Ex Parte Muller

Board of Patent Appeals and Interferences

Feb 27, 2012

12116303 (B.P.A.I. Feb. 27, 2012)

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.
12/116,303 05/07/2008 Walter Muller 512100-2037.1 6809
20999 7590 02/27/2012
FROMMER LAWRENCE & HAUG
745 FIFTH AVENUE- 10TH FL.
NEW YORK, NY 10151
EXAMINER
LANDAU, SHARMILA GOLLAMUDI
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
02/27/2012 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 WALTER MULLER
__________

Appeal 2012-000649
Application 12/116,303
Technology Center 1600
__________

Before DONALD E. ADAMS, STEPHEN WALSH, and JACQUELINE
WRIGHT BONILLA, Administrative Patent Judges.

BONILLA, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to directed
to a transdermal therapeutic system comprising a polyisobutylene active
substance layer with microreservoirs dispersed within, where the drug
sufentanyl is dissolved in the microreservoirs. The Examiner has rejected
the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.
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STATEMENT OF THE CASE
The present invention relates to a transdermal therapeutic system
comprising: a) an impermeable backing layer; b) an active substance layer
comprising polyisobutylene with microreservoirs dispersed within, where
sufentanyl is dissolved in the microreservoirs; and c) a protective layer.
Claims 1-4 and 8-20 are on appeal. Appellant argued claims 2 and 3
separately from other pending claims.1 Claim 1 is the only independent
claim and reads as follows (emphasis added):
1. A transdermal therapeutic system (TTS) containing an active
substance comprising:
a) an active substance impermeable backing layer,
b) an active substance layer,
wherein the active substance is sufentanyl,
where said active substance layer comprises a polymer or a
polymer mixture with microreservoirs dispersed therein,
wherein the active substance is dissolved in the microreservoirs,
and
c) a protective layer, which is removed before use
wherein the polymer or polymer mixture is a pressure sensitive
adhesive polymer which is a polyisobutylene.

1 Appellant states that “[c]laim 2 and 3 will be argued separately” but
also that “[i]n order to expedite the Appeal, claims 3-20 will be considered
to stand or fall with the rejection of claim 1.” (App. Br. 3.) For the purposes
of our analysis, we assume that Appellant intended claims 4 and 8-20 to
stand or fall with claim 1, and that we should consider claims 2 and 3
separately from other pending claims.
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Claim 2 depends on claim 1 and recites that “the concentration of the active
substance in the active substance layer is between 2 and 5% by weight.”
Claim 3, which also depends on claim 1, recites that “at least 50% by weight
of the active substance in the TTS is contained within said microreservoirs.”
The claims stand rejected as follows:
• Claims 1, 3, 8-15, and 20 under 35 U.S.C. §103(a) as obvious over
Müller (WO 01/01967, Jan. 11, 2001) in view of Levy et al. (U.S. Pat. No.
4,822,802, issued Apr. 18, 1989) and Xiong and Patel (WO 01/35883, May
25, 2001) (“Patel”).
• Claims 2,16, and 18-19 under 35 U.S.C. §103(a) as obvious over
Müller in view of Levy and Patel as applied to claims 1, 3, 8-15, and 20, and
further in view of Gale et al. (U.S. Pat. No. 4,588,580, issued May 13, 1986)
as evidenced by the instant Specification.
• Claim 4 under 35 U.S.C. §103(a) as obvious over Müller in view of
Levy and Patel as applied to claims 1, 3, 8-15, and 20, and further in view of
Fischer et al. (U.S. Pat. No. 5,683,711, issued Nov. 4, 1997).
• Claim 17 under 35 U.S.C. §103(a) as obvious over Müller in view
of Levy and Patel as applied to claims 1, 3, 8-15, and 20, and further in view
of Chang et al. (U.S. Pat. No. 4,849,224, issued Jul. 18, 1989).
Findings of Fact
1. Appellant and Examiner agree that while Müller describes a
transdermal therapeutic system, Müller does not teach the “use of sufentanyl
as an active ingredient or the substitution of polyisobutylene for
polysiloxane.” (App. Br. 5; Ans. 5.)

