Ex Parte Lee

Board of Patent Appeals and Interferences

Dec 14, 2011

10850072 (B.P.A.I. Dec. 14, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte FRANCIS Y.F. LEE
__________

Appeal 2011-002616
Application 10/850,072
Technology Center 1600
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

Opinion for the Board filed by Administrative Patent Judge GRIMES.

Opinion Dissenting filed by Administrative Patent Judge MILLS.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating cancer. The Examiner has rejected the claims for obviousness
and obviousness-type double patenting. We have jurisdiction under 35
U.S.C. § 6(b). We reverse the obviousness rejections but affirm the double
patenting rejection.
Appeal 2011-002616
Application 10/850,072

2
STATEMENT OF THE CASE
Claims 121-127 and 141-143 are on appeal. Claim 121 is
representative and is directed to a method of treating pancreatic or lung
cancer by administering, in combination, two compounds:
(a) Compound (1), which is also known as ixabepilone (Lee
Declaration,1 ¶ 3), C-15-Aza-EpoB (Appeal Br. 7), 15-Aza-EpoB (id. at 8),
or BMS 247550 (id.), and
(b) antibody C225, which is also known as cetuximab (Appeal Br. 7).
The full text of claim 121 is reproduced in Appellant’s Claims Appendix
(Appeal Brief 17).
Claims 121-127 and 141-143 stand rejected under 35 U.S.C. § 103(a)
as obvious based on Danishefsky2 and Chen3 (Answer 3) or based on Vite4
and Chen (Answer 5). Claims 121-127 and 141-143 also stand rejected for
obviousness-type double patenting based on the claims of Lee5 in view of
Chen (Office Action mailed July 8, 2009, pp. 2-36).

1 Declaration under 37 C.F.R. § 1.132 of Francis Y.F. Lee, executed Feb. 19,
2009.
2 Danishefsky et al., US 6,867,305 B2, Mar. 15, 2005.
3 Chen et al., US 2002/0147198 A1, Oct. 10, 2002.
4 Vite et al., WO 99/02514, Jan. 21, 1999.
5 Lee, U.S. RE41,393 E, reissued June 22, 2010.
6 The double-patenting rejection is not set out in the Answer but the record
shows that Examiner intended to maintain the rejection, as discussed in more
detail infra.
Appeal 2011-002616
Application 10/850,072

3
I.
Issue
The Examiner has rejected all of the claims on appeal as obvious
based on either Danishefsky or Vite, combined with Chen (Answer 3, 5).
The Examiner finds that Danishefsky and Vite teach Compound (1) for
treating cancer (id. at 3-4, 6) and Chen teaches treatment of cancer using
cetuximab (id. at 5, 6). The Examiner concludes that it would have been
obvious to treat cancer, including lung or pancreatic cancer, using a
combination of Compound (1) and cetuximab because Danishefsky and Vite
teach that Compound (1) is useful for treating cancer in combination with
other cancer-treating agents (id. at 4, 6).
Appellant contends that the references would not have made obvious
the specific combination of agents required by the claims (Appeal Br. 7-10).
Appellant also contends that he has provided evidence of synergism that
rebuts any prima facie case of obviousness (id. at 10-14).
The issues with respect to this rejection are:
Do the cited references support the Examiner’s conclusion that
treating pancreatic cancer or lung cancer with a combination of
Compound (1) and cetuximab would have been prima facie obvious?
If so, has Appellant presented evidence of unexpected results that
outweighs the evidence supporting the prima facie case of obviousness?
Findings of Fact – Prima facie obviousness
1. The Examiner finds that Danishefsky discloses Compound (1)
recited in the claims (Answer 3). Appellant does not dispute this finding
(see Appeal Br. 7-8).
Appeal 2011-002616
Application 10/850,072

4
2. Danishefsky teaches treatment of tumors in mice using Compound
(1) (aka C-15-Aza-EpoB) (Danishefsky, Fig. 33).
3. Danishefsky teaches that Compound (1) (aka BMS 247550) “is
currently under clinical investigations” (id. at col. 109, ll. 45-46).
4. Danishefsky teaches that its “compounds and pharmaceutical
compositions . . . can be employed in combination therapies” (id. at col. 59,
ll. 45-47), including in combination with other cancer-treatment agents (id.
at col. 60, ll. 2-14).
5. Appellant acknowledges that Vite teaches “Compound (1) as an
Example” (Appeal Br. 9).
6. Vite teaches that its compounds are “useful in the treatment of a
variety of cancers” (Vite 8: 21).
7. Vite teaches that its compounds “are also useful in combination
with known anti-cancer and cytotoxic agents” (id. at 10: 10-11).
8. Chen teaches that “anti-neoplastic agents” include cetuximab
(Chen 19, ¶ 291).
Analysis – Prima Facie Obviousness
We agree with the Examiner that the teachings of Danishefsky or
Vite, viewed in combination with Chen, would have made obvious the
method of the claims on appeal. Danishefsky and Vite disclose that
Compound (1) is useful in treating cancer, and both suggest combining
different cancer-treatment agents. Chen discloses that cetuximab was also a
known anti-neoplastic agent. Therefore, it would have been obvious to
combine Compound (1) with cetuximab with a reasonable expectation that
Appeal 2011-002616
Application 10/850,072

