Child et al.v.Kolar et al.

Board of Patent Appeals and Interferences

Apr 28, 2000

07358544 (B.P.A.I. Apr. 28, 2000)

Application 07/358,544, filed May 26, 1989. Accorded the1
benefit of Application 06/824,404, filed January 31, 1986, now
U.S. Patent No. 4,880,790, issued November 14, 1989. Assigned
to American Cyanamid Company, Stamford, CT, A Corporation of
Maine.
Application 06/770,996, filed August 30, 1985, now U.S.2
Patent No. 4,730,069, issued March 8, 1988. Accorded the
benefit of West German Patent Application P 34 32 320.1, filed
September 3, 1984. Assigned to Behringwerke
Aktiengesellschaft, A Corporation of Germany.
1
Paper No. 92
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today
(1) was not written for publication in a law journal and
(2) is not binding precedent of the Board.
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
RALPH G. CHILD, PANAYOTA BITHA,
JOSEPH J. HLAVKA and YANG-I LIN,
Junior Party,1
v.
CENEK KOLAR, HANS P. KRAEMER and
KONRAD DEHMEL,
Senior Party.2
__________
Patent Interference No. 102,408
__________
Interference No. 102,408
2
Before DOWNEY, GRON, and HANLON, Administrative Patent Judges.
HANLON, Administrative Patent Judge.
FINAL DECISION UNDER 37 CFR § 1.658
This is a final decision in Interference No. 102,408
between Child et al. (Child) and Kolar et al. (Kolar). Kolar
is the senior party by virtue of having been accorded the
September 3, 1984, filing date of West German patent
application P 34 32 320.1 in the decision on motions (Paper
No. 46).
Count 1, the sole count at issue in this interference,
relates to certain organoplatinum compounds and reads as
follows:
A compound of the formula I or II

Interference No. 102,408
3

in which R and R independently of one another represent 1 2
H-(CH ) -(O-(CH ) ) -O, where a=0 to 4, b=1 to 4 and c=1 to 7,2 a 2 b c
an alkoxy or arylalkoxy group with 1 to 20 carbon atoms, an
alkane- or aralkanesulfonyloxy group with 1 to 7 carbon atoms
or a tetrahydropyranyloxy radical, or R and R together1 2
represent an oxygen atom bonded in
an ether-like manner or an acetal
or ketal radical

where R and R independently of one another represent a3 4
hydrogen atom, an alkyl group with 1 to 20 carbon atoms or a
phenyl group, A and A are identical and represent a hydroxyl1 2
group, halide, nitrate, acetate, trifluoroacetate,
trifluorosulfonate, perchlorate or sulfate, or A represents1
Interference No. 102,408
4
sulfate or carbonate and A represents H O, or A or A together2 1 22
represent the dianion of an organic acid selected from the
group consisting of dibasic carboxylic, aconitic, 3- or 4-
carboxyphthalic and 3,4- dicarboxyphthalic acid, or A and A1 2
together represent a
Interference No. 102,408
The Child brief, reply brief and record will be referred3
to throughout this decision as CB, CRB, and CR, respectively,
followed by the appropriate page number. Similarly, the Kolar
brief will be referred to as KB followed by the appropriate
page number.
As discussed above, September 3, 1984, Kolar's effective4
filing date, is the critical date.
5
recurring anionic unit of a polymeric compound selected from
the group consisting of dextran sulfate, chondroitin sulfate,
galactan sulfate, polyglutamic acid or polyitaconic acid.

The claims of the parties which correspond to Count 1 are
as follows (Paper No. 47):
Child: claims 2-12, 33 and 34
Kolar: claim 1
Both parties filed records and briefs, Child also filing
a reply brief, and both parties waived the opportunity to3
present an oral argument at a final hearing (Paper No. 90).
Child's brief raises the following issues (CB1):
(1) Has junior party Child proven a reduction to
practice of the subject matter of the count prior to
August 30, 1985?4
(2) Did junior party Child suppress, conceal or abandon
an actual reduction to practice of the invention of
the count within the meaning of 35 U.S.C. § 102(g)?
(3) Should the rebuttal testimony of senior party Kolar
be stricken as untimely filed?
Interference No. 102,408
6
(4) Should the rebuttal testimony of senior party Kolar
be stricken as improperly executed?
(5) If the rebuttal testimony of Kolar is not stricken,
does it rebut the priority case of Child?
Kolar's brief raises the following issues (KB1-2):
(6) Has junior party Child established, by a
preponderance of the evidence, an actual reduction
to practice of the subject matter of the count prior
to Kolar's effective filing date of September 3,
1984?
(7) Does the testimonial evidence submitted by junior
party Child enable the skilled artisan to conclude
that the invention of the count was reduced to
practice by the junior party prior to Kolar's
effective filing date of September 3, 1984?
(8) Has junior party Child abandoned, suppressed or
concealed the invention of the count?