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2. According to the Examiner, Müller teaches that the active ingredient
in the described transdermal therapeutic system is not limited, and may
include “pain means” such as fentanyl. (Ans. 5, citing Müller, 4). Although
Müller fails to teach sufentanyl, the Examiner finds that Levy cures this
deficiency. (Ans. 5-6.)
3. Levy teaches transdermal delivery of “[f]entanyl and its analgetically
effective derivatives such as sufentanyl ….” (Levy, col. 1, ll. 15-18; see
also abstract.)
4. Müller also discloses a transdermal therapeutic system comprising an
active substance layer comprising a polymer with microreservoirs dispersed
therein, where the polymer is polysiloxane. (Müller, 1 (stating that the
“Prefered Polymer for micro reservoir systems is polysiloxanes”).)
5. As noted by the Examiner, Patel teaches transdermal patches
comprising a pressure sensitive adhesive that may be polyisobutylene or
polysiloxane. (Ans. 7.) Specifically, Patel states that “[s]pecific examples
of suitable rubber-based pressure sensitive adhesives include …
polyisobutylene (PIB), … and polysiloxanes ….” (Patel, 23, 2nd full ¶.)
6. Gale teaches a transdermal therapeutic system for delivery of fentanyl
and its analgetically effective derivatives, such as sufentanyl. (Gale,
abstract, col. 1, ll. 1-15, col. 2, ll. 56-59, col. 3, Table 1, col. 5, ll. 1-9.)
Gale’s system comprises “a pouch formed from an impermeable backing,”
as well as a strippable protective backing. (Id. at col. 5, ll. 2-6.) The
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impermeable backing “is configured to provide a central volume which
contains a drug reservoir 6 in the form of a gel having a dissolved and
suspended drug therein.” (Id. at col. 5, ll. 6-9.)
7. Gale, in Table 2 (col. 5), presents a general formulation for a preferred
gel reservoir composition, which includes a “broad range” of 0.1% to 10%
(w/w %) of a drug. (Gale, col. 5, ll. 29-40.)
8. In relation to its transdermal therapeutic system, Müller states that the
active ingredient is “mostly not in the polymere ingredients of the system,
but in the liquid micro reservoirs, which are [embedded] into the polymeric
layers ….” (Müller, 1.) The Examiner interprets “mostly” in this section of
Müller to mean more than half of the active ingredient is contained within
the liquid microreservoirs. (Ans. 7.)
9. Müller also teaches that at least 80% of the active ingredient is
contained in the microreservoir. (Müller, 2; Ans. 16.)
Principles of Law
The ultimate question of obviousness is one of law, based upon
factual inquiries set forth in the Graham case: (1) the scope and content of
the prior art; (2) the differences between the prior art and the claims at issue;
(3) the level of ordinary skill in the pertinent art; and (4) objective evidence
of non-obviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17-18
(1966). “An examiner bears the initial burden of presenting a prima facie
case of obviousness.” In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir.
2011). “Once the examiner establishes a prima facie case of obviousness,
the burden shifts to the applicant to rebut that case.” Id. If the applicant
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presents rebuttal evidence, such as unexpected results or that the prior art
teaches away from the claimed invention, the Examiner must consider the
totality of the evidence to determine whether the obviousness rejection
should stand. Id.
I.
Issues
Issues regarding claim 1 are (1) whether it would have been prima
facie obvious to one of skill in the art to combine the teachings of Müller
with those of Levy and Patel to prepare the transdermal therapeutic system
recited in pending claim 1, and if so, (2) whether the record presents
evidence of secondary considerations, such as unexpected results or teaching
away in the prior art, sufficient rebut the prima facie case.
Analysis
Our analysis in relation to Müller’s transdermal therapeutic system
(TTS) relates to whether it would have been obvious to use sufentanyl
(instead of fentanyl, as described in Müller) as the active substance, and
polyisobutylene (instead of polysiloxane, as described in Müller) as the
pressure sensitive adhesive polymer.
As noted by the Examiner, Müller teaches a relevant transdermal
therapeutic system (TTS) for administering a “pain means” active
ingredient, such as fentanyl, which is listed as an example (FF 1, 2; Müller,
4). Levy teaches transdermal delivery of fentanyl “and its analgetically
effective derivatives such as sufentanyl” (Levy, col. 1, ll. 15-19; abstract; FF
3). Thus, Levy establishes that sufentanyl was a well-known “analgetically
