IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MILTENYI BIOMEDICINE GmbH and MILTENYI BIOTEC INC.
`Petitioner
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`v.
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`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
`Patent Owner
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`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
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`PATENT OWNER’S OPPOSITION TO PETITIONERS’
`MOTION FOR ADDITIONAL DISCOVERY
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`41417243.2
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`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
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`PATENT OWNER’S EXHIBIT LIST
`
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`IPR2022-00855 (Patent 9,540,445 B2)
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`IPR2022-00855 (Patent 9,540,445 B2)
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`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`
`Petitioners again come to the Board asserting that there is something improper
`
`about Dr. Bagg’s hematopathology assessments resulting in co-authorship of Porter
`
`(EX1012) but not inventorship of the challenged patents. The Board should reject this
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`Motion for additional discovery, consistent with having repeatedly declined to adopt
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`Petitioners’ theory. IPR2022-00853, Paper 11 at 29-33 (denying institution, in part,
`
`because “we are not persuaded that Petitioner can establish that Porter qualifies as
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`prior art under §102(a)”); IPR2022-00855, Paper 10 at 28.
`
`The motion for additional discovery is based on at least two clear legal errors.
`
`First, it relies on Dr. Bagg’s credentials and inclusion as a co-author to again
`
`posit that Dr. Bagg must have made an inventive contribution in Porter. This
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`misapprehends the invention, the conception and reduction to practice of which were
`
`separate from Dr. Bagg’s follow-up work. And it further ignores the law for over 100
`
`years that credentialed scientists like Dr. Bagg can assist inventors in reducing an
`
`invention to practice without becoming inventors.
`
`Second, Petitioners presuppose that they are entitled to district-court-style
`
`discovery in an IPR. Petitioners fail to cite any Board precedent applying the Garmin
`
`factors and instead rely on district court discovery rulings. But this Board has long
`
`recognized Congress’s intent that discovery in IPRs be minimal. During the parties’
`
`meet and confer, Patent Owner specifically inquired whether Petitioners were aware
`
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`of any Board precedent authorizing discovery anywhere near the requested scope.
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
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`Petitioners had none to cite then, and their Motion is equally silent on that point.
`
`Petitioners’ burdensome requests are readily distinguishable from the limited
`
`discovery authorized by the Board in other IPRs.
`
`I.
`
`
`
`Legal Standard
`
`The parties agree that the Garmin factors control. See Garmin Int’l v. Cuozzo
`
`Speed Techs, IPR2012-00001, Paper 26 at 6-7 (PTAB Mar. 5, 2013). However,
`
`Petitioners’ citation to Garmin ignores the Board’s recognition in Apple v. Achates
`
`that additional discovery in IPRs is “less than what is normally available in district
`
`court patent litigation,” for “Congress intended inter partes review to be a quick and
`
`cost effective alternative to litigation.” Apple Inc. v. Achates Reference Publ’g, Inc.,
`
`IPR2013-00080, Paper 18 at 3 (PTAB Apr. 3, 2013). See also Garmin at 5.
`
`II. Garmin Factor 1: Petitioners’ assertions are wrong and fail to show more
`
`than a possibility or mere allegation that discovery will yield useful information.
`
`A.
`
`Petitioners fail to link Dr. Bagg’s work in Porter to the claims.
`
`Petitioners base their request for documents on the premise that Dr. Bagg
`
`“substantively contributed to the determination of effectiveness.” Mot. 2-3. The
`
`Petition pointed to, and Petitioners again highlight, Porter’s disclosure of remission
`
`“ten months after treatment.” ‘852 Pet. 59 & ‘855 Pet. 76 (emphasis added) (citing
`
`EX1012, 727); see Mot. 3 (discussing EX2044). But Petitioners never explain how
`
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`9
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`any assessment Dr. Bagg helped perform was necessary to, let alone part of
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`
`conceiving—or even reducing to practice (which would be irrelevant in any case)—a
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`claim to a composition having an “anti-tumor effect.” Nor do Petitioners mention, let
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`alone rebut, the evidence that the laboratory results Dr. Bagg generated (within the
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`ordinary course of his role as a laboratory-based pathologist and at the request and
`
`direction of his co-authors) regarding remission were “subsequent to and distinct from
`
`appreciation of an ‘anti-tumor effect,’” IPR2022-00852, Paper 18 at 29 (emphasis
`
`added). Petitioners have not demonstrated that Dr. Bagg’s work would constitute
`
`inventorship even if the requested discovery were to establish that Dr. Bagg was not
`
`“a mere lab technician,” Mot. 4. That alone defeats Garmin factor 1.
`
`wB. Petitioners’ hypothesis is wrong as a matter of law.