(9) Has senior party Kolar properly filed the
declaration of Dr. Cenek Kolar as rebuttal testimony
under 37 CFR § 1.672(b)?
(10) Does the rebuttal testimony of Dr. Kolar
effectively support Kolar's allegations with
respect to Child's priority case?
In addition, Child filed a motion to strike the rebuttal
testimony of Dr. Cenek Kolar (Paper Nos. 63 and 64) which was
opposed by Kolar (Paper Nos. 68 and 69). Kolar filed a motion
to suppress evidence under 37 CFR § 1.656(h) (Paper No. 85)
which was opposed by Child (Paper No. 89).
Interference No. 102,408
7
Motion to suppress
Senior party Kolar filed a motion under 37 CFR § 1.656(h)
(1993) to suppress certain portions of the Child record. See
Paper No. 85. However, whether or not those portions of the
Child record are suppressed, the junior party does not prevail
in this interference. Therefore, Kolar's motion to suppress
is dismissed.
Priority case of junior party
The dispositive issue in this case is whether junior
party Child has established, by a preponderance of the
evidence, an actual reduction to practice of the subject
matter of the count prior to September 3, 1984, Kolar's
effective filing date. Holmwood v. Sugavanam, 948 F.2d 1236,
1238, 20 USPQ2d 1712, 1714 (Fed. Cir. 1991) (requiring junior
party to prove priority case by a preponderance of the
evidence); see also Bosies v. Benedict, 27 F.3d 539, 541-42,
30 USPQ2d 1862, 1864 (Fed. Cir. 1994) (preponderance of the
evidence standard and clear and convincing evidence standard
distinguished). As senior party Kolar points out, junior
party Child does not rely on conception coupled with diligence
Interference No. 102,408
8
to establish priority of invention (KB4). See Keizer v.
Bradley, 270 F.2d 396, 397, 123 USPQ 215, 216 (CCPA 1959).
A party establishing an actual reduction to practice of
the subject matter of a count must show a reduction to
practice of each and every limitation of the count. Newkirk
v. Lulejian, 825 F.2d 1581, 1582, 3 USPQ2d 1793, 1794 (Fed.
Cir. 1987); Correge v. Murphy, 705 F.2d 1326, 1329, 217 USPQ
753, 755 (Fed. Cir. 1983); Parker v. Frilette, 462 F.2d
544, 548, 174 USPQ 321, 325 (CCPA 1972); Szekely v. Metcalf,
455 F.2d 1393, 1396, 173 USPQ 116, 119 (CCPA 1972); Schur v.
Muller, 372 F.2d 546, 551, 152 USPQ 605, 609 (CCPA 1967).
However, where, as here, the count embraces a number of
compounds, a reduction to practice of a single compound within
the scope of the count constitutes a reduction to practice of
the invention defined by the count for purposes of priority of
invention in an interference proceeding. Compare Breuer v.
DeMarinis, 58 F.2d 22, 24 n.5, 194 USPQ 308, 309 n.5 (CCPA
1977); Mikus v. Wachtel, 504 F.2d 1150, 1152, 183 USPQ 752,
753 (CCPA 1974); Den Beste v. Martin, 252 F.2d 302, 304-05,
116 USPQ 584, 586 (CCPA 1954).
Interference No. 102,408
Declaration of Ralph G. Child dated September 29, 19925
(CR354-64).
Declaration of Yang I. Lin dated September 28, 19926
(CR54-57).
9
Manifestly, a reduction to practice of the subject matter
of a count must be independently corroborated. Mikus v.
Wachtel, 542 F.2d 1157, 1159, 191 USPQ 571, 573 (CCPA 1976);
see also Reese v. Hurst, 661 F.2d 1222, 1228, 211 USPQ 936,
940 (CCPA 1981) (“adoption of the ‘rule of reason’ has
not altered the requirement that evidence of corroboration
must not depend solely on the inventor himself”).
According to junior party Child, it has proven a
corroborated reduction to practice of a compound within the
scope of the count in the United States prior to September 3,
1984, Kolar's effective filing date (CB4). In addition to the
declarations of inventors Ralph G. Child and Yang I. Lin,5 6
junior party relies on the declaration testimony of John C.
Interference No. 102,408
Declaration of John C. James dated September 25, 19927
(CR1-5).
Declaration of Jeffrey B. Medwid dated September 29, 19928
(CR80-85).
Declaration of Franz Scheidl dated September 30, 19929
(CR189-91).
Declaration of Stanley A. Lang dated September 29, 199210
(CR218-20).
Declaration of Bruce Heiser dated September 29, 199211
(CR225-27).
Declaration of Frederick Durr dated September 29, 199212
(CR285-89).
10
James, Jeffrey B. Medwid, Franz Scheidl, Stanley A. Lang,7 8 9 10
Bruce Heiser, and Frederick Durr to support a corroborated11 12
reduction to practice of seven compounds falling within the
scope of the count.
