Ex Parte Chaudry et al

Board of Patent Appeals and Interferences

Feb 14, 2011

11037574 (B.P.A.I. Feb. 14, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/037,574 01/18/2005 Imtiaz Chaudry 048765/287266 6491
826 7590 02/14/2011
ALSTON & BIRD LLP
BANK OF AMERICA PLAZA
101 SOUTH TRYON STREET, SUITE 4000
CHARLOTTE, NC 28280-4000
EXAMINER
WESTERBERG, NISSA M
ART UNIT PAPER NUMBER
1618
MAIL DATE DELIVERY MODE
02/14/2011 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte IMTIAZ CHAUDRY and PARTHA BANERJEE
__________

Appeal 2010-005705
Application 11/037,574
Technology Center 1600
__________

Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL1

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

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STATEMENT OF CASE
The following claims are representative.
1. A system for inducing bronchodilation or providing relief of
bronchospasm in an individual suffering from chronic obstructive
pulmonary disease, said system comprising:
(a) one or more single dispensing containers; and
(b) an aqueous inhalation solution comprising a therapeutically
effective amount of albuterol and a therapeutically effective amount of about
0.001 mg to about 1.0 mg of ipratropium bromide;
wherein the aqueous inhalation solution is prefilled in each of the one
or more dispensing containers as a premixed, premeasured, single unit dose
of about 0.1 ml to about 0.5 ml that, when administered from a nebulizer
chamber, is delivered such that the mist is removed from the nebulizer
chamber in less than 12 minutes when said aqueous inhalation solution is
introduced into a high performance nebulizer.

18. A method of inducing bronchodilation or providing relief of
bronchospasm in an individual suffering from chronic obstructive
pulmonary disease, said method comprising the step of:
(a) providing one or more single dispensing containers; the one or more
containers each being prefilled with a content of about 0.1 ml to about 0.5
ml of a premixed, premeasured aqueous inhalation solution comprising a
single unit dose of a therapeutically effective amount of albuterol and
ipratropium bromide; wherein the amount of albuterol is about 0.6 mg to
about 5.0 mg and the amount of ipratropium bromide is about 0.1 mg to
about 1.0 mg; and
(b) administering the inhalation solution in one of the containers from a
nebulizer chamber such that the mist is removed from the nebulizer chamber
in less than 12 minutes.

49. A system for inducing bronchodilation or providing
relief of bronchospasm in an individual suffering from chronic obstructive
pulmonary disease, said system comprising:
(a) one or more single dispensing containers; and
(b) an aqueous inhalation solution comprising a therapeutically effective
amount of albuterol and a therapeutically effective amount of about 0.001
mg to about 1.0 mg of ipratropium bromide;
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wherein the aqueous inhalation solution is prefilled in each of the one or
more dispensing containers as a premixed, premeasured, single unit dose of
about 0.1 ml to about 0.5 ml.

Cited References

COMBIVENT® product information sheet, 1997.

The COMBIVENT Inhalation Solution Study Group (Chest 1997), Routine
Nebulized Ipratropium and Albuterol Together Are Better Than Either Alone
in COPD, 112 CHEST 1514-1521 (1997).

Tandon et al., Measuring Nebulizer Output: Aerosol Production vs
Gravimetric Analysis, 111 CHEST 1361-1365 (1997).

Allan L. Coates and Sharon L. Ho, Drug Administration by Jet Nebulization,
26 PEDIATRIC PULMONOLOGY 412-423 (1998).

Asmus et al, Bronchoconstrictor additives in bronchodilator solutions, 104
J. ALLERGY CLIN. IMMUNOL. S53-60 (1999).

Grounds of Rejection
1. Claims 1, 4-11 and 49 are rejected under 35 U.S.C. § 103(a) for
obviousness over Combivent in view of Asmus and Coates.
2. Claims 1, 4-11, 18, 21, 22, 30-33 and 38-49 are rejected under 35 U.S.C.
§ 103(a) for obviousness over Chest 1997 in view of Asmus and Coates.

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages 3-8.

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Discussion
1. Claims 1, 4-11 and 49 are rejected under 35 U.S.C. § 103(a) for
obviousness over Combivent in view of Asmus and Coates.

