Not Reported in F.Supp., 1998 WL 151411 (D.Del.)
`(Cite as: 1998 WL 151411 (D.Del.))
`
`Page 1
`
`Only the Westlaw citation is currently available.
`
`United States District Court, D. Delaware.
`AJINOMOTO CO., INC., Plaintiff,
`v.
`ARCHER–DANIELS–MIDLAND CO., Defendant.
`
`No. 95–218–SLR.
`March 13, 1998.
`
`Edward M. McNally, and Peter A. Pietra, of Morris,
`James, Hitchens & Williams, Wilmington, Delaware, of
`counsel Arthur I. Neustadt, Marc R. Labgold, William
`J. Healey, and Catherine B. Richardson, of Oblon,
`Spivak, McClelland, Maier & Neustadt, P.C., Arlington,
`VA, Thomas Field, and Lawrence Rosenthal, of Strook
`& Strook & Lavan, New York City, for plaintiff.
`
`Jack B. Blumenfeld, and Thomas C. Grimm, of Morris,
`Nichols, Arsht & Tunnell, Wilmington, Delaware, of
`counsel Charles A. Laff, John T. Gabrielides, Kevin C.
`Trock, of Laff, Whitesel, Conte & Saret, Ltd., Chicago,
`Illinois, J. Alan Galbraith, and Ari S. Zymelman, of
`Williams & Connolly, Washington, D.C., for defendant.
`
`OPINION
`
`ROBINSON, J.
`I. INTRODUCTION
`*1 Plaintiff Ajinomoto Co.,
`(“Ajinomoto”)
`Inc.
`filed this suit pursuant to 35 U.S.C. § 271(g) against
`defendant Archer–Daniels–Midland Co. (“ADM”) on
`April 6, 1995 seeking damages (lost royalty income)
`and
`an
`injunction
`against
`defendant
`for
`Archer–Daniels–Midland
`(“ADM”)
`alleged
`infringement of a patent that is directed to a method for
`the preparation of bacterial strains possessing enhanced
`capability of producing amino acids.
`
`that ADM
`charges
`Specifically, Ajinomoto
`willfully infringed claims 1 and 2 of U.S. Patent No.
`4,278,765 (“the '765 patent”) entitled “Method for
`Preparing Bacterial Strains Which Produce Amino
`Acids” issued on July 14, 1981. The priority patent to
`
`this patent was filed in the former Soviet Union on June
`30, 1978.
`
`Defendant denies infringement and challenges the
`validity and enforceability of the '765 patent under 35
`U.S.C. §§ 112 (“obviousness”), 103 (“best mode” and
`“enablement”), and 115 and 116 (“oath of applicant”).
`Specifically, ADM charges that: (1) the specification of
`the '765 patent: (a) does not disclose the best mode
`contemplated by the inventors of carrying out
`their
`invention, (b) fails to enable the full scope of generic
`claims 1 and 2 without undue experimentation, and (c)
`lacks the deposit of
`the biological materials in a
`depository that will distribute samples of the material to
`members of
`the public who wish to practice the
`invention after
`the patent
`issues ( § 112);
`(2)
`the
`differences between the patented invention and the prior
`art are such that claims 1 and 2 would have been
`obvious to one of ordinary skill in the pertinent art (§
`103); and (3) not all of the inventors personally signed
`the declarations required to grant the '765 patent (§§
`115, 116). Additionally, ADM contends that Ajinomoto
`lacks standing to sue ADM for infringement of the '765
`patent because the chain of title of the '765 patent from
`the named inventors to Ajinomoto was not established.
`Moreover, ADM affirmatively defends that
`the '765
`patent
`is
`invalid
`because
`the
`patent
`applicants
`conducted themselves inequitably in their prosecution
`of the patent application by withholding and concealing
`prior art and by concealing the best mode of carrying
`out the invention.
`
`The court has jurisdiction over this matter pursuant
`to 28 U.S.C. § 1338(a).
`
`The parties tried this matter to the court from
`October 28, 1996 through November 11, 1996. The
`following constitutes the court's findings of fact and
`conclusions of law pursuant to Fed.R.Civ.P. 52(a).
`
`II. FINDINGS OF FACT
`
`A. The Invention
`
`1. Amino Acids. The '765 patent is directed to a
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`AVS EXHIBIT 2011
`Toyota Inc. v. American Vehicular Sciences LLC
`IPR2013-00417
`
`

`

`Not Reported in F.Supp., 1998 WL 151411 (D.Del.)
