PERGOLIZZI et al.v.URDEA et al.

Patent Trials and Appeals Board

Jun 4, 2014

07340031 - (J) (P.T.A.B. Jun. 4, 2014)

NOTICE: "Any agreement or understanding between parties to an interference, including any
collateral agreements referred to therein, made in connection with or in contemplation of the
termination of the interference, shall be in writing and a true copy thereof filed in the Patent and
Trademark Office before the termination of the interference as between the said parties to the
agreement or understanding." 35 U.S.C. 135(c); see also Bd.R. 205 (settlement agreements).

BoxInterferences@uspto.gov Entered: 4 June 2014
Telephone: 571-272-4683

UNITED STATES PATENT AND TRADEMARK OFFICE
PATENT TRIAL AND APPEAL BOARD

Patent Interference No. 105,489

SIEMENS HEALTHCARE
DIAGNOSTICS, INC.
(5,124,246),
Junior Party,

v.

ENZO LIFE SCIENCES, INC.
(08/479,995),
Senior Party.

Before: RICHARD E. SCHAFER, RICHARD TORCZON and JOHN G. NEW,
Administrative Patent Judges.

PER CURIAM.

JUDGMENT
Bd.R. 127
on merits

Interference No. 105,489 Page 2

The board has granted a motion barring all but eight of the claims of the
senior party (Enzo). The board denied a motion for no interference-in-fact for the
unbarred Enzo claims. The junior party (Siemens) did not provide a basis for
prevailing on priority and was placed under an order to show cause. The board
subsequently reconsidered the decision and the order to show cause, but decided
that no modification was warranted. Accordingly—
Judgment on priority is entered against Siemens for count 1;1
Claims 39-41 and 43-56 of Siemen's involved 5,124,246 patent are
CANCELED;2
Claims 283-362, 364, 365, 382, 383, 400, 401, 403, 404, 406, 407, 409-439,
441-505 and 532-547 of Enzo's involved 08/479,995 are FINALLY REFUSED;3
A copy of this judgment shall be entered in the administrative records of the
involved patent and application; and
Any party seeking judicial review timely must serve notice on the Director
of the United States Patent and Trademark Office.4

cc:

THOMAS J. ENGELLENNER, LANA A. GLADSTEIN and DANIEL M. SCOLNICK, Pepper
Hamilton LLP, of Boston Massachusetts (docketingpgh@pepperlaw.com).

MICHAEL K. LEVY and RICHARD L. DELUCIA, Kenyon & Kenyon LLP, of New
York City, New York.

1 Paper 1 at 3.
2 35 U.S.C. 135(a) (2012).
3 Id.
4 37 C.F.R. §§ 90.1 and 104.2.

BoxInterferences@uspto.gov Entered: 4 June 2014
Telephone: 571-272-4683

UNITED STATES PATENT AND TRADEMARK OFFICE
PATENT TRIAL AND APPEAL BOARD

Patent Interference No. 105,489

SIEMENS HEALTHCARE
DIAGNOSTICS, INC.
(5,124,246),
Junior Party,

v.

ENZO LIFE SCIENCES, INC.
(08/479,995),
Senior Party.

Before: RICHARD E. SCHAFER, RICHARD TORCZON and JOHN G. NEW,
Administrative Patent Judges.

PER CURIAM. Dubitante opinion by TORCZON, Administrative Patent Judge.
DECISION
Bd.R. 125
on request for rehearing and
on response to order to show cause

The request of the senior party (Enzo) for rehearing has been considered, but
relief is DENIED. The response of the junior party (Siemens) to the order to show
cause has been considered, but relief is DENIED.
Interference No. 105,489 Page 2

MEMORANDUM OPINION
I. INTRODUCTION
The board entered a decision granting Siemens motion 1 and denying
Siemens motion 2.1 As a consequence, all Enzo claims except claims 507, 508,
510, 511 and 528-531 were held to be barred under 35 U.S.C. 135(b),2 but Siemens
did not succeed in showing that Enzo's remaining claims do not interfere with
Siemens' claims.3 Because there was still an interference-in-fact and Siemens had
not provided a basis for prevailing on priority, the board placed Siemens under an
order to show cause why judgment should not be entered against it on priority.4
Enzo has filed a request for rehearing of the decision.5 Siemens has filed a
response to the order to show cause.6
II. ENZO REQUEST FOR REHEARING
Enzo seeks relief from the decision granting Siemens motion 1. Because
Enzo had so many claims, Siemens briefed the bar in terms of six Enzo claim
limitations, at least one of which appeared in each Enzo claim at risk. In its
request, Enzo addresses only limitations 2, 3 and 6, which Enzo present in a table:7
Contested Limitation Affected claims
Limitation 2: "more than one non-
radioactive signaling entity"
360-362, 364, 411-437, 479-
487, 538, 539, 544 and 545
Limitation 3: "said bridging entity
first portion is covalently bound to
540-545

