Kaneko et al.v.Wengel et al.

Patent Trial and Appeal Board

May 29, 2014

12804500 (P.T.A.B. May. 29, 2014)

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Mail Stop Interference
P.O. Box 1450 Filed: May 29, 2014
Alexandria VA 22313-1450
Tel: 571-272-4683
Fax: 571-273-0042

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

MASAKATSU KANEKO, KOJI MORITA,
and
TAKESHI IMANISHI
Junior Party
(Application No. 12/804,500),

v.

JESPER WENGEL
and
POUL NIELSON,
Senior Party
(Patent 7,034,133 and Reissue Application 13/690,982)

Patent Interference No. 105,907 (SGL)
(Technology Center 1600)

Before: RICHARD SCHAFER, SALLY GARDNER LANE, and JOHN G. NEW,
Administrative Patent Judges.

LANE, Administrative Patent Judge.

Judgment – Bd.R. 127(a)

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A Decision on Motions has been entered in the interference. (Decision, 1
Paper 264). Based on the Decision, all the Wengel involved claims have been 2
determined to be unpatentable to Wengel. As explained further in the Decision, it 3
is appropriate to enter judgment against Wengel at this time. (Decision at 41). 4
It is 5
ORDERED that judgment on priority as to Count 1 (Declaration, 6
Paper 1 at 4), the sole count of the interference, is entered against senior party 7
Wengel; 8
FURTHER ORDERED that claims 1-25, 29-33 of Wengel Patent 9
7,034,133, which correspond to Count 1 (Declaration at 5), are CANCELLED; 35 10
USC 135(a); 11
FURTHER ORDERED that claims 1-25, 29-34 and 39 of Wengel 12
reissue application 13/690,982, which correspond to Count 1 (Redeclaration, Paper 13
84 at 2), are FINALLY REFUSED; 35 USC 135(a); 14
FURTHER ORDERED that the parties are directed to 35 USC 135(c) 15
and Bd. R. 205 regarding the filing of settlement agreements; and 16

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FURTHER ORDERED that a copy of this judgment and the Decision 1
on Motions (Paper 264) shall be entered into the administrative records of the 2
involved Kaneko application, Wengel patent, and Wengel reissue application. 3

cc:
Attorney for Kaneko:

George E. Quillin, Esq.
Michael D. Kaminski, Esq.
Kristel Schorr, Esq.
Foley & Lardner, LLP
Email: gquillin@foley.com
Email: mkaminski@foley.com
Email: kschorr@foley.com

Attorney for Wengel:

John M. Covert, Esq.
Eric K. Steffe, Esq.
Sterne, Kessler, Goldstein & Fox, PLLC
Email: jcovert-ptab@skgf.com
Email: esteffe-ptab@skgf.com

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Mail Stop Interference
P.O. Box 1450 Filed: 29 May 2014
Alexandria VA 22313-1450
Tel: 571-272-4683
Fax: 571-273-0042

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

MASAKATSU KANEKO, KOJI MORITA,
and
TAKESHI IMANISHI
Junior Party
(Application No. 12/804,500),

v.

JESPER WENGEL
and
POUL NIELSON,
Senior Party
(Patent 7,034,133 and Reissue Application 13/690,982)

Patent Interference No. 105,907 (SGL)
(Technology Center 1600)

Before: RICHARD E. SCHAFER, SALLY GARDNER LANE, and
JOHN G. NEW, Administrative Patent Judges.

LANE, Administrative Patent Judge.

DECISION – MOTIONS - Bd. R. 125(a)

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I. Introduction 1
2
Background 3
4
The Count of this interference is directed generally to a compound referred 5
to as a locked nucleoside analogue (LNA) and more particularly to an LNA which 6
is an ethylene-bridged nucleoside analogue (ENA). LNAs are capable of forming 7
nucleobase specific complexes and are useful in therapeutics such as antisense 8
therapy. The complexes formed are said to exhibit enhanced properties, e.g., 9
enhanced thermostability and enhanced nuclease resistance, as compared to 10
complexes formed with unmodified nucleic acids. (Wengel involved patent 11
7,034,133 (‘133) (‘133 Patent, Ex 2010 at 1:20-32, 2:63-67, and 38:58-60) and 12
Kaneko involved application 12/804,500 (‘500) (‘500 application, Ex 1001 at 1-2). 13
Each party contends, inter alia, that its opponent’s claims are unpatentable. 14
Junior party Kaneko1 contends that while the Wengel involved patent and reissue 15
application might support LNAs in general, they do not support the breadth of the 16
Wengel claims directed to LNAs or the more narrow limitations found in the 17
Wengel claims directed to ENAs. Senior party Wengel2 contends that the Kaneko 18

1 The Kaneko real party in interest is Daiichi Sankyo Co., Limited. (Notice of Real Party
in Interest , Paper 4)).

2 The Wengel real party in interest is Exiqon A/S. (Notice of Real Party in Interest , Paper
8)).

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claims are unpatentable as either being anticipated or rendered obvious over the 1
involved Wengel patent. 2
As further explained below, we are persuaded that the involved Wengel 3
claims lack support under 35 USC § 112, ¶1. Further we are persuaded that 4
Wengel set forth a prima facie showing that the Kaneko claims would have been 5
obvious in view of the involved Wengel patent. However, when we consider the 6
evidence of unexpected results pointed out to us by Kaneko we do not conclude 7
that the Kaneko claims are unpatentable under 35 USC §103. 8
The following substantive motions are before us for decision:3 9
Junior Party Kaneko Motions 10
1. Motion for judgment on the basis that the Wengel claims are unpatentable 11
under 35 USC §112, ¶1, for lack of written description and enablement. 12
(Kaneko Motion 1, Paper 37). 13
2. Motion to be accorded priority benefit for application JP 11-33863. 14
(Kaneko Motion 2, Paper 38). 15
3. Motion to deny Wengel priority benefit of its earlier filed applications. 16
(Kaneko Motion 3, Paper 39). 17

3 The parties appeared for oral argument on 17 September 2013. George Quillin argued on
behalf of Kaneko and John Covert argued on behalf of Wengel. (Appearance Record, Paper
262). A transcript of the oral argument is of record. (Transcript, Paper 263).

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4. Motion for judgment on the basis that the involved Wengel claims are 1
unpatentable under 35 USC §§102 and 103 in view of the Kaneko published 2
PCT application. (Kaneko Motion 4, Paper 40). 3
In addition, Kaneko filed a miscellaneous motion to exclude certain evidence 4
filed by Wengel. (Kaneko Miscellaneous Motion 5, Paper 72). 5
Senior Party Wengel Motions 6
1. Motion for judgment on the basis that the Kaneko claims are unpatentable 7
under 35 USC §§102 and 103 over the involved Wengel patent. (Wengel 8
Motion 1, Paper 33). 9
2. Motion to add a second Count. (Wengel Motion 2, Paper 34). 10
Wengel reissue application 11
In response to Kaneko Motion 1, Wengel filed a miscellaneous motion to 12
add to the interference application 13/690,982 (‘982), a reissue application of the 13
involved Wengel patent. (Wengel Responsive Motion 3, Paper 46). Because the 14
Board exercised its discretion to add sua sponte the reissue application to the 15
interference, Wengel Responsive Motion 3 was dismissed as moot. (Order, Paper 16
83 at 3). As noted in the Order, rather than authorizing additional briefing 17
concerning the patentability of the added claims, we consider the arguments and 18
supporting evidence of record for and against the patentability of the added claims 19

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including those arguments raised in Wengel Responsive Motion 3, Kaneko 1
Opposition 3 (Paper 55) and Wengel Reply 3 (Paper 70). (Order, Paper 83 at 2). 2
II. Findings of Fact 3
4
The following findings of fact, as well as any other findings of fact set forth 5
in this Decision, are supported by a preponderance of the evidence. 6
Count 1 7
1. The sole Count of the interference, Count 1, is directed to an ENA and is as 8
follows: 9
10
A nucleoside analog represented by the following structural formula I, or an 11
oligonucleotide made therefrom, 12
13
14
15
[the above figure shows the formula of Count 1] 16
17
wherein, B is adenine, guanine, thymine, 5-methyl-cytosine, cytosine, or 18
uracil; 19
wherein R1 is selected from the group consisting of hydrogen, a benzyl 20
group, and a (2-cyanoethyl N, N-diisopropyl) phosphoramidite group; 21

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wherein R2 is selected from the group consisting of hydrogen, a benzyl 1
group, and a 5´-O-dimethoxytrityl group; 2
with the proviso that if B is guanine, it is optionally functional group 3
protected with an isobutyryl group and if B is adenine, thymine, 5-methyl- 4
cytosine, cytosine, or uracil, it is optionally functional group protected with a 5
benzoyl group. 6
(Declaration, Paper 1, at 4). 7
2. Junior Party Kaneko is involved on the basis of application 12/804,500 8
(‘500) filed 22 July 2010. (Declaration at 3). 9
3. All of the claims of the ‘500 application, i.e., claims 32-35, 37, 38, and 40-10
46, correspond to Count 1. (Declaration at 5). 11
4. Kaneko was accorded priority benefit of the following applications as to 12
Count 1: 13
Application 11/881,775, filed 27 July 2007, now U.S. Patent 7,816,333, 14
issued 19 October 2010 15
16
Application 10/430,705, filed 5 May 2003, now U.S. Patent 7,314,923 17
issued 18
01 January 2008 19
20
Application 09/925,673, filed 9 August 2001, now U.S. Patent 7,335,765, 21
issued 26 February 2008 22
23
Application PCT/JP00/00725 filed 10 February 2000 24
25
(Declaration at 5). 26

