UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`PAR PHARMACEUTICAL, INC., WOCKHARDT BIO AG, and
`AMNEAL PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`
`_____________________
`
`Case IPR2015-005541
`Patent 7,668,730 B2
`_____________________
`
`PETITIONERS’ REPLY TO PATENT OWNER’S RESPONSE
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`1 Case IPR2015-01818 has also been joined with this proceeding.
`
`

`
`I.
`II.
`
`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
`
`TABLE OF CONTENTS
`
`INTRODUCTION............................................................................................1
`ARGUMENT....................................................................................................1
`A.
`The ACA (Exs. 1003-1006) was publicly accessible prior to the
`critical date .............................................................................................1
`1.
`FDA was required to make Exs. 1004-1006 available to
`the public prior to or at the ACM, and there is no
`evidence that FDA violated the law.............................................2
`Ex. 1003 further corroborates the availability of Exs.
`1004-1006 at the ACM ................................................................4
`The dates on Exs. 1004-1006, coupled with corroborating
`evidence, establish public availability prior to the critical
`date...............................................................................................4
`The totality of Internet Archive evidence shows that Exs.
`1004-1006 were publicly available before the critical date.........5
`a)
`Internet Archive evidence corroborates the Federal
`Register notice and FDA website......................................5
`Jazz’s Internet Archive evidence does not prove
`that Exs. 1004-1006 were not publicly available
`until after the critical date..................................................6
`The ACA was readily accessible by persons interested in
`the subject matter before the critical date....................................7
`a)
`A POSA here is interested in drug distribution,
`safety and abuse, and would have been motivated
`to look at the Federal Register for relevant notices...........8
`A POSA exercising reasonable diligence would
`have been able to locate the ACA ...................................10
`Claim Construction ..............................................................................12
`1.
`Jazz’s proposed narrowing of “periodic reports” has no
`basis............................................................................................12
`Jazz seeks to unduly restrict “information identifying
`patients” .....................................................................................15
`
`2.
`
`3.
`
`4.
`
`5.
`
`b)
`
`b)
`
`B.
`
`2.
`
`-i-
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`

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`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
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`3.
`
`C.
`
`Jazz also seeks to unduly restrict “information identifying
`prescribers” ................................................................................17
`Jazz has failed to rebut Petitioners’ showing that the ACA
`would have rendered the claims of the ’730 patent obvious................19
`1.
`The claimed “periodic reports” would have been obvious
`based on the ACA......................................................................19
`The
`claimed
`“prescription
`requests”
`containing
`“information
`identifying patients” and “information
`identifying prescribers” would have been obvious based
`on the ACA ................................................................................20
`“Confirming with a patient that educational material has
`been read prior to [shipping/providing the prescription
`drug/GHB]” would have been obvious based on the ACA.......24
`III. CONCLUSION ..............................................................................................25
`
`2.
`
`3.
`
`-ii-
`
`

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`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
`
`TABLE OF ABBREVIATIONS
`
`ACA = “Advisory Committee Art”— i.e., Exs. 1003–1006.
`
`ACM = “Advisory Committee Meeting”—i.e., the June 6, 2001 meeting of the
`
`Peripheral and Central Nervous System Drugs Advisory Committee.
`
`FACA = “Federal Advisory Committee Act”
`
`FDA = “U.S. Food and Drug Administration”
`
`IPR = “inter partes review proceeding”
`
`OMI = “Orphan Medical, Inc.” (predecessor to patent owner Jazz Pharmaceutical,
`
`Inc.)
`
`POSA = “person of ordinary skill in the art at the time of the alleged invention”
`
`-iii-
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`

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`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
`
`I.
`
`INTRODUCTION
`
`In its July 29, 2015 Institution Decision on U.S. Patent No. 7,668,730 (“the
`
`’730 patent”), the Board correctly found that the ACA was accessible to the public
`
`prior to the critical date and that there was a reasonable likelihood that the ACA
`
`rendered obvious each claim of the ’730 patent. Paper No. 20 (“Decision”) at 46.
