Ex Parte Power et al

Patent Trial and Appeal Board

Jun 21, 2013

10833932 (P.T.A.B. Jun. 21, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JOHN S. POWER, DECLAN MORAN, DONAL DEVERY,
GAVAN O’SULLIVAN, JAMES FINK, and NIALL SMITH1
__________

Appeal 2011-011481
Application 10/833,932
Technology Center 3700
__________

Before TONI R. SCHEINER, MELANIE L. McCOLLUM, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
nebulizer and a nebulizing method. The Examiner has rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
Claims 1-19, 21, and 23-39 are pending and on appeal (App. Br. 2).
Claims 1 and 35 are illustrative and read as follows:

1 Appellants identify the real party in interest as Novartis AG (App. Br. 2).
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1. A nebuliser to deliver a medicament comprising:
a housing having a reservoir for the medicament;
an aerosol generator comprising a vibratable member having a
plurality of apertures extending between a first surface and second surface of
the member that can be supplied the medicament from the reservoir, wherein
the generator aerosolizes at least a portion of the medicament into an
aerosol;
a gas venting inlet to permit a gas to enter the nebuliser and form a
mixture with the aerosol;
a passage through which the mixture of the aerosol and the gas is
delivered to an outlet port of the nebulizer; and
a drive circuit for the aerosol generator;
wherein the drive circuit is configured to, substantially throughout
aerosolization, repeatedly change a frequency of vibration of the vibratable
member between a first frequency and a second frequency.
35. A method for nebulising a liquid comprising:
providing a vibratable thin shell member comprising a front surface, a
rear surface and a plurality of tapered apertures extending therebetween, said
apertures being tapered to narrow from the rear surface to the front surface;
vibrating the thin shell member; and
substantially throughout nebulisation, repeatedly sweeping a
frequency of vibration of the vibrating thin shell member across a delivery
range of the vibratable member.
Claims 1-6, 9-19, 21, and 34-36 stand rejected under 35 U.S.C.
§ 103(a) as obvious over Feiner et al. (US 7,059,320 B2, Jun. 13, 2006) in
view of Blakley et al. (US 6,830,046 B2, Dec. 14, 2004) and Takahashi et al.
(US 5,312,281, May 17, 1994) (Ans. 4).
Claims 7 and 8 stand rejected under 35 U.S.C. § 103(a) as obvious
over Feiner in view of Blakley, Takahashi, and Callaway (US 4,993,411,
Feb. 19, 1991) (Ans. 7).
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Claims 23-26 stand rejected under 35 U.S.C. § 103(a) as obvious over
Feiner in view of Blakley, Takahashi, and Stimpson et al. (US 5,551,416,
Sep. 3, 1996) (Ans. 8).
Claims 27-33 stand rejected under 35 U.S.C. § 103(a) as obvious over
Feiner in view of Blakley, Takahashi, and Kocinski (US 5,170,782, Dec. 15,
1992) (Ans. 8).
Claims 37-39 stand rejected under 35 U.S.C. § 103(a) as obvious over
Feiner in view of Blakley, Takahashi, and Ingebrethsen (US 5,388,574,
Feb. 14, 1995) (Ans. 10).
In rejecting the claims, the Examiner relies on Feiner for disclosing
a nebulizer (1) to deliver a medicament (3); a housing
(Figure 1) having a reservoir (2) for the medicament (3); an
aerosol generator (7) comprising a vibratable member . . . that
can be supplied the medicament (3) from the reservoir (2),
wherein the generator (7) aerosolizes at least a portion of the
medicament (3) into an aerosol; a gas venting inlet (12) to
permit a gas to enter the nebulizer (1) and form a mixture with
the aerosol; and a passage (4) through which the mixture of the
aerosol and the gas is delivered to an outlet (11) of the
nebulizer (1).
(Ans. 4.) With regard to the drive circuit, the Examiner finds that “Feiner
discloses a control means (10) for activating the nebulizer” (id.). However,
the Examiner acknowledges that “Feiner does not expressly disclose the
plurality of apertures extending between a first surface and the second
