`(August 2018)
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`Introduction ................................................................................................................................... 2
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`I. General Procedures .................................................................................................................. 2
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`G. Expert Testimony .................................................................................................................. 2
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`II. Petitions and Motions Practice .............................................................................................. 5
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`A. General Motions Practice Information .................................................................................. 5
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`3. Word Count and Page Limits ............................................................................................. 5
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`D. Institution of Trial ................................................................................................................. 8
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`2. Considerations in Instituting a Review .............................................................................. 8
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`35 U.S.C. §§ 314(a), 324(a) ................................................................................................ 8
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`35 U.S.C. § 325(d) ............................................................................................................ 11
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`I. Reply to Patent Owner Response and Reply for a Motion to Amend; Sur-Replies ............. 14
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`K. Challenging Admissibility; Motions to Exclude; Motions to Strike................................... 16
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`M. Oral Hearing ....................................................................................................................... 19
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`APPENDIX A: Sample Scheduling Order for Inter partes Review, Post-Grant Review, and
`Covered Business Method Patents Review (based on the trial rules). ................................... 24
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`A. GENERAL INSTRUCTIONS ....................................................................................... 24
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`B. DUE DATES .................................................................................................................. 27
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`IPR2018-01714
`Celgene Ex. 2002, Page 1
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`Introduction
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`The Office published the Office Patent Trial Practice Guide (“Practice Guide”) in August 2012,
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`concurrent with the promulgation of the AIA Trial Rules. See 77 Fed. Reg. 48,756 (Aug. 14,
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`2012). The Practice Guide was intended to apprise the public of standard practices before the
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`Board during AIA trial proceedings, including inter partes reviews, post-grant reviews, covered
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`business method reviews, and derivation proceedings. The Practice Guide was also intended to
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`encourage consistency of procedures among panels of the Board.
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`
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`The Office is committed to updating the Practice Guide to take into account stakeholder
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`feedback, lessons learned during the years since the first AIA trial, and the natural evolution of
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`the Board’s practices. In order to expedite these updates and provide guidance to the public as
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`quickly as possible, the Office has chosen to issue updates to the Practice Guide on a section-by-
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`section, rolling basis, rather than a single, omnibus update addressing all aspects of the current
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`Practice Guide. Sections of the Practice Guide changed or added in this update are set forth
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`below.
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`
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`I. General Procedures
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`G. Expert Testimony
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`Expert testimony may be submitted with the petition, preliminary response, and at other
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`appropriate stages in a proceeding as ordered or allowed by the panel overseeing the trial.
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`Expert opinion testimony is generally permitted where the expert’s scientific, technical, or other
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`specialized knowledge will help the trier of fact to understand the evidence or to determine a fact
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`in issue. Fed. R. Evid. 702(a).
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`IPR2018-01714
`Celgene Ex. 2002, Page 2
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`An expert witness must be qualified as an expert by knowledge, skill, experience, training, or
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`education to testify in the form of an opinion. Fed. R. Evid. 702. There is, however, no
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`requirement of a perfect match between the expert’s experience and the relevant field. SEB S.A.
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`v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). A person may not need to be
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`a person of ordinary skill in the art in order to testify as an expert under Rule 702, but rather
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`must be “qualified in the pertinent art.” Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d
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`1356, 1363–64 (Fed. Cir. 2008). For example, the absence of an advanced degree in a particular
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`field may not preclude an expert from providing testimony that is helpful to the Board, so long as
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`the expert’s experience provides sufficient qualification in the pertinent art.
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`
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`Expert testimony is presented in the form of an affidavit or declaration. See 37 C.F.R.
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`§ 42.53(a). Expert testimony may have many uses. For example, it may be used to explain the
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`relevant technology to the panel. It may also be used to establish the level of skill in the art and
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`describe the person of ordinary skill in the art. Experts may testify about the teachings of the
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`prior art and how they relate to the patentability of the challenged claims. Expert testimony may
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`also be offered on the issue of whether there would have been a reason to combine the teachings
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`of references in a certain way, or if there may have been a reasonable expectation of success in
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`doing so. If evidence of objective indicia of nonobviousness has been entered into the record, an
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`expert may also provide testimony as to how this evidence should be weighed against evidence
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`of unpatentability, or may explain the nature and import of such objective evidence.
