Dung v. Buehler

____________________
____________________
____________________
BoxInterferences@uspto.gov 	Paper 121
Telephone: 571-272-4683 	Entered: 23 July 2013
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Patent Interference 105,893 McK
Technology Center 1600
JEN-SEN DUNG, EMO M. KESKENY
and JAMES J. MENCEL,
Patent 7,851,482 B2,
Junior Party,
v.
HENRY J. BUEHLER, WILLIAM E. DUMMITT
ANTHONY MANNINO, DENNIS C. AUBUCHON and HONG GU,
Application 11/915,606,
Senior Party.
Before: FRED E. McKELVEY, RICHARD E. SCHAFER, and
DEBORAH KATZ, Administrative Patent Judges.
McKelvey, Administrative Patent Judge.
ORDER DENYING DUNG MOTION 3
(Requesting leave to file recently discovered evidence)

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
Background
At the conclusion of Time Period 1, Dung timely filed a motion
for judgment based on priority. Paper 104.
At the conclusion of Time Period 2, Buehler timely filed a
motion for judgment based on priority. Paper 109.
Oppositions to both motions are due on at the conclusion of
Time Period 3.
On 09 July 2013, a conference call was held in response to an
email received by the PTAB on 8 July 2013 (10:50 a.m.). The
relevant part of the email said:
Party Dung has uncovered additional HPLC data
relating to the reductions to practice asserted in its motion
for priority. Dung would like permission to file a motion
requesting belated entry of that evidence. Buehler has
indicated that it will oppose the filing of such a motion and
entry of the underlying evidence.
During the conference call, counsel for Dung explained that
new evidence had recently been found by scientists at Johnson
Matthey (“JM”)—the original assignee of the involved Dung patent.
As a result of discussion during the conference call, Dung was
authorized to file a motion seeking leave to present the recently found
evidence. Paper 110.
Dung Motion 3 was timely filed on 12 July 2013. Paper 112.
While Buehler has been authorized to file an opposition, we find
that the Dung Motion 3 can be decided adversely to Dung without an
opposition.
2

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
An interlocutory order denying Dung Motion 3 was entered on
15 July 2013. Paper 119.
This order explains the reason for denying Dung Motion 3.
Facts
The facts are taken in large measure from Dung Motion 3.
In deciding the motion, we do not apply “summary judgment”
standards typically applied in practice before U.S. district courts. 	Cf.
Basmadjian v. Landry, 54 USPQ2d 1617 (BPAI 1997).
Rather, in filing the motion Dung is under a burden to establish
that it is prima facie entitled to the relief it requests. 37 C.F.R.
§ 41.121(b) (2011).
According to Dung, an actual reduction to practice said to have
occurred in 2006 is based on preparation of two samples.
The two samples are said to be oxymorphone samples
containing less than 10 ppm 14-hydroxymorphione (“14-OHM”) as
determined by high performance liquid chromatography (“HPLC”).
We are told that in the 2006 time frame, scientists at the
Analytical Research and Development (“AR&D”) division of Johnson
Matthey (“JM”) had two sets of HPLC instruments.
The two sets were (1) instruments from Waters and (2) four
instruments from Shimadzu.
The Waters instruments generated data which is said to have
been compatible with an AR&D electronic data storage system called
“Empower.”
The Shimadzu instruments are identified as “stand-alone”
instruments.
3

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
In 2006, the Shimadzu instruments were used at a West
Depford, New Jersey location.
In 2012, two of the Shimadzu instruments were moved to a
Riverside, New Jersey location.
Sometime between January and July 2006, the “Empower”
software was updated. We have not been told (1) why an update is
relevant or (2) why or how earlier software was inadequate for any
purpose relevant to the motion.
In the 2006 time frame, some scientists at JM using data
generated by stand-alone HPLC instruments, “taped copies of HPLC
traces” into their laboratory notebooks. We understand that (1) HPLC
results in a paper “trace” being generated and (2) “taped” means that
a paper copy of an HPLC trace is physically taped on a page in a
laboratory notebook.
Jen-Sen Dung is said to have been one of the scientists who
taped HPLC copies into his laboratory notebook.
Other scientists, including Erno Keskeny, kept separate files
containing HPLC traces.
In 2006, Robert Hogan is said to have been a Senior AR&D
Chemist III.
According to Dung, Robert Hogan is said to “have diligently
searched for . . . January 2006 HPLC traces which . . . [are said to
be] the basis for Erno Keskeny’s January 2006 “conclusion” recorded
in his [laboratory] notebook at page 2128-189.
The conclusion was that his samples 2128-175 and 2128-189
contained either undetectable levels, or less than 10 ppm of 14-OHM.
4

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
By the end of February 2013, it is said that “they” were unable
to locate any of the January data, but were able to retrieve from
Empower data obtained by Nisha Patel on sample 2128-189.
According to Dung, Nisha Patel was able to confirm that
sample 2128-189 contained less than 10 ppm of 14-OHM.
Prior to the end of February 2013, Robert Hogan was unable to
recall having run any of Dr. Keskeny’s low-ABUK oxymorphone
samples of HPLC.
However, Robert Hogan is said to have “recently located”
HPLC traces from January 26, 2006. How those traces were
“recently located” is not explained.
The traces apparently are located on page 152 of Hogan
laboratory notebook 884.
Based on the recently located traces, Robert Hogan now
concludes that no 14-OHM could be detected in sample 2128-175.
Discussion
The rules provide that belatedly filed papers or evidence is not
considered. There are two exceptions: (1) a showing of excusable
neglect or (2) a PTAB determination that consideration of the late
filing would be in the interest of justice. 37 C.F.R. § 41.4(a)(2)
(2011).
In this case, neither exception applies.
(1)
We interpret “excusable neglect” in the context of applicable
rules relating to practice in interference cases before the PTAB.
Firsthealth of the Carolinas, Inc. v. Carefirst of Maryland, Inc.,
479 F.3d 825, 829 (Fed. Cir. 2007) [the TTAB has discretion to
5

