Ex Parte Mathiesen et al

Patent Trial and Appeal Board

Nov 28, 2018

13627691 (P.T.A.B. Nov. 28, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/627,691 09/26/2012 Jacob Mathiesen
100807 7590 11/30/2018
Mintz Levin/Special Group
One Financial Center
Boston, MA 02111
UNITED ST A TES OF AMERICA
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.
49711-501001 us 8456
EXAMINER
MILLIGAN, ADAM C
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
11/30/2018 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 MARTINI NIELSEN,
PEDER MOHR OLSEN, and POUL EGON BERTELSEN1
Appeal2017-010841
Application 13/627 ,691
Technology Center 1600
Before ERIC B. GRIMES, TIMOTHY G. MAJORS, and RYAN H. FLAX,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a process
for preparing a particulate material, which have been rejected as obvious.
We have jurisdiction under 35 U.S.C. § 6(b ).
We reverse.
STATEMENT OF THE CASE
The Specification discloses "roller compaction of [a] calcium-
containing compound to form agglomerates having suitable properties for
1 Appellants identify the Real Party in Interest as TAKEDA NY CO MED
AS. Appeal Br. 2.
Appeal2017-010841
Application 13/627 ,691
further processing into a solid dosage form such as, e.g., tablets." Spec. 3 :4--
6. "The present invention relates to a particulate material ... 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. A "micro structure enables a certain deformation
and sufficient distribution throughout the tablet during the roller compaction
process in order to establish sufficient bonding between the individual
calcium (and sugar alcohol) particles." Id. at 5:5-7.
Claims 49-52 and 55-70 are on appeal. Claim 49 is illustrative and is
reproduced below (along with withdrawn claim 1, from which it depends):
1. (Withdrawn) A particulate material comprising one or
more regularly shaped calcium-containing compounds as an
active substance and one or more pharmaceutically acceptable
sugar alcohols having a micro structure.
49. A process for the preparation of a particulate material of
claim 1, the process comprises roller compaction of a
composition comprising at least 60% w/w of a regularly shaped
calcium-containing compound and one or more
pharmaceutically acceptable sugar alcohols having a micro
structure;
wherein
the particulate material is obtained without use of any solvent;
the pharmaceutically acceptable sugar alcohol employed has a
mean particle size of at the most about 150 µm;
the calcium-containing compound is calcium carbonate; and
the sugar alcohol is sorbitol or isomalt or mixtures thereof.
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Appeal2017-010841
Application 13/627 ,691
DISCUSSION
The Examiner has rejected claims 49--52 and 55-70 under 35 U.S.C.
§ I03(a) as obvious based on Piene,2 Virtanen, 3 and Gereg. 4 Ans. 3. The
Examiner finds that Piene discloses a process that meets most of the
limitations of claim 49, although acknowledging that Piene does not teach a
sugar alcohol with a particle size of 150 µm or less and does not teach using
roller compaction. Id. at 3--4.
The Examiner finds that "Virtanen teaches a xylitol-based binding and
diluting agent comprising the sugar-substitutes xylitol, sorbitol or isomalt"
and teaches "producing granules using xylitol having an average particle
size of 0.07mm (i.e. 70 micrometers)." Id. at 4. The Examiner finds that
"Gereg teaches that an alternative way to make granules is by roller
compaction" and teaches that roller compaction "improves efficiency ...
and removes the possibility of drug/solvent reactions." Id.
The Examiner concludes that it would have been obvious to make
Piene's tablets
using a diluent having an average particle size of 70 microns in
order to alleviate any gritty texture and undesirable mouth feel
as taught by Virtanen. Further, it would have been obvious to
make said granules using roller compaction in order to improve
efficiency, increase dosage form density (i.e. reduce the size of
the dosage form) and remove any possibility of reaction
between the drug and solvents.
Id. at 5.
2 WO 00/28973, published May 25, 2000.
3 US 5,616,361, issued Apr. 1, 1997.
4 US 2002/0039603 Al, published Apr. 4, 2002.
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Appeal2017-010841
Application 13/627 ,691
Appellants argue that "[ t Jo establish a prima facie case of
obviousness, the Examiner must establish that the prior art included each
element claimed," and "the combination of Piene, Virtanen and Gereg does
not disclose or suggest each and every element of Claim 49." Appeal Br. 6.
Appellants argue that "in order to make sufficiently strong tablets having a
high content of regularly shaped Calcium Carbonate particles, it was
required to identify excipients, and especially a binder, capable of increasing
the compactability." Id. at 8. Appellants argue that they "have shown within
the instant specification as filed a clear illustration of the impact of particle
size on the obtainable hardness of the tablets." Id. at 9 (citing Figure 4).
We agree with Appellants that the Examiner has not provided
adequate evidence to show that the cited references would have made
obvious a process meeting all of the limitations of claim 49. In particular, the
claimed process requires roller compaction of a composition that includes a
"pharmaceutically acceptable sugar alcohol [that] has a mean particle size of
at the most about 150 µm." Claim 49. The sugar alcohol is sorbitol and/or
isomalt. Id.
The Examiner cites Virtanen as disclosing "a xylitol-based binding
and diluting agent comprising the sugar-substitutes xylitol, sorbitol or
isomalt." Ans. 4. The Examiner finds that Virtanen discloses "producing
granules using xylitol having an average particle size of 0.07mm (i.e. 70
micrometers)." Id.
Xylitol, however, is not sorbitol or isomalt. Virtanen's granulate was
made by agglomerating "finely ground xylitol crystals" "with a polyol based
syrup to obtain granules which are subsequently dried to a water content of
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Appeal2017-010841
Application 13/627 ,691
less than about 1 % by weight." Virtanen 5:65 to 6:2. See also id. at 5:27-28
("another physiologically accepted polyol, preferably sorbitol"). Virtanen
states that "[i]n a preferred embodiment of the method of the present
invention, the ground xylitol has a particle size of about 0.01 mm to about
0 .10 mm .... In a particularly preferred embodiment, the average particle
size of the xylitol is about 0.07 mm." Id. at 6:7-14 (emphasis added).
Thus, the prior art particles cited by the Examiner are xylitol, not
sorbitol. The Examiner has not pointed to any disclosure in the cited
references of sorbitol particles, let alone sorbitol particles having a size of
150 µm or less. Nor has the Examiner persuasively shown that Virtanen's
disclosure of using a polyol (e.g., sorbitol) syrup to agglomerate xylitol
crystals of the size recited in claim 49 would have made obvious the use of
solid sorbitol particles of the same size in Piene' s method, even if Piene' s
method were modified to use the roller compaction disclosed by Gereg.
SUMMARY
We reverse the rejection of claims 49-52 and 55-70 under 35 U.S.C.
§ 103(a) based on Piene, Virtanen, and Gereg.
REVERSED
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