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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`ENZO LIFE SCIENCES, INC.
`
`Plaintiff,
`
`v.
`
`ABBOTT LABORATORIES, and
`
`ABBOTT MOLECULAR INC.,
`
`Defendants.
`
`Civil Action No. 12—274—LPS
`
`JURY TRIAL DEMANDED
`
`ENZO’S ANSWER TO ABBOTT’S COUNTERCLAIMS
`
`Plaintiff Enzo Life Sciences, Inc. (“Enzo”) answers Abbott Laboratories and Abbott
`
`Molecular, Inc.’s (“Abbott’s”) Counterclaims as follows:
`
`Parties
`
`32. On information and belief, Enzo admits the allegations in Paragraph 32 of the
`
`Counterclaims.
`
`33. On information and belief, Enzo admits the allegations in Paragraph 33 of the
`
`Counterclaims.
`
`34. Enzo admits the allegations in Paragraph 34 of the Counterclaims.
`
`Jurisdiction and Venue
`
`35. Enzo admits that Abbott purports to set forth claims that arise under 28 U.S.C. §§ 2201
`
`and 2202 and to seek declaratory relief and further relief based upon a declaratory judgment or
`
`decree. Enzo admits that Abbott states that it is seeking a judicial declaration as to non-
`
`infringement, invalidity, and unenforceability of U.S. Patent No, 6,992,180 (“the ’ 1 80 patent”).
`
`Enzo further admits that this Court has original jurisdiction over all counterclaims under 28
`
`

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`U.S.C. §§ 1331, l338(a), and 1367. Enzo denies all remaining or different allegations in
`
`Paragraph 35 of the Counterclaims.
`
`36. Enzo admits the allegations in Paragraph 36 of the Counterclaims.
`
`Prosecution of the ’180 patent
`
`37. Enzo admits that the ’180 patent contains claims that generally relate, among other
`
`things, to oligo- or polynucleotides comprising at least one modified nucleotide or modified
`
`nucleotide analog having the formula Sig-PM-SM-BASE wherein PM is a phosphate moiety and
`
`Sig is directly or indirectly attached to the PM. Enzo denies all remaining or different
`
`allegations in Paragraph 37 of the Counterclaims.
`
`38. Enzo admits that the ’ 180 patent contains claims generally relating to oligonucleotide and
`
`polynucleotide compositions, and that the scope of the claims is defined by the claims
`
`themselves. Enzo denies all remaining or different allegations in Paragraph 38 of the
`
`Counterclaims.
`
`39. Enzo admits that in an Amendment Under 37 C.F.R. § 1.116, dated July 14, 1987,
`
`applicants stated:
`
`Applicants have determined that the examples set forth at pages 55-81, except
`Examples 1, 21, 22, 23, 30, 31, 40, are “Paper”, rather than “working examples”
`(Manual of Patent Examining Procedure § 608.01 (q)) and may,
`therefore, be
`incorrectly represented by use of the past tense. By this Amendment, applicants call
`this inadvertent misstatement to the attention of the Examiner, and eventually to the
`public should this application issue as a patent.
`
`U.S. Patent Application No. 06/674,242 (“the ’352 Application”), Amendment under 37 C.F.R. §
`
`1.116, dated July 14, 1987, at 5. Enzo denies all remaining or different allegations in Paragraph
`
`39 of the Counterclaims.
`
`40. Enzo admits that in an Amendment under 37 C.F.R. § 1.116, dated July 14, 1987,
`
`applicants requested that the Patent Office amend the specification as follows:
`
`