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`IPR2018-01714
`Celgene Ex. 2002, Page 3
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`The Board has broad discretion to assign weight to be accorded expert testimony. Yorkey v.
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`Diab, 601 F.3d 1279, 1284 (Fed. Cir. 2010). However, the testimony must be based on
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`sufficient facts and data. Fed. R. Evid. 702(b). “Expert testimony that does not disclose the
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`underlying facts or data on which the opinion is based is entitled to little or no weight.”
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`37 C.F.R. § 42.65(a). Furthermore, the testimony must be the product of reliable principles and
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`methods. Fed. R. Evid. 702(c). Moreover, an expert must reliably apply the principles and
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`methods to the facts of the case. Fed. R. Evid. 702(d).
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`
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`The rules governing the conduct of AIA trial proceedings were designed to promote fairness and
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`efficiency. For instance, 37 C.F.R. § 42.24(a) sets word limits for petitions, motions, and replies,
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`and § 42.6(a)(3) prohibits incorporating arguments by reference from one document into another.
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`Thus, parties that incorporate expert testimony by reference in their petitions, motions, or replies
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`without providing explanation of such testimony risk having the testimony not considered by the
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`Board. See Cisco Systems, Inc. v. C-Cation Techs., LLC, Case IPR2014-00454 (PTAB Aug. 29,
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`2014) (Paper 12) (informative).
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`
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`Expert testimony may be presented to establish the scope and content of the prior art for
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`determining obviousness and anticipation. Such testimony may be helpful in evaluating, for
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`example, the “prior art as viewed with the knowledge of one of skill in the art at the time of
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`invention.” Trintec Indus., Inc. v. Top-U.S.A. Corp., 295 F.3d 1292, 1297 (Fed. Cir. 2002).
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`Expert testimony, however, cannot take the place of a disclosure in a prior art reference, when
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`that disclosure is required as part of the unpatentability analysis. For example, because “[a]
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`claim is anticipated only if each and every element as set forth in the claim is found, either
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`IPR2018-01714
`Celgene Ex. 2002, Page 4
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`expressly or inherently described, in a single prior art reference,” Verdegaal Bros., Inc. v. Union
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`Oil Co. of Cal., 814 F.2d 628, 631 (Fed. Cir. 1987), a petitioner asserting anticipation cannot rely
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`on its expert to supply disclosure of a claim element that is not expressly or inherently present in
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`the reference. Similarly, in an obviousness analysis, conclusory assertions from a third party
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`about general knowledge in the art cannot, without supporting evidence of record, supply a
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`limitation that is not evidently and indisputably within the common knowledge of those skilled in
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`the art. K/S Himpp v. Hear-Wear Techs., LLC, 751 F.3d 1362, 1365 (Fed. Cir. 2014).
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`Furthermore, because an inter partes review may only be requested “on the basis of prior art
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`consisting of patents or printed publications,” 35 U.S.C. § 311(b), expert testimony cannot take
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`the place of disclosure from patents or printed publications. In other words, expert testimony
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`may explain “patents and printed publications,” but is not a substitute for disclosure in a prior art
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`reference itself.
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`
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`II. Petitions and Motions Practice
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`A. General Motions Practice Information
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`
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`
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`3. Word Count and Page Limits
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`A word count limit applies to petitions, patent owner preliminary responses, patent owner
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`responses, and petitioner replies to patent owner responses, and any sur-replies filed in AIA trial
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`proceedings. For all other briefing, a page limit applies. 37 C.F.R. § 42.24. The rules set a limit
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`of 14,000 words for petitions requesting IPR and derivation proceedings, and a limit of 18,700
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`words for petitions requesting PGR and CBM proceedings. § 42.24(a). Motions, other than
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`motions to amend, are limited to 15 pages. Id. Motions to amend are limited to 25 pages. Id.
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`Patent owner preliminary responses and patent owner responses to a petition are subject to the
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`IPR2018-01714
`Celgene Ex. 2002, Page 5
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`same word limits as the corresponding petition. Oppositions to other motions, including motions
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`to amend, are subject to the same page limits as the corresponding motion. 37 C.F.R. § 42.24(b).
