Ex Parte McDonald

Board of Patent Appeals and Interferences

Sep 25, 2003

08330517 (B.P.A.I. Sep. 25, 2003)

MAIL STOP INTERFERENCE Paper149
ALEYANDRIA VA 22313-1450
703-308-9797 UNITED STATES PATENT AND TRADEMARK OFFICE
703-305-0942 (fax) BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES
Interference No. 104,544
TED P. McDONALD -M-A-1 L-E D
(5,593,666),
Junior Party, SEP 2 5 2003
V. PAT &TM OFHCE
BOARD OF PATENT APPEALS
HIROSHI MIYAZAKI, AND INTERFERENCES
TAKASHI KATO, KINYA OHGAMI, and AKIHIRO IWAMATSU
(08/278,083, 08/361,811, and 08/964,039),
Senior Party.
HEARD: 28 May 2003
Before LEE, TORCZON, and NAGUMO, Administrative Patent Judcles.
TORCZON, Administrative Patent Judge.
JUDGMENT
(PURSUANT TO 37 CFR § 1.658)
INTRODUCTION
This proceeding relates to compositions and methods for increasing platelet
production, involving fragments of a specific functional sequence of the protein
thrombopoietin (TPO).1
For the final hearing, McDonald has briefed the issues of priority and derivation.
Miyazaki opposes McDonald's brief, but rests its own case for priority on its accorded
1 TPO has several synonyms, including c-myleoproliferative leukemia receptor ligand (c-mpl-L) and
megakaryocyte growth and development factor (MGDF).
Interference No. 104,544 Paper149
McDonald v. Miyazaki Page 2
benefit. Miyazaki has also briefed inequitable conduct. A belated Miyazaki motion
regarding unpatentability has been deferred.
McDonald also seeks reconsideration of the following preliminary motions:
McDonald preliminary motion 2 (denied) to adjudge Miyazaki
claims unpatentable over an earlier McDonald patent or article.
McDonald preliminary motion 5 (denied) to substitute a generic
count.
Miyazaki preliminary motion 1 (granted in part) to broaden count 1
slightly (see count 5).
FINDINGS
At least a preponderance of the evidence of record supports the enumerated
findings below, except in the case of findings regarding inequitable conduct, which are
supported by at least clear and convincing evidence.
The junior part
[1] The junior party, McDonald, is involved in this interference on the basis of its 5,593,666
[6661 patent.
[2] McDonald's 666 patent issued on 14 January 1997 from an application filed 27 October
1994, which claimed the benefit under 35 U.S.C. 120 of an application filed 16 August
1994 [1048) .2
The senior parly
[3] The senior party, Miyazaki, is involved in this interference on the basis of its 08/278,083
(083], 08/361,811 [811 ], and 08/964,039 [039] applications.
2 Senior party exhibits are numbered beginning with 1001; junior party exhibits start at 2001.
Interference No. 104,544 Paper149
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[4] The Miyazaki applications claim the benefit via 35 U.S.C. 119-121 to JP -76-39090,
filed 14 February 1994.
The counts
[5] There are two counts in this interference, count 3 and count 5.
[6] Count 3 is:
The method of McDonald claim 24 or Miyazaki 039 claim 74.
[7) McDonald claim 24 is:
24. The method of claim 22 131 wherein the active fragment is the C
terminal fragment.
[8] A polypeptide is formed by the covalent peptide bonding of the carboxyl group
(designated "C") of an a-amino acid to the a-amino group (designated "N") of another
a-amino acid. The C-terminus of a polypeptide is end of the peptide with the free
carboxyl group. The N-terminus is the end with the free amino group. By convention,
the amino-acid residues of a polypepticle are numbered from the N-terminus.
[9] Miyazaki 039 claim 74 is:
74. A method for increasing platelet production in an individual
comprising administering an effective amount of a thrombopoietin (TPC)
polypeptide having the biological activity of specifically stimulating and
increasing platelet production in combination with a pharmaceutically
acceptable carder, said TPO polypeptide selected from the group
3 McDonald claim 22: The method of claim 20 wherein the active fragment is selected from the group
consisting of the N-terminal and the C-terminal.
McDonald claim 20: A method of increasing platelet cell counts in a patient in need thereof which
comprises administering to the patient a therapeutic composition comprising a therapeutic amount of
thrombopoietin or an active fragment of thrombopoietin and a pharmaceutically acceptable carrier, said
therapeutic amount being sufficient to increase platelet cell counts in said patient by at least about 20% above
a baseline count.
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consisting of polypeptides comprising the amino acid sequence 2 to 332,
3 to 332, 4 to 332, 5 to 332, and 6 to 332 of SEQ ID NO:6
[10] McDonald has been accorded the benefit of its 16 August 1994 effective filing date as
its earliest constructive reduction to practice for the invention of count 3.
[11] Miyazaki has been accorded the benefit of its 14 February 1994 effective filing date as
its earliest constructive reduction to practice for the invention of count 3.
[121 The following claims have been designated as corresponding to count 3:
1 Total claims Count 3
McDonald: 1-27 4 1-22 & 24-27
Miyazaki 083:18-37 None
811: 43-67 None
039: 53, 55, 57-60 & 71-79 153, 55, 57-60, 71-79
[131 Count 5 is:
The method of McDonald claim 23 or Miyazaki 811 claim 49 or the
polypeptide of Miyazaki 083 claim18.
[14] McDonald claim 23 is:
23. The method of claim 22 wherein the active fragment is the N
terminal fragment.
[15] Miyazaki 811 claim 49 is:
49. A method for increasing platelet production comprising
administering to a patient a pharmaceutical composition in an amount
effective to increase platelet production; said pharmaceutical composition
comprising a polypeptide having the biological activity of specifically
stimulating and increasing platelet production and a pharmaceutically
acceptable carrier, said polypeptide consisting of a continuous amino
terminal fragment of the sequence set out in SEQ ID NO:12 commencing
4 McDonald's claims 9-12,18, 20, 21, and 25-27 have been held to be unpatentable (Paper No. 95).
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at residue number 1, said fragment being 151 or more residues in length
and 232 or fewer residues in length.
[16] Miyazaki 083 claim 18 is:
18. A polypeptide having the biological activity of specifically
stimulating and increasing platelet production, said polypeptide consisting
of a continuous amino terminal fragment of the sequence set out in SEQ
ID NO: 12 commencing at residue number 1, and lacking at least carboxy
terminal residues thereof beyond residue 232.