effective derivative” of fentanyl, and those skilled in the art would have
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thought to administer fentanyl or sufentanyl via transdermal delivery for the
purpose of providing pain relief. Likewise, Patel teaches that well-known
pressure sensitive adhesives for use in transdermal drug delivery systems
included polyisobutylene and polysiloxane. (FF 5.)
Appellant asserts that “the delivery systems of Levy and Patel lack
any teaching of the use of microreservoirs, or that sufentanyl is dissolved
within the microreservoirs.” (App. Br. 7.) This assertion ignores the Müller
disclosure, and, as noted by the Examiner, “Levy and Patel are not relied
upon for their teaching of microreservoirs.” (Ans. 15.) Based on teachings
in Levy, absent evidence to the contrary, it would have been obvious to
those skilled in the art to use sufentanyl in place of fentanyl in the
transdermal therapeutic system described in Müller. Based on teachings in
Patel, absent evidence to the contrary, it would have been obvious to use
polyisobutylene in place of polysiloxane as a pressure sensitive adhesive in
the TTS described in Müller.
Thus, we conclude that the Examiner has established a prima facie
case that the TTS of claim 1 is obvious over Müller in view of Levy and
Patel. The question therefore becomes whether Appellant provides
sufficient evidence, such as evidence of secondary considerations of non-
obviousness, to rebut the prima facie case.
Appellant provides no evidence that one would have thought that
known alternatives to fentanyl (such as its derivative sufentanyl) and known
alternatives to the pressure sensitive adhesive polysiloxane (such as
polyisobutylene) would not work in the Müller system. Likewise, Appellant
provides no evidence that anyone might have thought it was necessary to use
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only the specific drugs and pressure sensitive adhesives described in Müller
for any reason when using Müller’s system.
Appellant asserts that the parent to the instant application issued as
U.S. Pat. No. 7,390,500. (App. Br. 3.) Appellant then “speculates” that a
different Examiner allowed claims in the ‘500 patent “in spite of
consideration of the Müller reference because one of ordinary skill in the art
would have been surprised that a TTS would have been capable of
delivering a drug such as sufentanyl in sufficient amounts to not produce a
lag time before showing analgesic effects while controlling the delivery of
sufentanyl in sufficient amounts not to effect an overdose.” (Id. at 5.)
Appellant then states that Levy and the instant Specification describe
concerns relating to lag time, and Patel and the instant Specification describe
concerns relating to overdosing. (Id. at 5-6.) In this context, Appellant
asserts that Patel teaches away from Appellant’s TTS “by trying to reduce or
even eliminate the need for using an opioid such as sufentanil by disclosing
the use of the aconitum species of compounds.” (Id. at 6.)
As an initial matter, we note that “speculation” does not constitute
evidence. Moreover, we agree with the Examiner that “[n]o such unexpected
results have been presented or argued in the instant case.” (Ans. 14.)
Rather, Appellant asserts a “teaching away” based on the contention that
Patel teaches the use of aconitum species as analgesic agents, and that
aconitine and sufentanyl have “great differences in chemical structure.”
(App. Br. 6, 7.)
Appellant cites to “col. 1, lines 28-32” in Patel as describing the
“concern regarding overdosing.” (App. Br. 5.) Patel is a published PCT
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document, WO 01/35883, and does not present columns. That said, we
assume that Appellant refers to Patel, page 1, lines 28-32, which describes
“for more severe pain, opioids such as morphine, …, oxycodone … fentanyl,
and heroin” and states that “heavy use of opioids … leads to chemical
dependence, or addiction.” Chemical dependence or addiction is not the
same thing as overdosing, such as might occur via a leak of a transdermal
system containing an opioid. (See App. Br. 4, describing disadvantages of a
leak in a pouch of a reservoir system.)
In the context of treating drug addition, Patel teaches that “[b]ecause
extracts of Aconite roots have no affinity for opioid receptors, they may be
used to expediently relieve drug addiction.” (Patel, page 2, ll. 27-32.) In
other words, Patel does not teach away from therapeutic use of opioids, such
as fentanyl and its derivatives, but rather discloses a composition that might
be useful to treat addiction to opioids, as well as for amelioration of pain and