5
the combination would provide more effective cancer treatment than either
Compound (1) or cetuximab alone.
Appellant argues that Danishefsky discloses that Compound (1) was a
known compound, but Danishefsky’s invention was directed to different
epithilone derivatives (Appeal Br. 7-8); therefore “[a]t best, what
Danishefsky teaches is the combination of the 12,13 desoxy epithilones and
other cytotoxic agents” (id. at 8). Appellant also argues that Vite’s general
teaching of combining its compounds with other anti-cancer agents “does
not teach or suggest the specific combination of Compound (1) with
cetuximab” (id. at 10), and that Chen “gives a 3-page laundry list of the anti-
cancer agents, one of which happens to be cetuximab” (id. at 8). Appellant
argues that these teachings would not have made obvious the instantly
claimed method.
We are not persuaded. Danishefsky and Vite provide evidence that it
was known in the art to treat cancer using combinations of known cancer-
treatment agents. The cited references also disclose that the two compounds
recited in the claims on appeal were known cancer-treatment agents, and
therefore would have made it obvious to treat cancers – including lung
cancer and pancreatic cancer – using the combination.
Findings of Fact – Secondary Considerations
9. Appellant has provided a declaration under 37 C.F.R. § 1.132
(Declaration of Francis Y. F. Lee, signed Feb. 19, 2009).
10. The Lee Declaration presents data showing the effect of
Compound (1) (aka ixabepilone) in combination with cetuximab in treating
Appeal 2011-002616
Application 10/850,072

6
human lung carcinoma L2987 xenografts in nude mice (Lee Declaration,
¶ 5).
11. The Lee Declaration compares the results of treating human lung
carcinoma with a combination of ixabepilone and cetuximab to the results of
treating lung carcinoma with either ixabepilone or cetuximab alone (id. at
¶ 6).
12. The Lee Declaration states that the combination therapy produced
an LCK (gross log 10 cell kills) of >3.8 and 75% cures, compared with an
LCK of 3.2 and 13% cures for ixabepilone alone and an LCK of 3 and 13%
cures with cetuximab alone (id. (Table A-B)).
13. The Lee Declaration states that a second study of lung carcinoma
L2987 resulted in an LCK of >6.5 and 38% cures for the combination of
ixabepilone and cetuximab, compared to an LCK of 3.1 and 0% cures for
ixabepilone alone and an LCK of 2.4 and 0% cures for cetuximab alone
(id.).
14. The Lee Declaration states that the “combination of the two
agents surprisingly yielded synergistic anti-tumor efficacy results for the
combination which were significantly superior to either of the single agent
ixabepilone alone, or, the single agent cetuximab alone” (id. at ¶ 5).
15. The Lee Declaration presents data showing the treatment of lung
carcinoma A549 xenografts in nude mice with ixabepilone alone, cetuximab
alone, or ixabepilone in combination with cetuximab (Lee Declaration, ¶¶ 8,
9).
16. The Lee Declaration states that the combination therapy produced
an LCK of 2.7 and a growth delay of 55 days, compared with an LCK of 1.2
Appeal 2011-002616
Application 10/850,072

7
and a growth delay of 25 days for ixabepilone alone and an LCK of 0.7 and
a growth delay of 14.8 days with cetuximab alone (id. at ¶ 8 (Table C)).
17. The Lee Declaration states that treatment with the combination
“was substantially more effective than each drug alone in tumor growth.
These results are indeed surprising, unexpected and synergistic” (id. at ¶ 9).
18. The Lee Declaration presents data showing the treatment of
human pancreatic carcinoma Bx-PC3 xenografts in nude mice with
ixabepilone alone, cetuximab alone, or ixabepilone in combination with
cetuximab (Lee Declaration, ¶ 12).
19. The Lee Declaration states that the combination therapy produced
a delay in tumor growth of 31.2 days, compared with 21.5 days with
ixabepilone alone and 5 days with cetuximab alone (id. (Table E)).
20. The Lee Declaration states that these results “are surprising,
unexpected and synergistic given that the combination of ixabepilone and
cetuximab produced a significant delay in tumor increase over the
ixabepilone alone and the cetuximab alone” (id.).
Principles of Law – Secondary Considerations
“One way for a patent applicant to rebut a prima facie case of
obviousness is to make a showing of ‘unexpected results,’ i.e., to show that
the claimed invention exhibits some superior property or advantage that a
person of ordinary skill in the relevant art would have found surprising or
unexpected.” In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995).
“Mere improvement in properties does not always suffice to show
unexpected results. In our view, however, when an applicant demonstrates
substantially improved results . . . and states that the results were
Appeal 2011-002616
Application 10/850,072

