Ex Parte Clark et al

Patent Trial and Appeal Board

Feb 8, 2013

10627591 (P.T.A.B. Feb. 8, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ANDREW CLARK and GEORGE H. FOULDS
__________

Appeal 2011-001435
Application 10/627,591
Technology Center 3700
__________

Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a device
for increasing bioavailability of an aerosolized active agent. The Examiner
rejected the claims as anticipated. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm.

Appeal 2011-001435
Application 10/627,591

2
Statement of the Case
Background
“[T]he present invention is directed to a method for delivering an
active agent formulation to the lungs of a human patient, said method
comprising providing the active agent formulation at an inspiratory flow rate
of below 17 liters per minute” (Spec. 4, ll. 3-6).
The Claims
Claims 23, 24, 26, 28-32 and 38-52 are on appeal.1 Claim 23 is
representative and reads as follows:
23. A device for increasing the bioavailability of an
aerosolized active agent, said device comprising a flow
restrictor for limiting the inspiratory flow of an aerosolized
active agent formulation to a human patient to less than 17
liters per minute, wherein the device is adapted to aerosolize
the active agent formulation and wherein the active agent
formulation is (i) a powder, (ii) a solution, suspension, or
slurry that may be nebulized, or (iii) suspended or dissolved
in a propellant.

The issue
The Examiner rejected claims 23, 24, 26, 28-32 and 38-52 under 35
U.S.C. § 102(e) as anticipated by Rubsamen2 (Ans. 4-7).
The Examiner finds that Rubsamen teaches a device “for increasing
the bioavailability of an aerosolized active agent, said device comprising a

1 Claims 33-37 were cancelled by Appellants in the Reply Brief
filed August 23, 2010 and entered by the Examiner on October 29,
2010. This cancellation renders the New Grounds of Rejection
over claims 33-37 moot.
2 Rubsamen et al., US 5,735,263, issued Apr. 7, 1998.
Appeal 2011-001435
Application 10/627,591

3
flow restrictor (9, 22,37)” (Ans. 4). The Examiner finds that Rubsamen
“discloses that a microprocessor controls and monitors the inspiratory flow
of an aerosolized active agent formulation to a human patient (though the
valve in the case of fig.1 and though the opening of the mouthpiece in the
case of fig.10)” (id. at 5). The Examiner finds that Rubsamen limits
inspiratory flow to “a rate of 0.1 to 2 liters per second ~ 6 to 12 liters per
minute, which meets claimed flow rate of ‘less than 17 liters per minute’ and
‘10 liters per minutes’” (id.). The Examiner finds that Rubsamen “discloses
wherein the device is adapted to aerosolize the active agent formulation and
wherein the active agent formulation is (i) a powder, (ii) a solution,
suspension, or slurry that may be nebulized, or (iii) suspended or dissolved
in a propellant” (id.).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Rubsamen anticipates claim 1?
Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
1. The Specification teaches a
device comprising a flow restricter for limiting the flow of
the aerosolized active agent formulation to below 17 liters
per minute. The flow restricter may be in the form of a
simple orifice, a valve that provides for increasing
resistance with increasing flow rate, a valve that provides for
decreasing resistance with increasing flow rate or a valve
that provides for high resistance at all flow rates except the
desired flow rate

(Spec. 4, ll. 17-22).
Appeal 2011-001435
Application 10/627,591

4
2. Rubsamen teaches that to “maximize the efficiency of the
delivery the narcotic formulation is released at (1) a measured inspiratory
flow rate in the range of from about 0.10 to about 2.0 liters/second and (2) a
measured inspiratory volume in the range of about 0.15 to about 0.8 liters”
(Rubsamen, col. 5, ll. 50-54).
3. Figure 1 of Rubsamen is reproduced below:

“FIG. 1 is a cross-sectional view of a drug delivery device” (Rubsamen, col.
7, l. 45).
4. Rubsamen teaches “when treating a patient the drug should be
released at approximately (±10%. preferably ±5% and most preferable as
close as possible to the first release point) the same inspiratory flow rate and
inspiratory volume each time-going back to the same point each time for the
same patient ensures repeatable dosing” (Rubsamen, col. 13, ll. 27-32).
5. Rubsamen teaches that the “drug which is released to the
patient may be in a variety of different forms. For example, the drug may be
an aqueous solution of drug, i.e., drug dissolved in water and formed into
Appeal 2011-001435
Application 10/627,591

5
small particles to create an aerosol which is delivered to the patient”
(Rubsamen, col. 14, l. 64 to col. 15, l. 1).
6. Rubsamen teaches that “the drug may be in a solution wherein a
low-boiling point propellant is used as a solvent. In yet another embodiment
the drug may be in the form of a dry powder which is intermixed with an
airflow in order to provide for particleized delivery of drug to the patient”
(Rubsamen, col. 15, ll. 1-6).
7. Rubsamen teaches:
[A] hand-held, portable device which is comprised of (a) a
means for separately measuring and analyzing the
inspiratory flow rate and inspiratory volume of a patient and
(b) a means for automatically releasing a measured amount
of a narcotic into the inspiratory flow path of a patient, e.g.
an automatic valve actuation means or mechanism for
moving formulation through a porous membrane.