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5. Senior party Wengel is involved in the interference on the basis of its patent 1
7,034,133 (‘133), issued 25 April 2006, from application 10/208,650 (‘650), 2
filed 29 July 2002. (Declaration at 3). 3
6. Wengel also is involved on the basis of reissue application 13/690,982 4
(‘982), filed 30 November 2012, which is a reissue application of the ‘133 5
patent. (Redeclaration, Paper 84). 6
7. Claims 1-25 and 29-33 of the ‘133 patent correspond to Count 1 while 7
claims 26-28 do not. (Declaration at 5).4 8
8. Claims 1-25, 29-34, and 39 of the ‘982 application correspond to Count 1 9
while claims 26-28 do not. (Redeclaration at 2). 10
9. Wengel was accorded priority benefit of the following applications as to 11
Count 1: 12
Application 09/152,059 filed 11 September 1998 now U.S. Patent 6,794,499 13
issued 21 September 2004 14
15
Provisional Application 60/058,541, filed 12 September 1997 16
17
Provisional Application 60/068,293, filed 19 December 1997 18
19
Provisional Application 60/071,682, filed 16 January 1998 20
21
Provisional Application 60/076,591, filed 3 March 1998 22
23
Provisional Application 60/083,507, filed 29 April 1998 24

4 Claims 35-38 were cancelled by amendment. (Ex 2041 at 14).

-8-
1
Provisional Application 60/088,309 filed 5 June 1998 2
3
Provisional Application 60/094,355, filed 28 July 1998 4
5
(Declaration at 5 and Redeclaration at 2). 6
7
Wengel claims 8
10. Wengel claim 1 is directed to nucleoside analogues having the general 9
formula: 10
11
The above figure shows formula I of the Wengel claim. 12
(Wengel Clean Copy of Claims, Paper 9). 13
14
15
11. Wengel claim 2 is directed to nucleoside analogues having the general 16
formula: 17

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1
The above figure shows formula IIa of the Wengel claim. 2
3
12. In each of the above formulae: 4
B is selected from a list including at least the following: 5
nucleobases, 6
DNA intercalators, 7
photochemically active groups, 8
thermochemically active groups, chelating groups, 9
reporter groups 10
ligands; 11
12
R4* and R2* together designate a biradical selected from the following 13
group: 14
(a) −(CR*R*)r-O-(CR*R*)s− wherein r is 0 (zero) and s is greater than 1, or 15
s is 0 (zero) and r is greater than 1 and further wherein here each R* is 16
independently selected from hydrogen, halogen, hydroxy, mercapto, amino, 17
optionally substituted C1-6 -alkoxy, optionally substituted C1-6-alkyl, DNA 18
intercalators, photochemically active groups, thermochemically active groups, 19
chelating groups, reporter groups, and ligands. 20

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1
13. Involved Wengel claim 24 is directed to a compound labeled as “ENA” 2
(ethylene-bridged nucleoside analog). 3
14. Claim 24 is narrower than claims 1 and 2 and is directed to the following: 4
5
6
The above figure shows the formula of Wengel claim 24. 7
15. In claim 24, “B = adenine, guanine, thymine, 5-methyl-cytosine, cytosine, 8
uracil, 2, 6-diaminopurine”. 9
16. Wengel appear to have added the claims to ENAs, as claims 180 and 181, as 10
well as the term “ENA”, in January of 2004 which is after the filing date of the 11
‘650 application and after the publication of the Kaneko PCT application which 12
disclosed ENAs. (Gryaznov Decl., Ex 2050 at ¶36, Ex 2051 at 2 and 12; 13

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Kaneko Opposition 3, Paper 55 at MF5 96, admitted by Wengel). 1
17. Reissue claim 34 depends from claim 1 and limits r to 0 (zero) and s to 2-3, 2
or s to 0 (zero) and r to 2-3 and indicates that each R* is hydrogen. (Wengel 3
Responsive Motion 3 at Appendix 3). 4
18. Reissue claim 39 depends from claim 24 and limits B to adenine, guanine, 5
thymine, cytosine, or uracil. (Wengel Responsive Motion 3 at Appendix 3). 6
Kaneko claims 7
19. The Kaneko claims generally are directed to an “antigene oligonucleotide 8
comprising two or more nucleoside units” that are ENAs where “B is a group 9
selected from the group consisting of 6-benzoylaminopurin-9-yl, adeninyl, 2-10
isobutyrylamino-6-hydroxypurin-9-yl, guaninyl, 2-oxo-4-benzoylamino-11
pyrimidin-l-yl, cytosinyl, 2-oxo-5-methyl-4-benzoylamino-pyrimidin-l-yl, 5-12
methylcytosinyl, uracinyl and thyminyl groups.” (Kaneko Clean Copy of 13
Claims, Paper 7). 14
Testimony-Dr. Gryaznov and Dr. Armitage 15
20. Dr. Sergei Gryaznov has offered testimony on behalf of Kaneko that is 16
referenced in the Discussion portion of this Decision. 17

5 Material fact.

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21. Dr. Gryaznov is a Director and Senior Research Fellow of Nucleic Acid 1
Chemistry at Geron Corporation (Ex 2044, Gryaznov Decl., Ex 2050 at ¶ 1), 2
has over 30 years of experience in oligonucleotides, nucleotides and nucleoside 3
analogs, more than 20 years of experience in antisense and antigene 4
technologies, (Ex 2044 and Gryaznov Decl., Ex 2050 at ¶2) and has published 5
extensively in the general area of nucleic acids. (Ex 2045 and Gryaznov Decl., 6
Ex 2050 at ¶4). 7
22. We find Dr. Gryaznov to be qualified to testify about issues relevant to this 8
interference. 9
23. Dr. Bruce Armitage has offered testimony on behalf of Wengel that is 10
referenced in the Discussion portion of this Decision. 11
24. Dr. Armitage has a Ph.D. in organic chemistry and is a professor of 12
chemistry and co-director of the Center for Nucleic Acids Science and 13
Technology at Carnegie Mellon University. (Armitage Decl., Ex 1020 at ¶ 6). 14
25. Dr. Armitage has worked extensively in, and has published many times 15
about, the synthesis of oligonucleotide analogues and their application as 16
diagnostics and therapeutics. (Armitage Decl., Ex 1020 at ¶¶ 11-12). 17
26. We find Dr. Armitage to be qualified to testify about issues relevant to this 18
interference. 19

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27. The testimony of Dr. Gryaznov and Dr. Armitage establish that the level of 1
skill in the art is high such that the person of ordinarily skill would have had, 2
during the relevant time frame, significant education and experience in the field 3
as discussed in the testimony. (Gryaznov Decl., Ex 2050 at ¶¶15, 16 and Ex 4
1042 at ¶5; See also Kaneko Motion 1, MFs 37 and 38 admitted by Wengel in 5
Wengel Opposition 1, Paper 52). 6
28. As acknowledged by Kaneko and Dr. Gryaznov, as of the filing date of the 7
‘650 and ‘982 Wengel applications, “one of skill in the art would have had a 8
clear understanding of the [claimed] ENA compounds …and how to make such 9
compounds.” (Kaneko Motion 1 at 3:19-4:4 and Gryaznov Decl., Ex 2050 at ¶ 10
61). 11
Evidence Regarding Unexpected Results 12
29. Dr. Makoto Koizumi has presented testimony on behalf of Kaneko. 13
30. Dr. Koizumi is Chief Researcher of Lead Discovery & Optimization 14
Research Laboratories at Daiichi Sankyo and is currently in charge of 15
development of ENA at Daiichi Sankyo. (Koizumi Decl., Ex 2015 at ¶1). 16
31. Dr. Koizumi has more than 20 years of experience in antisense technology, 17
and, with particular regard to nucleoside analogues. (Koizumi Decl., Ex 2015 18
at ¶4 and Ex 2013). 19

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32. Dr. Koizumi testified regarding experiments that were conducted under his 1
supervision and that were presented, via “Certificates of Experimental Results” 2
(CER), during prosecution of application 09/925,673 (‘673), parent application 3
to the involved Kaneko application) to overcome prior art to Wengel, i.e., patent 4
6,794,499 (‘499), parent to the involved Wengel patent). (Second Koizumi 5
Decl., Ex 2081 at 5-7, referring to CER at Ex 2066). 6
33. After presentation of the CER the Examiner in the ‘673 application stated in 7
Reasons for Allowance: 8
The closest prior art Wengel et al (US 6,794,499) teaches general 9
structure IIa in which one of the embodiments is a structure wherein 10
R2* and R4* are bridged via an -OCH2CH2 group, which is the same 11
as the compound instantly claimed. Wengel does not provide an 12
example wherein the said compound is made or any experimental 13
results regarding its stability and activity. Wengel's structure IIa also 14
reads on several different combinations for the substitutions. The 15
Declaration filed by the applicants shows that the compounds as 16
instantly claimed (containing the 2'-4'-O-ethylene bridge) are 17
highly stable and resistant to nuclease activity. This is neither 18
taught nor obvious from the teachings of the prior art. 19
20
(Second Koizumi Decl., Ex 2081 at ¶ 10 and Ex 2068 at 2). 21
22
23

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34. Dr. Koizumi’s work with ENAs also was the subject of a paper he and his 1
co-worker’s submitted to the journal of Bioorganic and Medicinal Chemistry 2
Letters, (Morita Paper, Ex 2077,6 p. 73-76; Second Koizumi Decl., Ex 2081, ¶ 3
20). 4
35. The article describes experiments comparing the stability of oxymethylene-5
bridged LNA, ENA, and a natural DNA oligonucleotide in the presence of 6
snake venom phosphodiesterase. (Exs 2077, p. 75; Second Koizumi Decl., Ex 7
2081, ¶¶ 13, 21). 8
36. As a summary of that stability, Dr. Koizumi stated that “[t]hese data show 9
that one 2´- O,4´-C-ethylene modification resulted in more than 500 times 10
higher stability than natural nucleotides, and approximately 55 times higher 11
stability than the 2´-O,4´-C-methylene nucleotide.” (Ex 2077, p.75, Second 12
Koizumi Decl., Ex 2081, ¶ 21). 13
37. In February of 2002 Dr. Henrik Ørum, Chief Science Officer for Cureon,7 14
sent a letter to Dr. Koizumi regarding a review article that would reference his 15

6 Koji Morita et al., 2´-0,4´-C-Ethylene-Bridged Nucleic Acids (ENA): Highly Nuclease-
Resistant and Thermodynamically Stable Oligonucleotides for Antisense Drug, 12 BIOORG. MED.
CHEM. LETT. 73-76 (2002).
(Ex 2077).
7 It appears that Cureon was a subsidiary of Exiqon at one time. ( Second Koizumi Decl.,
Ex 2081, ¶ 24 and Ex 2078 (said to be a copy of webpage from Exiqon’s website at
http://www.exiqon.com/Pages/History.aspx, printed on 21 March 2013) at 1) (Kaneko Exhibit
List, Paper 79).(Ex 2076).

