Case 1:12-cv-00274-LPS Document 10 Filed 08/06/12 Page 1 of 21 PageID #: 70
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`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.
`
`ANSWER, DEFENSES, AND COUNTERCLAIMS
`
`Defendants Abbott Laboratories and Abbott Molecular Inc. (collectively “Abbott”)
`
`answer the Complaint for Patent Infringement (“the Complaint”) of Plaintiff Enzo Life Sciences
`
`Inc. (“Enzo” or “Plaintiff”) as follows. The 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
`
`that a response is deemed required, Abbott admits that Enzo’s Complaint
`
`is
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`purportedly for the alleged infringement of United States Patent No. 6,992,180 (“the ’180
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`Patent”) under the Patent Laws of the United States, 35 U.S.C. § 1, et seq. Abbott denies all
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`other allegations of Paragraph 4.
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`

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`JURISDICTION AND VENUE
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`5.
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`This Paragraph contains legal conclusions to which no response is required. To
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`the extent that a response is deemed required, Abbott admits this Court has subject matter
`
`jurisdiction over this action. Abbott denies all remaining allegations in Paragraph 5.
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`6.
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`This Paragraph contains legal conclusions to which no response is required. To
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`the extent that a response is deemed required, Abbott does not contest personal jurisdiction in
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`this Court for purposes of this action only. Abbott denies all remaining allegations in Paragraph
`
`6.
`
`7.
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`This Paragraph contains legal conclusions to which no response is required. To
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`the extent that a response is deemed required, Abbott will not contest personal jurisdiction in this
`
`Court for purposes of this action only. Abbott denies all remaining allegations in Paragraph 7.
`
`8.
`
`This Paragraph contains legal conclusions to which no response is required. To
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`the extent that a response is deemed required, Abbott does not currently contest that venue in this
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`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
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`the extent that a response is deemed required, Abbott admits the ’180 Patent is entitled “Oligo-
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`Or Polynucleotides Comprising Phosphate-Moiety Labeled Nucleotides,” the issue date is
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`January 31, 2006, and that an uncertified copy of the ’180 Patent was attached as Exhibit A to
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`Plaintiff’s Complaint. Abbott denies that the ’180 Patent was duly or legally issued, and further
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`denies any remaining allegations in Paragraph 9.
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`10.
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`Abbott lacks knowledge or information sufficient to form a belief as to the truth
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`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 10 Filed 08/06/12 Page 3 of 21 PageID #: 72
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`COUNT 1
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`Infringement of the ’180 Patent
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`11.
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`Abbott repeats and reasserts its responses to Paragraphs 1-10 as if fully set for
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`herein.
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`12.
`
`13.
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`14.
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`15.
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`16.
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`Denied.
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`Denied.
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`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
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`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
`
`17.
`
`Abbott has not infringed and is not infringing, directly, contributorily, or by
`
`inducement, any valid and enforceable claim of the ’180 Patent either literally or under the
`
`doctrine of equivalents. Abbott is not liable in any respect for any alleged infringement of the
`
`’180 Patent by anyone else.
`
`Second Defense
`
`18.
`
`Each of the claims of the ’180 Patent is invalid or unenforceable for failing to
`
`comply with one or more of the requirements for patentability pursuant
`
`to one or more
`
`provisions specified in 35 U.S.C. §§ 101, 102, 103, and 112.
`
`3
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`

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`Third Defense
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`19.
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`The ’180 Patent is unenforceable due to the inequitable conduct of the inventors
`
`of the ’180 Patent and/or Enzo employees and/or other representatives substantively involved in
`
`the preparation or prosecution of the application that issued as the ’180 Patent and/or their
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`attorneys and/or agents (collectively “Enzo and its agents”). Abbott incorporates by reference as
`
`fully stated herein Paragraphs 37-76, 85-88 of its Counterclaims below.
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`Fourth Defense
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`20.
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`Plaintiff’s Complaint fails to state a claim upon which relief may be granted.
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`Fifth Defense
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`21.
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`Each of the claims of the ’180 Patent are invalid and void pursuant to the doctrine
`
`of obviousness-type double patenting.
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`Sixth Defense
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`22.
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`Enzo’s allegations of infringement of the ’180 Patent are barred because the ’180
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`Patent is unenforceable due to prosecution laches.
`
`Seventh Defense
`
`23.
`
`Enzo’s claims are barred, in whole or in part, by the equitable doctrine of waiver,
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`acquiescence, estoppel,
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`including, without
`
`limitation, prosecution history estoppel, unclean
`
`hands, or laches.
`
`Eighth Defense
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`24.
`
`Enzo’s claims are barred, in whole or in part, by the doctrine of patent misuse.
`
`Ninth Defense
`
`25.
`
`All or part of Enzo’s claims are barred by the statute of limitations.
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`4
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`