[17] McDonald has been accorded the benefit of its 16 August 1994 effective filing date as
its earliest constructive reduction to practice for the invention of count 5.
[181 Miyazaki has been accorded the benefit of its 14 February 1994 effective filing date as
its earliest constructive reduction to practice for the invention of count 5.
[191 The following claims have been designated as corresponding to count 5:
1 Total claims Count 5
McDonald: 1-271 9-12, 18, 20-23 & 25-27
Miyazaki 083:18-37 18-37
811: 43-67 43-67
L- 039: 53, 55, 57-60 & 71-79 ý 53, 55, 57-60 & 71-73
Relationship of McDonald's 449 and 666 patent
[20] McDonald's 5,128,449 [449] patent issued 7 July 1992 from an application filed 5 July
1988[2002].
[21] The 449 patent discloses a thrombocytopoiesis-stimulating factor [TSF] summarized as
follows in 449 claim 1, the sole 449 claim:
A purified polypeptide useful in stimulating thrombocytopoiesis
wherein said polypeptide:
5 McDonald's claims 9-12,18, 20, 21, and 25-27 have been held to be unpatentable (Paper No. 95).
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has a specific activity at least 160,000 times greater than the
unpurified polypepticle in a human embryonic kidney cell
culture containing the unpurified polypepticle;
has a molecular weight, as determined by sodium dodecyl sulfate
polyacrylamide gel electrophoresis under reducing
conditions, of about 15,000 daltons as a monomer;
is stained by Coomassie blue;
has an isoelectric pH of about 4.47; and
has a specific activity of at least 21,000 units per milligram of said
polypepticle where a unit of specific activity is determined by
dividing one milligram by the weight of said polypeptide
required to increase the percent 3S incorporation into
platelets of mice by 50 percent above baseline in an
immunothrombocythernic assay.
[22] The 449 patent disclosure contains no sequence information for TSF.
[23] McDonald has not been accorded the benefit of its 449 patent.
[24] The 449 patent issued before the earliest claimed effective filing date for McDonald's
involved 666 patent.
Miyazaki's priorily case
[25] Miyazaki has rested its priority case on the 14 February 1994 filing date of its JP -76
39090 application, for which it has been accorded benefit as a constructive reduction to
practice within the scope of count 3 and the scope of count 5.
MCDONALUS PRIORITY CASE
As junior party seeking a determination of priority, McDonald must demonstrate
by a preponderance of the evidence reduction to practice before the senior party's
priority date, or prior conception coupled with reasonable diligence in reducing the
invention to practice from a time just before the senior party entered the field to the
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junior party's own reduction to practice. Griffin v. Bertina, 285 F.3d 1029, 1032,
62 USPQ2d 1431, 1433 (Fed. Cir. 2002). McDonald always bears the ultimate burden
of proof for establishing priority over Miyazaki. This burden does not shift. Brown v.
Barbacid, 276 F.3d 1327, 1332, 61 USPQ2d 1236, 1239 (Fed. Cir. 2002).
Conception
[26] Dr. Ted P. McDonald is the sole named inventor of the claimed subject matter of the
involved 666 patent claims [1048].
McDonald argues (Paper 141 at 8) that Dr. McDonald is the first inventor of the
inventions involved in this interference, as demonstrated by the affidavits of Dr.
McDonald, Rose Clift, and Marilyn Cottrell, pointing to Fact 12.
[27] McDonald Fact 12 (Paper 141 at 5) states:
Affidavits of Rose Clift, Marilyn Cottrell, and Ted McDonald
establish that Ted McDonald conceived of the use of an active fragment
of TPO to treat thrombocytopenia in a patient prior to February 14, 1994.
(a) McDonald Affidavit 4 of Ted P. McDonald, paragraph 2, page 38 of
the record [Paper 147 6],
(b) paragraph 23 of McDonald Affidavit of Rose Clift, page 26 of the
record, and
(c) paragraph 23 of McDonald Affidavit of Marilyn Cottrell, page 35 of
the record.
[28] According to Dr. McDonald (Paper 147 at 38, T2):
In December 1991, 1 conceived of the idea of using TSF, an active
fragment of thrombopoietin (TPO), to treat thrombocytopenia in an animal
model of a human disease. I conceived of this idea at the time after 1
6 McDonald Record under 37 C.F.R. § 1.653.
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learned that MAIDS (mouse-AIDS) virus produces a mild
thrombocytopenia in infected mice.
[29] We note that in his testimony on inequitable conduct, Dr. McDonald testified that at the
time of his conception he did not know the full amino acid sequence of TSF
[1055 at 71:4-6].
[30] According to Ms. Clift (Paper 147 at 26, ý23):
On or about January 8, 1992, the day we returned to work following
winter break at the University of Tennessee, Dr. Ted McDonald informed
Ms. Cottrell and me that we were going to be doing laboratory studies
such as described above and that the purpose of such studies would be
to establish that TSF can be used to treat thrombocytopenia that occurs in
an animal model of a human disease.
[31] According to Ms. Cottrell (Paper 147 at 35, T23):
On or about January 8, 1992, the day we returned to work following
winter break at the University of Tennessee, Dr. Ted McDonald informed
Ms. Clift and me that we were going to be doing laboratory studies such
as described above and that the purpose of such studies would be to
establish that TSF can be used to treat thrombocytopenia that occurs in
an animal model of a human disease.
[32] In the case of both Ms. Cottrell's testimony and Ms. Clift's testimony, the "laboratory
studies as described above" involve testing TSF. No sequence information is provided
for the TSF that was used.
[33] Miyazaki denies (Paper 145 at 11) McDonald Fact 12 as wholly unsupported by factual
evidence. Specifically Miyazaki contends:
McDonald Affidavit 4 of Ted P. McDonald, cited as record reference 12(a),
describes nothing but TSF and does not establish conception of use of
any fragment of TPO. McDonald Affidavit of Rose Clif [t], cited as record
reference 12(b), describes nothing but experimental work with TSF.
McDonald Affidavit of Marilyn Cottrell, cited as record reference 12(c),
describes nothing but experimental work with TSF.
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Conception is the formation in the mind of the inventor of a definite and
permanent idea of the complete and operative invention, as it is later applied in
practice. Cooper v. Goldfarb, 154 F.3d 1321, 1327, 47 USP02d 1896, 1901 (Fed. Cir.