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research on ENAs along with a copy of the article. (Second Koizumi Decl., Ex 1
2081, referring to Exs. 2074 and 2075). 2
38. The article by Dr. Ørum and Dr. Lars Kongsback, who in 2003 was 3
appointed CEO of Exiquon, appears in the book, Peptide Nucleic Acids, 4
Morpholinos and Related Antisense Biomolecules8, and refers to ENA as 5
“a new LNA analogue, termed ENA” and points to results reported in the 6
Morita paper including the 55 times enhanced stability. (Ørum Article, 7
Ex 2076 at 213). 8
III. Discussion 9
10
A. Kaneko Motion 1 11
12
In its Motion 1, Kaneko moves for judgment against Wengel on the basis 13
that the Wengel claims lack both written description and enablement support under 14
35 USC §112, ¶1. Kaneko argues that “[t]he situation here is a classic example 15
of…overreaching.” Kaneko notes that it was only after the Kaneko PCT 16
application published ENA compounds that Wengel added the involved claims that 17
are directed to ENAs. (Kaneko Motion 1 at 1). 18
Wengel argues that its specification would have conveyed to a person of 19
ordinary skill in the art that Wengel had possession of, and enablement for, the 20
claimed invention as of at least its 29 July 2002 filing date. (Wengel Opposition 1 21

8 PEPTIDE NUCLEIC ACIDS, MORPHOLINOS AND RELATEDANTISENSE BIOMOLECULES, E.G.
Janson and M.J. During, eds. Kluwer Academic / Plenum Publishers (2006) at Chapter 13.

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at 1). 1
35 USC §112 2
3
The first paragraph of 35 USC § 112 contains both a written description 4
requirement and a separate and distinct enablement requirement. Ariad Pharms., 5
Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340 (Fed. Cir. 2010) (en banc). The 6
specification must “contain a written description of the invention, and of the 7
manner and process of making and using it, in such full, clear, concise, and exact 8
terms as to enable any person skilled in the art to which it pertains, or with which it 9
is most nearly connected, to make and use the same...” 35 USC §112(a). 10
“To satisfy [the written description] requirement, the specification must 11
describe the invention in sufficient detail so ‘that one skilled in the art can clearly 12
conclude that the inventor invented the claimed invention as of the filing date 13
sought.’” In re Alonzo, 545 F.3d, 1015, 1019 (Fed. Cir. 2008), citing Lockwood v. 14
Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed.Cir.1997). In determining whether 15
sufficient description is provided we consider what the specification reasonably 16
would have conveyed to one of ordinary skill in the art, Bilstad v. Wakalopulos, 17
386 F.3d 1116, 1125 (Fed. Cir. 2004), as well as the predictability of the art. 18
Noelle v. Lederman, 355 F.3d 1343, 1350 (Fed. Cir. 2004). “Such description need 19
not recite the claimed invention in haec verba but must do more than merely 20

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disclose that which would render the claimed invention obvious.” ICU Medical, 1
Inc. v. Alaris Medical Systems, Inc. 558 F.3d 1368, 1377 (Fed. Cir. 2009). 2
To satisfy the enablement requirement, the specification must teach those 3
skilled in the art how to make and use the full scope of the claimed invention 4
without requiring “undue experimentation”. In re Wright, 999 F.2d 1557, 1561 5
(Fed. Cir. 1993). “The determination of what level of experimentation is ‘undue,’ 6
so as to render a disclosure non-enabling, is made from the viewpoint of persons 7
experienced in the field of the invention.” Elan Pharmaceutical, Inc. v. Mayo 8
Foundation, 346 F.3d 1051, 1055 (Fed. Cir. 2003), citing Enzo Biochem, Inc. v. 9
Calgene, Inc., 188 F.3d 1362, 1373-74 (Fed. Cir. 1999) as discussing evidence of 10
enablement and nonenablement in an unpredictable field of biotechnology). In 11
determining whether a specification provides an enabling disclosure for the 12
claimed subject matter we consider factors that include (1) the quantity of 13
experimentation necessary, (2) the amount of direction or guidance presented, (3) 14
the presence or absence of working examples, (4) the nature of the invention, (5) 15
the state of the prior art, (6) the relative skill of those in the art, (7) the 16
predictability or unpredictability of the art, and (8) the breadth of the claims. In re 17
Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). 18

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Wengel Claims 1-22 and 29-33 (LNA claims) 1
In the formulae found in claims 1-22 and 29-33, “R4* and R2* together 2
designate a biradical selected from the following group: (a) −(CR*R*)r-O-3
(CR*R*)s− wherein r is 0 (zero) and s is greater than 1, or s is 0 (zero) and r is 4
greater than 1 and further wherein here each R* is independently selected from 5
hydrogen, halogen, hydroxy, mercapto, amino, optionally substituted C1-6 -alkoxy, 6
optionally substituted C1-6-alkyl, DNA intercalators, photochemically active 7
groups, thermochemically active groups, chelating groups, reporter groups, and 8
ligands.” We understand that the left hand substituent, i.e., that having the r 9
subscript, to be attached at the R2* position of the Wengel formulae. (‘133 Patent, 10
Ex 2010, at 10-189). 11
As to the these LNA claims, Kaneko argues that the Wengel “specification 12
fails to support (i) the unbounded limitations where s is greater than 1 or where r is 13
greater than 1; (ii) the limitation where s is 0, and (iii) the claimed group of 14
compounds that may represent R*.” (Kaneko Motion 1 at 2). 15

9 In the Decision we will cite to the Wengel patent disclosure which is the same disclosure
as the Wengel involved reissue application.

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Unbounded s and r values 1
Kaneko argues, and we agree, that the Wengel LNA claims provide no upper 2
boundary on the value of r or s. The plain reading of the claim language, i.e., 3
“greater than 1”, does not contain an upper boundary. Further, testimony of 4
Kaneko witness Dr. Gryaznov indicates that one skilled in the art would have 5
understood the claimed values of r and s to be “unlimited”. (Gryaznov Decl., Ex 6
2050 at ¶ 41). 7
Kaneko argues that the Wengel specification fails to support a claim with no 8
upper boundary on r or s. Dr. Gryaznov points out that the Kaneko specification 9
defines each of r and s to be 0-3 with the proviso that the sum of r + s is 1-4. 10
(Gryaznov Decl., Ex 2050 at ¶¶ 41, 42 citing to ‘133 Patent, Ex 2010 at 31:1-19; 11
See also col. 29:67-30:15). Further Dr. Gryaznov testifies that “[n]o examples are 12
provided in the ‘133 Patent where s is any number other than 1, and where r is any 13
number other than 0.” (Gryaznov Decl., Ex 2050 at ¶ 42). 14
Wengel on the other hand points to the testimony of its expert Dr. Armitage 15
indicating that one skilled in the art would have known there is an upper limit for r 16
and s since the claimed nucleoside analogues are conformationally restricted or 17
“locked”. (Third Armitage Decl., Ex 1047 at ¶ 12). Dr. Armitage testifies that one 18
skilled in the art would have known the upper limit based on the properties the 19

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Wengel specification says should be obtained and what actually could be made. 1
(Third Armitage Decl., Ex 1047 at 13). According to Wengel, “there is an 2
inherent, albeit no precisely known upper limit to the length of biradical bridges” 3
of the claimed LNA. (Wengel Opposition 1, Paper 52, at 5). Wengel urges that 4
“the sum of r and s is actually quite low.” (Wengel Opposition 1 at 6:7-9). Dr. 5
Gryaznov agrees to the extent that an unlimited value for either r or s would not 6
function to form the required bridge between the 4´and 2´ positions on the furanose 7
ring of the claimed LNA. (Gryaznov Decl., Ex 2050 at ¶ 41). 8
As pointed out by Kaneko and the testimony of Dr. Gryaznov, the Wengel 9
specification discloses an upper limit to r and s, i.e., each being 0-3 with the 10
proviso that the sum of r + s is 1-4. (Kaneko Motion 1 at 5:15-6:13 and Gryaznov 11
Decl., Ex 2050 at ¶ 42). We note Wengel’s argument that its specification has 12
written description support for “a biradical consisting of 1-8 groups/atoms” 13
(Opposition at 5, citing to Gryaznov Decl., Ex 1002 at 15:4), but the cited portion 14
of its specification, unlike the portion cited by Dr. Gryaznov, does not appear to be 15
specific to r and s or the 2´,4´ biradical. At any rate, the claims are not limited to 16
an upper limit value of 4 or even the value of 8 urged by Wengel. 17
Even if one skilled in the art would have thought that r and s could be some 18
not “precisely known” limit that is higher than that disclosed by Wengel, we agree 19

-22-
with Kaneko that there is insufficient description within the specification for such a 1
higher limit, i.e., a limit “greater than 1.” Wengel seems to be arguing that it is 2
entitled to claim any r and s value that results in a locked furanose structure but 3
that is not what its specification describes as the invention. (Wengel Opposition 1 4
at 6:12-18). 5
To the extent Wengel argues that we should read “greater than 1” as limited 6
to those values explicitly described in its specification we are not persuaded that it 7
is proper to do so. Although the claims are read in view of the specification, it is 8
not appropriate for us to read limitations from the specification into a claim. 9
Phillips AWH Corp., 415 F.3d 1303, 1323 (Fed. Cir. 2005). 10
Wengel cites Scripps Clinic & Research Foundation v. Genentech Inc. 927 11
F.2d 1565 (Fed. Cir. 1991) and In re Fischer, 427 F.2d 833 (Fed. Cir. 1970) for 12
the proposition that open-ended claims are sometimes proper. (Wengel Opposition 13
1 at 5). Both cases discuss enablement of claims that contain open-ended terms. 14
See Scripps Clinic at 1572, citing Fisher; (“Open-ended claims are not inherently 15
improper; as for all claims their appropriateness depends on the particular facts of 16
the invention, the disclosure, and the prior art. They may be supported if there is 17
an inherent, albeit not precisely known, upper limit and the specification enables 18
one of skill in the art to approach that limit.”) and Fisher at 1108 (“In the present 19