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`Tenth Defense
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`26.
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`Enzo’s infringement claims and prayer for relief are limited by 35 U.S.C. § 287.
`
`Eleventh Defense
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`27.
`
`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
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`28.
`
`Abbott has not engaged in any conduct that would entitle Enzo to an award of
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`enhanced damages.
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`Thirteenth Defense
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`29.
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`Abbott has not engaged in any conduct that would make this an exceptional case
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`or that would entitle Enzo to an award of its reasonable attorneys’ fees.
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`Fourteenth Defense
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`30.
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`Enzo’s damages claims are contractually barred, in part or in whole, with respect
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`to any alleged infringement occurring prior to January 1, 2008.
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`Reservation of All Defenses
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`31.
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`Abbott reserves the right to offer any other and additional defenses that are now
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`or may become available or appear during, or as a result of, discovery proceedings in this action.
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`COUNTERCLAIMS
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`Defendants and Counterclaimants Abbott Laboratories and Abbott Molecular
`
`Inc.
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`(collectively “Abbott”) assert the following counterclaims against Plaintiff and Counterclaim-
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`Defendant Enzo Life Sciences Inc. (“Enzo”):
`
`5
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`Parties
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`32.
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`Abbott Laboratories is an Illinois corporation with its principal place of business
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`at 100 Abbott Park Road, Abbott Park, Illinois 60064.
`
`33.
`
`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.
`
`34.
`
`On information and belief, and based upon the allegation of Paragraph 1 of
`
`Plaintiff’s Complaint, Plaintiff Enzo 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
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`35.
`
`Abbott’s Counterclaims arise under 28 U.S.C. §§ 2201 and 2202 and seek
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`declaratory relief and further relief based upon a declaratory judgment or decree.
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`In these
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`Counterclaims, Abbott seeks a judicial declaration as to non-infringement,
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`invalidity, and
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`unenforceability of U.S. Patent No. 6,992,180 (“the ’180 Patent”). This Court has original
`
`jurisdiction over all Counterclaims herein pursuant to 28 U.S.C. §§ 1331, 1338(a), and 1367.
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`36.
`
`Venue is proper in this district pursuant to 28 U.S.C. § 1391. This Court has
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`personal jurisdiction over Enzo.
`
`Prosecution of the ’180 Patent
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`37.
`
`The ’180 Patent purports to claim oligonucleotide or polynucleotide compositions
`
`characterized by containing 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.
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`(See, e.g., Exhibit A to Plaintiff’s Complaint at Claim 1).
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`6
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`Case 1:12-cv-00274-LPS Document 10 Filed 08/06/12 Page 7 of 21 PageID #: 76
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`38.
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`The ’180 Patent claims
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`include a vast genus of oligonucleotide and
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`polynucleotide compositions.
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`39.
`
`The ’180 Patent does not include any working examples of the claimed invention.
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`Enzo, including at least Dean L. Engelhardt, co-inventor of the ’180 patent, admitted that
`
`Examples 2-20, 24-29, and 32-39 in the ’352 Application’s specification 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 U.S. Patent Application No. 06/674,352, (“the ’352 Application”)).
`
`These prophetic examples encompass Example V, as provided in the specification of the ’180
`
`Patent as issued.
`
`40.
`
`Specifically,
`
`in a July 14, 1987 submission requesting amendment of the
`
`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,
`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).
`
`41.
`
`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
`
`7
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`Case 1:12-cv-00274-LPS Document 10 Filed 08/06/12 Page 8 of 21 PageID #: 77
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`the examples in her
`Examiner has relied on the tense of
`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.
`
`42.
`
`Subsequently, on June 7, 1995, Enzo and its agents, including at least Fedus and
`
`Engelhardt, filed the ’180 Patent Application (Application No. 08/479,997 or “the ’997
`
`Application”). Specifically, Enzo’s patent counsel, Ronald C. Fedus, was attorney of record for
`
`the ‘997 application and continued to prosecute the application until it issued as the ’180 Patent.
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`Engelhardt is listed as a co-inventor and is the first-listed inventor for the ’180 Patent and, at the
`
`time the Declaration was filed, was a Senior Vice President of Enzo.
`
`43.
`
`During the prosecution of the ’180 Patent application, Fedus and Engelhardt were
