Ex Parte Mantelle et al

Patent Trial and Appeal Board

Apr 7, 2016

13071048 (P.T.A.B. Apr. 7, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/071,048 03/24/2011 Juan Mantelle
22428 7590 04/11/2016
Foley & Lardner LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
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.
041457-0956 3258
EXAMINER
ARNOLD, ERNST V
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
04/11/2016 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JUAN MANTELLE and TERESE A. DIXON
Appeal2013-009413
Application 13/071,048
Technology Center 1600
Before JEFFREY N. FREDMAN, KIMBERLY McGRAW, and
RICHARD J. SMITH, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
r-T"I .. • • .. 1 .. ,..... ,_ TT r'1 I'\ l\ -1,..... Al • "1 • "1 • , ims 1s an appear unaer j) u.~.L. s U4 mvo1vmg crnnns to a
transdennal methylphenidate composition. The Examiner rejected the
claims as indefinite, as anticipated, as obvious, and for double patenting.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as N oven
Pharmaceuticals, Inc. (see App. Br. 2).
Appeal2013-009413
Application 13/071,048
Statement of the Case
Background
A "controlled release tablet of methylphenidate ... which was
designed to eliminate the need for multiple administrations of a tablet during
the school day for children and reduce dosing to either once or twice a day,
falls short of providing effective treatment for a significant portion of the
patient's waking hours" (Spec. i-f 4).
The Claims
Claims 1, 2, 4--7, 39, 40, 46, 47, and 51-55 are on appeal.
Independent claim 1 is representative and reads as follows:
1. A transdermal methylphenidate composition,
comprising methylphenidate in a pharmaceutically
acceptable pressure-sensitive adhesive carrier, wherein said
composition transdermally delivers methylphenidate in an
amount and at a rate sufficient to achieve a methylphenidate
plasma concentration that increases over a period of about 6
to about 12 hours, followed by a steady decrease.
The Issues
A. The Examiner rejected claim 2 under 35 U.S.C. § 112, second
paragraph, as indefinite (Final Act. 2 3).
B. The Examiner denied benefit of priority under 35 U.S.C. §§ 119
and 120 for claims 1, 2, 4--7, 39, 40, 46, 47, and 51-55 to US provisional
Application 60/069,510 and to US Applications 09/618,626 and
09/163,351(Final Act. 2).
C. The Examiner rejected claims 1, 2, 4--7, 39, 40, 46, and 47 under
2 All citations to the Final Action refer to the Final action mailed
Aug. 21, 2012.
2
Appeal2013-009413
Application 13/071,048
35 U.S.C. § 102(a) as anticipated by Vickers3 (Final Act. 4---6).
D. The Examiner rejected claims 1, 2, 4--7, 39, 40, 46, 47, 51, 52, and 54
under 35 U.S.C. § 102(b) as anticipated by Mantelle '7054 (Final Act. 7-9).
E. The Examiner rejected claims 51-55 under 35 U.S.C. § 103(a) as
obvious over Vickers and Mantelle '6945 (Final Act. 10-12).
F. The Examiner rejected claims 1, 2, 4--7, 39, 40, 46, 47, and 51-55 on
the ground of nonstatutory obviousness-type double patenting over claims
1-15 and 18-24 ofUS 6,210,705 (Final Act. 13-14).
G. The Examiner rejected claims 1, 2, 4--7, 39, 40, 46, 47, and 51-55 on
the ground of nonstatutory obviousness-type double patenting over claims
1-27 of US 6,348,211 (Final Act. 14--15).
H. The Examiner rejected claims 1, 2, 4--7, 39, 40, 46, 47, and 51-55 on
the ground of provisional nonstatutory obviousness-type double patenting
over claims 39--46, 48, and 49 of US 12/981,154 (Final Act. 15-16).
A. 35 U.S.C. § 112, second paragraph
The Examiner finds that "'at least about 8 hours' is broader than the
range in claim 1 since 'at least about 8' could mean 13 hours which is at
least about 8" (Final Act. 3).
3 Vickers, WO 01/10420 Al, published Feb. 15, 2001.
4 Mantelle et al., US 6,210,705 Bl, issued Apr. 3, 2001 ("Mantelle
'705").
