Ex Parte Rohrs et al

Board of Patent Appeals and Interferences

Aug 15, 2011

11850152 (B.P.A.I. Aug. 15, 2011)

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.
11/850,152 09/05/2007 Brian R. Rohrs P04150 7014
23702 7590 08/15/2011
Bausch & Lomb Incorporated
One Bausch & Lomb Place
Rochester, NY 14604-2701
EXAMINER
BLAKELY III, NELSON CLARENCE
ART UNIT PAPER NUMBER
1629
MAIL DATE DELIVERY MODE
08/15/2011 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte BRIAN R. ROHRS,
TIMOTHY L. COMSTOCK, ZHENZE HU,
and GARY PHILLIPS
__________

Appeal 2011-000918
Application 11/850,152
Technology Center 1600
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to treating,
controlling, reducing, or ameliorating eye allergies. The Examiner entered a
rejection for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

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STATEMENT OF THE CASE
Claims 40, 42, 43, 57, and 58 stand rejected and appealed (App. Br.
2). Claims 40, 42, and 43 illustrate the appealed subject matter and read as
follows:
40. A method for treating, controlling, reducing, or
ameliorating allergy of an eye, the method comprising: (a)
providing a composition comprising: (1) a DIGRA [dissociated
glucocorticoid receptor agonist], a pharmaceutically acceptable
salt thereof, or a pharmaceutically acceptable ester thereof; and
(2) an anti-allergic medicament; and (b) administering to an
affected eye of a subject an effective amount of the composition
at a frequency sufficient to treat, control, reduce, or ameliorate
said allergy in the subject.

42. The method of claim 40, wherein said anti-allergic
medicament is selected from the group consisting of
antihistamines, H1-receptor antagonists, H3-receptor
antagonists, H4-receptor antagonists, leukotriene antagonists,
mast-cell stabilizers, immunomodulators, anti-IgE agents, and
combinations thereof.

43. The method of claim 42, wherein said allergy is selected
from the group consisting of seasonal allergic conjunctivitis,
perennial allergic conjunctivitis, vernal keratoconjunctivitis,
atopic keratoconjunctivitis, giant papillary conjunctivitis, toxic
conjunctivitis, contact ocular allergy, and combinations thereof.

The sole rejection before us for review is the Examiner’s rejection of
claims 40, 42, 43, 57, and 58 under 35 U.S.C. § 103(a) as obvious over
Jaroch,1 Yanni,2 and Serna3 (Ans. 7-8).

1 CA 2586689 A1 (published May 18, 2006).
2 WO 01/35963 A1 (published May 25, 2001).
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OBVIOUSNESS
The Examiner cited Jaroch as disclosing the use of DIGRAs to treat
“eye diseases that are accompanied by inflammatory, allergic and/or
proliferative processes, such as allergic keratitis (inflammation of the
cornea), uveitis (inflammation of the middle layer of the eye), iritis
(inflammation of the iris), and conjunctivitis” (Ans. 4). The Examiner also
noted Jaroch’s teaching that its compounds were useful when “administered
either simultaneously or in succession together with one or more
pharmaceutical agents for treating one of the [listed] pathologic conditions”
(id.).
The Examiner conceded that Jaroch did not specifically disclose using
a second anti-allergic agent that was “a mast-cell stabilizer, or wherein the
allergy is vernal keratoconjunctivitis (VKC), for example” and cited Yanni
to meet that deficiency (id.). The Examiner found that Yanni treated ocular
conditions, “such as VKC” by administering “a composition comprising an
H1 antagonist and a safe steroid” (id. at 4-5). The Examiner noted that
ketotifen was listed by Yanni as a suitable H1 antagonist, and cited Serna to
show that ketotifen was known to be a mast-cell stabilizer (id. at 5).
Based on the references’ teachings, the Examiner concluded that an
ordinary artisan would have “envisaged the use of the compound of general
formula IIa [a DIGRA; id. at 4] in combination with a pharmaceutical agent,
such as ketotifen, in the treatment of a conjunctivitis, such as vernal