-23-
case we must conclude, on the record before us, that appellant has not enabled the 1
preparation of ACTHs having potencies much greater than 2.3, and the claim 2
recitations of potency of ‘at least 1’ render the claims insufficiently supported 3
under the first paragraph of 35 U.S.C. § 112.” ) Whether a value for r or s of 4
“greater than 1” would have been enabled, the Wengel specification does not 5
describe the invention as including LNAs having an inherent, not precisely known 6
value for r and s. 7
Further we are persuaded that, as in Fisher, Wengel has not enabled the full 8
scope of preparations of LNAs having r or s values of “greater than 1” thus 9
“render[ing] the claims insufficiently supported under the first paragraph of 35 10
U.S.C. § 112.” Fisher at 1108. 11
Both Dr. Armitage and Dr. Gryaznov agree that not all r and s values of 12
“greater than 1” would function to form an LNA. (Third Armitage Decl., Ex 1047 13
at ¶ 12 and Gryaznov Decl., Ex 2050 at ¶ 41). Wengel indicates that most values 14
included within the claimed range of values would not. (Wengel Opposition at 6: 15
7-9, “The sum of r and s is actually quite low”). 16
A claim might be enabled even if including inoperative embodiments unless 17
the number of inoperative embodiments “becomes significant, and in effect forces 18
one of ordinary skill in the art to experiment unduly in order to practice the 19

-24-
claimed invention.” Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 1
F.2d 1569, 1577 (Fed. Cir. 1984), citing In re Cook, 439 F.2d 730, 735 (C.C.P.A. 2
1971)). Not only are there, by Wengel’s own admission, a significant number of 3
inoperative embodiments if r and s are unlimited, the Wengel specification does 4
not purport to teach one towards an “inherent, albeit not precisely known upper 5
limit.” Instead it indicates that “each of r and s is 0-3 with the proviso that the sum 6
of r + s is 1-4.” Nor do we understand the prior art cited by Wengel (Wengel 7
Opposition 1 at 7-8), which appears to relate to bridges of limited size (e.g., 8
Morita10 which teaches ethylene bridges), to teach towards an inherent, not 9
precisely known, upper limit. 10
When we consider the scope of the claims as well as the other factors set 11
forth in Wands, including the lack of guidance or working examples having r or s 12
values which are greater than where “each of r and s is 0-3 with the proviso that the 13
sum of r + s is 1-4,” we conclude that the LNA claims are not enabled for the 14
claimed r and s values. 15
Description of R* 16
Kaneko argues, and we agree, that the Wengel LNA claims’ requirement that 17
each R* be “independently selected from hydrogen, halogen, hydroxy, mercapto, 18

10 Morita, K., et al., Nucleic Acids ResearchSupplement No. 1:241-242 (2001).

-25-
amino, optionally substituted C1-6 -alkoxy, optionally substituted C1-6-alkyl, DNA 1
intercalators, photochemically active groups, thermochemically active groups, 2
chelating groups, reporter groups, and ligands” is not sufficiently described by the 3
Wengel specification.” Dr. Gryaznov’s testimony indicates that one skilled in the 4
art would consider certain terms, such as “DNA intercalator” to be “very open-5
ended and practically unlimited.” Dr. Gryaznov testified that “[n]o examples are 6
provided [working examples in the ‘633 specification] where R* is other than H. 7
(Gryaznov Decl., Ex 2050 at ¶ 28). 8
Further, as Kaneko points out, many of the possible R* groups are defined 9
functionally as, for example “photochemically active groups”, said to be 10
compounds “which are able to undergo chemical reactions upon irradiation with 11
light”, “reporter group” said to be a group “which is detectable either by itself or as 12
a part of an detection series”, and “ligand’ said to be “something which binds.” 13
(‘133 Patent, Ex 2010, at 12:1–13:34.) As Kaneko acknowledges, the specification 14
provides some identifiable subgroups within the possible R* groups cited in the 15
claims, including ligands that can comprise functional groups such as aromatic 16
groups (e.g., benzene, pyridine, naphthalene anthracene, and phenanthrene). 17
However, the specification provides for further broadening by stating that those 18
groups “correspond to the ‘active/functional’ part of the groups in question” which 19

-26-
can be linked to the molecule by an optional spacer wherein the spacer is “a 1
thermochemically and photochemically non-active distance-making 2
group…selected on the basis of a variety of characteristics including their 3
hydrophobicity, hydrophilicity, molecular flexibility and length.” (Kaneko Motion 4
1 at 12-13 and MF 26 (admitted by Wengel) and ‘133 Patent, Ex 2010, at 13:57-5
66). 6
Wengel argues that its specification provides “detailed guidance for the 7
species of R*” relying upon the testimony of Dr. Armitage that “[b]ased upon the 8
definitions [given for the R* groups] a POSA would have understood that Wengel 9
conveyed that incorporation of these R* groups was part of the invention.” 10
(Wengel Opposition at 14; Third Armitage Decl., Ex 1047 at ¶ 52). We have not 11
been directed to testimony where Dr. Armitage further elaborates by discussing 12
specific R* groups. 13
Wengel cites Falkner v. Inglis, 448 F.3d 1357, 1366 (Fed. Cir 2006) for the 14
proposition that “examples are not necessary to support the adequacy of a written 15
description”. We agree that a working example or exemplified embodiment is not 16
necessarily a requirement for description. However, where a generic claim term is 17
present in a claim, the specification must convey enough information, e.g., via 18
sufficient representative examples, to indicate invention of species sufficient to 19

-27-
constitute the genus. Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 967 1
(Fed. Cir. 2002). 2
In the present situation we agree with Dr. Gryaznov that the scope of the 3
possible R* groups is “very open-ended and practically unlimited.” The Wengel 4
specification provides some more specific possible choices within R* groups. 5
However, many of these possible choices are very broad, e.g., “toxins, antibiotics, 6
cell positions, and steroids” as “ligands”. (‘133 Patent, Ex 2010 at 13:30-32). We 7
are persuaded that the specification overall would not have conveyed to one skilled 8
in the art that the entire scope of, e.g., a “ligand” or a “reporter group” as defined 9
by the Wengel specification, was invented. While functional claim language can 10
meet the written description requirement if there is an art-recognized correlation 11
between the function and some structure, there does not seem to be a common 12
structural element within each of the possible R* groups that works to provide 13
sufficient description in this case. Ariad Pharmaceuticals, Inc. v. Eli Lilly and 14
Co., 598 F.3d 1336, 1350 (2010). 15
Further, Kaneko has shown that the Wengel specification does not enable 16
the full scope of what is encompassed by R*. Despite the significant breadth of 17
R*, Wengel does not provide a working example other than where R* is hydrogen. 18
The level of skill in the art is high but there is an almost complete lack of guidance 19

-28-
provided as to what specific R*, other than hydrogen, would function in the 1
claimed invention. It is not necessary that Wengel provide other working 2
examples in order to be enabled for the claimed scope of R*. However, when we 3
consider the lack of non-hydrogen working examples, in combination with the 4
other Wands factors, including the significant breadth of R* and the lack of 5
guidance and direction, we are persuaded that one skilled in the art would have had 6
to engage in undue experimentation in order to practice the invention as it is 7
claimed. 8
Accordingly, we are persuaded that the LNA claims, i.e., claims 1-22 and 9
29-33 are unpatentable for lack of written description and enablement for at least 10
the reasons that r, s, and R* are not supported by the Kaneko specification. 11
Claims where s is zero. 12
Kaneko argues that Wengel does not describe or enable the biradical 13
−(CR*R*)r-O-(CR*R*)s− where s is zero, even though its claims include such an 14
embodiment. Because we determine that LNA claims are unpatentable for reasons 15
discussed above, we do not reach this argument but do consider it below in the 16
context of added claim 34. 17
Claims 24 and 25 (ENA claims) 18
Wengel claims 24 and 25 (ENA claims) are narrower in that they are 19

-29-
directed to ENA compounds where R2* and R4* form a –O-(CH2)2– bridge and 1
where the nucleosides include a nucleobase “B” that is selected from adenine, 2
guanine, thymine, 5-methyl cytosine, cytosine, uracil, or 2,6-diaminopurine. 3
The record shows that one skilled in the art knew how to make the compound 4
having the 2´ ,4´ oxyethylene bridge as of the filing date of the ‘650 application, at 5
least by virtue of the publication of the Kaneko PCT application so we do not 6
determine that there is a lack of enablement here. However, whether the subject 7
matter was enabled is not the question for description. Novozymes A/S v. DuPont 8
Nutrition Biosciences APS, 723 F.3d 1336, 1350 (Fed. Cir. 2013) (“The question 9
before us is not whether one of ordinary skill in the art presented with the 2000 10
application would have been enabled to take those final steps, but whether the 2000 11
application ‘discloses the [variants] to him, specifically, as something appellants 12
actually invented.’” (citing In re Ruschig, 379 F.2d 990, 995 (Fed. Cir. 1967))). 13
As to these ENA claims, Kaneko argues that “the specification does not have 14
written description support for ENA compounds in general, or where R2* and R4* 15
form an –O-(CH2)2– bridge and where the nucleosides include a nucleobase “B” 16
that is selected from adenine, guanine, thymine, 5-methyl-cytosine, cytosine, 17
uracil, or 2, 6-diaminopurine.” (Kaneko Motion 1 at 2). 18
The Wengel specification provides a general description of the LNA 19