inflammation, for example by administering via a transdermal formulation.
Id.; see also id. at 3, ll. 1-2, at 12, ll. 10-14). Evidence of record (e.g.,
Müller, Levy, Gale) expressly taught the use of fentanyl and its derivatives
for therapeutic uses by administering such drugs using a TTS. Patel did not
teach otherwise by disclosing that aconitine may be administered
transdermally as an analgesic agent.
Thus, we find that no prior art of record teaches away from using
sufentanyl as the active substance instead of fentanyl, or polyisobutylene as
the pressure sensitive adhesive instead of polysiloxane, in the TTS of
Müller. In addition, Appellant has provided no evidence of unexpected
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results, nor any other evidence of secondary considerations of non-
obviousness, in relation to the TTS recited in claim 1.
Conclusion of Law
We agree with the Examiner that, based on the cited references, it
would have been prima facie obvious to combine the teachings of Müller
with those of Levy and Patel to prepare the transdermal therapeutic system
recited in claim 1. Because claims 4 and 8-20 stand or fall with claim 1, we
conclude that the Examiner has set forth a prima facie case of obviousness
with regard to these claims as well. We also conclude that the record before
us does not provide sufficient evidence of secondary considerations to rebut
the prima facie case.
II.
Issues
The issues regarding claim 2 are (1) whether it would have been prima
facie obvious to one skilled in the art to combine the teachings of Müller,
Levy and Patel, as applied to claim 1 above, with Gale to prepare the
transdermal therapeutic system recited in claim 2, and if so, (2) whether the
record presents evidence of secondary considerations sufficient rebut the
prima facie case.
Additional Principles of Law
As stated by the Federal Circuit, a “prima facie case of obviousness
typically exists when the ranges of a claimed composition overlap the ranges
disclosed in the prior art.” In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir.
2003); Ormco Corp. v. Align Technology, Inc., 463 F.3d 1299, 1311 (Fed.
Cir. 2006). Even a slight overlap in range establishes a prima facie case of
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obviousness. In re Peterson, 315 F.3d at 1329. A prima facie case of
obviousness likewise exists when the claimed range and the prior art range
do not overlap but are close enough such that one skilled in the art would
have expected them to have the same properties. Id. (citing Titanium Metals
Corp. v. Banner, 778 F.2d 775, 783 (Fed. Cir. 1985).
One “may overcome a prima facie case of obviousness by establishing
‘that the [claimed] range is critical, generally by showing that the claimed
range achieves unexpected results relative to the prior art range.’” Peterson,
315 F.3d at 1330 (quoting In re Geisler, 116 F.3d 1465, 1469-70 (Fed. Cir.
1997) (alteration in original). Alternatively, one “may rebut a prima facie
case of obviousness by showing that the prior art teaches away from the
claimed invention in any material respect.” In re Peterson, 315 F.3d at 1331
(citing In re Geisler, 116 F.3d at 1469).
Analysis
Claim 2 depends on claim 1. As noted above, the Examiner presents a
prima facie case with regarding to claim 1. The question therefore becomes
whether it would have been prima facie obvious to use sufentanyl in the TTS
system of claim 1 in the amount recited in claim 2, i.e., between 2 and 5%
by weight.
Appellant asserts that “Gale teaches such a concentration level
without the use of the microreservoirs of the invention and as such does not
teach this element of appellants’ claim 2.” (App. Br. 8.) This assertion
ignores the fact, however, that rejection is based on the combined teachings
of references, including Müller, and that the Examiner does not cite Gale for
its teaching of microreservoirs. See Ans. 15. Rather, as noted by the
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Examiner, because Müller does not teach a weight % range of the active
agent, one would have been motivated to look to Gale, which teaches a
weight % of fentanyl or sufentanyl in a transdermal delivery system. (Ans.
9.)
Specifically, Gale teaches using a “broad range” of 0.1% to 10% w/w
of fentanyl and its derivatives, such as sufentanyl, in a transdermal
therapeutic system (Gale, col. 5, Table 2). This range disclosed in Gale
encompasses the narrower claimed range of “between 2 and 5% by weight”
recited in claim 2. As stated by the Federal Circuit:
[W]hen, as here, the claimed ranges are completely encompassed by
the prior art, the conclusion is even more compelling than in cases of
