Ex Parte Slowey et al

Board of Patent Appeals and Interferences

Aug 31, 2009

10509184 (B.P.A.I. Aug. 31, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ALEXANDER D. SLOWEY,
SUSANNAH C. BOSWELL, and PHILLIP A. JINKS
__________

Appeal 2009-0027951
Application 10/509,184
Technology Center 1600
__________

Decided: August 31, 2009
__________

Before DEMETRA J. MILLS, LORA M. GREEN, and FRANCISCO C.
PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an aerosol
vial containing a pair of asthma-treating drugs combined with a propellant
and a bulking agent. The Examiner has rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1 3M Company is the real party in interest (App. Br. 3).
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STATEMENT OF THE CASE
Appellants have found that the use of a particulate bulking agent
having a mass median diameter of less than one micron in aerosol
compositions comprising formoterol and mometasone dispersed in HFC
134a, HFC 227 or mixtures thereof, allows the provision of dispersions of
both drugs showing desirably high physical stability and homogeneity.
(Spec. 3.)
Claims 1-14 and 17 are pending and on appeal (App. Br. 2-3). Claim
1 is representative and reads as follows:
1. A dispenser comprising an aerosol vial equipped with a
dispensing valve, said aerosol vial containing a
pharmaceutical aerosol formulation comprising particles
of (a) formoterol or a pharmaceutically acceptable salt,
solvate or physiologically functional derivative thereof
and (b) mometasone or a pharmaceutically acceptable
salt, solvate, or physiologically functional derivative
thereof dispersed in a propellant selected from the group
consisting of 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3-
heptafluoropropane and a mixture thereof, and a bulking
agent having a mass median diameter of less than one
micron, and wherein an interior surface of the aerosol
vial is coated with a fluorocarbon polymer.

The Examiner cites the following documents as evidence of
unpatentability:
Ashurst US 6,131,566 Oct. 17, 2000
Trofast WO 00/53187 A1 Sep. 14, 2000

Claims 1-14 and 17 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Trofast and Ashurst (Ans. 3-6).

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OBVIOUSNESS
ISSUE
The Examiner cites Trofast as teaching a composition having all of
the claimed ingredients, but concedes that the reference “do[es] not teach
coating the interior surface of the aerosol vial with a fluorocarbon polymer.
It is for this that Ashurst et al. is joined” (Ans. 5).
The Examiner cites Ashurst as teaching that “some aerosol drugs tend
to adhere to the inner surfaces of inhalers and that coating the interior
surfaces can reduce the problem of adhesion or deposition on the can walls”
(id.). Based on the two references’ teachings, the Examiner concludes that
an ordinary artisan would have considered it obvious “to make an aerosol
composition comprising particles of formoterol, a propellant and a bulking
agent, contained in a dispenser comprising an aerosol vial that is coated with
a fluorocarbon polymer” (id. at 5-6).
The Examiner finds that, “although the coated interior surfaces of
Ashurst et al. is used for albuterol, the same holds true for drugs that adhere
to the interior walls of aerosol vials” (id. at 6). Thus, the Examiner reasons,
“[b]ecause formoterol adheres to the interior wall of aerosol vials, it is
reasonable for one of ordinary skill to look to the combined teaching of
Trofast et al. and Ashurst et al. for a solution to the problem of undesired
adhesion” (id.).
Appellants contend, among other things, that the Examiner erred in
finding that Trofast suggests a composition with a bulking agent in
combination with the other ingredients recited in claim 1 (App. Br. 5).
Specifically, Appellants argue, Trofast distinguishes between the ingredients
suitable for use in pressurized metered dose inhalers (MDIs), which use
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propellants, and dry powder inhalers (DPIs), which do not use propellants
(id.).
Thus, Appellants urge, when taken in light of other disclosures in the
reference, Trofast’s teaching that its formulations can contain a “diluent or
carrier” that corresponds to the claimed bulking agent “appears to be
directed to the context of a DPI formulation and not as an MDI bulking
agent” (id.). Accordingly, Appellants contend, “the Examiner has not
established a prima facie case of obviousness” (id. at 6).
In view of the positions advanced by Appellants and the Examiner,
the issue with respect to this rejection is whether Appellants have
demonstrated that the Examiner erred in finding that Trofast teaches or
suggests a composition that includes a bulking agent in combination with
formoterol, mometasone, and the claimed propellants.
FINDINGS OF FACT (“FF”)
1. Trofast discloses using “the steroidal anti-inflammatory drug
mometasone (preferably in the form of its furoate ester) in combination with
the long-acting bronchodilator formoterol (preferably as the fumarate
dihydrate salt) for the treatment of respiratory disorders such as mild,
moderate and severe asthma, rhinitis and COPD” (Trofast 1).
Trofast discloses that “a first aspect the invention therefore provides a
pharmaceutical combination comprising:
(a) formoterol, a pharmaceutically acceptable salt or solvate thereof;
(b) mometasone or an ester thereof and optionally a solvate (e.g. mono-
hydrate) thereof;
and optionally
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(c) one or more pharmaceutically acceptable additives, diluents or
carriers[.]”
(Id. at 3.)
2. Trofast discloses:
The combination can be inhaled from a nebulizer, from a
pressurized metered dose inhaler or as a dry powder from a dry
powder inhaler e.g. multidose reservoir systems from Astra
(Turbuhaler®) or Schering-Plough or from a dry powder
inhaler utilizing gelatine, plastic or other capsules, cartridges or
blister packs. A diluent or carrier, generally being non-toxic
and chemically inert to the medicament e.g. lactose, dextran,
mannitol or glucose or any additives that will give the
medicament a certain taste can be added to the powdered
medicament in an amount of from 50 μg to 25 mg per dose,
more preferably in an amount of from 50μg to 10 mg, most
preferably in an amount of from 100 to 2000 μg. One or more
of the ingredients is preferably in the form of a dry powder,
more preferably a micronized dry powder, most preferably an
agglomerated micronized dry powder. As an alternative to
agglomeration, the finely divided active ingredients may be in
the form of an ordered mixture with the pharmaceutically
acceptable additive, diluent or carrier. An ordered mixture
comprises fine particles of an active ingredient in association
with coarse particles of the pharmaceutically acceptible [sic]
additive, diluent or carrier. A fraction of fine particles of
carrier may also be present. The ingredients used in the
invention can be obtained in these preferred forms using
methods known to those skilled in the art. The particle size of
the active ingredients is less than 20 μm, preferably less than 10
μm.