(Rubsamen, col. 23, ll. 14-21.)
8. Rubsamen teaches that the “device preferably includes a mouth
piece at the end of the flow path, and the patient inhales from the mouth
piece which causes an inspiratory flow to be measured within the flow path.
This inspiratory flow causes an air flow transducer to generate a signal”
(Rubsamen, col. 23, ll. 37-41).
9. Rubsamen teaches that the
microprocessor can further integrate this continuous air flow
rate signal. . . . At an appropriate point in the inspiratory
cycle, the microprocessor can send a signal to an actuation
means. When the actuation means is signaled, it releases a
valve allowing analgesic drug and propellant to escape into
the inspiratory flow path of the device and ultimately into
the patient’s lungs
Appeal 2011-001435
Application 10/627,591

6

(Rubsamen, col. 23, ll. 44-52).
10. Rubsamen teaches that:
Propellant and narcotic drug are released from the canister 3
via the electrically controlled solenoid 7. In that the valve 5
of the canister is continuously open, another valve,
contained within solenoid 7, facilitates the release of the
drug. When the solenoid 7 allows release of propellant and
drug, the propellant and drug flows through the flow path 8
and then through the solenoid actuated valve 9 into the flow
path 10, out through the nozzle 13 and then into the
inspiratory flow path 11

(Rubsamen, col. 24, ll. 25-33).
11. The Examiner finds that “a rate of 0.1 to 2 liters per second . . .
meets the claimed flow rate of ‘less than 17 liters per minute’” (Ans. 5).
Principles of Law
“A single prior art reference that discloses, either expressly or
inherently, each limitation of a claim invalidates that claim by anticipation.”
Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1375 (Fed. Cir.
2005).
Analysis
Claim interpretation is at the heart of patent examination because
before a claim is properly interpreted, its scope cannot be compared to the
prior art. In this case, Appellants contend that “Rubsamen et al discloses no
flow restrictor for limiting the inspiratory flow of an aerosolized active
agent” (App. Br. 5). Appellants also contend that “Rubsamen et al does not
in any way limit the inspiratory flow to less than 17 liters per minute” (id.).
Appeal 2011-001435
Application 10/627,591

7
During prosecution, claim terms are given their broadest reasonable
interpretation as they would be understood by persons of ordinary skill in the
art in the light of the Specification. Therefore, we first turn to the
Specification to interpret the term “flow restrictor.”
The Specification teaches that the “flow restricter may be in the form
of a simple orifice, a valve that provides for increasing resistance with
increasing flow rate, a valve that provides for decreasing resistance with
increasing flow rate or a valve that provides for high resistance at all flow
rates except the desired flow rate” (Spec. 4, ll. 19-22; FF 1).
We therefore interpret the term “flow restricter” in claim 1 to broadly
encompass any valve which releases the active agent only at the desired flow
rate and which does not release the active agent at flow rates other than the
desired flow rates. There is no structural requirement imposed by either
claim 23 or by the Specification regarding how the valve achieves this
specific release. Also, since claim 23 uses the open transitional phrase
“comprising,” claim 23 does not exclude the use of additional components to
assist the valve in releasing the active agent only at the desired flow rate. See
Georgia-Pacific Corp. v. U.S. Gypsum Co., 195 F.3d 1322, 1327 (Fed. Cir.
1999) (The transitional term “comprising” is “inclusive or open-ended and
does not exclude additional, unrecited elements or method steps.”)
Turning to the prior art, Rubsamen teaches:
[A] hand-held, portable device which is comprised of (a) a
means for separately measuring and analyzing the
inspiratory flow rate and inspiratory volume of a patient and
(b) a means for automatically releasing a measured amount
of a narcotic into the inspiratory flow path of a patient, e.g.
Appeal 2011-001435
Application 10/627,591

8
an automatic valve actuation means or mechanism for
moving formulation through a porous membrane.