`
`This is because, of course, the ACA is a public disclosure of the proposed risk
`
`management system for Xyrem—the very same system covered by the ’730 patent.
`
`Faced with its own prior art, Jazz argues, with the barest of evidence, that the ACA
`
`somehow was not a printed publication, and that POSAs would not have been able
`
`to find it. Paper No. 39 (“Response”) at 5-14, 14-24. And as a last-ditch effort to
`
`save the ’730 patent, Jazz argues that specific, preferred embodiments in the
`
`specification constitute limitations on the claims—something that has no basis in
`
`the patent specification, file history, or standards of claim construction. Response
`
`at 24-36. The Board should thus cancel each challenged claim of the ’730 patent.
`
`II.
`
`ARGUMENT
`
`A.
`
`The ACA (Exs. 1003-1006) was publicly accessible prior to the
`critical date
`
`As the Board noted, the key inquiry as to whether the ACA was publicly
`
`accessible as prior art is whether it “has been disseminated or otherwise made
`
`available to the extent that persons interested and ordinarily skilled in the subject
`
`matter or art exercising reasonable diligence, can locate it.” Decision at 25-26
`
`-1-
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`

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`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
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`(quoting Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir.
`
`2006). The analysis boils down to a two-step inquiry(1) was the reference
`
`available to the public; and (2) could persons interested in the subject matter locate
`
`it. On the first point, Jazz ignores the totality of the evidence that Exs. 1004-1006
`
`were available to the public.2 On the second point, Jazz presents no credible
`
`evidence that Exs. 1003-1006 were not sufficiently accessible by interested
`
`persons. The Board’s initial determination that the ACA was publicly accessible
`
`was correct.
`
`1.
`
`FDA was required to make Exs. 1004-1006 available to the
`public prior to or at the ACM, and there is no evidence that
`FDA violated the law
`
`Jazz argues there is insufficient evidence to conclude that Exs. 1004-1006
`
`would have been available from FDA’s website prior to the critical date. Response
`
`at 12-13. But Jazz overlooks FDA’s requirement to make such information
`
`available to the public prior to or at an ACM, and substantial evidence that shows
`
`FDA did so here.
`
`It is undisputed that Exs. 1004-1006 were prepared for and made available to
`
`the Advisory Committee in conjunction with the June 6, 2001 ACM on Xyrem.
`
`
`2 Jazz does not contest that Ex. 1003 was publicly available before the
`
`critical date.
`
`-2-
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`

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`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
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`See, e.g., Ex. 1005 at 1. The FACA requires that “documents which were made
`
`available to or prepared for or by each advisory committee shall be made available
`
`for public inspection.” 5 U.S.C. app. 2 § 10(b) (2001) (emphasis added). FDA has
`
`construed the FACA “to require that … those materials that are provided to the
`
`members of an advisory committee in connection with [an ACM] must be made
`
`available for public inspection and copying before or at the time of the advisory
`
`committee meeting.” Ex. 1057 at 2 (emphasis added). While, as Jazz pointed out,
`
`the cover letter to Ex. 1005 was “addressed to [the Xyrem] Advisory Committee
`
`panel,” (Response at 11), Jazz provide no evidence that the FDA failed to follow
`
`its own guidance and the law in making Exs. 1004-1006 available to the public as
`
`well.
`
`To the contrary, the evidence here shows that FDA followed its general
`
`practice, further corroborating the public availability of Exs. 1004-1006. For
`
`example, according to FDA practice, a “fully releasable [submission to the
`
`Advisory Committee] should be clearly marked ‘AVAILABLE FOR PUBLIC
`
`DISCLOSURE WITHOUT REDACTION’ in uppercase, bolded script.” Ex.
