Not Reported in F.Supp., 1998 WL 151411 (D.Del.)
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`
`Page 1
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`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 de-
`fendant Archer–Daniels–Midland Co.
`(“ADM”) on
`April 6, 1995 seeking damages (lost royalty income)
`and
`an
`injunction
`against
`defendant
`Arch-
`er–Daniels–Midland (“ADM”) for alleged infringement
`of a patent that is directed to a method for the prepara-
`tion of bacterial strains possessing enhanced capability
`of producing amino acids.
`
`Specifically, Ajinomoto charges that ADM will-
`fully infringed claims 1 and 2 of U.S. Patent No.
`4,278,765 (“the '765 patent”) entitled “Method for Pre-
`paring Bacterial Strains Which Produce Amino Acids”
`issued on July 14, 1981. The priority patent to this pat-
`
`ent 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 con-
`templated by the inventors of carrying out their inven-
`tion, (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 or-
`dinary skill in the pertinent art (§ 103); and (3) not all
`of the inventors personally signed the declarations re-
`quired to grant the '765 patent (§§ 115, 116). Addition-
`ally, 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 in-
`ventors to Ajinomoto was not established. Moreover,
`ADM affirmatively defends that the '765 patent is inval-
`id because the patent applicants conducted themselves
`inequitably in their prosecution of the patent application
`by withholding and concealing prior art and by conceal-
`ing 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 Octo-
`ber 28, 1996 through November 11, 1996. The follow-
`ing constitutes the court's findings of fact and conclu-
`sions 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
`method for the construction of genetically engineered
`
`© 2014 Thomson Reuters. No Claim to Orig. US Gov. Works.
`
`AVS EXHIBIT 2029
`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.))
`
`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, aspar-
`agine, glutamine, cysteine, serine, threonine, tyrosine,
`aspartic acid, glutamic acid, lysine, arginine, and histid-
`ine.
`
`*2 2. The '765 patent specifically discloses a meth-
`od 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 pro-
`duced 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 particu-
`lar 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 as-
`partyl phosphate into aspartate semialdehyde. (D.I. 313
`at 940–43; DX 298 at 346; DX 1005) The third step in-
`volves 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-
`phospho homoserine. (D.I. 313 at 940–43; DX 298 at
`346; DX 1005) And finally, in step 5, O-phospho ho-
`
`Page 2
`
`(D.I. 313 at
`moserine is converted into threonine.
`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 ho-
`moserine, 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 en-
`zyme—aspartokinase for thrA 1 and homoserine dehyd-
`rogenase for thrA 2—which catalyze steps 1 and 3, re-
`spectively. (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)
`
`FN1. The biosynthetic pathway for the produc-
`tion 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 Corynebac-
`teria although the thrA and asd genes are to-
`gether on one part of the bacterial chromo-
`some, 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 isoen-
`zymes, 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 in cata-
`lytic properties, but can be distinguished based
`on variations in physical properties.
`
`© 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.))
`
`FN3. The term operon is defined as “[a] unit of
`genetic expression consisting of one or more
`related genes and the operator and promotor se-
`quences that regulate their transcription.” Al-
`bert 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)
`6. The product of the asd gene,FN4 which is loc-
`ated 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.
`
`testi-
`FN4. Although Ajinomoto asserts that
`mony 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 inhibi-
`tion effect that changes the activity of the level of the
`available enzyme, isoleucine and threonine also affect
`the level of available enzyme—as the levels of isoleu-
`cine and threonine increase, the amount of enzyme de-
`creases. (D.I. 313 at 940–43)
`
`Page 3
`
`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 Micro-
`biology (“Genetika”) in the former Soviet Union. (D.I.
`307 at 123–24) In developing the process, the research-
`ers combined skills from both classical genetics and re-
`combinant 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 Stan-
`ford University and the University of Califor-
`nia, San Francisco respectively developed re-
`combinant 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 typic-
`ally 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) Us-
`ing recombinant DNA technology,FN6 the researchers
`isolated the threonine operon from the strain and com-
`bined 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 auxo-
`trophic FN8 with respect to threonine and contained a
`
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`
`

