Ex Parte Koenen et al

Patent Trial and Appeal Board

Jun 13, 2013

10515896 (P.T.A.B. Jun. 13, 2013)

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.
10/515,896 08/15/2005 Ruediger Koenen 26428U 8423
34375 7590 06/13/2013
NATH, GOLDBERG & MEYER
112 South West Street
Alexandria, VA 22314
EXAMINER
HUANG, GIGI GEORGIANA
ART UNIT PAPER NUMBER
1629
MAIL DATE DELIVERY MODE
06/13/2013 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

Ex parte RUEDIGER KOENEN and RUDOLF LINDER

________________

Appeal 2011-012238
Application 10/515,896
Technology Center 1600
________________

Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and
JOHN G. NEW, Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

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SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 7, 13, and 16-29.1 Specifically,
claims 7, 13, and 16-20 stand rejected as unpatentable under 35 U.S.C.
§ 103(a) as being obvious over the combination of Amschler (US
5,712,298, January 27, 1998) (“Amschler”) and Maurizio Rolando and
Manfred Zierhut, The Ocular Surface and Tear Film and Their Dysfunction
in Dry Eye Disease, 45 SURVEY OF OPHTHALMOLOGY (Supp. 2) S203-S210
(2001) (“Rolando”).
Claims 7, 13, and 16-20 also stand rejected as unpatentable under 35
U.S.C. § 103(a) as being obvious over the combination of Gamache (US
6,872,382 B1, March 29, 2005) (“Gamache”) and Peter Reid, Roflumilast
Altana Pharma, 3(8) CURRENT OPINION IN INVESTIGATIONAL DRUGS 1165-
1170 (2002) (“Reid”).
Claims 21-24 and 26-29 stand rejected as unpatentable under 35
U.S.C. § 103(a) as being obvious over the combination of Amschler,
Rolando, and Friesen et al. (WO 01/90076 A1, November 29, 2001)
(“Friesen”).
Claims 22, 23, and 25 stand rejected as unpatentable under 35 U.S.C.
§ 103(a) as being obvious over the combination of Gamache, Reid, and E.J.
German, M.A. Hurst, and D. Wood, Reliability of drop size from multi-dose
eye drop bottles: is it cause for concern?, 13(1) EYE (LOND.) 93-100 (1999)
(“German”).

1 Claims 1-6 and 8 are canceled. App. Br. 30. Claims 9-12, 14, and 15 are
withdrawn. App. Br. 30-32.
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Claim 21 stands rejected as unpatentable under 35 U.S.C. § 103(a) as
being obvious over the combination of Amschler, Rolando, Cagle (WO
00/18388, April 6, 2000) (“Cagle”), and Pfizer CentreSource,
Dexamethasone USP Micronized (“Pfizer”).
Claim 21 also stands rejected as unpatentable under 35 U.S.C. §
103(a) as being obvious over the combination of Gamache, Reid, and
Neena Washington, Clive Washington, and Clive G. Wilson,
PHYSIOLOGICAL PHARMACEUTICS, BARRIERS TO DRUG ABSORPTION (2d ed.)
(CRC Press, 2001) (“Washington”).
Claims 7, 13, and 16-29 also stand provisionally rejected on the
ground of obviousness type double patenting over claims 29-33 of USSN
12/149,250.2
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

NATURE OF THE CLAIMED INVENTION
Appellants’ invention is directed to a pharmaceutical preparation for
treatment of diseases of the eye comprising a PDE 4 inhibitor, to processes
for producing the pharmaceutical preparation and methods for treatment of
diseases of the eye. Specification 1.

2 The rejection of claims 22-29 under 35 U.S.C. § 112 (second paragraph)
are withdrawn by the Examiner. Ans. 4.
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REPRESENTATIVE CLAIM

Claim 7 is representative of the claims at issue. App. Br. 15. Claim
7 recites:
7. A method of treating a patient suffering from dry eye
syndrome (keratitis sicca) comprising administering to said
patient in need thereof an ophthalmological pharmaceutical
preparation comprising a therapeutically effective and
pharmacologically suitable amount of an active pharmaceutical
ingredient chosen from roflumilast, a salt of roflumilast, the N-
oxide of roflumilast and a salt thereof;

wherein the ophthalmological pharmaceutical preparation
is suitable for administration in, on or close to the eye.