8
unexpected, this should suffice to establish unexpected results in the absence
of evidence to the contrary.” Id. at 751.
“If an applicant demonstrates that an embodiment has an unexpected
result and provides an adequate basis to support the conclusion that other
embodiments falling within the claim will behave in the same manner, this
will generally establish that the evidence is commensurate with [the] scope
of the claims.” In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011).
Analysis – Secondary Considerations
The Lee Declaration presents evidence showing the results of treating
human lung carcinoma and human pancreatic carcinoma in an animal model
with a combination of Compound (1) and cetuximab. The evidence
provided shows that treatment with the combination is more effective than
treatment with either agent alone (FFs 12, 13, 16, 19), and Dr. Lee has stated
that the results observed showed synergism and were unexpectedly superior
(FFs 14, 17, 20). Thus, Appellant has demonstrated substantially improved
results and stated that the results were unexpected; “this should suffice to
establish unexpected results in the absence of evidence to the contrary.” In
re Soni, 54 F.3d at 751.
The Examiner responds that “although the data can be considered
synergistic, they are based on a single dosage for each active agent. . . .
Examiner submits that a showing of a few data points regarding dosages will
not support the entire claimed range, which is any dosage amount.”
(Answer 8-9.)
The Examiner, however, has not provided any evidence or technical
reasoning to support a conclusion that the results shown in the Lee
Appeal 2011-002616
Application 10/850,072

9
Declaration would not be representative of other dosages. The Examiner
therefore has not provided an adequate basis for concluding that the data are
not commensurate with the scope of the claims. Cf. In re Kao, 639 F.3d at
1068.
The Examiner also argues that
it is not certain what conclusions can be gathered from Table A-
B. For example, the LCK and Tumor Growth Delay variables
for L2987 (Lung) No. 140 seem to show mere additive effects,
while the % cures seem to show synergism. In Table C, there
seems to be additive effects for LCK and synergism for Tumor
Growth Delay, while no data is given for % cures. The same
goes for Tables D-E. Taking all the data as a whole, it appears
that there are some synergistic results along with some additive
effects.
(Answer 9.)
This argument is also unpersuasive, because the Examiner has
provided no analysis of the data to show that they would have been expected
or do not show synergism. Dr. Lee has testified that the data show
synergistic results for the combination of ixabepilone and cetuximab,
compared to the results for either agent alone (FFs 14, 17, 20). If the
Examiner’s position is that Dr. Lee’s conclusion is not supported by the
evidence presented in the Lee Declaration, the Examiner must provide
adequate evidence or technical reasoning to show that the evidence does not
support the declarant’s conclusion. The Examiner, however, has provided
only conclusory statements of disagreement with Dr. Lee’s view of the
evidence, which is not adequate to cast doubt on the accuracy of the
evidence provided by the Lee Declaration.
Appeal 2011-002616
Application 10/850,072

10
Conclusions of Law
The cited references support the Examiner’s conclusion that treating
pancreatic cancer or lung cancer with a combination of Compound (1) and
cetuximab would have been prima facie obvious, but Appellant has
presented evidence of unexpected results that outweighs the evidence
supporting the prima facie case of obviousness.
II.
In the Final Rejection, the Examiner rejected claims 121-127 and 141-
143 for obviousness-type double patenting based on the claims of either U.S.
Patent 6,686,380 B2 or U.S. Patent 7,312,237 B2, combined with Chen
(Office Action mailed July 8, 2009, pp. 2-3). The Examiner also
provisionally rejected claims 121-127 and 141-143 for obviousness-type
double patenting based on the claims of either co-pending application
11/009,579 or application 11/346,579, combined with Chen (id. at 3).
In the Appeal Brief, as a ground of rejection to be reviewed on appeal,
Appellant included “[w]hether claims 121-127 and 141-143 are unpatentable
under the judicially created doctrine of obviousness-type double patenting
over claims 1-15 of US Patent 6,686,380 or claims 38-50 of US application
No. 11/346,579 (reissue application of US Patent 6,686,380) in view of
Chen” (Appeal Br. 6). Appellant addressed these rejections on the merits
(id. at 14-15).
In the Answer, the Examiner did not repeat any of the double-
patenting rejections from the Final Rejection but stated that the “appellant’s
statement of the grounds of rejection to be reviewed on appeal is correct”
(Answer 2). The Examiner also responded to Appellant’s argument
Appeal 2011-002616
Application 10/850,072