`
`Not Reported in F.Supp., 1998 WL 151411 (D.Del.)
`(Cite as: 1998 WL 151411 (D.Del.))
`
`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 bac-
`teria was capable of the over production of threonine.
`
`FN6. For basic background information about
`molecular biology and recombinant DNA tech-
`nology, see In re O'Farrell, 853 F.2d 894,
`895–99 (Fed.Cir.1988).
`
`FN7. The term plasmid refers to “[a]n extra-
`chromosomal, independently replicating small
`circular DNA molecule.” Albert L. Lehninger,
`Principles of Biochemistry 977 (Sally Ander-
`son & June Fox eds., 1982).
`
`FN8. An auxotrophic bacterial strain possesses
`a mutation that renders it “defective in the syn-
`thesis of a given biomolecule, which must thus
`be supplied for its normal growth.” Principles
`of Biochemistry 970 (Sally Anderson & June
`Fox eds., 1982).
`
`B. The '765 Patent Application
`10. The Russian Patent Application. On June 30,
`1978, fourteen Genetika researchers FN9 filed a Russi-
`an 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,
`Mikhail N. Rozinov, Rustem S. Shakulov, Bor-
`is A. Rebentish, Vitaly A. Livshits, Mikhail M.
`Gusyatiner, Sergei V. Mashko, Vera N.
`Moshentseva, Ljudmila F. Kozyreva, and Raisa
`A. Arsatiants.
`
`Page 4
`
`*4 The Russian patent application listed sixteen ref-
`erences, 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-hy-
`droxynorvaline appearing in the publication Genetika
`14(6) (June 1978) (“Genetika II”) and (2) an article en-
`titled A Suitable Method for Construction and Molecu-
`lar 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 Ge-
`netics in 1977 (“the Kozlov article”).
`
`11. U.S. Patent Application. The same fourteen in-
`ventors who filed the Russian patent application filed
`the United States counterpart to the Russian patent ap-
`plication on June 28, 1979, two days before the end of
`the one year priority period.FN10 (PX 2) The 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 ap-
`plication: (1) a Russian Language Declaration for Ori-
`ginal Patent Application (“Russian Language Declara-
`tion”); (2) the original Russian patent application; and
`(3) an English translation of the Russian patent applica-
`tion. (PX 2)
`
`FN10. Title 35 U.S.C. § 119 provides a right of
`priority for U.S. patent applications if an ap-
`plication for a patent on the same invention
`was previously filed in a foreign country. Sec-
`tion 119 provides, in part:
`
`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
`
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`
`

`
`Not Reported in F.Supp., 1998 WL 151411 (D.Del.)
`(Cite as: 1998 WL 151411 (D.Del.))
`
`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 Lan-
`guage Declaration and the Russian patent application
`contain fourteen signatures purporting to be the signa-
`tures 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 testi-
`fied that the signature on the Russian Language Declar-
`ation is not his own; however, the signor, who he be-
`lieved to be an employee in Genetika's patent depart-
`ment, “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 declara-
`tion or whether it was explained to him before he gran-
`ted permission for someone to sign it for him. (DX 1106
`at 145–46)
`
`FN11. Only two of the original fourteen invent-
`ors 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 declara-
`tion, 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 ap-
`plication 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 in-
`
`Page 5
`
`troduction 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 Car-
`bon 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 accompan-
`ied by a copy of each listed patent or publication. 37
`C.F.R. § 1.98(a). A prior art statement was not submit-
`ted as part of the '765 patent application.
`
`According to ADM's expert in Patent and Trade-
`mark 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 test-
`ified 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 ex-
`amination 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 been considered: (1) cit-
`ing the documents in the patent application or (2) pla-
`cing his initials next to the citation with an indication
`that it had been checked. (D.I. 316 at 1423–24) The re-
`cord indicates that neither method was employed with
`respect to the '765 patent.
`
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`