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`Replies to patent owner responses to petitions are limited to 5,600 words, replies to oppositions
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`to motions to amend are limited to 12 pages, and replies to all other oppositions are limited to
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`5 pages. § 42.24(c). Sur-replies, if authorized, are subject to the same word or page limits as the
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`reply, unless the Board orders otherwise.
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`
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`37 C.F.R. § 42.24(d) requires that any paper whose length is specified by type-volume limits
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`must include a certification stating the number of words in the paper. In making such a
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`certification, a party may rely on the word count of the word-processing system used to prepare
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`the paper. Page and word count limits do not include table of contents, a table of authorities,
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`mandatory notices under § 42.8, a certificate of service, or appendix of exhibits or claim listing;
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`but this exemption from word count limits does not apply to grounds for standing. See 37 C.F.R.
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`§ 42.24(a)(1); 81 FR 24702–03 (April 27, 2016). A party is not required to submit a statement of
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`material facts in its briefing. § 42.22. Further, double spacing is not required for claim charts.
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`§ 42.6(a)(2)(iii).
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`
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`Federal courts routinely use word count limits to manage motions practice, as “[e]ffective
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`writing is concise writing.” Spaziano v. Singletary, 36 F.3d 1028, 1031 n.2 (11th Cir. 1994).
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`Federal courts have found that word count limits ease the burden on both the parties and the
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`courts, and patent cases are no exception. Microsoft Corp. v. DataTern, Inc., 755 F.3d 899, 910
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`(Fed. Cir. 2014) (explaining that allowing a party to incorporate by reference, resulting in
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`exceeding court’s allowable word count would be fundamentally unfair).
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`IPR2018-01714
`Celgene Ex. 2002, Page 6
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`Although parties are given wide latitude in how they present their cases, the Board’s experience
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`is that the presentation of an overwhelming number of issues tends to detract from the argument
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`being presented, and can otherwise cause meritorious issues to be missed or discounted. Thus,
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`parties should avoid submitting a repository of all the information that a judge could possibly
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`consider, and instead focus on concise, well-organized, easy-to-follow arguments supported by
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`readily identifiable evidence of record. Another factor to keep in mind is that judges of the
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`Board are familiar with the general legal principles involved in issues which come before the
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`Board. Accordingly, unless there is a dispute over the applicable law, extended discussions of
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`general patent law principles may not be necessary.
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`
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`The Office provides the following practical guidance regarding compliance with the word count
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`limits. With a word count limit, parties may include concise arguments in claim charts if they
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`choose. Moreover, when certifying word count, a party need not go beyond the routine word
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`count supplied by their word processing program. Parties should not abuse the process.
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`Excessive words in figures, drawings, or images, deleting spacing between words, or using
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`excessive acronyms or abbreviations for word phrases, in order to circumvent the rules on word
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`count, may lead to a party’s brief not being considered. See, e.g., Pi-Net Int’l, Inc. v. JPMorgan
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`Chase & Co., 600 F. App’x 774 (Fed. Cir. 2015). Except in cases of obvious abuse, the Board
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`will generally accept a party’s certification of compliance with word count limits. If a party feels
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`that it would suffer undue prejudice from an opposing party’s alleged word count limit violation
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`or abuse, that party should raise the issue with the Board promptly after discovering the issue.
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`The Board expects the parties to take reasonable steps to remedy any such issues before
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`IPR2018-01714
`Celgene Ex. 2002, Page 7
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`approaching the Board. If an opposing party raises a word count limit violation or abuse, the
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`Board will consider such a violation or abuse on a case-by-case basis.
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`D. Institution of Trial
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`2. Considerations in Instituting a Review
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`The Board institutes the trial on behalf of the Director. 37 C.F.R. § 42.4(a). In deciding whether
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`to institute the trial, the Board considers at a minimum whether or not a party has satisfied the
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`relevant statutory institution standard. The Board will also take into account whether various
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`considerations, including those discussed below, warrant the exercise of the Director’s discretion
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`to decline to institute review. See, e.g., 35 U.S.C. §§ 314(a), 324(a). Among other things, the
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`Board will also take into account whether the same or substantially the same prior art or
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`arguments were previously presented to the Office. See, e.g.,35 U.S.C. § 325(d).
