Ex Parte Jong

Patent Trial and Appeal Board

Oct 19, 2016

13975261 (P.T.A.B. Oct. 19, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/975,261 08/23/2013 Ling Jong
23379 7590 10/21/2016
RICHARD ARON OSMAN
530 Lawrence Expy # 332
Sunnyvale, CA 94085
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.
SRI-6271-2US 1363
EXAMINER
RAMACHANDRAN, UMAMAHESW ARI
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
10/21/2016 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):
RICHARD@SCI-TECH.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LING JONG
Appeal2015-008035
Application 13/975,261
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
RYAN H. FLAX, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL 1
This appeal under 35 U.S.C. § 134(a) involves claims 21, 25, 26, 31-
33, and 38--40.2, 3 Examiner entered rejections under 35 U.S.C. § 103(a) and
obviousness-type double patenting. We have jurisdiction under 35 U.S.C.
§ 6(b). We AFFIRM.
1 Appellant identifies "[t]he real party in interest [as] SRI
INTERNATIONAL" (App. Br. 1).
2 Pending claims 27-30 and 34--37 stand withdrawn from consideration
(App. Br. 1 ).
3 Notwithstanding Appellant's contention to the contrary, Appellant
canceled claims 22-24 (see March 1, 2015 Amendment l; March 16, 2015
Advisory Action (entering Appellant's March 1, 2015 Amendment); App.
Br. 9 (claims "22-24. (canceled)"); cf App. Br. 1 ("Claims 21-40 are
pending ... and claims 21-26, 31-33 and 38-40 are ... the subject of this
appeal").
Appeal2015-008035
Application 13/975,261
STATEMENT OF THE CASE
Appellant's claims are directed to "[a] method for treating a person
determined to have an amyloid beta-associated neurodegenerative disease"
(App. Br. 9). Claim 21 is representative and reproduced below:
21. A method for treating a person determined to have an
amyloid beta-associated neurodegenerative disease, the method
comprising administering to the person an effective amount of a
bisindole of formula (I):
R6
I
wherein:
R1 R3 R4 R5 R7 and R8 are hydrogell"
' ' ' ' '
R2 and R6 are independently selected from H; halo;
carbonyl groups, cyano, nitro, and halogenated alkyl;
R9, and R 10 are substituents independently selected from
the group consisting of hydrogen, C1-C24 alkyl, C2-C24 alkenyl,
C2-C24 alkynyl, Cs-C20 aryl, C6-C24 alkaryl, C6-C24 aralkyl, halo,
hydroxyl, sulfuydryl, C1-C24 alkoxy, C2-C24 alkenyloxy, C2-C24
alkynyloxy, Cs-C20 aryloxy, acyl, acyloxy, C2-C24
alkoxycarbonyl, C6-C20 aryloxycarbonyl, C2-C24 alkylcarbonyl,
C6-C20 arylcarbonyl, halocarbonyl, C2-C24 alkylcarbonato,
C6-C20 arylcarbonato, carboxy, carboxylato, carbamoyl, mono-
(C1-C24 alkyl)-substituted carbamoyl, di-(C1-C24
alkyl)substituted carbamoyl, thiocarbamoyl, carbamido, cyano,
isocyano, cyanato, isocyanato, dihydroxyboryl, di-(C1-C24)-
alkoxyboryl, isothiocyanato, azido, formyl, thioformyl, amino,
mono- and di-(C1-C24 alkyl)-substituted amino, mono- and di-
(Cs-C20 aryl)-substituted amino, C2-C24 alkylamido, imino,
alkylimino, nitro, nitroso, sulfo, sulfonato, C1-C24 alkylsulfanyl,
2
Appeal2015-008035
Application 13/975,261
C1-C24 alkylsulfinyl, C1-C24 alkylsulfonyl, phosphono,
phosphonato, phosphinato, phospho, phosphino, and
combinations thereof; and
(App. Br. 9.)
R 11 and R 12 are hydrogen or methyl;
or a salt thereof.
In response to a restriction requirement, Appellant elected:
"Alzheimer's disease ([as the] species for neurodegenerative disease)[,]
memantine ([as the] additional agent for claims 38-40)" and "Compound 1,
[reproduced below, as the] compound of formula 1 of claim 21" (Ans. 4 and
11).
Compound 1
(see Spec. i-f 120.) We limit the scope of our review to Appellant's elected
invention. Ex parte Ohs aka, 2 USPQ2d 1460, 1461 (BP AI 1987).