1998). Conception must include every feature or limitation of the count. Kridl v.
McCormick, 105 F.3d 1446,1449, 41 USPQ2d 1686,1689 (Fed. Cir. 1997). The
critical contested issue is whether McDonald's proof of conception includes any of the
polypeptides in either of the counts.
[34) McDonald contends (Paper 141 at 9):
It has been established in this interference that TSF necessarily and
inherently comprise[s] the sole portion of thrombopoietin (TPO) that is
responsible for TPO's thrombopoietic activity. See (a) Facts 1, 2, 3, 5, 6,
and 17.
[35] Miyazaki denies McDonald Facts 1, 2, 3, 5, 6, and 17 (Paper 145 at 8-10 & 17).
[36] The relative identities of TSF and the polypeptides of the counts are a source of
continuing uncertainty in this proceeding. McDonald contends (Paper 141 at Fact 17,
see also Facts 1 (e) & 5(c)) that:
The Board has recognized that TSF is an active fragment of TPO.
(a) Paper 106 in this Interference entitled Decision on
Reconsideration, pages 210 to 219 of the record.
[37] What the Board said (Paper 106 at 5) was:
McDonald complains that he is being held to a higher standard of
proof because his proofs that TSF is an active fragment of TPO are not
being accepted. The decision [Paper 95] did accept that TSF is an active
fragment of some undefined TPO.
Part of the confusion may stem from the fact that TPO is being used to mean
both (1) the highly specific genus of polypeptides the parties are claiming and (2) any
Interference No. 104,544 Paper149
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isolated factor with thrombopoietic activity. TSF is probably a TPO within the second
sense, but the record before us provides only a basis for speculation as to whether TSF
is a TPO in the first sense.
[38] Facts 1, 2, and 3 are unhelpful because, while summarizing the thrombopoietic activity
of fragments of the TPO sequence both parties disclose in their specifications, they say
nothing about the identity of TSF and do not correlate the fragments to any TSF
property other than the possession of thrombopoietic activity.
Even if we assume the truth of Facts 1, 2, and 3, they do not say anything about
TSF. For these facts to be relevant we would have to assume that the only things that
have thrombopoietic activity are the disclosed TPOs. McDonald has provided no basis
beyond attorney argument and unsupported inventor testimony for reaching such a
conclusion.
Attorney argument and conclusory statements of fact witnesses are not sufficient
to satisfy the burden of going forward. Biotec Biologische Naturve!packungen v.
Biocorp., Inc., 249 F.3d 1341, 1353, 58 USP02d 1737,1745 (Fed. Cir. 2001).
[39] Facts 5 and 6 are similarly unhelpful because (1) they point unspecifically to large
portions of the record and (2) they assume the fact to be proved: that TSF is the same
as the TPO that the parties have disclosed in their specifications.
It is not the Board's responsibility to scour the record for the evidence that
McDonald might have, but did not, discuss in detail in its brief. Id. at 1353, 58 USPQ2d
at 1745.
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McDonald's insistence that TSF is inherently a TPO polypeptide fragment of the
counts is based on an assumption of the very thing McDonald must prove with a
preponderance of the evidence. McDonald urges that knowledge of the TSF sequence
at the time of invention was not required (Paper 141 at 10-137), but this is not the real
issue. The real issue is whether, now that McDonald knows about the sequences at
issue, he has taken any steps to prove what he contends is an inherent feature of TSF:
that it has a polypeptide sequence within a count. If he has, he has not shared the
results with us.
Even assuming McDonald has demonstrated that TSF is a disclosed TPO
polypeptide fragment, he has not demonstrated which fragment it is. Thus, if TSF were
the C-terminal fragment, it would still not be a priodty proof for count 5, which requires
an N-terminal fragment and, conversely, an N-terminal fragment would not suffice to
prove priodty for count 3. Thus, even if we made the most generous assumptions
possible about the nature of TSF, we would still not know what McDonald had proved
with respect to the two counts under consideration.
[401 The identity of TSF relative to the polypeptides of the counts remains a mystery.
7 Citing Riney v. Thomas, 77 F.2d 525, 25 USPO 418 (CCPA 1935) and Silvestri v. Grant, 496 F.2d
593, 181 USPQ 706 (CCPA 1974). The Court of Appeals for the Federal Circuit has characterized BjM and
Silvestri as "rare" exceptions to the general rule that a putative inventor must have known of all of the elements
of the count at the time of conception. Hitzeman v. Rutter, 243 F.3d 1345, 1354-55, 58 USP02d 1161, 1167
(Fed. Cir. 2001). To rely on inherency to prove conception, the allegedly inherent element must add nothing to
the count beyond the other recited limitations. Id. at 1355, 58 USP02d at 1167. McDonald has not shown that
the sequence information in the counts is extraneous in view of the other recited limitations.
McDonald also cites Mycogen Plant Science, Inc. v. Monsanto Co., 243 F.3d 1316, 58 USP02d 1030
(Fed. Cir. 2001) as citing Silvestri with approval. Mycogen, however, cites Silvestri for the unremarkable
proposition that the conception does not have to employ exactly the same words as the count. Moreover, it
continues by discussing how the inventors actually appreciated the limitation of the count at the time of
conception. Id. at 1336, 58 USPQ2d at 1047.
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The most direct way of addressing this mystery would have been to prepare TSF
and then sequence it. Neither party has seen fit to do so. An unexplained failure by the
party with the burden of proof to produce the most probative evidence can, itself, be
very telling. Cf. Crown Operations Int'l. v. Solutia, Inc., 289 F.3d 1367, 1377 n.4,
62 USPQ2d 1917, 1923 nA (Fed. Cir. 2002) (expressing frustration with a party's failure
to generate test data to support its argument); accord Borror v. Herz, 666 F.2d 569,
573-74, 213 USPO 19, 23 (CCPA 1981) (citations omitted) (considering the effect of
missing inventor testimony):
[T]he unexplained absence of inventors testimony cannot and should not
be ignored. The inventor's testimony forrns a natural and expectable
element of an interference party's total proof. Under the evidentiary rule,
the unexplained failure to call any known non-hostile person who has
direct knowledge of the facts being developed by the party raises the
inference that the testimony would be unfavorable or at least would not
support the case, unless the testimony of such a witness would be
cumulative or inferior to what is utilized.