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`line 2, after “invention”, delete “z” and substitute thererfor (sic) ——.
`Page 55,
`Examples 2-20, 24-29 and 32-39, although expressed in the past tense hereinafter,
`were not in fact actually carried out. Thus, those examples are [prophetic], not actual,
`examples.
`
`’352 Application, Amendment under 37 C.F.R. § 1.116, dated July 14, 1987, at 1. Enzo
`
`denies all remaining or different allegations in Paragraph 40 of the Counterclaims.
`
`41. Enzo admits that in an Amendment under 37 C.F.R. § 1.116, dated July 14, 1987,
`
`applicants stated:
`
`Applicants have determined that the examples set forth at pages 55-81, except
`Examples 1, 21, 22, 23, 30, 31, 40, are “Paper”, rather than “working examples”
`(Manual of Patent Examining Procedure § 608.01(q)) and may,
`therefore, be
`incorrectly represented by use of the past tense. By this Amendment, applicants call
`this inadvertent misstatement to the attention of the Examiner, and eventually to the
`public should this application issue as a patent. Although, applicants do not believe
`that the Examiner has relied on the tense of the examples in her examination of this
`application, they specifically request that the Examiner reconsider this application in
`view of their disclosure of these paper examples. E Robin & Haas Co. v. Crystal
`Chemical C0,, 722 F.2d 1556, 1572 (Fed.Cir. 1983).
`
`’352 Application, Amendment under 37 C.F.R. § 1.116, dated July 14, 1987, at 5. Enzo denies
`
`all remaining or different allegations in Paragraph 41 of the Counterclaims.
`
`42. Enzo admits that Application No. 08/479,997 (“the ’997 application”) was filed on June
`
`7, 1995. Enzo further admits that Ronald C. Fedus was an attorney of record. Enzo also admits
`
`that Dean Engelhardt is listed as a co-inventor of the ’180 patent. Enzo denies all remaining or
`
`different allegations in Paragraph 42 of the Counterclaims.
`
`43. Enzo admits that the ’352 application is a parent application to the ’997 application.
`
`Enzo also admits that the ’ 180 patent states on its face that the ’997 application is a continuation
`
`of Application No. 08/046,004, filed on April 9, 1993, which is a continuation of Application
`
`No. 07/532,461 filed on May 31, 1990, which is a division of Application No. 07/140,980 filed
`
`on January 1, 1988, which is a continuation of the ’352 application, which is a continuation of
`
`

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`Application No. 06/391 ,440 filed June 23, 1982. Enzo lacks knowledge or information sufficient
`
`to form a belief as to the truth of the remaining or different allegations relating to Ronald C.
`
`Fedus and Dean Engelhardt in Paragraph 43 of the Counterclaims, and therefore denies the same.
`
`Enzo denies all remaining or different allegations in Paragraph 43 of the Counterclaims.
`
`44. Enzo admits the allegations in Paragraph 44 of the Counterclaims.
`
`45. Enzo admits that Dean Engelhardt (“Engelhardt”) signed an inventor declaration under
`
`37 C.F.R. 1.63 during prosecution of the applications that eventually issued as the ’ 180 patent.
`
`Enzo lacks knowledge or information sufficient to form a belief as to the truth of the remaining
`
`or different allegations relating to Engelhardt in Paragraph 45 of the Counterclaims, and
`
`therefore denies the same. Enzo denies all remaining or different allegations in Paragraph 45 of
`
`the Counterclaims.
`
`46. Enzo admits that during the prosecution of the ’997 application, Enzo added new claims
`
`relating generally to oligo- or polynucleotides comprising at least one nucleotide having the
`
`formula “Sig-PM-SM-BASE,” wherein Sig is directly or indirectly attached to a Phosphate
`
`Moiety (PM). Enzo also admits that on September 18, 1995, Enzo amended the application to
`
`seek patentability of the following claim:
`
`
`
`3“ 1' 6 mar moiety an-1 wise as 3
`PM b9l“9 attached to the 3' or
`ah nucleotide is a
`909150“ when said nudealidc 5.;
`'
`_'‘““'‘° W the 1' Dosilion. oz SM tram the N1
`'°'”" 9' MN’ 90530011 when BASE is a
`859 is CL alently ajiached 10 PM gtiraclly or
`95""’fi""”l“ 471059’? when attached
`\
`
`
`
`Position when BASE is a py
`purine or ‘J’-deazapurine, an
`
`