`
`1057 at 4 (emphasis in original). This exact verbiage is located on OMI’s
`
`submission. Ex. 1005 at 4. In addition, FDA’s stated practice is to post a redacted
`
`version of FDA’s briefing information. Ex. 1057 at 8. Such a redacted version was
`
`posted here. See, e.g., 1004 at 108–110, 114; see also Ex. 1019.. Finally, FDA
`
`-3-
`
`

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`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
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`practice provides that when a non-FDA submission is posted on FDA’s website, it
`
`will be accompanied by a notice disclaiming any statements in the submission. Ex.
`
`1057 at 6. Such a disclaimer is prominent on FDA’s website here. See Ex. 1019 at
`
`1. Jazz ignores this substantial corroborating evidence.
`
`2.
`
`Ex. 1003 further corroborates the availability of Exs. 1004-
`1006 at the ACM
`
`The transcript of the June 6, 2001 ACM (Ex. 1003) further corroborates the
`
`public availability of Exs. 1004-1006. Several speakers referenced the briefing
`
`materials in their remarks. See Ex. 1003 at 12, 179, 284, 330, 342. Indeed, one
`
`such speaker who attended the meeting by telephone noted that briefing material
`
`“was distributed prior to the meeting.” Ex. 1003 at 284. Thus, the ACM transcript
`
`further corroborates the availability of Exs. 1004-1006.
`
`3.
`
`The dates on Exs. 1004-1006, coupled with corroborating
`evidence, establish public availability prior to the critical
`date
`
`Jazz argues that the dates on the faces of Exs. 1004-1006 do not establish
`
`public accessibility. Response at 5. But the Board has held that the date marked on
`
`a document, when coupled with corroborating evidence similar to the evidence
`
`here, supports public availability. See Chicago Mercantile Exchange, Inc. v. 5th
`
`Market, Inc., CBM2014-00114, Paper No. 35 at 17-20 (Aug. 18, 2015) at 17-20
`
`(dates on face of document submitted to government agency, coupled with
`
`marking of “PUBLIC COPY” and supportive declaration, sufficiently evidences
`
`-4-
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`

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`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
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`public availability).
`
`Furthermore, the Federal Register notice of the ACM, Ex. 1015, provides a
`
`URL for the Advisory Committee “docket site,” and instructions on how to locate
`
`the materials from that URL (“Click on the year 2001 and scroll down to the
`
`Peripheral and Central Nervous Systems Drugs meetings.”). Ex. 1015. Following
`
`those instructions, one obtains a page (Ex. 1017), which states that the Peripheral
`
`and Central Nervous Systems Drugs advisory committee page was updated on July
`
`13, 2001, though the entire page was updated in November of 2006. See Ex. 1017.
`
`Moreover, several pages are listed as having been updated after July of 2001—
`
`some as late as 2005—providing further corroboration that Exs. 1004-1006 were
`
`publicly available as of July 13, 2001. See id.
`
`4.
`
`The totality of Internet Archive evidence shows that Exs.
`1004-1006 were publicly available before the critical date
`
`The totality of the Internet Archive evidence further establishes that Exs.
`
`1004-1006 were publicly available prior to the critical date.
`
`a)
`
`Internet Archive evidence corroborates the Federal
`Register notice and FDA website.
`
`Internet Archive evidence corroborates the statements made in the Federal
`
`Register notice about the availability of the ACA. The Federal Register notice
`
`states that background materials will be posted prior to the June 6, 2001 ACM, and
`
`that the minutes, transcript and slides from the ACM would be posted about 3
`
`-5-
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`

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`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
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`weeks after the ACM. Ex. 1015 at 1. These statements are corroborated by Internet
`
`Archive captures of FDA’s website. An Internet Archive capture from June 17,
`
`2001 (i.e., less than 3 weeks after the ACM), contains links to only the background
`
`materials, as expected. Ex. 1018 at 5. An Internet Archive capture from October 4,
`
`2001, on the other hand, contains further links to the minutes, transcript and slides.
`
`Ex. 1020 at 8-9. Thus, the Internet Archive evidence is consistent with, and
`
`corroborates, the statements made in the Federal Register notice about the
`
`availability of the ACA on FDA’s website.
