Ex Parte MCNAIR

Patent Trial and Appeal Board

Jan 25, 2019

12688593 (P.T.A.B. Jan. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/688,593 01/15/2010
46169 7590 01/29/2019
SHOOK, HARDY & BACON L.L.P.
(Cerner Corporation)
Intellectual Property Department
2555 GRAND BOULEVARD
KANSAS CITY, MO 64108-2613
FIRST NAMED INVENTOR
DOUGLAS S. MCNAIR
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
CRNI.146536 3930
EXAMINER
LUONG, PETER
ART UNIT PAPER NUMBER
3793
NOTIFICATION DATE DELIVERY MODE
01/29/2019 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
IPDOCKET@SHB.COM
IPRCDKT@SHB.COM
BPARKERSON@SHB.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DOUGLAS S. MCNAIR 1
Appeal 2017-011482
Application 12/688,593
Technology Center 3700
Before RICHARD M. LEBOVITZ, RY AN FLAX, and TA WEN CHANG,
Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to methods of optimizing
aerosolization and administration of an inhaled drug to a patient via a
vibratory inhaler device. The Examiner rejected the claims as obvious under
35 U.S.C. § 103. Pursuant to 35 U.S.C. § 134(a), Appellants appeal the
Examiner's determination that the claims are unpatentable. We have
jurisdiction under 35 U.S.C. § 6(b ). The rejection is reversed.
STATEMENT OF THE CASE
Claims 1, 3-9, and 11-16 stand rejected under pre-AIA 35 U.S.C.
1 The Appeal Brief ("Br."; entered March 2, 2017) identifies Cemer
Innovation, Inc., as the real party in interest.
Appeal 2017-011482
Application 12/688,593
§ I03(a) as obvious in view of Burnell et al. (US 2007/0225587 Al,
published Sep. 27, 2007) ("Burnell") and Dunsmore et al. (US
2009/0126731 Al, published May 21, 2009) ("Dunsmore"). Ans. 2.
DISCUSSION
Claim 1
Claim 1 is reproduced below ( with annotations [ 1 ]-[ 4] added to
number each step of the claim):
1. A method of optimizing an aerosolization and administration
of an inhaled drug to a patient via a vibratory inhaler device to
facilitate the aerosolization as a plume of fine particles and to
inhibit agglomeration or coagulation of particles within the
plume, the method comprising:
[ 1] collecting time-domain response measurements by
performing acoustic pulse reflectometry on a patient, the
measured time-domain response corresponding to acoustic and
anatomical properties associated with the patient's mouth,
pharynx, and upper airway;
[2] identifying a frequency spectrum of acoustic
vibrations that are specific to the patient's mouth, pharynx, and
upper airway, wherein the frequency spectrum identified is
based on the time-domain response measurements collected by
performing acoustic pulse reflectometry on the patient; and
[3] identifying a vibratory inhaler device having a first
dispersal configuration, wherein the vibratory inhaler device
having the first dispersal configuration is specifically identified
based on a determination that the first dispersal configuration
produces the frequency spectrum of acoustic vibrations that are
specific to the patient's mouth, pharynx, and upper airway,
wherein the first dispersal configuration includes a size of the
vibratory inhaler device and a geometry of the vibratory inhaler
device.
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Application 12/688,593
As indicated above, claim 1 has three recited steps of 1) "collecting
time-domain response measurements by performing acoustic pulse
reflectometry on a patient," 2) "identifying a frequency spectrum of acoustic
vibrations that are specific to the patient's mouth, pharynx, and upper
airway," and 3) "identifying a vibratory inhaler device having a first
dispersal configuration." The "first dispersal configuration" of step 3) is
based on "the frequency spectrum of acoustic vibrations that are specific to
the patient's mouth, pharynx, and upper airway."
The Examiner found that Burnell discloses the three claimed steps
"substantially as claimed except for identifying a frequency spectrum of
acoustic vibrations that are specific to the patient," which corresponds to
step 3) of claim 3. Final Act. 2. For this limitation, the Examiner cited
Dunsmore as describing the frequency spectrum of a patient's airway. Id. at
2-3. The Examiner determined that it would have been obvious to one of
ordinary skill in the art to have "to have identified the frequency spectrum of
the patient's airway as taught by Dunsmore et al. in order to determine the
most effective therapy." Id.
Appellant states that Dunsmore describes locating the resonance
frequency of the patient's lungs when running a test utilizing a continuous
positive airway pressure (CPAP) machine to deliver percussive therapy to
keep patient airways open. Br. 10. Appellant contends, however, that
Dunsmore does not determine the acoustic vibrations that are specific to the
patient's mouth, pharynx, and upper airway as required by steps 2) and 3) of
claim 1. Id. at 11. Appellant also argues that neither of "Burnell nor
Dunsmore make any statements regarding the identification of a frequency
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Application 12/688,593
spectrum produced by a vibratory inhaler device" as required by step 3) of
the rejected claim. Id. at 12.
We agree with Appellant that the Examiner did not meet the burden of
establishing that claim 1 is obvious based on the Burnell and Dunsmore
publications.