11
concerning the double patenting rejections, and concluded that it did not
overcome the rejection (id. at 10-11).
In the Reply Brief, Appellant noted that application 11/346,579 issued
as RE41,393 on June 22, 2010, effecting the surrender of the ‘380 patent and
thus the “rejection based on claims 1-15 of US Patent 6,686,380 in view of
Chen is moot” (Reply Br. 2, n.1). Appellant also noted that the rejections
outstanding after the Appeal Brief was filed were discussed by telephone on
May 11, 2010, and that “Appellant was still of the opinion that the
obviousness-type double patenting rejection was improper and thus declined
to file a TD” (id. at 3). Appellant again presented arguments addressing the
Examiner’s position on double patenting (id. at 6).
Based on the record, we understand the Examiner to maintain the
rejection of claims 121-127 and 141-143 for obviousness-type double
patenting based on application 11/346,5797 (now RE41,393) in view of
Chen. We understand the Examiner’s failure to reproduce this rejection in
the Answer to be an oversight rather than a decision to withdraw the
rejection. We note that Appellant apparently shared this understanding, as
indicated by the comments and argument in the Reply Brief regarding the
rejection.
The Examiner concludes that the claims of RE41,393, read in view of
Chen, are unpatentable for obviousness-type double patenting based on “the
same reasoning as set forth in the 103(a) rejection” (Office Action mailed

7 The Examiner apparently also meant to maintain the double patenting
rejection based on the ‘380 patent but, as noted by Appellant, this rejection
is moot now that the ‘380 patent has been reissued as RE41,393.
Appeal 2011-002616
Application 10/850,072

12
July 8, 1009, p. 3). That is, the reissued claims are directed to a method of
using Compound (1) to treat cancer and Chen teaches cetuximab to treat
cancer, in combination with other cancer-treating compounds, so the
combination therapy method of the instant claims is an obvious variation of
the method defined by the reissue claims (see id. at 4-6 (reasoning of the
rejection based on 35 U.S.C. § 103(a)).
We agree with the Examiner’s reasoning and conclusion.
Appellant argues that the showing of unexpected results in the Lee
Declaration rebuts the obviousness-type double patenting rejection for the
same reason that it rebuts the rejections based on 35 U.S.C. § 103 (Appeal
Br. 14-15).
We agree, however, with the Examiner that “while a Declaration
showing unexpected results can overcome a 103(a) obviousness rejection,
the same Declaration cannot overcome an obviousness double patenting
rejection” (Answer 11). The Examiner’s position is supported by the case
law. See Geneva Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373,
1378 n.1 (Fed. Cir. 2003) (“The distinctions between obviousness under 35
U.S.C. § 103 and nonstatutory double patenting include: . . . Obviousness
requires inquiry into objective criteria suggesting non-obviousness;
nonstatutory double patenting does not.”); Procter & Gamble Co. v. Teva
Pharms. USA, Inc., 566 F.3d 989, 999 (Fed. Cir. 2009) (“In general, the
obviousness analysis applies to double patenting, except for three
distinctions. . . . Finally, double patenting does not require inquiry into
objective criteria suggesting non-obviousness.”).
Appeal 2011-002616
Application 10/850,072

13
Thus, unexpected results cannot be relied on to rebut a rejection for
nonstatutory, obviousness-type double patenting. Since the claims were not
argued separately, we affirm the rejection of claims 121-127 and 141-143.
37 C.F.R. § 41.37(c)(1)(vii).
SUMMARY
We reverse the rejection of claims 121-127 and 141-143 under 35
U.S.C. § 103(a) based on either Danishefsky and Chen or Vite and Chen.
We affirm the rejection of claims 121-127 and 141-143 for obviousness-type
double patenting based on the claims of RE41,393 in view of Chen.
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

App
App

Mill

rejec

to th

The

polic
paten
Adva
1996
eal 2011-0
lication 10
s, Adminis
I concur
tions over
I respect
e obviousn
issues are:
1. Wheth
Lee ’380
patentab

2. Whet
results, t
same inv
“The po
y because
t protectio
nced Sem
).
“T
patentee
same inv
Poliolefi
proscrip
02616
/850,072
trative Pat
with the m
Danishefs
fully disse
ess-type d

er the pen
, now RE4
ly distinct
her in view
he patente
ention or
licy underl
it preclud
n for an in
iconductor
he doctrin
from obta
ention or
ne Italia S
tion agains
ent Judge
ajority de
ky and Vi
nt from th
ouble pate
I
ding claim
1,393, an
from the L
of secon
e obtains a
an obviou
PRINCIP
ying a dou
es the imp
vention.”
Materials
e of doub
ining a tim
an obviou
.P.A., 547
t double p
14
, concurrin
cision wit
te in view
e decision
nting reje
SSUES
s are enco
d whether
ee RE41,
dary consi
timewise
s modifica
LES OF L
ble paten
roper exte
In re App
Am., Inc.
le patentin
ewise ext
s modifica
F.3d 1371
atenting t
g in part,
h regard to
of Chen.
of my col
ction for th
mpassed b
the pendin
393 patent
derations
extension
tion thereo
AW
ting reject
nsion of th
lied Mater
, 98 F.3d 1
g is intend
ension of
tion thereo
, 1375 (F
akes two f
dissenting
the obvio
leagues w
e followin
y the clai
g claims a
in view o
such as un
of a paten
f.
ion is an im
e statutory
ials, Inc. v
563, 1577
ed to prev
[a] patent f
f.” In re B
ed. Cir. 20
orms: (1)
in part.
usness
ith respect
g reasons
ms of the
re
f Chen.
expected
t for the
portant
term of
.
(Fed. Cir
ent a
or the
asell
08). The
statutory

