Before ANDREI IANCU, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, ANDREW HIRSHFELD, Commissioner for Patents, and SCOTT R. BOALICK, Chief Administrative Patent Judge.

The Office received a request for Precedential Opinion Panel (POP) review of an issue raised in this case.

The request was referred to the POP panel referenced above.

Upon consideration of the request, it is ORDERED that the request for POP review is denied; and FURTHER ORDERED that the original panel maintains authority over all matters.

Formulations 1 and 2 also include, inter alia, a polyhydric alcohol in the form of polyethylene glycol (PEG-600) and a carboxyvinyl polymer (Carbopol 940) that acts as a gelling agent.

Petitioner does not explain sufficiently why one of ordinary skill in the art would have continued to use the same amounts of ethanol and benzyl alcohol in Cartt ’865 in the absence of the 15% or 20% polyethylene glycol and the 0.8% or 0.6% carboxyvinyl polymer used in formulations 1 and 2 of Ueda.

1 Petitioner’s Request for Rehearing includes additional citations to Dr. Peppas’ declaration that were not provided in the section addressing Petitioner’s obviousness ground based on Cartt ’865 and Ueda.

Patent 9,763,876 B2 ordinary skill in the art would have sought to use the same levels of ethanol and benzyl alcohol in Cartt ’865’s benzodiazepine-based nasal spray, especially in the absence of the additional 15% or 20% polyethylene glycol and 0.8% or 0.6% gelling agent used in formulations 1 and 2 of Ueda.

In view of the foregoing, we are not persuaded that we erred in not instituting an inter partes review with respect to Petitioner’s obviousness ground based on Cartt ’865 and Ueda.

The Office has received a request for Precedential Opinion Panel (POP) review of an issue raised in these cases.

The request is under review.

The Office will provide another notification after a decision on the request has been made.

Neurelis, Inc. (“Patent Owner”) requests rehearing of the Board’s Decision (Paper 8) (“Decision”) instituting inter partes review of claims 1– 36 of U.S. Patent No. 9,763,876 B2 (Ex. 1001, “the ’876 patent”).

First, Petitioner did challenge the ’876 patent priority claim in contending that “the presence of any alkyl glycosides (either generally or particularly) – regardless of amount – was not disclosed, described, or enabled by [the] ’558 Provisional.” Petition 20.

Furthermore, with supporting testimony from Dr. Nicholas A. Peppas, Petitioner further asserted that the ’558 provisional’s “generic disclosure of ‘surface active agents (especially non-ionic materials)’ ... does not disclose, describe, and/or enable alkyl glycosides in general (or dodecyl maltoside in particular).” Id. (citing Ex. 1008 ¶ 152; Ex. 1041 ¶ 68).

As explained in Dynamic Drinkware, a petitioner has the initial burden of going forward to show that there is invalidating prior art.

On this record, Patent Owner fails to satisfy its burden of production to show entitlement to an earlier filing date.

Reasonable expenses and attorneys’ fees incurred by any party may be levied on a person who impedes, delays, or frustrates the fair

To satisfy this requirement, Patent Owner should request a conference call with the Board no later than two weeks prior to DUE DATE 1.

The parties are further directed to the Board’s Guidance on Motions to Amend in view of Aqua Products (https://go.usa.gov/xU6YV), and Lectrosonics, Inc. v. Zaxcom, Inc., Case IPR2018-01129 (Paper 15) (PTAB Feb. 25, 2019) (precedential).

As indicated in the MTA Pilot Program Notice, Patent Owner has the option at DUE DATE 3 to file a revised motion to amend (instead of a reply, as noted above) after receiving petitioner’s opposition to the original motion to amend and/or after receiving the Board’s preliminary guidance (if requested).

Jeffrey Guise Richard Torczon Lorelei Westin Lee Johnson Nathaniel Leachman Alina L. Litoshyk

On this record, and upon review of Petitioner’s arguments and supporting evidence, we determine that Petitioner sufficiently explains why one of ordinary skill in the art would have looked to Meezan ’962’s disclosure when seeking to enhance the bioavailability of the therapeutic agents in the compositions disclosed in Gwozdz.

For the reasons stated supra with regard to claims 8–10 and 15, Petitioner’s assertion that Patent Owner never showed any unexpected results with respect to the amount of ethanol and benzyl alcohol is not sufficiently supported by the evidence of record.

We are not persuaded that Petitioner and Dr. Peppas have provided sufficient argument and supporting evidence to explain why one of ordinary skill in the art would have reasonably expected success in achieving the bioavailabilities recited in claims 34–36 of the ’876 patent when combining the teachings of Gwozdz and Meezan ’962.

Petitioner argues that, since neither Gwozdz nor Meezan ’962 provide specific dosing regimens for benzodiazepines/diazepam, one of ordinary skill in the art would look to the similar reference of Cartt ’784, titled “Nasal Administration of Benzodiazepines,” for these teachings.