`
`Jazz argues that case law supports its assertion of unavailability based on
`
`Internet Archive evidence. Response at 7-8. However, in each of the cases Jazz
`
`cites, the petitioner failed to authenticate the alleged prior art, an issue Jazz does
`
`not raise here. See ServiceNow, Inc. v. Hewlett-Packard Co., IPR2015-00707,
`
`Paper 12 at 14 (Aug. 26, 2015); Chamilia LLC v. Pandora Jewelry, LLC, No. 04-
`
`cv-6017, 2007 WL 2781246, at *6 n.4 (S.D.N.Y. Sept. 24, 2007); see also Paper
`
`No. 22 (Jazz’s Objections to Evidence) (lacking any objection to Exs. 1003-1006
`
`as inauthentic). Jazz’s cited cases are inapposite.
`
`b)
`
`Jazz’s Internet Archive evidence does not prove that
`Exs. 1004-1006 were not publicly available until after
`the critical date
`
`Jazz argues that because the web pages for Exs. 1004-1006 were first
`
`archived after the critical date, this proves the documents were not available until
`
`-6-
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`

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`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
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`after the critical date. Response at 8. This is not so. Submitted herewith is a Third
`
`Affidavit from Mr. Butler in which he soundly rejects this notion:
`
`The date a URL was first captured by the Wayback
`Machine is not indicative of the first date such material
`was available at that URL; it may have been available
`days, weeks, months, or years prior to the date it was first
`captured.
`
`Ex. 1058, ¶ 6. Indeed, the first available capture dates for Exs. 1004-1006 “do[ ]
`
`not represent the first time that the pdf was posted online at that address and it is
`
`possible that the pdf was available at this URL on an earlier date.” Ex. 1058, ¶¶ 6-
`
`8. Thus, Jazz’s Internet Archive evidence does not prove that Exs. 1004-1006 were
`
`not publicly available until after the critical date.
`
`5.
`
`The ACA was readily accessible by persons interested in the
`subject matter before the critical date
`
`Jazz argues that a POSA neither “would have been motivated to look to the
`
`Federal Register” for ACM announcements, nor “would have been sufficiently
`
`capable of finding” Ex. 1015 and following the link to FDA’s website to retrieve
`
`the ACA. Response at 15. But Jazz fails to show what an interested person would
`
`have done. Here, a POSAwho by definition is interested in drug distribution,
`
`safety and abusewould have readily located the ACA.
`
`-7-
`
`

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`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
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`a)
`
`A POSA here is interested in drug distribution, safety
`and abuse, and would have been motivated to look at
`the Federal Register for relevant notices
`
`Besides certain education and work experience, a POSA here “would have
`
`had knowledge of the literature” concerning drug distribution, and “would have
`
`been well aware of techniques related to” drug distribution, safety and abuse.
`
`Petition at 2-3 (citing Ex. 1007, ¶ 20). Naturally, such an interested POSA would
`
`have been motivated to look at the Federal Register for notices from “those
`
`agencies that are active in the world of drug distribution and drug safety and
`
`prescription drug abuse prevention.” Ex. 2045 at 293:12-14; see also Ex. 1007,
`
`¶ 47 (“[a] POSA would have known to look in the Federal Register and on the
`
`FDA’s website to obtain information related to existing and proposed risk
`
`management programs.”)
`
`Jazz does not offer its own definition of a POSA. Instead, Jazz truncates
`
`Par’s definition to eliminate those individuals “with a specific focus on drug
`
`distribution, safety, and abuse”i.e., any interested persons. Response at 20.3
`
`Armed with this modified definition, Jazz unsurprisingly concludes that such
`
`uninterested “POSAs” would not look at the Federal Register for notices relevant
`
`
`3 According to Jazz, such a POSA only would be interested in “post-market
`
`and/or post-approval” drug information. Response at 20.
`
`-8-
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`

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`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
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`to drug distribution, safety, and abuse. Response at 19-20.
