Ex Parte Friesen et al

Patent Trial and Appeal Board

Dec 21, 2018

12312826 (P.T.A.B. Dec. 21, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/312,826 05/28/2009 Dwayne Thomas Friesen
24197 7590 12/26/2018
KLARQUIST SPARKMAN, LLP
121 SW SALMON STREET
SUITE 1600
PORTLAND, OR 97204
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.
8191-92855-01 6585
EXAMINER
MILLIGAN, ADAM C
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
12/26/2018 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):
docketing@klarquist.com
AS CChair@klarquis t. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DWAYNE THOMAS FRIESEN, LEAH E. APPEL,
JOSHUA RICHARD SHOCKEY, SANJA Y KONAGURTHU,
and EDWARD DENNIS LACHAPELLE
Appeal2017-007748
Application 12/312,826 1
Technology Center 1600
Before TA WEN CHANG, TIMOTHY G. MAJORS, and DAVID COTTA,
Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
pharmaceutical composition comprising multiparticulates. The Examiner
rejected the claims on appeal under 35 U.S.C. § 103(a) as obvious and on the
grounds of non-statutory obviousness-type double patenting. We have
jurisdiction over the appeal under 35 U.S.C. § 6(b ).
We reverse.
1 According to Appellants, the real party in interest is Bend Research, Inc.
App. Br. 3.
Appeal2017-007748
Application 12/312,826
STATEMENT OF THE CASE
"It is well known that poorly water soluble drugs may be formulated
as a solid amorphous dispersion of a drug in a polymer to improve the
bioavailability of poorly soluble drugs." Spec. 1. Such dispersions may be
formed by spray drying; however, "[a] drawback of such spray dried
dispersions is that the particles resulting from the spray-drying process are
often very small (typically less than 100 microns in diameter) and have high
specific volume (typically greater than 3 cm3/g)." Id. As a result, these
dispersions are "difficult to handle," which "complicate[ s] formulation of
such dispersions into dosage forms suitable for oral delivery." Id.
It was also known to "spray-coat" solid amorphous dispersions onto
an inert core, such as "an inert sugar sphere or microcrystalline cellulose."
Id. However, "conventional sugar cores and the like are friable" and "have a
tendency to break apart into smaller pieces in the fluid bed during the
coating process." Id. In addition, they may have "non-reproducible
dissolution rates" and "rough, irregular surfaces, which can be difficult to
coat uniformly." Id. Another problem with sugar cores is that they may
"rapidly absorb water, causing the multiparticul[ates] to rupture and
prematurely release the drug." Id. at 2.
The Specification discloses that what is desired is:
[A] composition comprising a solid amorphous dispersion of
drug and polymer coated onto a small, smooth inert core to
provide a multiparticulate that has a size and density that
facilitates processing of the dispersion into oral dosage forms,
and that also allows the drug dissolution rate and release rate of
the drug to be adjusted.
Id. To this end, the Specification discloses "a pharmaceutical composition
comprising a drug and polymer spray-coated onto a meltable core." Id. at 1.
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Appeal2017-007748
Application 12/312,826
Claims 21, 23-28, and 31-34 are on appeal. Claim 21 is illustrative
and reads as follows:
21. A pharmaceutical composition comprising
multiparticulates, the multiparticulates comprising:
(a) a melt-congeal core comprising a matrix
material present in an amount of at least 30 wt% of said
core, said matrix material being solid at 25°C and having
a melt temperature of less than 200°C, wherein said
matrix material is selected from the group consisting of
waxes, long chain alcohols, fatty acid esters, glycolized
fatty acid esters, phosphoglycerides, polyoxyethylene
alkyl ethers, long chain carboxylic acids, sugar alcohols,
and mixtures thereof, wherein the melt-congeal core
further comprises a dissolution enhancer or a dissolution-
inhibiting agent; and
(b) a solid amorphous dispersion layer coating said
melt-congeal core, said solid amorphous dispersion layer
comprising a drug and a polymer, wherein the matrix
material and the polymer are not the same compound,
wherein at least 75 wt% of said drug in said solid
amorphous dispersion layer is amorphous and wherein at
least a portion of said solid amorphous dispersion layer is
in the form of a substantially homogeneous solid
solution, and wherein said solid solution exhibits a single
glass-transition temperature;
wherein the weight of said solid amorphous dispersion
layer ranges from 1 wt% to 90 wt% of said multiparticulates.
App. Br. 15.
The claims stand rejected as follows:
Claims 21, 23-28, and 31-34 were rejected under 35 U.S.C. § I03(a)
as obvious over Babcock. 2
2 Babcock et al., US Patent Publication No. 2004/0013734 Al, published
Jan. 22, 2004 ("Babcock").
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Appeal2017-007748
Application 12/312,826
Claims 21, 23-28, and 31-34 were rejected on the ground ofnon-
statutory obviousness-type double patenting over claims 1-3 of US Patent
No. 8,481,081 ("the '081 patent").
Claims 21, 23-28, and 31-34 were rejected on the ground ofnon-
statutory obviousness-type double patenting over claims 1-11 of US Patent
No. 8,883,209 ("the '209 patent").
OBVIOUSNESS
Babcock discloses solid amorphous dispersions comprising a low-
solubility drug in a polymer (Babcock ,r 30) and teaches that such solid
amorphous dispersions can be coated onto a "tablet, bead or capsule." Id.