[41] As late as 15 May 1992, Dr. McDonald noted [1028 at 80]8 in distinguishing TSF from
other possible cytokines with thrombopoietic activity:
While it is possible that thrombocytopoiesis may be regulated by multiple
factors, the ability of our TSF preparation to stimulate platelet recovery in
irradiated mice in a manner similar to RAMPS suggests the presence of a
single factor with thrombocytopoietic physiological regulatory potential.
This factor in our preparation does not appear to be IL-6 or GM-CSF, but
until DNA sequence for the factor is cloned, the exact identity of this
molecule remains unknown.
8 C.D. Carter & T.P. McDonald, OThrombopoietin from Human Embryonic Kidney Cells Causes
Increased Throbocytopoiesis in Sublethally Irradiated Mice", 132 Radiation Res. 74 (1992). At page 80, the
publication notes that the manuscript was received 6 February 1992 and accepted 15 May 1992.
1
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[421 In the present case, McDonald was on notice that the lack of better evidence on the
relationship between TSF and the claimed polypeptides was a source of concern for the
Board (Paper 95 at 15 and 19-22).
[43] McDonald argues (Paper 141 at 18 n.2) that sequencing TSF is well within the ordinary
skill of the art.
McDonald is the party with the burden of proof to establish his date of conception
for the invention of the counts. McDonald has failed to provide a preponderance of
evidence linking his proofs regarding TSF conceptions with the TPO polypeptide
fragments of the count. Consequently, we find no support for McDonald's contention
that he conceived of the inventions of the counts prior to Miyazaki's earliest accorded
benefit date.
Reduction to practice
[44] According to McDonald (Paper 141 at 5-6, Fact 13):
Affidavits of Rose Clift, Marilyn Cottrell, and Ted McDonald establish that
Ted McDonald's conception of the use of an active fragment of TPO to
treat thrombocytopenia in a patient was reduced to practice prior to
February 14, 1994.
(a) McDonald Affidavit 4 of Ted P. McDonald, pages 37 to 45 of the
record,
(b) McDonald Affidavit of Rose Clift, pages 19 to 27 of the record, and
(c) McDonald Affidavit of Marilyn Cottrell, pages 28 to 36 of the record.
The brief cites to 27 pages of the record with little or no guidance as to which
facts we should note, This form of briefing is an invitation to the Board to become
Interference No. 104,544 Paper149
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McDonald's advocate. We decline the invitation. In re Swartz, 232 F.3d 862, 864,
56 USPQ2d 1703, 1704 (Fed. Cir. 2000) (declining a similar invitation).
[45] Miyazaki denies McDonald Fact 13 (Paper 145 at 11) as wholly unsupported by factual
evidence. Specifically Miyazaki contends:
McDonald Affidavit 4 of Ted P. McDonald, cited as record reference 13(a),
describes nothing but use of TSF and does not establish reduction to
practice of use of any fragment of TPO. McDonald Affidavit of Rose
Clif[t], cited as record reference 13(b), describes nothing but experimental
work with TSF. McDonald Affidavit of Marilyn Cottrell, cited as record
reference 13(c), describes nothing but experimental work with TSF.
In order to establish an actual reduction to practice, the inventor must prove that:
(1) he constructed an embodiment or performed a process that met all the limitations of
the interference count; and (2) he determined that the invention would work for its
intended purpose. Moreover, the inventor must contemporaneously appreciate that the
embodiment worked and met all of the limitations in the count. Coope , 154 F.3d
at 1327, 47 USPQ2d at 1901. These are two distinct requirements and a party must
satisfy each one to establish an actual reduction to practice. Eaton v. Evans, 204 F.3d
1094, 1098, 53 USPQ2d 1696, 1699 (Fed. Cir. 2000).
Once again, the glaring weakness in McDonald's proofs is that they are directed
to TSF rather than to a TPO polypeptide fragment within the scopes of either count.
While McDonald contends that TSF is such a fragment, we do not agree for the
reasons provided above.
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Diliaence
Since we conclude that McDonald did not establish either prior conception or
prior actual reduction to practice, the question of diligence is moot.
DERIVATION
A party asserting derivation must establish (1) pHor conception of the claimed
subject matter and (2) communication of the conception to the opponent. Price v.
Symse , 988 F.2d 1187, 1190, 26 USPQ2d 1031, 1033 (Fed. Cir. 1993); accord Eaton
Cori). v. Rockwell Int'l Co!p., 323 F.3d 1332,1344, 66 USP02d 1271, 1280 (Fed. Cir.
2003) (in the context of an invalidity suit).
[46] Since we concluded that McDonald has not established conception of the inventions of
either count prior to Miyazaki's accorded benefit date, we find no derivation of the
invention of either count by Miyazaki.
The question of communication is moot since it presupposes a conception to
communicate.
RECONSIDERATION OF DECISION ON MOTIONS
We have already reconsidered (Paper 106) our decision on motions.
Nevertheless, McDonald seeks reconsideration of our denials of McDonald preliminary
motions 2 and 5 and of our partial granting of Miyazaki preliminary motion 1. We have
reconsidered our earlier decision again and find nothing requiring revision.
Nevertheless, we provide the following elaborations in view of McDonald's brief.
Interference No. 104,544 Paper149
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McDonald preliminary motion 2
[47] McDonald argues that the claims of Miyazaki's 083 application were anticipated by
McDonald's 449 patent (Paper 141 at 15).
A movant under 37 C.F.R. § 1.633(a) Oudgment on the basis of un patentability)
has the burden of proof for any relief it seeks. 37 C.F.R. § 1.637(a).
[481 McDonald's argument for anticipation in his brief hinges on McDonald's contention that
TSF as disclosed in McDonald's 449 patent is inherently the same as the TPO
polypeptide fragments in Miyazaki's 083 claims.
[491 Count 5 explicitly includes Miyazaki 083 claim 18, which is directed to an N-terminal
fragment of a specific TPO polypeptide, as one alternative within its scope.
The Board must determine the patentability (or unpatentability) of claims rather
than counts. In re Van Geuns, 988 F.2d 1181, 1184, 26 USPQ2d 1057, 1059 (Fed. Cir.
