Case 1:12-cv-00274-LPS Document 75 Filed 05/08/13 Page 1 of 41 PageID #: 904
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. 12-274-LPS
`
`JURY TRIAL DEMANDED
`
`))))))))))))))))
`
`ENZO LIFE SCIENCES, INC.,
`
`Plaintiff,
`
`v.
`
`ABBOTT LABORATORIES, and
`ABBOTT MOLECULAR INC.,
`
`Defendants,
`
`and
`
`LUMINEX CORPORATION,
`
`Intervening Defendant.
`
`ANSWER, DEFENSES, AND COUNTERCLAIMS
`TO PLAINTIFF’S SECOND AMENDED COMPLAINT
`
`Defendants Abbott Laboratories and Abbott Molecular Inc. answer the Second Amended
`
`Complaint for Patent Infringement of Plaintiff Enzo Life Sciences Inc. as follows. The
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`numbered paragraphs below correspond to the numbered paragraphs in the complaint:
`
`PARTIES
`
`Admitted, based on information and belief.
`
`Admitted.
`
`Admitted.
`
`NATURE OF THE ACTION
`
`This paragraph contains legal conclusions to which no response is required. To
`
`1.
`
`2.
`
`3.
`
`4.
`
`the extent a response is required, Abbott admits that Enzo’s complaint is purportedly for the
`
`alleged infringement of United States Patent Nos. 6,992,180 (“the ‘180 Patent”), 7,064,197 (“the
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`

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`Case 1:12-cv-00274-LPS Document 75 Filed 05/08/13 Page 2 of 41 PageID #: 905
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`‘197 Patent”), and 8,097,405 (“the ‘405 Patent”) under the Patent Laws of the United States, 35
`
`U.S.C. § 1 et seq. Abbott denies all other allegations of paragraph 4.
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`JURISDICTION AND VENUE
`
`5.
`
`This paragraph contains legal conclusions to which no response is required. To
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`the extent a response is required, Abbott admits this Court has subject matter jurisdiction over
`
`this action. Abbott denies the remaining allegations in paragraph 5.
`
`6.
`
`This paragraph contains legal conclusions to which no response is required. To
`
`the extent a response is required, Abbott does not contest personal jurisdiction in this Court for
`
`purposes of this action only. Abbott denies the remaining allegations in paragraph 6.
`
`7.
`
`This paragraph contains legal conclusions to which no response is required. To
`
`the extent a response is required, Abbott does not contest personal jurisdiction in this Court for
`
`purposes of this action only. Abbott denies the remaining allegations in paragraph 7.
`
`8.
`
`This paragraph contains legal conclusions to which no response is required. To
`
`the extent a response is required, Abbott does not contest that venue in this Court is proper for
`
`purposes of this action only.
`
`The Patent-In-Suit
`
`9.
`
`This paragraph contains legal conclusions to which no response is required. To
`
`the extent a response is required, Abbott admits the ‘180 patent
`
`is entitled “Oligo- Or
`
`Polynucleotides Comprising Phosphate-Moiety Labeled Nucleotides,” the issue date is January
`
`31, 2006, and that an uncertified copy of the ‘180 patent is attached as Exhibit A to Enzo’s
`
`Second Amended Complaint. Abbott denies that the ‘180 patent was duly or legally issued, and
`
`further denies any remaining allegations in paragraph 9.
`
`10.
`
`Abbott lacks knowledge or information sufficient to form a belief as to the truth
`
`of the allegations in paragraph 10, and therefore, denies the same.
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`2
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`