`
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`’997 application, Second Preliminary Amendment dated Sept. 18, 1995, at 4. Enzo denies all
`
`remaining or different allegations in Paragraph 46 of the Counterclaims.
`
`47. Enzo admits that in a Final Office Action dated May 13, 1997, the Patent Office rejected
`
`Claims 207-224, 227-262, 265, and 267 alleging inter alia that “the specification, as originally
`
`filed, does not provide support for the invention as is now claimed.” Enzo further admits that in
`
`a Final Office Action dated September 29, 1998, the Patent Office rejected Claims 310-372 and
`
`405-453 under 35 U.S.C. § 112, first paragraph. Enzo denies all remaining or different
`
`allegations in Paragraph 47 of the Counterclaims.
`
`48. Enzo admits that during prosecution of the ’180 patent, Enzo Biochem, Inc. filed a
`
`November 24, 1997 Declaration by Dean L. Engelhardt. Enzo also admits that Dr. En gelhardt is
`
`a listed co—inventor for the ’180 patent and, at the time the November 24, 1997 Declaration was
`
`filed, was a Senior Vice President of Enzo Biochem, Inc. Enzo denies all remaining or different
`
`allegations in Paragraph 48 of the Counterclaims.
`
`49. Enzo admits the allegations in Paragraph 49 of the Counterclaims.
`
`50. Enzo admits that the November 24, 1997 Engelhardt Declaration states:
`
`In all, there are no fewer than nine (9) instances where the Sig moiety component
`is described in the specification as being attached to the phosphate moiety P, the
`sugar moiety S and/or the base moiety B! These nine separate and distinct
`instances include the following:”
`
`’997 Application, Declaration of Dr. Dean L. Engelhardt in Support of Adequate Description and
`
`Enablement, dated Nov. 24, 1997, at 10, 1] 9(B). Enzo denies all remaining or different
`
`allegations in Paragraph 50 of the Counterclaims.
`
`51. Enzo admits that Paragraph 9B of the November 24, 1997 Engelhardt Declaration lists
`
`nine instances where the Sig moiety component is described in the ’ 180 patent specification as
`
`

`
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`being attached to the phosphate moiety. Enzo denies all remaining or different allegations in
`
`Paragraph 51 of the Counterclaims.
`
`52. Enzo admits that the November 24, 1997 Engelhardt Declaration states, in part:
`
`In addition to those portions in the specification cited above, Example V
`C.
`describes a method for attaching biotin, one of the embodiments for Sig,
`to the
`phosphate moiety of a mononucleotide and an oligonucleotide that are coupled to a
`protein, poly-L-lysine. Using the procedure in Example V in the specification .
`.
`. the
`biotinylated poly-L-lysine is coupled to a terminal oxygen of the phosphate moiety or
`to a terminal phosphorus. These reaction schemes are set forth in Figure 1 on page
`374 in Halloran and Parker, J. Immunol., 962373 (1966) cited in Example V, page 57
`in the specification (a copy of Halloran’s publication also having been attached hereto
`as Exhibit 1).
`
`Id., 1] 9(C). Enzo further admits that in the Remarks, in the Amendment under 37 C.F.R. §1.116
`
`in Response to the June 25, 1997 Office Action, applicants stated:
`
`According to Dr. Engelhardt, using the procedure in Example V in the
`specification (page 57), the biotinylated poly-L-lysine is coupled to a terminal
`oxygen of the phosphate moiety or to a terminal phosphorus.
`
`Enzo denies all remaining or different allegations in Paragraph 52 of the Counterclaims.
`
`53. Enzo admits that the Amendment under 37 C.F.R. §1.116 in Response to the June 25,
`
`1997 Office Action and the November 24, 1997 Engelhardt Declaration did not cite the
`
`Amendment under 37 C.F.R. § 1.116, dated July 14, 1987. Enzo denies all remaining or
`
`different allegations in Paragraph 53 of the Counterclaims.
`
`54. Enzo admits that on November 20, 1998, applicants added new claims generally relating
`
`to oligo- or polynucleotides comprising at least one modified nucleotide or modified nucleotide
`
`analog having the formula Sig—PM—SM-BASE wherein PM is a phosphate moiety and Sig is
`
`directly or indirectly attached to the PM. Enzo also admits that these new claims included the
`
`following claim:
`
`