1993). Where, as here however, the opposing party does not urge the separate
patentability of the other claims, they may be treated as standing or falling together. Id.,
988 F.2d at 1186, 26 USPQ2d at 1060. We treat Miyazaki's 083 claims as standing or
falling with claim 18, which is an alternative of count 5.9
Inherency may not be established by probabilities or possibilities. The fact that a
result may occur in a specific set of circumstances is not sufficient. MEHIJBiophile Int'l
Corp. v. Milgraum, 192 F.3d 1362, 1365, 52 USPQ2d 1303, 1305 (Fed. Cir. 1999). A
finding of anticipation by inherent disclosure is appropriate only when the reference
9 McDonald's arguments directed to specific claims are new (cf. Paper 95 at 20-21), but they all
depend on the same finding of inherency. Since we do not find anticipation by inherency for claim 18, the new
arguments directed to the other claims are moot.
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must necessarily include the limitation not expressly disclosed. Transclean Co[p. v.
Bridgewood Svs., 290 F.3d 1364,1373, 62 USPQ2d 1865,1871 (Fed. Cir. 2002).
[50) We have already found that McDonald has not directed us to a preponderance of
evidence that TSF is necessarily the same as any TPO polypeptide fragment in the
present counts. This finding applies equally to a TPO polypeptide fragment within the
scope of Miyazaki 083 claim 18.
[51] McDonald's disclosure of TSF did not anticipate the invention of Miyazaki's involved
083 claims.
[52] McDonald also requests that the finding of anticipation be extended to the involved
Miyazaki 811 and 039 claims (Paper 141 at 20-21).
[53] This argument was not part of McDonald's original motion (Paper 141 at 20).
[54] McDonald has offered no claim-specific analysis for any of Miyazaki's involved 811 or
039 claims.
As previously noted, we must determine patentability in view of the particular
limitations of each claim. Van Geuns, 988 F.2d at 1184, 26 USP02d at 1059.
McDonald benefitted from this requirement in the motions decision, in which only some
of McDonald's claims were held to be unpatentable for reasons specific to those claims.
Once again, we have reconsidered our decision on McDonald preliminary
motion 2, but the relief it seeks is still DENIED.
McDonald prelimina!y motion 5
[55] McDonald wishes reconsideration of the decision not to adopt a new count that
McDonald proposed in his preliminary motion 5 "[i]n view of the arguments above" to
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11 eliminate the distinction without a difference between present Counts 3 and 5"
(Paper 141 at 24-25). No further explanation is provided in the brief.
It is not clear which "arguments above" McDonald means. Again, it is not the
Board's responsibility to search the brief and record for potential arguments favorable to
McDonald's cause. Cf. Winner Int'l Royalty CoLp. v. Wang, 202 F.3d 1340, 1351,
53 USPQ2d 1580, 1589 (Fed. Cir. 2000) (refusing to "search the record on the chance
of discovering which witnesses Wang was complaining of and then determine whether
the district court abused its discretion,"). In the absence of a showing of error in the
earlier decision, we see no basis for changing the earlier decision at all.
[56] The earlier decisions (Paper 95 at 31 & Paper 106 at 7) explained that McDonald's
request for a count that would encompass TSF is inconsistent with his position during
prosecution of his involved claims that they were separately patentable from the prior
arl disclosure of TSF in McDonald's earlier (and not co-pending) 449 patent.
[57] The earlier motions decision also noted (Paper 95 at 31) that McDonald's involved
patent disclosed that C-terminal fragments are a different invention than N-terminal
fragments.
McDonald's arguments smack of trying to have it both ways. McDonald took the
position during the prosecution of its involved claims that they were separately
patentable from TSF and that the N-terminal and C-terminal fragments are separately
patentable from each other. Now that this position is inconvenient for the purpose of
establishing priority, McDonald dismisses all of the purported differences as
Interference No. 104,544 Paper149
McDonald v. Miyazaki Page 19
meaningless. Having argued one way during prosecution, McDonald will not now be
permitted to reverse course now.
(581 McDonald also proposes a new count (Paper 141 at 25).
[59] The earlier decision on reconsideration (Paper 95 at 7) explains how this new proposal
is untimely.
Miyazaki prelimina[y motion 1
[60] McDonald contends that the polypeptide of Miyazaki 083 claim 18 should not be an
alternative of the count (Paper 141 at 22-23) because the other alternatives in the count
are directed to methods of using such polypeptides.
McDonald has not provided any new reason for departing from the decision on
motions or the first reconsideration of that decision. In any case, the issue is moot.
The addition of the polypeptide alternative did not change the benefit dates accorded to
the parties because McDonald did not oppose the according of an earlier benefit date
for either the original count 1 or for the substituted count 5 (Paper 95 at 33). Miyazaki
did not put on a separate priority case (and thus did not put on an earlier proof to the
polypeptide rather than the method). Consequently, the presence or absence of the
polypeptide alternative in count 5 has no effect on the outcome in this case.
INEQUITABLE CONDUCT
[61] Miyazaki moves under 37 C.F.R. § 1.635 for a holding that the claims in McDonald's
666 patent are unenforceable.
We note that Miyazaki moves under § 1.635 (miscellaneous motions) rather than
§ 1.633(a) (unpatentability of involved claims). Under the latter section, the scope of
Interference No. 104,544 Paper149
McDonald v. Miyazaki Page 20
our judgment would be limited to involved claims. Miscellaneous motions are not, on
the face of the rule, so limited. Nevertheless, we read 35 U.S.C. 135(a), which provides
in part:
A final judgment adverse to a patentee from which no appeal or other
review has been or can be taken or had shall constitute cancellation of the
claims involved in the patent....
to limit the scope our judgment to claims designated as corresponding to a count.
For the purposes of this proceeding, inequitable conduct before the United
States Patent and Trademark Office is defined in paragraph (a) of 37 C.F.R. § 1.56
[Rule 561.
[62] The 1992 version of Rule 56 was in force during the prosecution of the McDonald
666 patent.
The 1992 rule has since been slightly amended, but neither party has asserted a
reliance interest in the 1992 version of the rule as opposed to the existing rule. Under
Rule 56(a):
(a) A patent by its very nature is affected with a public interest. The public
interest is best served, and the most effective patent examination occurs
when, at the time an application is being examined, the Office is aware of
and evaluates the teachings of all information material to patentability.