Burnell explains that pre-lung deposition is undesirable when using
inhaler devices to deliver medication to the lung because such deposition in
the pre-lung upper respiratory tract results in the delivery of medication that
"never reaches its primary therapeutic delivery target point at the lung."
Burnell ,r 4. For this reason, Burnell states that"[ c ]onsiderable effort has
therefore been directed towards understanding pre-lung deposition to enable
the design of improved in vitro laboratory performance testing apparatus ...
that more effectively simulates what happens in vivo." Id. To address the
problem of pre-lung deposition, Burnell teaches utilizing acoustic reflecting
imaging "to map the internal geometry of the mouth, throat and upper
respiratory tract of each patient in the sample group." Id. at ,r 6. Burnell
further teaches:
matching said at least one internal physical parameter of the
airway of the first patient's throat with a dataset comprising
pre-determined data relating to the corresponding internal
physical parameter for the throat of at least one other patient,
Burnell ,r 12. Data from the patient's throat is thus matched to pre-
determined throat data obtained from at least one other patient.
Burnell teaches that the matching step "enables prediction of the
tendency of particles to deposit within a first-patient's throat when said
particles are orally inhaled through said first throat." Id. at ,r 13. Burnell
teaches that this information is "suitable for use in the assessment of
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Application 12/688,593
inhalation-type medicament dispenser devices." Id. at ,r 146. Burnell's
method enables the determination of how much drug will be deposited in the
throat of the patient and therefore how much will ultimately reach the lung,
the desired destination.
While Burnell utilizes acoustic reflecting imaging as does the claimed
method ("acoustic pulse reflectometry"), Burnell does not use this technique
to measure "a frequency spectrum of acoustic vibrations that are specific to
the patient's mouth, pharynx, and upper airway" as required by the claims,
but rather uses it to measure the internal geometry of the mouth, throat and
upper respiratory tract to determine how much drug is deposited in these
regions before reaching the lung. Id. at ,r 6.
Dunsmore does not compensate for this deficiency. In paragraph 43
cited by the Examiner, Dunsmore describes programming a controller of a
respiratory device "to perform an example routine in which a resonant
frequency (where the most effective therapy is likely to occur) of the
patient's lungs is 'located."' Dunsmore ,r 43. Dunsmore explains:
Throughout the example routine, the patient is monitored for
chest wiggle, as is information signaled from the pressure
sensors 67, 120, to determine the pulse rate frequency that best
fits the resonant frequency, or "sweet spot," for a particular
patient. In one embodiment, an accelerometer can be coupled
to the patient's chest and provide a signal indicative of chest
movement. This chest movement signal can be monitored
based on the rate of frequency pulses delivered to identify an
optimal frequency.
Id. at ,r 44. Thus, Dunsmore describes locating a resonant frequency of the
lung, but not the resonant frequency of the patient's mouth, pharynx, and
upper airway as required by all the claims ("a frequency spectrum of
acoustic vibrations that are specific to the patient's mouth, pharynx, and
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Application 12/688,593
upper airway"). The Examiner did not explain why one of ordinary skill in
the art would have used Burnell' s acoustic imaging, which is utilized to
measure the geometry of the throat, to determine "a frequency spectrum of
acoustic vibrations that are specific to the patient's mouth, pharynx, and
upper airway." Dunsmore determined resonance frequency, but of the lungs.
The Examiner did not provide an adequate reason why one of ordinary skill
would have reached, from the teachings in Burnell and Dunsmore, the
claimed step of "[2] identifying a frequency spectrum of acoustic vibrations
that are specific to the patient's mouth, pharynx, and upper airway, wherein
the frequency spectrum identified is based on the time-domain response
measurements collected by performing acoustic pulse reflectometry on the
patient."
Because the Examiner did not meet the burden of establishing the
claims are prima facie obvious in view of Burnell and Dunsmore, the
rejection of claim 1, and dependent claims 3-8, is reversed.
Claim 9
Independent claim 9 is reproduced below:
9. Non-transitory computer readable media having computer-
executable instructions embodied thereon that, when executed,
perform a method for identifying an optimal configuration of a
vibratory inhaler device for a patient, the method comprising:
collecting time-domain response measurements by
performing acoustic pulse reflectometry on a patient;
storing the time-domain response measurements of the
patient as acoustic reflectometry data in a medical record of the
patient;
identifying a frequency spectrum of acoustic vibrations
that are specific to the acoustic reflectometry data
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Application 12/688,593
corresponding to the patient and spirometry data corresponding
to the patient; and
selecting a vibratory inhaler device having a first
dispersal configuration, wherein the vibratory inhaler device
having the first dispersal configuration is selected based on a
determination that the first dispersal configuration that produces
a frequency spectrum that matches (i) the frequency spectrum
of acoustic vibrations that are specific to the acoustic
reflectometry data corresponding to the patient and (ii) the
spirometry data corresponding to the patient, wherein the first
dispersal configuration increases deep-lung drug deposition
rates in the patient based on the matching frequency spectrum
produced via the first dispersal configuration, wherein the first
dispersal configuration includes a size of the vibratory inhaler
device and a geometry of the vibratory inhaler device; and
initiating an order of the vibratory inhaler device having
the first dispersal configuration for the patient.