.
.
App
App

Sun
1384
I
m
o
W
m
o
S

8 See
2005
9 See
n.1 (
eal 2011-0
lication 10
double p
later pat
matter, a
, which i
covering
432 F.3d
The seco
patenting
distinct f
Basell, 5
analysis
later pat
two step
claim[s]
determin
whether
“A later
over[] or
type dou
955, 968
Pharmace
(Fed. Cir
f one claim
ust proce
bvious va
ithout a p
erely an o
vercome t
ee In re E

Perricone
)
Geneva P
Fed. Cir. 2
02616
/850,072
atenting, w
ent from c
s an earlie
s a judicia
a slight v
at 1372-7
nd type of
, prohibit
rom claim
47 F.3d at
, which “co
ent or appl
s, Pfizer, 5
in the earl
es the diff
those diffe
claim that
anticipate
ble patent
(Fed. Cir
utical Ind
. 2010).
ed invent
ed to a sec
riation of t
atentable
bvious va
he double
ckel, 393 F

v. Medic
harms., In
003)
hich stem
overing th
r patent, a
lly created
ariation of
3[8]; see G
double p
s “claims i
s in a com
1375. An
mpares cl
ication,” G
18 F.3d at
ier patent
erences.”
rences ren
is not pate
d by,” an
ing. Eli Li
. 2001).
ustries Ltd
ion has a b
ond inquir
he other p
distinction
riation of
patenting
.2d 848, 1

is Pharm.
c. v. Glax
15
s from 35
e same inv
nd (2) obv
doctrine t
an earlier
eneva, 34
atenting, o
n a later p
monly ow
obviousne
aims in an
eneva, 34
1363. Fir
and the cla
Id. Second
der the cl
ntably dis
earlier cla
lly & Co.
. v. Eli Lil
roader sco
y: whethe
atent claim
-- becaus
the patente
rejection b
57 USPQ
Corp., 432
oSmithKlin
U.S.C. §
ention, i.e
iousness-t
hat preven
patented i
9 F.3d at
bviousnes
atent that
ned earlie
ss-type do
earlier pa
9 F.3d at
st, the cou
im[s] in th
, the court
aims paten
tinct from
im is inval
v. Barr La
ly and Co
pe than th
r one claim
. Vogel, 4
e the pend
d claim --
y filing a
415 (CCP
F.3d 136
e PLC, 34
101 and pr
., identical
ype doubl
ts a later p
nvention.
1377-78.[9
s-type dou
are not pat
r patent.” I
uble pate
tent to cla
1378 n.1, c
rt “constru
e later pa
“determin
tably disti
,” i.e., “is
id for obv
bs., Inc., 2
., 611 F.3d
e other, th
defines m
22 F.2d at
ing claim
the patent
terminal d
A 1968).
8, 1372-73
9 F.3d 13
ohibits a
subject
e patentin
atent from
Perricone
]
ble
entably
n re
nting
ims in a
onsists of
es the
tent and
es
nct.” Id.
obvious
iousness-
51 F.3d
1381,
e court
erely an
441.
defines
ee may
isclaimer.
(Fed. Cir
73, 1378

g

,

.
App
App

In re

In re
1272
U
d
i
c
d
d
T

Id at
eal 2011-0
lication 10
Goodman
“T
(CCPA
patenting
says that
twice? If
Does any
of an inv
patenting
patenting
of a pend
If the rej
patentab

General F
, 1278 (F
“T
SPQ 213
eterminin
s the exist
laims. The
istinguish
ifferences
hey are al
1279 .

In deter
we ask w
patents n
the prior
This par
analogou
Longi, 7
02616
/850,072
, 11 F.3d
he opinio
1970), und
as enunc
the first q
the answe
claim in
ention cla
? If the an
. The cou
ing paten
ected claim
ly distinct
oods Corp
ed. Cir. 19
he extens
(CCPA 19
g factor in
ence vel no
phrases a
able,” “pa
would ha
l equivale
mining pa
hether the
on-obviou
art. See I
t of the ob
s to an ob
59 F.2d 88
1046, 1053
n in In re
ertook a “
iated by th
uestion is
r to that i
the applic
imed in th
swer to th
rt was spe
t applicatio
defines m
.”
. v. Studi
92).
ive opinion
66), … sh
deciding w
n of paten
ctually us
tentable di
ve been ob
nt.”
tentable di
identified
s to a pers
n re Kapla
viousness-
viousness
7, 892 n.4
16
(Fed. Cir
Vogel, 422
restatemen
is court.”
: Is the sam
s no, a sec
ation defin
e patent as
at questio
aking, of c
n intende
ore than
engesellsc
in In re B
ows beyon
hether or
table diffe
ed in the o
stinctions,
vious to o
stinctivene
differenc
on of ordi
n, 789 F.2
type doub
analysis u
(Fed. Cir
. 1993).
F.2d 438,
t of the la
To summa
e inventio
ond questi
e merely a
serted as s
n is no, the
ourse, abo
d to forest
an obviou
haft Kohle
orah, 354
d questio
not there
rence bet
pinion inc
” and “wh
ne of ordin
ss or “obv
e renders t
nary skill
d 1574, 15
le patentin
nder 35 U
. 1985) (“
164 USPQ
w of doub
rize it, the
n being cl
on must be
n obvious
upporting
re is no d
ut the PTO
all double
s variation
mbH, 972
F.2d 100
n that the
is double
ween two
lude “pate
ether such
ary skill i
ious varia
he claims
in the art i
80 (Fed. C
g analysis
.S.C. §103
[A] double
619
le
opinion
aimed
asked:
variation
double
ouble
rejection
patenting
, it is
F.2d
9, 148
patenting
sets of
ntably