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`Case 1:12-cv-00274-LPS Document 75 Filed 05/08/13 Page 3 of 41 PageID #: 906
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`11.
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`This paragraph contains legal conclusions to which no response is required. To
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`the extent a response is required, Abbott admits the ‘197 patent is entitled “System, Array and
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`Non-Porous Solid Support Comprising Fixed or Immobilized Nucleic Acids,” the issue date is
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`January 31, 2006, and that an uncertified copy of the ‘197 patent is attached as Exhibit B to
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`Enzo’s Second Amended Complaint. Abbott denies that the ‘197 patent was duly or legally
`
`issued, and further denies any remaining allegations in paragraph 11.
`
`12.
`
`Abbott lacks knowledge or information sufficient to form a belief as to the truth
`
`of the allegations in paragraph 12, and therefore, denies the same.
`
`13.
`
`This paragraph contains legal conclusions to which no response is required. To
`
`the extent a response is required, Abbott admits that the ‘405 patent is entitled “Nucleic Acid
`
`Sequencing Processes Using Non-Radioactive Detectable Modified or Labeled Nucleotide
`
`Analogs, and Other Processes for Nucleic Acid Detection and Chromosomal Characterization
`
`Using Such Non- Radioactive Detectable Modified or Labeled Nucleotides or Nucleotide
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`Analogs,” that the issue date is January 17, 2012, and that an uncertified copy of the ‘405 patent
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`is attached as Exhibit C to Enzo’s Second Amended Complaint. Abbott denies that the ‘405
`
`patent was duly or legally issued, and further denies the remaining allegations in paragraph 13.
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`14.
`
`Abbott lacks knowledge or information sufficient to form a belief as to the truth
`
`of the allegations in paragraph 14, and therefore, denies the same.
`
`COUNT I
`
`Infringement Of The ‘180 Patent
`
`15.
`
`Abbott repeats and reasserts its responses to paragraphs 1-14 as if fully set forth
`
`herein.
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`16.
`
`Denied.
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`3
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`

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`Case 1:12-cv-00274-LPS Document 75 Filed 05/08/13 Page 4 of 41 PageID #: 907
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`17.
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`Abbott admits that in April 2007 it entered into a cross-license agreement with
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`Enzo that names the ‘180 patent. Abbott denies the remaining allegations of paragraph 17.
`
`18.
`
`19.
`
`20.
`
`21.
`
`Denied.
`
`Denied.
`
`Denied.
`
`Denied.
`
`COUNT II
`Infringement Of The ‘197 Patent
`
`22.
`
`Abbott repeats and reasserts its responses to paragraphs 1-21 as if fully set forth
`
`herein.
`
`23.
`
`24.
`
`Denied.
`
`Abbott admits that in April 2007 it entered into a cross-license agreement with
`
`Enzo that names the ‘197 patent. Abbott denies the remaining allegations of paragraph 24.
`
`25.
`
`26.
`
`27.
`
`28.
`
`Denied.
`
`Denied.
`
`Denied.
`
`Denied.
`
`COUNT III
`Infringement Of The ‘405 Patent
`
`29.
`
`Abbott repeats and reasserts its responses to paragraphs 1-28 as if fully set forth
`
`herein.
`
`30.
`
`Denied.
`
`4
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`

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`Case 1:12-cv-00274-LPS Document 75 Filed 05/08/13 Page 5 of 41 PageID #: 908
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`31.
`
`Abbott admits that it became aware on or about January 18, 2013 that Enzo
`
`planned to allege that Abbott infringes the ‘405 patent. Abbott denies the remaining allegations
`
`of paragraph 31.
`
`32.
`
`33.
`
`34.
`
`35.
`
`36.
`
`Denied.
`
`Denied.
`
`Denied.
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`DEFENSES
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`Abbott denies that Enzo is entitled to any relief against Abbott.
`
`Upon information and belief, Abbott asserts defenses to the complaint in the
`
`following paragraphs. By asserting such defenses, Abbott does not concede that it has the
`
`burden of proving the matters asserted.
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`First Defense
`
`37.
`
`Abbott has not infringed and is not infringing, directly, contributorily, or by
`
`inducement, any valid and enforceable claim of the ‘180 patent, the ‘197 patent, or the ‘405
`
`patent, either literally or under the doctrine of equivalents. Abbott is not liable in any respect for
`
`any alleged infringement of the ‘180 patent, the ‘197 patent, or the ‘405 patent by anyone else.
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`Second Defense
`
`38.
`
`Each of the claims of the ‘180 patent, the ‘197 patent, and the ‘405 patent is
`
`invalid for failing to comply with one or more of the requirements for patentability pursuant to
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`one or more provisions specified in 35 U.S.C. §§ 101, 102, 103, 112, and other judicially created
`
`bases for invalidity including obviousness-type double patenting.
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`5
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`

