Ex Parte Mathiesen et al

Patent Trial and Appeal Board

Jul 23, 2018

11597454 (P.T.A.B. Jul. 23, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
11/597,454 07/10/2007 Jacob Mathiesen
100807 7590 07/25/2018
Mintz Levin/Special Group
One Financial Center
Boston, MA 02111
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.
49711-501001US 5668
EXAMINER
MILLIGAN, ADAM C
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
07/25/2018 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):
IPDocketingBOS@mintz.com
IPFileroombos@mintz.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JACOB MATHIESEN, CARSTEN M. NIELSEN,
PEDER M. OLSEN, and POUL E. BERTELSEN1
Appeal2017-007843
Application 11/597 ,454
Technology Center 1600
Before ERIC B. GRIMES, RYAN H. FLAX, and TIMOTHY G. MAJORS,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a calcium
supplement dosage form, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
"Calcium salts such as, e.g., calcium carbonate is used as a source of
calcium especially for patients suffering from or at risk of osteoporosis."
Spec. 2: 1-2. The Specification discloses "an easy way for producing e.g.
1 Appellants identify the Real Party in Interest as TAKEDA AS. Appeal
Br. 2.
Appeal2017-007843
Application 11/597,454
chewable tablets containing a physiologically tolerable calcium-containing
compound by using a granulate comprising agglomerates of [a] calcium-
containing compound." Id. at 3: 1-3. The method "involves the technique of
roller compaction of the calcium-containing compound to form
agglomerates having suitable properties for further processing into a solid
dosage form such as, e.g., tablets." Id. at 3:4---6.
"The present invention relates to a particulate material and a solid
dosage form notably tablets comprising a regularly shaped calcium-
containing compound ... and a pharmaceutically acceptable sugar alcohol
such as, e.g., sorbitol and/or isomalt that has a micro structure." Id. at 1 :5-9.
"[T]he term 'regularly shaped' in connection with a calcium-containing
compound is intended to denote that the individual particles as evidenced by
SEM have a rounded or smooth-like surface." Id. at 4:30-32. "[T]he term
'micro structure' used in connection with sugar alcohols is intended to
denote that a single crystal of the sugar alcohol is a polycrystal such as
multiple crystals or fiber crystals comprising smaller units, i.e. the crystals
have an identifiable substructure that is detectable by SEM." Id. at 5: 1--4.
Claims 106-122 and 130-137 are on appeal. Claim 131 is illustrative
and reads as follows:
131. A roller compacted granulate consisting of:
iii) one or more regularly shaped calcium-containing
compounds as an active substance,
iv) one or more pharmaceutically acceptable sugar alcohols
having a micro structure selected from sorbitol and isomalt,
wherein the one or more sugar alcohols have a mean particle
size of at the most 150 micrometers, and
iii) mannitol.
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Application 11/597,454
Claims 106 and 13 7 are the other independent claims, and are both
directed to a solid dosage form comprising the same granulate as recited in
claim 131, along with one or more pharmaceutically acceptable excipients.
DISCUSSION
The Examiner has rejected all of the claims under 35 U.S.C. § I03(a)
as obvious based on either Piene2 or Piene combined with Niecestro. 3 Ans.
2, 3. The same issue is dispositive for both rejections.
The Examiner finds that
Piene teaches a first granulate comprising calcium carbonate as
Scoralite®IB and sorbitol as Neosorb®PIOOT (mean diameter
= 110 microns) (p.13, lines 2-7). A diluent and/or binder is/are
added to form granules (p.13, lines 2-29). Suitable binders are
taught to include PVP or a polysaccharide (p.6, lines 5-12).
Suitable diluents are taught to include mannitol (p.5, lines 4-5).
Id. at 2. The Examiner finds that Piene also teaches combining the first
granulate with excipients. Id.
The Examiner finds that "Piene does not teach that the first granulate
is made by roller compaction," but the claims are written in product-by-
process format and, because
it would have been obvious to have chosen mannitol (it is
suggested at page 5, line 4 and 5 of the reference), ... there is a
reasonable expectation that upon choosing mannitol as the
diluent/binder, the granules taught by the prior art would be the
same as those instantly recited.
2 WO 00/28973, published May 25, 2000.
3 US 2004/0166162 Al, published Aug. 26, 2004.
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Application 11/597,454
Id. at 3. The Examiner cites Niecestro for its disclosure that granules can be
prepared by fluid bed granulation ( as taught by Piene) or by roller
compaction ( as in the instant claims), and therefore concludes that it would
have been obvious to modify Piene's process "to use roller compaction
instead of fluid bed granulation given that Niecestro teaches the two
processes are equivalents." Id. at 4.
Appellants argue, among other things, that "one of ordinary skill in
the art at the time of filing would not have expected mannitol to act as a