App. Br. 24.

ISSUES AND ANALYSES
A. Claims 7, 13, and 16-20
1. Issue 1
Appellants argue that the Examiner erred because the combination of
Amschler and Rolando neither teaches nor suggests every limitation of
claim 7. App. Br. 16. We therefore address the issue of whether the
Examiner so erred.

Analysis
Appellants argue that although Amschler teaches the use of
fluoroalkoxy-substituted benzamides as cyclic nucleotide phosphodiesterase
IV (“PDE-IV”) inhibitors (such as roflumilast, the compound recited in
claim 7) for the treatment inflammatory disorders, including allergic
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conjunctivitis, Amschler neither teaches nor suggests the use of the claimed
active pharmaceutical ingredients in the treatment of a patient suffering
from dry eye syndrome. App. Br. 16. Appellants also argue that although
Rolando teaches “that dry eye syndrome can be a consequence of chronic
allergic conjunctivitis due to the continuous activation of the local immune
system,” Rolando neither teaches nor suggests “the use of any PDE-IV
inhibitors for the treatment of any of these diseases and/or disorders,
including allergic conjunctivitis or dry eye.” Id.
Appellants contend that allergic conjunctivitis and dry eye are two
distinct “diseases” and that a person of ordinary skill in the art would not
necessarily equate treatment of the divergent diseases taught by Rolando
with the treatment of dry eye and would, therefore, have no motivation to
combine the teachings of the two references. App. Br 16-17.
Furthermore, argue Appellants, even if such motivation were to exist,
there is no teaching or suggestion in Rolando that would suggest to the
ordinarily skilled artisan that treating chronic allergic conjunctivitis would
also treat every distinct and divergent “resulting and related” condition
(e.g., dry eye) associated with chronic allergic conjunctivitis (or with other
inflammatory responses). App. Br. 17-18. Appellants admit that the
combination of Amschler and Rolando might suggest to an artisan of
ordinary skill that roflumilast may be used to treat allergic conjunctivitis,
thereby preventing dry eye syndrome from ever occurring. App. Br. 18.
However, argue Appellants, Amschler and Rolando neither teach nor
suggest that roflumilast may be used to treat allergic conjunctivitis and, in
so doing, also treat every distinct and divergent “resulting and related”
condition, including dry eye syndrome. Id.
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The Examiner responds that although Amschler does not explicitly teach
the treatment of dry eye with PDE-IV inhibitors, Amschler does teach the
utility of such compounds, including roflumilast, for the treatment of
inflammatory conditions of the eye generally and, specifically, for the
treatment of allergic conjunctivitis. Ans. 18-19 (citing Amschler, col. ll.
39-42; col. 12 ll. 12-13). The Examiner also finds that Rolando teaches that
dry eye (a known inflammatory condition) is a common consequence of
chronic allergic conjunctivitis. Ans. 19 (citing Rolando, Fig. 3, S207).
The Examiner finds that a person of ordinary skill in the art would therefore
have been motivated, with a reasonable expectation of success, to treat not
only allergic conjunctivitis with the claimed compound, as taught by
Amschler, but also any subsequent symptoms and related conditions,
including dry eye. Ans. 19.
The Examiner rejects Appellants’ argument that allergic
conjunctivitis and dry eye are two distinct diseases, finding that Rolando
explicitly teaches that: “dry eye is a common consequence of chronic
allergic conjunctivitis due to the continuing activation of the local immune
system. A vicious cycle of irritation and ocular surface damage may cause
dry eye symptoms to persist for months after the allergic episode.” Ans. 20
(quoting Rolando, S207). The Examiner also finds that it is well-accepted
in the ophthalmic art that steroids have been used for chronic allergic
conjunctivitis and chronic dry eye, contrary to Appellants’ assertion that
both conditions are not treated with the same medication. Id. Therefore,
the Examiner finds, when presented with a drug that can treat inflammatory
conditions of the eye such as allergic conjunctivitis (as taught by
Amschler), one of ordinary skill in the art would find it obvious to treat its
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related and common consequence — including dry eye (which Rolando
teaches is also an inflammatory response) with the same effective drug.
Ans. 20.
The Examiner finds further that Amschler teaches treating various
inflammatory conditions, but does not necessarily teach the elimination of
the condition. Ans. 21. The Examiner finds that treatment of a condition
includes addressing the condition and its symptoms via, e.g., management
and/or reduction of symptoms, but does not necessarily require the actual
elimination of a disease condition—particularly an inflammatory one. Ans.
22.
We are not persuaded by Appellants’ arguments. We agree with the
Examiner that Amschler explicitly teaches the use of the claimed
composition for the treatment of various inflammatory responses, including
those of the eye, such as allergic conjunctivitis. Amschler, col. 12 ll. 12-13;
Ans. 18-19. We further agree with the Examiner’s finding that Rolando
teaches or suggests that dry eye is an inflammatory response (viz., an
irritation) of the tissues of the eye that is related to, and may be caused by,
allergic conjunctivitis. Rolando, S207; Ans. 20. Moreover, we find that
there is nothing in the language of claim 7 that precludes administration of
PDE-IV compounds, including those recited in claim 7, to patients with
allergic conjunctivitis who are at risk of developing dry eye, or who have
allergic conjunctivitis as well as dry eye, as Rolando suggests. We
therefore find that the Examiner did not err in concluding that claim 7
would have been obvious over the teachings and suggestions of Amschler
and Rolando and accordingly affirm the Examiner’s rejection of that claim
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over those references. As they were not argued separately, claims 13 and
16-20 fall with claim 7. 37 C.F.R. § 41.37(c)(1)(vii).