`(Cite as: 1998 WL 151411 (D.Del.))
`
`method for the construction of genetically engineered
`bacterial strains possessing an enhanced capability of
`producing selected amino acids, such as threonine,
`without the need for additional growth factors. (Joint
`Exhibit (“JX”) 1 at col. 3, lines 1–4) Amino acids are
`the building blocks of proteins. Proteins are complex
`macromolecules composed of long chains of amino
`acids that carry out structural and/or catalytic functions
`in cells. (D.I. 307 at 97–99) There are twenty amino
`acids: alanine, valine,
`leucine,
`isoleucine, proline,
`phenylalanine, methionine,
`tryptophan,
`glycine,
`asparagine, glutamine,
`cysteine,
`serine,
`threonine,
`tyrosine, aspartic acid, glutamic acid, lysine, arginine,
`and histidine.
`
`*2 2. The '765 patent specifically discloses a
`method for producing an Escherichia coli (“E.coli”)
`bacteria capable of overproducing the amino acid
`threonine.
`(JX 1) Threonine is of great
`industrial
`importance. It is an essential amino acid which, because
`it cannot be produced by any animal, must be supplied
`through dietary supplements. ADM's animal
`feed
`supplements
`supply various essential amino acids,
`including threonine.
`
`3. A bacterial strain is a type or variety of a
`particular species of bacteria. There are thousands of
`known species of bacteria, as well as many bacterial
`strains within each species. All bacteria naturally make
`amino acids. Bacterial strains prepared in accordance
`with the patented technology can reduce the cost of
`producing amino acids, which are used, inter alia, as
`feedstuff and food additives in the agriculture and food
`industry. (JX 1 at col. 1, lines 8–12)
`
`4. Threonine Biosynthesis. Threonine synthesis in
`a cell is a five step process. (Docket Item (“D.I.”) 308 at
`322–24; D.I. 313 at 941; Defendant's Exhibit (“DX”)
`298 at 346; DX 1005) In step 1, aspartate is converted
`into aspartyl phosphate. (D.I. 313 at 940–43; DX 298 at
`346; DX 1005) Step 2 involves the conversion of
`aspartyl phosphate into aspartate semialdehyde. (D.I.
`313 at 940–43; DX 298 at 346; DX 1005) The third step
`involves the conversion of aspartate semialdehyde into
`homoserine. (D.I. 313 at 940–43; DX 298 at 346; DX
`1005)
`In step 4, homoserine is converted into O-
`
`Page 2
`
`phospho homoserine. (D.I. 313 at 940–43; DX 298 at
`346; DX 1005) And finally,
`in step 5, O-phospho
`homoserine is converted into threonine. (D.I. 313 at
`940–43; DX 298 at 346; DX 1005) Subsequently, some
`of
`the threonine is converted into isoleucine;
`the
`product of the ilvA gene catalyzes the first step in this
`transformation. (D.I. 313 at 940–43; DX 298 at 346;
`DX 1005) Through separate pathways, the process also
`results in the synthesis of lysine and methionine from
`the threonine precursors aspartate semialdehyde and
`homoserine, respectively. (D.I. 313 at 940–43; DX 298
`at 346; DX 1005)
`5. In E. coliFN1 the entire process is catalyzed by a
`variety of enzymes,FN2 three of which are coded by the
`threonine operon. FN3 (D.I. 307 at 105–06; D.I. 313 at
`947; DX 298 at 346; DX 1005) The threonine operon
`contains three structural genes: thrA, thrB, and thrC.
`(D.I. 307 at 105–06; D.I. 313 at 947; DX 298 at 346;
`DX 1005) The thrA gene codes for a bifunctional
`enzyme—aspartokinase for
`thrA 1 and homoserine
`dehydrogenase for thrA 2 —which catalyze steps 1 and
`3, respectively. (D.I. 307 at 105–06; D.I. 313 at 940–43;
`DX 298 at 346; DX 1005) The two remaining genes,
`thrB and thrC, code for homoserine kinase (step 4) and
`threonine synthetase (step 5), respectively. (D.I. 307 at
`105–06; D.I. 313 at 940–43; DX 298 at 346; DX 1005)
`
`the
`for
`pathway
`biosynthetic
`FN1. The
`production of threonine is not the same in all
`bacterial species. (D.I. 307 at 944–946) For
`example, with respect
`to Corynebacteria,
`although the basic steps in the pathway are the
`same, the number of isoenzymes involved in
`the various steps varies as does the method of
`regulation. (D.I. 313 at 944–46) In addition, in
`Corynebacteria although the thrA and asd
`genes are together on one part of the bacterial
`chromosome,
`the thrB and thrC are on two
`separate pieces of DNA. (D.I. 313 at 944–46)
`
`FN2. The first step is catalyzed by three
`isoenzymes, the second by one, the third by
`two, the fourth by one, and the fifth by one.
