Ex Parte NILSSON et al

Patent Trial and Appeal Board

Jan 25, 2019

14212503 (P.T.A.B. Jan. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/212,503 03/14/2014
21559 7590
CLARK & ELBING LLP
101 FEDERAL STREET
BOSTON, MA 02110
01/29/2019
FIRST NAMED INVENTOR
Henrik NILSSON
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.
50887-0030016 1097
EXAMINER
CHANNA V AJJALA, LAKSHMI SARADA
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
01/29/2019 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):
patentadministrator@clarkelbing.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HENRIK NILSSON and BERND W. MUELLER
Appeal 2017-003061 1
Application 14/212,503
Technology Center 1600
Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and JOHN G. NEW,
Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to methods of
treating multiple sclerosis with dimethylfumarate (DMF). The Examiner
provisionally rejected the claims for obviousness-type double patenting.
We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm the Examiner's provisional obviousness-type double
patenting rejections.
We also enter a new ground of rejection for lack of written description
under 35 U.S.C. § 112, first paragraph, pursuant to 37 C.F.R. § 41.50(b).
1 Appellants state that the real party in interest in this appeal is Forward
Pharma A/S. Appeal Br. 1.
Appeal2017-003061
Application 14/212,503
STATEMENT OF THE CASE
The following rejections are before us for review:
(1) Claims 46-50 and 63-66, provisionally rejected on the ground of
nonstatutory double patenting as being unpatentable over claims 55-70 of
copending Application No. 11/576,871 ("the '871 application") (Ans. 2);
and
(2) Claims 51---62 and 67-70, provisionally rejected on the ground of
nonstatutory double patenting as being unpatentable over claims 55-70 of
the '871 application in view of Joshi '9992 or Joshi '992 3 (Ans. 3-5).
Claim 46, the only independent claim on appeal, is representative and
reads as follows:
46. A method of treating a subject in need of treatment for
multiple sclerosis comprising orally administering to the subject
in need thereof a pharmaceutical composition in unit dosage
form consisting essentially of (a) from 120 mg to 240 mg of
dimethylfumarate formulated for delayed release, and (b) one or
more pharmaceutically acceptable excipients, wherein
following the orally administering of the unit dosage form
monomethylfumarate appears in the plasma of the subject and
the Cmax of the monomethylfumarate in the plasma of the
subject is between about 0.4 and about 2 mg/L, and wherein
480 mg of dimethylfumarate per day is orally administered to
the subject.
Appeal Br. 5.
DOUBLE PATENTING
The Examiner's Prima Facie Case
The Examiner found that, although rejected claims 46-50 and 63---66,
and claims 55-70 of the '871 application, do not recite identical subject
2 US 7,320,999 B2 (issued Jan. 22, 2008).
3 US 6,436,992 B 1 (issued Aug. 20, 2002).
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matter, the rejected claims are not patentably distinct from the claims of the
'871 application "because both instant and the copending application[] claim
a method of treating multiple sclerosis by administrating an oral delayed
release composition comprising dimethylfumarate in combination with
pharmaceutical excipients such that a total daily dose of 480mg
dimethylfumarate is administered per day." Ans. 2. The Examiner noted, in
particular, that "[b ]oth sets of claims recite twice daily administration of
administering dimethylfumarate in the form of tablet or capsule." Id.
Further, the Examiner reasoned, "[ w ]hile the copending claims do not
recite the claimed plasma levels of monomethylfumarate, the compositions
of both sets of claims recite the same amount of the active agent and
therefore the claimed plasma levels are inherent to the composition of the
claims of 11/576,871." Id.
As to claims 51---62 and 67-70, all of which depend directly or
ultimately from claim 46, the Examiner cited Joshi '999 and Joshi '992 as
evidence that the additional elements recited in those dependent claims
would have been obvious variations of the process recited in claim 46. Id. at
3-5.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability ....
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
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In evaluating whether claims under examination should be rejected for
obviousness-type double patenting, the Examiner must determine, in an
analysis comparable to that under 35 U.S.C. § 103, whether one of ordinary
skill would have considered the examined claims obvious in view of the
conflicting claims. See In re Braat, 937 F.2d 589, 592-93 (Fed. Cir. 1991).
