NON-PUBLIC VERSION—PROTECTIVE ORDER MATERIAL
`Trials@uspto.gov Paper 36
`571-272-7822 Date: February 6, 2026
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`PADAGIS US LLC,
`Petitioner,
`v.
`NEURELIS, INC.,
`Patent Owner.
`
`IPR2025-00464 (Patent 8,895,546 B2)
` IPR2025-00465 (Patent 11,241,414 B2)
` IPR2025-00466 (Patent 11,793,786 B2)1
`
`
`Before GRACE KARAFFA OBERMANN, ANNETTE R. REIMERS, and
`TIMOTHY G. MAJORS, Administrative Patent Judges.
`
`MAJORS, Administrative Patent Judge.
`
`
`ORDER
`Denying Patent Owner’s Motion for Leave to File Petition for Certificate of
`Correction on Patents Undergoing Inter Partes Review
`37 C.F.R. §§ 1.323, 42.20
`
`
`1 This Order addresses issues common to the listed cases. Therefore, we
`exercise our discretion to issue one Order to be filed in each case. The
`parties are not authorized to use this style heading.
`
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`NON-PUBLIC VERSION—PROTECTIVE ORDER MATERIAL
`IPR2025-00464 (Patent 8,895,546 B2)
`IPR2025-00465 (Patent 11,241,414 B2)
`IPR2025-00466 (Patent 11,793,786 B2)
`
`2
`I. BACKGROUND
`On December 4, 2025, Patent Owner wrote to the Board seeking
`authorization to file a motion for leave to petition for a certificate of
`correction on each of the patents challenged in the above-captioned
`proceedings. Ex. 3001.2 The Board authorized the filing of the present
`motion (Paper 26, hereafter “Motion” or “Mot.”) and allowed Petitioner to
`file an opposition (Paper 30, hereafter “Opposition” or “Opp.”). Paper 23
`(Order dated Dec. 15, 2025, authorizing briefing and additional filings
`concerning exhibits submitted in support of the Motion).
`Patent Owner’s Motion asks the Board to cede its jurisdiction over the
`challenged patents in the ongoing IPRs so that Patent Owner may file a
`petition with the Director for a certificate of correction that adds to each
`patent a disclosure related to a “Joint Research Agreement” (“JRA”) and the
`parties to that agreement. Mot. 1–2. More specifically, Patent Owner seeks
`to add the following text at the beginning of each patent’s Specification:
`PARTIES TO A JOINT RESEARCH AGREEMENT
`The subject matter disclosed herein was developed and the
`claimed invention was made by or on behalf of the following
`parties to a joint research agreement: Particle Sciences, Inc. and
`Questcor Pharmaceuticals, Inc. (as predecessor -in-interest to
`Hale BioPharma Ventures, LLC).
`
`2 Unless otherwise noted, all citations are filings in IPR2025-00465. Similar
`papers and exhibits were filed in IPR2025-00464 and IPR2025-00466.
`
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`NON-PUBLIC VERSION—PROTECTIVE ORDER MATERIAL
`IPR2025-00464 (Patent 8,895,546 B2)
`IPR2025-00465 (Patent 11,241,414 B2)
`IPR2025-00466 (Patent 11,793,786 B2)
`
`3
`Mot. 6–7; see also id. at 1 n.1 (stating “Questcor is the predecessor in
`interest to Hale BioPharma Ventures (‘HBV’), which is the predecessor in
`interest to Neurelis, the Patent Owner”).
`The reason Patent Owner seeks to “correct” the patents with this
`additional language is clear—Patent Owner hopes to disqualify the primary
`prior art reference asserted by Petitioner in these proceedings; namely,
`Gwozdz. Mot. 1–4.
`On September 16, 2025, the Board instituted inter partes review,
`finding Petitioner was reasonably likely to prevail in showing that the
`challenged claims would have been obvious over the combination of
`Gwozdz and Meezan.
