Ex Parte Rudzinski et al

Patent Trial and Appeal Board

Nov 16, 2018

13196884 (P.T.A.B. Nov. 16, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/196,884 08/02/2011
44001 7590 11/20/2018
Marshall, Gerstein & Borun LLP (Baxter)
233 South Wacker Drive
6300 Willis Tower
Chicago, IL 60606-6357
FIRST NAMED INVENTOR
Ralph V. Rudzinski
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.
31203/30057A 4669
EXAMINER
HAGHIGHATIAN, MINA
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
11/20/2018 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):
mgbdocket@marshallip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RALPH V. RUDZINSKI and RALPH A. LESSOR
Appeal2017-003075 1
Application 13/196,884
Technology Center 1600
Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and JOHN G. NEW,
Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a
pharmaceutical product composed of an inhaled anesthetic contained within
a lined aluminum container. The Examiner rejected2 the claims for
obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants state that the "real parties in interest in this appeal are Baxter
International Inc. and Baxter Healthcare S.A., the assignees of record."
Appeal Br. 4.
2 We herein refer to the Specification, filed Aug. 2, 2011 ("Spec."); Final
Office Action, mailed Aug. 14, 2015 ("Final Act."); Appeal Brief, filed Jul.
19, 2016 ("Appeal Br."); and the Reply Brief, filed Dec. 27, 2016 ("Reply
Br."). The Examiner's Answer, mailed Oct. 27, 2016, has not been cited in
this Decision.
Appeal2017-003075
Application 13/196,884
STATEMENT OF THE CASE
The following rejections are before us for review:
(1) Claims 1-8, rejected under 35 U.S.C. § I03(a) as being
unpatentable over Flament-Garcia, et al., 3 Britto,4 and Wu et al., 5 (Final
Act. 2-8); 6 and.
(2) Claims 1, 3---6, and 8, rejected under 35 U.S.C. § I03(a) as being
unpatentable over Bieniarz, et al., 7 Ruebusch, et al., 8 and Wu (Final Act. 8-
11 ).
Claim 1, the only independent claim on appeal, is representative and
reads as follows:
1. A pharmaceutical product comprising an
inhalation anesthetic stored within an aluminum container,
the interior of the aluminum container provided with an
inert lining comprising an epoxyphenolic resin, and
the inhalation anesthetic selected from the group
consisting of sevoflurane, desflurane, isoflurane, enflurane,
methoxyflurane and halothane, and present therein as a liquid, a
vapor, or a combination thereof.
Appeal Br. A-1 (Claims App'x).
3 US 6,162,443 (issued Dec. 19, 2000) ("Flament-Garcia")).
4 US 6,253,762 Bl (issued Jul. 3, 2001).
5 US 6,315,985 Bl (issued Nov. 13, 2001) ("Wu")).
6 Final Office Action entered August 14, 2015.
7 US 5,990,176 (issued Nov. 23, 1999) ("Bieniarz")).
8 US 6,045,784 (issued Apr. 4, 2000) ("Ruebusch")).
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OBVIOUSNESS-
FLAMENT-GARCIA, BRITTO, AND WU
The Examiner's Prima Facie Case
The Examiner cited Flament-Garcia as disclosing a pharmaceutical
product composed of a fluoroether anesthetic, such as sevoflurane,
enflurane, isoflurane, methoxyflurane, or desflurane, enclosed within a
container lined with polypropylene, polyethylene, or an ionomeric resin.
Final Act. 3. The Examiner noted, in particular Flament-Garcia's teaching
that the material lining the container should not be reactive with the
anesthetic enclosed within the container. Id. at 3--4.
The Examiner found that Flament-Garcia's container differed from
the container recited in Appellants' claims in that Flament-Garcia "lacks
specific disclosure on the containers being made of aluminum and the resin
being epoxy phenolic resin in the lining of the inner surface." Id. at 4.
As evidence that the product recited in Appellants' claims would
nonetheless have been obvious, the Examiner cited Britto as disclosing that
it was known in the art to use aluminum to construct containers for inhaled
drugs, noting in particular that strengthened aluminum cans "are capable of
withstanding particularly stressful coating and curing conditions (see col. 4,
lines 34-50)." Id. at 5. The Examiner also noted Britto's teaching of
including an inert polymer lining in containers for inhaled drugs. Id.