`
`Not Reported in F.Supp., 1998 WL 151411 (D.Del.)
`(Cite as: 1998 WL 151411 (D.Del.))
`
`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 pro-
`cedure with respect to patent applications filed on be-
`half of Genetika was to check the application for com-
`pliance with PTO guidelines and to submit the applica-
`tion 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 know-
`ledge 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 ap-
`plication, the PTO Examiner rejected claims 1–4 as not
`enabled under 35 U.S.C. § 112. (PX 2 at 100) In an Of-
`fice 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 Microor-
`ganisms FN12 regarding the parent E. coli strains and
`the newly produced E. coli strains.FN13
`
`Page 6
`
`quired applicants to make “a deposit of a cul-
`ture of the microorganism in a depository af-
`fording 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 ir-
`revocably 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 In-
`stitute 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.
`
`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:
`
`(PX 2 at 100) The Examiner went on to state that
`“[t]he listed references [were] considered to be pertin-
`ent
`to the claimed invention, but
`the claims are
`deemed patentable thereover.” FN14
`
`Some inventions which are the subject of
`patent applications depend on the use of mi-
`croorganisms which must be described in the
`specification in accordance with 35 U.S.C.
`112. No problem exists when the microor-
`ganisms used are known and readily avail-
`able to the public. When the invention de-
`pends on the use of a microorganism which
`is not so known and readily available, applic-
`ants must
`take additional steps to comply
`with the requirements of Section 112.
`
`In the latter circumstances,
`
`the MPEP re-
`
`FN14. Two references were cited on Form
`PTP–892, Notice of References Cited: Sin-
`sheimer, Ann.Rev. Biochem 46, 415–438, 1977
`and Itokura et al., Science vol. 98, pp.
`1056–1063. (PX 2 at 101) A copy of the Sin-
`sheimer
`reference was included in the file
`wrapper. (PX 2 at 142–164)
`
`18. In May 1980, in response to the Examiner's re-
`jection,
`the one of the applicants' attorneys, Charles
`Rodman, agreed to “attempt to rectify depository defi-
`ciencies” by “furnishing a new declaration containing
`the required information.” (PX 2 at 103, 119) In addi-
`
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`

`
`Not Reported in F.Supp., 1998 WL 151411 (D.Del.)
`(Cite as: 1998 WL 151411 (D.Del.))
`
`tion, Mr. Rodman agreed to “amend [the] claims extens-
`ively 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, consist-
`ing 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 par-
`ent strains of VNIIGenetika MG442 and VNIIGenetika
`VL334 are also deposited in the aforesaid Central Mu-
`seum 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 con-
`taining 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 rel-
`evant thereto, a detailed discussion of them shall not ap-
`pear 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 At-
`torney (“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 ap-
`plication, [they had] made 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, under conditions which
`assure (a) that access to the culture will be available
`during pendency of the patent application to one de-
`termined 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
`
`Page 7
`
`B–1684.
`
`Name and address of the depository: Central Museum
`of Industrial Microorganisms of the All–Union Re-
`search Institute of Genetics and Selection of Industri-
`al Microorganisms, USSR, Moscow 113545, Dorozh-
`naya S.
`
`*7 Taxonomic description (if available): Escherichia
`coli K–12.
`
`(PX 2 at 126) The donor strain (MG442) was re-
`gistered 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 Sup-
`plemental 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,
`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 ex-
`plained to him by someone in the patent department.
`
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`
`

`
`Not Reported in F.Supp., 1998 WL 151411 (D.Del.)
`(Cite as: 1998 WL 151411 (D.Del.))
`
`(DX 1100 at 115–17)
`
`22. The PTO Examiner subsequently issued a No-
`tice of Allowance (PX 2 at 133) and the '765 patent is-
`sued 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 Supple-
`mental 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 know-
`ledge of the technical requirements of U.S. patent law
`and was made without any deceptive intent.” (PX 900)
`
`24. ADM' expert witness, Mr. Lyndal L. Shaney-
`felt, a retired FBI document examiner, compared the
`fourteen signatures on the Russian Language Declara-
`tion to the fourteen signatures on the Supplemental De-
`claration of 1980 and found that six (and possibly sev-
`en) of the signatures were not written by the same per-
`son. (D.I. 314 at 1247) However, Mr. Shaneyfelt con-
`ceded that the signatures were difficult to compare since
`those on the Russian Language Declaration were written
`using the Russian alphabet, whereas those on the Sup-
`plemental Declaration of 1980 were written using the
`Arabic alphabet. (D.I. 314 at 1246) Mr. Shaneyfelt also
`testified that a comparison of the English signatures on
`the Supplemental Declaration of 1980 revealed numer-
`ous significant writing features in common. (D .I. 314 at
`1248–50) He concluded that the at least three, and pos-
`sibly 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 be-
`cause there were not “a lot of the same letters.” (D.I.
`314 at 1251)
`
`*8 Mr. Shaneyfelt also testified that the Kozlov sig-
`nature 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
`
`Page 8
`
`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 Supplement-
`al 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 rep-
`resentative 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 in-
`ventors 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