Each individual associated with the filing and prosecution of a patent
application has a duty of candor and good faith in dealing with the Office,
which includes a duty to disclose to the Office all information known to
that individual to be matedal to patentability as defined in this section. The
duty to disclose information exists with respect to each pending claim until
the claim is cancelled or withdrawn from consideration, or the application
becomes abandoned. * * * However, no patent will be granted on an
application in connection with which fraud on the Office was practiced or
attempted or the duty of disclosure was violated through bad faith or
intentional misconduct. * * *
Material to patentability is defined in Rule 56(b) as:
Interference No. 104,544 Paper149
McDonald v. Miyazaki Page 21
(b) Under this section, information is material to patentability when it is not
cumulative to information already of record or being made of record in the
application, and
(1) It establishes, by itself or in combination with other information, a
prima facie case of unpatentability of a claim; or
(2) It refutes, or is inconsistent with, a position the applicant takes in:
(i) Opposing an argument of unpatentability relied on by the Office, or
(ii) Asserting an argument of patentability,
In requiring both materiality and intent, United States Patent and Trademark
Office practice corresponds to the practice in Article III courts:
Inequitable conduct includes affirmative misrepresentation of a material
fact, failure to disclose material information, or submission of false
material information, coupled with an intent to deceive.
Board of Ed. v. Am. Bioscience, Inc., 333 F.3d 1330,1343, 67 USPQ2d 1252, 1261
(Fed. Cir. 2003). The standard methodology for determining inequitable conduct
involves three steps. First, find whether the conduct meets a threshold level of
materiality. Second, find whether the conduct meets a threshold level of intent. Finally,
if the threshold levels have been found, weigh them to determine whether the conduct
is so culpable that the patent should be held unenforceable. Id., 333 F.3d at 1343,
67 USPQ2d at 1261-62.
In proceedings before the United States Patent and Trademark Office, as in
Article III court proceedings, the facts of inequitable conduct must be established by
clear and convincing evidence for both applications and patents. See In re Harita,
847 F.2d 801, 808, 6 USPC12d 1930, 1935 (Fed. Cir. 1988) (ex parte application);
Interference No. 104,544 Paper149
McDonald v. Miyazaki Page 22
Driscoll v. Cebalo, 731 F.2d 878, 884, 221 USPQ 745, 750 (Fed. Cir. 1984) (application
in interference).
[631 The McDonald 666 patent has at least one claim, e.g., claim 1, directed to the use of a
C-terminal fragment of the disclosed TPO polypeptide [1048 at 23:24-31]:
1. A method of increasing platelet cell counts in a patient in need
thereof which comprises administering to the patient a therapeutic
composition comprising a therapeutic amount of a C-terminal fragment of
thrombopoietin and a pharmaceutically acceptable carrier, said
therapeutic amount being sufficient to increase platelet cell counts in said
patient by at least about 20% above a baseline count within about 2 to 4
days after C-terminal fragment administration.
[64] McDonald's 666 patent defines what is meant by N-terminal and C-terminal in terms of
a sequence for TPO attributed to de Sauvage, such that the N-terminal of the disclosed
TPO runs from residue 1 to residue 153, while the C-terminal runs from residue 154 to
residue 332 [1048 at 3:4-31]:
With respect to the structure of the human TPO molecule, TPO consists
of 332 amino acid residues with a leader sequence of 21 amino acid
residues. At residues 153 and 154, there is an Arg-Arg sequence, which is
a degradation point. It has been reported that the first half of this molecule
up to residue 153, which is the N-terminal region of the TPO molecule,
has the same TPO activity as the whole molecule. This is based on the
results that both the full-length and N-terminal fragment of TPO stimulated
BaFjmpI cell in vitro. In this assay, supernatants from HEK 293 cells
transfected with the sequence for the N-terminal domain had activity
similar to that of supernatants from HEK 293 cells expressing the
full-length TPO. See de Sauvage et al, Nature, 369:533-538 (1994).
The N-terminal fragment has been characterized as the erythropoietin-like
(EPO-like) domain of TPO. Thus, it is disclosed in the de Sauvage
publication that the EPO-like domain (N-terminal portion) is the mature or
active moiety of TPO responsible for increasing platelet cell counts. In the
de Sauvage publication, page 537, it states that the importance of the
C-terminal region of the TPO molecule, which encompasses that portion
from the Arg residue at amino acid position 154 to the end of the
sequence, is unknown and remains to be elucidated. It is suggested that
Interference No. 104,544 Paper149
McDonald v. Miyazaki Page 23
this region may act to stabilize and increase the half-life of circulating
TPO. There is no suggestion in the de Sauvage publication that the
C-terminal region or any portion of that region possesses any TPO
activity.
[651 The nature of the C-terminal is further confirmed later in the disclosure [1048 at 7:51
54):
An N-terminal fragment or domain thereof encompasses amino acid
residues 1-153, and the C-terminal fragment or domain encompasses
residues 154-332.
[66] McDonald's 666 patent disclosed the unexpected importance of the C-terminal of the
disclosed TPO polypeptide [1048 at 4:51-62):
With respect to the fragments of the TPO molecule, it has now been
surprisingly discovered that both the N-terminal and C-terminal fragments
of TPO are active in stimulating platelet cell increases.
It has now been further surprisingly and unexpectedly discovered that the
C-terminal fragment is that portion of the TPO molecule which is the more
active moiety for advantageously increasing platelet cell counts. This is
surprising and unexpected in view of the above discussed publications,
which conclude that the N-terminal fragment is the active TPO moiety,
and that the role of the C-terminal fragment has not yet been elucidated.
[67] McDonald's 666 patent elaborated further on the relative importance of the C-terminal
fragment, confirmed the identity of the C-terminal as the 17910 amino acid fragment
running from residue 154 to the C-terminal, and linked the C-terminal to the TSF
disclosed in McDonald's 449 patent [1048 at 8:3-31 ]:
With regards to the C-terminal domain, there are six potential sites for
N-linked glycosylation. It is likely then that this domain is glycosylated.
This C-terminal domain of 179 amino acids in length corresponds
particularly well in size with a molecular weight of 15 kD, as described in
U.S. Pat. No. 5,128,499 (McDonald) for the monomer of TPO. This 15 kD
10 332 - 153 = 179.
Interference No. 104,544 Paper149
McDonald v. Miyazaki Page 24
fragment readily self-associates under appropriate conditions to the active
30 kD TPO dimer. By way of previous results, it was shown that this 30 kD
dimer possesses no EPO or EPO-like activity.
