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`Case 1:12—cv—OO274—LPS Document 20 Filed 10/15/12 Page 1 of 24 Page|D #: 323
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 12-274-LPS
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`JURY TRIAL DEMANDED
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`ENZO LIFE SCIENCES, INC.,
`
`Plaintiff,
`
`v.
`
`ABBOTT LABORATORIES, and
`ABBOTT MOLECULAR INC.,
`
`Defendants.
`
`ANSWER, DEFENSES AND COUNTERCLAIMS
`TO PLAINTIFF’S AMENDED COMPLAINT
`
`Defendants Abbott Laboratories and Abbott Molecular Inc.’s (collectively “Abbott”)
`
`answer Plaintiff Enzo Life Sciences Inc.’s (“Enzo” or “Plaintiff”) Amended Complaint as
`
`follows.
`
`The numbered Paragraphs below correspond to the numbered Paragraphs in the
`
`Amended Complaint:
`
`PARTIES
`
`Admitted, based on information and belief.
`
`Admitted.
`
`Admitted.
`
`1.
`
`2.
`
`3.
`
`NATURE OF THE ACTION
`
`4.
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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 that Enzo’s Amended Complaint is
`
`purportedly for the alleged infringement of United States Patent Nos. 6,992,180 (“the ‘I80
`
`Patent”) and 7,064,197 (“the ‘197 Patent”) under the Patent Laws of the United States, 35
`
`U.S.C. § 1, er seq. Abbott denies all other allegations of Paragraph 4.
`
`

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`JURISDICTION AND VENUE
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`5.
`
`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.
`
`6.
`
`This Paragraph contains legal conclusions to which no response is required.
`
`Abbott Molecular admits that it is a Delaware corporation and is subject to personal jurisdiction
`
`in Delaware. Abbott Laboratories, without admitting any allegations in paragraph 6, does not
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`challenge personal jurisdiction by this Court for this matter only. Abbott denies all remaining
`
`allegations in Paragraph 6.
`
`7.
`
`This Paragraph contains legal conclusions to which no response is required.
`
`Abbott, without admitting any allegations in paragraph 7, does not challenge personal
`
`jurisdiction by this Court for this matter only. Abbott denies all 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 Court is proper for purposes of this action only.
`
`The Patents-In-Suit
`
`9.
`
`This Paragraph contains legal conclusions to which no response is required. To
`
`the extent that a response is deemed 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 ’ISO Patent was attached as Exhibit A to
`
`Plaintiff’ s Amended Complaint. Abbott denies that the ’180 Patent was duly or legally issued,
`
`and further denies any remaining allegations in Paragraph 9.
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`

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`10.
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`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.
`
`11.
`
`This Paragraph contains legal conclusions to which no response is required. To
`
`the extent that a response is deemed required, Abbott admits the ’l97 Patent is entitled “System,
`
`Array and Non-Porous Solid Support Comprising Fixed or Immobilized Nucleic Acids,” the
`
`issue date is January 31, 2006, and that an uncertified copy of the ’l97 Patent was attached as
`
`Exhibit B to Plaintiffs 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.
`
`COUNT I
`
`Infringement of the ’180 Patent
`
`13.
`
`Abbott repeats and reasserts its responses to Paragraphs 1-12 as if fully set for
`
`herein.
`
`14.
`
`Denied.
`
`15.
`
`Denied.
`
`16.
`
`Denied.
`
`17.
`
`Denied.
`
`18.
`
`Denied.
`
`1 9.
`
`Denied.
`
`

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`COUNT II
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`Infringement of the ’197 Patent
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`20.
`
`Abbott repeats and reasserts its responses to Paragraphs 1-19 as if fully set for
`
`herein.
`
`21 .
`
`Denied.
`
`22.
`
`Denied.
`
`23.
`
`Denied.
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`DEFENSES
`
`24.
`
`Abbott denies that Enzo is entitled to any relief against Abbott.
`
`25.
`
`Upon information and belief, Abbott asserts defenses to the Amended Complaint
`
`in the following paragraphs. By asserting such defenses, Abbott does not concede that it has the
`
`burden of proving the matters asserted.
`
`First Defense
`
`26.
`
`Abbott has not infringed and is not infringing, directly, contributorily, or by
`
`inducement, any valid and enforceable claim of the ’18O Patent either literally or under the
`
`doctrine of equivalents. Abbott is not liable in any respect for any alleged infringement of the
`
`“I80 Patent by anyone else.
`
`Second Defense
`
`27.
`
`Each of the claims of the ‘I80 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.
`
`