Facts
Junior party Child's brief at final hearing fails to
effectively aid this panel in understanding its case for
priority. See Ernst Haas Studio, Inc. v. Palm Press, Inc.,
164 F.3d 110, 112, 49 USPQ2d 1377, 1379 (2d Cir. 1999)
("Appellant's Brief is at best an invitation to the court to
scour the record, research any legal theory that comes to
mind, and serve generally as an advocate for appellant. We
Interference No. 102,408
Compound no. 1 was used to prepare the remaining six13
platinum compounds, i.e., compound nos. 2-7. See KB10; CR370;
CR375; CR379; CR384; CR391; CR393.
11
decline the invitation."). At best, we ascertain junior party
Child's position to be as follows.
The declaration of Ralph G. Child provides a detailed
explanation of the preparation and testing of seven platinum
compounds said to fall within the scope of the count (CB4).
The preparation of the first of these compounds, identified as
"compound no. 1" and allegedly having the following 13
structure:
is said to be described in Exhibit 1 attached to the Child
Declaration (CR355, ¶ 4; CR365). Exhibit 1 is said to be a
copy of page 47 from notebook 12459B (CR355, ¶ 4).
According to Child, on May 31, 1984, he prepared compound
Interference No. 102,408
American Cyanamid Company, Lederle Laboratories14
Division, Pearl River, New York, USA (hereinafter "Lederle").
Presumably, the notation "12459B-47B" is intended to15
identify the product labeled "B" on page 47 of Child's
notebook 12459B, the preparation of which is described
therein. Compare CR365 (product "B" described as "bright
yellow crystals wt=0.44 mp 270-273E") with CR366
("[Stru]cture, Color and State [:] yellow crystals [;] BP or
12
no. 1 at Lederle by (CR355):14
[T]reating 945 mg. of 3,3-oxetainedimethanamine in
40 cc of water with 820 mg. of sodium acetate and
2.075 g of potassium tetrachloroplatinate. The
mixture was stirred for three hours and filtered.
The filtered crystals weighed 0.37g; mp 262 dec. and
were labeled “A”. The filtrate was allowed to stand
overnight and then the resulting solid was collected
giving 440 mg of product as bright yellow crystals
melting at 270-272E which was labeled “B”.
Compare CR365 (product labeled "A" described as beige solid
having melting point of 262E; product "B" described as bright
yellow crystals having melting point of 270-273E). Products
labeled “C”, “D” and “E” also appear to have been prepared
during the process (CR365).
Various notations have been used throughout the record to
identify products which appear to be described on page 47 of
notebook 12459B. For example, a request for infrared analysis
prepared by Ralph G. Child uses the notation "sample no.
12459B-47B" to identify one such compound. See CR356, ¶ 4;15
Interference No. 102,408
MP [:] 270-273E").
Presumably, the notation "12459B-47A" is intended to16
identify the product labeled "A" on page 47 of Child's
notebook 12459B, the preparation of which is described
13
CR366. In turn, sample no. 12459B-47B was assigned Cyanamid
Laboratory (CL) number CL285605. See CR228.
"Samples of the products" described on page 47 of
notebook 12459B were said to have been subjected to infrared
analysis, elemental analysis, and biological testing for anti-
cancer activity (CR355, ¶ 4). The infrared absorption curve
for sample no. 12459B-47B is said to be attached to the James
declaration as exhibit O. See CR20; CR3-4, ¶ 9. According to
Dr. James, the current supervisor of the spectroscopy group at
Lederle (CR1,
¶ 3):
I have reviewed each of Exhibits O-R and T-V
[(CR20-23 and 25-27)] to compare the structural
formula which is written on each Exhibit with the
infrared absorption curve and confirm that the
infrared curve for each structural formula is
consistent with each structural formula [(CR4, ¶
10)].
Exhibits 11 and 12, attached to the Medwid Declaration
(CR96 and CR97), were identified as reports of the elemental
analyses of sample nos. 12459B-47A and 12459B-47B,16
Interference No. 102,408
therein. Compare CR365 ("[a]fter stirring for 3 hrs beige
solid filtered off and washed separately with water and dried
A. wt = 0.37g mp 262E") and CR355, ¶ 4 ("[t]he mixture was
stirred for three hours and filtered. The filtered crystals
weighed 0.37g; mp 262 dec. and were labeled 'A'.") with CR368
("RANGE B.P. OR M.P. 262E dec . . . [P]HYSICAL APPEARANCE
beige solid").
As discussed above CL number CL285605 was assigned to17
sample no. 12459B-47B. See CR228.