The Examiner cited Wu as also disclosing the use of lined aluminum
cans as containers for inhaled drugs, noting in particular Wu's disclosure
that its most preferred type of container was "a conventional aluminum ( or
aluminum alloy) aerosol canister, but with an interior coating of an inert
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material, such as a spray-coated, baked epoxy-phenolic lacquer ( col. 3, lines
48-53; col. 7, lines 43-55)." Id.
Based on the references' combined disclosures, the Examiner
reasoned that an ordinary artisan would have considered it obvious "to have
selected the inert epoxyphenolic resins to coat the inner lining of an
aluminum container disclosed within the prior art disclosures (Britto and Wu
et al), to arrive at a product/process 'yield[ing] no more than one would
expect from such an arrangement."' Id. at 7 ( citing KSR Int 'l Co. v. Teleflex
Inc., 550 U.S. 398 (2007)).
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability ....
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
Having carefully considered all of the evidence and arguments
presented by Appellants and the Examiner, Appellants do not persuade us
that the preponderance of the evidence fails to support the Examiner's
conclusion of obviousness as to claim 1 in view of Flament-Garcia, Britto,
and Wu.
As required by Appellants' claim 1, Flament-Garcia discloses a
product composed of an inhaled fluoroether anesthetic enclosed within a
container. See Flament-Garcia, abstract; see also id. at 3:12-16
("Fluoroether-containing inhalation anesthetics useful in connection with the
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present invention include, but are not necessarily limited to, sevoflurane,
enflurane, isoflurane, methoxyflurane, and desflurane.").
As required by Appellants' claim 1, Flament-Garcia discloses that the
container may be lined with an inert material that does not react with the
inhaled anesthetic compounds. See id. at 4:30-32 (disclosing embodiment
in which "interior surface 14 of container 12 is preferably constructed of a
material containing polyethylene napthalate"); id. at 3:60-65 ("[C]ertain
copolymers and blends of polyethylene napthalate can be used in connection
with the present invention, provided they provide an adequate barrier to the
transmission of vapors, e.g., inhalation anesthetic and water vapors,
therethrough, and provided that they provide the desired strength and non-
reactivity to inhalation anesthetic 18. ").
As the non-reactive container lining, in addition to polyethylene
napthalate, Flament-Garcia discloses that, "[a]ltematively, interior surface
14 of container 12 is constructed of a material containing one or more of
polypropylene, polyethylene, and ionomeric resins such as a SURL YN®
ionomeric resin manufactured by DuPont." Id. at 4:58---61. Flament-Garcia
discloses that, alternatively, the container liner may be composed of
polycyclomethylpentene/polymethylpentene. Id. at 4:40-49.
Flament-Garcia's product thus differs from the product recited in
Appellants' claim 1 only in that Flament-Garcia does not use an
epoxyphenolic resin-lined aluminum container as the vessel for the
fluoroether anesthetics.
As the Examiner found, however, Wu discloses that such containers
were known in the art to be useful as vessels for inhaled drugs. See Wu,
3 :48-52 ("The most preferred type of container for use in the present
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invention is a conventional aluminum ( or aluminum alloy) aerosol canister,
but with an interior coating of an inert material, such as a spray-coated,
baked epoxy-phenolic lacquer (available from Cebal Printal U.K. Ltd.).");
see also id. at abstract (Wu's invention is a "medicinal aerosol steroid
solution formulation product with enhanced chemical stability. The steroid
is a 20-ketosteroid having an OH group at the C-17 or C-21 position and the
aerosol container has a non-metal interior surface which has been found to
reduce chemical degradation of such steroids.").
Britto similarly discloses that polymer-lined aluminum cans were
useful as vessels for inhaled drugs. See Britto, 4:34--5:38.
As the Supreme Court has explained, "when a patent claims a
structure already known in the prior art that is altered by mere substitution of
one element for another known in the field, the combination must do more
than yield a predictable result." KSR, 550 U.S. at 416.