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`Third Defense
`
`28.
`
`On information and belief, the ‘180 Patent is unenforceable due to the inequitable
`
`conduct of the inventors of the ’l8O 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 attorneys and/or agents (collectively “Enzo and its agents”). Abbott
`
`incorporates by reference as fully stated herein Paragraphs 50 - 89 of their Counterclaims below.
`
`Fourth Defense
`
`29.
`
`Plaintiffs Amended Complaint, in whole or in part, fails to state a claim upon
`
`which relief may be granted.
`
`Fifth Defense
`
`30.
`
`Each of the claims of the ’180 Patent is invalid and void pursuant to the doctrine
`
`of obviousness-type double patenting.
`
`Sixth Defense
`
`31.
`
`Enzo’s allegations of infringement of the ’l80 Patent are barred because the ’ISO
`
`Patent is unenforceable due to prosecution laches.
`
`Seventh Defense
`
`32.
`
`Abbott has not infringed and is not infringing, directly, contributorily, or by
`
`inducement, any valid and enforceable claim of the ’l97 Patent either literally or under the
`
`doctrine of equivalents. Abbott is not liable in any respect for any alleged infringement of the
`
`’l97 Patent by anyone else.
`
`

`
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`Eighth Defense
`
`33.
`
`Each of the claims of the ’197 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.
`
`Ninth Defense
`
`34.
`
`Each of the claims of the ’l97 Patent is invalid and void pursuant to the doctrine
`
`of obviousness-type double patenting.
`
`Tenth Defense
`
`35.
`
`Enzo’s allegations of infringement of the ’l97 Patent are barred because the ’197
`
`Patent is unenforceable due to prosecution laches.
`
`Eleventh Defense
`
`36.
`
`Enzo’s claims are barred, in whole or in part, by the equitable doctrine of waiver,
`
`acquiescence, estoppel,
`
`including, without
`
`limitation, prosecution history estoppel, unclean
`
`hands, or laches.
`
`Twelfth Defense
`
`37.
`
`Enzo's claims are barred, in whole or in part, by the doctrine of patent misuse.
`
`Thirteenth Defense
`
`38.
`
`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.
`
`Fourteenth Defense
`
`39.
`
`Enzo’s infringement claims and prayer for relief are limited by 35 U.S.C. § 287.
`
`Fifteenth Defense
`
`40.
`
`Enzo’s prayers for injunctive relief are barred in light of the availability of an
`
`

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`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.
`
`Sixteenth Defense
`
`41.
`
`Abbott has not engaged in any conduct that would entitle Enzo to an award of
`
`enhanced damages.
`
`Seventeenth Defense
`
`42.
`
`Abbott has not engaged in any conduct that would make this an exceptional case
`
`or that would entitle Enzo to an award of its reasonable attorneys’ fees.
`
`Eighteenth Defense
`
`43.
`
`Enzo’s damages claims are contractually barred, in part or in whole, with respect
`
`to any alleged infringement occurring prior to January 1, 2008.
`
`Nineteenth Defense
`
`44.
`
`Each of the claims of the ‘I97 Patent is invalid, unenforceable, and void for
`
`failure to satisfy the requirements of 35 U.S.C. § 116.
`
`Reservation of All Defenses
`
`45.
`
`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.
`
`COUNTERCLAIMS
`
`Defendants and Counterclaimants Abbott Laboratories and Abbott Molecular Inc.
`
`(collectively “Abbott”) assert the following counterclaims against Plaintiff and Counterclaim—
`
`Defendant Enzo Life Sciences Inc. (“Enzo”):
`
`

