Ex Parte Alston

Board of Patent Appeals and Interferences

Jul 30, 2009

10729847 (B.P.A.I. Jul. 30, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte WILLIAM ALSTON
__________

Appeal 2008-0025861
Application 10/729,847
Technology Center 3700
__________

Decided: July 30, 20092
__________

Before TONI R. SCHEINER, DONALD E. ADAMS, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

1 Nektar Therapeutics (formerly Inhale Therapeutic Systems, Inc.) is the real
party in interest (App. Br. 2).
2 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

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DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
aerosolization apparatus. The Examiner has rejected the claims as
anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
Claims 1-20 are pending and on appeal (App. Br. 2). Claims 1 and
10, the independent claims, are representative and read as follows:

1. An aerosolization apparatus comprising:
a body defining an inlet opening, an outlet
opening, and an aerosolization chamber between the inlet
opening and the outlet opening,
wherein the aerosolization chamber is adapted to
receive an elongated receptacle containing a pharmaceutical
formulation and wherein the elongated receptacle rotates end-
over-end about an axis substantially orthogonal to an axis
passing through the outlet opening when air or gas flows
through the body.

10. An aerosolization apparatus for delivering an
aerosolized pharmaceutical formulation to a user’s respiratory
tract, the apparatus comprising:
a body defining an inlet opening, an outlet
opening, and an aerosolization chamber between the inlet
opening and the outlet opening,
wherein the aerosolization chamber is adapted to
receive an elongated receptacle containing a pharmaceutical
formulation and wherein the elongated receptacle rotates end-
over-end about an axis substantially orthogonal to an axis
parallel to an inhalation direction when the user inhales to cause
air or gas to pass through the body.

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The Examiner cites the following documents as evidence of
unpatentability:
Dean US 4,249,526 Feb. 10, 1981
Chiprich US 5,614,217 Mar. 25, 1997

The following rejections are before us for review:
Claims 1-7, 10-17, and 20 stand rejected under 35 U.S.C. § 102(b) as
being anticipated by Dean (Ans. 3-6).
Claims 8 and 18 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Dean (Ans. 6-7).
Claims 9 and 19 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Dean in view of Chiprich (Ans. 7-8).

ANTICIPATION
ISSUE
The Examiner finds that Dean discloses an aerosolization apparatus
that has a body, inlet and outlet openings, and an aerosolization chamber
adapted to receive an elongated receptacle containing a pharmaceutical
composition (Ans. 4-5). The Examiner further finds that the elongated
receptacle in Dean’s apparatus “rotates . . . end-over-end about an axis
substantially orthogonal to an axis passing through the outlet opening when
air or gas flows through the body (2-fold axis of symmetry reads on end-
over-end, see col.4 lines 32-38, figs.3 and 4)” (Ans. 4).
Appellant contends that, contrary to the Examiner’s finding, Dean’s
Figures 1 and 2 show “a receptacle (24) in the aerosolization chamber (15)
of Dean et al rotates about an axis that is parallel to the axes passing through
the cutlet opening (5) of Dean” (App. Br. 4). Thus, Appellant argues, Dean
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“does not disclose a chamber wherein a receptacle would rotate about an
axis that is orthogonal to the axis of the outlet opening. Accordingly, Dean
et al does not anticipate claim 1” (id.). Appellants make the same contention
with respect to the corresponding limitation in claim 10 (id. at 4-5).
In view of the positions advanced by Appellant and the Examiner, the
issues with respect to this rejection are:
1. Did the Examiner err in finding that Dean’s apparatus meets
the limitation in claim 1 requiring the aerosolization chamber
to be configured such that “the elongated receptacle rotates
end-over-end about an axis substantially orthogonal to an
axis passing through the outlet opening when air or gas flows
through the body?”
2. Did the Examiner err in finding that Dean’s apparatus meets
the limitation in claim 10 requiring the aerosolization
chamber to be configured such that “the elongated receptacle
rotates end-over-end about an axis substantially orthogonal to
an axis parallel to an inhalation direction when the user
inhales to cause air or gas to pass through the body?”

FINDINGS OF FACT (“FF”)
1. Appellant’s Figure 1A, reproduced below, shows an embodiment of
the claimed invention “in an initial position” (Spec. 4):
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Figure 1 shows aerosolization apparatus 100, which “comprises a
housing 105 defining a chamber 110 having one or more air inlets 115 and
one or more air outlets 120. The chamber 110 is sized to receive a
receptacle 125 which contains an aerosolizable pharmaceutical formulation”
(Spec. 5).
Also seen in Figure 1A are:
An opening mechanism 130 [which] comprises an
opening member 135 that is moveable within the chamber 110.
Near or adjacent the outlet 120 is an end section 140 that may
be sized and shaped to be received in a user’s mouth or nose so
that the user may inhale through an opening 145 in the end
section 140 that is in communication with the outlet 120.