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`
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`35 U.S.C. §§ 314(a), 324(a)
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`Sections 314(a) and 324(a) provide the Director with discretion to deny a petition. See 35 U.S.C.
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`§ 314(a) (stating “[t]he Director may not authorize an inter partes review to be instituted unless .
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`. . .”); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2140 (“[T]he agency’s decision to deny
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`a petition is a matter committed to the Patent Office’s discretion.”). Under 35 U.S.C.
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`§ 316(a)(2), the Director shall prescribe regulations “setting forth the standards for the showing
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`of sufficient grounds to institute a review under section 314(a).” Once instituted, “[petitioner] is
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`entitled to a final written decision addressing all of the claims it has challenged.” SAS Institute,
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`Inc. v. Iancu, 138 S. Ct. 1348, 1359 (2018).
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`IPR2018-01714
`Celgene Ex. 2002, Page 8
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`The Director’s discretion is informed by 35 U.S.C. §§ 316(b) and 326(b), which require the
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`Director to “consider the effect of any such regulation [under this section] on the economy, the
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`integrity of the patent system, the efficient administration of the Office, and the ability of the
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`Office to timely complete proceedings instituted under this chapter.” The AIA was “designed to
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`establish a more efficient and streamlined patent system that will improve patent quality and
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`limit unnecessary and counterproductive litigation costs.” H.R. Rep. No. 112–98, pt. 1, at 40
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`(2011), 2011 U.S.C.C.A.N. 67, 69 (Post grant reviews were meant to be “quick and cost
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`effective alternatives to litigation”); see also S. Rep. No. 110–259, at 20 (2008). In General
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`Plastic Co., Ltd. v. Canon Kabushiki Kaisha, the Board recognized these goals of the AIA, but
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`also “recognize[d] the potential for abuse of the review process by repeated attacks on patents.”
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`IPR2016-01357, slip op. 16–17 (PTAB Sept. 6, 2017) (Paper 19) (precedential).
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`
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`Accordingly, to aid the Board’s assessment of “the potential impacts on both the efficiency of the
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`inter partes review process and the fundamental fairness of the process for all parties,” General
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`Plastic enumerated a number of non-exclusive factors that the Board will consider in exercising
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`discretion on instituting inter partes review, especially as to “follow-on” petitions challenging
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`the same patent as challenged previously in an IPR, PGR, or CBM proceeding. Id. at 18. The
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`General Plastic non-exclusive factors include the following:
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`1. whether the same petitioner previously filed a petition directed to the same claims of
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`the same patent;
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`2. whether at the time of filing of the first petition the petitioner knew of the prior art
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`asserted in the second petition or should have known of it;
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`IPR2018-01714
`Celgene Ex. 2002, Page 9
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`3. whether at the time of filing of the second petition the petitioner already received the
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`patent owner’s preliminary response to the first petition or received the Board’s
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`decision on whether to institute review in the first petition;
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`4. the length of time that elapsed between the time the petitioner learned of the prior art
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`asserted in the second petition and the filing of the second petition;
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`5. whether the petitioner provides adequate explanation for the time elapsed between the
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`filings of multiple petitions directed to the same claims of the same patent;
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`6. the finite resources of the Board; and
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`7. the requirement under 35 U.S.C. § 316(a)(11) to issue a final determination not later
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`than 1 year after the date on which the Director notices institution of review.
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`Id. at 15–16.
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`
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`The General Plastic factors, alone or in combination, are not dispositive, but part of a balanced
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`assessment of all relevant circumstances in the case, including the merits. Id. at 15 (“There is no
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`per se rule precluding the filing of follow-on petitions.”). The General Plastic factors are also
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`not exclusive and are not intended to represent all situations where it may be appropriate to deny
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`a petition. Id. at 16. There may be other reasons besides the “follow-on” petition context where
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`the “effect . . . on the economy, the integrity of the patent system, the efficient administration of
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`the Office, and the ability of the Office to timely complete proceedings,” 35 U.S.C. § 316(b),
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`favors denying a petition even though some claims meet the threshold standards for institution
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`under 35 U.S.C. §§ 314(a), 324(a). This includes, for example, events in other proceedings
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`related to the same patent, either at the Office, in district courts, or the ITC. See NetApp, Inc. v.