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`aware of the statements by Enzo and its agents, including at least Engelhardt, in the ’352
`
`Application, the parent of the ’180 Patent. The ’180 Patent states on its face that it is a
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`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.
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`07/140,908 filed on January 1, 1988, which is a continuation of the ’352 Application, which is a
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`continuation of Application No. 06/391,440 filed June 23, 1982.
`
`44.
`
`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.
`
`45.
`
`On information and belief, Engelhardt signed inventor declarations, indicating his
`
`understanding that as a named inventor, he understood his duty of candor and good faith with the
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`8
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`Case 1:12-cv-00274-LPS Document 10 Filed 08/06/12 Page 9 of 21 PageID #: 78
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`Patent Office for both the ’352 Application and the ’180 Patent application, and indicating that
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`he would provide any and all material information regarding the same.
`
`46.
`
`During the prosecution of the ’180 Patent’s application, Enzo and its agents,
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`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.
`
`(Ex. B at 4, Amended Claims filed September 18, 1995).
`
`47.
`
`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
`
`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 Ex. C at 2, see also June 20, 1996
`
`Non-Final Rejection; January 6, 1998 Non-Final Rejection; September 29, 1998 Final
`
`Rejection).
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`9
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`48.
`
`In response to the May 13, 1997 Final Office Action rejecting all pending claims
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`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
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`November 24, 1997 Declaration by co-inventor Dean L. Engelhardt
`
`(the “Engelhardt
`
`Declaration,” attached hereto as Exhibit D). Engelhardt is listed as the first inventor for the ’180
`
`Patent and, on information and belief, at the time the Declaration was filed was a Senior Vice
`
`President of Enzo.
`
`49.
`
`In the Engelhardt Declaration, he 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).
`
`50.
`
`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)).
`
`51.
`
`However, each of these nine “instances” referenced in the Declaration only
`
`restated the generic formula that Sig can be attached to the phosphate moiety.
`
`52.
`
`The Engelhardt Declaration further referred to “Example V” of the specification
`
`stating:
`
`In addition to those portions in the specification cited above,
`C.
`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
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`10
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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 further 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.” (’997 Application, November 24, 1997 Remarks at 40 (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)).
`
`53.
`
`Neither Engelhardt nor Fedus directed the Examiner in the November 24, 1997
`
`Amendment and Response or in Engelhardt’s Declaration in support of the same to the previous
`
`disclaimer in the parent application that Example V was prophetic despite being written in
`
`present tense or provided any evidence that the experiments disclosed in Example V had since
`
`been actually performed.
`
`54.
`
`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
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`attached to PM or when said nucleotide is incorporated into said
`oligo- or polydeoxyribonucleotide.
`
`(See Ex. E, Amended Claims filed November 20, 1998; see also Amended Claims filed January
`
`18, 2001 (adding same)).
`
`55.
`
`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.”
`
`56.
`
`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). 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
`
`12
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`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)).
`
`57.
`
`Neither Engelhardt nor Fedus directed the Examiner in the Appeal Brief or in
`
`Engelhardt’s Declaration in support of the same to the previous disclaimer in the parent
`
`application that Example V was prophetic despite being written in present tense or provided any
`
`evidence that the experiments disclosed in Example V had since been actually performed.
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`58.
`
`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:
`
`1. In view of the appeal brief, filed 8/20/01, and newly found
`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).
`
`59.
`
`Neither Engelhardt nor Fedus directed the new Examiner to the previous
`
`disclaimer in the parent application that Example V was prophetic despite being written in
`
`present tense or provided any evidence that the experiments disclosed in Example V had since
`
`been actually performed.
`
`60.
`
`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).
`
`61.
`
`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; May 28,
`
`2002 Response to November 26, 2001 Office Action).
`
`14
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`Case 1:12-cv-00274-LPS Document 10 Filed 08/06/12 Page 15 of 21 PageID #: 84
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`62.
`
`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.
`
`63.
`
`The specification of the ’180 Patent fails to provide even a single species that falls
`
`within the scope of the claimed genus.
`
`64.
`
`The specification of the ’180 Patent fails to show structural features common to
`
`members of the genus claimed by the patent.
`
`MATERIALITY AND INTENT
`
`65.
`
`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.
`
`66.
`
`Enzo and its agents, including at least Fedus and Engelhardt, relied consistently
`
`on an Example (specifically, 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.
`
`67.
`
`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.
`
`68.
`
`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.
`
`15
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`