-30-
compounds that allows for many variables and “numerous interesting possibilities 1
for the structure of the biradical(s) in the LNA(s) incorporated in the oligomers 2
according to the invention” as well as a large number of possible choices for the B 3
substituent. (‘133 Patent, Ex 2010 at 16:19-22 and 11:30-67). Dr. Gryaznov 4
testified that a “minimum selection of 1.3 X 1014 possible compounds… [are] 5
encompassed by general formula II” for example. (Gryaznov Decl., Ex 2050 at ¶ 6
24). 7
1. 2´,4´ oxyethylene bridge: 8
Within this general description the Wengel specification provides numerous 9
“preferred” or “particularly interesting embodiments”. Dr. Gryaznov testifies 10
about what is said to be “[t]he narrowest embodiment surrounding the selection of 11
a biradical represented by –O-(CH2)2–” found at column 28 of the ‘133 patent. In 12
this “particularly interesting embodiment” of the monomeric LNA, the Wengel 13
specification notes a “further particularly interesting embodiment” where the 14
biradical is “selected from −(CH2)0-1−O−(CH2)1-3−, −(CH2)0-1−S−(CH2)1-3−, and 15
−(CH2)0-1−N(RN)−(CH2)1-3−, in particular −O−CH2−, −S−CH2−, and −RN−CH2−.” 16
(‘133 Patent, Ex 2010 at 28:20-24). 17
Dr. Gryaznov testified that this “particularly interesting” embodiment 18
discussed in the Wengel specification still would not have guided one skilled in the 19

-31-
art to the ENA compounds claimed which could only be arrived at by “cherry 1
picking of particular species from a list of possible groups.” (Gryaznov Decl., Ex 2
2050 at ¶ 49). For example, Dr. Gryaznov testifies that there is “no guidance to the 3
specific biradical represented by O−(CH2)2−ˮ (Gryaznov Decl., Ex 2050 at ¶ 50). 4
Dr. Gryaznov provided similar testimony regarding that portion of the 5
Wengel specification found at column 18 of the involved Wengel patent. 6
(Gryaznov Decl., Ex 2050 at ¶ 29). Kaneko was questioned about the column 18 7
disclosure at oral argument, in particular the stated preference for a “two carbon 8
bridge” (Transcript at 8:11-9:13). This disclosure refers to a “two carbon atom 9
bridge, i.e., [where] the biradical forms a five-membered with the furanose ring” 10
and thus does not refer to ENA which instead forms a six carbon ring. (‘133 11
Patent, Ex 2010 at 18:35-39; See also Morita (Ex 1068)11 at 73 discussing five 12
membered oxymethylene bridge versus six membered oxyethylene bridge). 13
Wengel points to its “preferred” or “interesting” embodiments, arguing that 14
“having chosen the oxygen containing 2´,4´-bridge −(CH2)0-1−O –(CH2)1-3−, a 15
POSA would have immediately envisaged all six members of the group.” (Wengel 16
Opposition 1 at 15). First, even if one were directed to this biradical only, we do 17
not accept that this general disclosure amounts to explicit description of each 18

11 Morita, K. et al, Bioorg. & Chem. Letters, 12:73-76 (2002). (Ex 1068).

-32-
possible member of the group. Fujikawa v. Wattansin, 93 F.3d 1559, 1571 (Fed. 1
Cir. 1996) (“just because a moiety is listed as one possible choice for one position 2
does not mean there is ipsis verbis support for every species of sub-genus that 3
chooses that moiety” ). 4
Further, we do not agree with Wengel’s argument that one would have been 5
directed to an oxygen-containing bridge over the other particularly called out 6
biradicals that do not contain oxygen. (Wengel Opposition 1 at 15-16). Even were 7
one so directed, the direction would be to an oxymethylene bridge, not an 8
oxyethylene bridge. (‘133 Patent, Ex 2010 at 23, “in particular −O –CH2−”; See 9
also Koizumi Decl., Ex 2015 at ¶ 21 and Gryaznov Decl., Ex 2050 at ¶ 49). 10
Two biradicals other than the −(CH2)0-1−O –(CH2)1-3 biradical are called out 11
as “particularly interesting” with none of the three being noted as preferable over 12
the other two. Within the −(CH2)0-1−O –(CH2)1-3 biradical, only one biradical, i.e., 13
−O –CH2− , is called out “in particular” . Two other biradicals not falling within 14
the −(CH2)0-1−O –(CH2)1-3 biradical also are called out “in particular”, with none of 15
the three being noted as preferable over the other two. (‘133 Patent, Ex 2010 at 16
28:16-24). Even if the selection of the oxyethylene bridge would have been 17
obvious, as we have noted that is not the standard for written description. 18
Wengel argues that one skilled in the art reading its specification would have 19

-33-
been directed to the ENA embodiment, i.e., that having a 2´,4 ´ oxyethylene bridge, 1
since the specification discloses a 2´,4´ oxymethylene bridge and a 2´,3´ 2
oxyethylene bridge. However, the fact that Wengel specifically discloses an 3
oxyethylene bridge formed by the 2´, 3´ position but choose not to specifically 4
disclose such a bridge formed by the 2´, 4´ position does not persuade us of 5
direction to the 2´, 4´ bridge. Rather, the choice tends to show that Wengel 6
considered oxyethylene at the 2´, 3´ position, but not at the 2´, 4´ position, to be 7
part of its invention. 8
Wengel directs us to Singh v. Brake, 317 F.3d 1334 (Fed. Cir. 2002) for the 9
proposition that description is sufficient in the present situation since it does not 10
require “replacing a functional group on a chemical compound [that can have] 11
highly unpredictable results.” (Wengel Opposition 1 at 18). Even if the present 12
situation is not analogous to replacing a functional group on a chemical compound, 13
the situation before us differs from that in Singh where the Court found the 14
specification to contain ipsis verbis support for the limitation at issue. Singh, 317 15
F.3d at 1344 (“Here, moreover, claim 5 of Brake 1 discloses that ‘n is 0 or 1 to 4,’ 16
which is a clear “blaze mark” providing in ipsis verbis support for ‘n = 0’ in the 17
count” citing In re Ruschig, 370 F.2d at 994-95). Here, in contrast to the situation 18
in Singh and as we explain above (supra at 31-32), we do not find ipsis verbis 19

-34-
support for the claimed O−(CH2)2− biradical within the Wengel specification. 1
2. Nucleobases 2
Dr. Gryaznov further notes that, within this narrowest embodiment, there is 3
no specific guidance to select 2,6-diamonpurine or 5-methyl-cytosine as the 4
nucleobase even though these are included in claims 24 and 25. (Gryaznov Decl., 5
Ex 2050 at ¶¶51-51). Indeed within the narrower embodiment at column 28, the 6
Wengel specification states that “B designates a nucleobase, preferably a 7
nucleobase selected from thymine, cytosine, urasil, adenine and guanine” and does 8
direct one to 2, 6-diamonpurine or 5-methyl-cytosine. 9
Wengel argues that a person of skill in the art “would have appreciated 10
that….both 5-methyl-cytosine and 2, 6-diamonpurine had long been recognized as 11
nucleobase analogues possessing characteristics especially well-suited for synthetic 12
oligonucleotides used in antisense applications” and that one skilled in the art 13
would have “special reason to choose” these nucleobases as they were known to 14
increase nucleic acid stability. (Wengel Opposition 1 at 18-19). However, it is 15
not sufficient for written description that the claimed subject matter would have 16
been obvious to one skilled in the art. Thus, having a special reason to choose the 17
nucleobases, without more, would not have conveyed invention of ENAs having 18
these nucleobases as the B substituent. See ICU Medical, Inc., 558 F.3d at 1377. 19

-35-
1
3. Summary 2
We are persuaded that the Wengel specification does not provide sufficient 3
guidance to convey to one skilled in the art that Wengel invented the ENA 4
embodiments of claims 24 and 25. It is apparent that if the correct selections are 5
made within one of the “particularly interesting” embodiments described by 6
Wengel then the 2´, 4´ oxyethylene embodiment would result. However, there are 7
numerous subgenuses, “further embodiments” and embodiments called out as 8
“”preferred”, “even more preferred” , “particularly interesting” or “in particular”. 9
Further, selecting 6-diamonpurine or 5-methyl-cytosine as B might have been 10
obvious to one skilled in the art but we are not convinced that the specification 11
would have conveyed to one so skilled that having these nucleobases as the B 12
substituent was invented. When we “ view[]..the matter from the proper vantage 13
point ‘of one with no foreknowledge of the specific compound,’” of interest we do 14
not see “meaningful support” within the Wengel specification for the claimed ENA 15
subject matter. Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d at 16
1349, citing Ruschig, 379 F.2d at 995. While some of these embodiments are very 17
close to the claimed ENA compounds, we agree that, when we consider all the 18
evidence before us, there are insufficient “blaze marks” within the Wengel 19

-36-
specification to guide one to the specific ENA compounds claimed. Fujikawa v. 1
Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996), citing In re Ruschig, 379 F.2d at 2
995 (“Were we to extend Ruschig’s metaphor to this case, we would say that it is 3
easy to bypass a tree in the forest, even one that lies close to the trail, unless the 4
point at which one must leave the trail to find the tree is well marked. Wattanasin’s 5
preferred embodiments do blaze a trail through the forest; one that runs close by 6
Fujikawa’s proposed tree. His application, however, does not direct one to the 7
proposed tree in particular, and does not teach the point at which one should leave 8
the trail to find it.”). 9
Reissue claims 10
In what was said to be a motion in response to Kaneko Motion 1, Wengel 11
asked to add the ‘982 reissue application to the involved interference. The ‘982 12
contains claims 34 and 39 (in addition to the claims already discussed above).12 13
The addition of claims 34 and 39 appears to be an attempt to address issues raised 14
in Kaneko Motion 1 by narrowing the definitions of r, s and R* from those in the 15
LNA claims (as in claim 34) or narrowing B from that in the ENA claims (as in 16
claim 39). 17