2. Issue 2
Appellants also argue that the Examiner erred in rejecting claim 7
over Gamache and Reid because neither reference provides a reasonable
expectation of success. App. Br. 24. We therefore address the issue of
whether the Examiner so erred.

Analysis
Appellants argue that Gamache teaches the use of PDE-IV inhibitors
generally for treating dry eye disorders via topical administration to the eye
in the form of eye drops or eye ointments, which are formulated as
suspensions, solutions or other topical administration forms. App. Br. 24
(citing Gamache, col. 3, ll. 2-7; col 4, lines 4-19). Appellants contend,
however, that Gamache does not teach or suggest roflumilast as the
selective PDE-IV inhibitor. App. Br. 25.
Appellants argue that Reid teaches the systemic administration of
roflumilast for the treatment of airway disorders, such as asthma, but does
not teach or suggest either the use of roflumilast for the treatment of eye
disorders or the incorporation of roflumilast in any composition suitable for
administration in, on or close to the eye, as required by claim 7. App. Br.
25. Appellants contend that one of ordinary skill in the contemporaneous
art would not have had a reasonable expectation of successfully
incorporating roflumilast from Reid into the topical composition of
Gamache because it would not have been obvious to such an artisan to
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incorporate a drug that is known for systemic administration for airway
disorders (Reid) into a topical composition for treating eye disorders
(Gamache). App. Br. 25-26. Appellants also argue that, because Reid
allegedly teaches that roflumilast is less potent than piclimast, an artisan of
ordinary skill would not have been motivated to combine the two teachings
to reach Appellants’ claimed invention. App. Br. 25.
The Examiner responds that Gamache explicitly teaches the use of
selective PDE-IV inhibitors for treating dry eye and that Reid expressly
teaches that roflumilast is a monoselective (i.e., selective) PDE-IV
inhibitor. Ans. 26 (citing Gamache, Abstract, claims 1-3). The Examiner
finds that, based upon the combined teachings of Gamache and Reid, one of
ordinary skill in the art would have had a reasonable expectation of success
when using roflumilast, a known, effective PDE-IV inhibitor, for the
treatment of dry eye. Id.
The Examiner also finds that Reid explicitly teaches that: “[a]lthough
a number of [PDE-IV] inhibitors are in development roflumilast is the most
potent and has better oral bioavailability than piclamast. Ans. 27-28
(quoting Reid, 1168). The Examiner also rejects Appellants’ assertion that
one of skill in the art would pick only one PDE-IV inhibitor, in light of
Gamache’s more general teaching that selective PDE-IV inhibitors are
effective in the treatment of dry eye. Ans. 28.
We are persuaded by the Examiner’s reasoning and adopt it as our
own. We agree with the Examiner that Gamache teaches that selective
PDE-IV inhibitors are effective in the treatment of dry eye. See Gamache,
Abstract; Ans. 26. We also agree that Reid teaches that roflumilast, is a
potent monoselective PDE-IV inhibitor. See Reid, 1165, 1168; Ans. 27-28.
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Although Reid explicitly teaches the use of roflumilast as an inhaled