`
`Case 1:12-cv-00274-LPS Document 10 Filed 08/06/12 Page 16 of 21 PageID #: 85
`
`69.
`
`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.
`
`70.
`
`Neither Engelhardt nor Fedus directed the Examiners to the previous disclaimer in
`
`the parent application that Example V was prophetic despite being written in present tense or
`
`provided any evidence that the experiments disclosed in Example V had since been actually
`
`performed.
`
`71.
`
`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.
`
`72.
`
`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.
`
`16
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`

`
`Case 1:12-cv-00274-LPS Document 10 Filed 08/06/12 Page 17 of 21 PageID #: 86
`
`73.
`
`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.
`
`74.
`
`Enzo and its agents,
`
`including at
`
`least Fedus and Engelhardt, made these
`
`misrepresentations with the intent to deceive the Patent Office.
`
`75.
`
`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.
`
`76.
`
`The misrepresentations in the prosecution of the ’180 Patent by Enzo and its
`
`agents, including at least Fedus and Engelhardt, constitute egregious misconduct.
`
`COUNT 1
`
`Declaration of Noninfringement of the ’180 Patent
`
`Abbott repeats and realleges Paragraphs 1-76 as if fully set forth herein.
`
`Enzo, by its Complaint, alleged that Abbott has infringed and continues to
`
`77.
`
`78.
`
`infringe one or more claims of the ’180 Patent.
`
`79.
`
`Abbott has not infringed, and is not infringing, directly, contributorily, or by
`
`inducement, any valid claim of the ’180 Patent.
`
`80.
`
`To resolve the legal and factual questions raised by Enzo and to afford relief from
`
`the uncertainty and controversy precipitated by Enzo’s allegations, Abbott
`
`is entitled to
`
`declaratory judgment by this Court that Abbott has not infringed, and is not infringing, directly,
`
`contributorily, or by inducement, any valid and enforceable claim of the ’180 Patent.
`
`17
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`

`
`Case 1:12-cv-00274-LPS Document 10 Filed 08/06/12 Page 18 of 21 PageID #: 87
`
`COUNT 2
`
`Declaration of Invalidity of the ’180 Patent
`
`81.
`
`82.
`
`Abbott repeats and realleges Paragraphs 1-80 above, as if fully set forth herein.
`
`One or more of the claims of the ’180 Patent is invalid for failing to meet one or
`
`more of the requisite statutory and decisional requirements and/or conditions for patentability
`
`pursuant to one or more provisions of Title 35 of the United States Code, including without
`
`limitation §§ 101, 102, 103, and 112.
`
`83.
`
`One or more of the claims of the ’180 Patent are invalid and void under the
`
`doctrine of obviousness-type double patenting.
`
`84.
`
`To resolve the legal and factual questions raised by Enzo and to afford relief from
`
`the uncertainty and controversy precipitated by Enzo’s allegations, Abbott
`
`is entitled to
`
`declaratory judgment by this Court that one or more of the claims of the ’180 Patent are invalid
`
`for one or more of the grounds set forth in 35 U.S.C. §§ 101, 102, 103, and/or 112 and/or
`
`obviousness type double-patenting.
`
`COUNT 3
`
`Declaration of Unenforceability
`
`85.
`
`86.
`
`Abbott repeats and realleges paragraphs 1-84 above, as if fully set forth herein.
`
`One or more claims of the ’180 Patent are unenforceable under the doctrine of
`
`prosecution laches.
`
`87.
`
`The ’180 Patent, including all claims therein, is unenforceable as a result of the
`
`inequitable conduct of Enzo and its agents, including at least Fedus and Engelhardt before the
`
`Patent Office during the prosecution of this patent.
`
`18
`
`

`
`Case 1:12-cv-00274-LPS Document 10 Filed 08/06/12 Page 19 of 21 PageID #: 88
`
`88.
`
`To resolve the legal and factual questions raised by Enzo and to afford relief from
`
`the uncertainty and controversy that Enzo’s accusations have precipitated, Abbott is entitled to a
`
`declaratory judgment that the ’180 Patent is unenforceable due to prosecution laches and/or
`
`inequitable conduct.
`
`ABBOTT’S PRAYER FOR RELIEF
`
`WHEREFORE, Abbott respectfully requests that this Court:
`
`A. Declare that Enzo is not entitled to any of the relief requested in its Complaint;
`
`B. Dismiss Enzo’s Complaint with prejudice;
`
`C. Declare that Abbott has not infringed any valid and enforceable claims of the ’180 Patent;
`
`D. Declare that the claims of the ’180 Patent are invalid under the patent laws of the United
`States for failure to comply with the requirements of patentability set forth in Title 35,
`U.S.C. § 1, et seq. and obviousness-type double patenting;
`
`E. Declare that the ’180 Patent is unenforceable;
`
`F. Find that this cas