Independent claim 9 is not limited to identifying a frequency spectrum
of acoustic vibrations that are specific to the patient's mouth, pharynx, and
upper airway as in claim 1, but rather does not specify where the frequency
is ascertained ("the frequency spectrum of acoustic vibrations that are
specific to the acoustic reflectometry data corresponding to the patient").
However, as argued by Appellant, the Examiner did not provide adequate
evidence that the "selecting" step of claim 9 is met by either cited
publication alone, or in combination.
Independent claim 9 comprises a step of "selecting a vibratory inhaler
device having a first dispersal configuration." The selection is based on two
criteria: "i) the frequency spectrum of acoustic vibrations that are specific to
the acoustic reflectometry data corresponding to the patient and (ii) the
spirometry data corresponding to the patient."
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Application 12/688,593
The Examiner found that "Burnell et al. discloses a method
comprising measuring time-domain response by acoustic pulse
reflectrometry ... and identifying a device type," i.e., the "selecting" step of
claim 9. Ans. 2. The Examiner also found that Burnell does not disclose
initiating an order of the vibratory inhaler device for the patient as required
by the last step of claim 9. Id. However, the Examiner found Burnell
"discloses the method is suitable for assessment of inhalation-type
medicament dispenser devices for delivery of medicaments for treatment of
respiratory disorders ([0146])." Id. The Examiner determined that "it would
have been obvious to one of ordinary skill in the art at the time the invention
was made to have provided the step of initiating an order of the inhaler
device in order to provide treatment of respiratory disorders." Id.
As indicated above, claim 9 requires "selecting" a device "based on a
determination" that the frequency spectrum of the device matches the
frequency spectrum and spirometry data corresponding to the patient.
Burnell performs "assessment of inhalation-type medicament dispenser
devices" (Burnell ,r 146) based on the geometry of the patient's airway, but
does not describe selecting a device based on matching the device's
characteristics to the patient's airway. The device is already selected in
Burnell. Dunsmore describes finding a pulse rate frequency of a device that
"best fits" the resonance frequency of the lung. Dunsmore ,r 44. Dunsmore
does not "select" a device either, but rather operates the valve of the pre-
selected device to change the frequency pulses to match the lung resonance.
More particularly, the example routine includes the controller
28 operating the electronic valve 40 to initially generate higher
frequency pulse rates (e.g., 20 Hz) and gradually decrease to a
lower rate (e.g., 2 Hz). The process is then repeated at
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Application 12/688,593
incrementally higher pressures. The rate can also decrease, if
desired, by starting at a high frequency pulse rate and
decreasing to a lower rate.
Dunsmore ,r 4 3 .
The issue in the rejection of claim 9 boils down to whether one of
ordinary skill in the art would have had reason to have selected a device
having a frequency spectrum that "best fits" the resonance frequency of the
lung, rather than proceeding through the example routine described by
Dunsmore. The Examiner found that Burnell discloses identifying a device
type, citing paragraphs 15, 17, 87, and 134 of Burnell. Ans. 2. However, we
have reviewed these paragraphs and do not find the Examiner's finding to be
supported by these disclosures in Burnell.
Paragraph 15 of Burnell describes the "predictive assessment of
particle deposition within a patient's throat to which particulate product is
delivered by a delivery system (e.g. from an inhaler device)." Paragraph 17
describes "the particles are deliverable by means of an inhaler-type delivery
device ( e.g. a dry powder inhaler (DPI) device for the delivery of dry
powdered medicament or medicament formulation; or metered dose inhaler
(MDI) device for the delivery of aerosol medicament formulation)." Neither
of these paragraphs refer to selecting or identifying the device. Rather, the
disclosure refers generally to characterizing the device or using a specific
kind of device, but not selecting it based on its delivery characteristics.
Paragraph 87 refers to using "a more active delivery system, in which the
inhaler provides initial energy ( e.g. kinetic energy) to the medicament to be
inhaled ( e.g. release of aerosolised medicament from a metered dose
inhaler)." However, again, it does not describe selecting the device to match
characteristics "corresponding to patient" as required by claim 9. Finally,
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Application 12/688,593
paragraph 134 refers to "relevant data (obtained for a particular inhalation
device and formulation) for each of Throats A to F." Thus, paragraph 134
does not describe selecting an inhaler, but rather it shows what kind of
deposition to expect using a specific device.
In sum, none of the portions of Burnell cited by the Examiner describe
"selecting a vibratory inhaler device having a first dispersal configuration"
where the configuration is "selected based on" characteristics of the patient
as required by claim. Rather, in Burnell, the device is assessed, but not
selected:
It is a further object of the present invention to provide
improved laboratory testing apparatus for use in predicting pre-
lung deposition of medicament delivered by an inhaler device.
Burnell ,I 9.
The Examiner did not meet the burden of establishing that Burnell and
Dunsmore describe or suggest the recited "selecting" step of claim 9.
Accordingly, the obviousness rejection of claim 9, and dependent claims 10-
16, is reversed.
REVERSED
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