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`Third Defense
`
`39.
`
`Enzo’s allegations of infringement of the ‘180 and the ‘405 patents are barred
`
`because the ‘180 and ‘405 patents are unenforceable due to inequitable conduct. Abbott
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`incorporates herein paragraphs 61-101 and 124-149 below.
`
`Fourth Defense
`
`40.
`
`Enzo’s allegations of infringement of the ‘180 patent, the ‘197 patent, and the
`
`‘405 patent are barred because the ‘180 patent, the ‘197 patent, and the ‘405 patent are
`
`unenforceable due to prosecution laches.
`
`Fifth Defense
`
`41.
`
`Enzo’s claims with regard to the ‘405 patent are barred because Enzo has
`
`expressly and/or impliedly licensed Abbott under the ‘405 patent.
`
`Sixth Defense
`
`42.
`
`Enzo’s claims are barred, in whole or in part, by the doctrine of equitable
`
`estoppel.
`
`Seventh Defense
`Enzo’s claims are barred,
`in whole or in part, by the doctrines of waiver,
`
`43.
`
`acquiescence, unclean hands, and/or laches.
`
`Eighth Defense
`Enzo’s claims are barred, in whole or in part, by the doctrine of prosecution
`
`44.
`
`history estoppel.
`
`Ninth Defense
`
`45.
`
`Enzo’s claims are barred, in whole or in part, by the doctrine of patent misuse.
`
`Tenth Defense
`
`46.
`
`Enzo’s infringement claims and prayer for relief are limited by 35 U.S.C. § 287.
`
`6
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`

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`Eleventh Defense
`
`47.
`
`Enzo’s prayers for injunctive relief are barred in light of the availability of an
`
`adequate remedy at law, to the extent any remedy is justified. Enzo will not suffer any
`
`irreparable harm or injury if no injunction is issued.
`
`Twelfth Defense
`
`48.
`
`Abbott has not engaged in any conduct that would entitle Enzo to an award of
`
`enhanced damages.
`
`Thirteenth Defense
`
`49.
`
`Enzo’s complaint fails to state a claim for an exceptional case.
`
`Fourteenth Defense
`
`50.
`
`Enzo’s complaint fails to state a claim for willful infringement.
`
`Fifteenth Defense
`
`51.
`
`Enzo’s damages claims are contractually barred, in part or in whole, with respect
`
`to any alleged infringement occurring prior to January 1, 2008.
`
`Fifteenth Defense
`
`52.
`
`Enzo has sought and obtained a recovery for alleged infringement of the ‘405
`
`patent and therefore Enzo is barred from obtaining a second recovery in this action.
`
`Sixteenth Defense
`Each of the claims of the ‘197 patent is invalid, unenforceable, and void for
`
`53.
`
`failure to satisfy the requirements of 35 U.S.C. § 116.
`
`Seventeenth Defense
`
`54.
`
`All or part of Enzo’s claims for infringement are barred, in whole or in part, to the
`
`extent they allege acts of infringement barred by the statute of limitations.
`
`7
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`

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`Case 1:12-cv-00274-LPS Document 75 Filed 05/08/13 Page 8 of 41 PageID #: 911
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`Reservation of All Defenses
`
`55.
`
`Abbott reserves the right to offer any other and additional defenses that are now
`
`or may become available or appear during, or as a result of, discovery proceedings in this action.
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`COUNTERCLAIMS
`
`Defendants and Counterclaimants Abbott Laboratories and Abbott Molecular, Inc. assert
`
`the following counterclaims against Plaintiff and Counterclaim-Defendant Enzo Life Sciences:
`
`Parties
`
`56.
`
`Abbott Laboratories is an Illinois corporation with its principal place of business
`
`at 100 Abbott Park Road, Abbott Park, Illinois 60064.
`
`57.
`
`Abbott Molecular, Inc. is a Delaware corporation with its principal place of
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`business at 1300 E. Touhy Avenue, Des Plaines, IL 60018. Abbott Molecular, Inc. is a wholly
`
`owned subsidiary of Abbott Laboratories.
`
`58.
`
`On information and belief, and based upon the allegation of paragraph 1 of Enzo’s
`
`complaint, Enzo Life Sciences Inc. is a New York corporation with its principal place of
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`business at 10 Executive Boulevard, Farmingdale, NY 11735.
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`Jurisdiction and Venue
`
`59.
`
`Abbott’s counterclaims arise under 28 U.S.C. §§ 2201 and 2202 and 35 U.S.C.
`
`§§ 1, et seq. and seek declaratory relief and further relief based upon a declaratory judgment or
`
`decree. This Court has original jurisdiction over all counterclaims herein pursuant to 28 U.S.C.
`
`§§ 1331, 1338(a), and 1367.
`
`60.
`
`Venue is proper in this district pursuant to 28 U.S.C. § 1391. This Court has
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`personal jurisdiction over Enzo.
`
`8
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`

