Ex Parte Chaudry et al

Patent Trial and Appeal Board

Jun 9, 2016

13160009 (P.T.A.B. Jun. 9, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/160,009 06/14/2011 Imtiaz Chaudry
122945 7590 06/13/2016
Mylan Pharmaceuticals Inc,
5005 Greenbag Road
Morgantown, WV 26501
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.
048765/404650 2528
EXAMINER
WESTERBERG, NISSA M
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
06/13/2016 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):
mylan_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte IMTIAZ CHAUDRY and PAR THA BANERJEE 1
Appeal2013-006992
Application 13/160,009
Technology Center 1600
Before MELANIE L. McCOLLUM, JEFFREY N. FREDMAN, and
RICHARD J. SMITH, Administrative Patent Judges.
McCOLLUM, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a system
for inducing bronchodilation or providing relief of bronc ho spasm. The
Examiner has rejected the claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Claims 1-14 are on appeal (App. Br. 16). Claims 1, 3, 4, and 5 are
representative and read as follows:
1 Appellants identify the real party in interest as Dey Pharma, L.P. (App.
Br. 1).
Appeal2013-006992
Application 13/160,009
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, the aqueous inhalation solution administered
without dilution to the individual from a nebulizer chamber 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.
3. The system of claim 1, wherein said amount of albuterol ranges from
about 2.0 mg to about 3.0 mg.
4. The system of claim 1, wherein the albuterol is albuterol base, and
said amount of albuterol base is about 2.5 mg and the amount of ipratropium is
about 0.5 mg.
5. The system of claim 1, wherein the inhalation solution in each of the
one or more containers is sterile.
Claim 14 is also independent and is set forth in the Claims Appendix to
Appellants' Appeal Brief (id. at 18-19).
Claims 1-14 stand rejected under 35 U.S.C. § 103(a) as obvious over:
(1) COMBIVENT2 in view of Asmus3 and Coates4 (Ans. 2); and
2 Boehringer Ingelheim (N.Z.) Limited, COMBIVENT® Data Sheet (1999),
http://www.medsafe.govt.nz/Profs/Datasheet/c/Combiventinhresp.htm.
3 Michael J. Asmus et al., Bronchoconstrictor Additives in Bronchodilator
Solutions, 104 J Allergy Clin. Immunol. S53-S60 (1999).
4 Allan L. Coates & Sharon L. Ho, Drug Administration by Jet Nebulization,
26 Pediatric Pulmonology 412-23 (1998).
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Application 13/160,009
(2) Chest5 in view of Asmus (id. at 4).
In the first rejection, the Examiner relies on COMBIVENT for
disclosing "Respules [that] contain 2.5 ml of a preservative-free solution
containing 2.5 mg of salbutamol (albuterol) and 500 micrograms of
ipratropium bromide"; that this "formulation is indicated for the treatment of
reversible bronchospasm associated with obstructive airway diseases"; and
that the "solution in the containers may be administered from a nebulizer or
positive pressure ventilator" (id. at 2). In the second rejection, the Examiner
relies on Chest for disclosing "a study in which 0.5 mg of ipratropium
bromide (IB) and 3 mg albuterol sulfate (ALB) were administered using a
small volume nebulizer ... in patients with moderate to severe chronic
obstructive pulmonary disease" and that the "medication was delivered in
2.5 ml of solution" (id. at 4--5). However, the Examiner finds that neither
COMBIVENT nor Chest "disclose[ s] smaller volumes of solution
comprising these two ingredients" or "explicitly state[ s] that the solution
contained in the vial is sterile" (id. at 3 & 5).
In both rejections, the Examiner relies on Asmus for disclosing
"2.5 mg of albuterol in a total volume of 0.5 mL in a multidose dropper vial"
and a "[ s ]terilized single unit do[ se] of various bronchodilators" (id.). In
particular, the Examiner finds that Asmus discloses that "sterile-filled single
dose products are about one half of the nebulized bronchodilator solutions
manufactured in the United States" (id.).
5 The COMBIVENT Inhalation Solution Study Group, Routine Nebulized
Ipratropium and Albuterol Together Are Better Than Either Alone in COPD,
112 Chest 1514--21 (1997).
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Application 13/160,009
(Id.)
The Examiner concludes:
It would have been obvious to one of ordinary skill in the art at
the time of the instant invention to place a smaller, concentrated
volume of albuterol, 0.5 ml, and ipratropium bromide in a
container because such concentrated albuterol solutions are
known in the art and to maintain the ratio of albuterol and
ipratropium bromide of the COMBIVENT® respules [or of
Chest], the same amount of ipratropium should also be included
in the more concentrated solution[.] The recitation of the
delivery time for the solution in the system in the claim and that
the solution is administered from the dispensing container is
intended use language that does not further limit the product of
the claims. The recitation of"premixed, premeasured, single unit
dose" is also the intended use of the composition and the claims
are being interpreted as not excluding subsequent dilution of the
volumes in the containers.
ANALYSIS
For both rejections, we incorporate the Examiner's findings of fact
and conclusions of law (Ans. 2-5), as summarized above. We conclude that