mere overlap. The normal desire of scientists or artisans to improve
upon what is already generally known provides the motivation to
determine where in a disclosed set of percentage ranges is the
optimum combination of percentages.
In re Peterson, 315 F.3d at 1330. Here, the fact that the range recited in
claim 2 is “completely encompassed by the prior art” is sufficient to
establish a prima facie case of obviousness. Id.
As noted above, one may overcome a prima facie case of obviousness
by establishing that the claimed range is critical, e.g. achieves unexpected
results, or by showing that the prior art “teaches away from the claimed
invention in any material respect.” In re Peterson, 315 F.3d at 1331.
Here, however, the Examiner correctly finds that Appellant provides
no evidence of unexpected results. (Ans. 14.) As noted the Examiner, “[t]he
instant specification does not contain a single example using sufentanyl” and
presents no “unexpected results over the prior art as relate to a lack of lag
time.” (Id.) In other words, Appellant points no evidence (in the
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Specification or elsewhere) of any unexpected advantage of the TTS recited
in claim 1 or 2 regarding a prior art “lag time” or any other alleged concern.
Moreover, Appellant provides no evidence indicating that Gale, or
any other cited reference, disparages or otherwise discourages the use of
sufentanyl in the claimed system in the % weight range recited in claim 2.
For example, in addition to teaching the 0.1% to 10% w/w range of fentanyl
and its derivatives, Gale discloses that:
[W]e have found that fentanyl or its derivatives may be administered
to the human body via the transdermal route for the purpose of
inducing analgesia, if administered through about 5-100 cm2 and
preferably about 10-50 cm2 of intact skin over an extended period of
time at a rate within the range of about 0.5 to 10 µg/cm2/hour and
preferably at a rate within the range of approximately 1-5
µg/cm2/hour. When so delivered it is possible, by appropriate
selection of the surface area of the drug delivery device to obtain total
drug input rates which provide an adequate range of titration for
individual patient needs while maintaining a safe and effective dosage
form.
Gale, col. 2, ll. 55-67 (emphasis added). Thus, Gale indicates that the use of
the described % range of fentanyl or its derivatives can be delivered in a safe
manner. Appellant provides no evidence that one of skill in the art would
have believed that the same range of active substance would fail to work in
Appellant’s claimed system.
At most, Appellant refers to alleged disadvantages due to “leaking”
and “lag time” with reservoir systems such as presented in Gale (App. Br.
4.). That said, Appellant does not point to any evidence, for example in the
Specification or prior art, indicating that one would not use the range
amounts of sufentanyl (as described in Gale) in the system presented in
Müller based on such concerns. Assuming those skilled in the art would
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have worried about leaks and lag time, there is no evidence that a person of
ordinary skill in the art would have considered them to teach away from
using fentanyl or its derivatives in transdermal therapeutic systems in the
first place. Multiple references of record, i.e., Gale, Levy, and Müller,
however, clearly taught using fentanyl in transdermal therapeutic systems.
Thus, skilled artisans were motivated to prepare such systems for
administering fentanyl and its derivatives, even if users would have
understood that they should be careful regarding leaks and lag time. Those
skilled artisans would have looked to prior art transdermal therapeutic
systems, such as the one disclosed in Gale, to determine the relevant
amounts of fentanyl and its derivatives to use in the system described in
Müller. Appellant does not provide sufficient rebutting evidence to the
contrary.
Appellant asserts that “appellant’s invention and Levy are actively
trying to avoid being similar to Gale.” (App. Br. 8.) To the contrary,
however, Levy does not teach away from using fentanyl in a transdermal
system as suggested by Appellant. While it is correct that Levy teaches that
a solution to “Gale’s disadvantage” of lag time is to apply “a fentanyl
solution transdermal in conjunction with via intravenous administration,” it
is not correct that Levy teaches “to dispense with the reservoir system”
altogether. (App. Br. 4). Rather, Levy teaches that:
When fentanyl is administered as described in U.S. Pat. No.
4,588,580 [Gale], certain patients exhibited a lag time of about 12
