Ex Parte Roehrich

Patent Trials and Appeals Board

Jan 28, 2019

13058769 - (D) (P.T.A.B. Jan. 28, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/058,769 03/14/2011
25944 7590 01/30/2019
OLIFF PLC
P.O. BOX 320850
ALEXANDRIA, VA 22320-4850
FIRST NAMED INVENTOR
Tillmann Roehrich
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.
148500 3565
EXAMINER
GOTFREDSON,GAREN
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
01/30/2019 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):
OfficeAction25944@oliff.com
jarmstrong@oliff.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TILLMANN ROEHRICH
Appeal2017-005495
Application 13/058,769 1
Technology Center 1600
Before DEBORAH KATZ, RACHEL H. TOWNSEND, and DAVID
COTTA, Administrative Patent Judges.
COTT A, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
method for producing a nicotine-containing granulate. The Examiner
rejected the claims on appeal under 35 U.S.C. § 103(a) as obvious.
We reverse.
1 According to Appellant, the real party in interest is Siegfried Ltd. App. Br.
1.
Appeal2017-005495
Application 13/058,769
STATEMENT OF THE CASE
Claims 9-27 are on appeal. Claim 9 is illustrative and reads as
follows:
9. A method for producing a nicotine-containing granulate,
the method comprising the steps of:
(a) mixing nicotine or a pharmaceutically acceptable
nicotine derivative with an excipient;
(b) compacting the mixture obtained in step (a) in a roller
compactor to produce granules; and
( c) screening the granules obtained in step (b) to remove
granules that have a particle size smaller than 250 µm, wherein
the granulate has a bulk density of at least 0.5 g/ml.
Claim App 'x. A-1.
The claims stand rejected as follows.
Claims 9, 11-14, and 16-27 were rejected under 35 U.S.C. § I03(a)
as obvious over the combination of Irwin, 2 Gereg, 3 Liu, 4 and Hansson. 5
Claim 10 was rejected under 35 U.S.C. § I03(a) as obvious over the
combination of Irwin, Gereg, Liu, Hansson, and Hafermann. 6
2 Irwin, FR 2 792 200, published Oct. 20, 2000 ("Irwin"). Irwin is written in
French. All citations to Irwin are to the certified translation provided by
Appellant.
3 Gereg et al., Roller Compaction Feasibility for New Drug Candidates,
Laboratory to Production Scale, PHARMACEUTICAL TECHNOLOGY
TABLETING & GRANULATION (2002) ("Gereg").
4 Liu et al, Effect of Particle Properties on the Flowability of Ibuprofene
Powders, 362 INTERNATIONAL JOURNAL OF PHARMACEUTICS 109-117
(2008) ("Liu").
5 Hansson, US Patent Publication No. 2004/0191322 Al, published Sep. 30,
2004 ("Hansson").
6 Hafermann et al., US Patent Publication No. 2001/0019763, published Sep.
6, 2001 ("Hafermann").
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Application 13/058,769
Claim 15 was rejected under 35 U.S.C. § 103(a) as obvious over the
combination of Irwin, Gereg, Liu, Hansson, and Baker. 7
ANALYSIS
The same issue is dispositive with respect to all three obviousness
rejections. Accordingly, we address all of the rejections together.
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
ofunpatentability." Appellant has persuaded us that the Examiner has not
carried the burden of establishing that the claimed invention would have
been obvious over the cited art.
Irwin discloses the following procedure for making compressed
nicotine tablets:
First, the nicotine salt was granulated by mixing in a rotating
drum with the Keltrol F, the green dye and the aspartame, was
passed through a sieve of 250 µm and was collected in a further
clean and dry drum. The solid base in powder form, the silicon
dioxide and the flavoring materials were then added to the new
drum that was sealed and agitated on rolls. After about 10
minutes, the icing sugar and the other excipients for tablet
formation were added and continuously mixed during another
10 to 15 minutes. Tablets were formed by compression in a
tabletting machine and were packed in sealed polyethylene
containers that may have an internal vapor resistant lining.
Irwin 3 ( emphasis added).
Liu discloses that for pharmaceutical powders, "[i]t is generally
accepted that the larger the particles, the better the flow" and that "[p ]articles
larger than 250 µmare usually free-flowing" while "powders become
7 Baker et al., US Patent No. 5,135,753, issued Aug. 4, 1992 ("Baker").
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Appeal2017-005495
Application 13/058,769
cohesive and flow problems are likely to occur" when particle size "falls
below 100 µm." Liu 109.
The Examiner found that the cited art disclosed the requirement of
claim 9 to remove granules that have a particle size smaller than 250 µm
based on the combined disclosures of Irwin and Liu. The Examiner
explained:
[I]t would have been prima facie obvious to ... improve
flowability of the powder [ disclosed in Irwin] by optimizing the
size of the sieve used to screen the granules in order to arrive at
the step of removing particles smaller than 250 microns or 500
microns, or larger than 2000 microns, since the particle size is a
result effective variable that will affect the flowability of the
particles as taught by Liu and Liu expressly teaches that it is