14
respectively, requested by Child which identify the amounts of
C, H, N, Cl and Pt in both samples. Franz Scheidl was said to
have analyzed the amounts of Cl and Pt in sample nos. 12459B-
47A and 12459B-47B prior to June 9, 1984. See CR191, ¶ 13;
CR192; see also CR96 (sample no. 8406019 corresponds to sample
no. 12459B-47A); CR97 (sample no. 8406052 corresponds to
sample no. 12459B-47B). However, the evidence relied on by
Child is silent as to when either sample was analyzed for C,
H, and N.
Finally, sample no. "285605 (12459B 47A)" was said to17
have been tested for anti-cancer activity. During 1984,
Frederick Durr was said to have been "in charge of the group
which had the responsibility for testing chemotherapeutic
agents for anti-cancer activity” (CR285, ¶ 2). One of the
tests which was used at that time was the P 388 test which if
Interference No. 102,408
15
positive was accepted as an indication that a compound had
anti-cancer activity (CR285,
¶ 2).
According to Durr (CR286, ¶ 3):
During 1984 at Lederle, the standard procedure
for carrying out the P 388 test was as follows:
The animals used were BDF 1 mice, all of one
sex, weighing a minimum of 17 g and all with a 3 g
weight range. There were 5 or 6 mice per test
group. The tumor transplant was by intraperitoneal
injection of 0.5 ml of diluted ascitic fluid
containing 10 cells of lymphocytic leukemia P 388. 6
The test compounds in 0.5 ml of 0.2% Klucel in
normal saline were administered intraperitoneally on
days 1, 5 and 9 after tumor implantation, at the
indicated doses. The mice were weighed and the
survivors recorded on a regular basis for up to 30
days. The ratio of survival time for treated
(T)/control (C) animals times 100 was calculated. A
score of 125 or greater is an indication that the
compound was active in the P 388 test. [Compare
CR291.]
Exhibit B attached to the Durr declaration is said to
report the results of a P 388 test carried out on compound
"285605 (12459B 47A)." See CR287, ¶ 7; CR292. The exhibit
bears the following dates: (1) “DATE 6/20/84”, (2) “Data
Entered 7/27/84,” (3) "A.J. Hauss 9/25/84," and (4) “9/27/84
H.L. Lindsay.”
Additionally, junior party Child relies on the
Interference No. 102,408
16
declaration of Stanley A. Lang, the Head of the Chemistry
Department of the Infectious and Neoplastic Disease Research
Section at Lederle from 1980-1990. According to Lang, Yang-I
Lin, Ralph G. Child, Panayota Bitha and Joseph Hlavka, the
inventors in the Child application involved in this
interference, would prepare and submit monthly reports to Lang
(CR218, ¶ 2). Lang would review these reports and use the
information to prepare a monthly summary which would be
integrated into a monthly report for the Infectious and
Neoplastic Disease Section (CR218-19, ¶¶ 3-4). The summary
for August 1984 reads in part as follows (CR223):
Chemistry (Bitha, Child, Hlavka, Lin, and Sliskovic)
As a continuation of our work reported last month on
the synthesis of 3,3-bisaminomethyloxetane platinum
complexes, dichloro(3,3-bisaminomethyloxetane)
platinum complex 1a reacted with a series of acids
by the silver nitrate process to give the following
complexes 1b-g. The water soluble complex 1h (water
solubility = 3.5 mg/ml) showed good activity over a
wide dose range; i.e., T/C x 100 of 253 at 50 mg/kg
and 136 at 3.1 mg/kg.
Issues (1), (6) and (7)
Based on the record before us, junior party Child has
failed to establish an actual reduction to practice of the
subject matter of the count prior to September 3, 1984,
Kolar's effective filing date. An actual reduction to
Interference No. 102,408
17
practice requires a showing of three elements: (1) production
of a composition of matter satisfying the limitations of the
count, (2) recognition of the composition of matter, and (3)
recognition of a specific practical utility for the
composition. Estee Lauder Inc. v. L'Oreal S.A., 129 F.3d 588,
592, 44 USPQ2d 1610, 1613 (Fed. Cir. 1997) citing Standard Oil
Co. (Indiana) v. Montedison, S.p.A., 494 F. Supp. 370, 206
USPQ 676 (D. Del. 1980), aff'd, 664 F.2d 356, 212 USPQ 327 (3d
Cir. 1981); see also Hahn v. Wong, 892 F.2d 1028, 1032-33, 13
USPQ2d 1313, 1317 (Fed. Cir. 1989); Blicke v. Treves, 241 F.2d
718, 720, 112 USPQ 472, 475 (CCPA 1957) (whether a composition
of matter must be tested in order to establish an actual
reduction to practice, and if so, what tests are necessary
must be decided on a case-by-case basis). The evidence relied
on by junior party Child fails to satisfy these three
elements.
A. Compound no. 1
Kolar argues that the evidence submitted by Child does
not establish by a preponderance of the evidence that
"compound no. 1" was actually prepared and known to have
utility as an anti-cancer agent prior to the critical date.