`(D.I. 313 at 941) An isoenzyme (or isozyme) is
`one of a group of enzymes that are very similar
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`

`

`Not Reported in F.Supp., 1998 WL 151411 (D.Del.)
`(Cite as: 1998 WL 151411 (D.Del.))
`
`in catalytic properties, but can be distinguished
`based on variations in physical properties.
`
`FN3. The term operon is defined as “[a] unit of
`genetic expression consisting of one or more
`related genes and the operator and promotor
`sequences that
`regulate their
`transcription.”
`Albert
`L.
`Lehninger,
`Principles
`of
`Biochemistry 977 (Sally Anderson & June Fox
`eds., 1982). In the '765 patent, the term operon
`is defined as “a jointly controlled group of
`genes generally monitoring the synthesis of a
`single product, e.g. aminoacid.” (JX 1 at col. 1,
`lines 49–51)
`
`the asd gene,FN4 which is
`6. The product of
`located outside of the threonine operon (approximately
`1500 genes away), catalyzes the conversion of aspartyl
`phosphate into the semialdehyde of aspartic acid (the
`second step in threonine synthesis). (D.I. 313 at 947)
`This is not a limiting step in the biosynthetic process.
`
`that
`asserts
`FN4. Although Ajinomoto
`testimony regarding the role of the asd gene in
`the
`biosynthesis
`of
`threonine
`should
`be
`discarded because of insufficient notice,
`the
`issue was raised by Ajinomoto's expert witness,
`Dr.
`Joseph O. Falkinham III, on cross-
`examination when he was questioned regarding
`threonine synthesis in E. coli.
`
`*3 7. In E. coli, regulation of the threonine operon
`is accomplished by means of a multivariant repression
`mechanism (negative feedback regulation), so that when
`a large amount of a particular product is formed, it
`blocks its own synthesis. (D.I. 313 at 942) With respect
`to the first step of threonine synthesis, lysine inhibits
`one of
`the isozymes, methionine inhibits a second
`isozyme, and isoleucine and threonine inhibit the third
`isozyme. (D.I. 313 at 940–43; DX 298 at 346; DX
`1005) Lysine and methionine also regulate their own
`synthesis. (D.I. 313 at 940–43; DX 298 at 346; DX
`1005) In addition, threonine and isoleucine inhibit one
`of the isozymes involved in step 3. (D.I. 313 at 940–43;
`DX 298 at 346; DX 1005) Besides the feedback
`inhibition effect that changes the activity of the level of
`
`Page 3
`
`isoleucine and threonine also
`the available enzyme,
`affect the level of available enzyme—as the levels of
`isoleucine and threonine increase,
`the amount of
`enzyme decreases. (D.I. 313 at 940–43)
`
`8. The Technology Developed by the Genetika
`Researchers. The method of preparation set forth in the
`'765 patent was developed by fourteen researchers at the
`Institute
`for Genetic Engineering
`and
`Industrial
`Microbiology (“Genetika”) in the former Soviet Union.
`(D.I. 307 at 123–24) In developing the process,
`the
`researchers combined skills from both classical genetics
`and recombinant DNA technology. (D.I. 307 at 126)
`Although not the first scientists to employ recombinant
`DNA technology,
`the Genetika researchers were the
`first in the former Soviet Union to do so. (DX 1100 at
`30–31) Unlike their peers in other countries who were
`applying recombinant DNA technology FN5 to the
`development
`of
`pharmaceuticals,
`the Genetika
`researchers applied this technology to the production of
`enzymes and, as in the case of the '765 patent, amino
`acids. (D.I. 307 at 124–26)
`
`FN5. Herb Boyer and Stanley Cohen of
`Stanford University and the University of
`California,
`San
`Francisco
`respectively
`developed recombinant DNA technology. (D.I.
`307 at 111) The technology was first described
`in a paper in The Proceedings of the National
`Academy of Sciences in November 1973. (D.I.