the Examiner has set forth a prima facie case that the systems of claims 1, 3-
5, and 14 would have been obvious.
Appellants argue, however, that the applied references do not "Teach
a Concentrated Aqueous Inhalation Solution having Albuterol and
Ipratropium Bromide in a Premixed, Premeasured Single Unit Dose of about
0.1 ml to about 0.5 ml that is Delivered Directly to an Individual Without
Dilution as Recited in Claim 1" (App. Br. 6 & 12 (emphasis omitted)). In
particular,
Appellant[ s] respectfully suggest that "premixed, premeasured,
single unit dose" and "administered without dilution" as recited
in Appellant[s'] invention is not intended use language. These
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Application 13/160,009
limitations, which are part of the body of Appellant[ s '] claims
and not recited in the preamble, provide that the aqueous solution
of the system claims will be directly administered to the
individual and that such aqueous solutions will not be diluted in
anyway.
(Id. at 7-8; see also id. at 13.) We are not persuaded.
Consistent with our prior opinion in related U.S. Application
No. 11/037,574 (Appeal 2010-005705), we are interpreting system claim 1
to be directed to a product (Prior Opinion 7). "It is well settled that the
recitation of a new intended use for an old product does not make a claim to
that old product patentable." In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir.
1997). We conclude that this is true whether an intended use recitation is
recited in the preamble or, as in the present case, in a wherein clause. See
Griffin v. Bertina, 283 F.3d 1029, 1034 (Fed. Cir. 2002).
In addition, Appellants do not adequately explain how either of the
relied upon features define more that the intended use of the product.
Specifically, Appellants do not adequately explain why the product
suggested by COMBIVENT or Chest in view of Asmus would not be
capable of being administered without dilution to an individual.
Appellants also argue that the "issue here is not a new use of an
otherwise old or obvious compound, but, rather, whether the subject-matter
of the claimed system possesses an unexpected use of such compositions-
i. e., direct administration of the claimed composition without dilution to an
individual for the treatment of COPD" (Reply Br. 7). We are not persuaded.
Appellants provide attorney argument stating that "the ability for the
claimed composition to treat chronic obstructive pulmonary disease
('COPD') in an individual was unexpected in the art prior to the time of
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Application 13/160,009
Appellant[s'] invention" (id.) However, Appellants have not provided
sufficient evidence to support this position.
With respect to the first rejection, Appellants additionally argue that
"Coates teaches away from volumes of about 0.1 ml to about 0.5 ml as
recited in Appellant[s'] claims as well as concentrated aqueous solutions
intended for direct delivery without dilution" (id. at 8). We are not
persuaded.
Coates discloses:
[A]erosolized 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. For
most devices, 4 mL is ideal, since drug output for volumes ::;3
mL are lower and much more device-dependent.
(Coates 418 (footnotes omitted).) In view of this disclosure, Appellants
argue that Coates "indicates any undiluted solutions are diluted upon
delivery to the patient" (Reply Br. 6). However, as discussed above, product
claim 1 merely requires an aqueous inhalation solution that is capable of
being administered to an individual without dilution. Appellants do not
adequately explain why the suggested concentrated solution would not be
capable of being administered without dilution.
For the same reasons, Appellants traverse the rejections of claim 14
(App. Br. 10-11 & 15-16). However, we are not persuaded by these
arguments for the reasons discussed above.
Appellants additionally argue that none of the applied references
disclose the amounts recited in claims 3 and 4 (id. at 10 & 14). However, as
noted by the Examiner (Ans. 3), Asmus specifically discloses 2.5 mg of
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Application 13/160,009
albuterol in 0.5 ml (Asmus S55, Table II). In addition, COMBIVENT and
Chest each disclose 0.5 mg (500 mcg) of ipratropium bromide
(COMBIVENT 2; Chest 1514). Appellants do not adequately explain why
the combination of COMBIVENT or Chest with Asmus fails to suggest the
additional features of claims 3 and 4.
Moreover, Appellants argue that none of the applied references
disclose the features of claim 5 (App. Br. 10 & 15). However, as noted by
the Examiner (Ans. 3), Asmus discloses a sterile solution (Asmus S55,
Table II). Appellants have not adequately explained why it would not have
been obvious to include a sterile solution.
CONCLUSION
The evidence supports the Examiner's conclusion that the applied
references suggest the systems of claims 1, 3-5, and 14. We therefore
affirm both obviousness rejections of these claims. For each rejection,
claims 2 and 6-13 have not been argued separately and therefore fall with
claim 1. 37 C.F.R. § 41.37( c )(1 )(iv).
TIME PERIOD FOR RESPONSE
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
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