bronchodilator in the treatment of asthma and other broncho-obstructive
conditions, its activity as a potent monoselective PDE-IV inhibitor was
known in the contemporaneous art, and Reid does not exclude or
discourage the use of roflumilast in other applications (viz., topical
treatment of red eye) in which selective PDE-IV inhibitors are known to be
effective, as taught by Gamache. See, e.g., In re Kotzab, 217 F.3d 1365,
1370 (Fed. Cir. 2000): (All elements of each prior art reference need not
read on the claimed invention, rather, the proper test for obviousness is
what the combined teachings would have suggested to a person of ordinary
skill in the art). We therefore find that the Examiner did not err in finding
that an artisan of ordinary skill in the contemporaneous art would have had
a reasonable expectation of success in combining the teachings of Reid and
Gamache to arrive at the claimed invention.
We therefore also find that the Examiner did not err in concluding
that claim 7 would have been obvious over the teachings and suggestions of
Reid and Gamache and accordingly affirm the Examiner’s rejection of that
claim over those references. As they were not argued separately, claims 13
and 16-20 fall with claim 7. 37 C.F.R. § 41.37(c)(1)(vii).

B. Claims 21-24 and 26-29
1. Issue
Appellants argue that, in addition to the arguments presented with
respect to issue A1 supra, the combination of Amschler, Rolando, and
Friesen do not teach the milligram amount of the active in the dosage unit
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recited in the claims. App. Br. 21. We therefore address the issue of
whether the Examiner so erred.

Analysis
Appellants argue that Friesen teaches the treatment of allergic
conjunctivitis with PDE IV inhibitors that be administered topically in the
form of creams, ointments, jellies, solutions or suspensions and that the
dosage level can be about 0.5 mg to about 7g per patient/day. App. Br. 21,
(citing Friesen, 11, lines 24-25). However, Appellants allege that Friesen
neither teaches the use of any PDE-IV inhibitor, let alone roflumilast, for
the treatment of dry eye. App Br. 21.
The Examiner responds that Friesen is cited to show that the
roflumilast compounds are known to be used for treating inflammatory
responses, including allergic conjunctivitis and that the compounds can be
formulated in various pharmaceutical forms for administration from about
0.01 mg/kg to about 140mg/kg body weight/day (i.e., 0.5mg-7g/day, about
Ans. 23 (citing Friesen, 3-5, claim 4; 11, l. 11; 12, l. 28; 14 l. 5-9).
We have related supra, our reasons for finding that the claims are
obvious over the combination of Amschler and Rolando. Friesen teaches a
range of doses for PDE-IV inhibitors that are effective for the treatment of
allergic conjunctivitis (see Friesen 12), and we agree with the Examiner that
it would have been obvious for a person of ordinary skill in the
contemporaneous art to combine the teachings of Friesen with those of
Amschler and Rolando to arrive at Appellants’ claimed dosage amounts for
the treatment of dry eye. We therefore find that the Examiner did not err in
concluding that claims 21-24 and 26-29 would have been obvious to an
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ordinary artisan and affirm the Examiner’s rejection of those claims over
Amschler, Rolando, and Friesen.