3 H. Serna et al., Mast Cell Stabilizer Ketotifen [4-(1-Methyl-4-
piperidylidene)-4H-benzo[4,5]cyclohepta[1,2-b]thiophen- 10(9H)-one
Fumarate] Prevents Mucosal Mast Cell Hyperplasia and Intestinal
Dysmotility in Experimental Trichinella spiralis Inflammation in the Rat,
319 J. PHARMACOL. EXPER. THERAPEUTICS 1104-1111 (2006).
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keratoconjunctivitis, as disclosed by Jaroch et al. and Yanni” (id.). The
Examiner reasoned that an ordinary artisan “would have been motivated to
combine the teachings of the aforementioned references when seeking a
combination therapy to relieve inflammation caused by allergic responses”
(id.).
Appellants argue, for a variety of reasons, that the Examiner failed to
make a prima facie case of obviousness. In particular, Appellants argue, the
cited combination of references fails to demonstrate prima facie obviousness
because “there is no articulatable reason or incentive for a combination of an
anti-allergic medicament and a DIGRA” (App. Br. 5, 7-8; see also Reply Br.
2-3 (urging that the Examiner misapplied In re Kerkhoven, 626 F.2d 846
(CCPA 1980))).
Moreover, Appellants urge, the Examiner erred in finding that an
ordinary artisan would have considered the compounds of Jaroch to be safe
steroids, as that term is used in Yanni (App. Br. 5-7). Further, Appellants
urge, when viewed as a whole, Jaroch’s disclosure is merely speculative as
to the possibility of combining its compounds with other ingredients, and
“[m]ere disclosure of a combination of two drugs does not render all future
combination therapies obvious” (id. at 9; see also Reply Br. 3-4).
Thus, Appellants contend, “Jaroch’s vague disclosure of innumerable
possible diseases that mankind has suffered couple[d] with Yanni[’s]
disclosure of steroids and anti-H1 receptor antagonist and Serna’s
classification of ketotifen as mast cell stabilizer does not render obvious the
claimed method of treating eye allergy with a DIGRA and an anti-allergic
medicament” (id. at 9-10).
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Appellants’ arguments do not persuade us that the Examiner failed to
make a prima facie case of obviousness. We adopt the Examiner’s findings
of fact and conclusions (see Ans. 3-9).
Claim 40 recites a method for treating, controlling, reducing, or
ameliorating an eye allergy. As seen from its dependent claim 43, a number
of conjunctivitis disorders, including vernal keratoconjunctivitis, are among
the allergies encompassed by claim 40’s method.
Claim 40 requires the practitioner to first provide a composition that
contains two ingredients – (1) a DIGRA or a pharmaceutically acceptable
salt or ester thereof, and (2) an anti-allergic medicament. As seen from its
dependent claim 42, claim 40’s anti-allergic medicament can be an H1-
receptor antagonist or a mast-cell stabilizer.
Claim 40 then requires the practitioner to administer the composition
to an affected eye of a subject in an amount, and at a frequency, effective to
treat, control, reduce, or ameliorate the subject’s allergy.
Jaroch discloses a number of “5-substituted quinoline and
isoquinoline derivatives . . . and their use as anti-inflammatory agents,”
noting that “surprisingly enough” certain of its compounds “are especially
active and are dissociated with respect to side effects and are preferably
suitable for local administration” (Jaroch 1). It is undisputed on this record
that Jaroch’s compounds are DIGRAs, as claim 40 requires.
Jaroch discloses that its compounds can be “used as medications for
treatment or prophylaxis of the following pathologic conditions in mammals
and humans; in particular for the local administration: . . . (x) Eye diseases
that are accompanied by inflammatory, allergic and/or proliferative
processes: . . . [including c]onjunctivitis“ (Jaroch 14-18).
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Jaroch further discloses:
The invention also relates to combination therapies or
combined compositions, in which a glucocorticoid receptor
(GR) agonist of formula (I) . . . is administered either
simultaneously (optionally in the same composition) or in
succession together with one or more pharmaceutical agents
for treating one of the above-mentioned pathologic conditions.
For example, for treatment of rheumatoid arthritis,
osteoarthritis, COPD (chronic obstructive lung disease), asthma
or allergic rhinitis, a GR agonist of this invention can be
combined with one or more pharmaceutical agents for treating
such a condition.