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`Case 1:12-cv-00274-LPS Document 75 Filed 05/08/13 Page 9 of 41 PageID #: 912
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`Prosecution of the ‘180 Patent
`
`61.
`
`The ‘180 patent states on its face that it issued from U.S. Patent Application No.
`
`08/479,997, which is a continuation of Application No. 08/046,004 filed 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. 07/140,908 filed on January 1, 1988, which is a continuation of Application No.,
`
`06/674,352, which is a continuation of Application No. 06/391,440 filed June 23, 1982.
`
`62.
`
`The ‘180 patent purports to claim oligonucleotide or polynucleotide compositions
`
`that contain one or more modified nucleotides, where the modified nucleotide(s) has a detectable
`
`label (including in “Sig”) attached to the phosphate moiety of a nucleotide. (See, e.g., Ex. A to
`
`Enzo’s Second Amended Complaint at claim 1.)
`
`63.
`
`The ‘180 patent claims include a vast genus of oligonucleotide and polynucleotide
`
`compositions.
`
`64.
`
`The ‘180 patent does not include any working examples of the claimed invention.
`
`Enzo, including at least Dean L. Engelhardt, co-inventor of the ‘180 patent, admitted that
`
`Examples II-XX, XXIV-XXIX, and XXXII-XXXIX in the specification of the ‘352 application,
`
`were not actually carried out, and despite being written in past tense, those examples were
`
`prophetic, rather than actual, examples. (See Exhibit A, July 14, 1987 Response to January 14,
`
`1987 Office Action from prosecution history of the ‘352 application). These prophetic examples
`
`encompass Example V, as provided in the specification of the ‘180 patent as issued.
`
`65.
`
`Specifically, in a July 14, 1987 submission requesting amendment of the ‘352
`
`application, Enzo and its agents, including at least Engelhardt, requested that the Patent Office
`
`amend the specification as follows (with the additional language underlined):
`
`The following examples are illustrative of various embodiments of
`the practices of this invention. Examples 2-20, 24-29 and 32-39,
`
`9
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`