`
`There is no credible evidence that the ACA was not sufficiently accessible
`
`by interested personsthe only persons relevant to the accessibility inquiry. See
`
`Bruckelmyer, 445 F.3d at 1378 (prior art must be accessible to “persons interested
`
`and ordinarily skilled in the subject matter”). Neither of Jazz’s alleged POSAs, Dr.
`
`DiPiro or Dr. Bergeron, has any interest or expertise in drug distribution, safety,
`
`and abuse. Ex. 1055 at 18:15-20:1, 243:2-5 (DiPiro); Ex. 1053 at 17:7-18:4, 48:10-
`
`51:9 (Bergeron). Dr. DiPiro opined that persons focused on drug distribution,
`
`safety, and abuse prevention exceed the skill of a POSA, and he had no opinion as
`
`to whether interested POSAs would have consulted the Federal Register for
`
`notices relevant to drug distribution, safety and abuse. Ex. 1056 at 293:1-10 and
`
`303:10-17.4 Indeed, in Dr. DiPiro’s opinion, a POSA “would not have knowledge
`
`of the ACA materials.” Ex. 1055 at 255:14-256:13.
`
`Even accepting, arguendo, Jazz’s “uninterested POSA” definition, Dr.
`
`DiPiro and Dr. Bergeron’s opinions that such a “POSA” would not have consulted
`
`
`4 Jazz also cited deposition testimony of Dr. Glenn Van Buskirk in an
`
`unrelated district court proceeding. Response at 17. However, Dr. DiPiro could not
`
`opine as to whether Dr. Van Buskirk even satisfied Jazz’s “uninterested POSA”
`
`definition. Ex. 1056 at 306:6-309:14.
`
`-9-
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`

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`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
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`the Federal Register here are subjective ipse dixit, and should be dismissed. “An
`
`expert's opinion must be supported by sufficient facts and data and cannot be based
`
`upon subjective belief or ipse dixit of the expert.” In re Maxim Integrated Prods.,
`
`Inc., Nos. 12-244, 12-945, 2015 WL 5311264, at *4 (W.D. Pa. Sept. 11, 2015).
`
`Here, Dr. DiPiro and Dr. Bergeron relied only on their subjective beliefs for their
`
`opinions, and neither conducted any research to support their opinions. Ex. 1055 at
`
`268:8-269:9, 294:8-296:11 (DiPiro); Ex. 1053 at 168:14-171:22 (Bergeron).5
`
`Because their opinions are mere ipse dixit, Dr. DiPiro and Dr. Bergeron’s opinions
`
`are of no probative value.
`
`b)
`
`A POSA exercising reasonable diligence would have
`been able to locate the ACA
`
`The Federal Register notice of the June 6, 2001 ACM “indicated that ‘[a]
`
`main focus of the deliberations will be on risk management issues’” attendant to
`
`Xyrem’s distributiona subject squarely of interest to a POSA here. Ex. 1007,
`
`¶ 47 (quoting Ex. 1015); see also id. ¶ 20. A POSA, exercising reasonable
`
`diligence, would have been able to locate the ACA by following the link in the
`
`Federal Register notice. Ex. 1007, ¶ 47. Jazz challenges this conclusion at its
`
`
`5 Indeed, Dr. DiPiro contradictorily stated in his declaration that a POSA
`
`would be capable of consulting the Federal Register for some purposes. See Ex.
`
`2046, ¶ 57.
`
`-10-
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`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
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`source, arguing that a POSA “would not have been sufficiently capable of finding
`
`the Federal Register notice” of the ACM “out of the 67,700 pages” of the Federal
`
`Register. Response at 22. Jazz’s argument amounts to an assertion that the Federal
`
`Register did not provide adequate notice to allow interested parties to find out
`
`about the ACM. This argument is without merit.
`
`The raison d'être of the Federal Register is to notify interested individuals of
`
`the actions of federal agencies. See Aris Gloves, Inc v. United States, 154 F. Supp.
