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Palette Life Sciences, Inc. v. Incept LLC

Docket IPR2020-00005, Patent Trial and Appeal Board (Oct. 14, 2019)
Erica Franklin, Tina Hulse, Ulrike Jenks, presiding
Case TypeInter Partes Review
Patent7744913
Patent Owner Incept LLC
Petitioner Palette Life Sciences, Inc.
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8 Institution Decision: Trial Instituted Document

Document IPR2020-00005, No. 8 Institution Decision - Trial Instituted Document (P.T.A.B. Apr. 17, 2020)
An inter partes review may not be instituted unless “the information presented in the petition ... and any response ... shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a).
Real time ultrasound guidance is used to ensure that the delivery, a needle, is positioned in the Denonvillier’s space located anterior to the rectal wall and posterior to the prostate.
Petitioner, however, does not identify, and we do not discern, any material differences relating to Fishman that substantively distinguish the arguments here from those made in connection with the Ein- Gal in the Wallace ’913 Petition.
For the foregoing reasons, based on the circumstances of this case, we exercise our discretion under 35 U.S.C. § 314(a) and deny the Petition requesting institution of an inter partes review of claims 1–25 of the ’913 patent.
Patent US 7,744,913 B2 For PETITIONER: Jeffrey Guise Lora Green Richard Torczon Lorelei Westin Kristin Havranek Tasha Thomas
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4 Notice of Filing Date Accorded to Petition: Notice of Accord Filing Date

Document IPR2020-00005, No. 4 Notice of Filing Date Accorded to Petition - Notice of Accord Filing Date (P.T.A.B. Oct. 23, 2019)
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.
Jeffrey W. Guise Lora Green Richard Torczon Lorelei Westin Kristin Havranek Tasha Thomas
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 IPR2020-00005 Patent 7,744,913 B2 PTAB would be interested to learn what mechanism (e.g., arbitration, mediation, etc.) was used and the general result.
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3 Other Not for motions: Petitioner¿¿¿s Explanation of Multiple Petitions Challenging Patent No 7,744,913 and Ranking of Petitions

Document IPR2020-00005, No. 3 Other Not for motions - Petitioner¿¿¿s Explanation of Multiple Petitions Challenging Patent No 7,744,913 and Ranking of Petitions (P.T.A.B. Oct. 14, 2019)
Pursuant to the July 2019 Trial Practice Guide Update ("Update"), Petitioner, Palette, is providing this Petitioner's Explanation of Multiple Petitions Challenging Patent No. 7,744,913 and Ranking of Petitions.
Wallace and Ball teach or suggest the introduction of a gel into a space between an organ and a nearby tissue, without the use of second filler material, such as a biodegradable envelope.
Specifically, the challenges based on Burg are based on the use of the transition phrase "comprising" in the independent claim, which does not preclude embodiments that use multiple fillers—Le., it does not preclude embodiments where a filler, in the form of a balloon or envelope, contains a second filler, in the form of a liquid or gel.
Namely, the '913 patent teaches an embodiment using a filler that comprises a device having a reversible volume, such as a balloon, wherein the balloon "may be introduced, inflated, and then deflated after a dose of radiation has been administered, or recovered after the radiation treatment has been completed."
First, the approaches involve different art and are drawn to different embodiments disclosed by the '913 patent specification.
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2 Petition: Petition for Inter Partes Review

Document IPR2020-00005, No. 2 Petition - Petition for Inter Partes Review (P.T.A.B. Oct. 14, 2019)
At its core, the claimed invention aims to protect healthy tissues and organs from unsafe levels of exposure to radiation—a fundamental tenet that has been recognized by those in the art since the inception of radiation therapy.
Accordingly, prior to June 2002, compositions containing biocompatible, biodegradable polymers, which are capable of forming gels in vivo, such as HA and collagen, had been proposed for use in preventing radiation-induced toxicity in abdominal tissue.
Independent Claim 1 a. [1.Preamble] A method of delivering a therapeutic dose of radiation to a patient comprising Burg teaches “an absorbable implantable tissue expander device that can be used in surgeries as a gradually diminishing space filler.” EX1041, Abstract; EX1003, ¶185.
As explained below in section V.G.1.g, a POSA would have considered it obvious to introduce a biocompatible, biodegradable tissue expander, like those taught by Burg and Fishman, into a patient to displace the rectum away from the prostate gland during radiation therapy.
Fishman particularly teaches that by displacing the rectum away from the prostate gland during radiation therapy, the harmful side effects that may result from irradiation of healthy rectal tissue may be avoided.
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7 Preliminary Response: Patent Owner Preliminary Response

Document IPR2020-00005, No. 7 Preliminary Response - Patent Owner Preliminary Response (P.T.A.B. Jan. 23, 2020)
Petitioner’s Ground 1 challenge to claim 17 is also deficient because Petitioner does not explain why a POSA would have reasonably expected to reduce the radiation dose to surrounding tissue by more than 50% using a collagen filler.
In particular, Petitioner does not explain how or why a person trained in providing clinical care to patients would have known enough materials science to understand how to design or select a “biocompatible, biodegradable filler device” that satisfies all claimed features.
In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”); 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which
Petitioner’s Ground 1 challenge to claim 17 is also deficient because Petitioner does not explain why a POSA would have reasonably expected to reduce the radiation dose to surrounding tissue by more than 50% using a collagen filler.
In particular, Petitioner and its expert assume that a POSA would have understood that “a higher dose of radiation, such as 70 to 100 Gy, could be applied,” and would have “readily appreciated the distance the tissue should be displaced to receive less than 50% of that dose.” Pet. 36–37, citing Ex. 1003 ¶¶ 205–207.
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5 Mandatory Notice: Patent Owner Mandatory Notices

Document IPR2020-00005, No. 5 Mandatory Notice - Patent Owner Mandatory Notices (P.T.A.B. Nov. 4, 2019)
Patent Owner Mandatory Notices Pursuant to 37 C.F.R. § 42.8, Patent Owner Incept LLC submits the following Mandatory Notices.
Related Matters Under 37 C.F.R. § 42.8(b)(2) Patent Owner is not presently aware of any proceedings other than those cited in the Petition.
Service information for lead and back-up counsel is provided in the designation of lead and back-up counsel, above.
Service of any documents via hand-delivery may be made at the postal mailing address of the respective lead and back-up counsel designated above.
Power of Attorney A Power of Attorney appointing the above-designated counsel is being filed concurrently with these Mandatory Notices.
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6 Power of Attorney: Patent Owner Power of Attorney

Document IPR2020-00005, No. 6 Power of Attorney - Patent Owner Power of Attorney (P.T.A.B. Nov. 4, 2019)
Patent 7,744,913 B2 Patent Owner Power of Attorney Pursuant to 37 CPR.
§ 42.10(b), Patent Owner Incept LLC (owner of the entire right, title, and interest as evidenced by an assignment from the inventor(s) recorded at Reel 020577, Frame 0041) appoints the practitioners associated with Customer Number 26853, including the following lead and back—up counsel, as its attorneys to transact all business in the United States Patent and Trademark Office associated with the above-captioned Inter Partes Review.
One CityCenter The New York Times Building
The individual signing below has the authority to execute this document on behalf of Patent Owner Incept LLC.
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