C. Claims 22, 23, and 25
1. Issue
Appellants argue that the Examiner erred in finding that combination
of Gamache, Reid, and German would have provided an artisan of ordinary
skill with a reasonable expectation that the proposed combination would
have been successful at the time of filing. App. Br. 27. We therefore
address the issue of whether the Examiner so erred.

Analysis
Appellants argue, as an initial matter, that German teaches no
milligram amount for the active ingredient in each drop. App. Br. 27.
Appellants argue further that one of ordinary skill in the art would not have
had a reasonable expectation of successfully incorporating the teaching of
Reid with respect to roflumilast into the topical composition taught by
Gamache, in the recited milligram amounts, because an artisan of ordinary
skill would not have found it obvious to incorporate a drug that is known
for systemic administration for airway disorders (as taught by Reid) into a
topical composition for treating eye disorders (as taught by Gamache) in the
amounts recited in the presently pending claims. Id.
The Examiner responds that the combination of Gamache and Reid
teaches or suggests the use of selective PDE-IV inhibitors, such as
roflumilast, for treating dry eye. Ans. 29. The Examiner finds that
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Gamache also teaches that the effective dosage range for selective PDE-IV
inhibitors is in the range of approximately 0.001- 1.0% w/v of the
composition with administration being 1-2 drops once or multiple times
daily (e.g., up to 10x/day). Id. (citing Gamache, col. 4, ll. 1-10, col. 5, ll.
40-50, col. 6, claims 1-2). The Examiner finds that a range of compositions
of approximately 0.001% - 1.0% w/v of the active compound (as taught by
Gamache), and a range of volumes of approximately 33.8-63.4 µL/drop (as
taught by German), administered between 1-10x daily results in a daily
dose of about 0.00000038mg to about 0.013mg. Ans. 29. The Examiner
finds further that it would have been well within the skill of one in the
contemporaneous art to adjust the amount of the active PDE-IV inhibitor in
the composition, and to adjust the frequency of administration, to attain the
desired therapeutic result with the minimal side effects. Id.
We have related supra in Section A2 why we agree with the
Examiner with respect to the combination of Gamache and Reid.
Moreover, we agree with the Examiner that, given range of suitable dosages
described in Gamache, the combination of Gamache and German suggests
the dosage ranges recited in the claims. We therefore conclude that the
Examiner did not err in so finding and accordingly affirm the Examiner’s
obviousness rejection of claims 22, 23, and 25 over Gamache, Reid, and
German.

D. Claim 21
1. Issue 1
Appellants argue that the combination of Amschler, Rolando, Cagle,
and Pfizer does not teach or suggest the particle size of the active ingredient
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in suspension recited in claim 21. App. Br. 22. We therefore address the
issue of whether the Examiner so erred.

