Paper No. ____
`Filed: March 9, 2020
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________
`
`MODERNA THERAPEUTICS, INC.,
`Petitioner,
`
`v.
`
`ARBUTUS BIOPHARMA CORPORATION,
`Patent Owner.
`_____________________________
`
`Case IPR2019-00554
`Patent No. 8,058,069
`_____________________________
`
`
`PATENT OWNER’S OBJECTIONS TO
`PETITIONER’S REPLY EVIDENCE
`
`
`
`
`
`
`
`
`Filed: March 9, 2020
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________
`
`MODERNA THERAPEUTICS, INC.,
`Petitioner,
`
`v.
`
`ARBUTUS BIOPHARMA CORPORATION,
`Patent Owner.
`_____________________________
`
`Case IPR2019-00554
`Patent No. 8,058,069
`_____________________________
`
`
`PATENT OWNER’S OBJECTIONS TO
`PETITIONER’S REPLY EVIDENCE
`
`
`
`
`
`
`
`
`
`
`
`I.
`
`INTRODUCTION
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner submits the following
`
`objections to Moderna Therapeutics, Inc. (“Petitioner”)’ Exhibits 1020, 1023, and
`
`1024 and any reference to or reliance on the foregoing Exhibits in the Petition or
`
`future filings by Petitioner. Patent Owner’s objections are made pursuant to the
`
`Code of Federal Regulations (“C.F.R.”) governing this proceeding, including
`
`without limitation 37 C.F.R. §§ 42.61-42.65 and § 42.6(a)(3). As required by 37
`
`C.F.R. § 42.62, Patent Owner’s objections below apply the Federal Rules of
`
`Evidence (“F.R.E.”).
`
`II. OBJECTIONS.
`
`1. Objections to Exhibit 1020, and any Reference to/Reliance
`Thereon
`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible),
`
`403 (Excluding Evidence for Prejudice, Confusion, Waste of Time, Duplication, or
`
`Other Reasons), F.R.E. 702, 703 (Expert Foundation and Opinions), F.R.E. 802,
`
`803, 805 (Inadmissible Hearsay).
`
`EX1020 is the declaration of Petitioner’s proffered expert, Dr.
`
`Anchordoquy. Patent Owner objects to the declaration in its entirety. First, Dr.
`
`Anchordoquy is not a qualified expert in the relevant field and does not even meet
`
`Petitioner’s definition of the ordinary artisan. Dr. Anchordoquy is a zoologist, not
`
`a lipid chemist with formal training in the subject matter at hand. EX1020, ¶9.
`-1-
`
`
`
`
`
`Moreover, Petitioner and Dr. Anchordoquy define the ordinary artisan as someone
`
`who “would have specific experience with lipid particle formation and use in the
`
`context of delivering therapeutic nucleic acid payloads.” EX1020, ¶25; see also
`
`Institution Decision (“Inst. Dec.”), 11-12 (discussing the level of ordinary skill in
`
`the art). Dr. Anchordoquy, as support for his expertise in the field, specifically
`
`discusses his first issued patent, U.S. Patent No. 7,914,714, which he asserts
`
`“described a process by which lipid bilayers could be formed around a solution of
`
`nucleic acids, effectively surrounding the nucleic acids to achieve complete
`
`encapsulation within a lipid vesicle.” EX1020, ¶14. That patent, however, claims
`
`a “method for making an encapsulated droplet … of an agent to be
`
`encapsulated…through electrostatic atomization….” This technology is neither the
`
`same nor similar to the technology at issue. Indeed, it does not seem that Dr.
`
`Anchordoquy has any relevant patents or patent applications at all. Furthermore,
`
`Petitioner does not demonstrate that Dr. Anchordoquy has any significant expertise
`
`in the technology at issue through his publications or academic studies.
`
`Accordingly, although Dr. Anchordoquy is the rare zoologist who may potentially
`
`have some degree of experience with lipid formulations, he is not an expert and it
`
`is apparent that he does not have the requisite experience with delivering
`
`therapeutic nucleic acids as required by Petitioner’s definition of the ordinary
`
`artisan and as adopted by Dr. Anchordoquy.
