Ex Parte Devane et al

Patent Trial and Appeal Board

Oct 30, 2013

11422226 (P.T.A.B. Oct. 30, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JOHN G. DEVANE, PAUL STARK, NIALL M. M. FANNING,
GURVINDER SINGH REKHI, GARY LIVERSIDGE,
and SCOTT A. JENKINS
__________

Appeal 2012-003388
Application 11/422,226
Technology Center 1600
__________

Before TONI R. SCHEINER, DONALD E. ADAMS, and
ERICA A. FRANKLIN, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
pharmaceutical composition. The Patent Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

STATEMENT OF THE CASE
Claims 1-11, 23-28, 35, 36, and 39-42 are on appeal. Claim 1 is
representative and reads as follows:
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1. A pharmaceutical composition comprising a first component
of active ingredient-containing particles and at least one subsequent
component of active ingredient-containing particles, wherein at least one of
said components comprises a combination of carbidopa, levodopa and
entacapone and at least one of said components further comprises a modified
release coating, a modified release matrix material, or both, such that the
composition, following oral delivery to a subject, delivers the active
ingredient in a bimodal or multimodal manner.

(Emphasis added.)

The Examiner rejected the claims as follows:
• claims 1-11, 23-28, 35, and 36 under 35 U.S.C. § 103(a) as
unpatentable over Mehta1 and Lansbury,2 as evidenced by the STALEVO®
data sheet;3 and
• claims 39-42 under 35 U.S.C. § 103(a) as unpatentable over Mehta
and Lansbury, as evidenced by the STALEVO® data sheet, and in further
view of Oshlack.4

OBVIOUSNESS
I. The Rejection of Claims 1-11, 23-28, 35, and 36
The Examiner found that Mehta differed from the claimed invention
in that it did not exemplify a composition comprising a combination of
carbidopa, levodopa, and entacapone. (Ans. 6.) Rather, Mehta exemplified
methylphenidate as the active ingredient in its dosage form. (Id.) However,

1 Patent No. US 6,635,284 B2 issued to Atul M. Mehta et al., Oct. 21, 2003.
2 Patent Application Publication No. US 2005/0272722 A1 by Peter T.
Lansbury et al., published Dec. 8, 2005.
3 Novartis, STALEVO® DATA SHEET, Rev. (2008).
4US Patent No. 5,639,476 issued to Benjamin Oshlack et al., Jun. 17, 1997.

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the Examiner found that Mehta did not restrict the disclosed formulation to
any particular drug. (Id.)
The Examiner found that Lansbury taught that an oral dosage form
combining carbidopa, levodopa, and entacapone was known in the art as
STALEVO® and that it can be formulated for slow/controlled-release or
rapid release. (Id.) Additionally, the Examiner found that STALEVO®
contains each of carbidopa, levodopa, and entacapone in the concentrations
within the range recited in claim 11, and that it further comprises mannitol,
an enhancer, as evidenced by the STALEVO® data sheet. (Id.)
According to the Examiner, a person of ordinary skill in the art at the
time the invention was made would have found it obvious to formulate the
combination of carbidopa, levodopa, and entacapone, as taught by Lansbury,
into a multi-particulate modified-release composition with a bimodal or
multimodal release profile, as taught by Mehta. (Id. at 6-7.) Specifically,
the Examiner reasoned that the person of ordinary skill in the art would have
been motivated to substitute a combination of carbidopa, levodopa, and
entacapone for methylphenidate to provide a composition to treat
Parkinson’s disease having an initial release, followed by a second release of
the active ingredient, as explained by Mehta and Lansbury. (Id. at 7.)
Appellants contend that “the STALEVO[®] data sheet does not
qualify as a prior art reference” because “[t]he effective date of the present
application precedes the date of the STALEVO[®] data sheet by at least
three years.” (App. Br. 10.) However, as the Examiner explained, the
STALEVO® data sheet was not cited as prior art in the rejection. Rather, it
was cited as evidence that the STALEVO® compound taught in Lansbury
contains (a) carbidopa, levodopa and entacapone, each in an amount within
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the range recited by claim 11; and (b) mannitol, an enhancer, as required by
claim 10. (See Ans. 9.)
In the Reply Brief, Appellants further assert that “even from an
evidentiary standpoint, the use of the STALEVO[®] data sheet is improper”
because “one of skill in the art would not have had access to the revised
August 2008 STALEVO[®] data sheet on or about the effective date (June
3, 2005) of the present application to provide any assistance in further
defining any meaning that might be associated with this trademark.” (Reply
Br. 10-11.) We remain unpersuaded as the Examiner’s rejection does not
rely on a skilled artisan having had access to the STALEVO® data sheet.
The Examiner cited the STALEVO® data sheet as evidence that the
STALEVO® disclosed in Lansbury inherently meets the limitations of
dependent claims 10 and 11. Appellants’ assertion that the STALEVO®
disclosed in Lansbury may have differed from the description in the
STALEVO® data sheet is merely attorney argument, unsupported by factual
evidence. In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974). Moreover, we
note that Appellants have not separately argued claims 10 and 11, which
contain the limitations for which the STALEVO® data sheet was referenced.
(See App. Br. 10-15.)
Appellants also contend that the Examiner’s substitution of
STALEVO® for methylphenidate in the delivery system described by Mehta
“amounts to nothing more than impermissible hindsight” because (a) Mehta
never specifies the use of any drug other than methylphenidate, and (b)
methylphenidate and STALEVO® “belong to two separate and distinct
classes of drugs.” (App. Br. 11.) Further, Appellants assert that one of skill
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in the art would have no reason to make the substitution because there is no
teaching or suggestion in either Mehta or Lansbury to do so. (Id. at 14-15.)
We are not persuaded by Appellants’ arguments. While “[a]ny
judgment on obviousness is in a sense necessarily a reconstruction based
upon hindsight reasoning,” In re McLaughlin, 443 F.2d 1392, 1395 (CCPA
1971), the Examiner has properly relied on what the references would have
suggested to an artisan of ordinary skill at the time of the invention and not
on knowledge gained solely from the Applicants’ disclosure. The Examiner
provided sound reasoning, supported by the evidence, that a skilled artisan
would have found it obvious to formulate a well-known combination of
carbidopa, levodopa, and entacapone using Mehta’s drug delivery system to
provide a composition that releases the active ingredient at two separate
times. (See Ans. 6-7.) In particular, while Mehta taught that its dosage
forms are “particularly suitable” for the administration of methylphenidate
hydrochloride, the disclosure provides a broader application. Specifically,
regarding the Field of the Invention, Mehta states:
The present invention relates to improved dosing of
medications. In particular, the present invention relates to
improved dosing of a medication whereby two or more
effective, time-separated doses may be provided by
administration of a single dosage unit. The second, and any
later, dose is time-delayed following administration. Based on
predictable in vitro release times, the dosage forms can be
formulated to deliver delayed doses in vivo at desired times.