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`Realtime Data LLC, Case IPR2017-01195, slip op. at 12–13 (PTAB Oct. 12, 2017) (Paper 9)
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`IPR2018-01714
`Celgene Ex. 2002, Page 10
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`(denying institution under § 314(a) of a follow-on petition filed by a different petitioner where,
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`due to petitioner’s delay, the Board likely would not have been able to rule on patentability until
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`after the district court trial date). Accordingly, parties may wish to address in their submissions
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`whether any other such reasons exist in their case that may give rise to additional factors that
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`may bear on the Board’s discretionary decision to institute or not institute, and whether and how
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`such factors should be considered along with the General Plastic factors.
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`
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`35 U.S.C. § 325(d)
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`35 U.S.C. § 325(d) provides that, in determining whether to order a reexamination or institute an
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`IPR, PGR, or CBM proceeding, the Director may take into account whether, and reject the
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`petition or request because, the same or substantially the same prior art or arguments previously
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`were presented to the Office. Thus, in exercising its discretion whether to institute trial, the
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`Board considers whether the same or substantially the same prior art or arguments were
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`presented previously. See, e.g., Cultec, Inc. v. StormTech LLC, Case IPR2017-00777 (PTAB
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`Aug. 22, 2017) (Paper 7) (informative) (denying institution under 35 U.S.C. § 325(d) where the
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`Office previously evaluated two asserted references during examination and additional relied-
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`upon references were cumulative of prior art considered during examination); Hospira, Inc. v.
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`Genentech, Inc., Case IPR2017-00739 (PTAB July 27, 2017) (Paper 16) (informative) (denying
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`institution under 35 U.S.C. § 325(d) where the Office previously considered and evaluated
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`during examination the same arguments regarding a patent owner’s priority claim).
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`
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`Whether to deny institution of trial on the basis of 35 U.S.C. § 325(d) is a fact-dependent
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`decision, in which the Board balances the petitioner’s desire to be heard against the interest of
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`IPR2018-01714
`Celgene Ex. 2002, Page 11
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`the patent owner in avoiding duplicative challenges to its patent. The Board also takes into
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`account the “efficient administration of the Office,” see 35 U.S.C. § 316(b), which may be
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`affected by consideration of trial petitions that raise the same or substantially the same prior art
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`or arguments presented previously to the Office during examination, a reexamination
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`proceeding, a reissue proceeding, or in an earlier-filed petition requesting an IPR, PGR, or CBM
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`review.
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`
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`In evaluating whether to deny institution on the basis of 35 U.S.C. § 325(d), the Board has
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`considered certain non-exclusive factors. See Becton Dickinson & Co. v. B. Braun Melsungen
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`AG, Case IPR2017-01586, slip op. at 17–18 (PTAB Dec. 15, 2017) (Paper 8) (informative). The
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`Becton Dickinson non-exclusive factors include:
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`1. the similarities and material differences between the asserted art and the prior art
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`involved during examination;
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`2. the cumulative nature of the asserted art and the prior art evaluated during examination;
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`3. the extent to which the asserted art was evaluated during examination;
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`4. the extent of the overlap between the arguments made during examination and the
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`manner in which a petitioner relies on the prior art or a patent owner distinguishes the
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`prior art;
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`5. whether a petitioner has pointed out sufficiently how the Office erred in evaluating the
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`asserted prior art; and
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`6. the extent to which additional evidence and facts presented in the petition warrant
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`reconsideration of the prior art or arguments.
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`Id.