While the N-terminal fragment of TPO possesses some activity with
regards to increasing numbers of platelets, it has now been unexpectedly
and surprisingly discovered that the C-terminal fragment is the more
active moiety or ligand of the TPO molecule. This moiety or ligand binds
the c-Mpl receptor, which is the receptor for TPO. It is the C-terminal
fragment then that unexpectedly stimulates the observed increase in
platelet cell counts in the MAIDS animal model described hereinafter.
The biological activity of the C-terminal fragment of the TPO of the
present invention of substantially increasing platelet cell counts is
demonstrated by its ability to stimulate platelet cell production in vivo in
thrombocytopenic mice infected with murine leukemia virus (LP-BM5).
This mouse model (MAIDS) is correlated with the thrombocytopenia
observed in HIV/AIDS patients, and is therefore believed to be predictive
of efficacious treatments for increasing platelet counts in such patients, as
well as other conditions inducing thrombocytopenia.
[68] We find clear and convincing evidence that McDonald's 666 patent disclosure identifies
C-terminal TPO as a specific 179 amino acid C-terminal fragment of the de Sauvage
TPO sequence.
[69] We further find clear and convincing evidence that McDonald's 666 patent disclosure
links the C-terminal fragment with the TSF disclosed in McDonald's prior art 449 patent.
[70] We further find clear and convincing evidence that McDonald's 666 patent disclosure
purports that the C-terminal TPO fragment associated with TSF is the factor mainly
responsible for the therapeutic benefits of the claimed method.
[71] In the face of a rejection over apparent prior art (in particular, Lok and de Sauvage),
McDonald submitted an declaration to antedate the references pursuant to 37 C.F.R.
§ 1.131 [1054].
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[72] The exhibit filed in support of the declaration explicitly refers to work done with TSF but
does not refer to any specific amino acid sequence for, or to any fragments of, TPO
[1054, Exh. 1].
[73] According to the declaration, the tested TPO "contained both N and C terminuses of the
molecule" [1054, T3.1.b].
[74] In the next sentence, the declaration states that it was the 15 kD form that was tested
[1054, Dec. ý31b]:
This preparation was a truncated form of the molecule that had 15 kd
molecular weight (MW).
[75] As noted above, the specification associates the 15 kD form with the C-terminal
fragment. It does not associate it with the N-terminal fragment plus a little bit of the C
terminal fragment.
[76] Following entry of Dr. McDonald's declaration, all claims were allowed. The examiner
indicated in his reasons for allowance that allowance was [1004 at 2, emphasis in
original]:
Based on the activity profile elicited by the C-terminal fragment of TPO
(i.e. residues 154-332) in MAIDS model, the therapeutic amount of a
C-terminal fragment is considered to constitute an amount sufficient to
increase platelet cell counts in a thrombocytopenic patiento by at least
20% or greater above a baseline count with[in] 2 to 4 days after
C-terminal fragment administration. Also, the in vivo assays disclosed in
the specification is considered to be adequate for the fragment smaller
than 154-332 amino acid residues of TPO.
Any comments considered necessary by Applicant must be
submitted no later than payment of the Issue Fee and, to avoid
processing delays, should preferably accompany the Issue Fee. Such
submissions should be clearly labeled "Comments on Statement of
Reasons for Allowance."
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[77] We find clear and convincing evidence that Dr. McDonald's declaration purporting to
show the prior invention and efficacy of the C-terminal fragment were highly material to
the allowance of at least the C-terminal claims of the 666 patent.
[78] McDonald testified that no attempt has ever been made to obtain an amino acid
sequence for TSF [1055 at 71:4-6].
[79] During cross-examination of Dr. McDonald regarding his Rule 131 declaration, he
admitted that the reference in his declaration to the presence of a C-terminus was
wrong (1055 at 81:7-11 ]:
Q. But there was no attempt to correct the statement that both the N
and C terminus -
A. And that's a mistake, I should have. I should have corrected that.
But that was the basis for claiming the C.
[80] Dr. McDonald provided an explanation of his thinking in his testimony [1055 at 81:21
85:15]:
Q. And the claims that you were attempting to secure at that time are
the same ones that were issued. And if you look at column 23
[1048 at 23], you'll see that claim 1, and by reference all the way
through to claim 17, all refer to a C-terminal fragment, which you
define as encompassing residues 154 to 352 [sic, 3321.
And you told the Patent Office in Exhibit 1054, in paragraph
Roman numeral I little "b" that the preparation that you used
contained both the N and C terminuses of the molecule.
A. I think that's true, it did. It had a little bit of the C. Now, it didn't say
all of the C, did it? It doesn't say all of the C. It has some N and C.
And I believe that to be true.
Q. Okay. Did you think it was worth telling the Patent Office that at the
time you made this declaration and at the time you did the MAIDS
model work that's referred to in the declaration, you did not know
the amino acid sequence of TSF?
Interference No. 104,544 Paper149
McDonald v. Miyazaki Page 27
A. Nobody asked me that.
Q. If you were an examiner, wouldn't you want to know?
A. Not really. And I'll tell you why. If you go back to what I've been
trying to tell you all along about the science involved in describing
the TSF molecule and the megakaryocyte growth and development
factor by Amgen, they're identical. Identical. The word means the
same, identical. There are no differences.
So why would you waste your time, if you were the
examiner, wanting to know the amino acid sequence of a molecule
that's already been described? Why would you do that?
Q. So you took it upon yourself not to inform -
A. No, no, wait a minute.
[Contentious interlude, lines 7-18, omifted)
Q. Dr. McDonald, are N-terminal fragments, TPO as you define them
in your 666 specification as comprising amino acid 154 through
332, biologically active in treatment of thrombocytopenia?
A. Technically, your question is incorrect. N terminus is not 154 to
332.
Q. Are C-terminal fragments biologically active in treating
thrombocytopenia?
A. A portion of the C terminus connected to the N terminus is. I do
know of one experiment that I leamed from, oh, I can't remember
his name. Lok. I think his name was Lok. He worked at
Zymogenetics. He told me in that [sic, the?] C terminus sometimes
had activity. But we never tested that.
Q. Did you ever test the biological activity of a C-terminal fragment as
you define a C-terminal fragment in column 7 [1048 at 71 of your
patent?
A. What I was trying to say was that there -
Q. Could you answer that question yes or no, please.
Interference No. 104,544 Paper149
McDonald v. Miyazaki Page 28
A. I'm kind of trying to figure out what you're asking me. I'm not
sure - - Repeat the question.
