that Appellants have compared their data
with the prior art fluoroquinolone compositions of Konno, which would
represent the closest known prior art. See In re Baxter Travenol Labs., 952
F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen unexpected results are used as
evidence of nonobviousness, the results must be shown to be unexpected
compared with the closest prior art.”).
We also conclude that even if there is some showing of unexpected
results, the showing is insufficient to overcome the strong showing of
obviousness in this case. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348,
1372 (Fed. Cir. 2007) (“[W]e hold that even if Pfizer showed that
amlodipine besylate exhibits unexpectedly superior results, this secondary
consideration does not overcome the strong showing of obviousness in this
case. Although secondary considerations must be taken into account, they do
not necessarily control the obviousness conclusion. Newell Cos., Inc. v.
Kenney Mfg. Co., 864 F.2d 757, 768 (Fed.Cir.1988)”).
In the instant case, as in Pfizer, the findings of fact “establish[] such a
strong case of obviousness that . . . alleged unexpectedly superior results are
ultimately insufficient”. Id. at 769.
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Conclusion of Law
Appellants have not demonstrated that the Examiner erred in finding it
obvious to combine the fluoroquinolone of formula 1 of Konno with the
topical ophthalmic composition of Dawson.
B. 35 U.S.C. § 103(a) over Dawson, Konno, and Davies
The Examiner finds it obvious to “to add cyclodextrins to the topical
antimicrobial formulations of Dawson containing quinolone carboxylic acid
derivatives of Konno because Davies suggests that cyclodextrins acts as
solubilizers for drugs and increases the intraocular absorption of the drugs,
which are otherwise impermeable through cornea” (Ans. 8).
Appellants argue that “[c]ontrary to the Examiner's conclusory
statement, Davies even concluded that ‘it is unclear as to [the] potential of
[cyclodextrins] for improving ocular bioavailability, which is seemingly
dependent and may be influenced by both the physicochemical properties of
the drug and the complex formed’ ‘in addition to other formulation
variables’” (App. Br. 11).
In view of these conflicting positions, we frame the obviousness issue
before us as follows:
Have Appellants demonstrated that the Examiner erred in finding it
obvious to form a topical ophthalmic composition of the fluoroquinolone of
formula 1 with a solubilizer “wherein said solubilizer is hydroxypropyl-β-
cyclodextrin”?

