Ex Parte Henke et al

Patent Trial and Appeal Board

Dec 23, 2016

13604266 (P.T.A.B. Dec. 23, 2016)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/604,266 09/05/2012 Stefan HENKE 01-1405-US-3 6970
28515 7590 12/28/2016
MICHAEL P. MORRIS
BOEHRINGERINGELHEIM USA CORPORATION
900 RIDGEBURY RD
P. O. BOX 3686
RIDGEFIELD, CT 06877-0368
EXAMINER
PURDY, KYLE A
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
12/28/2016 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):
US PTO.e-Office. rdg@ boehringer-ingelheim .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEFAN HENKE, MARTIN ANDREAS FOLGER,
JENS SCHMALZ, DIANA KEILHOFER, HANS-JUERGEN KROFF, and
NINA HERZ1
Appeal 2015-007110
Application 13/604,266
Technology Center 1600
Before ERIC B. GRIMES, JOHN G. NEW, and TAWEN CHANG,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
appellants state the real party-in-interest is Boehringer Ingelheim
Vetmedica GmbH. App. Br. 3.
Appeal 2015-007110
Application 13/604,266
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 1—20. Specifically, claims 1—8 and
13—20 stand rejected as unpatentable under 35 U.S.C. § 103(a) as being
obvious over the combination of Chen et al. (US 6,106,862, August 22,
2000) (“Chen”), Fuisz et al. (US 5,654,003, August 5, 1997) (“Fuisz”),
Uhrich et al. (US 2002/0106345 Al, August 8, 2002) (“Uhrich”), and Bock
et al. (US 6,869,948 Bl, March 22, 2005) (“Bock”).
Claims 9—12 stand rejected as unpatentable under 35 U.S.C. § 103(a)
as being obvious over the combination of Chen, Fuisz, Uhrich, Bock, and
Robinson et al. (US 6,071,539, June 6, 2000) (“Robinson”)
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CFAIMED INVENTION
Appellants’ invention is directed to water-soluble meloxicam
granules. Abstract.
REPRESENTATIVE CLAIM
Independent claim 1 is representative of the claims on appeal and
recites:
1. Water soluble meloxicam granules comprising:
(a) meloxicam;
(b) a salt forming agent which forms the meglumine, sodium,
potassium, or ammonium salt of meloxicam;
(c) a binder;
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Application 13/604,266
(d) a sugar or sweetener; and
(e) a carrier, and optionally a flavoring agent and optionally
other excipients;
wherein the granules have a particle size distribution of 125 pm
to 500 pm.
App. Br. 16.
ISSUES AND ANALYSES
We agree with, and adopt, the Examiner’s findings and conclusion
that the appealed claims are prima facie obvious over the cited prior art
references. We address below the arguments raised by Appellants.
A. Independent claims 1 and 20
Issue
Appellants argue that the Examiner erred because no combination of
the cited prior art references teaches or suggests the features of each of
claims 1 and 20. App. Br. 10.
Analysis
Appellants argue Chen teaches an analgesic tablet comprising a
nonsteroidal anti-inflammatory drug (NS AID) such as salicyclic acid,
indomethacin, ibuprofen, naproxen, naproxen sodium, flubiprofen,
indoprofen, ketoprofen, piroxicam, diclofenac, etodolac, and ketorolac, but
neither teaches nor suggests the anti-inflammatory meloxicam or meloxicam
granules. App. Br. 10. Furthermore, Appellants contend, Chen teaches that
the granules are micronized and preferably should have a particle size of less
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Application 13/604,266
than 20 microns. Id. (citing Chen col. 3,11. 23—24). Furthermore,
Appellants assert Chen teaches the granules are formed only as an
intermediate product and are subsequently compressed into a tablet which is
then coated with an external seal. Id. (citing Chen col. 4,11. 31—35).
Appellants contend Fuisz teaches making a solid tablet which can be
compressed directly after flash-flow processing. App. Br. 11 (citing Fuisz
col. 3,11. 10—13, 48—50). According to Appellants, Fuisz teaches that “the
majority of particles resulting from the flash flow process pass through the
first screen, which has a mesh size of 2000 microns and are retained on
screens which have a mesh size of 420 microns and 250 microns and that
“[tjhese particles are ideal for feeding into tableting dies.” Id. at 11—12
(quoting Fuisz col. 13,11. 23—27, emphasis omitted). Appellants argue there
is no teaching or suggestion by Fuisz of ensuring that the particles have a
particle size distribution of 125—500 microns as recited in claims 1 and 20.
Id.
Appellants next discuss Uhrich. The Examiner relies upon Uhrich as
teaching the substitution of etodolac, one of the preferred analgesics taught
by Chen, with meloxicam, since “both are known to have analgesic activity
through similar biological pathways.” App. Br. 13 (quoting Final Act. 6).
Appellants argue that if, in fact, etodolac could be readily substituted with
meloxicam, as suggested by the Final Office Action, and provide the same
desired analgesic effect, the question becomes why would Chen not have
listed meloxicam in the first place? Id.
Finally, Appellants argue that, while Bock teaches oral meloxicam
compositions in which a meglumine salt of meloxicam may be used, Bock
fails to cure the alleged deficiencies of Chen, Fuisz and Uhrich. App. Br.
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Application 13/604,266
13. Appellants contend that, absent improper hindsight and reliance upon
the claimed invention, there is no reasonable motivational or predictable
rationale for obtaining the combination of features of claims 1 and 20 based
upon the teachings of the Examiner’s cited references. Id. at 14.
The Examiner responds that term “micronized,” as taught by Chen,
does not teach away from the range recited by Appellants’ claims. Indeed,
the Examiner finds the claimed range of 125—500 microns is also