Q. I'll ask it again. Did you ever test the biological activity of a C
terminal fragment of TPO as that term is defined at column 7 of
your 666 patent? That is, [the] C-terminal fragment or domain
[that] encompasses residues 154 to 332. Did you ever test that
material?
A. I'm not going - - I'll say it this way: Not to my knowledge. But let me
say, I did test a lot of materials from Zymogenetics and also from
Genentech in my lab. And it is possible that they sent me that for
testing.
0. Before April 1996, when you signed this declaration?
A. Yes.
0. And do you have any documents that you've attached to any
document you've submitted in this interference that support that?
A. I've got a basement full of documents, mouse assays. I've
worked -
0. Dr. McDonald, documents that you have submitted. Documents
that you have submitted, not documents that you have.
A. I don't think we have, no.
[811 McDonald argues that any misrepresentation in the declaration is immaterial because
the claims would have also been allowed if the declaration had said TSF was the N
terminal f ragment plus a bit of the C-terminal f ragment (Paper 112 at 9).
McDonald's argument is implausible since the claims recite distinct fragments
with different sequences. A showing of prior invention must be consistent with what is
being claimed or it is meaningless. The examiner specifically relied on the showing as
it regarded the C-terminal fragment.
Interference No. 104,544 Paper149
McDonald v. Miyazaki Page 29
[821 We find clear and convincing evidence that during the prosecution that led to the
issuance of the 666 patent, Dr. McDonald knew or should have known that references
to a G-terminal fragment in his declaration would be understood by an examiner to
mean at least amino acids 154-332 of the disclosed de Sauvage sequence, as
explained in the specification.
[83] We find clear and convincing evidence that when Dr. McDonald submitted a declaration
showing data for TSF and purporting to show data for a preparation containing both N
terminal and C-terminal fragments of TPO that an examiner would have understood
references to TSF and C terminus to mean at least amino acids 154-332 of the
disclosed de Sauvage sequence.
[84] We find clear and convincing evidence that when the declaration was submitted, Dr.
McDonald did not know what the sequence of TSIF was or whether it was the same as
the de Sauvage sequence or any fragment of that sequence.
[85] We find clear and convincing evidence that Dr. McDonald did not think the tested
preparation contained the entire C-terminal fragment as that fragment is described in
the 666 patent disclosure. We note in particular his testimony that the test preparation
had only "little bit of the C", which we understand to mean a small portion of the C
terminus immediately following the N terminus sequence.
[86] We find clear and convincing evidence that Dr. McDonald was aware that his
representations about testing the T terminus" was not correct but that he chose not to
correct the record.
Interference No. 104,544 Paper149
McDonald v. Miyazaki Page 30
[87] We do not credit his contention that he only came to appreciate that his declaration
could be read to mean the C-terminal fragment was tested after the 666 patent had
issued. The strong implication of the declaration, when read in the context provided by
the specification, was that the test data applied to a C-terminal fragment.
[88] We find Dr. McDonald's testimony that he did not believe an examiner would want to
know the particulars of the sequence of TSF to be material to be incredible given (1) the
fact that fragments of a specific sequence were being claimed, (2) the same specific
sequence was disclosed in the prior art, (3) the specification for the 666 patent
repeatedly trumpets the particular advantages of the C-terminal fragment versus the N
terminal fragment, and (4) the specification strongly suggests that the C-terminal
fragment and TSF are the same. In particular, we give no weight to Dr. McDonald's
contention that TSF and MGDF" are identical, given the insistence in the 666 patent
disclosure that the C-terminal fragment of the de Sauvage sequence, which the
disclosure associates with TSF, is not the portion of the TPO polypeptide that other
researchers had believed to be significant.
[89] We find clear and convincing evidence that Dr. McDonald intentionally overstated the
relationship between TSF and the C-terminal fragment of the de Sauvage sequence
and intentionally withheld his doubts or any qualifications of his statements regarding
the C-terminal fragment because "that was the basis for claiming the C."
We hold that the level of materiality of the misrepresentation and withholding is
very high, that the level of intent is high, and that Dr. McDonald's conduct with regard to
11 A synonym for TPO. See n. 1, supra.
Interference No. 104,544 Paper149
McDonald v. Miyazaki Page 31
representations about the C-terminal fragment fell well below the duty of candor that
applicants owe to the United States Patent and Trademark Office when seeking a
patent. Dr. McDonald's conduct is the sort of over-reaching and truth-shaving that
Rule 56 was enacted to prevent.
ORDER
Upon consideration of the bdefs, motions, oppositions, and replies discussed
above, and in view of the evidence of recorded specifically cited by the parties, it is:
ORDERED that judgment on priodty as to Count 3 be awarded against
McDonald;
FURTHER ORDERED that McDonald not be entitled to a patent containing
claims 1-22 & 24-27 of the McDonald 5,593,666 patent, which correspond to Count 3;
FURTHER ORDERED that judgment on priority as to Count 5 be awarded
against McDonald;
FURTHER ORDERED that McDonald not be entitled to a patent containing
claims 9-12, 18, 20-23 & 25-27 of the McDonald 5,593,666 patent, which correspond to
Count5;and
Interference No. 104,544 Paper149
McDonald v. Miyazaki Page 32
FURTHER ORDERED that a copy of this decision be entered in the
administrative record of McDonald's 5,593,666 patent and Miyazaki's 08/278,083,
08/361,811, and 08/964,039 applications.
AMESON LEE
Administrative Patent Judge
BOARD OF
PATENT
ICHARD T CZON APPEALS AND
Administrative Patent J ge INTERFERENCES
INTERFERENCE
TRIAL SECTION
MARKNAGUM
A i lstrdministrative P entJudge
cc (first-class mail):
Counsel for McDonald (real party-in- Counsel for Miyazaki (real party-in
interest, University of Tennessee interest, Kirin Brewery K.K.):
Research Corp.):
Michael F. Borun
Howard M. Eisenberg MARSHALL, OTOOLE, GERSTEIN,
1600 ODS TwR MURRAY & BORUN
601 SW SECOND AVE 6300 SEARS TwR
PORTLAND OR 97204-3157 233 S WACKER DR
Fax: 503-228-4373 CHICAGO IL 60606-6402
Fax: 312-474-0448
Notice: Any agreement or understanding between parties to this 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 United States Patent and Trademark Office
before termination of the interference as between said parties to the agreement or understanding. 35 U.S.C.
135(c); 37 C.F.R. § 1.661.