Ex Parte Tarara et al

Board of Patent Appeals and Interferences

Mar 9, 2011

10750934 (B.P.A.I. Mar. 9, 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.
10/750,934 12/31/2003 Thomas E. Tarara 53279-US-CNT 1899
1095 7590 03/10/2011
NOVARTIS
CORPORATE INTELLECTUAL PROPERTY
ONE HEALTH PLAZA 101/2
EAST HANOVER, NJ 07936-1080
EXAMINER
SCHLIENTZ, LEAH H
ART UNIT PAPER NUMBER
1618
MAIL DATE DELIVERY MODE
03/10/2011 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 THOMAS E. TARARA and JEFFRY G. WEERS
__________

Appeal 2010-009841
Application 10/750,934
Technology Center 1600
__________

Before TONI R. SCHEINER, LORA M. GREEN, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL1
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 38, 39, 41, 44, 47-56, 58, 60, 62-68, 103-105,
and 109-111. 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.
Appeal 2010-009841
Application 10/750,934

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STATEMENT OF THE CASE
Claim 38 is representative of the claims on appeal, and reads as
follows:
38. A pharmaceutical formulation for pulmonary administration, the
pharmaceutical formulation comprising:
particulates comprising active agent particles in a matrix comprising a
phospholipid, the active agent particles having a geometric diameter of less
than about 3 µm and a solubility in water of about 0.1 to about 1.0 mg/ml
and wherein the active agent particles are dispersed within the phospholipid
matrix; and
wherein the particulates are porous, have a mass median diameter less
than 20 µm, a bulk density of less than about 0.5 g/cm3 a mass median
aerodynamic diameter less than about 2.6 µm, and wherein the particulates
do not comprise lactose.

The following grounds of rejection are before us for review:
I. Claims 38, 39, 41, 44, 47-56, 58, 60, 62-68, 103-105, and 109-1112
stand rejected under 35 U.S.C. § 103(a) as being rendered obvious
by Weers3 as evidenced by Weickert,4 Wiedmann,5 and Didriksen.6

2 The Examiner’s statement of the rejection refers to claims 38, 39, 41, 44,
47-56, 58, 60, 62-68, and 103-105 (Ans. 4). In the “Grounds of Rejection to
be Reviewed on Appeal” Appellants refer to claims 38, 39, 41, 44, 47-56,
58, 60, 62-68, 103-105, and 109-111 (App. Br. 5), and the Examiner states
that statement is correct (Ans. 2). We thus consider the Examiner’s
omission of claims 109-111 to be a typographical error.
3 Weers et al., WO 01/85136 A2, Nov. 15, 2001) (Weers et al. US
2002/0037316 A1, Mar. 28, 2002, is relied upon by the Examiner as an
equivalent, and all citations to Weers are to this publication).
4 Weickert et al., US 2002/0177562 A1, Nov. 28, 2002.
5 Wiedmann et al., Drug solubilization in lung surfactant, 65 J. CONTROLLED
RELEASE 43-47 (2000).
6Didriksen et al., WO 00/01365, published Jan. 13, 2000.
Appeal 2010-009841
Application 10/750,934

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II. Claims 38, 39, 41, 44, 47-56, 58, 60, 62-68, 103-105, and 109-1117
stand provisionally rejected on the ground of nonstatutory
obviousness-type double patenting as being unpatentable over the
claims of copending Application No. 11/187,757.

We affirm.
ISSUE
Has the Examiner established by a preponderance of the evidence that
Weers renders obvious a pharmaceutical formulation for pulmonary
administration comprising particulates comprising active agent particles in a
matrix comprising a phospholipid, wherein the particulates do not comprise
lactose?

FINDINGS OF FACT
FF1 The Examiner’s statement of the obviousness rejection may be found
at pages 3-9 of the Answer.
FF2 Specifically, the Examiner cites Example V of Weers as exemplifying
a water-insoluble drug (Ans. 4).
FF3 The Examiner notes that Example V incorporates lactose into the
particulates (id. at 7), but notes that lactose is but one of a list of excipients
taught by Weers (id. at 11 (citing Weers, ¶¶39 and 40)).
FF4 Specifically, Weers teaches that “it may be desirable to add other
excipients to a particulate composition to improve particle rigidity,

7 See footnote 2.
Appeal 2010-009841
Application 10/750,934

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production yield, emitted dose and deposition, shelf-life and patient
acceptance” (Weers, ¶39).
FF5 Weers teaches that other excipients include, but are not limited to,
among other things, “disaccharides such as lactose, maltose, sucrose,
trehalose, and the like” (id. at ¶40).

PRINCIPLES OF LAW
The Supreme Court has emphasized that “the [obviousness] analysis
need not seek out precise 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.” KSR
Int’l v. Teleflex Inc., 550 U.S. 398, 418 (2007). “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. Moreover, an
“[e]xpress suggestion to substitute one equivalent for another need not be
present to render such substitution obvious.” In re Fout, 675 F.2d 297, 301
(CCPA 1982).

ANALYSIS
Appellants argue that the only example of Weers that is drawn to
particles of an active agent in a phospholipid matrix is Example V, but in
that Example budesonide is combined with lactose (App. Br. 6). Claim 38,
however, Appellants assert, excludes lactose containing particles (id. at 6-7).
Appellants argue further that while the Examiner “contends that it would
have been obvious to one of ordinary skill in the art to use something other
Appeal 2010-009841
Application 10/750,934

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than lactose in the particulates of Example V,” the Examiner has provided
“no evidence for this allegedly-obvious modification” (Reply Br. 5).
As to Weickert, Wiedmann, and Didriksen, Appellants argue that they
were not relied upon, nor do they make up the deficiencies of Weers (App.
Br. 7).
Appellants’ arguments have been carefully considered, but are not
convincing. As noted by the Examiner, Weers teaches that lactose is but one
of a list of different excipients that may be used in the particulate
compositions, and other excipients include other disaccharides, such as
maltose, sucrose, etc. (FF5). Thus, we agree with the Examiner that it would
have been obvious and well within the level of skill of the ordinary artisan to
use another excipient as taught by Weers, such as maltose or sucrose, for the
lactose in formulating the particulates of Example V of Weers.
As to independent claims 54 and 104, Appellants reiterate the
arguments made with respect to independent claim 38 (App. Br. 8-10).
Those arguments are not found to be convincing for the reasons set forth
with respect to claim 38.

CONCLUSIONS OF LAW
We conclude that the Examiner has established by a preponderance of
the evidence that Weers renders obvious a pharmaceutical formulation for
pulmonary administration comprising particulates comprising active agent
particles in a matrix comprising a phospholipid, wherein the particulates do
not comprise lactose. We thus affirm claims 38, 39, 41, 44, 47-56, 58, 60,
Appeal 2010-009841
Application 10/750,934

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62-68, 103-105, and 109-111 under 35 U.S.C. § 103(a) as being rendered
obvious by Weers as evidenced by Weickert, Wiedmann, and Didriksen.
As to the obviousness-type double patenting rejection, Appellants
only argue that they “will file terminal disclaimers as appropriate upon the
indication of otherwise allowable claims” (App. Br. 10). As Appellants are
not arguing the merits of the rejection, we summarily affirm the rejection of
claims 38, 39, 41, 44, 47-56, 58, 60, 62-68, 103-105, and 109-111 on the
ground of nonstatutory obviousness-type double patenting as being
unpatentable over the claims of copending Application No. 11/187,757.

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

cdc

NOVARTIS
CORPORATE INTELLECTUAL PROPERTY
ONE HEALTH PLAZA 101/2
EAST HANOVER, NJ 07936-1080