1 Paper 85 (Dec. on Remand) at 1. Siemens started the proceeding as "Bayer";
hence, depending on the stage of the proceeding, a Siemens paper might be labeled
"Bayer".
2 Id. at 15.
3 Id. at 22.
4 Paper 86 (Order to Show Cause).
5 Paper 87 (Reh'g Req.).
6 Paper 88.
7 Paper 87 at 2.
Interference No. 105,489 Page 3

Contested Limitation Affected claims
said bridging entity second portion"
Limitation 6: "wherein said analyte
is a single-stranded DNA sequence
fixed to a solid support"
437, 540, and 542
A. Limitation 2: "more than one non-radioactive signaling entity"
An earlier district court decision held8 that:
the Board committed legal error in its conclusion that the limitation
"more than one non-radioactive signaling entity" necessarily resulted
from the limitations of the earlier-filed claims.
Enzo contends that the court simply rejected the board's differentiation between
pre-critical date claims 238 and 239, but did not foreclose a reanalysis of the same
issue on other bases.9 Enzo further contends that its originally argued combination
of pre-critical date claims 13, 238 and 239 provide a basis for denying Siemen's
motion.10
In its opposition, Enzo provided the following comparison:11
Claim 360.

An article of manufacture comprising:

a molecular bridging entity comprising a
first portion capable of recognizing and
binding to or hybridizing with a
molecularly recognizable portion on an
analyte,

and a second portion comprising one or
* * * * *
Claim 238. (Amendment of December
22, 1992 in Application No.
07/805,274.) The composition
according to claim 237, wherein said
direct signal providing signal generating
portion comprises a radioactive moiety.

Claim 239. (Amendment of December
22, 1992 in Application No.
07/805,274.) The composition

8 Siemens Healthcare Diagnostics, Inc. v. Enzo Life Sciences, Inc., 2013 WL
4411227 at *16 (D. Mass., Aug. 14, 2013).
9 Reh'g Req. at 3:8-18.
10 Id. at 4:7-18.
11 Id. at 35-36 (App'x 3, claim 360).
Interference No. 105,489 Page 4

more nucleic acid sequences or
segments; and

more than one non-radioactive
signalling entity, each such entity
comprising a nucleic acid portion
capable of hybridizing with said
bridging entity second portion nucleic
acid sequences or segments,

and one or more signal generating
portions, each capable of providing a
detectable signal.
according to claim 237, wherein said
direct signal providing signal generating
portion is selected from the group
consisting of a fluorogenic compound, a
phosphorescent compound, a
chromogenic compound, a
chemiluminescent compound and an
electron dense compound.

Claim 13. (Preliminary amendment-
December 10, 1991 in Application No.
07/805,274) The composition according
to claim 1, wherein said signalling entity
is selected from the group consisting of
a single-stranded, a double-stranded or
partially double stranded polynucleotide
polymer, a naturally occurring modified
DNA, a polynucleotide polymer derived
from a T even phage, a modified DNA
carrying a cloned insert, a polymer
derived from a filamentous phage, an
M13 phage or a variant thereof, and a
polymer derived from a circular DNA
molecule covalently attached to a non-
radiolabelled signal generating
po[r]tion. [Emphasis added.]

Although claims 238 and 239 were added at the same time and depend from
the same claim, claim 13 was presented earlier and depends from a different claim.
In reply, Siemens urged that claim grouping was improper, but that in any case the
pre-critical date claims differ from the involved claims because in the involved
claims the entire signalling entity must be non-radioactive rather than simply
having a non-radiolabelled signal generating portion.12 Moreover, Siemens