5 Mantelle et al., WO 99/30694 A2, published June 24, 1999
("Mantelle '694").
3
Appeal2013-009413
Application 13/071,048
Appellants contend that the "time period recited in claim 2 is a
different time period than the 'about 6 to about 12 hours' period recited in
claim 1" (App. Br. 12).
We find that Appellants have the better position because the "8 hours"
time period in claim 2 refers to the period of "steady decrease" while the
"about 6 to about 12 hours" time period in claim 1 refers to an earlier
increasing methylphenidate plasma concentration period. We note that
while there is no "Withdrawn Rejections" subheading in the Examiner's
Answer, the Examiner acknowledges that "[w]ith respect to the 112 second
paragraph rejection, it appears that Appellant is correct" (Ans. 8).
We reverse this rejection.
B. Priority
One of the central issues in this case is whether the claims receive
benefit of priority, and to which parent application(s) that benefit is
accorded, whether just to the filing date of the direct continuation parent US
application 10/024,513 filed on Dec. 21, 2001, or also to continuation-in-
part parents US application 09/618,626, filed July 18, 2000 and US
application 09/163,351, filed Sept. 30, 1998, and to US provisional
60/069,510, filed Dec. 15, 1997.
The Examiner finds that the phrase "about 6 to about 12 hours" in
claim 1 was first introduced in the original claims of US 10/024,513 filed on
Dec. 21, 2001 and lacks descriptive support in the earlier filed applications
(Final Act. 2).
4
Appeal2013-009413
Application 13/071,048
Appellants contend that the "priority applications reasonably convey
to those skilled in art Appellant's possession of the subject matter of the
claims on appeal" (App. Br. 7). Appellants specifically contend that:
Figures 1 and 3 in the priority applications demonstrate that
at least some of these compositions exhibit the
pharmacokinetic profile recited in the claims on appeal, e.g.,
that they deliver methylphenidate in an amount and at a rate
sufficient to achieve a methylphenidate plasma
concentration that increases over a period of about 6 to
about 12 hours, followed by a steady decrease.
(Id. at 8). Appellants contend that the "specifications of the priority
applications describe the compositions as achieving 'substantially zero-
order' kinetics for at least 10 hours" (id. at 9). Appellants conclude that
"[c]onsidering the 10 hour period in the context of the 2 to 4 hour duration
of action, the skilled artisan would understand that the methylphenidate
plasma concentration will increase over a period of about 6 to about 12
hours, followed by a steady decrease" (id. at 10).
We find that the Examiner has the better position. Under the written
description requirement of 35 U.S.C. § 112, first paragraph, the disclosure of
the application relied upon must reasonably convey to the artisan that, as of
the filing date of the application, the inventor had possession of the later-
claimed subject matter. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-
63 (Fed. Cir. 1991). Under 35 U.S.C. § 120, "in a chain of continuing
applications, a claim in a later application receives the benefit of the filing
date of an earlier application so long as the disclosure in the earlier
application meets the requirements of 35 U.S.C. § 112, i-f 1, including the
5
Appeal2013-009413
Application 13/071,048
written description requirement, with respect to that claim." Tech. Licensing
Corp. v. Videotek, Inc., 545 F.3d 1316, 1326 (Fed. Cir. 2008).
Therefore, the rule requires that in order for a claim in an application
to receive the benefit of priority to a particular parent application, that parent
application must provide descriptive support for each and every element of
that claim. Applying that rule here, Appellants' independent claim 1 must
be fully supported by the disclosures provided in either US application
09/618,626, US application 09/163,351, or US provisional 60/069,510 in
order for any of the claims to receive priority benefit.
There is no express disclosure of a range of "about 6 to about 12
hours" for increasing methylphenidate plasma concentrations in any the
priority documents. As Appellants acknowledge, the first express teaching
does not appear until the Specification of US 10/024,513 i-f 19 filed
December 21, 2001 (see App. Br. 8). We agree with the Examiner that there
is no clear possession of the range "about 6 to about 12 hours" in Figures 1
and 3 of US 09/163,351, reproduced below:
FIG, f
'•
----------------;-----------------~-----~~.