Here, as noted above, Flament-Garcia teaches that it was desirable to
use containers lined with non-reactive polymers as vessels for inhaled
fluoroether anesthetics, and Wu discloses that an aluminum container with
an inert epoxyphenolic resin lining was useful as a vessel for inhaled drugs.
We, therefore, agree with the Examiner that an ordinary artisan had good
reason for, and a reasonable expectation of success in, using the
epoxyphenolic resin-lined aluminum container disclosed in Wu as a vessel
for the fluoroether anesthetics disclosed in Flament-Garcia, particularly
given the advantages of aluminum containers taught in Britto. We,
therefore, also agree with the Examiner that the product recited in
Appellants' claim 1 would have been prima facie obvious to the ordinary
artisan.
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Appellants do not persuade us to the contrary. Appellants contend,
based on Bieniarz, that an ordinary artisan would have been dissuaded from
using an aluminum container because of the reactivity of aluminum oxides
with fluoroether anesthetics. Appeal Br. 9-10.
As noted above, however, the Examiner's prima facie case posits
using an aluminum container with an inert lining as the vessel for a
fluoroether anesthetic. We are not persuaded that any alleged concerns
about fluoroether anesthetics coming into contact with aluminum
demonstrate that it would have been unobvious to coat the interior of an
aluminum container with an inert material that would prevent the anesthetic
compounds from coming into contact with the aluminum. Indeed, we
conclude that the opposite is true-given the knowledge in the art that
aluminum was a desirable material for inhaled drug containers (see, e.g.,
Britto, Wu), we agree with the Examiner that an ordinary artisan, advised by
Bieniarz and Flament-Garcia that fluoroether anesthetics should not contact
aluminum oxides, would have considered it obvious to use a container with
an inert lining in order to prevent such contact, for example the preferred
container described in Wu, noted above.
Appellants contend that, given fluoroether anesthetics' known
capacity to dissolve certain polymers, an ordinary artisan would have had no
reasonable expectation of success in using any polymer as a liner for a
container for fluoroether anesthetics, absent a prior showing of non-
reactivity between the polymer and the anesthetic. Appeal Br. 9-10 (citing
Spec. ,r 6); Reply Br. 2. Similarly, Appellants contend, because fluoroether
anesthetics were known to dissolve certain polymers, an ordinary artisan
would have had no motivation for using any polymer as a liner for a
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container for fluoroether anesthetics. Appeal Br. 10 ( citing Spec. ,r 6);
Reply Br. 2.
Appellants' argument relies on the following statement in the
Specification: "[I]nhalation anesthetics have strong organic solvent
properties, which typically will dissolve and/or react with the plastic
material, leading to measurable impurities in the inhalation anesthetic."
Spec. ,r 6 ( emphasis added).
In addition to the fact that the relied-upon disclosure in the
Specification relates to "plastic material," as opposed to polymers
specifically, neither Appellants nor their Specification cites to any specific
evidence that supports or explains the assertion that polymers "typically"
would be expected to be dissolved by, or react with, fluoroether anesthetics.
See Spec. ,r 6. Nor do Appellants identify any evidence of record suggesting
that the specific epoxyphenolic resin taught by Wu as lining its preferred
inhaled drug container would have been expected to be reactive with
Flament-Garcia's fluoroether anesthetics.
Indeed, as seen above, contrary to Appellants' contention that
fluoroether anesthetics would typically be expected to react with polymers,
Flament-Garcia discloses at least five types of polymers that are compatible
with fluoroether anesthetics: polyethylene napthalate and copolymers and
blends thereof, polypropylene, polyethylene, ionomeric resins, and
polycyclomethylpentene/polymethylpentene. See Flament-Garcia, 4:30-66.
We are not persuaded, therefore, that the evidence of record supports
Appellants' contention that an ordinary artisan would have expected the
epoxyphenolic inner coating of Wu's aluminum container to react with
Flament-Garcia's fluoroether anesthetics. To the contrary, given Flament-
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Garcia's disclosure that a variety of different polymers were useful as an
inert liner material for a container for inhaled fluoroether anesthetics, and
given Wu's disclosure that a conventional aluminum aerosol container with
an inert epoxyphenolic inner coating was a useful vessel inhaled drugs, and
further given Wu's disclosure, discussed below, that its containers were
compatible with ether as well as fluorocarbon propellants, Appellants do not
persuade us that an ordinary artisan lacked adequate motivation for, or a
reasonable expectation in, using Wu's container as a vessel for Flament-
Garcia's inhaled fluoroether anesthetics.