`307 at 111) As compared to classical genetics,
`which
`typically
`involves
`exposing
`microorganisms to mutagens that
`randomly
`alter genetic material and then screening for
`mutants
`with
`desired
`characteristics,
`recombinant DNA technology involves
`the
`making
`of
`specific
`alterations
`in DNA,
`generally through the cutting and then ligating
`of DNA from different sources. (D.I. 307 at
`111)
`
`9. In order to create a bacterial strain capable of
`overproducing threonine, the Genetika researchers used
`a strain of E. coli that was feedback resistant for the
`amino acid threonine. (JX 1 at col. 3,
`lines 30–36)
`recombinant DNA technology,FN6
`Using
`the
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`

`

`Not Reported in F.Supp., 1998 WL 151411 (D.Del.)
`(Cite as: 1998 WL 151411 (D.Del.))
`
`researchers isolated the threonine operon from the strain
`and combined this chromosomal
`fragment with a
`plasmid. FN7 (JX 1 at col. 3, lines 30–36) This hybrid
`plasmid was then inserted into a host bacterial strain
`that was auxotrophic FN8 with respect to threonine and
`contained a partial block (“leaky auxotroph”) in the
`related step of metabolism, the conversion of threonine
`to isoleucine. (JX 1 at col. 3, lines 46–51) The resultant
`strain of bacteria was capable of the over production of
`threonine.
`
`FN6. For basic background information about
`molecular biology and recombinant DNA
`technology, see In re O'Farrell, 853 F.2d 894,
`895–99 (Fed.Cir.1988).
`
`to “[a]n
`term plasmid refers
`FN7. The
`extrachromosomal,
`independently replicating
`small circular DNA molecule.” Albert L.
`Lehninger, Principles of Biochemistry 977
`(Sally Anderson & June Fox eds., 1982).
`
`FN8. An auxotrophic bacterial strain possesses
`a mutation that renders it “defective in the
`synthesis of a given biomolecule, which must
`thus be supplied for
`its normal growth.”
`970
`(Sally
`Principles
`of
`Biochemistry
`Anderson & June Fox eds., 1982).
`
`B. The '765 Patent Application
`10. The Russian Patent Application. On June 30,
`fourteen Genetika researchers FN9 filed a
`1978,
`Russian
`patent
`application
`entitled
`“Method
`for
`Preparing Strains Producing Aminoacids” (application
`no. 2639616)
`(“the Russian patent
`application”).
`(Plaintiff's Exhibit (“PX”) 2) This patent was directed to
`“a method for preparing strains of microorganisms
`possessing an increased ability of producing aminoacids
`[sic] and lack of demands
`for additional growth
`factors.” (PX 2 at 80) According to Soviet law, the
`Russian patent application was personally signed by all
`fourteen inventors. (D.I. 196 at Ex. 5, ¶ 44)
`
`FN9. The fourteen inventors were: Vladimir G.
`Debabov, Jury I. Kozlov, Nelli I. Zhdanova,
`Evgeny M. Khurges, Nikolai K. Yankovsky,
`
`Page 4
`
`Mikhail N. Rozinov, Rustem S. Shakulov,
`Boris A. Rebentish, Vitaly A. Livshits, Mikhail
`M. Gusyatiner, Sergei V. Mashko, Vera N.
`Moshentseva, Ljudmila F. Kozyreva, and Raisa
`A. Arsatiants.
`
`*4 The Russian patent application listed sixteen
`references,
`the pertinent contents of which were
`identified by use of reference numbers throughout the
`text of
`the specification.
`(PX 2 at 98) Of
`these
`references, only the following are relevant to the case at
`bar: (1) an article authored by several of the named co-
`inventors of the '765 patent (Gusyatiner, Zhdanova,
`Livshit [s]; and Shakulov) entitled Investigation of the
`function of the relA gene in the expression of amino
`acid operons: Communication II. Influence of the allelic
`state of the relA gene on oversynthesis of threonine by a
`mutant of Escherichia coli K–12 resistant
`to beta-
`hydroxynorvaline appearing in the publication Genetika
`14(6) (June 1978) (“Genetika II”) and (2) an article
`entitled A Suitable Method for Construction and
`Molecular Cloning Hybrid Plasmids Containing EcoRI-
`fragments of E. coli Genome authored by Kozlov et al.
`(including the named co-inventors Kozlov, Rebentish,
`and Debabov) published in Molecular and General
`Genetics in 1977 (“the Kozlov article”).