n the art.”
nt”,
of the …
n light of
ir. 1986)
is
. See In r
patenting

.

.
e

App
App

Amg
paten
Spec
a cla
and c
cove
349
Gene
cour
p
u
t
p
h
d
d
a
Sun
1384
eal 2011-0
lication 10
of the ob
the non-
patent pr
consider

en Inc. v.

There ar
t may be
ifically, th
im “merel
laimed,”
rage of [a]
F.3d 1373
In Pfizer
va Pharm
t
foun
atenting w
tility in th
he compou
atent. See
eld that a
istinct fro
isclosing
t 1385-86

Pharmace
(Fed. Cir
02616
/850,072
viousness
obviousne
incipally u
ed prior ar
F. Hoffma
e “certain
used in the
e specifica
y define[s]
“to learn th
claim.” S
(Fed. Cir.
, Inc. v. Te
s., Inc. v.
d claims o
here an e
e specifica
nd for a u
Pfizer, 51
“claim to
m an earli
the identic
.
utical Ind
. 2010).
type rejec
ss requirem
nderlying
t.” (quotat
nn-La Roc
instances”
obviousn
tion's disc
an obviou
e meaning
ee Geneva
2003).
va Pharm
GlaxoSmit
f a later p
arlier paten
tion, and
se describ
8 F.3d at
a method o
er claim to
al use.” Pf
ustries Ltd
17
tion is ana
ent of 35
the doubl
ion marks
he Ltd., 5
where the
ess-type d
losure ma
s variatio
of [claim
Pharm., I
s. USA, In
hKline PL
atent inval
t claimed
a later pate
ed in the s
1363; Gen
f using a c
the identi
izer, 518 F
. v. Eli Lil
logous to
U.S.C. §1
e patenting
omitted))
80 F.3d 13
specificat
ouble pate
y be used
n of what
] terms,” a
nc. v. Gla
c. 518 F.3
C, 349 F.3
id for obv
a compou
nt claimed
pecificatio
eva, 349 F
ompositio
cal compo
.3d at 136
ly and Co
[a failure t
03, except
rejection
.
40 (Fed.
ion of an
nting anal
to determi
is earlier d
nd to “int
xoSmithK
d 1353, 13
d 1373,13
iousness-t
nd, disclo
a method
n of the ea
.3d at 138
n is not pa
sition in a
3; Geneva
., 611 F.3d
o meet]
that the
is not
Cir. 2009)
earlier
ysis. …
ne whethe
isclosed
erpret[] th
line PLC,
63 and In
85-86, the
ype doubl
sing its
of using
rlier
5-86. We
tentably
patent
, 349 F.3d
1381,

.
r
e

e

App
App

unex
impl
that
Bair
searc
limit
fund
Cir.
a fin
claim
349
the c
later
“dete
Id. “
over
doub
eal 2011-0
lication 10
In re Lon
pected res
ied they m
“Disclo
fall within
d, 16 F.3d
“The use
hing comp
ations—w
amental ca
1995).

I am not
ding of ob
1. Wheth
Lee ’380
patentab

It is well

An obv
s in an ea
F.3d at 137
ourt “cons
patent and
rmines wh
A later cla
[] or antici
le patentin
02616
/850,072
gi, 759 F2
ults to ove
ay be con
sure of che
it.” In re
380, 382 (
of per se
arison of
ith the tea
se law app
persuaded
viousness-
er the pen
, now RE4
ly distinct
settled th
iousness-t
rlier paten
8 n.1, con
trues the c
determin
ether thos
im that is
pated by,”
g.
d 887, 89
rcome obv
sidered, bu
mical gen
Jones, 958
Fed. Cir.
rules, whi
the claime
chings of t
lying it.”
that the f
type (non-
ding claim
1,393, an
from the L
at
ype doubl
t to claims
sists of tw
laim[s] in
es the diff
e differen
not patenta
an earlier
18
4 (Fed. Ci
iousness-
t found th
us does no
F.2d 347
1994).
le undoubt
d inventio
he prior ar
In re Och
ANALYS
acts and le
statutory)
s are enco
d whether
ee RE41,
e patentin
in a later
o steps, Pf
the earlier
erences.” I
ces render
bly distin
claim is in
r. 1985), c
type doubl
em unconv
t render o
, 350 (Fed
edly less l
n—includ
t, flouts se
iai, 71 F.3
IS
gal preced
double pa
mpassed b
the pendin
393 patent
g analysis,
patent or a
izer, 518
patent an
d. Second
the claims
ct from,” i
valid for
onsidered
e patentin
incing.
bvious all
. Cir. 1992
aborious t
ing all its
ction 103
d 1565, 15
ent before
tenting.
y the clai
g claims a
in view o
which “co
pplication
F.3d at 13
d the claim
, the court
patentabl
.e., “is obv
obviousne
g rejection
species
); In re
han a
and the
72 (Fed.
us suppor
ms of the
re
f Chen.
mpares
,” Geneva
63. First,
[s] in the
y distinct.
ious
ss-type