We acknowledge the following statement in Wu identified by
Appellants (see, e.g., Appeal Br. 13-14; Reply Br. 5---6):
As used herein, the terms "coated", "inert coating" and the like
simply refer to a non-metal interior coating that does not
promote degradation at the OH substituents on C-17 /21 OH 20-
ketosteroids. Inert coating materials include any suitable
polymer, lacquer, resin, or other coating treatment that creates a
barrier to chemical interaction of the dissolved C-17 /21 OH 20-
ketosteroid and metal on the container ( especially metal
oxides).
Wu, 7:35--42.
Appellants do not persuade us, however, that the above-quoted
passage at column 7 of Wu would have suggested to an ordinary artisan that
the "inert" epoxyphenolic inner coating of Wu's preferred container (see id.
at 3:48-52) would only be non-reactive with the named steroid compounds,
but would be expected to be chemically reactive with a number of other
agents.
To the contrary, Wu discloses that its containers are compatible with,
i.e., non-reactive with, a number of organic propellant compounds, including
ethers and fluorocarbons:
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Preferred products/ devices according to the present
invention are pressurized aerosols such as MD Is [ metered dose
inhalers] that use liquefied gas propellants, including
chlorofluorocarbons (CFCs), hydro fluorocarbons (HF Cs),
fluorocarbons (PCs), hydrocarbons (HCs ),
hydrochlorofluorocarbons (HCFCs), and dimethyl ether
(DME). Propellants containing hydrogen are preferred.
Ethanol may also be included to assist in solubilizing the 20-
ketosteroid, preferably in an amount of about 1-25%.
Id. at 8:44--52.
Because Wu discloses that its containers are compatible with, i.e.,
non-reactive with, organic compounds including ethers and fluorocarbons,
which share a number of functional groups with Flament-Garcia's
fluoroether anesthetics, including an ether moiety and pendant fluorine
atoms (see, e.g., Spec. ,r 11 ), Appellants do not persuade us that an ordinary
artisan lacked adequate motivation for, or a reasonable expectation of
success in, using Wu's containers as vessels for the anesthetic compounds
taught in Flament-Garcia. Moreover, because Wu discloses that its
containers are suitable vessels for pressurized aerosols containing liquefied
organic gas propellants (see Wu, 8:44--52), Appellants do not persuade us
that an ordinary artisan lacked a reasonable expectation that Wu's container
would have the vapor barrier characteristics desired by Flament-Garcia. See
Appeal Br. 11 (citing Flament-Garcia 2:20-24).
In addition, given the teachings discussed above suggesting that Wu's
preferred epoxyphenolic resin-lined aluminum container would be useful as
a vessel for Flament-Garcia's fluoroether anesthetics, we are not persuaded
that the teachings in Flament-Garcia and Wu regarding Type III glass
diverge to the extent that an ordinary artisan would have lacked a good
reason for, or a reasonable expectation of success in, using Wu's preferred
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container as a vessel for Flament-Garcia's anesthetics. See Appeal Br. 11-
12, 14--15; Reply Br. 4--5.
We acknowledge Wu's disclosure, also identified by Appellants (see,
e.g., Appeal Br. 12; Reply Br. 3, 5, 7), that its epoxyphenolic coating is
superior to a teflon-like "PEP" coating at improving the chemical stability of
the steroid drugs present in its containers, because it adsorbs the steroid
degradation products:
[T]he data indicates the epoxy can is superior to the PEP
in preventing degradation. Without wishing to be held to any
particular mechanism to explain the difference in results
between the two coating types, it is hypoth[ e ]sized that it is not
that the phenolic epoxy provides a better barrier, but rather that
some adsorption of degradation products is taking place.
Essentially, the phenolic epoxy may be "soaking up" the
degradates. A small amount of budesonide may also be
adsorbed too, but the amount is apparently too small to affect
the target content amount.
Wu, 13:33--42.