(Id.)

2. Appellant’s Figure 1C is reproduced below:

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Figure 1C shows that, as force 150 is applied to opening mechanism
130, opening member 135 “is advanced to . . . extend into the wall of the
receptacle 125, as shown in Figure 1C. The opening member may comprise
one or more blunt or sharp tips 152 that contact the receptacle 125 in a
manner that provides an opening into the receptacle 125” (Spec. 6).
3. Appellant’s Figure 1D is reproduced below:

Figure 1D shows opening mechanism 130 in a retracted position after
deployment, “leaving an opening 160 through the wall of the receptacle 125
to expose the pharmaceutical formulation in the receptacle 125” (Spec. 6).
4. Appellant’s Figure 1E is reproduced below:

Figure 1E shows gas flowing through an inlet 115 as shown by arrows
165. “The flow of air causes the pharmaceutical formulation to be
aerosolized. When the user inhales 170 through the end section 140 the
aerosolized pharmaceutical formulation is delivered to the user's respiratory
tract” (Spec. 6).
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As can be seen in Figure 1E, the chamber 110 of the
aerosolization apparatus 100 is shaped so that the receptacle
125 rotates within the chamber 110. The airflow is designed so
that the receptacle 125 rotates in the direction of the arrows
175, that is in an end-over-end manner. The rotation is
substantially about an axis that is substantially orthogonal to the
inhalation direction 170 and/or to the direction through the
outlet 120.

(Id. at 7.)
5. Thus, when the elongated receptacle 125 rotates about an axis
substantially orthogonal to the inhalation direction and/or to the direction
through the outlet 120, the receptacle essentially tumbles such that one end
of the receptacle moves toward the outlet opening, and one end moves away
from the outlet, as shown by arrows 175.
6. Dean discloses “an inhalation device for powdered medicaments
contained initially in a container, which device is provided with means for
locating the container in a position to be opened and appropriate opening
means for the container” (Dean, col. 1, ll. 30-34).
7. Figure 1 of Dean, reproduced below, “is a longitudinal cross-section
through a device of [Dean’s] invention (id. at col. 3, ll. 39-40):
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Dean’s Figure 1 shows upper housing member 1 “and a lower housing
member 2 adapted to engage therewith. . . . Extending through upper
housing member 1 is an air passageway 5, which is interrupted by a coarse
sieve 6. Upper end 3 of housing member 1 is adapted for insertion into the
mouth” (id. at col. 3, ll. 58-65).
8. Figure 3 of Dean, reproduced below, is a “transverse cross-section[]
through the device of FIG. 1 along the line A--A, . . . showing the
orientation of the housing members when the device is in use” (id. at col. 3,
ll. 43-46):
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Dean’s Figure 3 shows how the upper and lower housings align, such
that when the device is in use, air inlets 11 and 12 communicate with
passageways 13 and 14 to allow air to pass into aerosolization chamber 15
(see id. at col. 4, ll. 39-44).
9. Dean discloses that when the device is to be used, “a capsule is placed
in depression 24. In position, the crowns of the capsule register with the
piercing pins 20 and 21” (id. at col. 4, ll. 16-18; see also Figure 1).
When the upper housing member 1 is properly placed onto lower
housing member 2, “push buttons 16 and 17 are depressed against the bias of
springs 18 and 19 by cam surfaces 7 and 8, and piercing pins 20 and 21
pierce the crowns of the capsule,” after which the pins retract (id. at col. 4,
ll. 21-24).
10. Dean discloses that, once the capsule has been pierced and pins
retracted:
Mouthpiece 3 is then placed in the mouth and air is sucked
through passageway 5. The air enters the housing through
inlets 11 and 12 and passes into swirl chamber 15, dislodging
the capsule from depression 24 and causing it to rotate about its
2-fold axis of symmetry. This movement causes the
medicament to escape through the holes pierced in the crowns
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of the capsule and become entrained in the airstream to be
carried into the mouth.