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`Parties
`
`46.
`
`Abbott Laboratories is an Illinois corporation with its principal place of business
`
`at 100 Abbott Park Road, Abbott Park, Illinois 60064.
`
`47.
`
`Abbott Molecular is a Delaware corporation with its principal place of business at
`
`1300 E. Touhy Avenue, Des Plaines, IL 60018. Abbott Molecular is a wholly owned subsidiary
`
`of Abbott Laboratories.
`
`48.
`
`On information and belief, and based upon the allegation of Paragraph 1 of
`
`Plaintiffs Amended Complaint, Plaintiff Enzo is a New York corporation with its principal place
`
`of business at 10 Executive Boulevard, Farmingdale, NY 11735.
`
`Jurisdiction and Venue
`
`49.
`
`Abbott’s Counterclaims arise under 28 U.S.C. §§ 2201 and 2202
`
`and seek
`
`declaratory relief and further relief based upon a declaratory judgment or decree.
`
`In these
`
`Counterclaims, Abbott seeks a judicial declaration as to non-infringement,
`
`invalidity, and
`
`unenforceability of U.S. Patent No. 6,992,180 (“the ’l80 Patent”). This Court has original
`
`jurisdiction over all Counterclaims herein pursuant to 28 U.S.C. §§ 1331, 133 8(a), and 1367.
`
`50.
`
`Venue is proper in this district pursuant to 28 U.S.C. § 1391. This Court has
`
`personal jurisdiction over Enzo.
`
`Prosecution of the ‘180 Patent
`
`51.
`
`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. (See,
`
`e.g., Exhibit A to Plaintiff’ s Amended Complaint at Claim 1).
`
`

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`52.
`
`The
`
`’180 Patent
`
`claims
`
`include
`
`a vast genus of oligonucleotide
`
`and
`
`polynucleotide compositions.
`
`53.
`
`The ‘I80 Patent does not include any working examples of the claimed invention.
`
`Enzo, including at least Engelhardt, admitted that Examples 2-20, 24-29, and 32-39 in the ‘3S2
`
`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 ‘I80 Patent as issued.
`
`54.
`
`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 l)(emphasis added).
`
`55.
`
`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 § 608.0l(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 Rohm
`
`

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`& 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.
`
`56.
`
`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.
`
`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.
`
`57.
`
`During the prosecution of the ’l80 Patent application, Fedus and Engelhardt were
`
`aware of the statements by Enzo and its agents,
`
`including at least Engelhardt,
`
`in the ‘352
`
`Application, the parent of the ‘I80 Patent. The ‘I80 Patent states on its face that it 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 the ‘352 Application, which is a
`
`continuation of Application No. 06/391,440 filed June 23, 1982.
`
`5 8.
`
`Fedus, as an attorney of record involved in the prosecution of the ’l80 Patent had
`
`a duty of candor and good faith with the Patent Office.
`
`59.
`
`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
`
`Patent Office, for both the ‘352 Application and the ’180 Patent application and indicating he
`
`would provide any and all material information regarding the same.
`
`10
`
`

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`60.
`
`During the prosecution of the ’180 Patent’s 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
`
`19, 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, Amended Claims filed September 18, 1995).
`
`61.
`
`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).
`
`62.
`
`In response to the May 13, 1997 Final Office Action rejecting all pending claims
`
`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,
`
`11
`
`

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`1997 Declaration by one of the inventors, 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.
`
`63.
`
`In the Engelhardt Declaration, he asserted: “It 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 1[
`
`7).
`
`64.
`
`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. 1] 9(B)).
`
`65.
`
`However, each of these nine “instances” referenced in the Declaration only
`
`restated the generic formula that Sig can be attached to the phosphate moiety.
`
`66.
`
`The Engelhardt Declaration further referred to “Example V” of the specification
`
`which Engelhardt stated that:
`
`In addition to those portions in the specification cited above, Example
`C.
`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 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., 26373 (1966) cited in Example V, page 57 in the
`specification (a copy of Halloran’s publication also having been attached
`hereto as Exhibit 1).
`
`12
`
`