`
`Furthermore, even a “substantial contribution to [...] the acquisition, analysis, or
`
`interpretation of data for the work” under the cited ICMJE framework for authorship
`
`is legally insufficient to render Porter the work of another. “An inventor may use the
`
`services, ideas, and aid of others in the process of perfecting his invention without
`
`losing his right to a patent.” Shatterproof Glass Corp. v. Libbey-Owens Ford Co., 758
`
`F.2d 613, 624 (Fed. Cir. 1985).
`
`
`
`Indeed, the fact pattern alleged here—an attempt to invalidate an invention
`
`based on the involvement of others in assessing efficacy—has been repeatedly
`
`rejected by courts of all levels for over a century. E.g., Minerals Separation v. Hyde,
`
`
`
`10
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`

`242 U.S. 261 (1916). For example, the defendant in Burroughs Wellcome Co. v. Barr
`
`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`
`Laboratories, Inc. sought to invalidate claims directed to methods of treating HIV by
`
`asserting that NIH scientists who performed tests that demonstrated efficacy were co-
`
`inventors. Burroughs Wellcome Co. v. Barr Labs., Inc., 828 F.Supp. 1208, 1210-11
`
`(E.D.N.C. 1993). Both the district court and the Federal Circuit rejected this attempt,
`
`with the district court stating, “The court does not believe that the phrase ‘definite and
`
`permanent idea’ requires that the BW Co. inventors know that AZT would be effective
`
`in treating humans having AIDS. For conception to be complete, the law does not
`
`require an idea to be proven to actually work.” Id. at 1212 (emphasis in original),
`
`aff’d, 40 F.3d 1223 (Fed. Cir. 1994). Of relevance to Petitioners’ “mere lab
`
`technician” characterization, Mot. 4, the Federal Circuit noted that that scientists
`
`aiding with assessment of efficacy can act as more than the canonical “pair of hands”
`
`without being co-inventors. 40 F.3d at 1230.
`
`
`
`Moreover, Dr. Bagg’s credentials and experience do not create any tension with
`
`the proper inventorship. Even an accomplished pathologist such as Dr. Bagg can act
`
`on others’ (such as a Principal Investigator’s) behalf, just like the doctoral-level NIH
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`scientists in Burroughs Wellcome. 828 F.Supp. at 1213 (E.D.N.C. 1993). Similarly,
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`the Board’s predecessor rejected a pre-A.I.A. § 102(f) assertion where work relating
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`to expression of the EPO gene in mammalian host cells and isolation of the EPO
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`glycoprotein expression product were each led by two non-inventive colleagues (each
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`having a Ph.D.). Fritsch v. Lin, 1991 WL 332570 at *3 (B.P.A.I. 1991).
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`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
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`C. Google’s “design, trial, and analysis of results” quote is taken out of context.
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`
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`Petitioners cite Google LLC v. IPA Techs. for the proposition that, “the inquiry
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`focuses on whether the relevant content of the reference—‘which includes the design,
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`trial, and analysis of results’—was solely the work of the inventor(s).” Mot. 1.
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`Google did not purport to suggest a blanket rule that any analysis of any results
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`referenced in a paper would be dispositive of the inventorship inquiry. Google, like
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`other cases, focused on the particular facts at hand and who conceived of the
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`invention. Moreover, the quoted language actually comes from Allergan, Inc. v.
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`Apotex Inc., 754 F.3d 952, 969 (Fed. Cir. 2014)—a citation Petitioners omit. In that
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`case, the patent owner belatedly attempted to disqualify references by asserting that
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`they described the work of a named inventor who was not even listed as a co-author
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`on one of them. Id. at 968-70. The Court rejected that attempt on the basis of a
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`number of facts. The Court’s reference to the “design, trial, and analysis of results”
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`did not purport to set forth the test of whether the reference described “the work of
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`another,” but was rather a description of the content of the references at issue. Id. at
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`969.
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`III. Garmin Factor 2: This factor is undisputedly inapplicable and thus neutral.
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`IV. Garmin Factor 3: Equivalent information is available by deposition.
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`Petitioners cite to district-court decisions such as Penn National and Pugh for
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`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
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`the proposition that depositions are not a substitute for document discovery. But those
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`decisions are entirely inapposite here, where the Board has consistently held that
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`sweeping district-court-style document discovery is not available in IPRs in the first
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`place. See, e.g., Garmin and Apple, infra. Penn National’s statement regarding
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`whether a deposition would be an adequate substitute for something Petitioners have
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`no entitlement to in the first place in this forum is therefore entirely beside the point.