`
`-2-
`
`
`
`
`
`Second, even if the Board were to find Dr. Anchordoquy an expert in this
`
`case, his declaration is irrelevant for the purposes proffered by Petitioner. Dr.
`
`Anchodoquy’s declaration is used as a means to assert new argument and
`
`obviousness theories unsupported by the petition. The petition was based on a
`
`faulty application of the relevant caselaw and, as detailed in the Patent Owner
`
`Response, lacked critical evidence to support an obviousness charge. In Reply,
`
`Petitioner now attempts to submit evidence that is required to have been submitted
`
`with the petition materials. 37 CFR § 42.23(b). Petitioner did not do so, but
`
`instead, now attempts to abandon arguments and explanation proffered by its
`
`previous expert in order to advance different and new obviousness arguments.
`
`Third, Dr. Anchordoquy fails to describe the underlying facts or data on
`
`which his opinions are based, thereby failing to provide a proper foundation for his
`
`opinions. There is no basis in the Board’s rules or opinions, nor in the case law of
`
`the Court of Appeals for the Federal Circuit, that requires a fact finder to credit the
`
`unsupported assertions of an expert witness.
`
`Accordingly, what little (if any) probative weight to which the declaration is
`
`entitled is outweighed by the its prejudicial effect.
`
`2. Objections to Exhibit 1023, and any Reference to/Reliance
`Thereon
`Grounds for Objection: F.R.E. 401, 402 (Irrelevant Evidence Inadmissible),
`
`403 (Excluding Evidence for Prejudice, Confusion, Waste of Time, Duplication, or
`-3-
`
`
`
`
`
`Other Reasons), F.R.E. 802, 803, 805 (Inadmissible Hearsay), F.R.E. 901
`
`(Authenticating or Identifying Evidence).
`
`Dr. Anchordoquy describes EX1023 as the “label for Onpattro from the
`
`FDA. EX1020, ¶139. Neither the exhibit itself nor Dr. Anchordoquy, however,
`
`point to the source of the electronic record or to how or when it was obtained.
`
`3. Objections to Exhibit 1024, and any Reference to/Reliance
`Thereon
`Grounds for Objection: F.R.E. 106 (Remainder of or Related Writings or
`
`Recorded Statement), F.R.E. 401, 402 (Irrelevant Evidence Inadmissible), 403
`
`(Excluding Evidence for Prejudice, Confusion, Waste of Time, Duplication, or
`
`Other Reasons), F.R.E. 802, 803, 805 (Inadmissible Hearsay), F.R.E. 901
`
`(Authenticating or Identifying Evidence).
`
`Exhibit 1024 is entitled “Liposomal Formulations for Nucleic Acid
`
`Delivery,” and is identified as “Chapter 9.” Neither Dr. Anchordoquy’s
`
`declaration nor Petitioner’s reply identify the source of the exhibit. E.g., Reply, iii
`
`(identifying EX1024 as “Ian MacLachlin, Liposomal Formulations for Nucleic
`
`Acid Delivery (2007), but not identifying the source); EX1022, ¶29 (merely
`
`referencing EX1024).
`
`III. CONCLUSION
`
`The aforementioned exhibits were filed on March 2, 2020. These objections
`
`are made within 5 business days of institution pursuant to 37 C.F.R. § 42.64.
`-4-
`
`
`
`
`
`
`
`
`
`
`
`Dated: March 9, 2020
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
`/ Michael T. Rosato /
`Michael T. Rosato, Lead Counsel
`Reg. No. 52,182
`
`
`
`
`
`
`-5-
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that the foregoing Patent Owner’s Objections to
`
`Petitioner’s Reply Evidence was served on March 9, 2020, at the following
`
`electronic service addresses:
`
`Michael Fleming
`C. Maclain Wells
`IRELL & MANELLA LLP
`mfleming@irell.com
`mwells@irell.com
`ModernaIPR@irell.com
`
`
`
`Dated: March 9, 2020
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
`
`
`
`
`
`
`
`
`/ Michael T. Rosato /
`Michael T. Rosato, Lead Counsel
`Reg. No. 52,182
`
`
`
`-6-
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