In the present appeal, having carefully considered all of the evidence
and arguments presented by Appellants and the Examiner, Appellants do not
persuade us that the preponderance of the evidence fails to support the
Examiner's conclusion that the invention recited in claims 55-70 of the '871
application would have rendered obvious the invention recited in rejected
claims 46-50 and 63---66.
Claims 55-70 of the '871 application, like the claims under rejection
herein, recite treating multiple sclerosis by administering 480 mg/day of
dimethylfumarate (DMF). See '871 application, Response filed January 21,
2014, pp. 3-5.
We acknowledge, as Appellants contend (Appeal Br. 2-3; Reply Br.
2), that representative rejected claim 46 recites a DMF dosage form
formulated for delayed release (Appeal Br. 5). Appellants' Specification,
however, broadly defines delayed release as simply being release of the
active substance at any point in time later than the commercial product
Fumaderm®. See Spec. 6.
We acknowledge that, in contrast to the rejected claims, claims 55-70
of the '871 application do not expressly recite a delayed release formulation.
See '871 application, Response filed January 21, 2014, pp. 3-5.
As the Examiner contends, however (see Ans. 6-7), a number of the
claims of the '871 application recite achieving a daily dosage of 480 mg/day
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Application 14/212,503
of DMF in as many as three separately administered dosages. See id. at 3--4
( claims 57 and 59), id. at 5 ( claims 66 and 68 also reciting administration of
480 mg/day DMF spread across three separate doses).
Because the '871 application recites that the daily dosage of 480
mg/day of DMF may be spread across as many as three separately
administered dosages, whereas the claims under rejection recite
administering the drug in a single daily dosage (see, e.g., Appeal Br. 5
(claim 47)), we discern no error in the Examiner's determination that it
would have been obvious in view of the '871 application claims to prepare
and administer, a single daily dosage, in a delayed release dosage form as
recited in rejected claim 46, in order to achieve the same three-dosage daily
profile of the MS treatment regimen as recited in the '871 application
claims.
We acknowledge, as Appellants contend (Appeal Br. 3; Reply Br. 2-
3), that rejected claim 46 recites that, following oral administration of the
unit dosage form, monomethylfumarate appears in the plasma of the patient,
and the Cmax of the monomethylfumarate in the patient's plasma is between
about 0.4 and about 2 mg/L (Appeal Br. 5).
Appellants' Specification explains, however, that the claimed Cmax
range is simply the result obtained by oral administration of 120 to 240 mg
of DMF, including in a delayed release formulation:
Apart from the characteristic in vitro release patterns described
herein, such a prolonged release is reflected in the
pharmacokinetic parameters obtained after a clinical study as
well. Accordingly, it is contemplated that the Cmax of the
monoalkylester of fumaric acid (which appears in the plasma
upon hydrolysis or metabolism of the dialkylester
administered) is of the same order of magnitude as previously
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Application 14/212,503
described in the literature provided that a similar or
equivalent dose is administered (i.e. Cmax of
monomethylfumarate in a range of from about 0.4 to about
2.0 mg/l corresponding to an oral dose of 120 to 240 mg
dimethylfumarate).
Spec. 31 ( emphasis added).
Because the broad Cmax range recited in rejected claim 46 is simply
the Cmax range previously described in the literature as being achieved by
oral administration of 120 to 240 mg of DMF, and because a number of
claims of the '871 application recite administering 240 mg DMF dosage
forms (see '871 application, Response filed January 21, 2014, pp. 3-5
(claims 58, 63, 70)), Appellants do not persuade us that the Examiner erred
in determining that the Cmax range recited in rejected claim 46 would have
been obvious in view of the claims of the '871 application.
To the contrary, on the current record, the Cmax limitation in claim 46
is simply a recitation of a result that occurs upon performing the process
steps positively recited in the claim. See Texas Instruments, Inc. v. US. Int 'l
Trade Comm 'n, 988 F.2d 1165, 1172 (Fed. Cir. 1993) ("A 'whereby' clause
that merely states the result of the limitations in the claim adds nothing to
the patentability or substance of the claim."). Moreover, given that the
monomethylfumarate Cmax range recited in claim 46 was the known
desirable range previously described in the literature (see Spec. 31 ),
Appellants do not persuade us that the Examiner erred in concluding that it
would have been obvious to administer DMF in a manner that achieves a
plasma concentration of monomethylfumarate encompassed by the range
recited in claim 46.