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`Nonetheless, consistent with the Board’s rules, Dr. Bagg will be made available
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`for deposition, and Petitioners will have the opportunity to cross-examine him and
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`explore their theories in that forum. As such, Petitioners are able to “generate
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`equivalent information by other means” as contemplated by Garmin factor 3.
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`V. Garmin Factors 4 & 5: The requests are broad and overly burdensome.
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`
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`Petitioners have not cited any decision by the Board authorizing document
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`discovery of a scope similar to that requested here. Petitioners’ requests seek all
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`documents in Patent Owner’s possession showing Dr. Bagg’s “contributions to
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`Porter” as well as his “involvement in” various determinations regarding numerous
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`patients a decade ago. Contrary to Petitioner’s characterizations, these requests would
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`be broad even in district court; IPR discovery, when permitted, is far more targeted.
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`Additionally, the “documents” sought include information which may
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`necessarily be derived from individual patient medical records. The burden is thus
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`compounded by the need for redaction. For example, if Dr. Bagg accessed Patent
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`Owner’s electronic medical records platform in 2006 to make his determinations,
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`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
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`Patent Owner would need to collect those records (e.g., as “showing [his] involvement
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`in determinations of remission”). This is a materially different undertaking than the
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`submission of selected patient-level data in a journal article such as Porter (which
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`Petitioners have and, of course, can review in preparation for Dr. Bagg’s deposition)
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`and is barred by 55 Pa. Code § 5100.35(b)(1) without a court order.
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`
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`Even if patient-level information can be derived from study documents or data
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`sets outside of electronic medical records, these documents are more than ten years
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`old and are unduly burdensome to locate and obtain through a paper and electronic
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`record search, and also unduly burdensome to review. Dr. Bagg and the inventors are
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`faculty members or former staff of Patent Owner. Patent Owner’s Policy on Privacy
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`in the Electronic Environment reflects the different considerations of an academic
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`setting relative to other patentees. EX2082. Collecting faculty documents such as e-
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`mail from Patent Owner’s faculty would further impose a “burden on human
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`resources” under Garmin by either requiring the relevant faculty members to step
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`away from their patient-care and research responsibilities to review any archives with
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`University counsel or by employing other procedures under Patent Owner’s policy.
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` VII. Conclusion
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`The Board should reject Petitioners’ attempt to contravene Congressional
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`guidance and turn these (and future) IPRs into discovery-intensive affairs resembling
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`district-court litigation.
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`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`
`Dated: April 4, 2023
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`Respectfully submitted,
`
`By:
`
`
`Jessamyn S. Berniker (Reg. No.
`72,328)
`David M. Krinsky (Reg. No. 72,339)
`Thomas S. Fletcher (Reg. No.
`72,383)
`WILLIAMS & CONNOLLY LLP
`680 Maine Avenue SW
`Washington, DC 20024
`Tel: (202) 434-5000
`jberniker@wc.com
`dkrinsky@wc.com
`tfletcher@wc.com
`
`
`Backup Counsel for Real Party in
`Interest and Licensee Novartis
`Pharma AG
`
`/Brian R. Landry/
`Brian Landry (Reg. No. 62,074)
`SAUL EWING LLP
`131 Dartmouth Street, Suite 501
`Boston, MA 02116
`Tel: (617) 912-0969
`brian.landry@saul.com
`
`Counsel for Patent Owner
`
`Kathryn Doyle (Reg. No. 36,317)
`SAUL EWING LLP
`Centre Square West
`1500 Market Street, 38th Floor
`Philadelphia, PA 19102
`Tel: (215) 972-7734
`kathryn.doyle@saul.com
`
`Alireza Behrooz (Reg. No. 60,882)
`SAUL EWING LLP
`1919 Pennsylvania Avenue, N.W.,
`Suite 550
`Washington, DC 20006-3434
`Tel: (202) 295-6687
`alireza.behrooz@saul.com
`Backup Counsel for Patent Owner
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`IPR2022-00852 (Patent 9,518,123 B2)
`IPR2022-00855 (Patent 9,540,445 B2)
`
`Certification of Service Under 37 C.F.R. § 42.6(e)(4)
`
`
`The undersigned hereby certifies that the Patent Owner’s Opposition to Petitioners’
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`Motion for Additional Discovery was served in its entirety by filing through the Patent
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`Trial and Appeal Case Tracking System (P-TACTS), as well as providing a courtesy
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`copy via e-mail to the following attorneys of record for Petitioners listed below:
`
`Yite John Lu
`
`Gary N. Frischling
`
`
`
`PTABDocketL2Y7@orrick.com
`
`PTABDocketG2F1@orrick.com
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`Date: April 4, 2023
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`
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`By: /Brian R. Landry/
`Reg. No. 62,074
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`16
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