The fact that Wu's preferred container might be particularly suited as
a vessel for steroid therapeutics does not persuade us that an ordinary artisan
would have considered Wu's container unsuitable as a vessel for Flament-
Garcia's fluoroether anesthetics. To the contrary, as discussed above, Wu
teaches that its containers are compatible and non-reactive not only with
steroid therapeutics, but also with a variety of organic propellant
compounds, including ethers and fluorocarbons. That Wu's container might
adsorb impurities only provides additional impetus for using the container as
a vessel for Flament-Garcia's anesthetic compounds.
In sum, on the current record, Flament-Garcia discloses that that it
was desirable to use containers lined with non-reactive polymers as vessels
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for inhaled fluoroether anesthetics. And Wu discloses that an aluminum
container having an inert epoxyphenolic resin lining, which is non-reactive
to ethers and fluorocarbons, was useful as a vessel for inhaled drugs. We,
therefore, agree with the Examiner that an ordinary artisan had good reason
for, and a reasonable expectation of success in, using the epoxyphenolic
resin-lined aluminum container disclosed in Wu as a vessel for the
fluoroether anesthetics disclosed in Flament-Garcia, particularly given the
advantages of aluminum containers taught in Britto.
Appellants do not persuade us, therefore, that the Examiner erred in
concluding that the product recited in Appellants' claim 1 would have been
prima facie obvious to the ordinary artisan. Because Appellants do not
identify any specific objective evidence of nonobviousness that might
outweigh the evidence of prima facie obviousness advanced by the
Examiner, we affirm the Examiner's rejection of claim 1 over Flament-
Garcia, Britto, and Wu. Because they were not argued separately, claims 2-
8 fall with claim 1. 37 C.F.R. § 4I.37(c)(l)(iv).
OBVIOUSNESS-
BIENIARZ, RUEBUSCH, AND WU
The Examiner's Prima Facie Case
The Examiner cited Bieniarz as disclosing a pharmaceutical product
composed of a fluoroether anesthetic, such as sevoflurane, enflurane, or
isoflurane, enclosed within a container. Final Act. 8. The Examiner found
that Bieniarz disclosed that "suitable containers include plastic, steel or other
material that can be used for holding goods. Examples of containers include
bottles, ampules, test tubes, beakers, etc, (see col. 5, lines 9-13)." Id.
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The Examiner conceded, however, that Bieniarz differs from the
rejected claims in that Bieniarz "lack[ s] specific disclosure on the container
being aluminum with an inner coating of an epoxyphenolic resin. This is
taught by Ruebusch et al and Wu et al." Id.
Specifically, the Examiner cited Ruebusch as evidence that metal
containers lined with inert polymeric materials including phenolic resin
coatings, epoxy resin coatings, and mixtures thereof, were useful for
preventing corrosion and/ or rust in the metal caused by Lewis acids present
in the contained material. Id. at 8-9. The Examiner cited Wu for its
teachings relied upon the rejection discussed above. Id. at 9.
Based on the references' combined disclosures, the Examiner
reasoned that an ordinary artisan would have considered it obvious to select
the inert epoxyphenolic resin-lined aluminum container taught in Wu as the
container for fluoroether anesthetics, as recited in Appellants claims,
"because Bieniarz et al teach that [a] fluoroether anesthetic[] such as
sevoflurane is a Lewis acid compound and a formulation comprising such
[a] compound requires measures to prevent degradation" and because
"Ruebusch et al teach that formulations comprising Lewis acid compounds
require measure[ s] to minimize degradation which include coating the inner
surface of the metal canister with a suitable material such as epoxy and/or
phenolic resins." Id. at 10.
Analysis
Having carefully considered all of the evidence and arguments
presented by Appellants and the Examiner, Appellants do not persuade us
that the preponderance of the evidence fails to support the Examiner's
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conclusion of obviousness as to claim 1 in view of Bieniarz, Ruebusch, and
Wu.
Bieniarz is directed to the discovery that the interior of glass vessels
containing inhaled fluoroether anesthetics can become etched or altered,
thereby exposing aluminum oxides in the glass to the contents of the vessels,
which in tum generates Lewis acids that can cause degradation of the
fluoroether anesthetics. Bieniarz, 1: 50-67. Bieniarz discloses addressing
this problem by including a Lewis acid inhibitor, such as water, in its vessel-
enclosed fluoroether formulations. Id. at 2:50-67.
