Skerra et al.v.Stemmer et al. V. Skerra et al.

Patent Trial and Appeal Board

Jun 2, 2015

12665565 (P.T.A.B. Jun. 2, 2015)

BoxInterferences@uspto.gov Filed: June 2, 2015
Tel: 571-272-9797

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

WILLEM P. STEMMER
and
VOLKER SCHELLENBERGER,

Junior Party
(Application 13/469,902)

v.

ARNE SKERRA,
INA THEOBALD, and
MARTIN SCHLAPSCHY,

Senior Party,
(Application 13/963,953 and Patent 8,563,521)

Patent Interference No. 106,017
(Technology Center 1600)

Before: RICHARD E. SCHAFER, SALLY GARDNER LANE, and DEBORAH
KATZ, Administrative Patent Judges.

LANE, Administrative Patent Judge.

Judgment - Bd.R. 127(a)

In view of the Decision on Motions (Decision, Paper 88), it is 1
ORDERED that judgment on priority as to Count 1 (Declaration, 2
(Paper 1, at 5), the sole count of the interference, is entered against junior party 3
WILLEM P. STEMMER and VOLKER SCHELLENBERGER; 4
FURTHER ORDERED that claims 1-16 of junior party application 5
13/469,902, which claims correspond to Count 1, are FINALLY REFUSED; 6
35 USC 135(a);
1
7
FURTHER ORDERED that the parties are directed to 35 USC 135(c) 8
and to Bd. R. 205 regarding the filing of settlement agreements; 9
FURTHER ORDERED that a copy of this judgment shall be entered 10
into the administrative record of the involved junior party application and the 11
involved senior party application and patent; and 12
FURTHER ORDERED that a party seeking judicial review of this 13
judgment promptly serve notice on the Director of the United States Patent and 14
Trademark Office. 37 C.F.R. §§ 90.1 and 104.2. 15
We direct the parties’ attention to Biogen MA, Inc., v. Japanese Foundation for 16
Cancer Research, ___ F.3d ___; 2015 WL 2109812 (Fed. Cir. 2015). 17
18

1 Any reference to a statute is to statute that was in effect on March15, 2013
unless otherwise indicated. See Pub. L. 112-29, § 3(n),125 Stat. 284, 293 (2011).

cc (via electronic): 1
2
Attorney for Stemmer: 3
4
Steven W. Parmelee, Esq. 5
Michael T. Rosata, Esq. 6
Wilson Sonsini Goodrich & Rosati 7
sparmelee@wsgr.com 8
mrosato@wsgr.com 9
10
Attorney for Skerra: 11
12
George E. Quillin, Esq. 13
Benjamin Berkowitz, Esq. 14
Simon J. Elliott, Esq. 15
Foley & Lardner, LLP 16
gquillin@foley.com 17
bberkowitz@foley.com 18
sjelliott@foley.com 19
20
BoxInterferences@uspto.gov Filed: June 2, 2015
Tel: 571-272-9797

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

WILLEM P. STEMMER
and
VOLKER SCHELLENBERGER,

Junior Party
(Application13/469,902)

v.

ARNE SKERRA,
INA THEOBALD, and
MARTIN SCHLAPSCHY,

Senior Party,
(Application 13/963,953 and Patent 8,563,521)

Patent Interference No. 106,017
(Technology Center 1600)

Before RICHARD E. SCHAFER, SALLY GARDNER LANE, and
DEBORAH KATZ, Administrative Patent Judges.

LANE, Administrative Patent Judge.

Decision – Motions - Bd.R. 125(c)

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I. Introduction 1
Stemmer was authorized to file (Order Authorizing Motion, Paper 17),
1
and 2
did file, a single motion to redefine the interfering subject matter. (Stemmer 3
Motion 1).
2
Skerra was authorized to file (Order Authorizing Opposition, 4
Paper 48), and did file an opposition to Stemmer Motion 1. (Skerra Opposition 1, 5
Paper 50). In its Motion 1, Stemmer moves to add a count, proposed Count 2, and 6
to have Skerra add, in its involved application, a claim that would correspond to 7
proposed Count 2. Further, Stemmer was required to include within its motion a 8
showing of why it would prevail on priority as to Count 1 and proposed Count 2.
3
9
(Order Authorizing Motion at 5:13-15 and Bd. R. 202(d)(1)). 10
Stemmer has not provided sufficient reason to modify the interfering subject 11
matter to include a second Count. Further, Stemmer has not shown why it would 12
prevail on priority as to Count 1. Stemmer Motion 1 is denied and judgment 13
against Stemmer as to Count 1 will be entered in a separate paper. 14
II. Findings of Fact 15
The record supports the following findings of facts and any other findings of 16
fact set forth in this Decision by a preponderance of the evidence. 17

1
Skerra requested rehearing of the Order Authorizing Motion (Request, Paper
18) but the Order was not modified. (Decision on Rehearing, Paper 47).
2
Stemmer styled the paper as a “Response” but we consider it as “Stemmer
Motion 1”.
3
Since Stemmer was not required to comply with Bd. R. 202(d) during
ex parte prosecution, Stemmer was given an opportunity to present evidence
sufficient to show why it would prevail on priority without restriction against
new evidence. (Order, Paper 3). Thereafter Stemmer requested authorization
to file Stemmer Motion 1.