The claims stand rejected as follows:
Claims 21, 25, 26 and 31-33 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over the combination of Gazit4 and Chao. 5, 6
4 Gazit et al., US 2010/0240726 Al, Sept. 23, 2010.
5 Wan-Ru Chao, et al., Computer-Aided Rational Drug Design: A Novel
Agent (SRI 3668) Designed to Mimic the Unique Anticancer Mechanisms of
Dietary Indole-3-Carbinol to BlockAkt Signaling, 50 J. Med. Chem. 3412-
3415 (2007).
6 Examiner's statement of rejection includes canceled claims 22-24 (see
Ans. 3). We did not include canceled claims 22-24 in our deliberations.
3
Appeal2015-008035
Application 13/975,261
Claims 38--40 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Gazit, Chao, and Forest.7
Claims 21, 25, 26, 31-33 stand(s) rejected under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1-24 of Jong8 in view of Gazit and Chao. 9
Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Gazit relates to "indole derivatives and compositions including same,
which can be efficiently used for preventing amyloid fibril formation and
thus for the treatment of amyloid associated diseases, such as ...
Alzheimer's dementia or diseases" (Gazit i-f 68).
7 Forest Laboratories, Inc., FDA Approves Namenda(TM) (memantine HCl)
for the Treatment of Moderate to Severe Alzheimer's Disease,
http ://investor. frx. com/press-release/product-news/f da-approves-name
ndatm-memantine-hcl-treatment-moderate-severe-alzheimers, (Oct. 1 7,
2003).
8 Jong et al., US 6,800,655 B2, issued Oct. 5, 2004.
9 Examiner's statement of rejection includes canceled claims 22-24 (see
Ans. 7-8). We did not include canceled claims 22-24 in our deliberations.
4
Appeal2015-008035
Application 13/975,261
FF 2. Gazit discloses that:
An indole derivative, according to [Gazit's] invention, 1s
represented by the general formula:
a pharmaceutically acceptable salt thereof, or a prodrug thereof,
wherein,
the dashed line denotes a double bond either between X and Y,
or, between Y and Z;
X, Y and Z are each independently selected from the group
consisting of carbon and nitrogen, whereas at least one of X, Y,
and Z is nitrogen; and
Ri-R10 are each independently selected from the group
consisting of hydrogen, lone pair electrons, hydroxyl, alkyl,
cycloalkyl, phenyl, phenol, hydroxyphenol, dihydroxyphenol,
aryl, alkenyl, alkynyl, heteroaryl, heteroalicyclic, halo, alkoxy,
aryloxy, thiohydroxy, thioalkoxy, thioaryloxy, C-carboxy, 0-
carboxy, thiocarboxy, carbonyl, oxo ... or, alternatively, at
least two of Ri-R10 form at least one five- or six-membered ...
heteroaromatic.
(Gazit iTiT 76-79.)
FF 3. Gazit defines "[a] 'heteroaryl' group [as] a monocyclic or fused ring
(i.e., rings which share an adjacent pair of atoms) group having in the ring(s)
one or more hetero-atoms, such as, for example, nitrogen" and, wherein,
"[t]he heteroaryl group may be substituted or unsubstituted" (Gazit iT 89).
FF 4. A representative compound that falls within the scope of Gazit's
genus of indole derivatives is indole-3-carbinol [(I3C]), which "is known as
5
Appeal2015-008035
Application 13/975,261
a food supplement that can be used in anti-cancer therapy" (Gazit if 75; Ans.
5).
FF 5. Gazit discloses "[a] method of treating Alzheimer's dementia or
disease in a subject in need thereof, the method comprising administering to
the subject a therapeutically effective amount of indole-3-carbinol" (Gazit
14:Claim 14; Ans. 5 and 11; App. Br. 7).
FF 6. Examiner finds that Gazit does not expressly teach Appellant's
elected species of "bisindole compound[,] SR 13 668 ... in a method of
treating ... Alzheimer's disease" (Ans. 5)
FF 7. Chao discloses a "class of indole analogs [that] optimize I3C's
anticancer actions ... [wherein,] [t]he most promising of [Chao's] analogs,
[is] SR13668[, which] exhibited potent oral anticancer activity against
various cancers and no significant toxicity" (Chao, Abstract; Ans. 5 and 10-
12; see App. Br. 8).