As required by Appellants' claim 1, Bieniarz discloses a product
composed of an inhaled fluoroether anesthetic enclosed within a container:
[A] container, such as a glass bottle, is first washed or rinsed
with the Lewis acid inhibitor and then filled with the
fluoroether compound. . . . [ A ]s used herein, the term
"container" refers to a receptacle made from glass, plastic, steel
or other material that can be used for holding goods. Examples
of containers include bottles, ampules, test tubes, beakers, etc.
Id. at 5:2-13
The container/fluoroether anesthetic combination taught in Bieniarz,
thus, differs from the product recited in Appellants' claim 1 in that
Bieniarz's product does not include an aluminum container lined with an
inert epoxyphenolic resin.
As discussed above, however, Wu discloses that such containers were
known in the art to be useful as vessels for inhaled steroid drugs. See Wu,
3:48-52 ("The most preferred type of container for use in the present
invention is a conventional aluminum ( or aluminum alloy) aerosol canister,
but with an interior coating of an inert material, such as a spray-coated,
baked epoxy-phenolic lacquer (available from Cebal Printal U.K. Ltd.).")
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Given Wu's teaching that an aluminum container with an inert
epoxyphenolic resin lining was a particularly preferred vessel for certain
inhaled drugs, we agree with the Examiner that an ordinary artisan had good
reason for, and a reasonable expectation of success in, using the
epoxyphenolic resin-lined aluminum container disclosed in Wu as a vessel
for the inhaled fluoroether anesthetic drugs disclosed in Bieniarz,
particularly given Bieniarz's teaching that it was desirable to minimize
contact between fluoroether anesthetic formulations and Lewis acids
generated by interactions with the container walls. In that regard, we note
Ruebusch' s disclosure, identified by the Examiner, that corrosion of metal
aerosol containers caused by the presence of Lewis acids (see Ruebusch,
1 :6-2: 14) can be avoided by providing the containers with an inner lining
composed of a thermoplastic resin coating, including "phenolic resin
coatings, ... epoxy resin coatings ... and mixtures of these coatings" (id. at
6:36-38).
Because we agree with the Examiner that an ordinary artisan would
have considered it obvious to use Wu's preferred inert epoxyphenolic resin-
lined aluminum container as a vessel for Bieniarz's fluoroether anesthetics,
particularly in view of the cited teachings in Ruebusch, we also agree with
the Examiner that the product recited in Appellants' claim 1 would have
been obvious over those references. Appellants' arguments do not persuade
us to the contrary.
We acknowledge, as seen above, and as Appellants contend (see
Appeal Br. 16; Reply Br. 8), that Bieniarz is directed to using Lewis acid
inhibitors to avoid the undesired effects of inadvertently generated Lewis
acids on fluoroether compositions, whereas Ruebusch is directed to using an
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inner liner to prevent interaction between metal containers and Lewis acids
intentionally placed within the containers. Those facts, however, fail to
explain why it would have been unobvious to use a container, taught in Wu,
known to be useful as an inert vessel for inhaled drugs, as a container for
Bieniarz's inhaled fluoroether drugs.
As noted above, "when a patent claims a structure already known in
the prior art that is altered by mere substitution of one element for another
known in the field, the combination must do more than yield a predictable
result." KSR, 550 U.S. at 416. In the present case, Appellants identify no
unpredicted or unexpected result coming from the claimed used of Wu's
container as a vessel for fluoroether anesthetics. Moreover, because both
Bieniarz and Ruebusch suggest isolating Lewis acid-containing materials
from metal container components, we do not find the references' teachings
to be antithetical.
As to Appellants' contention, based on Bieniarz, that an ordinary
artisan would have been dissuaded from using an aluminum container
because of the reactivity of aluminum oxides with fluoroether anesthetics
(see Appeal Br. 16-17), we note again that the Examiner's prima facie case
posits using an aluminum container with an inert lining as the vessel for a
fluoroether anesthetic. As discussed above, we are not persuaded that any
alleged concerns about fluoroether anesthetics coming into contact with
aluminum demonstrate that it would have been unobvious to coat the interior
of an aluminum container with an inert material that would prevent the
anesthetic compounds from coming into contact with the aluminum.
