PTAB

IPR2017-00547

VDF FutuRECeuTicals Inc v. ABBas AbdoLMAlaki

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Enriched 10-Boron Composition for Cancer Therapy and a Method of Synthesizing the Same
  • Brief Description: The ’025 patent discloses an enriched ¹⁰B-calcium fructoborate (¹⁰B-CF) composition for use in Boron Neutron Capture Therapy (BNCT), along with methods for its synthesis and administration in cancer treatment.

3. Grounds for Unpatentability

Ground 1: Obviousness of Claim 1 over Scorei (I) and Scorei (II)

  • Prior Art Relied Upon: Scorei (I) (a January 2011 journal article) and Scorei (II) (a January 2011 journal article).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Scorei (I) explicitly disclosed the use of ¹⁰B-enriched calcium fructoborate as a promising delivery agent for BNCT. It was asserted that Scorei (II), published by the same author in the same month, disclosed the exact α-D-fructofuranose borate (Formula A) and β-D-fructofuranose borate (Formula B) isomeric structures of calcium fructoborate that are recited in claim 1.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) would combine the two articles because they were written by the same author, addressed the same molecule (calcium fructoborate), were published contemporaneously, and discussed its therapeutic potential. Petitioner contended that Scorei (II) simply provided the specific structural information for the compound whose therapeutic use was proposed in Scorei (I).
    • Expectation of Success: Combining the known chemical structures from Scorei (II) with the proposed BNCT application from Scorei (I) would have been a predictable application of known elements to achieve a desired result.

Ground 2: Obviousness of Claims 2-3 and 5-6 over Scorei (I) and Miljkovic 1997

  • Prior Art Relied Upon: Scorei (I) (a January 2011 journal article) and Miljkovic (Patent 5,962,049).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that method claims 2-3 and 5-6 recited a well-known process for synthesizing calcium fructoborate. While Scorei (I) provided the goal of using an enriched ¹⁰B-CF complex for BNCT, Miljkovic allegedly disclosed a detailed, step-by-step synthesis method that mapped directly onto the limitations of claim 2. This included dissolving fructose in a solvent, adding boric acid, adjusting pH to 3-4, adding calcium carbonate, and separating the resulting product.
    • Motivation to Combine: A POSITA, seeking to create the enriched ¹⁰B-CF for BNCT as taught by Scorei (I), would be motivated to use the established synthesis method disclosed in Miljkovic, a reference Scorei (I) itself indirectly relies upon. It would have been obvious to substitute commercially available, enriched ¹⁰B-boric acid for the standard boric acid in Miljkovic’s process to achieve the enriched final product desired by Scorei (I).
    • Expectation of Success: The synthesis was a standard, documented procedure. Substituting an isotopically enriched precursor for a standard one was a routine technique in the BNCT field with highly predictable results.

Ground 4: Obviousness of Claims 7 and 9 over Scorei (I) and Barth 1999

  • Prior Art Relied Upon: Scorei (I) (a January 2011 journal article) and Barth 1999 (a 1999 journal article).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner argued that method of treatment claims 7 and 9 merely recited the standard, fundamental steps of performing BNCT, which were well-known long before the ’025 patent. Barth 1999, a foundational review article on BNCT, was alleged to disclose each claimed step: administering a boron-containing drug, allowing the drug to accumulate in tumor cells, and bombarding the tumor cells with thermal or epithermal neutrons to destroy them. Further, Barth 1999 explicitly taught the "predetermined concentration" range of 20-35 µg/g of tumor recited in claim 9 as being critical for successful BNCT. Scorei (I) only proposed substituting a new boron agent (enriched ¹⁰B-CF) into this conventional therapeutic framework.
    • Motivation to Combine: A POSITA would be motivated to combine Scorei (I)’s disclosure of a new BNCT agent with the established, universal BNCT treatment protocol detailed in Barth 1999. This represented a routine application of a new compound within a known therapeutic modality.
    • Expectation of Success: Applying a new boron delivery agent to a standard, well-understood therapeutic protocol was a routine path for clinical development with a high expectation of success.

  • Additional Grounds: Petitioner asserted additional obviousness challenges, including claim 4 over Scorei (I), Scorei (II), and Miljkovic, and claim 8 over Scorei (I), Barth 1999, and Kikihata 2009, relying on similar theories of combining known elements for predictable purposes.

4. Key Claim Construction Positions

  • “enriched 10-Boron” complex: Petitioner proposed this term be construed to mean a compound where the relative abundance of the ¹⁰B isotope is greater than its natural occurrence of approximately 20%. This construction was central to arguing that the general concept of isotopic enrichment for BNCT was well-known in the prior art.
  • “enriched ¹⁰B boric acid with maximum content of ¹⁰B”: Petitioner argued this term means boric acid in which the relative abundance of ¹⁰B is near 100%. This construction supported the obviousness argument by aligning the claim language with the standard and commercially available >99% enriched boric acid used as a precursor for all BNCT drugs.
  • “administering a drug composition...at a predetermined concentration”: Petitioner proposed this term refers to administering the drug to achieve the well-known, therapeutically effective concentration of ¹⁰B in a tumor (approximately 20-35 µg/g) required for BNCT. This construction framed the limitation not as an inventive step but as a recitation of a known therapeutic target, as disclosed in references like Barth 1999.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-9 of Patent 9,327,025 as unpatentable under 35 U.S.C. §103.