(Id. at 5-6.)
3. The following paragraph in Trofast reads as follows:
When the ingredients of the system are adapted to be
administered from a pressurized inhaler (pMDI), they are
preferably in micronized form. They are dissolved, or,
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preferably suspended in a liquid propellant mixture. The
propellants which can be used include chlorofluorocarbons,
hydrocarbons or hydrofluoroalkanes. Especially preferred
propellants are P134a (tetrafluoro-ethane) and P227
(heptafluoropropane) each of which may be used alone or in
combination. They are optionally used in combination with one
or more other propellants and/or one or more surfactants and/or
one or more other excipients, for example ethanol, a lubricant,
an anti-oxidant and/or a stabilising agent.
(Id. at 6.)
4. Trofast’s examples consist of eight different compositions (id. at 7-8).
The compositions in Examples 1 through 3 contain only formoterol and
mometasone (id. at 7).
5. The compositions in Examples 4-6 contain formoterol, mometasone,
and lactose monohydrate (id. at 7-8).
6. The compositions in Examples 7 and 8 contain formoterol,
mometasone, propellant(s), ethanol and oleic acid (id. at 8).
7. An “aerosol” is defined as, “a substance, such as a drug containing
therapeutically active ingredients, packaged under pressure with a gaseous
propellant for release as a spray of fine particles.” The American Heritage
Medical Dictionary on line, http://www.yourdictionary.com/medical/aerosol

PRINCIPLES OF LAW
In proceedings before the Patent and Trademark Office,
the Examiner bears the burden of establishing a prima facie
case of obviousness based upon the prior art. “[The Examiner]
can satisfy this burden only by showing some objective
teaching in the prior art or that knowledge generally available to
one of ordinary skill in the art would lead that individual to
combine the relevant teachings of the references.”

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In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992) (citations omitted,
bracketed material in original).
In KSR Int’ l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), the
Supreme Court emphasized “an expansive and flexible approach” to the
obviousness question. The Court nonetheless reaffirmed that “a patent
composed of several elements is not proved obvious merely by
demonstrating that each of its elements was, independently, known in the
prior art.” Id. at 418.
Rather, as the Court stated:
[I]t can be important to identify a reason that would have
prompted a person of ordinary skill in the relevant field to
combine the elements in the way the claimed new invention
does . . . because inventions in most, if not all, instances rely
upon building blocks long since uncovered, and claimed
discoveries almost of necessity will be combinations of what, in
some sense, is already known.

Id. at 418-419 (emphasis added); see also id. at 418 (requiring a
determination of “whether there was an apparent reason to combine the
known elements in the fashion claimed by the patent at issue”) (emphasis
added).
Ultimately, therefore, as our reviewing court has stated, “[i]n
determining whether obviousness is established by combining the teachings
of the prior art, the test is what the combined teachings of the references
would have suggested to those of ordinary skill in the art.” In re GPAC Inc.,
57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal quotations omitted).
Moreover, “obviousness requires a suggestion of all limitations in a
claim.” CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir.
2003) (citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
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When evaluating claims for obviousness, “the prior art as a whole
must be considered. The teachings are to be viewed as they would have
been viewed by one of ordinary skill.” In re Hedges, 783 F.2d 1038, 1041
(Fed. Cir. 1986). Thus, “‘[i]t is impermissible within the framework of
section 103 to pick and choose from any one reference only so much of it as
will support a given position, to the exclusion of other parts necessary to the
full appreciation of what such reference fairly suggests to one of ordinary
skill in the art.’” Id. (quoting In re Wesslau, 353 F.2d 238, 241 (CCPA
1965)).