Indeed, as discussed above, we conclude that the opposite is true-
given the knowledge in the art that aluminum was a desirable material for
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inhaled drug containers (see, e.g., Wu), we agree with the Examiner that an
ordinary artisan, advised by Bieniarz that fluoroether anesthetics should not
contact aluminum oxides, would have considered it obvious to use a
container with an inert lining in order to prevent such contact, for example
the preferred container described in Wu, noted above. Appellants do not
persuade us, therefore (see Appeal Br. 17), that the cited references fail to
provide a sufficient reason for, or a reasonable expectation of success in,
using Wu's preferred container as a vessel for Bienarz's fluoroether
anesthetics.
Appellants reiterate their contentions that an ordinary artisan would
not have had motivation or a reasonable expectation of success in using
Wu's container as a vessel for fluoroether anesthetics because fluoroether
anesthetics were known to degrade plastics, and because Wu's disclosure
only relates to its epoxyphenolic liner's inertness in relation to the disclosed
steroid compounds, but not other materials. Appeal Br. 17-18.
As discussed above, however, in addition to expressly describing its
epoxyphenolic liner as being inert, Wu discloses that its containers are
compatible with, i.e., non-reactive with, a number of organic propellant
compounds, including ethers and fluorocarbons (Wu, 8:44--52), which share
a number of functional groups with Bieniarz's fluoroether anesthetics,
including an ether moiety and pendant fluorine atoms (see, e.g., Spec. ,r 11 ).
Appellants do not persuade us, therefore, that an ordinary artisan lacked
adequate motivation for, or a reasonable expectation of success in, using
Wu's containers as vessels for the anesthetic compounds taught in Bieniarz.
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We find that Appellants' argument, that Ruebusch is non-analogous
art (Reply Br. 9), is improperly presented for the first time in the Reply
Brief, and we therefore decline to consider it.
As explained in 37 C.F.R. § 4I.37(c)(l)(iv), except in certain
circumstances not applicable here, "any arguments or authorities not
included in the appeal brief will be refused consideration by the Board for
purposes of the present appeal." We are not persuaded, therefore, that this
new argument is properly presented for the first time in the Reply Brief,
such that we should consider it. See also 37 CPR§ 4I.41(b)(2) ("Any
argument raised in the reply brief which was not raised in the appeal brief, or
is not responsive to an argument raised in the examiner's answer, including
any designated new ground of rejection, will not be considered by the Board
for purposes of the present appeal, unless good cause is shown."); Ex parte
Borden, 93 USPQ2d 14 73, 14 77 (BP AI 2010) (The reply brief is not "an
opportunity to make arguments that could have been made in the principal
brief on appeal to rebut the Examiner's rejections, but were not.")
("Informative").
In any event, as discussed above, Bieniarz discloses that inhaled
fluoroether drugs can be stored in any number of different types of
containers, including metal containers. As also discussed above, Wu
discloses that a preferred vessel for inhaled steroid drugs, an aluminum
container with an inert epoxyphenolic lining, is compatible with a number of
organic compounds, including an ether propellant, that share functional
groups with fluoroether anesthetics. Thus, even if we were to consider and
accept (which we do not) Appellants' argument that Ruebusch constitutes
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Appeal2017-003075
Application 13/196,884
non-analogous art, we would still conclude that the Examiner had shown the
product of claim 1 to be obvious over Bieniarz and Wu.
In sum, for the reasons discussed, Appellants do not persuade us that
the Examiner erred concluding in that the product recited in Appellants'
claim 1 would have been prima facie obvious to the ordinary artisan in view
of Bieniarz, Ruebusch, and Wu. Because Appellants do not identify any
specific objective evidence of nonobviousness that might outweigh the
evidence of prima facie obviousness advanced by the Examiner, we affirm
the Examiner's rejection of claim 1 over Bieniarz, Ruebusch, and Wu.
Because they were not argued separately, claims 3---6 and 8 fall with claim 1.
37 C.F.R. § 4I.37(c)(l)(iv).
SUMMARY
For the reasons discussed, we affirm both of the Examiner's
obviousness rejections.
TIME PERIOD
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
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