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1. The Count, Count 1, is: 1
Claim 2 of the Stemmer [involved] application (13/469,902) 2
or 3
Claim 1 of the Skerra [involved] application (13/963,953) 4
(Declaration, Paper 1, at 5). 5
2. Claim 2 of the Stemmer involved application depends from claim 1. Both 6
claims 1 and 2 are reproduced below: 7
A biologically active protein comprising at least two domains wherein 8
(a) a first domain of said at least two domains comprises an amino 9
acid sequence having and/or mediating said biological activity; and 10
(b) a second domain of said at least two domains comprises an amino 11
acid sequence consisting of at least about 80 amino acid residues 12
forming random coil conformation, wherein said second domain 13
consists of three types of amino acid residues, whereby said random 14
coil conformation mediates an increased in vivo and in vitro stability 15
of said biologically active protein compared to said biologically active 16
protein lacking said random coil forming second domain. 17
18
2. The biologically active protein according to claim 1, wherein said second 19
domain forming random coil conformation consists of alanine, serine and 20
proline residues. 21
22
(Stemmer Clean Copy of Claims, Paper 8). 23
24
3. Claim 1 of the Skerra involved application is: 25
A biologically active protein comprising a) a first domain comprising an 26
amino acid sequence having said biological activity; and (b) a second 27
domain consisting of at least 80 amino acid residues which consists 28
essentially of alanine, serine and proline residues and which forms a random 29
coil conformation which mediates an increased in vivo and/or in vitro 30

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1
stability of said biologically active protein compared with the biologically 2
active protein lacking said second domain. 3
4
(Skerra Clean Copy of Claims, Paper 11). 5
4. Claim 1 of the Stemmer involved application does not contain a limitation 6
requiring that the second domain conformation consists of alanine, serine 7
and proline residues and thus claim 1 is broader than claim 2. 8
5. Stemmer generally refers to the subject matter of its claim 1 as the genus 9
subject matter and the subject matter of its claim 2 as the species subject 10
matter. 11
6. Claim 1 of the Stemmer involved application is designated as corresponding 12
to Count 1 since Count 1 would have anticipated the genus subject matter of 13
claim 1. (Declaration at 5 and Bd. R. 207(b)(2)). 14
7. All of Skerra’s involved claims include a second domain that consists, or 15
consists essentially of, alanine, serine and proline and thus all of Skerra’s 16
involved claims are directed to the species subject matter. (Skerra Clean 17
Copy of Claims). 18
8. Proposed Count 2, said to be directed to the genus, is: 19
A biologically active protein comprising at least two domains wherein 20
(a) a first domain of said at least two domains comprises an amino 21
acid sequence having and/or mediating said biological activity; and 22
(b) a second domain of said at least two domains comprises an amino 23
acid sequence consisting of at least about 80 amino acid residues 24
forming random coil conformation, wherein said second domain 25
consists of three types of amino acid residues, whereby said random 26
coil conformation mediates an increased in vivo and in vitro stability 27
of said biologically active protein. 28
29
(Stemmer Motion 1 at 4:17-5:1). 30

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9. According to Stemmer, Count 1 is patentably distinct from proposed 1
Count 2. (Stemmer Motion 1 at 5:19-22). 2
10. Proposed Count 2 is substantially the same as claim 1 of the involved 3
Stemmer application but for the final clause, which Stemmer represents was 4
added during prosecution to obviate a possible issue of indefiniteness. 5
(Stemmer Motion 1 at 5:4-6).
4
6
11. The claim that Stemmer proposes that Skerra add to its involved 7
application, said to be directed to the genus, is as follows: 8
1. A biologically active protein comprising at least two domains 9
wherein 10
(a) a first domain of said at least two domains comprises an 11
amino acid sequence having and/or mediating said biological activity; 12
and 13
(b) a second domain of said at least two domains comprises an 14
amino acid sequence consisting preferably of at least about 100 amino 15
acid residues forming random coil conformation whereby said random 16
coil conformation mediates an increased in vivo and/or in vitro 17
stability of said biologically active protein. 18
19
(Stemmer Motion 1 at 10:3-18). 20
21
12. According to Stemmer, the proposed claim was originally presented in 22
Skerra benefit application 12/665,565 manifesting intent by Skerra to claim 23
the subject matter. (Stemmer Motion 1 at 10:13-15). 24

4
Stemmer indicates that it removed the limitation from the Count it proposes
also to “simplify priority proofs for both parties without changing the scope of the
Count” and because “this clause did not appear in Skerra’s original claim in the
published application WO2008/155134.” (Stemmer Motion 1 at 5:6-11).