`3 Paper 13, 2, 6, 30–36. Gwozdz is a published
`international patent application filed March 27, 2009, and it further claims
`the priority benefit of a provisional application filed March 28, 2008.
`Ex. 1009, codes (22), (30). The three named inventors on Gwozdz are
`named inventors (among several others) on the challenged patents.
`Compare id. at code (72), with Ex. 1001, code (72). According to Patent
`Owner, Gwozdz was owned and filed by Patent Owner’s joint-research
`partner Particle Sciences, Inc. (“PSI”), the JRA predates the relevant
`
`3 IPR2025-00464 and IPR225-00465 include only one ground (Gwozdz plus
`Meezan); IPR2025-00466 includes one primary ground (Gwozdz plus
`Meezan), and two subsidiary grounds against a handful of the dependent
`claims based on Gwozdz and Meezan, in further combination with additional
`references. See IPR2025-00466, Paper 13, 7.
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`NON-PUBLIC VERSION—PROTECTIVE ORDER MATERIAL
`IPR2025-00464 (Patent 8,895,546 B2)
`IPR2025-00465 (Patent 11,241,414 B2)
`IPR2025-00466 (Patent 11,793,786 B2)
`
`4
`application filing dates for Gwozdz and the challenged patents,4 and
`Gwozdz allegedly arose from PSI’s activities under the JRA. Mot. 1–2. If
`the Specifications are amended as proposed, Patent Owner plans to invoke
`the “safe harbor defense” of 35 U.S.C. § 103(c)(2)(C) (pre-AIA) and argue
`Gwozdz, as a § 102(e) reference, “cannot be used for obviousness.” Id. at
`1–3 (noting Gwozdz is “asserted to be prior art solely under 35 U.S.C.
`§ 102(e) (pre-AIA)”), 6–10.
`In short, the relief Patent Owner is seeking may eliminate Gwozdz
`from Petitioner’s obviousness grounds and be case dispositive across all
`three proceedings.
`II. DISCUSSION
`Whether a certificate of correction may be entered on an already-
`issued patent is informed by 35 U.S.C. § 255, which reads as follows:
`Whenever a mistake of a clerical or typographical nature, or of a
`minor character, which was not the fault of the Patent and
`Trademark Office, appears in a patent and a showing has been
`made that such mistake occurred in good faith, the Director may,
`upon the payment of the required fee, issue a certificate of
`correction, if the correction does not involve such changes in the
`patent as would constitute new matter or would require re -
`examination. Such patent, together with the certificate, shall
`have the same effect and operation in law on the trial of actions
`for causes thereafter arising as if the same had been originally
`issued in such corrected form.
`
`4 The ’414 patent, for example, issued from an application filed May 27,
`2021, and claims the priority benefit of several non-provisional applications,
`the earliest of which was filed March 27, 2009 (Ex. 1039), as well as a
`provisional application filed March 28, 2008 (Ex. 1008). Ex. 1001, codes
`(22), (60), (63).
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`NON-PUBLIC VERSION—PROTECTIVE ORDER MATERIAL
`IPR2025-00464 (Patent 8,895,546 B2)
`IPR2025-00465 (Patent 11,241,414 B2)
`IPR2025-00466 (Patent 11,793,786 B2)
`
`5
`35 U.S.C. § 255. As the Federal Circuit has explained, the Director—not the
`Board—is responsible for deciding whether a certificate of correction is
`appropriate under § 255. Honeywell Int’l Inc. v. Arkema Inc., 939 F.3d
`1345, 1348–50 (Fed. Cir. 2019) (holding the Board abused its discretion in
`assuming authority that § 255 expressly delegates to the Director).
`Notwithstanding the above, when a patentee seeks a certificate of
`correction on a patent that is undergoing a post-issuance review proceeding
`before the Board, the filing of a petition for correction requires the Board’s
`approval. That is, a “patentee must first file a motion with the Board
`seeking authorization to petition the Director for a Certificate of Correction,
`asking the Board to temporarily cede its exclusive jurisdiction over the
`proceedings.” Honeywell, 939 F.3d at 1348–49 (citing 37 C.F.R. §§ 1.323,
`42.3).