(Rubsamen, col. 23, ll. 14-21; FF 7). Rubsamen teaches that the “device
preferably includes a mouth piece at the end of the flow path, and the patient
inhales from the mouth piece which causes an inspiratory flow to be
measured within the flow path. This inspiratory flow causes an air flow
transducer to generate a signal” (Rubsamen, col. 23, ll. 37-41; FF 8).
Rubsamen teaches that the
microprocessor can further integrate this continuous air flow
rate signal. . . . At an appropriate point in the inspiratory
cycle, the microprocessor can send a signal to an actuation
means. When the actuation means is signaled, it releases a
valve allowing analgesic drug and propellant to escape into
the inspiratory flow path of the device and ultimately into
the patient’s lungs

(Rubsamen, col. 23, ll. 44-52; FF 9).
Thus, Rubsamen teaches a device with a valve that acts as a “flow
restrictor,” since the valve releases the active agent only at the desired flow
rate and which does not release the active agent at flow rates other than the
desired flow rates. While Rubsamen’s valve is controlled by a
microprocessor which operates an actuation means, consistent with our
claim interpretation above, this valve satisfies the “flow restrictor”
requirements since the claim and Specification do not require any specific
valve structure for the “flow restrictor” and permit the inclusion of
additional components as discussed above.
In addition, regarding the claimed flow rate of less than 17 liters per
minute, Rubsamen teaches that to “maximize the efficiency of the delivery
Appeal 2011-001435
Application 10/627,591

9
the narcotic formulation is released at (1) a measured inspiratory flow rate in
the range of from about 0.10 to about 2.0 liters/second” (Rubsamen, col. 5,
ll. 50-53; FF 2). The Examiner finds that this flow rate includes the claimed
range (see Ans. 5; FF 11). Anticipation has been found when a prior art
range “does not exactly correspond to [the] claimed range,” but the prior art
range “does not significantly deviate from [the] claimed ranges.” See
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir.
2005).While Appellants urge that Rubsamen’s methods include flow rates
higher than those claimed, Appellants have provided no rebuttal evidence
showing that the flow rate range of Rubsamen fails to describe flow rates
within the claimed range.
Appellants also contend that the “Rubsamen et al device certainly is
not capable of limiting flow rates to less than 17 liters per minute” (App. Br.
7).
As noted, Rubsamen expressly teaches that the device can deliver a
formulation at rates ranging from 0.10 to about 2.0 liters/second (FF 2)
which encompasses a range less than 17 liters per minute. Appellants have
provided no evidence that Rubsamen is not enabled for the claimed flow
rate. Antor explains that “[e]nablement of prior art requires that the
reference teach a skilled artisan to make or carry out what it discloses in
relation to the claimed invention.” In re Antor Media Corp., 689 F.3d 1282,
1289, 1290 (Fed. Cir. 2012). Antor further teaches that the Appellants must
show “that undue experimentation would be required to perform the claimed
invention based on the teaching” in the prior art. Id. at 1289. Appellants
Appeal 2011-001435
Application 10/627,591

10
have made no clear or specific evidentiary showing as to undue
experimentation of Rubsamen.
Appellants separately list claims 33, 38, 42, and 47, but only provide a
specific argument for claim 42. Appellants contend that “Rubsamen et al
does not disclose orifices sized so that an aerosolized active agent
formulation may be delivered at an inspiratory flow rate of less than 17 liters
per minute” (App. Br. 8).
We are not persuaded. Claim 42 simply requires an orifice sized to
permit “an aerosolized active agent formulation may be delivered at an
inspiratory flow rate that is limited to a rate of less than 17 liters per
minute.” Rubsamen teaches such an orifice, teaching that the “device
preferably includes a mouth piece at the end of the flow path, and the patient
inhales from the mouth piece which causes an inspiratory flow to be
measured within the flow path” (Rubsamen, col. 23, ll. 37-40; FF 8). As
discussed above, Rubsamen expressly teaches that the device can deliver a
formulation at rates ranging from 0.10 to about 2.0 liters/second (FF 2)
which encompasses a range less than 17 liters per minute.
While in Rubsamen, the flow rate is not solely limited by the orifice
or mouthpiece, claim 42 does not require that the orifice is the sole element
controlling the inspiratory flow rate. Claim 42 simply requires the ability to
limit the flow rate below 17 liters per minute, a feature taught by Rubsamen
(FF 2-10).
SUMMARY
In summary, we affirm the rejection of claims 23, 24, 26, 28-32 and
38-52 under 35 U.S.C. § 102(e) as anticipated by Rubsamen.
Appeal 2011-001435
Application 10/627,591

11

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

cdc