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13. According to Stemmer the proposed claim, if added, would correspond to 1
proposed Count 2. (Stemmer Motion 1 at 10:16-18). 2
3
III. Discussion 4
Stemmer was required to comply with Bd. R. 202(d) because it did not 5
appear that it was provided an opportunity to do so during ex parte prosecution. 6
(Order requiring compliance with 202(d) entered 4 March 2015, Paper 3).
5
7
Thereafter Stemmer requested, and was granted, authorization to file a single 8
motion to redefine the interfering subject matter. Stemmer was given the option 9
either to move to add a second count directed to the genus or to move to substitute 10
Count 1 with a count that encompasses both the genus and the species subject 11
matter. Rather than move to substitute a count for Count 1, Stemmer opted to 12
propose to add a count, proposed Count 2, said to be “directed to the subject matter 13
of the genus” and to have its genus claims, i.e., claims 1 and 5-11, and a claim it 14
proposes that Skerra add to its involved application, designated as corresponding to 15
proposed Count 2. (Stemmer Motion 1 at 1:22-23 and 4:9-5:16). Stemmer also 16
moves, within the same motion, to have Skerra add a single genus claim to its 17
involved application. Further, within its Motion 1, Stemmer provides a showing of 18
why it would prevail on priority as to proposed Count 2. 19
Thus, we have before us the issues of whether the interference should be 20
redefined to add proposed Count 2, whether Skerra should be required to add a 21
genus claim, and whether Stemmer has complied with Bd. R. 202(d) as to either 22
Count 1, or, if added, proposed Count 2. For each of these issues Stemmer has the 23
burden of proof. Bd. R. 202(d)(1) and Bd. R. 121(b). 24

5
Stemmer remains under this Order (Order Authorizing Motion at 5:13-16).

-7-
Requiring Skerra to add a claim 1
We first consider whether Stemmer has shown that Skerra should be 2
required to add to its involved application the genus claim proposed by Stemmer. 3
If Skerra is not required to add such a claim then there is no basis to add proposed 4
Count 2 since Skerra would not have a claim corresponding to the proposed Count. 5
Stemmer moves to have the Board require Skerra to add the following claim: 6
1. A biologically active protein comprising at least two domains 7
wherein 8
(a) a first domain of said at least two domains comprises an amino 9
acid sequence having and/or mediating said biological activity; and 10
(b) a second domain of said at least two domains comprises an amino 11
acid sequence consisting preferably of at least about 100 amino acid 12
residues forming random coil conformation whereby said random coil 13
conformation mediates an increased in vivo and/or in vitro stability of 14
said biologically active protein. 15
16
(Stemmer Motion 1 at 10:3-18). 17
18
Stemmer asserts that Skerra originally presented this claim in its 12/665,565 19
benefit application and it was this claim that Stemmer copied into its 12/646,566 20
benefit application. (Stemmer Motion 1 at 10:12-19). Stemmer reasons that, “as 21
Skerra has previously manifested an intent to claim the subject matter of its 22
previous claim 1, it should be required to reintroduce such a claim into its involved 23
’953 application and have it designated as corresponding to [proposed] Count 2.” 24
(Stemmer Motion 1 at 10:16-18). 25
A party moving to add a claim to an involved application must show that the 26
claim is patentable. Bd. R. 208(c)(2). The moving party must show the written 27
description for the claim in the disclosure of the involved application to which it 28