12 Paper 46 (Siemens Reply 1) at 6.
Interference No. 105,489 Page 5

contends that Enzo amended its claims to require more than one non-radioactive
signalling entity to overcome a prior art rejection.13
The Court of Appeals for the Federal Circuit has confirmed that in statute
and case law "there is no general prohibition against analyzing multiple pre-critical
date claims together".14 Moreover, the analysis is not limited to claims in a
dependency relationship.15 However, in Pioneer, all of the claims depended from
the same claim (Monsanto pre-critical date claim 1) and nothing in the further
limitation of the least related claim (9) indicated a choice away from the inventions
defined in the other dependent claims.16
In the present case, Enzo has not undertaken a comparable effort to show
that claims 13, 238 and 239 are all comparably related. At best, Enzo presents the
testimony of James Donegan, who testifies about what the claims say.17 Expert
testimony about what the claims say rather than how the claims would have been
understood by those in the art (and why) is entitled to little weight.18 We note that
claim 13 does not even appear to have been pending along with claims 238
and 239,19 which puts further distance between the facts of this case and the facts
of any cited case in which pre-critical date claim-grouping has been successfully
employed. Hence, there is no basis in law for concluding that Enzo claims 13, 238
and 239 show a constructive claiming of the interfering subject matter before the
critical date. Although the decision should have been explicit on this point, it

13 Id. at 6-7.
14 Pioneer Hi-Bred Int'l, Inc. v. Monsanto Tech. LLC, 671 F.3d 1324, 1329 (Fed.
Cir. 2012).
15 Id. at 1330.
16 Id.
17 Exh. 1004, ¶¶30-37.
18 Cf. Siemens Healthcare Diagnostics, 2013 WL 4411227 at *15.
19 Exh. 2014 (1992 Enzo Amd't) at 20.
Interference No. 105,489 Page 6

remains correct that there is no legal basis for Enzo's opposition that would be
consistent with precedent and the law of the case.
In the context of this contested limitation, we did not (and do not) reach
Siemens' reply argument that "more than one" is a material difference. Although
the argument is responsive to Enzo's opposition, it arose relatively late and thus has
a less developed record before the board.
B. Limitation 3: "said bridging entity first portion is covalently bound
to said bridging entity second portion"
Enzo contends that the board did not determine the materiality of this
limitation or the applicability of pre-critical date claim 20.20 The statute
provides:21
A claim which is the same as, or for the same or substantially the
same subject matter as, a claim of an issued patent may not be made
in any application unless such a claim is made prior to one year from
the date on which the patent was granted.
"Materiality" is a case law gloss on the statute to analyze whether the pre-critical
date claim is the statutory "such a claim".22 Significantly, the case law places the
"materiality" burden on the "party [that] must show that the later filed claim does
not differ from an earlier claim in any 'material limitation.'"23 As a matter of
process, this burden shift makes sense because the "unless" clause is an exception
to the bar and because (as Enzo's long and complex prosecution history
demonstrates) it is much simpler for Enzo to show the earlier basis for the

20 Reh'g Req. at 4:20-23.
21 35 U.S.C. 135(b)(1).
22 Regents of the Univ. of Cal. v. Univ. of Iowa Res. Found., 455 F.3d 1371, 1375
(Fed. Cir. 2006).
23 In re Berger, 279 F.3d 975, 981-982 (Fed. Cir. 2002), quoting Corbett v.
Chisholm, 568 F.2d 759, 765-66 (CCPA 1977).
Interference No. 105,489 Page 7

limitation than it would be for Siemens to examine and eliminate all of the possible
bases comprehensively.
Section 135(b)(1) sets forth a late-claiming bar. There are at least two
scenarios: (1) an existing claim is amended after the critical date and (2) a new
claim is added after the critical date. In the first scenario, the claim already exists
so the movant must show why the amendment was material (e.g., because it
responds to a substantive rejection). In the second scenario, the material-
amendment test is inapplicable because there was no existing claim to amend;
rather, the addition of a new claim in itself may trigger the bar.
Enzo added claims 540-545 expressly to request this interference.24 Once
Siemens established that these claims were filed after the critical date, the bar was
facially triggered and the focus shifted to the "unless such a claim" proviso, where
"such a claim" reflexively invokes "A claim" at the beginning of the statute. In re
Berger explains that this comparison requires of the post-critical date claim with
the pre-critical date claim to determine whether the contested limitation
"necessarily occur[s] in the prior claims."25 In Berger, the court held that the board
had correctly determined that the contested language was not present in the earlier
claim and that the language in the earlier claim differed in material ways.
The decision compared the contested limitation to claim 20 and concluded
that the new limitation "is neither the same nor substantially the same as the
limitation in claim 20."26 Any error attributable to the failure to use a variant of
"material" in the decision was harmless error: the opinion put Enzo on notice that
it had not carried its burden in demonstrating that pre-critical date claim 20 was
"such a claim" as contested claim 542.