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`Case 1:12-cv-00274-LPS Document 75 Filed 05/08/13 Page 10 of 41 PageID #: 913
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`although expressed in the past tense hereinafter, were not in fact
`actually carried out. Thus, those examples are phophetic [sic], not
`actual, examples. [Examples I-XL].
`
`(Id. at 1) (emphasis added).
`
`66.
`
`In this same submission, Enzo and its agents,
`
`including at
`
`least Engelhardt
`
`remarked that:
`
`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. See Rohm & Haas Co. v. Crystal Chemical
`Co., 722 F.2d 1556, 1572 (Fed. Cir. 1983).
`
`(Id. at 5). The amendment was never entered in the application that issued as the ‘180 patent,
`
`and the specification continues to refer to Example V in the past tense. The ’352 application was
`
`subsequently abandoned and Enzo revoked the prosecuting attorney’s power of attorney.
`
`67.
`
`Subsequently, on June 7, 1995, Enzo and its agents filed the ‘997 application from
`
`which the ‘180 patent issued. At that time, Ronald C. Fedus, was attorney of record for the ‘997
`
`application and continued to prosecute the application until it issued as the ‘180 patent.
`
`68.
`
`On information and belief, during the prosecution of the ‘180 patent, Fedus and
`
`Engelhardt were aware of the statements by Enzo and its agents, including at least Engelhardt, in
`
`the ‘352 application that Examples II-XX, XXIV-XXIX, and XXXII-XXXIX were prophetic
`
`examples that had not actually been performed.
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`10
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`Case 1:12-cv-00274-LPS Document 75 Filed 05/08/13 Page 11 of 41 PageID #: 914
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`69.
`
`Fedus, as an attorney of record involved in the prosecution of the ‘180 patent, had
`
`a duty of candor and good faith with the Patent Office.
`
`70.
`
`Engelhardt signed inventor declarations, indicating his understanding that as a
`
`named inventor, he understood his duty of candor and good faith with the Patent Office for both
`
`the ‘352 application and the ‘997 application, and indicating that he would provide any and all
`
`material information regarding the same.
`
`71.
`
`During the prosecution of the ‘997 application, Enzo and its agents, including at
`
`least Fedus and Engelhardt, added new claims directed at oligonucleotides containing modified
`
`nucleotides having the formula “Sig-PM-SM-BASE,” which includes a signaling moiety (“Sig”)
`
`attached to a phosphate moiety (“PM”). For example, on September 18, 1995, Fedus and
`
`Engelhardt amended the application to seek patentability of the following new claim:
`
`-- 236. (NEW) An oligo- or polynucleotide nucleotide comprising
`at least one nucleotide having the formula
`Sig – PM – SM – BASE
`wherein PM is a phosphate moiety, SM is a sugar moiety and
`BASE is a pyrimidine, purine or 7-deazapurine moiety, PM being
`attached to the 3’ or the 5’ position of the sugar moiety when said
`nucleotide is a deoxyribonucleotide and at the 2’, 3’, or 5’ position
`when said nucleotide is a ribonucleotide, BASE being attached to
`the 1’ position of SM from the N1 position when BASE is a
`pyrimidine or the N9 position when BASE is a purine or 7-
`deazapurine, and Sig is covalently attached to PM directly or via a
`chemical linkage, said Sig being a detectable moiety when attached
`to PM.
`
`(Exhibit B at 4, Amended Claims filed September 18, 1995, from prosecution history of ‘180
`
`patent).
`
`72.
`
`The Patent Office repeatedly rejected Enzo’s claims directed at a signaling moiety
`
`(Sig) attached to a phosphate moiety (PM) under 35 U.S.C. § 112, first paragraph, for lack of
`
`both written description and enablement. For example, the Patent Office rejected all the claims
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`11
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`