On this record, and upon review of Petitioner’s arguments and supporting evidence, we determine that Petitioner sufficiently explains why one of ordinary skill in the art would have looked to Cartt ’784’s disclosure when seeking dosing regimens for the compositions disclosed in Gwozdz and Meezan ’962.

A patentee may define a claim term in a manner that differs from its ordinary and customary meaning; however, any special definitions must be set forth in the specification with reasonable clarity, deliberateness, and precision.

To satisfy the written description requirement, the applicant must convey with reasonable clarity to those of ordinary skill in the art that, as of the filing date sought, he or she was in possession of the claimed invention.

Patent 9,763,876 B2 Based on this alleged lack of “unexpected effects,” Petitioner contends the disclosed ratios of ethanol and benzyl alcohol recited in the challenged claims would have been obvious.

We are not persuaded that Petitioner and Dr. Peppas have provided sufficient argument and supporting evidence to demonstrate a reasonable likelihood that challenged claims 34–36 would have been obvious over the combined teachings of Cartt ’865, Meezan, and Jamieson.

In view of the foregoing, we are not persuaded that Petitioner has demonstrated a reasonable likelihood that the subject matter of challenged claims 34–36 would have been obvious over the combined disclosures of Cartt ’865, Meezan, and Jamieson.

A patentee may define a claim term in a manner that differs from its ordinary and customary meaning; however, any special definitions must be set forth in the specification with reasonable clarity, deliberateness, and precision.

The Examiner subsequently issued a final rejection of the claims on November 21, 2011, disagreeing with the Applicants “teaching away” arguments and concluding that “one of ordinary skill in the art would have found it obvious to nasally administer a benzodiazepine composition that contains only tocopherol or tocotrienol, an alcohol and optionally one or more alkyl glycosides.” Id. at 514–515.

In subsequent Office Actions of July 14, 2016, March 30, 2017, and October 19, 2017, the Examiner maintained his position that Sonne’s broad disclosures would have led one of ordinary skill in the art to the claimed formulations.

Petitioner contends that because the nosedrop of DS-11 “may be too viscous to spray,” one of ordinary skill in the art would have followed Sonne’s teachings and reduced the viscosity of the solution by replacing the triacetin co-solvent with ethanol.

Likewise, in a July 14, 2016 Office Action in the ’439 application, the Examiner stated that Sonne teaches “[v]iscosity can be reduced by the addition of co-solvents such as ethanol” and that “[a] co-solvent such as ethanol can be used in order to optimize the formulations bioadhesion, sprayability, and viscosity.” Ex. 1007, 3096–3097 (citing Ex. 1013, 3:65– 66, 6:47–53).

Patent Owner may file a preliminary response to the petition no later than three months from the date of this notice.

Patent Owner may also file an election to waive the preliminary response to expedite the proceeding.

Patent Owner is advised of the requirement to submit mandatory notice information under 37 C.F.R. § 42.8(a)(2) within 21 days of service of the petition.

The parties are advised that under 37 C.F.R. § 42.10(c), recognition of counsel pro hac vice requires a showing of good cause.

Such motions shall be filed in accordance with the “Order -- Authorizing Motion for Pro Hac Vice Admission” in Case IPR2013-00639, Paper 7, a copy of which is available on the Board Web site under “Representative Orders, Decisions, and Notices.” The parties are reminded that unless otherwise permitted by 37 C.F.R. § 42.6(b)(2), all filings in this proceeding must be made electronically in the Patent Review Processing System (PRPS), accessible from the Board Web site at http://www.uspto.gov/PTAB.

For more information, please consult the Office Patent Trial Practice Guide, 77 Fed. Reg. 48756 (Aug. 14, 2012), which is available on the Board Web site at http://www.uspto.gov/PTAB.

Patent Owner is advised of the requirement to submit mandatory notice information under 37 C.F.R. § 42.8(a)(2) within 21 days of service of the petition.

The parties are advised that under 37 C.F.R. § 42.10(c), recognition of counsel pro hac vice requires a showing of good cause.

Many non-profit organizations, both inside and outside the intellectual property field, offer alternative dispute resolution services.

If the parties actually engage in alternative dispute resolution, the Case IPR2019-00449 Patent No. 9,763,876 PTAB would be interested to learn what mechanism (e.g., arbitration, mediation, etc.) was used and the general result.

For more information, please consult the Office Patent Trial Practice Guide, 77 Fed. Reg. 48756 (Aug. 14, 2012), which is available on the Board Web site at http://www.uspto.gov/PTAB.

Patent Owner is advised of the requirement to submit mandatory notice information under 37 C.F.R. § 42.8(a)(2) within 21 days of service of the petition.

The parties are advised that under 37 C.F.R. § 42.10(c), recognition of counsel pro hac vice requires a showing of good cause.

Many non-profit organizations, both inside and outside the intellectual property field, offer alternative dispute resolution services.

If the parties actually engage in alternative dispute resolution, the Case IPR2019-00450 Patent No. 9,763,876 PTAB would be interested to learn what mechanism (e.g., arbitration, mediation, etc.) was used and the general result.