,r 88. Babcock also discloses that"[ e ]xamples of ... matrix materials,
fillers, or diluents include ... mannitol, [and] xylitol .... " Babcock ,r 98.
In finding claims 21, 23-2 8, and 31-34 obvious, the Examiner relied upon
Babcock's disclosure that xylitol and mannitol may be used as fillers or
diluents and concluded that "it would have been obvious to use two known
fillers or diluents to form the inert bead" onto which the solid amorphous
dispersion may be coated. Ans. 3. The Examiner explained: "[ u ]nder this
interpretation, the instantly recited matrix material [ of the claimed melt-
congeal core] is xylitol and the instantly recited dissolution enhancer is
manni to 1." Id.
Appellants argue that Babcock "does not disclose the use of mannitol
as a core matrix material ... , but rather as a matrix material for use in its
solid dispersion." App. Br. 10.
As stated inJn 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." Appellants have persuaded us that the Examiner has not
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Application 12/312,826
carried the burden of establishing that the claimed invention would have
been obvious over the cited art.
We agree with Appellants that Babcock discloses mannitol and xylitol
as excipients used in the solid amorphous dispersion rather than as
excipients for use in the "tablet, bead or capsule" upon which the solid
amorphous dispersion may be coated. Babcock's disclosure of mannitol and
xylitol as examples of "matrix materials, fillers, or diluents" is in the context
of a discussion about excipients for the solid amorphous dispersion rather
than as excipients that make up the core on which the dispersion may be
coated. See Babcock ,r,r 93-108.
Absent a disclosure regarding the use of xylitol and mannitol to form
the core of a pharmaceutical product, or a teaching that any filler useful in
forming an amorphous dispersion can also be used to form a pharmaceutical
core, the Examiner's conclusion that xylitol and mannitol are suitable fillers
for forming the core of a pharmaceutical is unsupported by sufficient
evidence. See e.g., Ans. 6 ("One of ordinary skill in the art would
understand that coating a drug onto an inert bead is typical a means of
increasing the surface area and drug dissolution. Thus, one of ordinary skill
in the art would have found it obvious to choose the bead material to be a
suitable filler such as xylitol or mannitol as taught by Babcock, or a
combination thereof (see MPEP 2144.06(!).").
Although the Patent Office has subject matter expertise,
the Board cannot accept general conclusions about what is
"basic knowledge" or "common sense" as a replacement for
documentary evidence for core factual findings in a
determination of patentability. To hold otherwise would be to
embark down a slippery slope which would permit the
examining process to deviate from the well-established and
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Appeal2017-007748
Application 12/312,826
time-honored requirement that rejections be supported by
evidence. It would also ultimately "render the process of
appellate review for substantial evidence on the record a
meaningless exercise."
K/S Himpp v. Hear-Wear Techs., LLC, 751 F.3d 1362, 1366 (Fed.
Cir. 2014) (citation omitted), quoting In re Zurko, 258 F.3d 1379, 1385-86
(Fed. Cir. 2001). As the Examiner's conclusion of obviousness relies upon
the unsupported assertion that mannitol and xylitol are suitable components
for the core of a pharmaceutical composition, we reverse the Examiner's
rejection of claims 21, 23-28, and 31-34 as obvious over Babcock.
DOUBLE PATENTING
The Examiner rejected claims 21, 23-28, and 31-34 over claims 1-3
of the '081 patent and claims 1-11 of the '209 patent. The claims of the
'081 patent and the '209 patent disclose spray dried dispersions but do not
disclose coating the claimed dispersions on a melt-congeal core.
In rejecting the claims 21, 23-28, and 31-34 for double patenting, the
Examiner simply asserts, without evidentiary support, that it would have
been obvious to apply the dispersions to a melt-congeal core and further to
make the melt-congeal core firm a combination of mannitol and xylitol. See
Ans. 9 ("[I]t would ... have been obvious to one of ordinary skill in the art
making the composition claimed in the '081 patent to coat the claimed solid
amorphous drug dispersion layer onto an inert sugar core in order to increase
the surface area and improve dissolution of the drug. One of ordinary skill
in the art would understand that inert sugars commonly coated to improve
drug dissolution include mannitol (dissolution enhancer) and xylitol (matrix
material). See also MPEP 2144.06."); Ans. 11 (relying on similar rationale).
As discussed in connection with the obviousness rejection, this is
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Application 12/312,826
insufficient. See K/S Himpp, 751 F.3d at 1366; In re Zurko, 258 F.3d at
1385-86. Accordingly, we reverse both of the Examiner's double patenting
rejections.
SUMMARY
For the reasons set forth herein, we reverse the Examiner's rejection
of claims 21, 23-28, and 31-34 under 35 U.S.C. § 103(a) as obvious over
Babcock, the Examiner's rejection of claims 21, 23-28, and 31-34 on the
ground of non-statutory obviousness-type double patenting over claims 1-3
of the '081 patent, and the Examiner's rejection of claims 21, 23-28, and
31-34 on the ground of non-statutory obviousness-type double patenting
over claims 1-11 of the '209 patent.
REVERSED
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