`
`203, 209 (Cust. Ct. 1957), aff’d, 281 F.2d 954 (C.C.P.A. 1958) (“Congress, by
`
`statutory enactment, has designated the ‘Federal Register’ as the official
`
`publication in which notices by departments of the Federal Government shall
`
`appear”). The FACA requires that notice of ACMs “shall be published in the
`
`Federal Register” and that “[i]nterested persons shall be permitted to attend” such
`
`meetings. 5 U.S.C. app. 2 § 10(a)(2)-(3). Courts have consistently held that
`
`“publication in the Federal Register is legally sufficient notice to all interested or
`
`affected persons.” Williams v. Mukasey, 531 F.3d 1040, 1042 (9th Cir. 2008)
`
`(citation omitted).
`
`Jazz provides no factual basis to question the adequacy of notice here.
`
`Indeed, fifteen members of the public spoke at the June 7, 2001 ACM, refuting
`
`Jazz’s assertion that interested persons would not have been able to find the
`
`Federal Register notice. See Ex. 1003 at 3. Jazz’s argument should be dismissed.
`
`-11-
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`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
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`The totality of the evidence shows that Exs. 1004-1006 were available to the
`
`public and sufficiently accessible by interested persons. The Board correctly
`
`determined that the ACA was publicly accessible prior to the critical date.
`
`B.
`
`Claim Construction
`
`Claim terms in an IPR are given their broadest reasonable interpretation in
`
`light of the patent specification. 37 C.F.R. § 42.100(b) (2012). But, in an attempt to
`
`save the ’730 patent, Jazz and its experts ignore this standard by proposing overly
`
`restrictive constructions limited to specific embodiments in the specification.
`
`1.
`
`Jazz’s proposed narrowing of “periodic reports” has no
`basis
`
`The Board previously construed the claim term “generating with the
`
`computer processor periodic reports via the exclusive computer database to
`
`evaluate potential diversion patterns” to mean “querying the exclusive computer
`
`database via the computer processor to generate periodic reports containing
`
`prescriber, patient, and/or prescription related information that permits evaluation
`
`of potential diversion, misuse, or abuse of a prescription drug.” Decision at 22-23.
`
`Jazz now attempts to unreasonably narrow this term. In particular, Jazz
`
`asserts that “periodic reports” should be further construed to mean reports
`
`generated “at regular frequencies or intervals, as opposed to intermittently or upon
`
`request.” Response at 26. However, Jazz’s proposed construction contradicts the
`
`intrinsic and extrinsic evidence.
`
`-12-
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`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
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`The specification of the ’730 patent does not define the term “periodic.” Ex.
`
`1053 at 104:14-105:5 (Bergeron); Ex. 1056 at 318:14-319:18 (DiPiro). Jazz,
`
`however, asserts that “periodic reports” should be limited to reports “run at regular
`
`frequencies or intervals, as opposed to intermittently or upon request,” based solely
`
`on Figures 13A-C and their description in the specification. Response at 27 (citing
`
`Ex. 1001 at 8:22-24, 8:27-28; Figs. 13A-C). But Figures 13A-C are merely
`
`“sample reports” and there is no indication that the patent applicants intended to
`
`limit the scope of the claims to these Figures. See Ex. 1001 at 2:49-51, 2:55-65,
`
`8:22-24. Indeed, Dr. DiPiro admitted that Figures 13A-C are only sample
`
`embodiments of the alleged invention, and that other embodiments may be utilized.
`
`Ex. 1055 at 84:5-85:1, 85:7-11, 87:9-89:5, 90:2-7. Further, nothing in the
`
`specification indicates that the reports in Figures 13A-C are suitable for
`
`“evaluating potential diversion patterns.” See Ex. 1001 at 8:22-29.
