Ex Parte Chiou

Patent Trial and Appeal Board

Jul 16, 2018

13669318 (P.T.A.B. Jul. 16, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/669,318 11/05/2012
108547 7590 07/18/2018
McDermott Will & Emery LLP
500 North Capitol Street NW
Washington, DC 20001
FIRST NAMED INVENTOR
George C. Chiou
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.
091507-0030/8001.US04 9310
EXAMINER
HUANG, GIGI GEORGIANA
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
07/18/2018 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):
mweipdocket@mwe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GEORGE C. CHIOU
Appeal2017-007072
Application 13/669 ,318
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREY N. FRED MAN, and
DAVID COTTA, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a method
of treating dry age-related macular degeneration. The Examiner rejected the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
"Arteriosclerotic aging changes choroids blood vessels, particularly
the macular choriocapillaris with a decrease in total capillary membrane
blood flow." (Spec. ,r 3). "Gradually, Bruch's membrane shows thickening
1 Appellant identifies the Real Party in Interest as The Texas A & M
University System (see App. Br. 1 ).
Appeal2017-007072
Application 13/669,318
and decreased permeability, resulting with breakdown that allows choroidal
neovascularization (CNV) to appear ultimately resulting in age-related
macular degeneration and blindness" (Id.). "Thus, there is a need to identify
agents that prevent choroidal neovascularization" (Id.).
The Claims
Claims 9, 12, 15-18, 20, and 21 are on appeal. 2 Claims 9 and 12 are
representative and reads as follows:
9. A method of treating dry age-related macular
degeneration, comprising:
administering a composition comprising an interleukin- I
blocker to at least one eye of a subject diagnosed with dry age-
related macular degeneration, in an amount effective to increase
choroidal blood flow in the eye.
12. The method of claim 9, wherein the interleukin-I blocker
has a formula selected from
and
2 We limit our consideration of the merits of the appealed rejection to the
elected species. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BP AI 1987).
Thus, we read the claims as limited to the use of the elected CK-17
compound, also known as OB-101 (the first formula shown in claim 12) as
the active interleukin- I blocker (see Response to Election/Restriction filed
on May 3, 2013).
2
Appeal2017-007072
Application 13/669,318
wherein, R 1 is hydrogen, alkyl, substituted alkyl, aryl,
substituted aryl, arylalkyl, and substituted arylalkyl; R2 and R3
are the same or different and, at each occurrence, independently
hydrogen, alkyl, substituted alkyl, alkylcarboxyl or substituted
alkylcarboxyl; R 4 is hydrogen or alkyl; and R5 is alkyl.
The Rejections
A. The Examiner rejected claims 9, 12, 15-18, 20, and 21 under 35
U.S.C. § I03(a) as unpatentable over Chiou '8293 and Pershadsingh4 (Final
Act. 3-5).
B. The Examiner rejected claims 9, 12, 15-18, 20, and 21 under 3 5
U.S.C. § I03(a) as unpatentable over Chiou '4345 and Pershadsingh (Final
Act. 8-10).
C. The Examiner rejected claims 9, 12, 15-18, 20, and 21 on the ground
of obviousness-type double patenting over claims 1--4 of US 5,344,829,
Chou '434, and Pershadsingh (Final Act. 10-13).
D. The Examiner rejected claims 9, 12, 15-18, 20, and 21 on the ground
of obviousness-type double patenting over claims 1-6 and 9 of US
5,194,434 and Pershadsingh (Final Act. 13-15).
A. 35 US.C. § 103(a) over Chiou '829 and Pershadsingh
The Examiner finds Chiou '829 teaches treating ocular inflammation
with the elected compound, CK-17 (OB-101), which Chiou '829 teaches "is
useful for various ocular inflammatory diseases in both the anterior and
posterior portion of the eye, such as uveitis and keratitis" (Final Act. 3). The
3 Chiou, US 5,344,829, issued Sept. 6, 1994.
4 Pershadsingh et al., US 6,316,465 Bl, issued Nov. 13, 2001.
5 Chiou, US 5,194,434, issued Mar. 16, 1993.
3
Appeal2017-007072
Application 13/669,318
Examiner acknowledges Chiou '829 does not suggest treatment of macular
degeneration with the elected compound (Final Act. 4).
The Examiner finds Pershadsingh teaches "known
proliferative/inflammatory diseases of the eye include uveitis, keratitis, and
age-related macular degeneration- both wet/exudative and dry/atrophic
forms" (Final Act. 4 ).
The Examiner finds it obvious to treat macular degeneration with the
CK-17 (OB-101) compound of Chiou '829 because CK-17 (OB-101) "is
taught to be useful in the treatment of ocular inflammatory diseases and
Pershadsingh et al. addresses that macular degeneration ( wet and dry forms)
is a known inflammatory eye disease" (Final Act. 4).
The issue with respect to this rejection is: Does a preponderance of
evidence of record support the Examiner's conclusion that treatment of
macular degeneration with the elected CK-17 (OB-101) compound would
have been obvious?
Findings of Fact
1. Chiou '829 teaches
Ocular inflammation may occur in many different areas of the
eye. One type of ocular inflammation, uveitis, is the
inflammation of the uveal tract. Endogenous uveitis is caused
by various systemic processes or intraocular disorders whereas
exogenous uveitis is the result of the accidental introduction of
pathogenic organisms or foreign substances into the eye.
(Chiou '829 1 :35--40).
2. Chiou '829 teaches: "Toxoplasmosis, peripheral uveitis,
syphilis, tuberculosis, sarcoidosis and Vogt-Koyanagi-Harada syndrome
may occur in both the anterior and posterior segments of the eye. Although
4
Appeal2017-007072
Application 13/669,318
the etiology of these diseases can be different, they have the common
manifestation of ocular inflammation" (Chiou '829 1 :50-55).
3. Chiou '829 teaches "a method for the prevention and treatment
of ocular inflammation. In one embodiment, the invention is drawn to the
use of a new agent, OB- IO 1, as an ocular antiinflammatory agent. The
formula of this compound is as follows:
s
."(Chiou '829 2:65 to 3:10).
4. Chiou '829 teaches, regarding parenteral administration, that
"[a]n inflammation-controlling effective amount for purposes of preventing
or treating ocular inflammation is usually in the range of 0.1-20 mg/kg"
(Chiou '829 7:47-50).
5. Chiou '829 teaches that "OB-101 at doses of 3 mg/kg and 10
mg/kg and prednisolone at a dose of 10 mg/kg were injected
intraperitoneally" into Sprague-Dawley rats (Chiou 10:28-34) and that for
"3 mg/kg OB-101, uveitis responses measured at 3, 4 and 5 hours ... were
suppressed signifcantly at an average inhibition of 43%" (Chiou '829 10:53-
56).
6. Pershadsingh teaches, in claim 8, that
the inflammatory disease is selected from the group consisting
of uveitis, uveoretinitis, panuveitis, retinitis, iridocyclitis,
5
Appeal2017-007072
Application 13/669,318
immunological endophthalmitis, choroiditis, vitreitis, keratitis,
corneal ulceration, age-related macular degeneration, glaucoma,
conjunctivitis, and conjunctiva! ulceration, and the neovascular
proliferative disease is selected from the group consisting of
age-related macular degeneration, exudative macular
degeneration, atrophic macular degeneration, crystalline
retinopathy, retinal toxicosis of systemic medications,
idiopathic central serous choroidopathy, macular edema.
(Pershadsingh 40: 12-23, claim 8).
7. Table 1 of Pershadsingh is reproduced below:
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