Ex Parte Gumaste et al

Patent Trial and Appeal Board

Mar 22, 2013

11064201 (P.T.A.B. Mar. 22, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ANAND V. GUMASTE and JOHN BOWERS
__________

Appeal 2011-000621
Application 11/064,201
Technology Center 3700
__________

Before ERIC GRIMES, STEPHEN WALSH, and ERICA A. FRANKLIN,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
inhaler, which have been rejected for obviousness. We have jurisdiction
under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
The Specification states that prior art devices for inhalation of
powdered medicaments are “dominated by inhaler devices that are activated
by some mechanical means of activation” (Spec. 3:6-7), although Appellants
described in a previous patent a device that senses airflow via an acoustic
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element, such as a microphone, which outputs signals that control a high
frequency vibrator (id. at 3:10-15). “However, this acoustic sensor flow
does not have the ability to detect the direction of the flow of air” (id. at
3:17-18).
The Specification states that the “present invention provides an
improvement over the prior art inhalation devices such as our afore-
mentioned U.S. Patent No. 6,152,130. The present invention provides a
directional acoustic flow sensor to operate the inhaler.” (Id. at 4:2-4.) The
Specification states that, in one embodiment, “the microphone element 8
produces noise signals 48 in response to detected airflow” (id. at 7:23 to
8:1).
When breathing commences, signal 48 will have an
instantaneous voltage offset, relative to the voltage when there
is no breathing, due to the change of the pressure in [the] air
flow passage. . . . At the instant when breathing commences,
the difference between these two signals represents the
direction of the breathing, whether it is an inhalation or
exhalation.
(Id. at 9:23 to 10:7.)
Claims 20, 22-27, 29, and 39 are on appeal. Claim 20 is the only
independent claim:
20. An air inhalation device for delivering medicament from a
container to a user, said device comprising:
an acoustic controller, said acoustic controller including an acoustic
sensing element configured to detect noise from free air flow into and
through the device and to generate signals based on said detected noise, and
a circuit for processing said signals to identify a direction and amplitude of
said airflow; and
a high frequency vibrator separate from said acoustic sensing element
and coupled to said container for inducing said medicament from said
container into said air flow when said processed signals identify inhalation
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by said user, wherein a direction of said airflow is identified by said circuit
by measuring an instantaneous voltage offset generated by said acoustic
sensing element.

The Examiner has rejected all of the claims on appeal under 35
U.S.C. § 103(a) as obvious based on Abrams
1
and Haveri
2
(Answer 3). The
Examiner finds that Abrams discloses a device meeting most of the
limitations of claim 20 (id. at 3-4) but “is silent as to the controller
determining a direction of the airflow by measuring an instantaneous voltage
offset” (id. at 4).
The Examiner finds that “Haveri discloses a similar inhaler with a
vibrating element that has a piezoelectric sensing element (56) that produces
signals to identify airflow direction based on an instantaneous admittance
value,” and also discloses that “admittance is related to current and voltage
by Ohm’s law” (id.). The Examiner concludes that it would have been
obvious “to modify the controller of Abrams to also determine airflow
direction as taught by Haveri in order to more accurately ensure that the
patient was inhaling when the medicament was released to avoid wasting
medicament” and to determine direction from the voltage because it “can be
directly determined from the admittance” (id.).
Appellants argue that “Haveri determines direction of airflow using
gas pressure that compress and stretch a piezoelectric element” (Appeal Br.
12), and that Haveri’s system cannot be successfully combined with
Abrams’ system because “[b]oth Abrams and claim 20 function not from a