`
`Jazz and its experts admit that Figure 4B, which the Board cited in its
`
`Institution Decision as illustrative of a “risk diversion report” (Decision at 22-23),
`
`discloses reports generated to investigate early refill requests, an indication of
`
`possible diversion patterns. Response at 28; Ex. 1056 at 323:15-324:8 (DiPiro);
`
`Ex. 1053 at 81:10-82:24 (Bergeron). Circuitously, Jazz argues that Figure 4B is
`
`“an unclaimed embodiment” of the ’730 patent because it discloses reports that are
`
`generated intermittently or upon request, and not at regular frequencies. Response
`
`-13-
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`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
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`at 28-29 & n.10; Ex. 1056 at 344:20-345:4 (DiPiro); Ex. 1053 at 132:6-24
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`(Bergeron). But Jazz’s argument that the reports disclosed in Figure 4B are an
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`“unclaimed embodiment” directly contradicts the patent applicants’ statements
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`during prosecution. In an Appeal Brief, the patent applicants cited Figure 4B and
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`corresponding disclosure in the specification as support for the “periodic reports”
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`claim term. Ex. 1047 at 6 (citing Ex. 1048 at page 9, lines 12-19 and Figure 4,
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`436). Tellingly, the patent applicants did not point to Figures 13A-C as support for
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`this limitation. Id. Jazz’s proposed construction thus lacks basis in the intrinsic
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`record.
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`Jazz further asserts that its proposed construction of “periodic reports” is
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`supported by Dr. Valuck’s testimony. Response at 28 (citing Ex. 2044 at 184:8-
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`16). But Dr. Valuck merely testified that, according to the patent, “reports” to
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`evaluate diversion can be generated “either on an ad hoc basis or on a regular
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`basis.” Ex. 2044 at 184:15-16. There is no support for Jazz’s assertion that,
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`according to Dr. Valuck, “a POSA would not consider ‘ad hoc’ reports to be
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`‘periodic.’” Response at 28 (citing, inter alia, Ex. 2044 at 184:8-16). Indeed, Dr.
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`Valuck specifically testified that “periodic” could mean something occurring at
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`standard or non-standard (i.e., intermittent) intervals (Ex. 2044 at 177:16-178:3),
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`testimony that Dr. Bergeron admitted he did not consider in forming his opinions.
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`-14-
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`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
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`Ex. 1053 at 121:13-122:8. Dr. Valuck’s testimony does not support Jazz’s
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`proposed construction.
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`Finally, Jazz argues that the Merriam-Webster’s Collegiate Dictionary
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`definition of “periodic” supports its proposed claim construction. Response at 28
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`(citing Ex. 2043 at 3). But this extrinsic evidence should be accorded little weight:
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`Dr. DiPiro and Dr. Bergeron each admitted that it was the only dictionary
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`definition that he considered. Ex. 1053 at 163:14-164:15 (Bergeron); Ex. 1055 at
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`94:5-19 (DiPiro). Other dictionaries, including the unabridged Merriam-Webster’s
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`dictionary, also define “periodic” as “intermittent,” which contradicts Jazz’s
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`proposed construction. See Ex. 1049 at 3; Ex. 1050 at 3; Ex. 1051 at 3. Thus, the
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`extrinsic evidence does not support Jazz’s argument.
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`2.
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`Jazz seeks to unduly restrict “information identifying
`patients”
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`Jazz’s proposed construction of “the prescription requests [for GHB]
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`containing information identifying patients” fares no better. Jazz argues that, based
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`solely on Figure 9 and its description in the specification, the term requires the
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`prescription requests to contain “the patient’s name, social security number, date of
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`birth, sex, and complete address information, including city, state and zip code.”
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`Response at 31 (citing Ex. 1001 at 8:4-5 & Fig. 9). This construction is hardly the
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`-15-
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`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
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`broadest reasonable interpretation. There is no indication that the patent applicants
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`intended to limit the claims to the specific information Jazz proposes.