`Although the decision on the merits of a patentee’s petition rests with
`the Director, the Board is not merely a rubber stamp and need not cede
`jurisdiction whenever a patentee moves to halt an ongoing IPR to pursue a
`certificate of correction. To the contrary, the Board “determine[s] whether
`there is a sufficient basis supporting [a patentee’s] position that the mistake
`may be correctable” under § 255. Id. at 1349–50. Furthermore, the Board
`may, in deciding the motion, evaluate the parties’ arguments related to
`prejudice. Id. at 1350–51; see Kingston Tech., Inc. v. CATR Co., Ltd.,
`IPR2015-00559, Paper 44 at 3 (PTAB Nov. 6, 2015) (denying motion for
`leave and noting patentee’s delay in pursuing “correction” of claim language
`and unfairness to petitioner if the relief sought by patentee was granted).
`
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`NON-PUBLIC VERSION—PROTECTIVE ORDER MATERIAL
`IPR2025-00464 (Patent 8,895,546 B2)
`IPR2025-00465 (Patent 11,241,414 B2)
`IPR2025-00466 (Patent 11,793,786 B2)
`
`6
`Here, Patent Owner summarizes some of the details of the JRA and
`argues it “has a clear legal basis” to seek a certificate of correction. Mot. 4–
`7 (citing Master Services Agreement dated April 1, 2007 (Ex. 2030) and an
`Asset Purchase Agreement dated June 27, 2008, including an apparent
`assignment of rights from Questcor to HBV (Ex. 2031)). In support, Patent
`Owner cites Office rules, the MPEP, and excerpts of legislative history
`related to pre-AIA § 103(c)(2)(C), all of which state or suggest that issued
`patents can be corrected to include the names of parties to a joint research
`agreement. Id. at 3, 7–8. For example, Rule 1.71(g)(3) provides: “if the
`patent as issued does not include the names of the parties to the joint
`research agreement, the patent must be corrected to include the names of the
`parties to the joint research agreement by a certificate of correction under 35
`U.S.C. [§] 255 and [37 C.F.R.] § 1.323 for the amendment to be effective.”
`37 C.F.R. § 1.71(g)(3); see also MPEP § 2146.02 (citing Rule 1.71(g)(3) for
`same); Ex. 2032 (H.R. Rep. No. 108–425, p. 9 (2004) (“This information
`[(i.e., identities of parties to a joint research agreement)] may be . . . added
`by amendment to the patent (e.g., by a certificate of correction)” and stating
`“[t]he omission of the names of parties to the agreement is not an error that
`would justify commencement of a reissue or reexamination proceeding”)).
`Beyond the above, Patent Owner notes that it has submitted a copy of
`the JRA, identified the text it wants to add to the Specifications, and argues
`that “[t]he Board requires nothing more to conclude that the omission may
`be correctable.” Mot. 8. For the reasons discussed below, we disagree.
`
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`NON-PUBLIC VERSION—PROTECTIVE ORDER MATERIAL
`IPR2025-00464 (Patent 8,895,546 B2)
`IPR2025-00465 (Patent 11,241,414 B2)
`IPR2025-00466 (Patent 11,793,786 B2)
`
`7
`There are several requirements that Patent Owner must meet to be
`entitled to the proposed certificate of correction under 35 U.S.C. § 255.