generally accepted that flowability can be improved by using
particles having a particle size of greater than 250 microns.
Final Act. 8 6. The Examiner also noted that Liu teaches that particle size is
a result effective variable and that, in the absence of an explanation in Irwin
as to why it screens particles, the skilled artisan would have optimized
particle size in a manner consistent with Liu's teaching that, generally
speaking, larger particles have better flowability than smaller ones. Ans. 3.
Appellant argues that Irwin describes the removal of particles with a
size greater than 250 µm and that this is the opposite of what is recited in the
claims. App. Br. 6. Appellant contends that Liu would not have motivated
the ordinary artisan to remove particles smaller than 250 µm when Irwin
teaches to do the opposite and remove particles greater than 250 µm. Id. at
7.
8 Office Action mailed March 11, 2016 ("Final Act.").
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Application 13/058,769
This case turns on whether Irwin does, in fact, disclose removing
particles with a size greater than 250 µm. Simply put, the Examiner's
position that it would have been obvious to optimize particle size selection
in Irwin's process by retaining particles larger than 250 µmis not persuasive
if Irwin does exactly the opposite.
There can be no dispute that Irwin discloses using a 250 µm sieve to
screen nicotine salt. The question is whether Irwin uses the material that
passes through the sieve - i.e. particles smaller than 250 µm - to make
nicotine tablets or whether Irwin instead uses the material retained by the
sieve to make nicotine tablets. Appellant contends that Irwin uses the
material that has passed through the sieve to make nicotine tablets. App. Br.
6. The Examiner contends that Irwin "uses a size selection process that
retains particles of greater than 250 microns." Ans. 3. 9
We find that Irwin's disclosure is ambiguous. The relevant sentence
from Irwin reads as follows:
First, the nicotine salt was granulated by mixing in a rotating
drum with the Keltrol F, the green dye and the aspartame, was
passed through a sieve of 250 µm and was collected in a further
clean and dry drum.
Irwin 3 ( emphasis added). At oral argument, Appellant asserted that the
language "passed through" applied to the nicotine salt and, in order to pass
9 The Examiner's has taken various positions on whether Irwin discloses
removing particles smaller than 250 µm. Compare Ans. 3 ( quoted above),
with Final Act 4 (conceding that Irwin "does not ... expressly disclose ...
that the sieve screening step results in the removal of particles that are
smaller than 250 microns ... "), and Ans. 4 (suggesting that the skilled
artisan would optimize by "retaining additional particles that are smaller
than the 250 microns retained by Irwin, but larger than the 100 micron size
below which Liu suggests may cause flowability problems").
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Application 13/058,769
through the sieve, the nicotine salt must be smaller than 250 µm. According
to Appellant, this makes clear that Irwin is collecting rather than excluding
particles smaller than 250 µm. On the other hand, Irwin discloses that the
mixture of nicotine and excipients is "a free flowing mixture." Irwin 2.
When this is read in connection with Liu, which teaches that "[p ]articles
larger than 250 µmare usually free-flowing," (Liu 109) it suggests that
Irwin's sieving process retains nicotine particles larger than 250 µm. This
suggestion, however, is somewhat diminished by Liu' s teaching that "the
effect of particle size ... on ... flowability is ... material specific." Id.
Absent any explanation as to why Irwin sieved particles, we find the
evidence inconclusive. It is not clear whether Irwin used its sieve to collect
particles that are larger than 250 µm or to collect particles that are smaller
than 250 µm.
As discussed above, the Examiner's position that it would have been
obvious to optimize particle size selection in Irwin's process by retaining
particles larger than 250 µmis not persuasive if Irwin's process does exactly
the opposite. Because the evidence is inconclusive as to whether Irwin
retains or excludes particles larger than 250 µm, the preponderance of the
evidence does not show that the Examiner has carried the burden of showing
that the claimed method would have been obvious. Accordingly, we reverse
all three of the Examiner's obviousness rejections.
SUMMARY
In summary, we reverse the Examiner's rejection of claims 9, 11-14,
and 16-27 under 35 U.S.C. § 103(a) as obvious over the combination of
Irwin, Gereg, Liu, and Hansson.
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Application 13/058,769
We reverse the Examiner's rejection of claim 10 under 35 U.S.C. §
103(a) as obvious over the combination of Irwin, Gereg, Liu, Hansson, and
Hafermann.
We reverse the Examiner's rejection of claim 15 under 35 U.S.C. §
103(a) as obvious over the combination of Irwin, Gereg, Liu, Hansson, and
Baker.
REVERSED
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