`
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`
`
`wheratn M is annasnhm rv-mm-. M is a sugar moiety and BA§ is 1: moiety
`wamd from the group consisting or
`vvrisniaim. a purine and a deazapurine. 9:
`anaioo thereof. are an Minn macneu
`SM, said arise being snowed in spa,
`
`1:
`
`c1'n,- omia e cbomica! linkage, aaiu sfig
`and sly balng covalently attached to PM ll!
`591“! I “WEN Cflflflifi O’ non-radlnacave dc!
`'III|‘J?\ when flttmfiacd (9 PM 01 lung“
`said nucleotide In Incorporated into said any; air
`:Jyrr:nnr\rr=:aot1-Jckrot-tsat.
`._
`
`’997 application, Amendment under 37 C.F.R. § 1.116 dated Nov. 20, 1998, at 2. Enzo denies
`
`all remaining or different allegations in Paragraph 54 of the Counterclaims.
`
`55. Enzo admits that in Office Actions dated February 3, 1999 and July 18, 2000, the Patent
`
`Office rejected Enzo’s claims 454-575 under 35 U.S.C. § 112, first paragraph. Enzo also admits
`
`that in the Office Action dated February 3, 1999, the Patent Office rejected claims 454-5 75 and
`
`stated that “subject matter which was not described in the specification in such a way as to
`
`reasonably convey to one skilled in the relevant art that the inventor(s), at the time the
`
`application was filed, had possession of the claimed invention for reasons of record.” ’997
`
`application, Office Action dated February 3, 1999 at 2. Enzo denies all remaining or different
`
`allegations in Paragraph 55 of the Counterclaims.
`
`56. Enzo admits that Enzo Diagnostics, Inc. c/o Enzo Biochem, Inc. filed an Appeal Brief on
`
`August 20, 2001 that, in part, stated:
`
`

`
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`The original disclosure provides for Sig to be attached directfy or indirectly to the
`
`phosphate moiety PM nucleotide. This unrebutted fact has been made abundantly clear
`
`in the record. (See Amendmonl~— January 18, 2001. at 23-31; Agns Dectaration 1121-
`
`26.) Attachment of Sig to the oxygen atom of PM is set forth in the descnption of the
`
`invention, white attachment of Sig to the phosphate atom of ?M is set forth in Example
`
`v of the invention. (lat; see also Specification 31:57.) Specifically in Example V. both
`
`biotin and potybiotinylated po1y~i.-lysine were coupled to oligodeoxyribonucleotides
`
`using a carbodilrnide coupling procedure described in Hallo:-an and Parker‘ The Office
`
`even admits that ‘Hallmark discloses the attachment of a specific signal moiety. a
`
`protein. to the phosphorus atom at the phosphate moiety using a specific linker. a -C-
`
`{CH;).«N- chain.‘ (Fina! Otfioe Action «— July 18, 2000 313.) Further. attachment of Sig
`
`to various positions on the sugar moiety via a phosphate linkage have been described
`
`previousty in the prosecution. (399, 9,9. Amendment — January '18. 2001, at 2331;
`
`Agris Declaration 11 21-26.}
`
`It is important to take into consideration that Example V must be read in
`
`conjunction with Examples lvtll. which support the preparation of Exarnplev. Exarnpte I
`
`oemonstrates the preparation of the activated ester of biotin. Example It supports the
`
`preparation of the amide form or biotin. Finally. Example m supports the preparation of
`
`polybiotinytated poly-L-lysine. All of these compounds were used in Example V. as
`
`shown in the following figure,
`
`Relationship a1£xarnpIas I-III to Example V
`Pagu 55-57
`
`gm”;
`1
`§g_gg_gg,_1;[
`
`mpamuoa amcuvated Ester of Biotirt
`tatotinyt-N-ttydmxysocdnimide eslsr (BNHSJ
`{Preparation of Potyoiotinyiated poly-L-lysine)
`
`E_5_a_mp,'g_}[
`
`(couprnq afPolyblotlr\yta1oo polyyl.-lysine lo Ollnorrbomdc-woes
`
`fixarnpgg V
`
`(Coupling of Biotin to Oligoribonucleotnoosj
`
`Exam
`
`ll
`
`{Prspartion 0! Amino Form or Biotin)
`(filotlnyl-tfittizarrvirsohoxana amide)
`
`’997 application, Appeal Brief dated Aug. 20, 2001, at 15-16. Enzo denies all remaining or
`
`different allegations in Paragraph 56 of the Counterclaims.
`
`