In sum, for the reasons discussed, Appellants do not persuade us that
the Examiner erred in determining that the process recited in Appellants'
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rejected claim 46 would have been obvious in view of claims 55-70 of the
'871 application. We, therefore, affirm the Examiner's provisional rejection
of claim 46. Because they were not argued separately, claims 47-50 and
63---66 fall with claim 46. 37 C.F.R. § 4I.37(c)(l)(iv).
Other than the arguments discussed above, Appellants do not advance
specific argument as to the Examiner's provisional rejection of claims 51---62
and 67-70 over claims 55-70 of the '871 application in view of Joshi '999
or Joshi '992. See Appeal Br. 2--4; Reply Br. 2-3. Because Appellants,
therefore, do not identify, nor do we discern, error in the Examiner's
provisional rejection of claims 51---62 and 67-70, we also affirm the
Examiner's provisional rejection of claims 51---62 and 67-70.
NEW GROUND OF REJECTION
Under the provisions of 37 C.F.R. § 41.50(b ), we enter the following
new ground of rejection:
Claims 46-70 are rejected under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement.
Claim 46, the sole pending independent claim, recites treating a
subject in need of treatment for multiple sclerosis by administering 480 mg
ofDMF per day. Appeal Br. 5.
Our review of the '871 application, discussed above, to determine the
status of the claims forming the basis of the provisional double patenting
rejections, uncovered the fact that claims 55-70 of the '871 application had
been held by the Board to be unpatentable for failure to meet the written
description requirement. See FWP IP ApS v. Biogen MA, Inc.,
No. 2017-2109, 2018 WL 5292070, at *4 (Fed. Cir. Oct. 24, 2018) ("[T]he
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Board concluded that Forward's claims 55-70 failed to meet the written
description requirement.").
On appeal, the Federal Circuit agreed with the Board's determination
that the specification of the '871 application did not provide adequate
descriptive support for treating multiple sclerosis by administering 480
mg/day of DMF. See id. at *5 ("For the same reasons set forth by the Board,
we agree that the '871 application does not disclose the now-claimed MS
treatment as a unified whole."). More specifically, the Federal Circuit stated
as follows:
Given the brief references to MS and the lack of recognition of
480 mg/ day as a therapeutically effective daily dosage, we
agree with the Board's finding that there is no discussion in the
'871 application that would guide one skilled in the art to treat
MS with a therapeutically effective dose of 480 mg/day.
Id. at *6 (internal quotations, bracketing, and citation omitted).
The application under consideration herein is a continuation of the
'871 application. See Application Data Sheet entered March 14, 2014, at
p. 4. Therefore, the Specification of application under consideration herein
is identical to the specification of the '871 application.
As noted above, claim 46, the sole pending independent claim, recites
treating a subject in need of treatment for multiple sclerosis by administering
480 mg of DMF per day. Appeal Br. 5. That is, claim 46 and its dependent
claims all recite the same combination of elements held by the Federal
Circuit as lacking descriptive support in the specification of the '871
application-treating multiple sclerosis with 480 mg/day of DMF.
Thus, to summarize, the Specification of the application under
consideration herein is identical to the specification of the '871 application,
and claims 46-70 under consideration herein all require treatment of
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multiple sclerosis with 480 mg/day of DMF, the treatment regimen held by
the Federal Circuit to be lacking adequate descriptive support under§ 112,
first paragraph, in the '871 application. Accordingly, for the reasons set
forth in the Federal Circuit's decision in FWP IP ApS v. Biogen MA, 2018
WL 5292070, claims 46-70 lack adequate descriptive support in the
Specification of the application under consideration herein. We, therefore,
reject claims 46-70 under 35 U.S.C. § 112, first paragraph, for failure to
comply with the written description requirement.
SUMMARY
For the reasons discussed, we affirm both of the Examiner's
provisional obviousness-type double patenting rejections and enter a new
ground of rejection under 35 U.S.C. § 112, first paragraph, for failure to
comply with the written description requirement.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 4I.50(b) (2012). 37 C.F.R. § 4I.50(b) provides "[a] new ground
of rejection pursuant to this paragraph shall not be considered final for
judicial review."
37 C.F.R. § 4I.50(b) also provides that the appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating
to the claims so rejected, or both, and have the matter
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reconsidered by the examiner, in which event the prosecution
will be remanded to the examiner ....
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record.
AFFIRMED, 37 C.F.R. § 4I.50(b)
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