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Findings of Fact
13. Davies teaches that “[r]eformulation of ophthalmic suspensions
as solutions has many advantages. This may be achieved by complexation
using cyclodextrins” (Davies, abstract).
14. Davies teaches that “solubilization using cyclodextrins can
overcome many of the formulation problems. However, it is unclear as to
their potential for improving ocular bioavailability, which is seemingly drug
dependent” (Davies, abstract).
15. Davies teaches that one “approach to using water-soluble
derivatives is to use formulation strategies to increase the aqueous solubility
of poorly water-soluble compounds. This maintains the lipophilicity and,
hence, permeability characteristics of the parent compound. One such
strategy is to use cyclodextrins” (Davies, 560, col. 2).
16. Dawson teaches that “azalide antibiotics are poorly soluble in
water” (Dawson, col. 5, ll. 49-50).
Principles of Law
“If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability. For the same reason, if a technique has been
used to improve one device, and a person of ordinary skill in the art would
recognize that it would improve similar devices in the same way, using the
technique is obvious unless its actual application is beyond his or her skill.”
KSR Int'l v. Teleflex Inc., 550 U.S. 398, 417 (2007).
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Analysis
Davies teaches that cyclodextrins permit reformulation of ophthalmic
suspensions as solutions and teaches that their use has many advantages (FF
13-15). Davies specifically teaches that cyclodextrins “increase the aqueous
solubility of poorly water-soluble compounds. This maintains the
lipophilicity and, hence, permeability characteristics of the parent
compound” (Davies 560, col. 2; FF 15). Dawson teaches that the azalide
antibiotics are poorly soluble in water (FF 16).
We are not persuaded by Appellants’ argument that “the Examiner did
not articulate why cyclodextrin should be picked to combine with
Compound I and the other recited ingredients” (App. Br. 11). The Examiner
has provided specific reasons to use the cyclodextrins of Davies, including
that cyclodextrins improve the formulation since “cyclodextrins acts as
solubilizers for drugs” (Ans. 8). We conclude that the use of cyclodextrins
in the ophthalmic composition of Konno and Dawson represents a
predictable variation of the ophthalmic composition since they would
improve the aqueous solubility of the poorly soluble antibiotics within the
formulation (FF 13-16).
We are not persuaded by Appellants’ argument that “[s]uch late
forced rationalization shows that the Examiner uses Appellant’s claims as a
template for hindsight reconstruction of the claimed invention” (App. Br.
12). Modification of the formulation Konno and Dawson with cyclodextrin
as taught by Davies would have been the product of ordinary skill and
common sense, not of innovation. See KSR, 550 U.S. at 421. Thus, no
impermissible hindsight was employed by the Examiner.
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Conclusion of Law
Appellants have not demonstrated that the Examiner erred in finding it
obvious to form a topical ophthalmic composition of the fluoroquinolone of
formula 1 with a solubilizer “wherein said solubilizer is hydroxypropyl-β-
cyclodextrin”.
C. 35 U.S.C. § 103(a) over Dawson, Konno, and Ryde
The Examiner finds it obvious to “to prepare the quinolone carboxylic
acids of Konno in the form particles of suitable size and incorporate in the
composition of Dawson because Ryde suggests particles of active substance
and Dawson also desires the antibiotic in the form of particles” (Ans. 9).
Appellants argue that “an articulated reasoning is required for why
one would combine Ryde’s particulates with Kono’s compound and
Dawson's other ingredients to arrive at the claimed invention with
advantageous benefits” (App. Br. 13).
In view of these conflicting positions, we frame the obviousness issue
before us as follows:
Have Appellants demonstrated that the Examiner erred in finding it
obvious to form a topical ophthalmic composition of the fluoroquinolone of
formula I “wherein said quinolone carboxylic acid derivative of formula (I)
comprises particles prepared by micronization”?
Findings of Fact
17. Ryde teaches, regarding ophthalmic compositions, that “[i]f the
drug showing topical effect on the eye is in a solid, finely-divided form, the
selected particle size preferably lies within the range of approximately 150 µ
to approximately 5 µ” (Ryde, col. 3, ll. 27-30).
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18. Dawson teaches that “[t]his gelation or increase in gelation
leads to entrapment of the suspended azalide antibiotic particles . . . The
azalide antibiotic is released slowly as the suspended particles dissolve over
time” (Dawson, col. 11, ll. 26-30).
Analysis
We not persuaded by Appellants’ argument that “the Examiner has
not articulated logically followable reasoning for the combination of
Dawson, Kono [sic Konno], and Ryde to arrive at a reasonable expectation
of success” (App. Br. 14). The Examiner finds it obvious to “to prepare the
quinolone carboxylic acids of Konno in the form particles of suitable size
and incorporate in the composition of Dawson because Ryde suggests
particles of active substance and Dawson also desires the antibiotic in the
form of particles” (Ans. 9). Given that Dawson teaches the use of particles
in ophthalmic compositions (FF 18) and Ryde teaches the preferable size of
particles of antibiotics in ophthalmic compositions, we conclude that the
Examiner has provided a legally cognizable reason to micronize the
particles, which is to achieve the preferred size of Ryde in the ophthalmic
formulation (FF 17).
Conclusion of Law
Appellants have not demonstrated that the Examiner erred in finding it
obvious to form a topical ophthalmic composition of the fluoroquinolone of
formula I “wherein said quinolone carboxylic acid derivative of formula (I)
comprises particles prepared by micronization”.

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SUMMARY
In summary, we affirm the rejection of claim 50 under 35 U.S.C.
§ 103(a) as obvious over Dawson and Konno. Pursuant to 37 C.F.R.
§ 41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 51-56, 58-61,
63-69, 71-74, and 76 as these claims were not argued separately.
We affirm the rejection of claims 62 and 75 under 35 U.S.C. § 103(a)
as obvious over Dawson, Konno, and Davies.
We affirm the rejection of claims 57, 70, and 77 under 35 U.S.C.
§ 103(a) as obvious over Dawson, Konno, and Ryde.
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)(iv)(2006).
AFFIRMED

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