`
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`57. Enzo admits that the August 20, 2001 Appeal Brief did not cite the Amendment under 37
`
`C.F.R. § 1.1 16, dated July 14, 1987. Enzo denies all remaining or different allegations in
`
`Paragraph 57 of the Counterclaims.
`
`58. Enzo admits that in an Office Action dated November 26, 2001, the Patent Office stated:
`
`3'
`
`I" "5°"’°m’¢ “P939 5565 W85 359-0501, and newly found rejections summarm,-4 hcrcim
`
`PROSECUTION ls HEREBY REOPENED. New grounds ofrcjeciion art; 8:! forth below. To
`
`avoid nbannlumncni nffiae application, appellant must exercise one ofthe fflllowing two options;
`1} fl"-’ 3 "PIX find‘?! 37 cm L11 31 01' 2) itclllcst xeinstatement ofthe appeal
`if winstatemeszt of
`
`the appeal is requested. such rcqucst must be accompanied by a supplemental appm] brief 1,”,
`
`’'° “W ”“‘°‘"""°"‘§- “flid3Vi13(37 CFR 130, 1 131. or 1.132) or other evidence are permitted,
`Sec 37 cm L93 an (2).
`
`’997 application, Office Action dated Nov. 26, 2001. Enzo lacks knowledge or information
`
`sufficient to form a belief as to the truth of the remaining or different allegations in Paragraph 58
`
`of the Counterclaims, and therefore denies the same. Enzo denies all remaining or different
`
`allegations in Paragraph 58 of the Counterclaims.
`
`59. Enzo lacks knowledge or information sufficient to form a belief as to the truth of the
`
`remaining or different allegations in Paragraph 59 of the Counterclaims, and therefore denies the
`
`same.
`
`60. Enzo admits that The Patent Office also withdrew its objections and rejections based on
`
`failure to demonstrate possession of a Signaling Moiety (Sig) attached to a Phosphate Moiety
`
`(PM) as required by 35 U.S.C. § 112, first paragraph.
`
`’997 application, Non-Final Rejection
`
`filed November 26, 2001. Enzo further admits that the Patent Office cited Halloran et al. (J. of
`
`Immun. (1966)) in its November 26, 2001 Non-Final Rejection. Enzo denies all remaining or
`
`different allegations in Paragraph 60 of the Counterclaims.
`
`

`
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`61. Enzo admits that in a May 28, 2002 Reply Under 37 C.F.R. § 1.1 1 l(in Reponse to the
`
`November 26, 2001 Office Action), Enzo entered new claims 576-825. Enzo denies all
`
`remaining or different allegations in Paragraph 61 of the Counterclaims.
`
`62. Enzo denies all allegations in Paragraph 62 of the Counterclaims.
`
`63. Enzo denies all allegations in Paragraph 63 of the Counterclaims.
`
`64. Enzo denies all allegations in Paragraph 64 of the Counterclaims.
`
`MATERIALITY AND INTENT
`
`65. Enzo denies all allegations in Paragraph 65 of the Counterclaims.
`
`66. Enzo denies all allegations in Paragraph 66 of the Counterclaims.
`
`67. Enzo denies all allegations in Paragraph 67 of the Counterclaims.
`
`68. Enzo admits that the ’180 patent contains claims generally relating to oligonucleotide and
`
`polynucleotide compositions, and that the scope of the claims is defined by the claims
`
`themselves. Enzo denies all remaining or different allegations in Paragraph 68 of the
`
`Counterclaims.
`
`69. Enzo denies all allegations in Paragraph 69 of the Counterclaims.
`
`70. Enzo admits that it did not directly cite the Amendment under 37 C.F.R. § 1.116, dated
`
`July 14, 1987, during prosecution ofU.S. Patent Application No. 08/479,997. Enzo denies all
`
`remaining or different allegations in Paragraph 70 of the Counterclaims.
`
`71. Enzo denies all allegations in Paragraph 71 of the Counterclaims.
`
`72. Enzo denies all allegations in Paragraph 72 of the Counterclaims.
`
`73. Enzo admits that individuals who participated in the prosecution of the ’ l 80 patent,
`
`including Ronald C. Fedus and Dean Engelhardt, were aware that they owed a duty of candor to
`
`