24 Exh. 2026 (2003 Enzo Amd't) at 1-2.
25 In re Berger, 279 F.3d 975, 982 (Fed. Cir. 2002).
26 Dec. on Remand 11.
Interference No. 105,489 Page 8

On the merits, Enzo argues that the board impermissibly read claim 20 too
narrowly, thereby excluding "an embodiment where the covalent bond at issue is
between the first and second portions of the bridging entity."27 Claim 20 defined
the invention as:28
The method of Claim 1 wherein said polynucleotide sequence in said
bridging entity is covalently attached to another polynucleotide
sequence.
Enzo relied on the testimony of James Donegan that:29
Pre-critical date Claim 20 provides support for the covalent bonding
limitation between the two polynucleotide sequences of the bridging
entity, because one polynucleotide sequence represents the first
portion of the bridging entity and the second polynucleotide sequence
represents the second portion of the bridging entity.
Dr. Donegan points only to the language of claim 20 itself as support for his
opinion.30 His testimony omits the claim-word "another" from his analysis. Case
law has long cautioned against reliance on expert opinion that diverges from the
intrinsic evidence.31 In claim 20, "another polynucleotide sequence" is placed in
opposition to "said polynucleotide sequence in said bridging entity". On the face
of the claim, the "another polynucleotide sequence" is not part of the bridging
entity. Neither Enzo nor Dr. Donegan pointed us to other intrinsic evidence or to
particularly pertinent extrinsic evidence that would require us to diverge from the
facial import of "another". Enzo did not provide a reasonable basis for a claim
interpretation of the breadth it requires.

27 Reh'g Req. 7.
28 Exh. 1002 ('995 appl'n record) at 65.
29 Exh. 1004, ¶47.
30 Bd.R. 158(a) (requiring basis for testimony).
31 E.g., Aqua-Aerobic Sys., Inc. v. Aerators, Inc., 211 F.3d 1241, 1245 (Fed. Cir.
2000).
Interference No. 105,489 Page 9

C. Limitation 6: "wherein said analyte is a single-stranded DNA
sequence fixed to a solid support"
The decision noted that the claims associated with limitation 6 were also
associated either with limitation 2 or with limitation 3.32 In its request, Enzo
argues that the board overlooked its arguments on limitation 6. A better
characterization would be that the board did not reach either party's arguments on
limitation 6 because they are moot.
D. Holding
We have reconsidered the decision based on Enzo's request, but have
insufficient basis to modify the decision.
III. SIEMENS RESPONSE TO ORDER TO SHOW CAUSE
Siemens moved for judgment that Enzo's eight unbarred claims do not
interfere with Siemens' claims.33 The board determined that Siemens' motion did
not meet its burden because it did not adequately address the question of
obviousness on which an interference may be based.34 Because an interference
remained between the parties, and because Siemens had not proposed a basis for
proving priority in the interference, Siemens was placed under an order to show
cause why judgment should not be entered against it.35
In response to the order, Siemens argues that Enzo is no longer opposing the
no interference-in-fact motion.36 Siemens cites Enzo's statement that "counsel for

32 Dec. on Remand 15, citing Bayer CropScience AG v. Dow AgroSciences LLC,
728 F.3d 1324, 1331-32 (Fed. Cir. 2013), for the well-established proposition that
a decision on one dispositive issue may moot other issues.
33 Paper 36 (Siemens Mot. 2).
34 Dec. on Remand 21.
35 Order to Show Cause 2.
36 Paper 88 (Resp.) 2.
Interference No. 105,489 Page 10

Enzo agreed that if the Board granted Siemens’s Motion 1 (under § 135(b)), Enzo
would not oppose Siemens’s Motion 2 (no interference-in-fact). Enzo’s opposition
to Siemens’s Motion 2 was contingent on the Board’s decision on Motion 1."37
Siemens and Enzo refer to the following discussion during oral argument:38
JUDGE TIERNEY: So then it's your position that if motion 1 is
granted, motion 2 should not be granted?
MR. SCHULMAN: No, I’m not going to take that position. I think if
motion 1 is granted, then we want to walk off with the claims in
motion 2, no interference in fact if that makes sense. Yeah, okay. So if
motion 1 is granted, on 135(b), we would then say that we could
agree, on the condition that motion 1 is granted, we could agree that
motion 2 of no interference in fact, that there would be no interference
in fact with respect to those claims.
JUDGE TORCZON: So the opposition is withdrawn? I mean --
MR. SCHULMAN: On that condition.
JUDGE TORCZON: Well, yeah, it is a contingent motion as I
understand it.
MR. SCHULMAN: I can agree to that.
JUDGE TORCZON: Okay. I mean they still have to prevail on the
matter but that's a separate issue.
Siemens motion 2 was contingent on the grant of its motion 1.39 Enzo filed an
opposition, stating no contingency, but expressly arguing Siemens's failure to
address obviousness adequately.40
The discussion at oral argument indicates that Enzo had a change of heart
and was willing to withdraw its opposition if Siemens motion 1 were granted.
Siemens motion 1 has been granted, thus triggering the contingency for