2~: :]:)
6
Appeal2013-009413
Application 13/071,048
~~:~~{~.:~~F:~:D~ :~::
~:-~\:i~ :.:~;,,:::~-~:
FIB. J
Figure 1 shows the published blood levels for
methylphenidate over time in (a) two doses of the immediate
release 10 mg tablets given 5 hours apart, (b) a single dose
of the sustained release tablet and ( c) the superimposed
results from an in vitro flux study ....
Figure 3 shows a slower onset with a prolonged
duration at the substantially zero-order delivery as evidenced
by the results from an in vitro flux study.
(US 09/163,351 Spec. 5---6).
Viewing Figures 1 and 3 in the light most favorable to Appellants,
there is no specific guidance conveying that 6 or 12 hours represent
definitive endpoints, even as modified by the term "about." Indeed, because
the IR tablet line charted in Figure 1 shows eight data points between zero
hours and five hours (inclusive of the end points), it is unclear whether the
data points even represent different hours or whether the data was collected
over some other time interval. Moreover, there is no showing of an increase
that extends to 12 hours in either Figure 1 or Figure 3, further failing to
expressly or inherently support this end point of claim 1.
Moreover, even if it were obvious from Figures 1 and 3 that "about 6"
and "about 12" represented significant time points, a fact we do not concede,
7
Appeal2013-009413
Application 13/071,048
"while the description requirement does not demand any particular form of
disclosure ... or that the specification recite the claimed invention in haec
verba, a description that merely renders the invention obvious does not
satisfy the requirement" Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co.,
598 F.3d 1336, 1352 (Fed. Cir. 2010). Here, at best, the ordinary artisan
reviewing the Specification and Figures 1 and 3 of the priority documents
might find the claimed range as one of many obvious ranges that could be
selected based upon the data presented. However, we agree with the
Examiner that "the ordinary artisan cannot extrapolate the instant range from
the data provided" (Ans. 5).
We recognize, but find unpersuasive, Appellants' reliance on
Eiselstein (Reply Br. 5), because Eiselstein deals solely with the term
"about" and does not address the specific facts of the instant case where the
priority documents lack specific guidance conveying that 6 or 12 hours
represent definitive endpoints. See Eiselstein v. Frank, 52 F.3d 1035, 1039
(Fed. Cir. 1995).
Nor do we find persuasive Appellants' argument that one skilled in
the art would understand disclosure regarding zero-order delivery for at least
10 hours provides support for the limitation "about 6 to 12 hours." See App.
Br. 9-10. Attorney arguments and conclusory statements that are
unsupported by factual evidence are entitled to little probative value. In re
Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997).
Therefore, the claims are only afforded the benefit of the filing date of
the direct continuation parent US application 10/024,513 filed on Dec. 21,
2001, and priority is denied with regard to US application 09/618,626, filed
8
Appeal2013-009413
Application 13/071,048
July 18, 2000, US application 09/163,351, filed Sept. 30, 1998, and US
provisional 60/069,510, filed Dec. 15, 1997.
C. 35 U.S. C. § 102(a) over Vickers
The Examiner notes that the claims are "provided the priority date of
12/21/2001 but not earlier because it is a new concept to select 'about 6
hours to about 12 hours' from a graph which has invariable data points"
(Final Act. 2). The Examiner finds that
Vickers discloses transdermal patches comprising an
adhesive, which is inherently pressure sensitive, the free
base form of methylphenidate in an amount between 10 and
30% by weight capable of delivering 40% or more of the
entire load of methylphenidate over a 12 hour period
(Abstract; page 4, paragraph 2; and claims 1, 2 and 11) such
that the levels of methylphenidate increase gradually ....
As shown in Figure 4 below, there is at least about 6 or 8
hours over a period of about 6 to about 12 hours a steady
increase in methylphenidate plasma concentration followed
by a steady decrease over at least about 8 hours.
(Final Act. 4).