(Jaroch 21 (emphasis added).)
Yanni discloses “the use of an H1 antagonist in combination with an
ocularly safe steroid to treat ocular conditions, specifically vernal
keratoconjunctivitis (VKC), giant papillary conjunctivitis (GPC), and atopic
keratoconjunctivitis (AKC)” (Yanni 1).
Yanni also notes that “[t]opical ocular combination therapy is known.
For example, U.S. Patent No. 5,192,780 (York, et al) discloses the use of an
antihistamine and an antiallergic for treating ophthalmic allergic responses”
(id.).
Given Jaroch’s teaching that its compounds were useful for topically
treating conjunctivitis, and were suitably combined with one or more
additional therapeutic agents in the described treatment methods, we are not
persuaded that the Examiner erred in finding that an ordinary artisan would
have been prompted to include Jaroch’s compounds in a composition that
also contained Yanni’s conjunctivitis-treating H1-antagonist/steroid
combination, particularly in light of Yanni’s disclosure of the suitability of
topical ocular combination therapy. Thus, because the cited references
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suggest administering a composition containing the combination of
ingredients required by claim 40, to a subject suffering from a condition
encompassed by claim 40, we are also unconvinced that the Examiner erred
in concluding that claim 40 would have been prima facie obvious to an
ordinary artisan viewing the references.
It may be true, as Appellants argue, that an ordinary artisan would not
have considered Jaroch’s compounds to be steroids, such that the artisan
would have substituted Jaroch’s compounds for Yanni’s steroids. It may
also be true that Jaroch fails to disclose a specific example where an anti-
allergic medicament is combined with a DIGRA.
Nonetheless, “in a section 103 inquiry, ‘the fact that a specific
[embodiment] is taught to be preferred is not controlling, since all
disclosures of the prior art, including unpreferred embodiments, must be
considered.’” Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804,
807 (Fed. Cir. 1989) (quoting In re Lamberti, 545 F.2d 747, 750 (CCPA
1976)); see also In re Mills, 470 F.2d 649, 651 (CCPA 1972) (“All the
disclosures in a reference must be evaluated, including nonpreferred
embodiments, and a reference is not limited to the disclosure of specific
working examples.” (Citations omitted)).
Thus, because both Jaroch and Yanni at the very least suggest the
suitability of combining topically applied ocular allergy-treating agents, we
are not persuaded that the Examiner erred in finding that an ordinary artisan
would have been prompted to combine the active ingredients in Jaroch’s and
Yanni’s compositions – a DIGRA, ketotifen, and a steroid – and to have
administered them to treat such allergies, as claim 40 requires.
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Moreover, while Appellants urge that arriving at the claimed
invention from the cited references would have required the ordinary artisan
to “vary all parameters or to try each of numerous possible choices until one
possibly arrived at a successful result, where the prior art gave either no
indication of which parameters were critical or no direction as to which of
many possible choices is likely to be successful” (App. Br. 9 (citing In re
Kubin, 561 F.3d 1351, 1359 (Fed. Cir. 2009))), Appellants have not pointed
to any specific evidence in support of that assertion, and it is unclear what
parameters Appellants are asserting must varied. Absent some specific
evidence to the contrary, we are not persuaded that an ordinary artisan would
have been unable to treat the disorders specifically named by the references
according to the references’ teachings.
Further, the fact that Jaroch might include treating eye allergies,
including conjunctivitis, in a much longer list of other treatable disorders
does not persuade us that it would have been unobvious to treat any one of
the specifically named disorders with Jaroch’s compounds. Cf. Merck v.
Biocraft, 874 F.2d at 807 (species claim held obvious where it recited one of
1200 possible combination embodiments disclosed by reference and where
reference suggested no preference for claimed embodiment).
In sum, for the reasons discussed, Appellants’ arguments do not
persuade us that the Examiner erred in concluding that claim 40 would have
been obvious over the cited references. We therefore affirm the Examiner’s
obviousness rejection of claim 40.
Claims 42, 43, 57, and 58 fall with claim 40 as they were not argued
separately. See 37 C.F.R. § 41.37(c)(1)(vii).

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TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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