12 Claims 10, 12, 15, and 23, were amended but only to correct minor typographical errors.
Otherwise the originally involved claims are unchanged. The same reasons for unpatentability

-37-
Claim 34 1
Claim 34 depends from claim 1 (an LNA claim) and is directed to a 2
subgenus of the LNA genus of claims 1 and 2, limiting r to 0 and s to 2-3, or s to 0 3
and r to 2-3, and R* to hydrogen. While limiting R* to hydrogen might address a 4
portion of the arguments raised in Kaneko Motion 1, we are persuaded that claim 5
34 is not sufficiently described. 6
Kaneko argues that, by limiting r and s as in claim 34, Wengel has created 7
an “artificial subgenus” that is not supported by the Wengel specification. 8
(Kaneko Opposition 3 at 8). Wengel points to general support within its 9
specification where it states that “each of r and s is 0-3 with the proviso that the 10
sum of r + s is 1-4” (e.g., ‘133, Ex 2010 at 17:30-32) and more specific support 11
where it states that “R2* and R4* together designate a biradical selected from a 12
group of five other biradicals as well as the biradical of interest, i.e., “−(CH2)0-1−O 13
–(CH2)1-3− ˮ. Wengel argues that once this biradical of interest was selected one 14
skilled in the art “would have immediately envisaged all six members of the 15
group.” (Wengel Responsive Motion 3 at 10, citing to Ex 1042, ¶ 19). However, 16
as acknowledged by Wengel, this biradical of interest “specifically excludes “s” 17
from being 0 or “r” from being 2 or 3, as recited in claim 34.” (Kaneko Opposition 18

of the Wengel involved claims apply where they are presented in the reissue application (Wengel

-38-
3 at MF 67, admitted by Wengel; See also Second Gryaznov Decl, Ex 2080 at ¶¶ 1
79 and 80). 2
It is not necessary that Wengel provide ipsis verbis support for the claimed 3
subgenus so long as its disclosure reasonably conveys to persons skilled in the art 4
that Wengel invented the subgenus claimed, i.e., by adequately directing one 5
skilled in the art to that subgenus. In re Edwards, 568 F.2d 1349, 1351-52 (CCPA 6
1978). When we consider the Wengel disclosure as a whole and in view of the 7
record before us, we are persuaded that one skilled in the art would not have been 8
adequately directed to the claimed subgenus in particular to convey that it was 9
invented. 10
Citing In re Johnson, 558 F.2d 1008, 1019 (C.C.P.A. 1977), Wengel argues 11
that it should not be prohibited from changing what it regards as its invention. 12
However, here Wengel is adding an embodiment, i.e., where s is 0, whereas in 13
Johnson the applicant was removing species within a described genus. Further, in 14
Johnson, the Court noted that the specification contained extensive examples that 15
fully supported the subgenus claimed. In re Johnson, 558 F.2d at 1018. 16
(“Welstead is thus clearly distinguishable from the present case, in which 17
appellants’ grandparent application contains a broad and complete generic 18

Notice, Paper 23, p. 2).

-39-
disclosure, coupled with extensive examples fully supportive of the limited genus 1
now claimed.”). In the present situation Wengel does not provide sufficient 2
examples to support the created subgenus. 3
Wengel argues that the subgenus claimed would have been readily 4
discernible from that described in its specification where it states that “r and s is 0-5
3 with the proviso that the sum or r + s is 1-4”. (Wengel Reply 3 at 3-4 and ‘133, 6
Ex 2019 at, e.g., 9: 6-8). However, this statement does not appear in the context of 7
the biradical of interest, i.e., −(CH2)0-1−O –(CH2)1-3−, but instead is part of a much 8
larger disclosure of compounds such that one skilled in the art would not have been 9
directed to those r and s values for the particular LNAs of claim 34. (Second 10
Gryaznov Decl., Ex. 2080 at ¶ 79).13 11
Wengel also points to original claims of its ‘650 application, e.g., claims 60, 12
69, 71, 83, 89 and 90, that it says support the subgenus claimed. (Wengel 13
Responsive Motion 3 at 9 (Appendix 3) and Wengel Reply 3 at 2). While some of 14
the claims are specific to the 2´, 4´ bridge there is no disclosure of the subgenus 15
claimed, i.e., where r being 0 and s being 2-3, or s being 0 and r being 2-3. We do 16

13 For example, the r and s values apply to all the possible biradical linkages encompassed
at formula I. The specification specifically shows s values of 0 for some biradicals but not for
the 2´ 4´ biradical claimed. (‘133, Ex 2010 at, .e.g., 18:67 and 19:14 and Second Gryaznov
Decl. at ¶¶ 78-80).

-40-
not agree that these claims provided direction to the claimed subgenus sufficient to 1
convey that it was invented.14 2
Kaneko further argues that claim 34 is not enabled because it includes within 3
its scope an embodiment where s is 0. According to Kaneko, when s is 0 an acetal 4
linkage results that would not allow for oligonucleotide formation from the 5
putative acetal-nucleoside. Further, Kaneko directs us to the testimony of Dr. 6
Armitage regarding the difficulty in synthesizing a compound with a 4´ hydroxyl 7
group, as in when s is 0 and r is 2-3. (Kaneko Opposition 3 at 16-17). According 8
to Dr. Armitage using a 4´ hydroxyl instead of a 2´ hydroxyl in LNA to make an 9
alkyl linkage “while certainly possible[,] would require one to sit down and plan 10
out a very different route” and that based on the teaching of Wengel “I think it 11
would have been difficult to make a 4´ hydroxyl.” (Armitage Dep. Transcript, Ex 12
1046 at 87:3-6 and 13-14). However, because we are persuaded that claim 34 is 13
unpatentable based on a lack of description we need not and do not reach the issue 14
of whether claim 34 is enabled. 15
Claim 39 16
Claim 39 depends from claim 24 (an ENA claim) and limits B to the 17

14 Even if claim 34 finds support in these claims it appears that they were added upon the
filing of the ‘650 application. Kaneko disclosed the ENA embodiment prior to the ‘650 filing
date (e.g., in US 09/925,673 filed 9 August 2001; See also Kaneko unopposed Motion 3 for

-41-
nucleobases adenine, guanine, thymine, cytosine, or uracil. Thus, claim 39 differs 1
from claims 24 and 25 as it directed to a more limited subset of nucleobases. 2
Limiting the nucleobases to those specifically disclosed at column 28 of the 3
Wengel specification might address a portion of the written description issue raised 4
in Kaneko Motion 1. (‘133 Patent, Ex 2010 at 28: 17-20). However, since we are 5
persuaded that there are insufficient blaze marks to guide one skilled in the art to 6
the –O-(CH2)2 bridge as discussed above, we are persuaded that there is 7
insufficient description for the subject matter of claim 39. 8
Summary 9
We GRANT Kaneko motion 1 and determine that the Wengel involved 10
claims, including added claims 34 and 39, are not patentable to Wengel. As 11
Wengel has no patentable claims remaining in the interference it is appropriate to 12
enter judgment against Wengel. We note that Wengel relies only upon an earlier 13
application (i.e., provisional 60/058,541, filed 12 September 1997) as its earliest 14
reduction to practice in its priority statement. (Wengel Priority Statement, Paper 15
31). For the same reasons that the involved Wengel patent and reissue application 16
lack written description support for the ENA embodiment, the subject matter of the 17
Count, this earlier application did not describe ENA. Accordingly, for this further 18

priority benefit of JP 11-33863, filed 12 February 1999) and thus would be anticipating prior art

-42-
reason there is no cause to proceed to a priority phase in the interference. 1
Because we will not proceed to a priority phase, we need not and do not 2
consider Wengel Motion 2 to add a Count. 3
Further, we need not and do not consider Kaneko Motion 2 (to be accorded 4
benefit), Kaneko Motion 3 (to deny Wengel benefit) or Kaneko Motion 4 (for 5
judgment that the Wengel claims also are unpatentable over the Kaneko PCT 6
application). 7
B. Wengel Motion 1 8
We also have before us Wengel Motion 1 for judgment that the involved 9
Kaneko claims are unpatentable over the involved Wengel patent. Although we 10
might return the application to the Examiner to consider the prior art and the 11
briefing of the parties as Kaneko requests (Kaneko Opposition 1 at 23) (Bd. R. 12
127(c)), we believe that considering the Wengel Motion within this proceeding is 13
in the best interest of resolving the issues before us in the most just, speedy and 14
inexpensive manner. Bd. R. 1(a). We exercise our discretion to consider the 15
patentability of the Kaneko claims over the prior art raised in Wengel Motion 1. 16
Wengel moves for judgment on the basis that the Kaneko involved claims 17

to claim 34 (which encompasses ENA).