Interference No. 102,408
As discussed above, for purposes of this final decision18
we will presume that sample no. 12459B-47B refers to the
product labeled "B" in exhibit 1 attached to the Child
declaration, i.e. bright yellow crystals having a melting
point of 270-273E (CR365).
As discussed above, for purposes of this final decision19
we will presume that sample no. 12459B-47A refers to the
product labeled "A" in exhibit 1 attached to the Child
declaration, i.e. a beige solid having a melting point of 262E
(CR365).
Both sample nos. 12459B-47A and 12459B-47B appear to20
have the same empirical formula. Compare CR366 and CR368.
To the extent that sample no. 285605 is the same21
compound as CL 285605, as discussed above, CL 285605 was
assigned to sample no. 12459B-47B. See CR228; CR287, ¶ 7.
18
See generally KB12-26.
At the outset, we note that junior party Child has failed
to identify which one of products "A", "B", "C", "D" or "E"
described on page 47 of notebook 12459B is the compound
referred to as "compound no. 1". See CR365. According to the
evidence relied on by Child, infrared analysis was performed
on sample no. 12459B-47B , elemental analyses were performed18
on sample nos. 12459B-47A and 12459B-47B, and sample no.19 20
"285605 (12459B 47A)" was tested for anti-cancer activity. 21
However, the testimony of inventors Child and Lin and non-
inventors James, Medwid, Scheidl, Lang, Heiser and Durr is
Interference No. 102,408
19
silent as to which one of products "A" or "B" (or even "C",
"D" or "E") is "compound no. 1." See KB18-19 (junior party's
declarations fail to identify which sample is actually the
sample called compound 1; despite difference in color and 10EC
difference in melting point, we are left to draw an assumption
as to whether sample A, sample B, a combination of samples A
and B, or sample C, D or E is compound 1). Neither the brief
nor the reply brief of junior party Child clarifies the
matter. Compare Mikus, 542 F.2d at 1159-60,
191 USPQ at 574 (actual reduction to practice was not
established where priority proofs were shown to be
inconsistent).
For the reasons set forth below, the evidence relied on
by junior party Child as a whole fails to establish that a
compound within the scope of the count was actually reduced to
practice prior to the critical date.
1. Production and recognition of compound
Junior party Child relies on the results of an infrared
spectroscopy analysis of sample no. 12459B-47B and elemental
analyses of sample nos. 12459B-47A and 12459B-47B to establish
that a compound satisfying the limitations of the count was
Interference No. 102,408
20
produced prior to the critical date.
As discussed above, to establish an actual reduction to
practice, junior party Child must prove, inter alia, (1) that
a compound satisfying the limitations of the count was
produced prior to the critical date and (2) that the inventors
had contemporaneous appreciation of the compound produced.
Estee Lauder, 129 F.3d at 592, 44 USPQ2d at 1613; Cooper v.
Goldfarb, 154 F.3d 1321, 1331, 47 USPQ2d 1896, 1904 (Fed. Cir.
1998).
According to John C. James (CR4, ¶ 10):
I have reviewed each of Exhibits O-R and T-V
[(CR20-23 and 25-27)] to compare the structural
formula which is written on each Exhibit with the
infrared absorption curve and confirm that the
infrared curve for each structural formula is
consistent with each structural formula.
However, James' conclusions that the curves are
"consistent with" the structural formula provided on the
spectroscopy request card alone fail to "confirm" that a
compound satisfying the limitations of the count was produced
(KB15; KB20). See In re Brandstadter, 484 F.2d 1395, 1406,
179 USPQ 286, 294 (CCPA 1973) ("the affidavits fail in their
purpose since they recite conclusions and few facts to
buttress said conclusions"); see also Rohm and Haas Co. v.
Interference No. 102,408
21
Brotech Corp., 127 F.3d 1089, 1092,
44 USPQ2d 1459, 1462 (Fed. Cir. 1997) (“Nothing in the rules
or in our jurisprudence requires the fact finder to credit the
unsupported assertions of an expert witness.”).
Moreover, the James declaration fails to establish that
the infrared absorption curve of sample no. 12459B-47B was
"reviewed" and appreciated prior to the critical date. See
generally CR1-5. See Cooper v. Goldfarb, 154 F.3d at 1331, 47
USPQ2d at 1904 (to establish an actual reduction to practice,
the inventor must contemporaneously appreciate the invention
at issue; subsequent testing or later recognition may not be
used to show that a party had contemporaneous appreciation of
the invention). Indeed, the evidence relied on by Child fails
to establish when the infrared spectroscopy analysis of sample
no. 12459B-47B was even completed. Although the absorption
curve bears a date of June 7, 1984 (CR20), the meaning of that
date has not been explained on this record.