`Among them, Patent Owner must establish that the omission of the JRA and
`the parties to that agreement in the Specifications is “a mistake of a clerical
`or typographical nature, or of a minor character,” and also make a showing
`that “such mistake occurred in good faith.” 35 U.S.C. § 255 (emphases
`added). Patent Owner never squarely addresses why the alleged mistake
`here qualifies as clerical, typographical, or minor. Even if Patent Owner’s
`citation to the rules and MPEP may suggest that correction of a patent to add
`the names of the parties to a joint research agreement can be a “minor” and
`correctable mistake in some cases, Patent Owner never argues, much less
`provides any supporting evidence that might show, that it is a minor change
`in the circumstances of these cases. Opp. 3–4 (arguing “this correction is
`sought to effect a substantive change . . . that would potentially result in the
`unpatentable claims of the ’414 Patent being found patentable”).5
`But, assuming Patent Owner has done enough to put at issue for a
`merits decision by the Director whether the absence of disclosure about the
`JRA is a “clerical,” “typographical,” or “minor” mistake, Patent Owner does
`not address the additional terms of § 255, which require a showing that the
`mistake “occurred in good faith.” On that, Patent Owner’s filing is silent.
`
`5 Petitioner also argues that proposed changes to the patents cannot be minor
`because Patent Owner is not merely adding the names of parties of the JRA
`but proposing a “correction that discloses the JRA in the first instance.”
`Opp. 4–5 (noting that the cited rule and legislative history speak to the
`addition of “names of parties” to a JRA).
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`NON-PUBLIC VERSION—PROTECTIVE ORDER MATERIAL
`IPR2025-00464 (Patent 8,895,546 B2)
`IPR2025-00465 (Patent 11,241,414 B2)
`IPR2025-00466 (Patent 11,793,786 B2)
`
`8
`See generally Mot. On this record, Patent Owner has not set forth a
`“sufficient basis” supporting its position that the alleged mistake may be
`correctable. Honeywell, 939 F.3d at 1349.
`In fact, the record here suggests that the correction being sought did
`not arise from a simple “good faith” mistake.
`As Petitioner explains, Patent Owner has been (or should have been)
`aware of the alleged mistake for at least seven years. Opp. 5–6. On
`January 29, 2019, an IPR petition was filed against a patent that is a family
`member to the challenged patents here, with nearly identical claims. Id. at 5
`(citing IPR2019-00451, Paper 3 (“the 451 IPR”)). Like here, the 451 IPR
`was based on asserted obviousness of the claims over Gwozdz and Meezan.
`IPR2019-00451, Paper 3, 5. The 451 IPR was instituted, the Board held all
`claims unpatentable in a Final Written Decision dated August 6, 2020, and
`the Federal Circuit affirmed that holding on October 7, 2021. Ex. 10406;
`Ex. 1068. Patent Owner did not seek a certificate of correction to add any
`reference to the JRA before or during the 451 IPR. And despite Patent
`Owner’s longstanding knowledge that Gwozdz had been successfully
`asserted against its related patent, Patent Owner did not previously seek a
`
`6 In the 451 IPR (challenging U.S. Patent No. 9,763,876), Patent Owner
`attempted (unsuccessfully) to remove Gwozdz as prior art by arguing there
`was sufficient written description support in, and priority entitlement to, an
`earlier application in the 451 IPR patent’s priority chain. Ex. 1040, 17–23
`(rejecting Patent Owner’s priority arguments and finding Gwozdz was
`§ 102(e) prior art). Patent Owner sought to remove Gwozdz for similar
`reasons in its earlier filings in the present proceedings, which we also
`rejected on the preliminary record. See, e.g., Paper 13, 14–30.