Analysis
Appellants allege that Cagle teaches or suggests the use of antibiotic
pharmaceutical compositions to topically treat ophthalmic, otic and nasal
infections. App. Br. 22. Appellants also contend that Cagle teaches that
one or more anti-inflammatory agents can be incorporated into such
pharmaceutical compositions. App. Br. 22-23. However, argue Appellants,
Cagle does not teach or suggest treating any specific eye diseases, let alone
dry eye syndrome. App. Br. 23.
Appellants argue further that Pfizer does not teach or suggest treating
dry eye syndrome, nor does it teach or suggest treating dry eye syndrome
with a PDE-IV inhibitor. App. Br. 23.
Appellants contend that it is known in the pharmaceutical arts that
the therapeutic delivery profile of a compound depends not only upon the
particle size but also upon other properties including, for example, the
compound’s dissolution rate. Appellants argue that the Examiner failed to
demonstrate that roflumilast and dexamethasone have similar dissolution
rates and would therefore have similar dissolution rates at the same particle
size. Id. According to Appellants, there would therefore have been no
reasonable expectation of success in modifying the cited references to
arrive at the presently pending claims. Id.
The Examiner responds that Cagle and Pfizer are cited merely to
demonstrate that the formulation of micronized anti-inflammatory
ophthalmic suspensions was well-known by one of ordinary skill in the
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contemporary art and was neither new nor novel. Ans. 24. The Examiner
finds that Cagle establishes that micronized ophthalmic solutions and
suspension are known in the art and can be used in the formulation of anti-
inflammatory compounds such as roflumilast and dexamethasone. The
Examiner finds that Pfizer is teaches that when micronizing anti-
inflammatory compounds in a formulation such as roflumilast and
dexamethasone, it is well-known in the art to formulate the drug as
micronized as possible, and preferably within certain known ranges, e.g.,
with at least 99% of the particles of less than 20 µm and at least 75% at less
than 10 µm. App. Br. 24-25; Pfizer, 2. The Examiner therefore finds that
Pfizer teaches that not only are micronized ophthalmic formulations known
for anti-inflammatory agents like dexamethasone and roflumilast, but also
that anti-inflammatory agents are well-known in the art to be available in
commercial pharmaceutical forms in certain known ranges. App Br. 25.
We agree with the Examiner. We have addressed supra the reasons
why we find that Gamache and Reid teach the treatment of red eye with
selective PDE-IV inhibitors, including roflumilast. We find that Cagle
explicitly teaches the composition of ophthalmic suspensions of roflumilast
and dexamethasone. Cagle, 3, 9. Moreover, we agree with the Examiner
that Pfizer provides evidence that micronized suspensions of anti-
inflammatory drugs such as dexamethasone were known in the art, and
suggests that determining an effective particle size would have been
obvious to an artisan of ordinary skill. Ans. 24-25. We therefore conclude
that the Examiner did not err in finding that the cited prior art references
teach or suggest the limitations recited in claim 21 and affirm the rejection
of that claim over Amschler, Rolando, Cagle, and Pfizer.
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2. Issue 2
Appellants argue that the Examiner erred in finding that the
combination of Gamache, Reid, and Washington teaches or suggests the
acceptable particle size of roflumilast in a topical formulation for treating
dry eye, as recited in claim 21. App. Br. 28.

Analysis
Appellants argue that one of ordinary skill in the contemporary art,
reading the cited references, would not have had a reasonable expectation
of successfully incorporating roflumilast from Reid into the topical
composition of Gamache in the recited particle size, because one of
ordinary skill in the art would not find it obvious to incorporate a drug that
is known for systemic administration for airway disorders (as taught by
Reid) into a topical composition for treating eye disorders (as taught by
Gamache) in the particle sizes recited in the presently pending claims. App.
Br. 28.
The Examiner responds that Washington teaches or suggests that
poorly soluble drugs for ophthalmic administration, such as roflumilast, are
usually formulated as micronized suspensions, in which smaller particle
size is generally more acceptable for suspension formulations and also
improves patient comfort. Ans. 30. The Examiner also finds that
Washington further teaches or suggests that submicron or nanosphere sizes
(under 1 micron) have better therapeutic properties and a longer effect,
with better contact time for better ocular absorption. Id. The Examiner
therefore finds that an artisan of ordinary skill would have combined the
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references to arrive at the well-known micronized suspension used for
poorly soluble drugs such as roflumilast. Id.
We agree with the Examiner. We have addressed supra our reasons
for why we find that the combination of Gamache and Reid teaches or
suggests the treatment of red eye with roflumilast. Moreover, we agree
with the Examiner that Washington teaches or suggests micronized
suspensions, which were well-known in the contemporary art, as well as the
utility of micronized suspensions of particles of less than 10 microns. See
Washington, 265 (“Increasing the size of particles to 25 µm in diameter will
increase retention time to around 12 hours in a rabbit, compared to 3 µm
particles which disappear almost as fast as aqueous solutions…. Hence,
small particle sizes generally improve patient comfort and acceptability of
suspension formulations”); Ans. 30. We consequently conclude that the
Examiner did not err in finding that the combination of Gamache, Reid, and
Washington teaches or suggests the limitations of claim 21 and affirm the
rejection of that claim over those references.

DECISION

The Examiner’s rejection of claims 7, 13, and 16-29 as unpatentable
under 35 U.S.C. 103(a) is affirmed.

AFFIRMED

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