AdVanCell Pty Ltd v. SCiencons As

1. Case Identification

• Case #: PGR2025-00029
• Patent #: 12,125,603
• Filed: March 10, 2025
• Petitioner(s): AdvanCell Pty Ltd.
• Patent Owner(s): Sciencons AS
• Challenged Claims: 1-20

2. Patent Overview

• Title: Method and System for Generating Radioisotopes
• Brief Description: The ’603 patent describes a method and system for producing highly purified lead-212 (²¹²Pb), a radioactive isotope used in targeted alpha therapy for cancer. The patented process involves isolating and purifying ²¹²Pb from other isotopes in a decay chain that begins with thorium-228 (²²⁸Th).

3. Grounds for Unpatentability

Ground 1: Anticipation over Hassfjell-Hoff - Claims 1-8, 11-17, and 19 are anticipated by Hassfjell-Hoff

• Prior Art Relied Upon: Hassfjell-Hoff (a 1994 journal article titled “A Generator for Production of ²¹²Pb and ²¹²Bi”).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that Hassfjell-Hoff disclosed every limitation of the challenged claims. The reference described a radioisotope generator with two compartments separated by a gate valve. A precursor isotope source (packets of ²²⁸Th barium stearate) was held in a basket attached to a long, slidable tube (the "rod"). To generate isotopes, the tube was lowered from a closed position (in an upper housing chamber with the gate valve closed) to an open position, exposing the source to the interior of a polyethylene bottle (the "container"). After an "appropriate collection time" for the precursor to decay and emanate progeny isotopes (radon-220), the tube was withdrawn back to the closed position, isolating the source. This process directly maps to the method steps of independent claim 1 and the system components of independent claim 12.
  • Key Aspects: Petitioner contended that Hassfjell-Hoff’s detailed diagrams and operational descriptions, including the use of O-rings for sealing and dimensions ensuring the source does not touch the container walls, anticipated numerous dependent claims as well.

Ground 2: Obviousness over Hassfjell-Hoff and O'Hara - Claims 9-10, 18, and 20 are obvious over Hassfjell-Hoff in view of O'Hara

• Prior Art Relied Upon: Hassfjell-Hoff (a 1994 journal article) and O’Hara (Application # 2018/0047474).
• Core Argument for this Ground:
  • Prior Art Mapping: Hassfjell-Hoff disclosed the core generator system and method. O’Hara was introduced for its teaching of disposing a precursor isotope source in or on a porous substrate, such as a metal or mineral sponge, permeable membrane, or filter. Petitioner argued that combining O'Hara's porous substrate with Hassfjell-Hoff's generator would render claim 9 (source disposed in a sponge, wool, strip, etc.) and claim 18 (system with the source disposed on a sponge, etc.) obvious. Further, both references disclosed allowing the precursor isotope to decay for various time periods, with O'Hara explicitly showing tests run for up to 72 hours, making the time limitations of claims 10 and 20 obvious.
  • Motivation to Combine: A POSITA would combine O’Hara’s teachings with Hassfjell-Hoff’s generator to improve performance. Using a porous substrate as taught by O'Hara would enable a greater quantity or a more dispersed source isotope to be loaded into the generator, thereby maximizing the emanation of progeny isotopes and increasing the yield. This was presented as a predictable design choice to optimize a known system.
  • Expectation of Success: The combination involved applying a known technique (using a porous source substrate) to a known device (a radioisotope generator) to achieve a predictable improvement (increased emanation). A POSITA would have had a reasonable expectation of success.

Ground 3: Unpatentability under 35 U.S.C. §112 - Claims 1-3, 7-10, 12, and 20 are unpatentable under §112

• Core Argument for this Ground:

  • Lack of Written Description & Enablement: Petitioner argued claim 1 was not enabled because it requires a precursor to decay into "one or more" progeny isotopes that also emanate into the container. However, in the disclosed ²²⁸Th decay chain, only one progeny isotope (radon-220) is a gas that emanates.
  • Indefiniteness: Petitioner contended several claims were indefinite. Claim 2 was argued to be indefinite because it recites exposing a surface to a ²²⁸Th source, but the natural decay of ²²⁸Th means any such source inherently includes its progeny, ²²⁴Ra, making the "and/or" language ambiguous. Claim 7 was argued to be nonsensical due to a repetitive, grammatically incorrect phrase ("exposing the interior surface...exposing the interior surface..."). Claims 8 and 9 were challenged for lacking an antecedent basis for "the at least one progeny isotopes."

• Additional Grounds: Petitioner asserted that claims 5-7, 10-11, 15-16, and 20 are also obvious under 35 U.S.C. §103 based on Hassfjell-Hoff alone, arguing that any limitations not directly disclosed would have been obvious modifications or inherent results of the disclosed system.

4. Key Claim Construction Positions

• "disposed on the rod" (claim 1): Petitioner proposed this term should be construed to include both direct and indirect attachment. This construction was based on the patent’s specification, which describes the isotope source being deposited on a strip or sphere that is, in turn, attached to the rod. This construction supports the argument that Hassfjell-Hoff’s basket-on-a-tube arrangement meets the limitation.
• Claim 7 language: Petitioner argued the language of claim 7 is nonsensical as written due to a repeated phrase. Petitioner anticipated that the Patent Owner would propose rewriting the claim to correct the error and proceeded to argue that even the corrected version of the claim is anticipated by Hassfjell-Hoff.

5. Arguments Regarding Discretionary Denial

• Petitioner argued that discretionary denial would be inappropriate.
  • §314(a) (Fintiv): The Fintiv factors weigh against denial because there was no parallel district court litigation involving the ’603 patent.
  • §325(d): Denial was argued to be unwarranted because the primary reference, Hassfjell-Hoff, was not cumulative to the art considered during prosecution. Although a different article by the same author (Hassfjell-2001) was cited, it disclosed a materially different system (a bubbler generator). Petitioner asserted the examiner committed clear error by allowing the claims over art that did not disclose a precursor on a rod with an open/closed configuration, a key feature explicitly shown in Hassfjell-Hoff.

6. Relief Requested

• Petitioner requests institution of Post Grant Review (PGR) and cancellation of claims 1-20 of the ’603 patent as unpatentable.