`
`11. U.S. Patent Application. The same fourteen
`inventors who filed the Russian patent application filed
`the United States counterpart
`to the Russian patent
`application on June 28, 1979, two days before the end
`the one year priority period.FN10 (PX 2) The
`of
`inventors claimed a priority filing date of June 30, 1978
`based upon the Russian application.
`(PX 2) The
`following documents were included along with the U.S.
`patent application: (1) a Russian Language Declaration
`for Original Patent Application (“Russian Language
`Declaration”);
`(2)
`the
`original Russian
`patent
`application; and (3) an English translation of
`the
`Russian patent application. (PX 2)
`
`FN10. Title 35 U.S.C. § 119 provides a right of
`priority for U.S. patent applications if an
`application for a patent on the same invention
`was previously filed in a foreign country.
`Section 119 provides, in part:
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`

`

`Not Reported in F.Supp., 1998 WL 151411 (D.Del.)
`(Cite as: 1998 WL 151411 (D.Del.))
`
`An application for patent for an invention
`filed in this country ... shall have the same
`effect as the same application would have if
`filed in this country on the date on which the
`application for patent ... was first filed in
`such foreign country, if the application in
`this country is filed within twelve months
`from the earliest date on which such foreign
`application was filed; but no patent shall be
`granted on any application for patent for
`an invention which had been patented ... in
`any country more than one year before the
`date of the actual filing of the application in
`this country....
`
`35 U.S.C. § 119 (emphasis added).
`
`12. The Inventors' Signatures. The Russian
`Language Declaration
`and
`the Russian
`patent
`application contain fourteen signatures purporting to be
`the signatures of the fourteen original inventors. (PX 2
`at 48–53) With respect
`to the Russian Language
`Declaration, each signature is followed by a typed date
`of June 21, 1979. (PX 2 at 48–53) Dr. Juri Ivanovich
`Kozlov FN11 testified that the signature on the Russian
`Language Declaration is not his own; however,
`the
`signor, who he believed to be an employee in Genetika's
`patent department, “had [his] permission to put [his]
`signature in [his] absence.” (DX 1106 at 144) Dr.
`Kozlov further testified that he did not remember if he
`read the declaration or whether it was explained to him
`before he granted permission for someone to sign it for
`him. (DX 1106 at 145–46)
`
`fourteen
`the original
`FN11. Only two of
`inventors were deposed in this litigation. None
`of the inventors testified at trial.
`
`13. Dr. Vladimir Georgievich Debabov testified
`that his signature on the Russian Language Declaration
`is, in fact, his own. (DX 1100 at 42) Although he does
`not
`remember
`the date on which he signed the
`declaration, he believed it must have been June 21,
`1979 since that is the date on the form. (DX 1100 at 42)
`
`14. The Prior Art References. The U.S. patent
`
`Page 5
`
`application omitted the sixteen references found in the
`Russian patent application. However, unlike the Russian
`patent application, the U.S. patent application cited six
`publications which described in detail the method of in
`vitro preparation of hybrid DNA molecules and the
`introduction of these molecules into a recipient strain by
`means of transformation or transfection using a plasmid
`or bacteriophage as a vector. (JX 1 at col. 2,
`lines
`37–44) Of these publications two are relevant to the
`case at bar: (1) an article authored by Clarke and
`Carbon entitled Biochemical Construction and Selection
`of Hybrid Plasmids Containing Specific Segments of the
`Escherichia coli Genome, which was published in Proc.
`Nat'l Acad. Sci. USA, Vol. 72, No. 11 in November
`1975 (“the Clarke/Carbon article”) and (2) the Kozlov
`article. (JX 1 at col. 2, lines 52–53, 56–58)
`
`*5 15. At the time the '765 patent application was
`submitted, applicants were encouraged to file a prior art
`statement listing therein, “in the opinion of the person
`filing[,] ... the closest prior art of which that person is
`aware.” 37 C.F.R. § 1.97(a)–(b) (1978). Said statement
`was “not
`to be construed as a representation that a
`search ha[d] been made or that no better art exist[ed].”
`37 C.F.R. § 1.37(b). The statement was
`to be
`accompanied by a copy of each listed patent or
`publication. 37 C.F.R. § 1.98(a). A prior art statement
`was not submitted as part of the '765 patent application.