Aquestive fails to show why EX1013—a document that is cited only in support of a non-instituted ground—(and Dr. Peppas’ discussion thereof, EX1041, ¶¶171-191, 264-362, Appendix A (pp. 197-224), and EX1050) is relevant to the instituted grounds.

Aquestive’s reliance on Genzyme Therapeutic and/or Ariosa Diagnostics is disingenuous given that neither of those decisions involved the lack of notice, and resultant prejudice, that is present here.

The declaration does not provide any “personal knowledge” as required by FRE 901(b)(1), or any other evidence that EX1069 is what Aquestive purports it to be—a manual available to, and followed by, medical technicians in Florida prior to the priority date.

Separately, Dr. Wermeling’s experience in drug development does not qualify him to provide expert opinions on economics and/or regulatory procedures.

Aquestive block cites portions of Dr. Wermeling’s testimony in support of the alleged “expertise”—but, a closer look at the testimony reveals that he (1) is merely “familiar with economic principles” (EX2031, 8:19-22) and otherwise collaborated with trained economists for his written work (id., 10:2-14); (2) has never worked at, or received any formal certifications related to, FDA practice and procedure (id., 10:22-11:7); (3) has limited experience with pricing (id., 77:2-7) and could not make any pricing decisions on his own (id., 79:24-80:81:5), and; (4) is only “pretty familiar” with the 505(b)(2) pathway and would need to consult the “regulatory person at the company” for the answer to a complex question on the same (id., 85:6-86:13).

Committee Note to 2000 Amendment to Rule 703 (“[W]hen an expert reasonably relies on inadmissible information to form an opinion or inference, the underlying information is not admissible simply because the opinion or inference is admitted.”); Malletier v. Dooney & Bourke, Inc., 525 F. Supp.

807(a)(2); see Committee Note to 2019 Amendments (“proponent must show that the hearsay statement is more probative then any other evidence the proponent can obtain”).

Contrary to PO’s assertion, the narratives provided by PO’s expert in paragraphs 2, 5, 7 and 67 of his declaration is not relevant to the subject recited in the challenged claims of the ‘876 patent.

For example, PO’s expert opines, with insufficient personal knowledge, regarding the appropriate level of skill possessed by a POSA as of the invention date of the subject matter recited in the ’876 patent (e.g., ¶¶ 28-33), and the alleged secondary considerations PO attempts points to in an attempt to support patentability (e.g., ¶¶ 36, 48, 50-51).

PO’s expert, in paragraphs 34, 68-70, 75 and 114, offers his views on an ultimate question of law -- what constitutes sufficient incorporation by reference.

37 C.F.R. § 42.20(c); Fanduel, Inc., et al. v. CG Tech. Development LLC, IPR2017-00902, Paper 45, 83 n.21 (PTAB 2018) (“An opponent bears the burden of establishing inadmissibility of an exhibit by filing a motion to exclude the evidence”) (internal citations omitted).

Additionally, the SIGMA trademark and contact and pricing information further bear the “appearance, contents, substance, internal patterns, or other distinctive characteristics of the item, taken together with all the circumstances” under FRE 901(b)(4).

EX2010 otherwise meets the “residual exception” under FRE 807(a) as it is relied on by Dr. Gizurarson—see e.g., EX2012, ¶¶63, 111—and is more probative on the point for which it is offered (background on intranasal administration of benzodiazepine drugs) than other evidence that Neurelis could have obtained.

EX2014 otherwise meets the “residual exception” under FRE 807(a) as it is relied on by Dr. Gizurarson and Aquestive’s own expert—see e.g., EX2012, ¶90; EX1150, ¶210—and is more probative on the point for which it is offered (reactions of disclosed alcohols) than other evidence that Neurelis could have obtained.

For example, the press releases show their respective sources, publication dates, and contact information that bear the “appearance, contents, substance, internal patterns, or other distinctive characteristics of the item, taken together with the circumstances” under FRE 901(b)(4).

EX1041, ¶¶171-191 discuss Sonne (Exhibit 1013) and “document the knowledge that skilled artisans would bring to bear in reading the prior art identified as producing obviousness.” Genzyme Therapeutic Prod.

Exhibit 1069 is directly relevant and rebuts PO’s argument that “[o]bjective evidence of the failure of others to formulate a diazepam intranasal spray and a long-felt but unmet need to do so further supports a finding of non-obviousness.

Ex1152”), now being filed in support of Petitioner’s Opposition to PO’s Motion to Exclude, which expressly states at paragraph 3: “Exhibit 1069 is a true and correct copy of the Florida Regional Common EMS Protocols Field Guide, Jones and Barlett Publishers, MA (2005).

Statements relied on in EX1069 are supported by sufficient guarantees of trustworthiness and are probative regarding the administration of formulations of benzodiazepines intranasally and thus are admissible under FRE 807, the residual exception to hearsay.

Dr. Wermeling’s Declaration responds to and rebut arguments PO made in its responses, including the PPOR, POR and statements by PO’s expert, and addresses issues raised in the Institution Decision.