,
t
,
”
Appeal 2011-002616
Application 10/850,072

19

Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 968 (Fed. Cir. 2001).

Comparing the claims
The RE41,393 patented claims are to a method of treating a tumor
resistant to oncology therapy with taxane with a compound of the formula of
compound 1 (RE41,393 claim 16) which encompasses pending claim
compound 1 but does not encompass a method of treating cancer with a
combination therapy of compound 1 with antibody C225. Thus, the prior
patent claims and the pending claims are not to the same invention. The
difference between the patented subject matter and the pending claimed
subject matter is the C225 antibody.
We then must determine whether this difference in the pending claims
renders the claim patentably distinct from the RE41,393 patent claims in
view of Chen. One way of determining this is inquiring whether the pending
claims are an obvious variant of the RE41,393 patent claims. This inquiry
follows.
The obviousness-type double patenting rejections are set forth in the
Final Rejection at pages 2-3.
In addition to the RE41,393 patent claims the Examiner relies on
Chen in the obviousness-type double patenting rejection for the disclosure of
the C225 antibody (cetuximab) for the treatment of cancer.
In determining patentable distinctiveness or “obvious variant”,
“we ask whether the identified difference renders the claims of
the … patents non-obvious to a person of ordinary skill in the art in
light of the prior art. See In re Kaplan, 789 F.2d 1574, 1580 (Fed.
Cir. 1986). This part of the obviousness-type double patenting
analysis is analogous to an obviousness analysis under 35 U.S.C.
Appeal 2011-002616
Application 10/850,072

20
§103. See In re Longi, 759 F.2d 887, 892 n.4 (Fed. Cir. 1985) (“[A]
double patenting of the obviousness type rejection is analogous to [a
failure to meet] the non-obviousness requirement of 35 U.S.C. §103,
except that the patent principally underlying the double patenting
rejection is not considered prior art.” (quotation marks omitted)).

Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340 (Fed. Cir.
2009).

Since the double patenting of the obviousness-type rejection is
analogous to a failure to meet the non-obviousness requirement of 35 U.S.C.
§103, we look to relevant obviousness analysis. The question of
obviousness is resolved on the basis of underlying factual determinations
including: (1) the scope and content of the prior art; (2) the level of ordinary
skill in the art; (3) the differences between the claimed invention and the
prior art; and (4) secondary considerations of nonobviousness, if any.
Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
This analysis was not performed by the Examiner and is error. The
Examiner merely determined that Appellants evidence of non-obviousness
in the Lee Declaration was not relevant to the obviousness-type double
patenting rejection. The majority agrees citing Geneva, fn1.
I respectfully disagree.
When the appropriate 103 analysis is performed, patentable
distinctiveness is found and the obviousness-type double patenting rejection
should be reversed.
In reviewing the obviousness rejections over Danishefsky or Vite and
Chen, the majority performed the 103 analysis of Graham and concluded
that the Declaration of Lee provided convincing evidence of unexpected and
Appeal 2011-002616
Application 10/850,072

21
synergistic results when compound 1 is combined with cetuximab. The
majority reversed the obviousness rejections based on secondary
considerations of non-obviousness.
I agree with the majority’s conclusion that the Declaration of Lee
overcomes the obviousness rejections. For the same reasons, I find that the
Declaration also overcomes the obviousness-type double patenting rejection
and shows patentable distinctiveness of the claimed invention. See also, In
re Procter and Gamble Co. v. Teva Pharms USA, Inc. 566 F.3d 989, 999
(Fed. Circ.2009) wherein the Federal Circuit determined that risedronate was
not obvious under 103, considering a showing of long-felt need, and thus for
the same reason the obviousness-type double patenting rejection was not
affirmed.
Distinguishing Geneva and Pfizer
The Examiner assumes per se that a Declaration and secondary
considerations cannot overcome an obviousness-type double patenting
rejection. The majority cites Geneva and Procter & Gamble for this
proposition of law. I do not find this case law persuasive or relevant to the
pending facts. Moreover, “[t]he use of per se rules, while undoubtedly less
laborious than a searching comparison of the claimed invention—including
all its limitations—with the teachings of the prior art, flouts section 103 and
the fundamental case law applying it.” In re Ochiai, 71 F.3d 1565, 1572
(Fed. Cir. 1995).
The facts before us are distinct from those of Geneva cited by the
majority. The facts before us are not a “claim to a method of using a
composition [which] is not patentably distinct from an earlier claim to the
App
App

iden
Gen
its sp

meth
form
paten
panc
antib
l. 14
cons
Circu
the F
show
type
sugg
obvi
reaso
paten
legal