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`IPR2018-01714
`Celgene Ex. 2002, Page 12
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`Although the Board has considered the above-listed factors in the context of a trial petition that
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`raises art that is the same or substantially the same as art presented previously during
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`examination, parties to a IPR, PGR, or CBM proceeding may wish to analyze similar factors in
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`the context of a trial petition involving art that is the same or substantially the same as art
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`presented previously during a prior reexamination proceeding, a reissue proceeding, or an
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`earlier-filed petition requesting an IPR, PGR, or CBM review. In deciding whether to deny
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`institution under 35 U.S.C. § 325(d), the Board may also consider materially changed
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`circumstances or facts and evidence of which the Office was not aware during its previous
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`consideration of the asserted art or arguments. Kayak Software Corp. v. Int’l Bus. Machs. Corp.,
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`Case CBM2016-00075, slip op. at 10–12 (PTAB Dec. 15, 2016) (Paper 16) (informative). The
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`above-listed factors are not exclusive—the parties may wish to address additional factors they
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`consider relevant to the Board’s exercise of discretion to deny institution under 35 U.S.C.
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`§ 325(d).
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`
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`The above-listed factors are considered by the Board when determining whether to institute a
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`trial. When determining whether to order ex parte reexamination, however, the Office may not
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`necessarily consider these factors. An ex parte reexamination proceeding is not a trial
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`proceeding, and the considerations with respect to issues involving 35 U.S.C. 325(d) may differ
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`due to the different nature of an ex parte reexamination proceeding.
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`IPR2018-01714
`Celgene Ex. 2002, Page 13
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`I. Reply to Patent Owner Response and Reply for a Motion to Amend; Sur-Replies
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`A petitioner may file a reply to a patent owner response, and a patent owner may file a reply to
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`an opposition to a motion to amend. 37 C.F.R. § 42.23. Additionally, in response to issues
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`arising from the Supreme Court’s decision in SAS (138 S. Ct. at 1358), the Board will permit the
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`petitioner, in its reply brief, to address issues discussed in the institution decision. The Patent
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`Owner will similarly be allowed to address the institution decision in its sur-reply, if necessary to
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`respond to petitioner’s reply. Petitioner may not submit new evidence or argument in reply that it
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`could have presented earlier, e.g. to make out a prima facie case of unpatentability. But a
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`petitioner may submit directly responsive rebuttal evidence in support of its reply. See Belden
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`Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1077–78 (Fed. Cir. 2015). If a party submits a new expert
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`declaration with its reply, the opposing party may cross-examine the expert, move to exclude the
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`declaration, and comment on the declaration and cross-examination in any sur-reply. Id. at
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`1081−82.
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`
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`Sur-replies to motions are not generally permitted, but may be authorized on a case-by-case
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`basis. Sur-replies to principal briefs (i.e., to a reply to a patent owner response or to a reply to an
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`opposition to a motion to amend) normally will be authorized by the scheduling order entered at
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`institution. The sur-reply may not be accompanied by new evidence other than deposition
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`transcripts of the cross-examination of any reply witness. Sur-replies should only respond to
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`arguments made in reply briefs, comment on reply declaration testimony, or point to cross-
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`examination testimony. As noted above, a sur-reply may address the institution decision if
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`necessary to respond to the petitioner’s reply. This sur-reply practice essentially replaces the
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`previous practice of filing observations on cross-examination testimony.
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`IPR2018-01714
`Celgene Ex. 2002, Page 14
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`Generally, a reply or sur-reply may only respond to arguments raised in the preceding brief.
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`37 C.F.R. § 42.23, except as noted above. To the extent that a reply or sur-reply “responds” to
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`the institution decision as discussed above, “respond,” in the context of § 42.23(b), does not
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`mean embark in a new direction with a new approach as compared to positions taken in a prior
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`filing. While replies and sur-replies can help crystalize issues for decision, a reply or sur-reply
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`that raises a new issue or belatedly presents evidence may not be considered. The Board is not
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`required to sort proper from improper portions of the reply or sur-reply.
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`
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`Examples of new issues are new theories or arguments necessary to make out petitioner’s case-
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`in-chief for the unpatentability of an original or proposed substitute claim, such as a newly raised
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`rationale to combine the prior art references that was not expressed in the petition. See
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`Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369–70 (Fed. Cir.
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`2016) (holding that the Board did not err in refusing the reply brief as improper under 37 C.F.R.