Appellants do not specifically argue that Vickers fails to teach each
and every element as set forth in the rejected claims, either expressly or
inherently. Instead, Appellants urge "the Board to find that the claims on
appeal are entitled to the benefit of the priority applications, and reverse the
35 U.S.C. §§ 102 and 103 rejections" (App. Br. 5).
We find that the Examiner has the better position. For the reasons
already given, the instant claims are only given benefit of priority to US
application 10/024,513 filed on Dec. 21, 2001 and Vickers is prior art
9
Appeal2013-009413
Application 13/071,048
published on Feb. 15, 2001 (see Vickers title page). There is no rebuttal that
Vickers otherwise anticipates the claimed invention.
We affirm this rejection.
D. 35 U.S.C. § 102(b) over Mantelle '705
The Examiner finds that "[ s ]ince the amount of methylphenidate must
have a steady decrease after an initial increase (see Figures 1-3) and the
same adhesive carrier is disclosed, then the disclosure of Mantelle ['705]
must also have the same rate of methylphenidate plasma concentration
increase and decrease and anticipates instant claims" (Final Act. 8).
We are not persuaded. Claim 1 specifically requires a disclosure of "a
methylphenidate plasma concentration that increases over a period of about
6 to about 12 hours, followed by a steady decrease." Mantelle '705 issued
from US Application 09/163,351, discussed above. For the reasons given
above in the priority discussion, we see no express or inherent disclosure in
Mantelle '705 demonstrating that the specific range of "about 6 to about 12
hours" for increases in the methylphenidate plasma concentration. As
already noted above, there is no showing of an increase that extends to 12
hours in either Figure 1 or Figure 3, so that Mantelle '705 fails to expressly
or inherently support the "about 12 hour" end point of claim 1. "Inherency
... may not be established by probabilities or possibilities. The mere fact
that a certain thing may result from a given set of circumstances is not
sufficient." MEHL/Biophile Int'!. Corp. v. Milgraum, 192 F.3d 1362, 1365
(Fed. Cir. 1999).
We reverse this rejection.
10
Appeal2013-009413
Application 13/071,048
E. 35U.S.C.§103(a) over Vickers andMantelle '694
For the reasons already given, the instant claims are only given benefit
of priority to US application 10/024,513 filed on Dec. 21, 2001, and Vickers
and Mantelle '694 are prior art. We adopt the Examiner's sound fact-based
reasoning for combining Vickers and Mantelle '694 (Final Act. 10-12).
Appellants provide no specific arguments rebutting the obviousness
rejection of Vickers and Mantelle '694.
We affirm this rejection.
F.-H. Double Patenting
Appellants do not provide any arguments relating to the double
patenting rejections. We summarily affirm the obviousness-type double
patenting rejections. See Manual of Patent Examining Procedure§ 1205.02
("If a ground of rejection stated by the examiner is not addressed in the
appellant's brief, that ground of rejection will be summarily sustained by the
Board.")
SUMMARY
In summary, we reverse the rejection of rejected claim 2 under
35 U.S.C. § 112, second paragraph, as indefinite.
We affirm the rejection of claims 1, 2, 4--7, 39, 40, 46, and 47 under
35 U.S.C. § 102(a) as anticipated by Vickers.
We reverse the rejection of claims 1, 2, 4--7, 39, 40, 46, 47, 51, 52,
and 54 under 35 U.S.C. § 102(b) as anticipated by Mantelle '705.
We affirm the rejection of claims 51-55 under 35 U.S.C. § 103(a) as
obvious over Vickers and Mantelle '694.
11
Appeal2013-009413
Application 13/071,048
We affirm the rejection of claims 1, 2, 4--7, 39, 40, 46, 47, and 51-55
on the ground of nonstatutory obviousness-type double patenting over
claims 1-15 and 18-24 of US 6,210,705.
We affirm the rejection of claims 1, 2, 4--7, 39, 40, 46, 47, and 51-55
on the ground of nonstatutory obviousness-type double patenting over
claims 1-27 of US 6,348,211.
We affirm the rejection of claims 1, 2, 4--7, 39, 40, 46, 47, and 51-55
on the ground of provisional nonstatutory obviousness-type double patenting
over claims 39--46, 48, and 49 of US 12/981,154.
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
12