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`NON-PUBLIC VERSION—PROTECTIVE ORDER MATERIAL
`IPR2025-00464 (Patent 8,895,546 B2)
`IPR2025-00465 (Patent 11,241,414 B2)
`IPR2025-00466 (Patent 11,793,786 B2)
`
`9
`certificate of correction to the ’546 patent (now challenged in IPR2025-
`00464), which is the parent to the patent at issue in the 451 IPR. Nor did
`Patent Owner seek to add the JRA disclosure at any time during prosecution
`of the ’414 and ’786 patents, which issued from applications that Patent
`Owner filed in April and May, 2021—after the Board’s Final Written
`Decision in the 451 IPR and before the Federal Circuit’s affirmance.7
`Against that backdrop, we find insufficient Patent Owner’s statement
`that “[t]he correction to the specification was necessitated by the Board
`instituting trial” based on Gwozdz. Mot. 1–2. Tellingly, Patent Owner does
`not identify when it first discovered the alleged mistake, much less provide
`any reasoned explanation for its yearslong delay in seeking to add the JRA
`disclosure to its portfolio of related patents and applications—from at least
`2019 when Gwozdz was first asserted against that portfolio. It is only now,
`some seven years later and after Patent Owner’s other arguments have
`repeatedly failed to persuade the Board (or the Federal Circuit) that Gwozdz
`was not only available but invalidating prior art, that Patent Owner’s
`strategy has changed course. Opp. 2, 3 (citing In re Arnott, 1991 WL
`326548, *9 (Comm’r Pat. & Trademarks May 22, 1991) (explaining that “a
`mistake in judgment” is not correctable under § 255)).
`We further agree with Petitioner that “Patent Owner’s inexcusable
`seven-year delay to seek a [certificate of correction] creates unfair prejudice
`to Petitioner.” Opp. 7–10. Petitioner contends that, when it prepared and
`
`7 Petitioner provides a family tree showing the relationships between these
`various patents and applications, including filing dates. Paper 2, 13–14.
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`NON-PUBLIC VERSION—PROTECTIVE ORDER MATERIAL
`IPR2025-00464 (Patent 8,895,546 B2)
`IPR2025-00465 (Patent 11,241,414 B2)
`IPR2025-00466 (Patent 11,793,786 B2)
`
`10
`filed its petitions challenging the patents in these proceedings, it “reasonably
`relied on Patent Owner’s many years of silence” since Gwozdz was first
`successfully asserted in the 451 IPR. Id. at 8–9. But now, given Patent
`Owner’s delay in pursuing a certificate of correction for these patents that
`would putatively eliminate Gwozdz as available prior art, Petitioner is
`prejudiced. Based on the timing of Patent Owner’s district court complaint
`in parallel litigation, Petitioner is statutorily time-barred from filing another
`IPR petition against the challenged patents. Id. (citing 35 U.S.C. § 315(b)
`(petitions must be filed within 1 year after the date a petitioner is served with
`a complaint alleging infringement of the relevant patents)); Ex. 1063
`(complaint filed May 8, 2024); Pet. 4.
`We determine, on this record, that Petitioner is substantially
`prejudiced by Patent Owner’s delay. Furthermore, we also recognize the
`waste and prejudice that Patent Owner’s inaction and delay may have caused
`to the Board and the Federal Circuit panels that decided the 451 IPR. The
`public (including Petitioner here) reasonably relies on final outcomes at the
`Board and before the courts. If the alleged mistake in omitting the JRA
`applies to these challenged patents, so too it would have applied to the
`challenged patent in the 451 IPR—where Patent Owner might have removed
`Gwozdz as prior art applying similar reasoning. Yet that case held in a final
`and affirmed decision that Gwozdz was § 102(e) art that (together with
`Meezan) proved that the nearly identical claims would have been obvious.
`See generally Ex. 1040; Ex. 1068. We see no indication in the prior matter
`
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`NON-PUBLIC VERSION—PROTECTIVE ORDER MATERIAL
`IPR2025-00464 (Patent 8,895,546 B2)
`IPR2025-00465 (Patent 11,241,414 B2)
`IPR2025-00466 (Patent 11,793,786 B2)
`
`11
`that Patent Owner ever suggested Gwozdz might be subject to the safe
`harbor provisions of § 103(c)(2)(C).
`We find unpersuasive Patent Owner’s counterargument that there is
`no prejudice to Petitioner. Mot. 8–10. According to Patent Owner, the
`statute and regulations impose no time limit on seeking a certificate of
`correction and, Patent Owner contends, Petitioner will have a chance to file
`further briefing in these proceedings. Id. (noting the date for Petitioner’s
`Reply as March 24, 2026).