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`§ 42.23(b) because Petitioner relied on an entirely new rationale to explain why one of skill in
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`the art would have combined the references at issue). It is also improper to present in reply new
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`evidence (including new expert testimony) that could have been presented in a prior filing, for
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`example newly cited prior art references intended to “gap-fill” by teaching a claim element that
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`was not present in the prior art presented with the petition. See Genzyme Therapeutic Prods. Ltd.
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`v. Biomarin Pharm. Inc., 825 F.3d 1360, 1365–69 (Fed. Cir. 2016) (proper for Board to rely on
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`prior art references submitted with petitioner’s reply to establish the state of the art at the time of
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`the invention in response to patent owner arguments).
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`IPR2018-01714
`Celgene Ex. 2002, Page 15
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`K. Challenging Admissibility; Motions to Exclude; Motions to Strike
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`A party wishing to challenge the admissibility of evidence must file any objections within five
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`business days of service of evidence to which the objection is directed, or ten days after
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`institution of trial. 37 C.F.R. §§ 42.64(a), 42.64(b)(1). Supplemental evidence is not filed at the
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`time of the objection, but simply served, and is filed only in support of an opposition to a motion
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`to exclude. See § 42.64(b)(2).
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`Motions to Exclude. Objections may be preserved only by filing a motion to exclude the
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`evidence. 37 C.F.R. § 42.64(c). The due dates for filing a motion to exclude evidence, an
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`opposition, and a reply for a motion to exclude are usually set in the Scheduling Order.
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`A motion to exclude evidence should:
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`(a) Identify where in the record the objection originally was made;
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`(b) Identify where in the record the evidence sought to be excluded was relied upon by an
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`opponent;
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`(c) Address objections to exhibits in numerical order; and
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`(d) Explain the basis and grounds for each objection.
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`A motion to exclude must explain why the evidence is not admissible (e.g., relevance or hearsay)
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`but may not be used to challenge the sufficiency of the evidence to prove a particular fact. A
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`motion to exclude is not a vehicle for addressing the weight to be given evidence—arguments
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`regarding weight should appear only in the merits documents. Nor should a motion to exclude
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`address arguments or evidence that a party believes exceeds the proper scope of reply or sur-
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`reply.
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`IPR2018-01714
`Celgene Ex. 2002, Page 16
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`Generally, the Board waits until after the oral hearing, when it reviews the record in its entirety,
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`to decide the merits of any motions to exclude. In the Board’s experience, consideration of the
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`objected-to evidence is often unnecessary to resolve the patentability of the challenged claims,
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`and the motion to exclude is moot. Nevertheless, in certain circumstances, the evidence may be
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`so central to the parties’ dispute that mootness is unlikely and early resolution of the motion to
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`exclude may be warranted. In such cases, a party may request a pre-hearing conference with the
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`panel to seek early resolution of a motion to exclude on a limited number of objections. The
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`Board will preferably rule on such a motion during the pre-hearing conference (or after the pre-
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`hearing conference but before the oral hearing), but may also defer ruling until the oral hearing
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`or thereafter.
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`Motions to Strike. If a party believes that a brief filed by the opposing party raises new issues, is
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`accompanied by belatedly presented evidence, or otherwise exceeds the proper scope of reply or
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`sur-reply, it may request authorization to file a motion to strike. Alternatively, a party may
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`request authorization for further merits briefing, such as a sur-reply, to address the merits of any
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`newly-raised arguments or evidence.
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` A
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` motion to strike may be appropriate when a party believes the Board should disregard
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`arguments or late-filed evidence in its entirety, whereas further briefing may be more appropriate
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`when the party wishes to address the proper weight the Board should give to the arguments or
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`evidence. In most cases, the Board is capable of identifying new issues or belatedly presented
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`evidence when weighing the evidence at the close of trial, and disregarding any new issues or
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`belatedly presented evidence that exceeds the proper scope of reply or sur-reply. As such,
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`IPR2018-01714
`Celgene Ex. 2002, Page 17
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`striking the entirety or a portion of a party’s brief is an exceptional remedy that the Board
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`expects will be granted rarely. In some cases, however, whether an issue is new or evidence is
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`belatedly presented may be beyond dispute, or the prejudice to a party of waiting until the close
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`of the evidence to determine whether new issues or belatedly presented evidence has been
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`presented may be so great, that