hours before analgetically effective serum drug levels were achieved.
This was too long to achieve analgesia when recovering from
anesthesia after short duration surgical procedures. Part of this lag
time can be taken care of according to our invention by placing the
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transdermal system on the patient prior to anesthesia and surgery.
This, coupled with a 100 to 300 µg dose of fentanyl given at the
induction of anesthesia provides analgetically effective serum drug
levels when pain relief is needed….
Levy, col. 2, ll. 24-40. In other words, Levy expressly teaches administering
fentanyl as described in Gale, and overcoming the lag time problem by
doing so before anesthesia and surgery, and then also administering fentanyl
intravenously with anesthesia. Thus, Levy expressly teaches using Gale’s
TTS to administer fentanyl or sufentanyl. Neither Levy nor any other cited
prior reference teaches away from using sufentanyl in Gale’s system or any
other TTS.
Thus, we find that no prior art of record teaches away from using
sufentanyl as the active substance instead of fentanyl, or from using
sufentanyl in the Müller TTS at the % weight ranges taught in Müller. In
addition, Appellant has provided no evidence of unexpected results, nor
anyother evidence of secondary considerations of non-obviousness, in
relation to the TTS recited in claim 2, i.e., one having sufentanyl in the
active substance layer at a concentration between 2 and 5% by weight.
Conclusion of Law
We agree with the Examiner that, based on the cited references, it
would have been prima facie obvious to one skilled in the art to combine the
teachings of Müller, Levy and Patel, as applied to claim 1 above, with Gale
to prepare the transdermal therapeutic system recited in claim 2. We also
conclude that the record does not provide sufficient evidence of secondary
considerations to rebut the prima facie case.
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III.
Issues
Issues regarding claim 3 are (1) whether it would have been prima
facie obvious to one of skill in the art to combine the teachings of Müller
with those of Levy and Patel to prepare the transdermal therapeutic system
recited in pending claim 3, and if so, (2) whether the record presents
evidence of secondary considerations, such as unexpected results or teaching
away in the prior art, sufficient rebut the prima facie case.
Analysis
Claim 3 depends on claim 1. As noted above, the Examiner presents a
prima facie case with regarding to claim 1. The question therefore becomes
whether it would have been prima facie obvious to make and use the TTS
system of claim 1 where at least 50% by weight of the active substance in
the TTS was contained within the microreservoirs, as recited in claim 3.
Once again, we point out that Müller is the primary reference in the
obviousness analysis. As noted by the Examiner (Ans. 7), Müller teaches
that the “active ingredient is … mostly … in the liquid micro reservoirs.”
(Müller 1). We agree with the Examiner one of skill in the art would have
understood “mostly” in Müller to mean at least more than half of the active
ingredient was contained in the microreservoirs. (Ans. 7.) In addition,
Müller teaches that “preferably” at least 80% of the active ingredient is
contained in the microreservoirs. (Müller 2; Ans. 16). In other words,
Müller itself teaches the element recited in claim 3.

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Thus, we are back to the original question addressed above regarding
claim 1, i.e., whether, when making the TTS taught in Müller, it would have
been obvious to use sufentanyl as described in Levy (instead of fentanyl),
and polyisobutylene as described in Patel (instead of polysiloxane). For all
the reasons already discussed, we conclude that both claims 1 and 3 are
obvious over the cited references.
Conclusion of Law
We agree with the Examiner that, based on the cited references, it
would have been prima facie obvious to combine the teachings of Müller
with those of Levy and Patel to prepare the transdermal therapeutic system
recited in claim 3. We also conclude that the record does not provide
sufficient evidence of secondary considerations to rebut the prima facie case.
SUMMARY
We affirm the rejection of claims 1, 3, 4 and 8-20 under 35 U.S.C.
§103(a) as unpatentable over Müller in view of Levy and Patel. We also
affirm the rejection of claim 2 under 35 U.S.C. §103(a) as unpatentable over
Müller in view of Levy, Patel, and Gale.
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)(1)(iv).

AFFIRMED

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