1
Abrams et al., US 6,152,130, issued Nov. 28, 2000.
2
Haveri, US 6,978,779 B2, issued Dec. 27, 2005.
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direct pressure drop within the system, but use a microphone or fluid
pressure transducer to detect [ ] the noise created by airflow within a device
open to the atmosphere inhalation air flow. Haveri uses a direct pressure
drop system.” (Id. at 14.) Appellants argue that
the control logic that the Examiner finds in Haveri can only be
initiated within a pressurized system. . . . Appellants’ claimed
invention is not a pressurized system, and Abrams does not
teach a pressurized system. Thus, it is clear that the control
logic of Haveri is incompatible with the systems of claim 20
and Abrams.
(Id. at 15.)
We agree with Appellants that the Examiner has not persuasively
shown that the combined disclosures of Abrams and Haveri would have
made obvious the device of claim 20. Both Abrams and claim 20 require a
system with an acoustic sensing element, such as a microphone, to detect air
flow (Abrams, col. 2, ll. 18-26) or both air flow and direction (claim 20).
Haveri discloses a nebulizer for use in a breathing circuit that includes
a ventilator (Haveri, col. 5, ll. 7-9, 21-22). The ventilator can provide all or
part of the patient’s breathing gases, or the patient can breathe spontaneously
through the breathing circuit (id. at col. 5, ll. 31-40).
Haveri’s nebulizer includes a “ring-like vibrating element 56 . . .
mounted to the upper surface of plate 50” (id. at col. 6, ll. 60-61). Haveri
states that element 56 can be made of a piezoelectric material, which has the
property of changing its dimensions when electrically energized (id. at col. 6,
ll. 61-65). Thus, “high frequency alternating electrical energization . . .
causes the piezoelectric element 56 to alternately contract . . . to a radially
decreased state . . . and then expand to a radially increased state” (id. at col.
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8, ll. 56-64), along with attached plate 50 (id. at col. 8, l. 64 to col. 9, l. 9).
This vibration causes droplets of liquid medicament to be released into the
airstream to be inhaled by the patient (id. at col. 9, ll. 10-23).
Haveri discloses that “a piezoelectric element can also convert
mechanical energy to electrical energy. This characteristic is used in
[Haveri’s] invention to obtain information about the breathing gases in the
breathing circuit 2, and particularly the pressure of such gases.” (Id. at col. 9,
ll. 29-33.) “This pressure will vary significantly during inhalation and
exhalation conditions in breathing circuit 2. For example . . . [w]hen the
patient breathes spontaneously, . . . breathing circuit pressure will decrease
during inspiration and increase during expiration.” (Id. at col. 9, ll. 35-45.)
Pressure changes in breathing circuit 2 cause plate 50, and attached
piezoelectric element 56, to bend either toward or away from the airflow
passage (id. at col. 9, l. 53 to col. 10, l. 8). “The deflections of the
piezoelectric element 56 . . . result in a change in the dipole moment of the
piezoelectric material forming the element 56. This causes a voltage to be
generated in the element 56.” (Id. at col. 10, ll. 21-24.) This voltage can then
“be used to electrically measure the mechanical strains in element 56 caused
by the external forces applied to the piezoelectric element 56 resulting from
breathing gas pressures in breathing circuit 2 acting on plate 50” (id. at col.
10, ll. 31-35).
Haveri discloses that the signal from piezoelectric element 56 can be
analyzed to determine whether the mechanical loading on the element is
tensile or compressive (id. at col. 15, ll. 6-35) and that, based on the type of
loading and whether the patient is breathing spontaneously or with assistance
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from the ventilator, “the direction of gas flow in [the] patient limb 10 can be
determined” (id. at col. 15, ll. 41-42). “By detecting the direction and
pressure of the breathing gas flow in breathing circuit 2 . . . , and providing
this information to control unit 4 it is possible for the control unit 4 to initiate
and halt the atomization of the drug to coincide with the breathing of the
subject” (id. at col. 16, ll. 20-25).
The Examiner reasons that in Haveri’s system,
a fluctuating diaphragm (56) [ ] is used to determine the
direction of airflow for helping to control the release of
medicament. Since microphones (such as that found in Abrams)
use a fluctuating diaphragm to convert analog noise signals to
digital signals, the only modification to Abrams needed to read
on the instant invention is changing the control logic to also
determine direction of airflow from the fluctuating diaphragm
as taught by Haveri.
(Answer 6.)
We conclude that the Examiner’s rejection is not supported by a
preponderance of the evidence of record. As discussed above, Haveri’s
system determines the direction of airflow (inhalation or exhalation) based on
changes in air pressure in the system sensed by a piezoelectric element.
Haveri describes the detected pressure as “pressure of the breathing gas flow
in breathing circuit 2” (Haveri, col. 16, ll. 20-21). Haveri’s description of its
system as including a breathing circuit having one end (patient limb 10)
connected to the patient and the other end (inhalation limb 5 and exhalation
limb 7) connected to a ventilator (id. at col. 5, ll. 18-30) supports Appellants’
position that Haveri’s nebulizer is connected to a closed, pressurized system.
The Examiner has not pointed to evidence or provided persuasive technical
reasoning to show that inhalation and exhalation by a patient would have a
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similar effect on the air pressure in Abrams’ inhaler as it does in Haveri’s
nebulizer.
In addition, the Examiner has not provided evidence or persuasive
technical reasoning to support her position that
[a]s a person inhales or exhales air past the diaphragm in
Abrams’s microphone, the diaphragm flexes one way or an
opposite way depending on if the air is moving in a first
direction (inhalation) or a second direction (exhalation). The
amplitude of those fluctuations is measured to determine flow
amplitude and the direction of the fluctuations is used to
determine the flow direction in the same manner as taught by
Haveri.
(Answer 7.)
As discussed above, Haveri’s system uses a piezoelectric element that
is deformed either inwardly or outwardly, relative to the airflow passage, by a
change in air pressure (Haveri, col. 9, l. 53 to col. 10, l. 8) and the type of
loading (compressive or tensile) is determined and used together with the
breathing mode to determine the direction of airflow (id. at col. 15, ll. 6-42).
The Examiner has not shown that the vibrating diaphragm of a microphone,
as used by Abrams, is capable of providing the output necessary to carry out
the analysis used in Haveri’s system; e.g., an indication of compressive or
tensile loading that could be used to distinguish increased pressure from
decreased pressure in the airflow passage. The Examiner therefore has not
supported the position that “[t]here is nothing in either reference suggesting
that the control logic of Haveri is incompatible with Abrams” (Answer 7),
such that “[t]he simple and predictable modification of Abrams’s control
logic would then result in the instant invention” (id. at 8).
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SUMMARY
We reverse the rejection of claims under 35 U.S.C. § 103(a) based on
Abrams and Haveri.

REVERSED

cdc