As for the elemental analyses of sample nos. 12459B-47A
and 12459B-47B, we are not convinced that elemental analysis
conclusively establishes the identity of a compound. See
Interference No. 102,408
22
Thurston v. Wulff, 164 F.2d 612, 615, 76 USPQ 121, 124 (CCPA
1947) (“It must be emphasized that a test that agrees with the
theoretical C, H and N content of a desired compound does not
necessarily prove the identity of the same compound.”).
Furthermore, the evidence relied on by junior party Child
fails to establish that the results of the elemental analyses
of sample nos. 12459B-47B and 12459B-47A were appreciated
prior to the critical date. Exhibits 11 and 12 attached to
the Medwid declaration (CR96 and 97) appear to report two
different amounts of C, H, N, Pt and Cl for each sample, a
calculated amount and an amount obtained through elemental
analysis. At the very least, the evidence relied on by junior
party Child fails to establish that the discrepancies between
these two amounts were understood prior to the critical date.
See KB16-17. See Cooper, 154 F.3d at 1331, 47 USPQ2d at 1904
(to establish an actual reduction to practice, the inventor
must contemporaneously appreciate the invention at issue;
subsequent testing or later recognition may not be used to
show that a party had contemporaneous appreciation of the
invention). In addition, the evidence relied on by
junior party Child fails to establish that sample nos. 12459B-
Interference No. 102,408
23
47B and 12459B-47A were even analyzed for carbon, hydrogen and
nitrogen prior to the critical date (KB17). Compare CR191, ¶
13; CR192 (sample nos. 12459B-47B and 12459B-47B were analyzed
for platinum and chlorine prior to June 9, 1984).
2. Recognition of utility
The evidence relied on by junior party Child, i.e., the
declarations of Ralph G. Child (CR354-64), Durr (CR285-89) and
Lang (CR218-20), further fails to establish that a compound
within the scope of the count was known to have utility as an
anti-cancer agent prior to September 3, 1984. See generally
KB20-26.
According to Durr, one of the tests which was used at
Lederle to identify anti-cancer activity was the “P 388 test”
(CR285-86, ¶ 2). A copy of the protocol for the P 388 test is
said to be attached to the Durr declaration as Exhibit A
(CR286, ¶ 2; CR290-91). Compound "285605 (12459B 47A)" was
said to have been tested for anti-cancer activity using the P
388 test. See CR287, ¶ 7; CR292.
We find that the identity of compound "285605 (12459B
47A)" has not been established. Namely, it is unclear on this
record whether the notation "285605 (12459B 47A)" refers to
Interference No. 102,408
As discussed above, the product labeled "A" on page 4722
of notebook 12459B is described as a beige solid having a
melting point of 262E (CR365). On the other hand, the product
labeled "B" on page 47 of notebook 12459B is described as
bright yellow crystals having a melting point of 270-273E
(CR365).
Exhibit C attached to the Durr declaration which appears23
to be a computer generated report of the results of a P 388
test includes data for compound "285605-47A" (CR293).
24
sample no. 12459B-47A or 12459B-47B. According to the record22
in this interference, sample no. 12459B-47B was assigned CL
number 285605 (CR228). However, the notation "285605 (12459B
47A)" appears to refer to sample no. 12459B-47A (CR292). 23
Junior party Child fails to explain this inconsistency.
Assuming arguendo that compound "285605 (12459B 47A)"
does fall within the scope of the count, the evidence relied
on by junior party Child fails to establish that the inventors
knew, prior to the critical date, that the compound had
utility as an anti-cancer agent. See KB25-26. See Estee
Lauder Inc., 129 F.2d at 594-95, 44 USPQ2d at 1615 ("when
testing is necessary to establish utility, there must be
recognition and appreciation that the tests were successful
for reduction to practice to occur").
First, Kolar argues that the protocol for the "P 388
Interference No. 102,408
25
test" was not followed (KB21-22). We agree with Kolar that
two multi-dose assays, each performed at a different
laboratory, are not reported for the compounds tested. See
CR291 (“For confirmed activity a synthetic must have two
multi-dose assays (each performed at a different laboratory)
that produce a T/C $ 125%
. . . ."). Furthermore, it is unclear from exhibit B attached
to the Durr declaration whether 5-fluorouracil was used as the
positive control compound. See KB22; CRB12; CR291.
In addition, exhibit B attached to the Durr declaration
bears the following dates: "DATE 6/20/84", (2) "Data Entered
7/27/84," (3) "A.J. Hauss 9/25/84," and (4) "9/27/84 H.L.
Lindsay," two of which are after the critical date, and
exhibit C bears the date "6/20/84." However, with the
exception of the June 20, 1984, date, junior party Child has
not explained the significance of these dates. See CB8;
CR287, ¶¶ 7 and 8.
Child does state that "[p]rior to September 3, 1984, I
learned that the compound which is described in Exhibit 1 had
anti-cancer activity in the P 388 antileukemia test" (CR356, ¶
4; emphasis added). Nevertheless, as discussed above, exhibit
Interference No. 102,408
Sample no. 12459B-47B was assigned CL number CL285605. 24
See CR228.
