Ex Parte Bhalani et al

Board of Patent Appeals and Interferences

Feb 14, 2011

10207146 (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.
10/207,146 07/30/2002 Vinayak T. Bhalani 70164.0005USC2 9006
23552 7590 02/14/2011
MERCHANT & GOULD PC
P.O. BOX 2903
MINNEAPOLIS, MN 55402-0903
EXAMINER
TRAN, SUSAN T
ART UNIT PAPER NUMBER
1615
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 VINAYAK T. BHALANI and SATISHCHANDRA P. PATEL
__________

Appeal 2010-000803
Application 10/207,146
Technology Center 1600
__________

Before DONALD E. ADAMS, LORA M. GREEN, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
pharmaceutical composition. The Patent Examiner rejected the claims on
the ground of obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

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 2010-000803
Application 10/207,146

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STATEMENT OF THE CASE
Claims 57, 61, 69, 143, 156 and 166, which are all the pending claims,
are on appeal.2 Claim 143 is representative and reads as follows:
143. A pharmaceutical composition comprising:
a) at least one cyclosporin;
b) a surfactant component;
c) a polar lipid component comprising at least one fatty acid partial
glyceride comprising at least 50 weight percent monoglycerides of C6-C12
fatty acids;
d) at least one triglyceride;
e) said pharmaceutical composition does not contain a hydrophilic
phase containing 1,2-propylene glycol or an ether of formula R1-(-O-
(CH2))X-OR2, wherein R1 is alkyl or tetrahydrofurfuryl, R2 is alkyl,
tetrahydrofurfuryl, or hydrogen, and x is an integer of 1 to 6; and
wherein said at least one cyclosporin, said surfactant component, and
said polar lipid component are present in effective amounts relative to each
other so that the composition, on contact with an aqueous phase, is capable
of spontaneously forming a fine emulsion; and
wherein said pharmaceutical composition does not contain a
hydrophilic component.

The Examiner rejected the claims as follows:
• claim 143 under 35 U.S.C. § 103(a) as unpatentable over Hauer;3
and

2 When this appeal began, Appellants identified the appealed claims as 1-
18, 21, 22, 26, 33-44, 47-57, 60-64, 67-69, 72-83, 86-88, 89-110, 115-126,
128-132, 134-143, 146-147, 149-156, 159, 161-164, 166, 169 and 170.
(App. Br. 3.) After briefing was complete, Appellants cancelled most of the
claims and amended the remaining claims. The Examiner then advised
Appellants that “Claims 57, 61, 69, 143, 156 and 166 stay rejected over the
prior [art] of record. See Examiner’s Answer dated 04/04/08.” (Advisory
Action mailed Oct. 7, 2009.)
3 Birgit Hauer et al., US 5,342,625, issued Aug. 30, 1994.
Appeal 2010-000803
Application 10/207,146

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• claims 57, 61, 69, 156, and 166 under 35 U.S.C. § 103(a) as
unpatentable over Hauer and Lacy.4
OBVIOUSNESS
The Issue
The Examiner found that Hauer taught a composition comprising the
ingredients recited in Appellants claims and comprising a hydrophilic phase
“which is a 1,2-propylene glycol or an ether of formula R1-(O-(CH2))x-OR2.”
(Ans. 4.) According to the Examiner, “[t]here is nothing in the record
establishing the detrimental effect in the use of 1,2-propylene glycol or an
ether of formula R1-(O-(CH2))x-OR2.” (Id. at 4-5.) Notwithstanding the
proviso in the appealed claims excluding a hydrophilic phase having that
formula, the Examiner concluded that it would have been obvious “to
combine the cyclosporine with hydrophilic/lipophilic surfactants (b), and
mono/di-glycerides (c) to obtain a pharmaceutical composition, which
capable [sic] of forming a micro-emulsion with or without the use for the
hydrophilic phase, because the pharmaceutical composition of the claimed
invention permits other components including the hydrophilic component in
the use of the transitional phrase ‘comprising.’” (Id. at 5.)
Appellants point out that “[a]ll the claims pending in this application
call for a composition that:
does not contain a hydrophilic phase containing 1,2-propylene
glycol or an ether of formula R1-(O-(CH2))x-OR2, wherein R1 is
an alkyl or tetrahydrofuryl, R2 is alkyl, tetrahydrofuryl, or
hydrogen, and x is an integer of 1 to 6.”

4 Jonathan Ernest Lacy et al., US 5,645,856, issued Jul. 8, 1997.
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Application 10/207,146

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(App. Br. 9-10.) Appellants contend that the rejection is based on the idea
that it would have been obvious to eliminate the hydrophilic phase from the
Hauer composition, but that is incorrect because “the hydrophilic phase is
not only desired in the Hauer composition, it is required.” (Id. at 10,
emphasis deleted.)
The issues are:
does the transitional term “comprising” override the proviso excluding
a hydrophilic phase containing 1,2-propylene glycol or an ether of formula
R1-(O-(CH2))x-OR2;
did the rejection reasonably explain why it would have been obvious
to remove Hauer’s hydrophilic phase from Hauer’s composition?
Principles of Law
“Rejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), cited with
approval in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417-18 (2007).
Analysis
The appealed claims define compositions that do not comprise a
hydrophilic phase containing 1,2-propylene glycol or an ether of formula R1-
(O-(CH2))x-OR2. The Examiner provided no logical explanation for
interpreting the transitional phrase “comprising” to contradict a defining
clause in the claim. We cannot agree that a person of ordinary skill in the art
would interpret a claim that reads “said pharmaceutical composition does
not contain a hydrophilic phase containing 1,2-propylene glycol or an ether
of formula R1-(-O-(CH2))X-OR2” to mean the opposite. To the extent the
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Application 10/207,146

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rejection relies on the incorrect and internally contradictory claim
interpretation, it must be reversed.
The rejection gives one possible reason to remove the hydrophilic
phase from Hauer’s composition: that there is no evidence it has a
detrimental effect, and so it would have been obvious to make the
composition with or without it. We are not persuaded that this explanation
has a rational underpinning. See Kahn, 441 F.3d at 988. We conclude that
the rejection did not state a prima facie case of obviousness.
CONCLUSIONS
The rejection did not articulate reasoning with rational underpinning
sufficient to state a prima facie case of obviousness.
SUMMARY
We reverse the rejection of claim 143 under 35 U.S.C. § 103(a) as
unpatentable over Hauer.
We reverse the rejection of claims 57, 61, 69, 156, and 166 under
35 U.S.C. § 103(a) as unpatentable over Hauer and Lacy.

REVERSED

lp

Appeal 2010-000803
Application 10/207,146

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MERCHANT & GOULD PC
P.O. BOX 2903
MINNEAPOLIS MN 55402-0903