-8-
would be added and certify that the moving party is unaware of any reason why the 1
claim is not patentable. Regarding patentability, the moving party must address 2
any patentability issues that were raised during ex parte prosecution of an involved 3
or benefit file. (Standing Order (SO) at ¶ 208.5.1). 4
An opponent may oppose a motion to have a claim added to its involved 5
application on the basis that the claim is not patentable to the opponent. (SO at 6
¶ 208.5.1). Here Skerra opposes the motion on the basis that the proposed generic 7
claim is unpatentable over prior art cited during prosecution of a Stemmer benefit 8
application. (Skerra Opposition 1 at 6:30-33). 9
Stemmer has failed to meet its burden to show why the Board should require 10
Skerra to add the proposed claim. Stemmer asserts that, as claim 1 was an original 11
claim, it must have been supported but does not direct us to any specific portions of 12
the involved Skerra application that provide written description for the proposed 13
claim. (Stemmer Motion 1 at 10:13-14). For a genus claim especially, it cannot be 14
assumed that written description is satisfied by an original claim. Ariad 15
Pharmaceuticals, Inc. v. Eli Lilly and Co. 598 F.3d 1336, 1349 (Fed. Cir. 2010) 16
(“Although many original claims will satisfy the written description requirement, 17
certain claims may not. For example, a generic claim may define the boundaries of 18
a vast genus of chemical compounds, and yet the question may still remain whether 19
the specification, including original claim language, demonstrates that the 20
applicant has invented species sufficient to support a claim to a genus.”). Thus 21
Stemmer has not met its burden for the reason that it does not show written 22
description support for the proposed claim. 23
Stemmer has not met its burden for the further reason that Stemmer does not 24
certify that it is unaware of any reason why the proposed claim is not patentable to 25

-9-
Skerra. Instead Stemmer asserts that “a claim which substantially corresponds to 1
this claim, Stemmer claim 1, has been found allowable over the prior art by the 2
PTO.” (Stemmer Motion 1 at 13-15). However, this assertion is not a certification 3
by Stemmer that the proposed claim, which Stemmer acknowledges is not the same 4
as the claim found allowable but “substantially corresponds” thereto, is patentable 5
to Skerra. 6
A further reason the motion as is seeks to add the claim fails is that Stemmer 7
does not address prior art raised by the Examiner during ex parte prosecution of 8
Stemmer benefit application 12/646,566. (Examiner’s Action, Ex 1004
6
at 8). In 9
particular it appears that the reference Besman, WO 2006/081249 (Besman, Ex 10
1005) was cited by the Examiner as anticipatory of the proposed claim prompting 11
Stemmer to add a limitation limiting the second domain to one that “consists of 12
three types of amino acid residues”, a limitation that does not appear in the 13
proposed claim. (Ex 1003 at 3 and 11). Even had Stemmer proposed a claim 14
containing this limitation though, it was incumbent upon Stemmer to address such 15
highly relevant prior art within its Motion. 16
Stemmer has not shown that the Board should require Skerra to add the 17
proposed claim and the portion of Stemmer Motion 1 seeking this relief is denied. 18
Stemmer has not shown that Skerra otherwise has a claim that corresponds to 19
proposed Count 2 such that there is a reason to add proposed Count 2 to the 20
interference. Thus, the portion of Stemmer Motion 1 seeking this relief is denied 21
as well. 22

6 Skerra was authorized to file (Order Authorizing Replacement Exhibits,
Paper 87), and did file, replacement Exhibits 1001-1017. Any reference to a
Skerra exhibit is to the replacement exhibit.

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Priority showing 1
Stemmer asserts that its priority evidence for Count 2 antedates Skerra’s 2
earliest accorded benefit. Stemmer does not direct us to evidence or argument 3
explaining why it would prevail on priority as to Count 1. 4
Since we decline to add Count 2 to the interference we need not and do not 5
consider the priority evidence and argument as to Count 2. We further note that 6
Stemmer acknowledges that its evidence as to Count 2 is outside the scope of 7
Count 1. (Stemmer Motion 1 at 5:23-6:3).7 As Stemmer has not shown why it 8
would prevail on priority as to Count 1 as required by Bd. R. 202(d) (See also 9
Order Authorizing Motion at 5:13-16), we enter judgment against Stemmer as to 10
Count 1. 11
IV. Order 12
It is 13
ORDERED that Stemmer Motion 1 is DENIED, 14
FURTHER ORDERED that Stemmer has not shown why it would prevail 15
on priority as to Count 1, and 16
FURTHER ORDERED that judgment is entered as to Count 1 in a separate 17
paper. 18
19
20
21
22

7 We make no determination as to whether the showing would be sufficient to show
priority for a Count or claim that excludes the species of Count 1 since that is not the situation
before us. See In re Johnson, 558 F.2d 1008 (1013) (CCPA 1977) (After interference applicant
sought claim that excluded subject matter of the lost count).

-11-
cc (via electronic): 1
2
Attorney for Stemmer: 3
4
Steven W. Parmelee, Esq. 5
Michael T. Rosata, Esq. 6
Wilson Sonsini Goodrich & Rosati 7
sparmelee@wsgr.com 8
mrosato@wsgr.com 9
10
Attorney for Skerra: 11
12
George E. Quillin, Esq. 13
Benjamin Berkowitz, Esq. 14
Simon J. Elliott, Esq. 15
Foley & Lardner, LLP 16
gquillin@foley.com 17
bberkowitz@foley.com 18
sjelliott@foley.com 19
20