26
1 attached to the Child declaration describes five products,
i.e., "A," "B," "C," "D" and "E". See CR365. Therefore,
reference to "the compound which is described in Exhibit 1" is
ambiguous.
The August 1984 monthly report for the Infectious and
Neoplastic Disease Section is equally lacking. The report is
silent as to the anti-cancer activity of compound "285605
(12459B 47A)." See CR223. 24
3. Independent corroboration
Finally, the evidence relied on by junior party Child to
establish an actual reduction to practice of a compound within
the scope of the count prior to September 3, 1984, has not
been independently corroborated. As discussed above, the
inventors' testimony and documents, standing alone, are
insufficient to prove an actual reduction to practice. Hahn,
892 F.2d at 1032, 13 USPQ2d at 1317; see also Lacotte v.
Thomas, 758 F.2d 611, 613, 225 USPQ 633, 634 (Fed. Cir. 1985);
Price, 988 F.2d at 1194,
Interference No. 102,408
For the first time in the reply brief, Child also relies25
on the declaration of Kimberly Miner to establish independent
corroboration (CRB4). Arguments presented for the first time
in a reply brief will not be considered. See Photis v.
Lunkenheimer, 225 USPQ 948, 950 (Bd. Pat. Int. 1984) (matters
not raised in the brief are ordinarily regarded as abandoned).
27
26 USPQ2d at 1036; see also Mikus, 542 F.2d at 1153, 191 USPQ
at 573 (“objective sought in requiring independent
corroboration of reduction to practice of a chemical
composition is to insure that the inventor actually prepared
the composition”). Manifestly, there must be some evidence
independent from the inventor which corroborates the actual
reduction to practice. See Reese,
661 F.2d at 1228, 211 USPQ at 942 ("adoption of the 'rule of
reason' has not altered the requirement that evidence of
corroboration must not depend solely on the inventor
himself"). Junior party Child has failed to present such
evidence.
Junior party Child offers the declarations of non-
inventors John C. James, Jeffrey B. Medwid, Franz Scheidl,
Frederick Durr, Stanley A. Lang and Bruce Heiser as
independent corroboration. However, the testimony therein25
Interference No. 102,408
To the extent that this report could have been26
circulated prior to the critical date, the report neither
bears a date of circulation nor any indication that it was in
fact circulated to and seen by anyone (CRB8-9). See In re
Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)
(arguments in the brief do not take the place of evidence in
the record).
28
relating to an alleged actual reduction to practice of a
compound within the scope of the count is gleaned solely from
information obtained from the inventors. For example, Heiser
received his information relating to the alleged identity of
sample no. 12459B-47B from Ralph G. Child. See CR225-26, ¶ 4
(the chemist would provide Heiser with information identifying
the compound, including the structural formula of the
compound, its molecular formula and weight, the color of the
compound, the chemist's notebook and page number which
recorded the preparation of the compound, and the sample
spectrum number). Lang also received his information from the
inventors. See CR218-19, ¶¶ 2-4 (the inventors of the
involved Child application would prepare and submit monthly
reports to Lang that would be incorporated into a monthly
report for the Infectious and Neoplastic Disease Section). 26
To the extent that preparation of the compounds at issue
was part of an organized research program (CRB6), even the
Interference No. 102,408
29
product of an "organized research program" requires some form
of independent corroboration. See Reese, 661 F.2d at 1228,
211 USPQ at 940 ("adoption of the 'rule of reason' has not
altered the requirement that evidence of corroboration must
not depend solely on the inventor himself"); Berges v.
Gottstein, 618 F.2d 771, 774, 205 USPQ 691, 694 (CCPA 1980)
(although facts set forth "a highly organized procedure
routinely practiced," additional corroboration was provided by
relevant related independent events).
Finally, for the first time in its reply brief, junior
party Child relies on Blicharz v. Hays, 496 F.2d 603, 181 USPQ
712 (CCPA 1974), to advance a theory of corroboration based on
a comparison of laboratory notebooks and its subsequently
filed patent application (CRB4). Arguments presented for the
first time in a reply brief will not be considered. See Ernst
Haas Studio, Inc., 164 F.3d at 112, 49 USPQ2d at 1379 ("An
attempt is made in the Reply Brief to supply what was
conspicuously omitted in the main Brief . . . . However, new
arguments may not be made in a reply brief . . . and we
decline to entertain the theories so proffered."). Therefore,
we have not considered the argument.
Interference No. 102,408
30
B. Compound nos. 2-7
The evidence relied on by junior party Child further
fails to establish that any one of compound nos. 2-7, also
alleged to fall within the scope of the count, was actually
reduced to practice prior to the critical date. As discussed
above, compound no. 1 was used to prepare each one of compound
nos. 2-7. See KB10; CR370; CR375; CR379; CR384; CR391; CR393;
see also CR223 ("platinum complex 1a reacted with a series of
acids by the silver nitrate process to give the following
complexes 1b-g"). Having failed to establish, by a
preponderance of the evidence, that compound no. 1 was
actually reduced to practice prior to the critical date,
junior party Child has likewise failed to establish an actual
reduction to practice of any one of compound nos. 2-7 prior to
the critical date.