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`Case 1:12-cv-00274-LPS Document 75 Filed 05/08/13 Page 12 of 41 PageID #: 915
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`in a Final Rejection dated May 13, 1997 because “the specification, as originally filed, does not
`
`provide support for the invention as is now claimed.” (See Exhibit C at 2, Final Rejection dated
`
`May 13, 1997, from prosecution history of ‘180 patent;
`
`see also June 20, 1996 Non-Final
`
`Rejection; January 6, 1998 Non-Final Rejection; September 29, 1998 Final Rejection).
`
`73.
`
`In response to the May 13, 1997 Final Office Action rejecting all pending claims
`
`of the ‘180 patent application under 35 U.S.C. § 112, first paragraph, because, inter alia,
`
`“essential subject matter [the Halloran reference] cannot be incorporated by reference to a
`
`research article,” Enzo filed a November 24, 1997 Declaration by co-inventor Dean L.
`
`Engelhardt (attached hereto as Exhibit D).
`
`In his declaration, Engelhardt asserted: “[i]t is my
`
`opinion that the originally filed specification does indeed support the subject matter of the
`
`pending claims which are adequately described to the point that a skilled artisan would have
`
`reasonably concluded that the original disclosure evidenced possession of the invention currently
`
`being claimed.” (Ex. D at ¶ 7).
`
`74.
`
`To support this opinion, Engelhardt asserted that, “[i]n all, there are no fewer than
`
`(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 . . .” (Id. at ¶ 9(B)).
`
`75.
`
`However, each of these nine “instances” referenced in the declaration only
`
`restated the generic formula that Sig can be attached to the phosphate moiety.
`
`76.
`
`Englehardt further referred to “Example V” of the specification stating:
`
`In addition to those portions in the specification cited above,
`Example V 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 (page 57),
`the biotinylated poly-L-lysine is coupled to a terminal oxygen of
`
`12
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`Case 1:12-cv-00274-LPS Document 75 Filed 05/08/13 Page 13 of 41 PageID #: 916
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`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., 96:373 (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. at 9(C)). Fedus stated in Enzo’s accompanying Remarks that “[a]ccording 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.” (November
`
`24, 1997 Remarks at 40, from prosecution history of ‘180 patent (emphasis added); see also,
`
`April 23, 2004 Amendment at 83 (Example V says that “[b]iotin and polybiotinylated poly-L-
`
`lysine were coupled to oligonucleotides.”) (emphasis added)).
`
`77.
`
`Neither Engelhardt nor Fedus directed the examiner, in either the November 24,
`
`1997 Amendment and Response or in Engelhardt’s declaration, to the previous disclaimer in the
`
`‘352 application that Example V was prophetic despite being written in past tense. Nor did they
`
`provide any evidence that the experiments disclosed in Example V had since been actually
`
`performed.
`
`78.
`
`On November 20, 1998, Enzo and its agents,
`
`including at
`
`least Fedus and
`
`Engelhardt, added new claims again directed to oligonucleotides containing modified nucleotides
`
`having the formula “Sig-PM-SM-BASE.”
`
`For example, Fedus and Engelhardt sought
`
`patentability of the following claim for Enzo:
`
`-- 454. (NEW) An oligo- or polydeoxyribonucleotide comprising
`at least one nucleotide having the formula
`Sig – PM – SM – BASE
`wherein PM is a phosphate moiety, SM is a sugar moiety and
`BASE is a moiety selected from the group consisting of a
`pyrimidine, purine and a deazapurine, or analog thereof, said PM
`being attached to SM, said BASE being attached to SM, and Sig
`being covalently attached to PM directly or via a chemical linkage,
`said Sig being a moiety capable of non-radioactive detection when
`
`13
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`Case 1:12-cv-00274-LPS Document 75 Filed 05/08/13 Page 14 of 41 PageID #: 917
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`attached to PM or when said nucleotide is incorporated into said
`oligo- or polydeoxyribonucleotide.
`
`(See Exhibit E at 2, Amended Claims filed November 20, 1998 from prosecution history of ‘180
`
`patent; see also Amended Claims filed January 18, 2001 (adding same)).
`
`79.
`
`The Patent Office continued to reject Enzo’s claims directed at a signaling moiety
`
`(Sig) attached to a phosphate moiety (PM) under 35 U.S.C. § 112, first paragraph, for both lack
`
`of written description and enablement. For example, the Patent Office explained in both its
`
`February 3, 1999 Non-Final Rejection and July 18, 2000 Final Rejection that
`
`the claims
`
`contained “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.”
`
`80.
`
`After the July 18, 2000 Final Rejection, Enzo and its agents, including at least
`
`Fedus and Engelhardt, filed an appeal brief on August 20, 2001 arguing, among other things, that
`
`the pending claims directed a signaling moiety (Sig) attached to a phosphate moiety (PM) should
`
`be allowed because the Examples in the specification were actual examples of a signaling moiety
`
`(Sig) attached to a phosphate moiety (PM). (See Exhibit F, August 20, 2001 Appeal Brief from
`
`prosecution history of ‘180 patent). Specifically, the appeal brief filed by Fedus asserted:
`
`[t]he original disclosure provides for Sig to be attached directly or
`indirectly to the phosphate moiety (PM) nucleotide.
`This
`unrebutted fact has been made abundantly clear in the record. (See
`Amendment – January 18, 2001, at 23-31; Agris Declaration ¶ 21-
`26.) Attachment of Sig to the oxygen atom of PM is set forth in
`the description of the invention, while attachment of Sig to the
`phosphate atom of PM is set forth in Example V of the invention.
`(Id.; see also Specification at 57.) Specifically in Example V, both
`biotin and polybiotinylated poly-L-lysine were coupled to
`oligodeoxyribonucleotides
`using
`a
`carbodiimide
`coupling
`procedure described in Halloran and Parker. The Office even
`admits that “Halloran discloses the attachment of a specific signal
`moiety, a protein, to the phosphorus atom of the phosphate moiety
`
`14
`
`