(Id. at col. 4, ll. 28-36.)
11. Thus, as seen by the configuration of Dean’s swirl chamber 15, when
the user’s inhalation draws an airstream into the chamber through
passageways 13 and 14, the capsule does not rotate such that one end of the
receptacle moves toward the device’s outlet opening 3, and one end moves
away from the outlet. Rather, because of the orientation of the swirl
chamber, the capsule rotates such that its ends remain essentially the same
distance from the device’s outlet opening.

PRINCIPLES OF LAW
It is well settled that, for a reference to anticipate a claim “[e]very
element of the claimed invention must be literally present, arranged as in
the claim.” Richardson v. Suzuki Motor Co., Ltd., 868 F.2d 1226, 1236
(Fed. Cir. 1989) (emphasis added).
During examination, the PTO must interpret terms in a claim using
“the broadest reasonable meaning of the words in their ordinary usage as
they would be understood by one of ordinary skill in the art, taking into
account whatever enlightenment by way of definitions or otherwise that may
be afforded by the written description contained in the applicant’s
specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
The Examiner must therefore “determine[] the scope of claims in
patent applications not solely on the basis of the claim language, but upon
giving claims their broadest reasonable construction ‘in light of the
specification as it would be interpreted by one of ordinary skill in the art.’”
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Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed.Cir.2005) (emphasis
added) (quoting In re American Academy Of Science Tech Center, 367 F.3d
1359, 1364 (Fed. Cir. 2004).
To establish that a reference inherently discloses a specific limitation,
the Examiner may refer to extrinsic evidence showing that the descriptive
matter missing from the reference is necessarily present in the reference’s
disclosure. Continental Can Co. v. Monsanto Co., 948 F.2d 1264, 1268
(Fed. Cir. 1991).
Thus, the Examiner cannot establish inherency merely by
demonstrating that the asserted limitation is probable or possible. In re
Oelrich, 666 F.2d 578, 581 (CCPA 1981). “If, however, the disclosure is
sufficient to show that the natural result flowing from the operation as taught
would result in the performance of the questioned function, it seems to be
well settled that the disclosure should be regarded as sufficient.” Id.
(quoting Hansgirg v. Kemmer, 102 F.2d 212, 214 (CCPA 1939)).

ANALYSIS
We agree with Appellant that the Examiner erred in finding that
Dean’s apparatus meets the limitation in claim 1 requiring the claimed
device’s aerosolization chamber to be configured such that “the elongated
receptacle rotates end-over-end about an axis substantially orthogonal to an
axis passing through the outlet opening when air or gas flows through the
body,” and also erred in finding that Dean’s apparatus meets the
corresponding limitation in claim 10.
As discussed above, the Specification clarifies that when the
elongated receptacle in the aerosolization chamber rotates end-over-end
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about an axis substantially orthogonal to the inhalation direction and/or to
the direction through the outlet, as recited in claims 1 and 10, the receptacle
essentially tumbles such that one end of the receptacle moves toward the
outlet opening, and one end moves away from the outlet, as shown by
arrows 175 in Figure 1E (see FF 4, 5). In contrast, because of the
configuration of Dean’s swirl chamber 15, when a user’s inhalation draws an
airstream into the chamber through passageways 13 and 14, the capsule
rotates such that its ends remain essentially the same distance from the
device’s outlet opening (see FF 8, 10, and 11).
We therefore do not agree with the Examiner that Dean’s device is
configured such that the capsule in the aerosolization chamber rotates end-
over-end about an axis substantially orthogonal to the inhalation direction
and/or to the direction through the outlet, as recited in claims 1 and 10.
Nor do we agree with the Examiner that Dean’s apparatus is identical
to Appellant’s. As is evident from comparing Appellant’s figures and
Dean’s figures, the inlets of Dean’s swirl chamber are configured to cause
the capsule to rotate about the device’s longitudinal axis, whereas the
embodiment shown in Appellant’s Figure 1E has inlets configured to cause
the capsule to rotate along the device’s longitudinal axis (compare FF 4 to
FF 7, 8). Thus, while it may be true that the claims’ functional language is
relatively broad, we are not persuaded that Dean’s device is structurally
indistinguishable from the claimed device, given that the prior art device and
the claimed device are configured to rotate the capsule in different
directions.
The Examiner hypothesizes that, during inhalation, “it is likely that a
user may block one of the air inlet openings [of Dean’s device]. Therefore,
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when the user holds the inhaler such that he/she covers one of the inlet
openings (11), inhalation suction force would cause air to enter through the
other inlet (12)” (Ans. 10).
The Examiner urges that air “coming in from only one inlet would
turn/rotate the receptacle toward the direction of the airflow/outlet opening”
(id.). Thus, the Examiner argues, “a receptacle that is lifted and turned from
a position perpendicular to the outlet opening to a direction of the outlet
opening would inherently acquire[] a rotational axis that is orthogonal to the
axis of the outlet opening” (id. at 10-11).
The Examiner further urges that the claimed rotational limitation is
merely an intended use of the apparatus, and that Dean’s “is fully capable of
meeting such indented use recitation” (id. at 11). Specifically, the Examiner
notes, Dean “never stated that his receptacle must meet certain size. The
receptacle rotational axis would depend on the size of the receptacle as well
as the chamber” (id.).
Thus, the Examiner argues, “a receptacle small enough, say for
example, one third the size of the receptacle depicted in figure 2 of Dean et
al., can be adapted to the chamber of Dean et al., which will provide the
receptacle with enough space to rotate at any axis including an axis that is
orthogonal to the outlet opening” (id.).
We do not find the Examiner’s arguments persuasive. We agree, as
noted above, that if the “disclosure is sufficient to show that the natural
result flowing from the operation as taught would result in the performance
of the questioned function, it seems to be well settled that the disclosure
should be regarded as sufficient” to establish inherency. In re Oelrich, 666
F.2d at 581 (quoting Hansgirg v. Kemmer, 102 F.2d at 214)). However, it is
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well settled that the Examiner cannot establish inherency merely by
demonstrating that the asserted limitation is probable or possible. Oelrich,
666 F.2d at 581.
We also note that it is acceptable for the Examiner to use extrinsic
evidence to support a finding of inherency. Continental Can, 948 F.2d at
1268. In the instant case, however, the Examiner has not provided any
evidence supporting the assertions that using a sufficiently small capsule in
Dean’s device, or using Dean’s device with one of the inlets blocked, would
result in the capsule rotation required in claims 1 and 10.
In sum, we agree with Appellant that the Examiner has failed to make
a prima facie case of anticipation with respect to claims 1 and 10. We
therefore reverse the Examiner’s rejections of those claims, and their
dependents, as anticipated by Dean.