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`(Id. at 9(C)). Fedus further stated in Enzo’s accompanying Remarks that “according to
`
`Dr. Engelhardt, using the procedure in Example V in the specification (page 57), the biotinylated
`
`poly-L-lysine i_s coupled to a terminal oxygen of the phosphate moiety or to a terminal
`
`phosphorus.” (Id. at 40 (emphasis added); see also, April 23, 2004 Amendment, at 83 (Example
`
`V
`
`says
`
`that
`
`“[b]iotin
`
`and
`
`polybiotinylated
`
`poly-L-lysine M coupled
`
`to
`
`oligonucleotides.”)(emphasis added).
`
`67.
`
`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.
`
`68.
`
`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 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)).
`
`13
`
`

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`69.
`
`The Patent Office continued to reject Enz0’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.”
`
`70.
`
`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 ll 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 i_n
`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 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) been described previously in the prosecution. (See, e. g.,
`Amendment — January 18, 2001, at 23-31; Agris Declaration 1] 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 11 supports the preparation of the amide form of biotin.
`
`14
`
`

`
`Case 1:12-cv-00274-LPS Document 20 Filed 10/15/12 Page 15 of 24 PageID #: 337
`Case 1:12—cv—OO274—LPS Document 20 Filed 10/15/12 Page 15 of 24 Page|D #: 337
`
`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.
`
`Rliutwr-ii!-p~ at IE‘;-raisin I-EH inn» En-mplt V
`5&5:
`
`Efim-1
`
`iimpnulinnat Aaguvgaga Esau at I3.iuIm_
`urfltf IIENI-15;:
`
`Exam
`
`m
`
`rfiewmm at Polybielz-¢1;«_Ia1E«u paiy-L4¥&b:e]
`
`gfii
`
`{cauplnng
`
`pray-L-I5-511:: "In Ofigmbauclautaas
`
`ggmag
`
`{Sniping qfiflimiin an OI-qwitumvmieadiassfi
`
`Exam '
`
`‘
`
`II
`
`Wraparijnn d;Aml-5.9 Farm-I1! Bk:n.n_.}
`izflloliwl-13$-disfiiihdiauazte amide)
`
`(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)).
`
`71.
`
`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.
`
`72.
`
`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
`
`15
`
`

`
`Case 1:12-cv-00274-LPS Document 20 Filed 10/15/12 Page 16 of 24 PageID #: 338
`Case 1:12—cv—OO274—LPS Document 20 Filed 10/15/12 Page 16 of 24 Page|D #: 338
`
`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).
`
`73.
`
`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.
`
`74.
`
`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).
`
`75.
`
`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).
`
`76.
`
`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.
`
`77.
`
`The specification of the ‘l80 Patent fails to provide even a single species that falls
`
`within the scope of the claimed genus.
`
`78.
`
`The specification of the ‘180 Patent fails to show structural features common to
`
`members of the genus claimed by the patent.
`
`16
`
`

`
`Case 1:12-cv-00274-LPS Document 20 Filed 10/15/12 Page 17 of 24 PageID #: 339
`Case 1:12—cv—OO274—LPS Document 20 Filed 10/15/12 Page 17 of 24 Page|D #: 339
`
`MATERIALITY AND INTENT
`
`79.
`
`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 ‘I80 Patent.
`
`80.
`
`E1120 and its agents, including at least F edus 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.
`
`81.
`
`Enzo and its agents, including at least Fedus and Engelhardt, did not inform any
`
`Examiner of the ’180 Patent application of the prior disclaimer regarding Example V as
`
`prophetic and not an actual example in response to any claim rejection or during appeal.
`
`82.
`
`All of the ’l80 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.
`
`83.
`
`Specifically, Enzo and its agents,
`
`including at
`
`least Fedus and Engelhardt,
`
`repeatedly misrepresented to the Patent Office that the applicants of the ’ISO 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 ‘ISO Patent
`
`application were not actually carried out, and were prophetic, and not actual examples.
`
`17
`
`

`
`Case 1:12-cv-00274-LPS Document 20 Filed 10/15/12 Page 18 of 24 PageID #: 340
`Case 1:12—cv—OO274—LPS Document 20 Filed 10/15/12 Page 18 of 24 Page|D #: 340
`
`84.
`
`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.
`
`85.
`
`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 ‘I80 Patent. But for these misrepresentations
`
`by Enzo and its agents, including at least Fedus and Engelhardt, the claims of the ’18O Patent
`
`would not have issued.
`
`86.
`
`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 pu