(Mehta col. 1, ll. 18-26.) Thus, as the Examiner correctly explained (Ans.
6.), Mehta does not limit its disclosed formulation to any particular drug or
class of drugs. Rather, Mehta generally provides a motivation for
formulating “medications,” i.e., various medications, using its delivery
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system when there is a desire to provide the medication in a dosage form
allowing for two or more effective, time-separated doses with the
administration of a single dosage unit. (Mehta col. 1, ll. 20-22.) As the
Examiner explained, the benefits of Mehta’s dosage form are not drug
specific. (Ans. 10.)
Additionally, Appellants assert that “nothing in Mehta even supports
that Mehta has actually achieved a temporal separation of methylphenidate
in a single administered dosage form as depicted in its Figure 2.” (App. Br.
12.) According to Appellants, Mehta is not enabling for pulsatile or bimodal
delivery because Mehta’s Figure 2 is not based on “actual, measured pK
values,” but is instead “a schematic representation of an in vivo plasma
concentration of a drug released according to the dissolution profile shown
in Figure 1,” which “is an in vitro time-concentration relationship for certain
preferred dosage forms.” (Id.)
We are not persuaded by Appellants’ argument. Mehta’s Figure 2 is
reproduced below:

Mehta’s “FIG. 1 depicts an in vitro time-concentration relationship (release
profile) for certain preferred dosage forms in accordance with the invention.
FIG. 2 depicts a schematic representation of in vivo plasma concentration of
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a drug released according to the profile shown in FIG. 1.” (Mehta col. 3, ll.
7-12.) In other words, Mehta correlated in vivo results to in vitro testing.
Mehta expressly states that “[t]he temporal separation of the two
doses provided according to the present invention can be represented
graphically as in FIG. 1.” (Id. at col. 5, ll. 36-39.) Mehta teaches that the
release of the first dose preferably occurs substantially immediately and
then, following a period of little or substantially no drug release, the second
dose is released. (Id. at ll. 42-47.) Mehta states, “[t]he two releases can be
referred to as ‘pulses,’ and such a release profile can be referred to as
‘pulsatile.’” (Id. at ll. 51-52.) This description of a pulsatile release in
Mehta is consistent with the description of the term in the Specification,
which states, “pulsatile release profiles include release profiles in which at
least two discrete quantities of one or more pharmaceutical compounds are
released at different rates and/or over different time frames.” (Spec. 5, ll. 6-
8.) The Specification further explains that “[p]ulsatile plasma profiles
exhibiting two peaks may be described as ‘bimodal.’” (Id. at ll. 15-18.)
Therefore, we find that the record supports the Examiner’s finding (Ans. 5)
that Mehta disclosed a drug release profile that is pulsatile, reading on the
bimodal or multimodal manner recited in claim 1.
Further, we are not persuaded that Mehta is not enabling for pulsatile
or bimodal delivery. Contrary to Appellants’ position (see App. Br. 13, fn.
1), “a presumption arises that both the claimed and unclaimed disclosures in
a prior art patent are enabled.” Amgen Inc. v. Hoechst Marion Roussel, Inc.,
314 F.3d 1313, 1355 (Fed. Cir. 2003). Thus, it is Appellants’ burden to
prove that the relevant disclosures of the prior art patent are not enabled.
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(Id.) However, Appellants have not provided evidence in support of this
contention. (See App. Br. 12-14; Reply Br. 12.)
Accordingly, we affirm the obviousness rejection of independent
claim 1. Claims 2-11, 23-28, 35, and 36 have not been argued separately
and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

II. The Rejection of Claims 39-42
Appellants assert that Oshlack “does not cure the deficiencies of
Mehta in view of Lansbury as evidenced by the STALEVO[®] data sheet.
Oshlack only discloses pH dependent coatings. It does not disclose or
suggest a composition that delivers carbidopa, levodopa and entacapone in a
bimodal or multimodal manner.” (App. Br. 15-16.) However, as discussed
above, we are not persuaded that the Examiner’s proposed combination is
deficient. Accordingly, we affirm the rejection of claims 39-42 for the same
reasons discussed regarding the rejection of claim 1.

SUMMARY
We affirm both of the obviousness rejections.

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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