`
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`the U.S. Patent Office. Enzo denies all remaining or different allegations in Paragraph 73 of the
`
`Counterclaims.
`
`74. Enzo denies all allegations in Paragraph 74 of the Counterclaims.
`
`75. Enzo denies all allegations in Paragraph 75 of the Counterclaims.
`
`76. Enzo denies all allegations in Paragraph 76 of the Counterclaims.
`
`Declaration of Noninfringement of the ’180 Patent
`
`COUNT 1
`
`77. In response to Paragraph 77 of the Counterclaims, Enzo incorporates by reference the
`
`Answers set forth in Paragraphs 32-76 above as if fully set forth herein.
`
`78. Enzo admits that the Complaint in this action alleges that Abbott, alone or in conjunction
`
`with others, has infringed and continues to infringe, either literally or under the doctrine of
`
`equivalents, at least U.S. Patent No. 6,992,180 (“the ’180 patent”). Enzo denies all remaining or
`
`different allegations in Paragraph 78 of the Counterclaims.
`
`79. Enzo denies all allegations in Paragraph 79 of the Counterclaims.
`
`80. Enzo denies all allegations in Paragraph 80 of the Counterclaims.
`
`COUNT 2
`
`Declaration of Invaliditv of the ’180 Patent
`
`81.
`
`In response to Paragraph 81 of the Counterclaims, Enzo incorporates by reference
`
`the Answers set forth in Paragraphs 32-80 above as if fully set forth herein.
`
`82. Enzo denies all allegations in Paragraph 82 of the Counterclaims.
`
`83. Enzo denies all allegations in Paragraph 83 of the Counterclaims.
`
`84. Enzo denies all allegations in Paragraph 84 of the Counterclaims.
`
`

`
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`COUNT 3
`
`Declaration of Unenforceability
`
`85. In response to Paragraph 85 of the Counterclaims, Enzo restates and incorporates by
`
`reference each of the Answers set forth in Paragraphs 32-84 of this Answer.
`
`86. Enzo denies all allegations in Paragraph 86 of the Counterclaims.
`
`87. Enzo denies all allegations in Paragraph 87 of the Counterclaims.
`
`88. Enzo denies all allegations in Paragraph 88 of the Counterclaims.
`
`PRAYER FOR RELIEF
`
`Enzo denies that Abbott is entitled to any relief, either as prayed for in its Counterclaims
`
`or otherwise. Enzo further denies each allegation contained in Abbott’s Counterclaims that was
`
`not specifically admitted, denied, or otherwise responded to herein. Enzo respectfully requests
`
`that the Court enter judgment in its favor and against Abbott on the Counterclaims, declare this
`
`case exceptional under 35 U.S.C. § 285, award Enzo its attorneys’ fees, costs, and expenses, and
`
`grant Enzo such further relief as the Court deems just and proper.
`
`DEMAND FOR JURY TRIAL ON COUNTERCLAIMS
`
`Enzo demands trial by jury on all issues so triable.
`
`Respectfully submitted,
`
`Dated: August 30, 2012
`
`FARNAN LLP
`
`/s/ Brian E. Fa/"nan
`
`Brian E. Farnan (Bar No. 4089)
`Michael J. Farnan (Bar No. 5165)
`919 North Market Street
`
`12"‘ Floor
`
`Wilmington, DE 19801
`(302) 777-0336
`(302) 777-0301
`bfarnan@farnan1aw.com
`
`

`
`Case 1:12-cv-00274-LPS Document 13 Filed 08/30/12 Page 13 of 13 PageID #: 247
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`Of Counsel:
`John M. Desmarais (admitted pro hace vice)
`Michael P. Stadnick (admitted pro hac vice)
`Xiao Li (admitted pro hac vice)
`Joseph C. Akalski (admitted pro hac vice)
`Lauren M. Nowierski (admitted pro hac
`vice)
`DESMARAIS LLP
`
`230 Park Avenue
`
`New York, NY 10169
`(212) 351-3400 (Tel)
`(212)351-3401 (Fax)
`jdesmarais@desmarais11p.com
`mstadnick@desmaraisllp.com
`xli@desmaraisllp.c0m
`jaka1ski@desmaraisl1p.com
`1nowierski@desmarais11p.com
`
`Counselfor Plaintiff