Ex Parte Clark et al

Board of Patent Appeals and Interferences

Jul 25, 2012

09414384 (B.P.A.I. Jul. 25, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte ANDREW CLARK, CARLOS SCHULER, and
STEVE PABOOJIAN
____________

Appeal 2010-008081
Application 09/414,384
Technology Center 3700
____________

Before LINDA E. HORNER, MICHAEL C. ASTORINO, and
JOHN W. MORRISON, Administrative Patent Judges.

HORNER, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Andrew Clark et al. (Appellants) seek our review under 35 U.S.C.
§ 134 of the Examiner’s decision rejecting claims 21-36. Claims 1-20 are
canceled. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
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THE INVENTION
Appellants’ claimed invention relates to a “device for pulmonary
delivery of an active agent formulation for increased systemic bioavailability
of the active agent via absorption in the deep lung.” Spec. 1, ll. 6-8. “The
bioavailability is increased by modulating the flow rate of the aerosolized
active agent in a manner that is independent of patient instruction and flow
rate monitoring.” Spec. 1, ll. 8-10. The invention is based on the
observation that when an active agent is delivered to a patient at an initially
low inspiratory flow rate, the bioavailability of the active agent increases as
compared to delivery of the active agent at a constant but higher inspiratory
flow rate. Spec. 7, ll. 25-28. Claim 21, reproduced below, is representative
of the subject matter on appeal.
21. A device for controlling the delivery of an aerosolized
active agent to the lungs of a human patient, said device
comprising
a valve that provides a high flow resistance of at least 0.4
(cm H20)1/2 / SLM in the inhalation direction at the onset of the
patient’s inhalation and that subsequently opens during the
inhalation to provide a lower flow resistance,
wherein the lower flow resistance allows for a higher
flow rate through the device.
Independent claims 28 and 32 are also directed to a device comprising
a valve that provides a higher flow resistance in the inhalation direction at
the onset of the patient’s inhalation and that subsequently opens during the
inhalation to provide a lower flow resistance which corresponds to a higher
flow rate.
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THE REJECTIONS
Appellants seek review of the following rejections:
1. The Examiner rejected claims 21, 24, 28, 32, 34, and 36 under
35 U.S.C. § 102(b) as anticipated by Piper (US 5,479,920; iss. Jan. 2,
1996).
2. The Examiner rejected claims 22, 23, 26, 27, 30, 31, and 33 under
35 U.S.C. § 103(a) as unpatentable over Piper.
3. The Examiner rejected claims 25, 29, and 35 under 35 U.S.C. § 103(a)
as unpatentable over Piper and Carris (US 4,227,522; iss. Oct. 14,
1980).
ISSUE
Appellants argue the Examiner erred in finding that Piper’s flapper
valve 24 provides a high flow resistance in the inhalation direction at the
onset of the patient’s inhalation and subsequently opens during inhalation to
provide a lower flow resistance. Ans. 3-4; App. Br. 5-7. An issue presented
by this appeal is whether the Examiner has established by a preponderance
of the evidence that Piper discloses a valve that provides a higher flow
resistance in the inhalation direction at the onset of inhalation and a lower
flow resistance during inhalation.
ANALYSIS
Piper discloses an inhalation device including a one-way inhalation
valve 24. Col. 4, l. 22. Piper describes that valve 24 is a conventional
flapper valve that opens to permit flow in one direction but closes to prevent
flow in the other direction. Col. 4, ll. 23-25. Specifically, Piper discloses
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that valve 24 permits ambient air to be drawn in during inhalation but closes
during patient exhalation. Col. 4, ll. 25-28. Piper states:
In this manner, when the patient exhales, inhalation valve 24
closes and pressure builds up within the breathing circuit to a
level above atmospheric pressure due to the resistance across
the exhalation circuitry in the breathing circuit. Similarly,
when the patient inhales, valve 24 opens and pressure in the
breathing circuit drops to a level below atmospheric pressure.
Col. 4, ll. 28-34.
Piper does not describe how the valve opens when the patient begins
to inhale, the flow resistance of the valve in the inhalation direction at the
onset of inhalation, or the flow rate through the valve during the remainder
of the inhalation phase. Thus, the Examiner’s finding that at the onset of
inhalation the flow resistance of the Piper’s valve would be high and as the
user continues to inhale, the flow resistance would become lower appears to
be based on speculation and conjecture. Ans. 3-4. Rejections under
35 U.S.C. § 102 cannot be based on speculation and conjecture. Therefore,
it is our conclusion that the Examiner has not established by a
preponderance of the evidence that the inhalation valve 24 of Piper provides
a high flow resistance in the inhalation direction at the onset of the patient’s
inhalation and subsequently opens during the inhalation to provide a lower
flow resistance. As such, we cannot sustain the Examiner’s rejection of
independent claims 21, 28, and 32, or their dependent claims 24, 34, and 36,
under 35 U.S.C. § 102(b) as anticipated by Piper.
The Examiner relies on the same unsubstantiated finding in the
rejections under 35 U.S.C. § 103(a) of claims 22, 23, 26, 27, 30, 31, and 33
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based on Piper and of claims 25, 29, and 35 based on Piper and Carris.
Ans. 7-9. Accordingly, for the same reason, we cannot sustain the rejections
under 35 U.S.C. § 103.
CONCLUSION
The Examiner has not established by a preponderance of the evidence
that Piper discloses a valve that provides a higher flow resistance in the
inhalation direction at the onset of inhalation and a lower flow resistance
during inhalation.
DECISION
The decision of the Examiner to reject claims 21-36 is REVERSED.
REVERSED

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