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
reasonably interpret the meaning of "excusable neglect" in the
context of its own regulations, citing Thomas Jefferson University v.
Shalala, 512 U.S. 504, 512 (1994) (an agency's interpretation of its
own regulation is given controlling weight unless it is plainly
erroneous or inconsistent with the regulation)].
In an interference context, where the late filing involves newly
discovered evidence, to show excusable neglect a party must
establish that the evidence “could not have been earlier discovered,
and that the party exercised due diligence in discovering the
evidence.” Rivise & Caesar, 3 I NTERFERENCE L AW AND P RACTICE
§ 458, page 1962 (1947). 	See also Rivise, I NTERFERENCE PRACTICE
§ 138 (1932); Fordyce v. Taisey, 1903 C.D. 31, 35 (Comm’r Pat.
1903) (to warrant reopening of case to take further testimony it must
appear that the testimony could not have been previously discovered
by exercise of due diligence); Robinson v. Townsend, 1902 C.D. 405,
406 (Comm’r Pat. 1902) (a clear showing of diligence must be made
out); Dudley v. Blickensderfer, 1902 C.D. 119, 121 (Comm’r Pat.
1902 (same); Schmiedl v. Booth, 1891 C.D. 188, 189 (Comm’r Pat.
1891) (same).
Whether a party exercised the appropriate amount of diligence
is a question of fact which must be established by a preponderance
of the evidence on a case-by-case basis.
The proposed new evidence was in existence at the time Dung
(1) prepared its priority case and (2) filed its motion for judgment
based on priority.
6

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
The factual question is whether Dung has established by a
preponderance of the evidence that a diligent effort had been made
to locate the evidence. The answer in this case is: “No.”
All we are told in Dung Motion 3 and the accompanying
declaration testimony is that:
(1) 	Hogan and others “have diligently searched for the
January 2006 HPLC traces” (Dung Motion 3, page 3) (but no
testimony is presented as to what was involved in, or the nature
of, any search);
(2) 	“they were unable to locate any of the
January [2006] data” (Dung Motion 3, page (but no credible
explanation is given as to what effort was made to then locate
the data or precisely who “they” might be); and
(3) 	Hogan “recently located HPLC traces” (Dung
Motion 3, page 4) (no details are given on precisely how the
HPLC traces were “recently located”).
The motion and underlying declarations amount to a pleading—
not proof. No credible fact-based presentation is made detailing the
nature of (1) any search prior to the filing of Dung’s motion for
judgment based on priority or (2) any search after the motion was
filed.
The significance of Shimadzu instruments being moved from
one New Jersey location to another has not been shown to be
connected with any diligent search.
Witness testimony that diligent search was conducted, without
details as to the nature of the search, amounts to a mere opinion or
7

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
conclusion. We do not know factually what steps made up the
search. Accordingly, we cannot find that a diligent search was made.
Dung has failed to establish excusable neglect.
(2)
In this case, it would not be in the interest of justice to permit
introduction of the newly discovered evidence.
Whether the PTAB exercises discretion to implement the
interest of justice exception is determined on a case-by-case basis.
In this case, the “recently discovered” new evidence comes
(1) after Buehler has filed its motion for judgment based on priority
and (2) close to the time both parties are to file oppositions to their
opponent’s motion for judgment based on priority.
In this case the “excusable neglect” and “interest of justice”
provisions merge.
To permit late filing of evidence by Dung after Buehler has filed
its motion for judgment based on priority is highly prejudicial to
Buehler.
If the recently discovered evidence were to be admitted, then
Buehler should have an opportunity to (1) consider the evidence on
the merits and (2) determine what additional evidence it might need
for its priority case. Rivise & Caesar, at page 1972.
We cannot imagine that Buehler would not want to cross-
examine witnesses testifying on the merits with respect to the newly
discovered evidence. Buehler indicated as much in the conference
call.
We perceive of no legitimate justification in this case to
reconcile (1) a lack of diligence on the part of Dung with (2) requiring
8

1
2
3
4
5
6
7
8
9
10
11
12
Buehler to expend additional resources to answer the newly
discovered evidence. 37 C.F.R. § 41.2 (2011) (requiring that the
rules be interpreted to secure a just, speedy and inexpensive
resolution of contested cases before the PTAB).
This is not an appropriate case for the PTAB to exercise its
discretion by authorizing the new evidence based on an “interest of
justice” theory.
Order
Upon consideration of Dung Motion 3, and for the reasons
given, it is
ORDERED that Dung Motion 3 is denied.
9

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
cc (via electronic mail):
Attorney for Dung:
R. Danny Huntington, Esq.
Sharon E. Crane, Ph.D., Esq.
Rothwell, Figg, Ernst & Manbeck, P.C.
Email: dhuntington@rfem.com
Email: scrane@rfem.com
Attorney for Buehler:
Todd R. Walters, Esq.
Erin M. Dunston, Esq.
Christopher L. North, Ph.D., Esq.
Buchanan Ingersoll & Rooney, PC
Email: todd.walters@bipc.com
Email: erin.dunston@bipc.com
Email: christopher.north@bipc.com
10