ISSUE
The Examiner concludes that
It would have been obvious to one of ordinary skill in the
art at the time of the instant invention to reduce the total
volume of the single unit dose Combivent® respule, comprising
2.5 mg of albuterol and 0.5 mg of ipratropium bromide, to
reduce the volume of the solution that must be delivered that
contains the same total dose of albuterol and ipratropium
bromide as Coates et al. discloses that long nebulization times
can result in decreased patient compliance. Decreasing the
volume of the solution to be nebulized will result in shorter
treatment durations, as lesser volumes will require less time to
be nebulized and inhaled. As long nebulization times decrease
patient compliance, shorter nebulization times would tend to
increase patient compliance. The volume of the solution is a
result effective parameter that a person of ordinary skill in the
art would routinely optimize. Optimization of parameters is a
routine practice that would be obvious for a person of ordinary
skill in the art to employ and reasonably would expect success.
It would have been customary for an artisan of ordinary skill to
determine the optimal volume to deliver the active ingredients
in order to best achieve the desired results, such as the level of
patient compliance that results from the overall length of the
nebulization treatment.

(Ans. 4-5.) The Examiner finds that the delivery time for the solution
in the system claims is intended use language which does not further
limit the product of the claims. (Id. at 5.)
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Appellants argue that the Examiner has not set forth a prima facie case
of obviousness. (App. Br. 5.) Appellants argue that one of ordinary skill in
the art would not combine teachings around multidose forms of drug with
teachings around unit dosage forms. (Id. at 6-7.) Appellants argue that no
further dilution of the drug is required with the claimed system. (Id. at 11.)
Appellants argue that Coates does not suggest that nebulization times should
be decreased and teaches away from reduced nebulization volumes. (Id. at
9, 13.)
The issue is: Does the cited prior art disclose or suggest a dispensing
container prefilled with about 0.1 ml to about 0.5 ml of an aqueous
inhalation solution, as claimed?

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) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme
Court advised that, in determining whether the prior art supplied a reason for
practicing the claimed subject matter, the analysis “need not seek out precise
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teachings directed to the specific subject matter of the challenged claim, for
a court can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ.” Id. at 418; see also id. at 421 (“A
person of ordinary skill is . . . a person of ordinary creativity, not an
automaton.”).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
Id. at 416.
If a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability. For the same
reason, if a technique has been used to improve one device, and
a person of ordinary skill in the art would recognize that it
would improve similar devices in the same way, using the
technique is obvious unless its actual application is beyond his
or her skill.

Id. at 417.
In KSR, the Supreme Court also addressed the “obvious to try” issue:

When there is a design need or market pressure to solve
a problem and there are a finite number of identified,
predictable solutions, a person of ordinary skill has good
reason to pursue the known options within his or her
technical grasp. If this leads to the anticipated success, it
is likely the product not of innovation but of ordinary
skill and common sense. In that instance the fact that a
combination was obvious to try might show that it was
obvious under § 103.

Id. at 421.

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One “of the ways in which a patent’s subject matter can be proved
obvious is by noting that there existed at the time of the invention a known
problem for which there was an obvious solution encompassed by the
patent’s claims.” Id. at 419-20.
“A whereby clause that merely states the result of the limitations in
the claim adds nothing to the patentability or substance of the claim.” Texas
Instuments v. U.S. Int’l Trade Comm’n, 988 F.2d 1165, 1172 (Fed. Cir.
1993).

ANALYSIS
Claims 1 and 49
We begin with claim interpretation. Claims 1 and 49 are directed to a
system or product with one or more containers and an aqueous inhalation
solution comprising a therapeutically effective amount of albuterol and a
therapeutically effective amount of about 0.001 mg to about 1.0 mg of
ipratropium bromide, wherein the inhalation solution is prefilled in each of
the one or more containers as a dose of about 0.1 ml to about 0.5 ml. We
agree with the Examiner that the delivery time for the solution in the system
claim 1 is intended use language that does not further limit the product of the
claims (Ans. 5). In addition, we do not agree with Appellants that the
language in claims 1 and 49 describing the dose as “a premixed,
premeasured, single unit dose” excludes doses that are subsequently diluted,
as this would give unjustified patentable weight to an intended use of a
product.
Appellants argue that the Examiner has not set forth a prima facie case
of obviousness. (App. Br. 5.) Appellants argue that one of ordinary skill in
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the art would not combine teachings around multidose forms of drug with
teachings around unit dosage forms. (App. Br. 6-7.) Appellants argue that
no further dilution of the drug is required with the claimed system. (Id. at
11.) Appellants argue that Coates does not suggest that nebulization times
should be decreased and teaches away from reduced nebulization volumes.
(Id. at 9, 13.)
With respect to system claims 1 and 49, we are not persuaded by
Appellants’ arguments.
As to the Examiner’s prima facie case of obviousness, Combivent
teaches the claimed combination of albuterol and ipratroprum bromide for
use in a nebulizer. (Combivent, page 1; Ans. 3.) Combivent teaches 2.5 mg
of albuterol and 500 mcg of ipratropium bromide. Asmus teaches that it is
known to include 2.5 mg of albuterol in a total volume of 0.5 ml and single
dose products in table 2. (Ans. 4.)
Thus, Combivent and Asmus suggest the desirability of placing
smaller, concentrated volumes of albuterol, 0.5ml, and ipratropium bromide
in containers. While Appellants argue that it is well recognized that
concentrated volumes of drug are diluted for delivery by nebulization (App.
Br. 10), appealed claims 1 and 49 do not exclude dilution of the volumes in
the containers.
Appellants argue that Coates teaches away from reduced nebulization
times (id. at 13). Appellants argue that Coates teaches increasing the charge
volume of a given dose, which dilutes the concentration of the initial dose
(id. at 14.) Again, claims 1 and 49 do not exclude dilution of a dosage
container. For the reasons addressed in the claim interpretation above, we
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do not agree that the product of claims 1 and 49 excludes solutions that are
subsequently diluted.
Appellants argue that one of ordinary skill in the art would not
combine teachings around multidose forms of drug with teachings around
unit dosage forms. We are not convinced by this argument. Appellants have
provided no evidence that one of ordinary skill in the art would not
understand, as taught in Asmus, that albuterol can be formulated either in
multidose or unit dosage forms. (Ans. 10.)