good binder when combined with a regularly shaped calcium-containing
compound, as the instant claims require." Appeal Br. 7. Appellants argue
that Niecestro "classifies mannitol not as a binder, but as a filler." Id.
Thus, neither Piene nor Piene and Niecestro together ...
discloses, suggests or otherwise obviates the specific
combination of elements that the instant claims require ( a roller
compacted granulate consisting of one or more regularly
shaped calcium-containing compounds as an active substance,
one or more pharmaceutically acceptable sugar alcohols . ..
selected from sorbitol and isomalt, ... and mannitol).
Id. at 7-8.
We agree with Appellants that the Examiner has not shown that Piene,
by itself or combined with Niecestro, would have made the claimed
invention obvious to a person of ordinary skill in the art. Piene discloses "a
process by which a chewable calcium tablet may be produced with a calcium
compound content in excess of 60% by weight." Piene 2:3-5. The
process compris[ es] the steps of:
(i) obtaining a physiologically tolerable particulate calcium
compound having a mean particle size in the range 3 to 40µm,
having a crystalline structure ... ;
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Application 11/597,454
(ii) mixing said calcium compound with a water-soluble
diluent and an aqueous solution of a water soluble binder in a
fluid bed granulation apparatus and drying the resulting mixture
to produce a first granulate;
(iii) optionally mixing said first granulate with one or more
further components to produce a second granulate ... ; and
(iv) optionally compressing said first or second granulate to
form tablets.
Id. at 2:8-25.
Piene' s process thus requires mixing a calcium compound with a
diluent "and an aqueous solution of a water soluble binder." Id. at 2: 16-17.
Piene states that "[t]he water-soluble diluent used in step (ii) of the process
of the invention is preferably a sweetener or a mixture of sweeteners ....
Examples of suitable diluents include sorbitol, xylitol, isomalt and
mannitol." Id. at 4:37 to 5:5. Piene states that "[t]he water-soluble binder
used in step (ii) of the process of the invention may be selected from known
water-soluble pharmaceutical binders, e.g. it may be a soluble cellulose or
polysaccharide or a polyvinylpyrrolidone. . . . Inulin and maltodextrin may
also be used as binders." Id. at 6:4--12.
Thus, Piene discloses a process that requires mixing a calcium
compound with both a diluent and a binder. Piene discloses that sorbitol or
mannitol, or a combination of them, are suitable as diluents, but also requires
a binder in its granules. Piene states that soluble cellulose, polysaccharide,
polyvinylpyrrolidone, inulin, or maltodextrin are suitable binders.
The claims on appeal, however, are limited to granulates, or
compositions comprising them, that "consist[] of' only three components: a
calcium-containing compound, a sugar alcohol ( either sorbitol or isomalt ),
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Application 11/597,454
and mannitol. "'[C]losed' transition phrases such as 'consisting of are
understood to exclude any ... ingredients not specified in the claim." AFG
Indus., Inc. v. Cardinal JG Co., 239 F.3d 1239, 1245 (Fed. Cir. 2001). The
claims therefore do not encompass any granulates that include ingredients
other than those expressly specified. Piene's granules include a binder (in
addition to any calcium compound, sorbitol, and mannitol they might also
potentially include), and the binders suggested by Piene do not include any
of the three components of the claimed granules. We therefore agree with
Appellants that the claimed invention would not have been obvious based on
Piene.
The Examiner cited Niecestro as evidence that roller compaction and
fluid bed (wet) granulation were known to be equivalent methods of
granulating a pharmaceutical product. Ans. 4. However, as discussed
above, the product made obvious by the prior art-regardless of how it is
made----does not meet the closed limitations of the claims on appeal.
The Examiner concluded that "it would have been obvious to have
chosen mannitol (it is suggested at page 5, line 4 and 5 of the reference) ...
as the diluent/binder." Ans. 3. However, Piene's process requires both a
diluent and a binder. Mannitol is disclosed as a suitable diluent (Piene, 4:37
to 5:5), but not as a suitable binder (id. at 6:4--12). We conclude, therefore,
that the Examiner's reasoning is not supported by a preponderance of the
evidence of record. See In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992)
("[T]he examiner bears the initial burden, on review of the prior art or on
any other ground, of presenting a prima facie case of unpatentability ....
After evidence or argument is submitted by the applicant in response,
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patentability is determined on the totality of the record, by a preponderance
of evidence with due consideration to persuasiveness of argument.").
SUMMARY
We reverse both of the rejections on appeal.
REVERSED
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