FF 8. Examiner finds that the combination of Gazit and Chao "do not teach
memantine as an additional agent to be administered along with SR13668 in
treating Alzheimer's disease" and relies on "Fore st [to] teach[] that
memantine has been approved by [the] FDA for treating moderate[] to
severe Alzheimer's disease" (Ans. 6).
ANALYSIS
The combination of Gazit and Chao:
Based on the combination of Gazit and Chao, Examiner concludes
that, at the time Appellant's invention was made, it would have been prima
facie "obvious to use SR13668 for indole-3-carbinol [] in treating
Alzheimer's disease [because] SR13668 has been taught as an analog of
6
Appeal2015-008035
Application 13/975,261
[1]3C and both [l3C and SR13668] are shown to exhibit ... similar utilities"
(Ans. 5; see id. at 12; FF 1-7).
Appellant contends "[t]hat SR13688 was rationally developed to
mimic the anticancer activity of a natural, dietary compound does not imply
that it is a close structural analog - it is plainly not ... - and Chao makes no
contrary allegation" (App. Br. 8; see Reply Br. 2). We are not persuaded.
Chao characterizes SR13688 as an analog of I3C (FF 7). In addition,
Appellant failed to provide persuasive evidence or argument to support a
conclusion that SR13688 does not fall within the genus of compounds that
Gazit discloses as useful in Gazit's methods (FF 1-5; cf Reply Br. 2
("Chao's compounds were not designed, synthesized nor optimized for
treating [Alzheimer's disease], and there was no evidence or reason
suggesting a related mechanism of action ... there is no prior art teaching
suggesting treating [Alzheimer's disease] with a compound of [Appellant's]
claims, nor even a structurally similar compound")). See In re Geisler, 116
F.3d 1465, 1470 (Fed. Cir. 1997) ("[A]ttomey argument [is] not the kind of
factual evidence that is required to rebut a prima facie case of obviousness").
The combination of Gazit, Chao, and Forest:
Based on the combination of Gazit, Chao, and Forest, Examiner
concludes that, at the time Appellant's invention was made, it would have
been prima facie "obvious to use memantine along with SR13668 in treating
Alzheimer's disease" (Ans. 7; FF 1-8; see generally Ans. 13).
For the foregoing reasons, we are not persuaded by Appellant's
contention that "[t]he cited art does not teach the claimed activity for any
close structural analog" of I3C (App. Br. 8; Reply Br. 3).
7
Appeal2015-008035
Application 13/975,261
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claim 21under35 U.S.C. § 103(a) as unpatentable
over the combination of Gazit and Chao is affirmed. Claims 25, 26 and 31-
33 are not separately argued and fall with claim 21.
The rejection of claim 38 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Gazit, Chao, and Forest is affirmed. Claims 39 and
40 are not separately argued and fall with claim 38.
Obviousness-type Double Patenting:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness-type double patenting?
FACTUAL FINDINGS (FF)
FF 9. Examiner finds that Jong "claims compounds and compositions of
formula I of the instant application including the elected compound,
compound 1" (Ans. 8).
FF 10. Examiner finds that Jong "do[ es] not teach compounds of formula I
in treating Alzheimer's disease" and relies on the combination of Gazit and
Chao to make up for this deficiency in Jong (id.; FF 1-7).
ANALYSIS
Based on Jong in view of Gazit and Chao, Examiner concludes that, at
the time Appellant's invention was made, it would have been prima facie
"obvious to use SR13668 for indole-3-carbinol [] in treating Alzheimer's
disease []because SR13668[, as taught by Jong and Chao,] has been taught
8
Appeal2015-008035
Application 13/975,261
as an analog of [1]3C and both [l3C and SR13668] are shown to exhibit ...
similar utilities" (Ans. 8; FF 9-10; see generally Ans. 13-14).
For the foregoing reasons, we are not persuaded by Appellant's
contention "[t]hat SR13688 was rationally developed to mimic the
anticancer activity of a natural, dietary compound does not imply that it is a
close structural analog - it is plainly not ... - and Chao makes no contrary
allegation" (App. Br. 8; see Reply Br. 3).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner support a
conclusion of obviousness-type double patenting.
The rejection of claim 21 under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 1-24
of Jong in view of Gazit and Chao is affirmed. Claims 25, 26, 31-33 are not
separately argued and fall with claim 21.
TIME PERIOD FOR RESPONSE
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
9