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`Jazz’s proposed construction improperly reads the limitations of Figure 9
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`into the claims. Jazz’s expert Dr. DiPiro admitted that Figure 9 is “a copy of one
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`example prescription and enrollment form.” Ex. 1055 at 100:7-101:8; Ex. 1001 at
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`2:41-42 (emphasis added). Dr. DiPiro further admitted that the drawings in the
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`specification are only sample embodiments of the alleged invention, and that other
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`embodiments may be utilized. Ex. 1055 at 87:9-89:5, 90:2-7. “[A] particular
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`embodiment appearing in the written description may not be read into a claim
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`when the claim language is broader than the embodiment.” SuperGuide Corp. v.
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`DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004) (citing Electro Med.
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`Sys., S.A. v. Cooper Life Scis., Inc., 34 F.3d 1048, 1054 (Fed. Cir. 1994)). Jazz’s
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`proposed construction unduly and improperly narrows the scope of the claims.
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`Jazz further asserts that its proposed construction of “information identifying
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`patients” is supported by Dr. Valuck’s testimony. Response at 30-32 (citing Ex.
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`2044 at 99:18-100:10). But Dr. Valuck testified that “it would be possible to
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`identify the patient from a smaller number of pieces of information” than those
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`Jazz asserts are required. Ex. 2045 at 278:5-24. Thus, Jazz’s proposed construction
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`is not consistent with the understanding of a POSA.
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`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
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`Lastly, Jazz asserts that its proposed construction should be adopted because
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`it is consistent with the ’730 patent’s “entire goal [to] guard against potential
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`abuse, misuse, and diversion.” Response at 33. But Jazz fails to show why all of
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`the information Jazz asserts must be included on the prescription form meets that
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`goal, when only “a smaller number of pieces of information” would be sufficient.
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`Ex. 2045 at 278:20. Further, there is no legal basis for Jazz’s “entire goal” theory.
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`Indeed, the Board has rejected similar attempts to read limitations into claims
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`based on the “primary goal” of the patent. See SK Innovation Co. v. Celgard, LLC,
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`IPR2014-00679, 2015 WL 5722450, at *5–6 (P.T.A.B. Sept. 25, 2015). Jazz’s
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`proposed construction is thus improper.
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`3.
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`Jazz also seeks to unduly restrict “information identifying
`prescribers”
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`Similar to its proposed construction of “information identifying patients”
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`(see section II.B.2, supra), Jazz proposes that “information identifying . . . various
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`credentials of the any and all [medical doctors/authorized prescribers]” (hereinafter
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`“information identifying prescribers”) requires the prescription requests to contain
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`the prescriber’s “name, license number, DEA number, and physician specialty.”
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`Response at 35 (citing Ex. 2046, ¶¶ 45-49). Jazz again solely relies on Figure 9 and
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`its description in the specification, despite no indication that the applicants
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`intended to limit the claims to the specific information Jazz proposes.
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`-17-
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`IPR2015-00554—Patent No. 7,668,730
`Petitioners’ Reply to Patent Owner’s Response
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`Again, Jazz seeks to improperly narrow the scope of the claims to the
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`embodiment described in Figure 9. But Dr. DiPiro admitted that Figure 9 is one
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`example of a prescription form with the indicated prescriber information. Ex. 1055
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`at 104:21-105:9; Ex. 1001 at 2:41-42. Barring a clear disavowal of claim scope
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`(which is not present here), a broad claim term cannot be limited to what is
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`disclosed in a single embodiment. See SuperGuide Corp., 358 F.3d at 875.
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`Jazz further asserts that its proposed construction of “information identifying
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`prescribers” is supported by Dr. Valuck’s testimony. Response at 34-35 (citing Ex.
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`2044 at 181:1-23). But Dr. Valuck testified that “fewer pieces of that information
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`could be enough” to identify a prescriber. Ex. 2045 at 279:4-280:3. Therefore,
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`Jazz’s proposed construction is not consistent with the understanding of a POSA.
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`Lastly, Jazz again asserts that its proposed construction is consistent with the
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`’730 patent’s “entire goal.” Response at 36. As noted in section II.B.2, supra, the
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`Board has previously rejected such an argument. See SK Inn