`
`and
`in Patent
`expert
`to ADM's
`According
`Trademark Office (“PTO”) procedure, Mr. Van Horn, at
`the time of the invention, a PTO Examiner was not
`likely
`to
`review publications
`that were merely
`mentioned in the patent application. (D.I. 316 at 1420)
`Moreover, he testified that unless circumstances arose
`that necessitated an Examiner to review a priority patent
`application (e.g., a challenge to the priority date), the
`content of a priority patent was not reviewed as part of a
`normal examination of a patent application. (D .I. 316 at
`1427–28; DX 268 at 28) If an applicant wanted to be
`assured
`that
`the
`Examiner
`considered
`certain
`information, he could submit copies of publications or
`other information to the PTO. (D.I. 316 at 1421) Mr.
`Van Horn also testified that there were two ways for an
`Examiner to indicate that a particular reference had
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`

`

`Page 6
`
`microorganisms used are known and readily
`available to the public. When the invention
`depends on the use of a microorganism
`which is not so known and readily available,
`applicants must
`take additional
`steps
`to
`comply with the requirements of Section 112
`
`. I
`
`the MPEP
`circumstances,
`latter
`n the
`required applicants to make “a deposit of a
`culture of the microorganism in a depository
`affording permanence of
`the deposit and
`ready accessibility thereto by the public if a
`patent
`is granted....” The section further
`provided
`that
`“all
`restrictions
`on
`the
`availability to the public of the culture so
`deposited will be irrevocably removed upon
`the granting of the patent.” (D.I. 64, Ex C)
`
`FN13. According to the specification, two of
`the strains, VL334(pYN6) and VL334(pYN7)
`having registration numbers CMIM B–1649
`and CMIM B–1684, respectively, already were
`deposited in the Central Museum of Industrial
`Microorganisms of
`the All–Union Research
`Institute of
`Industrial Microorganisms (“the
`Central Museum”) at the time the application
`was filed. (PX 2 at 21–22)
`
`*6 (2) Claims are improper process claims in failing
`to affirmatively recite steps.
`
`the
`(3) The disclosure is not enabling to support
`breadth of the terms “vector DNA molecule.” Only
`plasmids appear to be suitable and operative as the
`vector.
`
`(PX 2 at 100) The Examiner went on to state that
`“[t]he listed references
`[were] considered to be
`pertinent to the claimed invention, but the claims are
`deemed patentable thereover.” FN14
`
`FN14. Two references were cited on Form
`PTP–892, Notice
`of References Cited:
`Sinsheimer, Ann.Rev. Biochem 46, 415–438,
`1977 and Itokura et al., Science vol. 98, pp.
`
`Not Reported in F.Supp., 1998 WL 151411 (D.Del.)
`(Cite as: 1998 WL 151411 (D.Del.))
`
`been considered: (1) citing the documents in the patent
`application or (2) placing his initials next to the citation
`with an indication that it had been checked. (D.I. 316 at
`1423–24) The record indicates that neither method was
`employed with respect to the '765 patent.
`
`16. The American attorneys who prosecuted the
`'765 patent did not recall providing the PTO Examiner
`with copies of Genetika II, the Clarke/Carbon article, or
`the Kozlov article. (DX 1101 at 44–45; DX 1119 at 28,
`32–33) The attorneys
`testified that
`their
`standard
`procedure with respect to patent applications filed on
`behalf of Genetika was to check the application for
`compliance with PTO guidelines and to submit
`the
`application
`basically
`as
`is,
`i.e.,
`without
`supplementation. (DX 1101 at 40–44; DX 1107 at
`28–29, 49–52; DX 1119 at 45–49) It is undisputed that
`the applicants had knowledge of the existence of the
`aforementioned articles. It is also undisputed that the
`Clarke/Carbon article and the Kozlov article are
`material.
`
`17. U.S. Patent Prosecution History. On January
`21, 1980, during the prosecution of the '765 patent
`application, the PTO Examiner rejected claims 1–4 as
`not enabled under 35 U.S.C. § 112. (PX 2 at 100) In an
`Office Action dated January 21, 1980, the Examiner
`cited the following reasons for his rejection of the
`claims:
`
`(1) Applicants fail[ed] to comply with requirements
`(1)
`and
`(3)
`of MPEP 608.01(p) Deposit
`of
`Microorganisms FN12 regarding the parent E. coli
`strains and the newly produced E. coli strains.FN13
`
`FN12. At the time the application for the '765
`patent was pending, § 608.01(p) of the Manual
`of Patent Examining Procedure (“MPEP”)
`provided as follows:
`
`Some inventions which are the subject of
`patent applications depend on the use of
`microorganisms which must be described in
`the specification in accordance with 35
`U.S.C. 112. No problem exists when the
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`

`

`Not Reported in F.Supp., 1998 WL 151411 (D.Del.)