Claims 7 and 8
Appellants argue that the cited prior art does not disclose or suggest
the subject matter of claims 7 and 8 which recite that the inhalation solution
is sterile and that the inhalation solution is free of the preservative
benzalkonium chloride, BAC. (App. Br. 19.)
Asmus discloses that preservatives such as benzalkonium chloride
should not be included in formulations as they can cause
bronchoconstriction. (Asmus, S55, col. 2.) Asmus discloses that
bronchodilator solutions are manufactured as sterile solutions and that the
FDA has proposed that all such solutions be sterile. Thus the prior art
discloses a reason to provide sterile bronchodilator solutions free of BAC.
The rejection of claims 7and 8 is affirmed.
For these reasons, the obviousness rejection is affirmed.

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2. Claims 1, 4-11, 18, 21, 22, 30-33 and 38-49 are rejected under 35 U.S.C.
§ 103(a) for obviousness over Chest 1997 in view of Asmus and Coates.
The Examiner additionally rejects the pending claims indicated over
Chest 1997 in view of Asmus and Coates, essentially substituting the Chest
1997 publication for the same teachings as Combivent. Thus, for the
reasons indicated above, the rejection of claims 1 and 49 and their dependent
claims are affirmed.
However, method claim 18 stands on a different footing than system
claims 1 and 49. The method of claim 18 requires a step of “(b)
administering the inhalation solution in one of the containers from a
nebulizer chamber” (emphasis added). We interpret this language to require
that the claimed volume of about 0.1 to about 0.5 ml is, without dilution,
administered from a nebulizer chamber.
Appellants argue that Coates teaches away from reduced nebulization
volumes. (App. Br. 9, 13.) The Examiner argues that Coates teaches that
long nebulization times can result in reduced patient compliance (Ans. 4)
and that it would have been obvious to one of ordinary skill in the art to
decrease the volume of the solution to be nebulized (id.).
To the contrary, Coates, page 418, col. 1, discloses that, in a
nebulizer, “aerosolized output can be increased for a given dose of drug by
minimizing the concentrating effects of nebulization, and by increasing the
charge volume, which dilutes the concentration of the initial dose, although
it will prolong nebulization time.” The Examiner has pointed to no
disclosure in Coates which suggests reducing the total nebulization volume
in a nebulizer (App. Br. 14) and Coates teaches that charge volume should
not be decreased, although it will prolong nebulization time. (Id.) Thus,
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when delivered in a nebulizer, as claimed, it would reasonably appear that
Coates teaches that the charge volume of broncodilator solution should not
be decreased. For this reason, the rejection of claim 18 and its dependent
claims 21-22, 30-33 and 42-48 is reversed.

CONCLUSION OF LAW
Rejection 1 is affirmed. Rejection 2 is affirmed for claims 1, 4-11,
38-41, and 49. Rejection 2 is reversed as to claims 18, 21-22, 30-33 and 42-
48.
With regard to the affirmed rejections, because our reasoning differs
from that of the Examiner, we designate our affirmance as new grounds of
rejection under 37 C.F.R. § 41.50(b) in order to give Appellants a fair
opportunity to respond.

TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)).
37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating
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to the claims so rejected, or both, and have the matter
reconsidered by the Examiner, in which event the proceeding
will be remanded to the Examiner. . . .
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record. . . .
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-IN-PART, 37 C.F.R. § 41.50(b)

cdc

ALSTON & BIRD LLP
BANK OF AMERICA PLAZA
101 SOUTH TRYON STREET, SUITE 4000
CHARLOTTE, NC 28280-4000