-43-
are unpatentable under 35 USC §102(e)15 or 35 USC §103(a) in view of the 1
involved Kaneko patent. 2
Anticipation 3
To anticipate, a prior art reference must disclose each and every feature of 4
the claimed invention, either explicitly or inherently such that it “place[s] the 5
inventive compound or composition in the possession of the public.” Eli Lilly and 6
Co. v. Zenith Goldline, 471 F.3d 1369, 1375-76 (Fed. Cir. 2006), citing Glaxo Inc. 7
v. Novopharm Ltd., 52 F.3d 1043, 1047 (Fed.Cir.1995) and In re Brown, 51 8
C.C.P.A. 1254, 329 F.2d 1006, 1011 (1964). Anticipation requires that the prior 9
art “clearly and unequivocally disclose the claimed compound or direct those 10
skilled in the art to the compound without any need for picking, choosing, and 11
combining various disclosures not directly related to each other by the teachings of 12
the cited reference.” In re Arkley, 455 F.2d 586, 587 (CCPA 1972) (emphasis in 13
original). 14
Wengel acknowledges that the subject matter of the Kaneko claims is not 15
explicitly disclosed in the involved Wengel patent. (Armitage Deposition 16
Transcript, Ex 1046 at 131:1-132:14). Instead Wengel directs us to In re Petering, 17

15 Wengel does not argue a § 102(b) anticipation by virtue of the addition of ENA claims in
January of 2004. We have determined that Wengel does not have support for these claims at any
rate. Further Wengel does not argue that Kaneko is not entitled to its earlier filing dates for prior

-44-
301 F.2d 676 (C.C.P.A. 1962) and In re Schaumann, 572 F.2d 312 1
(C.C.P.A.1987), arguing that one skilled in the art would have instantly envisaged 2
the ENA embodiments claimed by Kaneko once having selected the −(CH2)0-1−O –3
(CH2)1-3− biradical. According to Wengel, the ENA compound claimed by 4
Kaneko is a selection within what Wengel says is a 66-member “particularly 5
interesting” genus disclosed in its patent. (Wengel Motion 1 at 5, referring to Ex 6
1025 at 42). 7
As we have discussed in connection with description, the Wengel 8
specification does not direct one to only the −(CH2)0-1−O –(CH2)1-3− biradical, 9
and more particularly, not to the ENA compound of the Kaneko claims. In fact, 10
Wengel directs one to numerous “particularly interesting” embodiments including 11
embodiments having a 2´, 3´ bridge (‘133 Patent, Ex 2010 at 28:42-61) and where 12
RN is selected from “DNA intercalators, photochemically active groups, 13
thermochemically active groups, chelating groups, reporter groups and ligands.” 14
(‘133 Patent, Ex 2010 at 28:13-15). When Wengel does call out a particular 15
biradical from within the “particularly interesting” ones, it is not an oxyethylene 16
but, rather, among two other non-oxygen containing biradicals, an oxymethylene. 17
(‘133 Patent, Ex 2010 28:20-24). In contrast, in Schaumann and Petering the prior 18

art purposes. (Declaration at 5).

-45-
art “expressly spelled out a definite and limited class of compounds that enabled a 1
person of ordinary skill in the art to at once envisage each member of this limited 2
class.” Eli Lilly and Co. v. Zenith Goldline, 471 F.3d 1369, 1376 (Fed. Cir. 2006), 3
citing Schaumann, 572 F.2d at 315 and Petering, 301 F.2d at 681–82. We do not 4
find the Wengel specification to present the type of definite and limited class of 5
compounds that was set forth in the Schaumann and Petering prior art. 6
Because we find that the Wengel involved patent does not teach the subject 7
matter of the claimed Kaneko compounds, we need not and do not reach Kaneko’s 8
argument that the Wengel patent is not an enabling reference. 9
Obviousness 10
Wengel argues that, even if its disclosure does not anticipate the Kaneko 11
involved claims, it would have been rendered obvious the Kaneko claims under 35 12
USC §103. In particular, Wengel argues, relying upon the declaration testimony of 13
Dr. Armitage, one skilled in the art would have selected the ENA embodiment 14
because such a modification would have led to oligonucleotides having “an 15
increased stability and affinity for target single- and double-stranded nucleic acids 16
and increased resistance to enzyme degradation relative to oligonucleotides made 17
from unmodified nucleosides.” (Wengel Motion 1 at 15:14-20, citing to Armitage 18
Decl., Ex 1020 at ¶¶ 109, 110 and Ex 1002 at Abstract and 38:28-33). 19

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On the other hand, Kaneko argues that, based upon the teachings of the ‘133 1
Patent and relying upon the testimony of Dr. Gryaznov, the person of ordinary skill 2
in the art would have been had reason to keep the 2´, 4´-biradical bridge at a 3
minimal length e.g., as in the exemplified oxymethylene bridge, to impart 4
inflexibility, and therefore more stability, to the furanose ring. (Kaneko 5
Opposition 1 at 12). Wengel notes that the only exemplified ethylene bridge 6
within the ‘133 patent is formed by R2* and R3*, not R2* and R4*. (Kaneko 7
Opposition 1 at 22:7-19). 8
Obviousness is a question of law based on underlying findings of fact. An 9
analysis of obviousness must be based on several factual inquiries: (1) the scope 10
and content of the prior art; (2) the differences between the prior art and the claims 11
at issue; (3) the level of ordinary skill in the art at the time the invention was made; 12
and (4) objective evidence of nonobviousness, if any. See Graham v. John Deere 13
Co., 383 U.S. 1, 17-18 (1966). 14
Although we find that the ‘133 specification does not describe the ENA 15
embodiment, we are persuaded that the ENA embodiments of the Kaneko claims 16
would have been obvious to one skilled in the art in view of the ‘133 disclosure. In 17
particular, we agree with Dr. Armitage that, given the disclosure of the methylene 18
bridge along with the generic disclosure of preferred or particularly interesting 19

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bridges, one skilled in the art would have sufficient reason to select a bridge that 1
differs by the addition of a methyl group, i.e., the ENA embodiment. (Armitage 2
Decl., Ex 1020 at ¶ 71). While we understand the methylene bridge to have been 3
preferred due to its minimal length (Second Gryaznov Decl., Ex 2080 at ¶ 38), we 4
do not find the Wengel specification to teach away from the other selections that 5
could be made within the generic formula. In this case it appears that selecting the 6
oxyethylene bridge would have amounted to pursuing “known options” from a 7
“finite number of identified, predictable solutions.” KSR International Co. v. 8
Teleflex Inc., 550 U.S. 398, 421 (2007); see also In re Kubin, 561 F.3d 1351, 1360, 9
(Fed. Cir. 2009). (“This court also declines to cabin KSR to the “predictable arts” 10
(as opposed to the “unpredictable art” of biotechnology)).” We further are 11
persuaded that each of the involved Kaneko claims would have been obvious for 12
reasons discussed more particularly in the testimony of Dr. Armitage which 13
addresses each claim. (Armitage Decl., Ex 1020 at ¶¶ 72-89). 14
Although Kaneko makes an argument that the ‘133 patent only shows a 2´,3´ 15
- and not a 2´,4´ -oxyethylene bridge (Opp. at 22), Kaneko’s primary argument is 16
that the ENA compounds of its claims provide surprising and unexpected results 17
compared to oxymethylene-bridged LNA compounds. (Opposition at 18). We do 18
not find the argument regarding the 2´,3´ bridge persuasive since we conclude that 19

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a 2´,4´ -oxyetheylene would have been obvious from the 2´,4´ bridges disclosed 1
without considering the disclosure of the 2´,3´ bridges disclosed in the Wengel 2
patent. 3
Unexpected Results 4
A prima facie case of obviousness may be rebutted by showing unexpected 5
results i.e., a showing “that the claimed invention exhibits some superior property 6
or advantage that a person of ordinary skill in the relevant art would have found 7
surprising or unexpected [as] that which would have been surprising to a person of 8
ordinary skill in a particular art would not have been obvious.” In re Soni, 54 F.3d 9
746, 750 (Fed. Cir. 1995). We, like the Examiner in the ‘673 application, are 10
persuaded that the ENA compounds claimed by Kaneko demonstrate unexpected 11
results. 12
In examining ENA claims by Kaneko, the Examiner stated that: 13
The closest prior art Wengel et al (US 6,794,499) teaches general 14
structure IIa in which one of the embodiments is a structure wherein 15
R2* and R4* are bridged via an -OCH2CH2 group, which is the same 16
as the compound instantly claimed. Wengel does not provide an 17
example wherein the said compound is made or any experimental 18
results regarding its stability and activity. Wengel’s structure IIa also 19
reads on several different combinations for the substitutions. The 20
Declaration [by Dr. Koizumi] filed by the applicants shows that the 21
compounds as instantly claimed (containing the 2'-4'-O-ethylene 22
bridge) are highly stable and resistant to nuclease activity. This is 23
neither taught nor obvious from the teachings of the prior art. 24
25

-49-
(Second Koizumi Decl., Ex 2081 at ¶ 10 and Ex 2068 at 2). 1
2
Neither the Board nor Wengel is bound by a determination of the Examiner 3
made during ex parte prosecution. Glaxo Wellcome, Inc. v. Cabilly, 56 USPQ2d 4
1983, 1984 (BPAI 2000). However, upon a review of the CERs as discussed by 5
Dr. Koizumi and in view of other evidence before us, including the Morita paper 6
discussed below, we agree with the Examiner’s conclusion that the Kaneko ENA 7
claims would not have been obvious. 8
Dr. Koizumi’s work with ENAs was the subject of a paper he and his co-9
worker’s submitted to Bioorganic and Medicinal Chemistry Letters, (Morita Paper, 10
Ex 2077,16 at 73-76; Second Koizumi Decl., Ex 2081 at ¶ 20). The article 11
describes experiments comparing the stability of oxymethylene-bridged LNA, 12
ENA, and a natural DNA oligonucleotide in the presence of snake venom 13
phosphodiesterase. (Exs 2077 at 75; Second Decl. of Koizumi, Ex 2081at ¶ 21). 14
As a summary of that stability, Dr. Koizumi stated that “[t]hese data show that one 15
2´- O, 4´-C-ethylene modification resulted in more than 500 times higher stability 16
than natural nucleotides, and approximately 55 times higher stability than the 2´-17
O,4´-C-methylene nucleotide.” (Ex 2077 at 75, Second Koizumi Decl., Ex 2081, 18

16 Koji Morita et al., 2´-0,4´-C-Ethylene-Bridged Nucleic Acids (ENA): Highly Nuclease-
Resistant and Thermodynamically Stable Oligonucleotides for Antisense Drug, 12 BIOORG. MED.