C. Conclusion
For the reasons set forth above, the evidence relied on
by junior party Child fails to establish, by a preponderance
of the evidence, that a compound within the scope of the count
Interference No. 102,408
31
was actually reduced to practice prior to September 3, 1984.
Therefore, junior party Child's case for priority must fail.
Junior party Child takes issue with the fact that senior
party Kolar did not cross-examine junior party's declarants or
rebut certain declaration testimony. However, it is of no
moment that senior party failed to cross-examine junior party
Child's declarants. The initial burden is on junior party to
establish, by a preponderance of the evidence, an actual
reduction to practice of a compound within the scope of the
count prior to the critical date. Holmwood, 948 F.2d at 1238,
20 USPQ2d at 1714; Bosies, 27 F.3d at 541-42, 30 USPQ2d at
1864. For the reasons set forth above, Child has failed to
satisfy that burden.
Likewise, it is of no moment that the "Statement of
Facts" section of senior party Kolar's brief may contain
arguments. See CRB1. Child, as the junior party in this
interference, bears the initial burden of establishing
priority by a preponderance of the evidence. Holmwood, 948
F.2d at 1238, 20 USPQ2d at 1714; Bosies, 27 F.3d at 541-42, 30
USPQ2d at 1864. Manifestly, if the junior party has not met
Interference No. 102,408
32
its initial burden of proof, the senior party will prevail in
an interference regardless of whether or not it has even filed
an opposition brief. Fitch v. Cooper, 139 USPQ 382, 382 (Bd.
Pat. Int. 1962) (notwithstanding uncontested nature of the
case, the senior party is still presumed to be the first
inventor, and the burden of proof rests upon the junior party
to overcome this presumption). Accordingly, senior party's
brief will not be returned pursuant to 37 CFR § 1.618 (1993).
Issues (2) and (8)
With respect to senior party Kolar's allegations
concerning abandonment, suppression and concealment, for the
reasons set forth above, we have not found an actual reduction
to practice of a compound within the scope of the count prior
to September 3, 1984. "[W]ithout an actual reduction to
practice there is no invention in existence which can be
abandoned, suppressed, or concealed." Peeler v. Miller, 535
F.2d 647, 651, 190 USPQ 117, 120. Therefore, issues (2) and
(8) are moot.
Motion to strike rebuttal testimony of Kolar;
Issues (3)-(5), (9) and (10)
Since it was not necessary to address the rebuttal
testimony of Dr. Cenek Kolar, the motion to strike that
Interference No. 102,408
Kolar's motion under 37 CFR § 1.633(a) for judgment on27
the ground that Child's claim 33 corresponding to the count is
unpatentable to Child under 35 U.S.C. § 112 was granted in a
decision on motions mailed June 2, 1992 (Paper No. 46). Since
Child did not seek review of that decision in its brief at
final hearing, judgment is also properly entered against
junior party Child based on unpatentability.
33
testimony (Paper Nos. 63 and 64) is dismissed. Furthermore,
issues (3)-(5) raised by junior party Child in its brief and
issues (9) and (10) raised by senior party Kolar in its brief
relating to the rebuttal testimony of Dr. Kolar are moot.
Judgment
Judgment as to Count 1, the sole count at issue, is
entered against junior party Ralph G. Child, Panayota Bitha,
Joseph J. Hlavka and Yang-I Lin based on both priority and
patentability. Ralph G. Child, Panayota Bitha, Joseph J.27
Hlavka and Yang-I Lin are not entitled to a patent containing
claims 2-12, 33 and 34 which correspond to Count 1.
Judgment as to Count 1 is awarded in favor of senior
party Cenek Kolar, Hans P. Kraemer and Konrad Dehmel. On the
record before the Patent and Trademark Office in this
interference,
Interference No. 102,408
34
Cenek Kolar, Hans P. Kraemer and Konrad Dehmel are entitled to
their patent containing claim 1 which corresponds to Count 1.
MARY F. DOWNEY )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
TEDDY S. GRON ) APPEALS AND
Administrative Patent Judge ) INTERFERENCES
)
)
)
ADRIENE LEPIANE HANLON )
Administrative Patent Judge )
ALH:svt
Interference No. 102,408
35
Counsel for Child et al.:
James V. Costigan
HEDMAN, GIBSON & COSTIGAN, P.C.
1185 Avenue of the Americas
New York, NY 10036
Counsel for Kolar et al.:
William F. Lawrence
FROMMAR LAWRENCE HAUG LLP
745 Fifth Avenue
New York, NY 10151