surface of the member, nor does Feiner expressly disclose the changing of
the frequency of vibration of the vibratable member” (id. at 4-5).
The Examiner relies on Blakley for disclosing “the use of a plurality
of apertures (44) extending between the aerosol generator for the purpose of
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controlling the amount and droplet size of medicament being passed thru the
nebulizer” (id. at 5). The Examiner relies on Takahashi for disclosing a
“nebulizer where the voltage is oscillated from high voltage to low voltage
resulting in a change in the frequency range from several Hertz to
60 Kilohertz and a change in the droplet size” (id.). “Regarding the ability
of the frequency to change repeatedly, [the Examiner finds that] Takahashi
discloses the operation of the circuit has an oscillation period and a non-
oscillating people that repetitively alternates” (id.). The Examiner concludes
that it would have been obvious “to modify the device of Feiner to include a
plurality of apertures on the aerosol generator as taught by Blakley to
moderate the droplet size of medicament being nebulized and to modify the
operational frequency of Feiner as taught by Takahaski [sic] to change the
droplet size of the medicament” (id.).
ISSUES
Has the Examiner set forth a prima facie case that it would have been
obvious to configure Feiner’s drive circuit “to, substantially throughout
aerosolization, repeatedly change a frequency of vibration of the vibratable
member between a first frequency and a second frequency,” as recited in
claim 1?
Has the Examiner set forth a prima facie case that it would have been
obvious to modify Feiner’s method to, “substantially throughout
nebulisation, repeatedly sweep[] a frequency of vibration of the vibrating
thin shell member across a delivery range of the vibratable member,” as
recited in claim 35?
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PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citation omitted).
FINDINGS OF FACT
1. Takahashi discloses a nebulizer comprising:
a piezoelectric vibrator having a pair of electrodes on respective
each surfaces of the vibrator . . . ; [and] a high frequency
generator for exciting said vibrator; . . . said vibrator vibrating
in thickness direction of the vibrator upon being excited with
high frequency power between said electrodes to convert said
thin liquid film to mist; said high frequency generator exciting
said vibrator intermittently with a predetermined duty ratio.
(Takahashi, col. 2, ll. 30-50.)
2. Takahashi states: “In FIG. 3, the numeral 1 shows an
oscillation circuit which oscillates intermittently with a predetermined duty
ratio for exciting a vibrator TD.” (Id. at col. 4, ll. 6-8.)
3. Takahashi also states:
The oscillation circuit 1 is a self-oscillation circuit which
oscillates with the frequency which is close to the resonant
frequency of the vibrator TD, and has the vibrator TD
inductive. When the resistance of the series circuit of the
resistor R1 and the variable resistor VR is considerably larger
than the resistance which provides continuous oscillation, the
continuous oscillation stops in a short time, so that the
intermittent oscillation is obtained. The resistance of the series
circuit (R1 and VR) and the capacitor C3 provide a time
constant circuit. When the oscillation continues a
predetermined duration, the voltage across the capacitor C3
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decreases so that the base current of the transistor is decreased
lower than a threshold value for continuing oscillation.
Therefore, the oscillation stops. Then, the voltage across the
capacitor C3 increases, and the circuit oscillates again for a
predetermined duration. That operation repeats, and therefore,
the circuit has an oscillation period and a non-oscillation period
alternately. Thus, the intermittent oscillation is obtained.
(Id. at col. 4, ll. 29-48.)
4. Takahashi FIG. 4 is set forth below:

“FIG. 4 shows wave-form of intermittent oscillation of a vibrator TD. The
symbol D shows an intermittent period, DON shows the oscillation period.
The duty ratio of oscillation is defined by the ratio of D and DON so that the
duty ratio is DON/D. . . . A is amplitude of oscillation.” (Id. at col. 5, ll. 3-
12.)
5. In addition, Takahashi discloses:
FIG. 8 shows the experimental relationship between the duty
ratio (horizontal axis in %), and the amount of mist (vertical
axis in cm3/hour) in the separately excited circuit of FIG. 7,
where the diameter of a vibrator is 20 mm, the thickness of a
mesh is 0.043 mm, the oscillation frequency is 1.630 MHz, the
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intermittent frequency is 5 KHz, the voltage across the vibrator
is 40 V (peak-to-peak).
(Id. at col. 6, ll. 19-27.)
ANALYSIS
With regard to claim 1, Appellants argue that “none of the references
teach a nebulizer having a drive circuit adapted to vibrate a vibratable
member between a first frequency and a second frequency” (App. Br. 8). In
particular, Appellants argue:
An oscillator having a period for oscillation at a first frequency
value and a period for non-oscillation or no vibration that is a
frequency value of zero is not the same as the claimed
configuration, which repeatedly changes a frequency of
vibration between a first frequency and a second frequency. A
drive circuit to turn a frequency on and off as taught by
Takahashi is not the same as a drive circuit to change a
frequency from a first frequency to the second frequency -
thereby supplying driving energy at two different frequencies.
(Id. at 7-8.)
In response, the Examiner argues:
Takahashi teaches a first frequency oscillating frequency “close
to resonance frequency” (Column 4, Lines 29-31) and a second
intermittent frequency for “adjust[ing] the diameter of the mist
(Column 7, Lines 53-65). In these operational characteristics,
Takahashi teaches the oscillation frequency to be 1.630 MHz,
while the intermittent frequency is 5 KHz in order to drive the
circuitry of the nebulizer for the purpose of achieving the
desired droplet size (Column 6, Lines 20-30).
(Ans. 13.) We conclude that Appellants have the better position.
Takahashi discloses a “high frequency generator exciting [a] vibrator
[TD] intermittently with a predetermined duty ratio” (Findings of Fact (FF)
1-2). We agree with Appellants that the vibrator TD alternates between a
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period of oscillation and a period of no oscillation (FF 3-4). We note the
Examiner’s reliance on the teaching in Takahashi of an “oscillation
frequency” of 1.630 MHz and an “intermittent frequency” of 5 KHz
(Ans. 13 (citing col. 6, ll. 20-30 (see FF 5))). However, when this teaching
is read in context, we do not agree with the Examiner that it refers to two
different oscillation frequencies of the vibrator TD.
Claim 1 recites a drive circuit that is configured to “change a
frequency of vibration of the vibratable member between a first frequency
and a second frequency” (emphasis added). The Specification describes
changing the frequency between different frequencies that cause vibration
(see, for example, Spec. ¶ [0073]). The Examiner has not adequately
explained why the language of claim 1 would encompass alternating
between a frequency that causes vibration and no vibration. Therefore, we
conclude that the Examiner has not set forth a prima facie case that the
applied references teach or suggest a drive circuit that “is configured to,
substantially throughout aerosolization, repeatedly change a frequency of
vibration of the vibratable member between a first frequency and a second
frequency,” as recited in claim 1. We therefore reverse the obviousness
rejection of claim 1 and of claims 2-6, 9-19, 21, and 34, which depend from
claim 1.
With regard to claim 35, Appellants argue that the “action of
repeatedly sweeping a frequency of vibration across a delivery range of the
vibratable member is . . . not taught or suggested by any of Feiner et al.,
Blakely et al. and Takahashi et al.” (App. Br. 11). The Examiner does not
respond to this argument. Therefore, we conclude that the Examiner has not
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set forth a prima facie case that the applied references teach or suggest
“substantially throughout nebulisation, repeatedly sweeping a frequency of
vibration of the vibrating thin shell member across a delivery range of the
vibratable member,” as recited in claim 35. We therefore reverse the
obviousness rejection of claim 35 and of claim 36, which depends from
claim 35.
In rejecting claims 7, 8, 23-33, and 37-39, which either depend from
claims 1 or 35 or otherwise recite the features of one of these claims, the
Examiner does not explain how Callaway, Stimpson, Kocinski, or
Ingebrethsen overcome the deficiencies discussed above (Ans. 7-12). Thus,
we conclude that the Examiner has not set forth a prima facie case that
claims 7, 8, 23-33, and 37-39 would have been obvious and therefore reverse
the obviousness rejections of these claims.

REVERSED

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