`The absence of any specified time period in § 255 or the related
`regulations, however, does not negate the substantial prejudice to Petitioner
`caused by Patent Owner’s delay and inaction. Petitioner’s opportunity to
`file a reply brief in these proceedings does little to remedy this prejudice.
`Such reply cannot raise new grounds of unpatentability and, as noted above,
`Petitioner is now time-barred from filing any new challenge that does not
`rely on Gwozdz.
`Patent Owner further argues that it “should come as no surprise” to
`Petitioner that Patent Owner could correct the alleged mistake in the patents
`and, thereby, invoke the “Section 103 Safe Harbor defense.” Mot. 9. Patent
`Owner notes the partial overlap in listed inventors on Gwozdz and the
`challenged patents and contends that Petitioner has “long possessed the joint
`research agreement” because Patent Owner produced the agreement as part
`of discovery in the parallel litigation. Id. (stating that the Master Services
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`NON-PUBLIC VERSION—PROTECTIVE ORDER MATERIAL
`IPR2025-00464 (Patent 8,895,546 B2)
`IPR2025-00465 (Patent 11,241,414 B2)
`IPR2025-00466 (Patent 11,793,786 B2)
`
`12
`Agreement was produced on December 23, 2024, prior to the filing of the
`petitions on January 17, 2025).8
`Petitioner may well have possessed the JRA several weeks before its
`petitions were filed, but Patent Owner (or its predecessors-in-interest)
`possessed the agreement since it was signed in 2007. And, as already
`explained above, Patent Owner was put on direct notice that Gwozdz was
`being asserted against its related patent in early 2019 yet Patent Owner did
`nothing to correct the alleged mistake until late 2025. Patent Owner
`provides no persuasive explanation as to why it waited over these many
`years and until now to seek a certificate of correction that adds disclosure
`related to the JRA. Accordingly, we determine that Petitioner has the better
`position on the issue.
`Considering the Motion and Opposition, and for the reasons given
`above, we determine that Patent Owner has not provided a sufficient basis to
`support its position that the challenged patents may be corrected for the
`alleged mistake. In addition, as explained above, we determine that
`substantial prejudice to Petitioner warrants denial of the Motion.
`
`
`
`
`8 Patent Owner further states (without citing evidence) that, six weeks after it
`produced the agreement, it “informed” Petitioner in the related litigation that
`it intended to invoke the safe harbor provisions of § 103(c). Mot. 9.
`
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`
`NON-PUBLIC VERSION—PROTECTIVE ORDER MATERIAL
`IPR2025-00464 (Patent 8,895,546 B2)
`IPR2025-00465 (Patent 11,241,414 B2)
`IPR2025-00466 (Patent 11,793,786 B2)
`
`13
`III. ORDER
`In consideration of the foregoing, it is:
` ORDERED that Patent Owner Motion for Leave to File Petition for
`Certificate of Correction is denied; and
` ORDERED that within ten (10) days of this Order, the parties will
`meet and confer regarding any redactions to this Order and, as appropriate,
`file a motion to seal that includes, as an exhibit, a proposed redacted version
`of the Order; if no motion is filed, the unredacted version of the Order herein
`will be made available to the public.
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`
`
`NON-PUBLIC VERSION—PROTECTIVE ORDER MATERIAL
`IPR2025-00464 (Patent 8,895,546 B2)
`IPR2025-00465 (Patent 11,241,414 B2)
`IPR2025-00466 (Patent 11,793,786 B2)
`
`14
`FOR PETITIONER:
`
`James Murphy
`Corey Casey
`POLSINELLI PC.
`jpmurphy@polsinelli.com
`ccasey@polsinelli.com
`
`FOR PATENT OWNER:
`
`Michael A Sitzman
`Timothy Best
`MCDERMOTT WILL & EMERY LLP
`msitzman@mwe.com
`tbest@mwe.com
`
`Raymond Miller
`Nancy Stakleff
`DLA Piper LLP (US)
`raymond.miller@us.dlapiper.com
`nicole.endejann@us.dlapiper.com
`
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