-50-
¶ 21). According to the paper, both ENA and oxymethylene-LNA were more 1
stable than the natural nucleotides, however, the former demonstrated 55 times 2
more stability than the latter. 3
Kaneko also points to an article authored by Dr. Ørum, Chief Science 4
Officer for Cureon,17 and Dr. Lars Kongsback who in 2003 was appointed CEO of 5
Exiquon, the Wengel real party in interest (Notice or Real Party in Interest, Paper 6
8, Kaneko Opposition 1, MFs 92 and 96, admitted by Wengel, and Ex 208218). The 7
article appears in the book, PEPTIDE NUCLEIC ACIDS, MORPHOLINOS AND RELATED 8
ANTISENSE BIOMOLECULES19, and refers to ENA as “a new LNA analogue, termed 9
ENA” and points to the results, including the 55 times enhanced stability reported 10
with ENA, reported in the Morita paper. (Ørum Article, Ex 2076 at 213). We 11
have considered the Ørum paper as part of the totality of the evidence before us, 12
along with the other evidence that the Morita article was praised by those in the 13
field. (Second Koizumi Decl., Ex 2081 at ¶¶ 18, 19 and Exs 2070, 2071, 2072 and 14

CHEM. LETT. 73-76 (2002).
17 It appears that Cureon was a subsidiary of Exiqon at one time. ( Exs 2081, ¶ 24 and 2078
(said to be a copy of webpage from Exiqon’s website at
http://www.exiqon.com/Pages/History.aspx, printed on 21 March 2013) at 1) (Kaneko Exhibit
List, Paper 79).
18 The Exhibit is said to be Copy of webpage from Exiqon’s website at
http://www.exiqon.com/Pages/Management.aspx, as printed on 26 March 2013. (Kaneko
Exhibits List, Paper 79).
19 PEPTIDE NUCLEIC ACIDS, MORPHOLINOS AND RELATED ANTISENSE BIOMOLECULES, E.G.
Janson and M.J. During, eds. Kluwer Academic / Plenum Publishers (2006) at Chapter 13.

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2073). Even without the Ørum Article and the evidence of praise in the field, there 1
is a sufficient showing of unexpected results such that we are not persuaded of 2
obviousness. We note, however, that the Article and the evidence of praise in the 3
field contribute to our conclusion and tend to show that others in the field, 4
including those working for the Wengel real party in interest, thought the results 5
obtained using ENA were noteworthy. Dr. Armitage has testified that the stability 6
results obtained with the claimed ENAs were not unexpected (See, e.g.., Ex 1020 at 7
¶¶ 94-145), however, we do not credit his testimony on this point for reasons 8
discussed herein. 9
In its Reply, Wengel argues that the improvement in nuclease stability 10
reported for ENA as compared to LNA is only a difference in degree and not a 11
difference in kind as is required for unexpected results. (Wengel Reply 1, citing In 12
re Huang, 100 F.3d 135, 139 (Fed. Cir. 1996). Wengel directs us to, inter alia, 13
column 38 of its involved patent where it is stated that an object of the invention is 14
to provide “LNA modified oligonucleotides which are more resistant to nucleases 15
that their unmodified counterparts.” (‘133 patent, Ex 2010 at 38:58-60). 16
As noted in In re Soni, “[t]he principle [of unexpected results] applies most 17
often to the less predictable fields, such as chemistry, where minor changes in a 18
product or process may yield substantially different results.” Soni, 54 F.3d at 750. 19

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Here the change of adding a single methyl group to the 2´, 4´ bridge resulted in an 1
approximately 55 times higher stability. Some of the results reported in the CERs 2
do not show as high an improvement in stability, or other properties, as Wengel 3
notes (e.g., Wengel Reply 1 at 8:7-13). However, overall the ENA consistently 4
performed better than LNA, with at least one of improvements over LNA (that 5
reported in the Morita Paper) being significant enough to be included in the Ørum 6
Article. The fact that a minor change resulted in a significant change in property is 7
unexpected as Dr. Koizumi attested. (See, e.g., Ex 2081 at ¶¶ 16, 21). Further, we 8
find the result obtained through use of the ENAs to be “such a marked 9
improvement, over the results achieved [with LNAs], as to be classified as a 10
difference in kind, rather than one of degree.” See In re Waymouth, 499 F.2d 1273, 11
1276 (CCPA 1974). 12
Wengel argues that the results obtained were not unexpected since the art 13
recognized that modifying the 2´ oxygen of a nucleoside with a larger substituent 14
group would cause an increase in nuclease resistance. Wengel cites to Monia (Ex 15
1073) and Cummins et al. (Ex 1074) in support of its argument. (Wengel Reply 1, 16
Paper 64) at 8). However, as confirmed by Dr. Armitage, neither of these 17
references20 is directed to bridged compounds (Armitage Dep. Transcript, Ex 1076 18

20 Our understanding is that these references are being referred to as the “Isis papers” in the

-53-
at 202:11-17). We are not persuaded that these references would inform 1
expectations for bridged compounds like those claimed by Kaneko. Further, we 2
are not persuaded that one skilled in the art, even if expecting some increase, 3
would have expected an increase of the magnitude demonstrated by the results 4
reported in the CERs and the Morita Paper. 5
Kaneko argues that the ENAs exhibit another unexpected property, in that 6
“fully modified ENA oligonucleotides [i.e., where each nucleoside contains a 7
modification] form triplexes, while fully modified oxymethylene LNA 8
oligonucleotides do not, indicat[ing] very different and significant properties of the 9
two classes of nucleosides”. (Kaneko Opposition 1 at 21). We agree with 10
Wengel’s arguments on this point (Wengel Reply 1 at 9-10). We do not find 11
unexpected results on this basis for at least the reason that Kaneko has not shown 12
that the results, which appear to be limited to “fully modified” ENAs, are 13
commensurate in scope with its claims which do not appear to be so limited. In re 14
Peterson, 315 F.3d 1325, 1329-31, (Fed. Cir. 2003). 15

deposition of Dr. Armitage taken on 6 May 2013. (Ex 1076 at 200:14-24 and 202:11-17).

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Summary 1
Based on a consideration of the totality of evidence before us on this issue, 2
we conclude that the Kaneko claims would not have been obvious. 3
C. Kaneko Miscellaneous Motion 5 4
Kaneko filed a motion to exclude from evidence the following Wengel 5
Exhibits: 1003, 1004-1006, 1012- 1015, 1017, 1020, 1023, 1026, 1027, 1060, 6
1069, 1071, 1072, 1073, 1074, and 1075. (Kaneko Miscellaneous Motion 5 at 1). 7
In reaching our Decision we have not relied upon Exhibits 1004, 1006, 1012, 1013, 8
1014, 1015, 1017, 1023, 1026, 1027, 1060, 1069, 1071, 1072, and 1075. Thus, we 9
need not, and do not, decide whether these Exhibits should be excluded from 10
evidence. 11
Kaneko moves to exclude the curriculum vitae of Dr. Armitage (Ex 1003) on 12
the basis that it lacks relevance, is not discussed in the Wengel motions and is not 13
listed in the evidence Appendix of the motions. (Kaneko Miscellaneous Motion 5 14
at 2). We do not exclude this Exhibit as it provides insight into the qualifications 15
of Dr. Armitage, who refers to the Exhibit in his declaration testimony (Armitage 16
Decl., Ex 1020 at ¶ 6), to provide testimony relating to the issues in the 17
interference. 18

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Kaneko moves to exclude the declaration of Dr. Armitage (Armitage Decl., 1
Ex 1020) on the basis that it “does not satisfy FRE 702 and the case law addressing 2
that rule, and Bd. Rule 158(b).” (Kaneko Miscellaneous Motion 5 at 4). Kaneko 3
does not point to any specific portion of FRE 702 or specific case law supporting 4
its position. Nor does Kanko explain how the testimony of Dr. Armitage does not 5
comply with Bd. R. 158(b). At any rate, we consider whether Dr. Armitage has 6
provided sufficient underlying support for his testimony that is based on a 7
technical test or data to go to the weight, not the admissibility, of that testimony. 8
We do not exclude Exhibit 1020. 9
Kaneko moves to exclude Wengel patent US 6,794,499 (Ex 1005) on the 10
basis that “Wengel was not authorized to rely on this document in support of its 11
prior art motion.” (Kaneko Miscellaneous Motion 5 at 2). We do not understand 12
Wengel to be relying upon the patent as a basis for unpatentability but rather as 13
establishing the date to which the relied upon reference, i.e., the involved Wengel 14
patent, is entitled to under 35 USC §120. (See, e.g., Wengel Motion 1 at 1:2-4 and 15
2:15-18). We do not exclude Exhibit 1005. 16
Kaneko moves to exclude Exhibits 1073 and 1074 (Monia and Cummins 17
respectively) because each of the Exhibits “lacks relevance, is hearsay and lacks 18
authentication.” (Kaneko Miscellaneous Motion 5 at 6). Kaneko does not 19

-56-
elaborate further. We are not persuaded that Monia and Cummins lack relevance 1
as they show what one skilled in the art would have known in a relevant field of 2
technology. Further we understand that the Exhibits are relied upon not for the 3
truth of their contents, but for what they would have conveyed to one skilled in the 4
art. We therefore do not exclude Exhibits 1073 and 1074. Regardless, we deny 5
Wengel Motion 1 even if we consider these Exhibits. 6
Summary 7
Wengel Miscellaneous Motion 5 to exclude evidence is DISMISSED-IN-8
PART and DENIED-IN-PART. 9
IV. Order 10
It is 11
ORDERED that Kaneko Motion 1 is GRANTED; 12
FURTHER ORDERED that all the Wengel involved claims are unpatentable 13
to Wengel; 14
FURTHER ORDERED that Wengel Motion 2, Kaneko Motion 2, Kaneko 15
Motion 3, Kaneko Motion 4 are DISMISSED as moot; 16
FURTHER ORDERED that Wengel Motion 1 is DENIED; 17
FURTHER ORDERED that Kaneko Miscellaneous Motion 5 is 18
DISMISSED-IN-PART as moot and DENIED-IN-PART; and 19

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FURTHER ORDERED that judgment against Wengel shall be entered in a 1
separate paper. 2

cc:
Attorney for Kaneko:

George E. Quillin, Esq.
Michael D. Kaminski, Esq.
Kristel Schorr, Esq.
Foley & Lardner, LLP
Email: gquillin@foley.com
Email: mkaminski@foley.com
Email: kschorr@foley.com

Attorney for Wengel:

John M. Covert, Esq.
Eric K. Steffe, Esq.
Sterne, Kessler, Goldstein & Fox, PLLC
Email: jcovert-ptab@skgf.com
Email: esteffe-ptab@skgf.com