ANALYSIS
We agree with Appellants that the Examiner erred in finding that
Trofast teaches or suggests a composition that includes a bulking agent in
combination with formoterol, mometasone, and the claimed propellants.
We acknowledge Trofast’s disclosure that lactose, dextran, mannitol,
or glucose, can be included in its compositions (FF 2). Appellants do not
dispute that those ingredients are encompassed by the term “bulking agent”
in claim 1.
Appellants’ claim 1 is directed to a dispenser comprising an aerosol
vial containing an aerosol composition. However, the relevant teaching in
Trofast states that “[a] diluent or carrier, generally being non-toxic and
chemically inert to the medicament e.g. lactose, dextran, mannitol or glucose
or any additives that will give the medicament a certain taste can be added
to the powdered medicament” (FF 2 (emphasis added)). This sentence
immediately follows a sentence stating that “[t]he combination can be
inhaled from a nebulizer, from a pressurized metered dose inhaler or as a dry
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powder from a dry powder inhaler e.g. multidose reservoir systems from
Astra (Turbuhaler®) or Schering-Plough or from a dry powder inhaler
utilizing gelatine, plastic or other capsules, cartridges or blister packs” (id.).
Thus, Trofast states that the bulking agent can be added to the
powdered medicament, and that statement immediately follows a teaching
that distinguishes between dry powder inhalers, nebulizers, and pressurized
metered dose inhalers. Given these facts, we agree with Appellants that an
ordinary artisan reading Trofast’s disclosures in context would understand
Trofast as teaching that the bulking agents were to be added to the inhaled
dry powdered compositions, and not the nebulizers or metered dose inhalers.
This interpretation of the reference is buttressed by the fact that
Trofast discusses metered dose inhalers in the following paragraph without
mentioning the previously discussed diluent, carrier, lactose, dextran,
mannitol, glucose, or taste-enhancing additives (see FF 3). Rather, Trofast
discloses using the propellants encompassed by claim 1, “in combination
with one or more other propellants and/or one or more surfactants and/or one
or more other excipients, for example ethanol, a lubricant, an anti-oxidant
and/or a stabilising agent” (id.). Thus, in addition to not mentioning the
diluents and carriers previously described as being useful in dry powdered
inhalers, Trofast teaches that metered dose inhalers containing the
propellants recited in claim 1 use different types of excipients, i.e., ethanol, a
lubricant, an antioxidant and/or a stabilizing agent.
Appellants’ interpretation of Trofast is further supported by the fact
that none of the exemplified compositions that contain lactose also contain
propellants (see FF 5). Conversely, while the exemplified compositions that
contain propellants also contain ethanol and oleic acid, none of the
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propellant-containing compositions contains an additive that the Examiner
alleges as being a bulking agent, much less a bulking agent having the
claimed particle size (see FF 6).
Thus, we agree with Appellants that when the relevant teachings of
Trofast are read as whole, and in context, an ordinary artisan would not
interpret them as teaching or suggesting the use of a bulking agent as
claimed in a propellant-containing composition. Moreover, the Examiner
does not point to, nor do we see, any disclosure in Ashurst that remedies this
deficiency in Trofast.
The Examiner argues that, at page 6, lines 13-20, Trofast teaches that
“the ingredients can be adapted to be administered via a pressurized inhaler.
It is the position of the examiner that the ‘ingredients’, as taught, includes
the composition as disclosed on page 3, lines 14-18, which includes one or
more pharmaceutically acceptable additives, diluents or carriers” (Ans. 6).
We are not persuaded by this argument. While it is true that Trofast
provides a generic statement of ingredients suitable for its compositions (FF
1), that disclosure must be viewed in light of other teachings in the
reference.
As discussed above, Trofast distinguishes between the additives it
considers useful for compositions inhaled as dry powders, and the additives
suitable for propellant-containing compositions inhaled via metered dose
inhalers. Given the reference’s distinction between the ingredients suitable
for the two types of compositions, we agree with Appellants that, despite the
more generic disclosure on page 3 of Trofast, the reference’s more specific
disclosure would not have prompted an ordinary artisan to include the
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additives described as being suitable for powdered inhalers in propellant-
containing compositions.
In sum, because the Examiner has not explained why an ordinary
artisan viewing Trofast and Ashurst would have included a bulking agent as
claimed in an aerosol propellant-containing composition, we are compelled
to reverse the Examiner’s rejection of claim 1, and its dependents, as being
obvious over those references.

REVERSED

3M INNOVATIVE PROPERTIES COMPANY
PO BOX 33427
ST. PAUL MN 55133-3427