Ex Parte Bhalani et al

Board of Patent Appeals and Interferences

May 27, 2010

11400585 (B.P.A.I. May. 27, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte VINAYAK T. BHALANI and SATISHCHANDRA P. PATEL
__________

Appeal 2009-013010
Application 11/400,585
Technology Center 1600
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Decided: May 28, 2010
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Before TONI R. SCHEINER, LORA M. GREEN, and JEFFREY N. FREDMAN,
Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 1-19, directed to a composition for oral administration. The claims
have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
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Application 11/400,585

STATEMENT OF THE CASE
Claims 1 and 19 are representative of the subject matter on appeal:
1. A composition for oral administration comprising:
a cyclosporin and
a hydrophilic phase free carrier medium comprising a combination of
two or more surfactants;
wherein the combination of surfactants are selected to cause the
composition, on contact with an aqueous phase, to spontaneously form a
clear, fine emulsion.

19. A composition for oral administration comprising:
a cyclosporin and
a hydrophilic phase free carrier medium;
wherein the carrier medium is selected to cause the composition, on
contact with an aqueous phase, to spontaneously form a clear, fine emulsion,
and wherein the carrier medium is selected to cause the composition to form
an emulsion of mean particle size of less than about 50 nm.

The Examiner rejected claims 1-19 under 35 U.S.C. § 103(a) as
unpatentable over Hauer1 or Nakajima,2 in view of Bailey3 or Lacy.4, 5
ISSUE
The claims are directed, in part, to a composition “comprising: a
cyclosporin and a hydrophilic phase free carrier medium” (e.g., claim 1).
Appellants contend that “[a]ll of the claims . . . call for a composition
that is . . . ‘hydrophilic phase free’” (App. Br. 5), but “the cited references
. . . all fail to disclose the component: ‘hydrophilic phase free’” (id.).

1 U.S. Patent 5,342,625, issued August 30, 1994 to Hauer et al.
2 U.S. Patent 5,098,606, issued March 24, 1992 to Nakajima et al.
3 U.S. Patent 6,008,228, issued December 28, 1999 to Bailey et al.
4 U.S. Patent 5,645,856, issued July 8, 1997 to Lacy et al.
5 A rejection of claims 1-19 under 35 U.S.C. § 112, first paragraph, for lack
of enablement has been withdrawn by the Examiner (Ans. 5).
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The Examiner’s position is that “[t]he ‘comprising’ phrase in the
preamble of the claims is open-ended, and therefore, permits the
composition itself to include a hydrophilic phase” (Ans. 6). According to
the Examiner, “only the ‘carrier medium’ . . . excludes a hydrophilic phase”
(id.).
Thus, the issue raised by this appeal is one of claim construction: do
the claims preclude the presence of a hydrophilic phase in the composition,
or simply in the carrier medium?
FINDINGS OF FACT
FF1 Hauer describes “pharmaceutical compositions comprising a
cyclosporin as active ingredient, which compositions are in the form of a[n]
[oil-in-water] ‘microemulsion pre-concentrate’” (Hauer, col. 5, ll. 55-57; col.
6, ll. 54-55).
FF2 According to Hauer,
By the term “microemulsion pre-concentrate” as used
herein is meant a system capable on contacting with, e.g.,
addition to, water of providing a microemulsion. The term
microemulsion as used herein is used in its conventionally
accepted sense as a non-opaque or substantially non-opaque
colloidal dispersion comprising water and organic components
including hydrophobic (lipophilic) organic components.
Microemulsions . . . are formed spontaneously or substantially
spontaneously when their components are brought into contact,
that is without substantial energy supply, e.g., in the absence of
heating or the use of high shear equipment or other substantial
agitation.

(Hauer, col. 5, l. 58 - col. 6, l. 3.)
FF3 In addition to the cyclosporin active ingredient, Hauer’s
“‘microemulsion pre-concentrate’ compositions . . . comprise:
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1) a hydrophilic phase;
2) a lipophilic phase; and
3) a surfactant.