`(Cite as: 1998 WL 151411 (D.Del.))
`
`the
`(PX 2 at 101) A copy of
`1056–1063.
`Sinsheimer reference was included in the file
`wrapper. (PX 2 at 142–164)
`
`18. In May 1980, in response to the Examiner's
`rejection, the one of the applicants' attorneys, Charles
`Rodman, agreed to “attempt
`to rectify depository
`deficiencies”
`by
`“furnishing
`a
`new declaration
`containing the required information.” (PX 2 at 103, 119)
`In addition, Mr. Rodman agreed to “amend [the] claims
`extensively to eliminate [ § ] 112 rejections.” (PX 2 at
`103)
`
`19. On May 21, 1980, Mr. Rodman filed a response
`to the Office Action requesting reconsideration of the
`application and entry of numerous
`amendments,
`consisting mainly of
`editorial
`and typographical
`corrections in accordance with the PTO action. (PX 2 at
`119) He also added the following to the patent
`application:
`“The parent
`strains of VNIIGenetika
`MG442 and VNIIGenetika VL334 are also deposited in
`the aforesaid Central Museum and are identified by the
`registration numbers CMIM B–1641 and CMIM
`B–1628, respectively.” Mr. Rodman stated that he was
`in
`the
`“process
`of
`obtaining
`a Supplementary
`Declaration
`from the
`inventors
`containing
`the
`depository identification of the parent strains and the
`product strains.” He added that he “considered the
`references cited by the Examiner to show the state of
`the art, however, inasmuch as these references have not
`been cited against
`the claims, and do not appear
`relevant thereto, a detailed discussion of them shall not
`appear herein.” (PX 2 at 121) A supplemental response
`to the January 21, 1980 Office Action was filed in
`August 1980. (PX 2 at 122–24)
`
`20. On August 25, 1980, Mr. Rodman filed the
`Supplemental Combined Declaration and Power of
`Attorney (“Supplemental Declaration of 1980”) (PX 2
`at 125–129) with the PTO, representing under penalty
`of perjury that,
`
`no later than the effective U.S. filing date of the
`application, [they had] made a deposit of a culture of
`the microorganism in
`a
`depository
`affording
`permanence of the deposit and ready accessibility
`
`Page 7
`
`thereto by the public if a patent is granted, under
`conditions which assure (a) that access to the culture
`will be available during pendency of
`the patent
`application to one determined by the Commissioner to
`be entitled thereto under 37 C.F.R. 1.14 and 35
`U.S.C. § 122, and (b) that all restrictions on the
`availability to the public of the culture so deposited
`will be irrevocably removed upon the granting of the
`patent.
`
`This deposit is identified by: Deposit number CMIM
`B–1628, CMIM B–1641, CMIM B–1649, CMIM
`B–1684.
`
`Name and address of the depository: Central Museum
`of
`Industrial Microorganisms of
`the All–Union
`Research Institute of Genetics and Selection of
`Industrial Microorganisms, USSR, Moscow 113545,
`Dorozhnaya S.
`
`*7 Taxonomic description (if available): Escherichia
`coli K–12.
`
`(PX 2 at 126) The donor strain (MG442) was
`registered as CMIM B–1628;
`the recipient
`strain
`(VL334) was registered as CMIM B–1641; the product
`of claim 3 (VL334(pYN6)) was registered as CMIM
`B–1649; and the product of claim 4 (VL334(pYN7))
`was registered as CMIM B–1684. (PX 2 at 126) The
`filing of
`the Supplemental Declaration of 1980
`overcame the Examiner's § 112 rejection of the claims
`by representing that the strains had been deposited.
`
`21. The Inventors' Signatures. The Supplemental
`Declaration of 1980 contains fourteen signatures, all
`dated July 17, 1980, that purport to be the signatures of
`the fourteen original
`inventors.
`(PX 2 at 127–29)
`However, Dr. Kozlov testified that the Kozlov signature
`is not his own, and that he was unaware of who signed.
`(DX 1106 at 146–47) Nevertheless, Kozlov testified
`that he knew of and authorized the signing of his name
`to the Supplemental Declaration of 1980 but that he was
`unsure of the date of the signing. (DX 1106 at 146–47)
`The Kozlov signature on the Supplemental Declaration
`is consistent in appearance with the Kozlov signature on
`the Russian Language Declaration. (D.I. 314 at 1256,
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`

`

`Not Reported in F.Supp., 1998 WL 151411 (D.Del.)