“micronized” as their size dimensions are in microns. Ans. 7. The
Examiner also finds Chen’s teaching of a particle of less than 20 microns is
simply a preference and, although preferred, should not be construed as a
requirement. Id.
The Examiner finds further that Fuisz teaches that particles “having a
size greater than 150 microns (e.g., those retained on 150, 180, 250 and 420
micron mesh), are preferable as they are ideal for feeding into tabletting [sic]
dies, exhibit optimum flowability and are easily moved by machine.” Ans. 8
(citing Fuisz col. 13,11. 22—27, Table 8). The Examiner finds Fuisz teaches
that this preferred range, i.e., 250-2540 microns, overlaps with Appellants’
recited range of 125—500 microns. Id.
The Examiner therefore concludes it would have been obvious to a
person of ordinary skill to: “(1) adjust and optimize the size of Chen’s
analgesic particle so as to achieve a particle size distribution ideal for
feeding into tabletting [sic] dies, exhibit optimum flowability and being
easily moved by machine; and (2) apply the technique of isolating particles
which are retained on the 250 microns mesh after passing through the 420
micron mesh to use in a tabletting [sic] process. Id. The Examiner finds that
applying such a technique would include particles between 250 and 420
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microns in size (i.e., those retained on the 250 micron mesh) which would
possess the favorable properties taught by Fuisz. Id. at 8—9. The Examiner
also finds, although as Appellants argue Fuisz does not teach granules
explicitly in the final product, a tablet is comprised of compressed granules,
and therefore that final composition still comprises granules. Id. at 9.
The Examiner next finds that Chen teaches that its anti-inflammatory
analgesics may be preferably selected from etodolac, naproxen, ibuprofen,
piroxicam, amongst others. Ans. 10. The Examiner finds Uhrich also
teaches anti-inflammatory analgesics, including etodolac, piroxicam and
meloxicam, which overlap with the teachings of Chen. Id. The Examiner
concludes it would be obvious to a person of ordinary skill in the art to
substitute anti-inflammatory analgesic actives (e.g., etodolac or piroxicam)
for other known anti-inflammatory analgesics (e.g., meloxicam), all of
which are well-known in the art and which would have led to predictable
results (i.e., an analgesic composition). Id.
We are not persuaded by Appellants’ arguments. We agree with
Appellants that Chen teaches that particles of 20 microns or less are
preferable in the compositions taught therein, but Fuisz articulates a rational
motivation to select, by meshing, larger granules, including those between
240 and 420 microns in diameter, which have improved properties in the
formulation of compressed pills. See Chen col. 3,11. 22—23; see also Fuisz,
col. 2,11. 27—30 (stating that “very tiny particles on the order of 150 micron
. . . can interfere with operation of apparatus feeding tabletting [sic]
machines as well as the operation of the tabletting [sic] machines”); see also
id. at col. 13,11. 22—27.
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Furthermore, we are not persuaded by Appellants’ arguments that
Chen must either teach or suggest a granule as the final product, instead of
an intermediate product. Such a requirement is not a limitation of
Appellants’ claims.
Moreover, we agree with the Examiner that it would have been
obvious to substitute the anti-inflammatory analgesic meloxicam, taught by
Uhrich, for the non-steroidal anti-inflammatory analgesics taught by Chen.
Chen teaches a range of preferred analgesics (i.e., salicylic acid,
indomethacin, ibuprofen, naproxen, naproxen sodium, flubiprofen,
indoprofen, ketoprofen, piroxicam, diclofenac, etodolac, ketorolac or their
pharmaceutically acceptable derivatives). See Chen col. 1,11.8—12. Uhrich
also teaches a number of non-steroidal anti-inflammatory analgesics, with
similar mechanisms (i.e., COX inhibitors) that overlaps with those taught by
Chen (i.e., etodolac, celebrex, meloxicam, piroxicam, nimesulide,
nabumetone, and rofecoxib). Uhrich 138 (emphasis added). Appellants ask
why, if the substitution of meloxicam for the analgesics taught by Chen is
obvious, then why did not Chen include meloxicam in its teachings?
Such is not the test of obviousness; rather, “the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art.” In re Keller, 642 F.2d 413, 425 (C.C.P.A. 1981).
In the appeal before us, we agree with the Examiner that it would have been
obvious to a person of ordinary skill to substitute one well-known non­
steroidal anti-inflammatory analgesic for another, also well known the art.
See KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The
combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results”). Furthermore,
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“[i]f a person of ordinary skill can implement a predictable variation, § 103
likely bars its patentability.” Id. at 417. Appellants make no argument that
the substitution of meloxicam for the other non-steroidal anti-inflammatory
analgesics taught by Chen would not yield predictable results. We
consequently affirm the Examiner’s rejection of independent claims 1 and
20.
Moreover, because Appellants rely upon the same arguments for the
remaining claims on appeal (see Appeal Br. 14—15), we affirm the
Examiner’s rejection of those claims for the same reason.
DECISION
The Examiner’s rejection of claims 1—20 as unpatentable under 35
U.S.C. § 103(a) is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
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