10 In
earli
eal 2011-0
lication 10
tical comp
eva, 349 F
ecific fact
To the c
od of trea
ula 1 (clai
t does not
reatic and
ody C225
-16)10 as p
A carefu
istent with
it determ
ederal Cir
ing of lon
double pa
In the pr
est a paten
ousness-ty
ns as the
Moreove
ting does
ly unsupp

Pfizer, the
er patent.
02616
/850,072
osition in
.3d at 138
s.
ontrary, th
ting a tumo
m16. ) Un
disclose
lung canc
(Imclone
resently cl
l review o
the legal
ined that ri
cuit, in ad
g-felt need
tenting rej
esent case
tably disti
pe double
obviousne
r, footnot
not requir
orted and i

newly cla
a patent di
5-86. The
e facts bef
r which is
like Gene
a method o
ers by adm
antibody i
aimed.
f In re Pro
precedent
sedronate
dition to 1
, and thus
ection was
, as in Pro
nct invent
patenting
ss rejection
e 1 in Gen
e objective
s simplex

imed use
22
sclosing th
holding in
ore us are,
taxane re
va, the Sp
f treating
inistration
mmunospe
cter and G
cited herei
was not ob
03 conside
for the sa
not affirm
cter, the se
ion is bein
rejection s
s.
eva, espou
criteria su
or obiter d
was descri
e identica
Geneva s
RE41,393
sistant wit
ecification
cancer sel
of the cla
cific for t
amble su
n. In Proc
vious und
rations, al
me reason
ed. 566 F
condary c
g claimed
hould be r
sing that n
ggesting
ictum to th
bed in the
l use” as s
hould be l
patented
h a compo
of the RE
ected from
imed com
he EGFR,
ggests a ho
ter the Fe
er 103. In
so conside
the obvio
.3d at 999
onsiderati
and that th
eversed fo
on-statuto
non-obvio
e Geneva
specificat
et forth in
imited to
claims to
und of
41,393

pound wit
Spec. 24,
lding
deral
that case
red a
usness-
.
ons
e
r the same
ry double
usness is

ion of the

a
h

Appeal 2011-002616
Application 10/850,072

23
decision. 11 To the contrary, In re Longi, 759 F.2d 887, 897 (Fed. Cir. 1985)
considered whether unexpected results can overcome obviousness-type
double patenting rejection, implied that they could, but found them
unconvincing on the facts of that case. Moreover, the holding in Geneva
addresses “the situation in which an earlier patent claims a compound,
disclosing the utility of that compound in the specification, and a later patent
claims a method of using that compound for a particular use described in the
specification of the earlier patent.” Sun Pharmaceutical Industries Ltd. v.
Eli Lilly and Co., 611 F.3d 1381, 1384 (Fed. Cir. 2010). Those are not the
facts in the present case.
Therefore, in view of secondary considerations, the pending claims
define a patentably distinct invention from those of Lee RE41,393, and the
holding and dicta in Geneva is not germane to the facts in the present case.

2. Whether the secondary considerations such as unexpected
results provide the patentee with a timewise extension of a
patent for the same invention or an obvious modification
thereof.

It has long been recognized in the law that unobvious improvement
patents do not result in a timewise extension of a patent for the same

11 As the United States Supreme Court has put it: "dicta may be
followed if sufficiently persuasive but are not binding." Central Green
Co. v. United States, 531 U.S. 425 (2001), quoting Humphrey's
Executor v. United States, 295 U. S. 602, 627 (1935).

Appeal 2011-002616
Application 10/850,072

24
invention or an obvious modification thereof. As there has been a showing
of patentable distinctiveness on the facts in the present case in the
Declaration of Lee, there is no timewise extension of a patent for the same
invention or an obvious modification thereof. The modification of
coadministering compound one with antibody C225 for the treatment of
specific cancers is an unobvious modification of the Lee Rexamined ‘380
claims. Further, when the patent term on the Lee Reexamined ‘380 patent
expires, the use of compound 1 for the treatment of taxane resistant cancers
by the public is no longer controlled by the patent, and thereafter, only the
patentably distinct use of the compound 1 in combination with antibody
C225 would be covered by a distinct patent term. Thus, no extension of
patent term would result.

CONCLUSION

The pending claims are partially encompassed by the Lee RE41,393
patent, however the pending claims are patentably distinct from the claims
of the Lee RE41,393 patent in view of Chen.
No timewise extension of patent protection results from patentability
of the pending claims.
For these reasons, the obviousness-type double patenting rejection
should be reversed.

lp