`
`Case 1:12-cv-00274-LPS Document 75 Filed 05/08/13 Page 15 of 41 PageID #: 918
`
`using a specific linker, a –C-(CH2)4-N- chain.” (Final Office
`Action – July 18, 2000 at 3.) Further, attachment of Sig to various
`positions on the sugar moiety via a phosphate linkage have (sic)
`(See,
`e.g.,
`been described previously in the prosecution.
`Amendment – January 18, 2001, at 23-31; Agris Declaration ¶ 21-
`26.)
`It is important to take into consideration that Example V must be
`read in conjunction with Examples I-III, which support
`the
`preparation of Example V.
`Example I demonstrates
`the
`preparation of the activated ester of biotin. Example II supports
`the preparation of the amide form of biotin. Finally, Example III
`supports the preparation of polybiotinylated poly-L-lysine. All of
`these compounds were used in Example V, as shown in the
`following figure.
`
`(Id. at 15-16) (emphasis added); (see also April 23, 2004 Amendment, at 83 (Example V says
`
`that “[b]iotin and polybiotinylated poly-L-lysine were coupled to oligoribonucleotides”)
`
`(emphasis added)).
`
`81.
`
`Neither Engelhardt nor Fedus directed the examiner in the appeal brief or in
`
`Engelhardt’s declaration in support of the same to Enzo’s previous disclaimer in the ‘352
`
`application that Example V was prophetic despite being written in past tense or provided any
`
`evidence that the experiments disclosed in Example V had since been actually performed.
`
`15
`
`

`
`Case 1:12-cv-00274-LPS Document 75 Filed 05/08/13 Page 16 of 41 PageID #: 919
`
`82.
`
`After the appeal brief was filed, a new Patent Office examiner, Mr. Alexander H.
`
`Spiegler, reopened prosecution of the pending claims directed at a signaling moiety (Sig)
`
`attached to a phosphate moiety (PM), based on the arguments that Fedus made in that brief for
`
`Enzo:
`
`newly found
`In view of the appeal brief, filed 8/20/01, and
`rejections summarized herein, PROSECUTION IS HEREBY
`REOPENED. New grounds of rejection are set forth below. To
`avoid abandonment of the application, appellant must exercise one
`of the two following options: 1) file a reply under 37 CFR 1.111;
`or 2) request reinstatement of the appeal.
`If reinstatement of the
`appeal
`is requested, such request must be accompanied by a
`supplemental appeal brief, but no new amendments, affidavits (37
`CFR 1.30, 1.131, or 1.132) or other evidence is permitted. See 37
`CFR 1.93(b)(2).
`
`(November 26, 2001 Non-Final Rejection at 2).
`
`83.
`
`Neither Engelhardt nor Fedus directed the new examiner
`
`to the previous
`
`disclaimer in the ‘352 application that Example V was prophetic despite being written in past
`
`tense. Nor did they provide any evidence that the experiments disclosed in Example V had since
`
`been actually performed.
`
`84.
`
`The Patent Office withdrew its objections and rejections based on the
`
`specification’s failure to demonstrate the inventors’ possession of a signaling moiety (Sig)
`
`attached to a phosphate moiety (PM) invention as required by 35 U.S.C. § 112, first paragraph
`
`and instead asserted that
`
`the 1966 Halloran reference incorporated in full
`
`in Example V
`
`anticipated the ‘180 patent claims. (See November 26, 2001 Final Rejection).
`
`85.
`
`Further, after the 1966 Halloran publication was cited by the examiner as
`
`anticipatory prior art, Enzo amended the claims to exclude polypeptide labels, by limiting the Sig
`
`definition to “non-polypeptide” label moieties.
`
`(See November 26, 2001 Office Action from
`
`prosecution of ‘180 patent; May 28, 2002 Response to November 26, 2001 Office Action).
`
`16
`
`