OBVIOUSNESS
Claims 8 and 18 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Dean (Ans. 6-7).
Claims 8 and 18 ultimately depend from claims 1 and 10,
respectively, and require the receptacle to be present in the device in the
form of a capsule that contains a “powder pharmaceutical formulation
[which] comprises particles having a mass median diameter less than 10
μm.” (Claims 8 and 18.)
The Examiner finds that the mass median diameter of a
pharmaceutical powder “can be made smaller or larger to respectively
increase or decrease the absorbent nature of tissue, and tissue can vary from
patient to patient[]” (Ans. 7). Therefore, the Examiner concludes, “it would
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have been obvious to one of ordinary skills in the art at the time the
invention was made to manipulate the mass median diameter of
pharmaceutical formulation particles because doing so would have allowed
treatment depending on patient’s tissue absorbent efficiency” (id.).
We reverse this rejection as well. Claims 8 and 18 depend from
claims 1 and 10 and also require the device to be configured in the manner
recited in claims 1 and 10. The Examiner points to no disclosure in Dean, or
any other rationale, that remedies the deficiencies of Dean discussed above
with respect to claims 1 and 10. Thus, on the current record, Dean fails to
teach or suggest all of the limitations of claims 8 and 18.
Claims 9 and 19 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Dean in view of Chiprich (Ans. 7-8).
Claims 9 and 19 ultimately depend from claims 1 and 10,
respectively, and require the powder in receptacle to have “a moisture
content below 5% by weight.” (Claims 9 and 19.) The Examiner concedes
that Dean fails to meet this limitation, and cites Chiprich to meet it (id. at 8).
However, the Examiner points to no disclosure in Dean or Chiprich,
or any other rationale, that remedies the deficiencies of Dean discussed
above with respect to claims 1 and 10. We therefore reverse the Examiner’s
rejection of claims 9 and 19 as being obvious in view of Dean and Chiprich.
SUMMARY
We reverse the Examiner’s rejection of claims 1-7, 10-17, and 20
under 35 U.S.C. § 102(b) as being anticipated by Dean.
We also reverse the Examiner’s rejection of claims 8 and 18 under
35 U.S.C. § 103(a) as being unpatentable over Dean.
We also reverse the Examiner’s rejection of claims 9 and 19 under
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35 U.S.C. § 103(a) as being unpatentable over Dean in view of Chiprich.

REVERSED

alw

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