The cyclosporin is carried in the lipophilic phase. Suitably both the
hydrophilic and lipophilic phases will serve as carrier medium.” (Hauer,
col. 6, ll. 46-53.) The compositions may contain a lipophilic and/or
hydrophilic surfactant or mixture of surfactants (id. at col. 9, ll. 40-46; col.
12, ll. 16-22).
FF4 Nakajima’s disclosure is similar to Hauer’s (see col. 1, l. 60 –
col. 2, l. 2).
FF5 The Examiner cited Bailey and Lacy for their disclosures of
specific carrier mediums for lipophilic drugs.
PRINCIPLES OF LAW
During prosecution before the Office, claims are to be given their
broadest reasonable interpretation consistent with the specification as it
would be interpreted by one of ordinary skill in the art. In re American
Academy of Science Tech Center, 367 F.3d 1359, 1364 (Fed. Cir. 2004).
However, the claims are not to be confined to the embodiments found in the
specification, and it is improper to import limitations from the specification
into the claims. In re Trans Texas Holdings Corp., 498 F.3d 1290, 1299
(Fed. Cir. 2007).
“‘Comprising’ is a term of art used in claim language which means
that the named elements are essential, but other elements may be added and
still form a construct within the scope of the claim.” Genentech, Inc. v.
Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997). “Consisting of,” on the
other hand, is a closed transitional phrase that is “understood to exclude any
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elements, steps, or ingredients not specified in the claim.” AFG Indus., Inc.
v. Cardinal IG Co., Inc., 239 F.3d 1239, 1245 (Fed. Cir. 2001). Moreover,
the Federal Circuit has construed a claim to an “oligonucleotide comprising
at least a portion of the nucleotide sequence of SEQ ID NO:1, wherein said
portion consists of nucleotide sequence from 521 to 2473 . . .” as reading on
a plasmid that includes more than just the recited portion of SEQ ID NO:1.
In re Crish, 393 F.3d 1253, 1254 (Fed. Cir. 2004) (emphasis added). As the
court explained, “[t]he reasonable interpretation of . . . claims containing
both of the terms ‘comprising’ and ‘consists’ is that the term ‘consists’ limits
the ‘said portion’ language to the subsequently recited numbered
nucleotides, but the earlier term ‘comprising’ means that the claim can
include that portion plus other nucleotides.” Id. at 1257.
ANALYSIS
Hauer describes a pharmaceutical composition in the form of an oil-
in-water “microemulsion pre-concentrate” comprising a hydrophilic phase
and a lipophilic phase, wherein a cyclosporin is carried in the lipophilic
phase (FF3). The dispute between Appellants and the Examiner centers on
whether the present claims preclude a hydrophilic phase in the composition
as a whole.
As discussed above, when the terms “comprising” and “consisting of”
are used in a single claim, it’s reasonable to interpret the more restrictive
transitional phrase “consisting of” as limiting the element(s) immediately
associated with the more restrictive phrase, as opposed to the element(s)
associated with the term “comprising” (AFG, Crish). While the present
claims don’t actually use the transitional phrase “consisting of” to limit the
carrier phase, the phrase “hydrophilic phase free” has the same restrictive,
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exclusionary effect, and is used in an analogous manner. Therefore, we
agree with the Examiner that the composition as a whole is open to a
hydrophilic phase and a hydrophilic phase is only excluded from the carrier
medium.
We recognize that the Specification discusses the disadvantages of
cyclosporin formulations that include hydrophilic components (¶¶ 3-5), and
that none of the compositions described in the Specification’s working
examples (other than the comparative examples) includes a hydrophilic
phase (Examples 1-10). Nevertheless, it is well settled that it is the claims
themselves that define the boundaries of the invention, and it is improper to
import limitations from the Specification into the claims (Genentech). Quite
simply, there are a number of ways to draft claims that would exclude a
hydrophilic phase from the composition as a whole, but the claims presented
do not do so.
CONCLUSIONS OF LAW
The claims do not preclude the presence of a hydrophilic phase in the
composition.
The rejection of claims 1-19 under 35 U.S.C. § 103(a) as unpatentable
over Hauer or Nakajima, in view of Bailey or Lacy is affirmed.

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)(1)(iv)(2006).

AFFIRMED

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