`
`Case 1:12-cv-00274-LPS Document 75 Filed 05/08/13 Page 17 of 41 PageID #: 920
`
`86.
`
`Because the biotinylated poly-L-lysine label moiety in Example V is a
`
`polypeptide label moiety which is expressly excluded from the claims as issued, the ‘180 patent
`
`specification fails to provide even a single species that falls within the ambit of the claims.
`
`87.
`
`The specification of the ‘180 patent fails to provide even a single species that falls
`
`within the scope of the claimed genus.
`
`88.
`
`The specification of the ‘180 patent fails to show structural features common to
`
`members of the genus claimed by the patent.
`
`Materiality and Intent – ‘180 Patent
`
`89.
`
`Before the ‘180 patent issued and while the application was pending at the Patent
`
`Office, Enzo and its agents, including at least Fedus and Engelhardt, misrepresented to the Patent
`
`Office material information relevant to the patentability of the claims of the ‘180 patent.
`
`90.
`
`Enzo and its agents, including at least Fedus and Engelhardt, relied consistently
`
`on Example V as evidence of their possession of an alleged invention and sufficient enabling
`
`disclosure in the specification such that one of skill in the art could practice that alleged
`
`invention.
`
`91.
`
`Enzo and its agents, including at least Fedus and Engelhardt, did not inform any
`
`examiner of the prior disclaimer regarding Example V as prophetic and not an actual example in
`
`response to any claim rejection or during appeal.
`
`92.
`
`All of the ‘180 patent claims require a Sig-PM bond, specifically independent
`
`claims 1, 29, 59, and 87 and those claims dependent on the same, for which Enzo and its agents,
`
`including at least Fedus and Engelhardt, repeatedly relied on Example V as evidence that, with
`
`respect to these claims, the specification satisfied the requirements of 35 U.S.C. § 112, first
`
`paragraph.
`
`17
`
`

`
`Case 1:12-cv-00274-LPS Document 75 Filed 05/08/13 Page 18 of 41 PageID #: 921
`
`93.
`
`Specifically, Enzo and its agents,
`
`including at
`
`least Fedus and Engelhardt,
`
`repeatedly misrepresented to the Patent Office that the applicants of the ‘180 patent were in
`
`possession of an invention directed at a signaling moiety (Sig) attached to a phosphate moiety
`
`(PM) based on Example V (and other Examples), even though Enzo and its agents, including at
`
`least Fedus and Engelhardt, knew that Example V (and most other Examples) in the ‘180 patent
`
`application were not actually carried out, and were prophetic, and not actual examples.
`
`94.
`
`Neither Engelhardt nor Fedus directed the Examiners to the previous disclaimer in
`
`the parent application that Example V was prophetic despite being written in past tense or
`
`provided any evidence that the experiments disclosed in Example V had since been actually
`
`performed.
`
`95.
`
`A reasonable examiner would have considered material to the patentability of the
`
`claims of the ‘180 Patent, specifically claims 1, 29, 59, and 87 as well as those claims that
`
`depend therefrom, the fact that, despite Enzo’s (and its agents, including at least Fedus and
`
`Engelhardt), repeated reliance on Example V, Example V had previously been disclaimed as
`
`prophetic and not actually performed.
`
`These misrepresentations were material
`
`to the
`
`patentability of the subject matter claimed in the ‘180 patent. But for these misrepresentations
`
`by Enzo and its agents, including at least Fedus and Engelhardt, the claims of the ‘180 patent
`
`would not have issued.
`
`96.
`
`Enzo and its agents,
`
`including at
`
`least Fedus and Engelhardt,
`
`intentionally
`
`misrepresented material information from the examiner and the Patent Office during prosecution
`
`of the application that issued as the ‘180 patent by repeatedly relying on a prophetic example to
`
`overcome § 112, first paragraph rejections by not disclosing the true nature of that example to
`
`the Examiner pursuant to their statutory duty of candor and good faith with the Patent Office.
`
`18
`
`

`
`Case 1:12-cv-00274-LPS Document 75 Filed 05/08/13 Page 19 of 41 PageID #: 922
`
`97.
`
`Enzo and its agents, including at least Fedus and Engelhardt, were aware of their
`
`individual and respective duties of candor and good faith in dealing with the Patent Office under
`
`37 C.F.R. § 1.56.
`
`98.
`
`Enzo and its agents,
`
`including at
`
`least Fedus and Engelhardt, made these
`
`misrepresentations with the intent to deceive the Patent Office.
`
`99.
`
`The misrepresentations in the prosecution of the ‘180 Patent by Enzo and its
`
`agents, including at least Fedus and Engelhardt, meet the threshold level of materiality and intent
`
`to mislead.
`
`100.
`
`The misrepresentations in the prosecution of the ‘180 patent by Enzo and its
`
`agents, including at least Fedus and Engelhardt, constitute egregious misconduct.
`
`101. But for Enzo’s misrepresentations in the prosecution of the ‘180 patent, the patent
`
`would not have issued.
`
`Enzo’s Delay in Prosecuting the ‘405 Patent
`
`102.
`
`The ‘405 patent purports to claim, amon