37 Exh. 2110 (Enzo Resp. in D.Ct.) 2-3 (citations omitted).
38 Paper 58 (Arg. Transcript) at 35:1-17 (emphasis added).
39 Siemens Mot. 2 at 1.
40 Paper 42 (Enzo Opp. 2) 2-3.
Interference No. 105,489 Page 11

considering Siemens motion 2 but also implicating Enzo's willingness not to
contest Siemens motion 2.
A movant seeks to change the status quo and, hence, must carry its burden to
justify the change.41 The lack of an opposition, or even the support of the
opponent, might make the burden lighter,42 but the burden remains.43
A movant for no interference-in-fact, specifically, has the burden to show no
interference-in-fact.44 Even when the parties agree there is no interference-in-fact,
the board is not bound by the agreement.45 It is not uncommon for even a joint
motion for no interference-in-fact to be denied because it does not adequately
address the known prior art.46 This practice makes sense because an interference is
effectively a rejection of the claims under 35 U.S.C. 102(g)(1).47 Hence, an
interference is not a private litigation between private litigants, but instead is a
patentability determination. The parties cannot stipulate to the patentability of
their claims, which is the effect of a stipulation to no interference-in-fact: neither
party's claims would be subject to the section 102(g)(1) rejection.
While we acknowledge that Enzo has elected not to pursue an interference
on the basis of its unbarred claims, the existence of an interference (or not) is not a

41 Bd.R. 121(b); Johnson & Johnson Consumer France SAS v. Indena S.p.A.,
84 USPQ2d 1925, 1926-27 (BPAI 2006).
42 Pfizer, Inc. v. Teva Pharms. USA, Inc., 429 F.3d 1364, 1377 (Fed. Cir. 2005)
(noting lack of opposing evidence is not a burden shift).
43 Zenith Elecs. Corp. v. PDI Commc'n Sys., Inc., 522 F.3d 1348, 1363 (Fed. Cir.
2008) (explaining opposition failures not important where movant fails to carry
initial burden).
44 Yorkey v. Diab, 605 F.3d 1297, 1300 (Fed. Cir. 2010).
45 Jones v. Stuart, 192 USPQ 475, 475-76 (Comm'r Pat. 1975).
46 Univ. of Cal. v. Children's Med. Ctr. Corp., 79 USPQ2d 1029, 1036 (BPAI
2005).
47 Capon v. Eshhar, 418 F.3d 1349, 1351 (Fed. Cir. 2005).
Interference No. 105,489 Page 12

matter for Enzo to decide.48 The fact remains that, on the record before us,
Siemens failed to account for obviousness sufficiently for us to grant the motion.
Accordingly, Siemens has not provided cause for us not to proceed to judgment.
IV. CONCLUSION
Neither party has provided sufficient basis to modify the decision on
remand. Accordingly, for the reasons given in the order to show cause, we proceed
to judgment.

48 35 U.S.C. 135(a) ("Whenever an application is made for a patent which, in the
opinion of the Director, would interfere. . .") (emphasis added).
Interference No. 105,489 Page 13

UNITED STATES PATENT AND TRADEMARK OFFICE
PATENT TRIAL AND APPEAL BOARD

Patent Interference No. 105,489

SIEMENS HEALTHCARE
DIAGNOSTICS, INC.
(5,124,246),
Junior Party,

v.

ENZO LIFE SCIENCES, INC.
(08/479,995),
Senior Party.

RICHARD TORCZON, Administrative Patent Judge, dubitante.

Once again, the majority has provided a reasonable analysis of the merits of
the interference. Once again, I must note that the case is not properly before us for
the reasons discussed in my opinion with the previous decision.49
The board has over one thousand (self-funded) post-grant trials and tens of
thousands of (self-funded) appeals pending. Spending resources on (unfunded)
interference advisory opinions to help a district court, while a generous example of
inter-branch comity, is hard to justify fiscally.

49 Decision on Remand, Paper No. 85 at 23-28.
Interference No. 105,489 Page 14

cc:

THOMAS J. ENGELLENNER, LANA A. GLADSTEIN and DANIEL M. SCOLNICK, Pepper
Hamilton LLP, of Boston Massachusetts (docketingpgh@pepperlaw.com).

MICHAEL K. LEVY and RICHARD L. DELUCIA, Kenyon & Kenyon LLP, of New
York City, New York.