`(Cite as: 1998 WL 151411 (D.Del.))
`
`1258–59; DX 149; DX 390; DX 1106 at 1104) Dr.
`Kozlov further testified that he did not remember if he
`read the Supplemental Declaration of 1980 or if it was
`explained to him before he authorized someone to sign
`for him. (DX 1106 at 145–46)
`
`Dr. Debabov testified that he personally signed the
`Supplemental Declaration of 1980 but that someone else
`wrote the date next to his signature. (DX 1100 at 44–45)
`Dr. Debabov further testified that he did not read the
`Supplemental Declaration of 1980 because it was
`explained to him by someone in the patent department.
`(DX 1100 at 115–17)
`
`22. The PTO Examiner subsequently issued a
`Notice of Allowance (PX 2 at 133) and the '765 patent
`issued on July 14, 1981.
`
`23. In order to rectify the signature discrepancies,
`on August 5, 1996, Ajinomoto filed with the PTO a
`Supplemental Declaration (“Supplemental Declaration
`of 1996”) that contains the true signatures, according to
`counsel for Genetika, Mr. Mtibelishvili, of the fourteen
`inventors along with a petition to the Commissioner of
`Patents and Trademarks pursuant to 37 C.F.R. §§ 1.67
`and
`1.182
`requesting
`that
`the PTO place
`the
`Supplemental Declaration of 1996 in the file wrapper.
`(PX 900) Ajinomoto claimed that the filing containing
`the authorized signatures “was the result of a lack of
`knowledge of the technical requirements of U.S. patent
`law and was made without any deceptive intent.” (PX
`900)
`
`expert witness, Mr. Lyndal L.
`24. ADM'
`Shaneyfelt, a retired FBI document examiner, compared
`the fourteen signatures on the Russian Language
`Declaration
`to
`the
`fourteen
`signatures
`on
`the
`Supplemental Declaration of 1980 and found that six
`(and possibly seven) of the signatures were not written
`by the same person. (D.I. 314 at 1247) However, Mr.
`Shaneyfelt conceded that the signatures were difficult to
`compare
`since
`those
`on
`the Russian Language
`Declaration were written using the Russian alphabet,
`whereas those on the Supplemental Declaration of 1980
`were written using the Arabic alphabet. (D.I. 314 at
`1246) Mr. Shaneyfelt also testified that a comparison of
`
`Page 8
`
`the English signatures on the Supplemental Declaration
`of 1980 revealed numerous significant writing features
`in common. (D .I. 314 at 1248–50) He concluded that
`the at least three, and possibly five, of the signatures
`were written by the person who made the Debabov
`signature. (D.I. 314 at 1252) However, he found the
`examination problematic because there were not “a lot
`of the same letters.” (D.I. 314 at 1251)
`
`*8 Mr. Shaneyfelt also testified that the Kozlov
`signature on the Russian Language Declaration (DX
`390) was “generally consistent” with the exemplar (DX
`149) that was done at Dr. Kozlov's deposition in the
`summer of 1996. (D.I. 314 at 1258) In addition, Mr.
`Shaneyfelt testified that, after comparing the Kozlov
`signatures on the Russian Language Declaration and the
`Supplemental Declaration of 1980 with the Kozlov
`signature on the Supplemental Declaration of 1996, he
`was “not able to make [a] determination” that
`the
`Kozlov signature was or was not Mr. Kozlov's personal
`signature
`because
`there
`were
`“too
`many
`inconsistencies.” (D.I. 314 at 1258)
`
`According to Mr. Van Horn, if a foreign company
`owns the patent application,
`it
`is appropriate for a
`representative of the company to sign the declaration as
`representative of the owner of the application if he has
`authority and that authority is clearly indicated. (D.I.
`316 at 1454) Thus, there is no requirement that the
`inventors personally sign the declaration. (D.I. 316 at
`1454)
`
`C. The '765 Patent
`25. The abstract described the invention claimed in
`the '765 patent as follows:
`
`A method for constructing strains which produce
`aminoacids [sic] comprising combining of a DNA
`chromosome fragment of a donor microorganism
`containing genes controlling the synthesis of a
`selected aminoacid and having a mutation destroying
`the negative regulation of
`the synthesis of
`this
`aminoacid with a vecto