PTAB

IPR2022-00677

WestMiNSTer Pharmaceuticals LLC v. Chemo Sa France Now Known As Lpri France

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Compositions, kits and methods for nutrition supplementation
  • Brief Description: The ’227 patent relates to nutritional compositions, specifically prenatal vitamin formulations, consisting of a defined combination and dosage of various vitamins, minerals, and omega-3 fatty acids containing docosahexaenoic acid (DHA).

3. Grounds for Unpatentability

Ground 1: Obviousness over Bentley Combination - Claims 1-10 are obvious over Bentley in view of Bischoff-Ferrari and Koletzko.

  • Prior Art Relied Upon: Bentley (a 2011 clinical journal article), Bischoff-Ferrari (a 2008 journal article), and Koletzko (a 2008 journal article).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that Bentley, which discloses a standard prenatal vitamin (PNV) formulation based on products available in April 2010, teaches nearly all ingredients of claim 1 in overlapping dosage ranges. Petitioner asserted the main differences were Bentley’s lower Vitamin D content (200-400 IU vs. about 1000 IU), its lack of a specific DHA amount, and its inclusion of calcium, which is absent from the claimed composition.
    • Motivation to Combine: Petitioner argued a Person of Ordinary Skill in the Art (POSA) would combine the teachings to create an improved all-in-one prenatal supplement. A POSA would start with the standard PNV formulation in Bentley and make three predictable modifications: (1) increase the Vitamin D dose to about 1000 IU, as taught by Bischoff-Ferrari, to address the widely known inadequacy of lower doses for achieving optimal health; (2) include about 200 mg of DHA, per Koletzko’s consensus recommendation for fetal development; and (3) eliminate calcium, as it was common knowledge that calcium inhibits iron absorption and adds significant bulk to the dosage form, negatively affecting patient compliance.
    • Expectation of Success: A POSA would have a reasonable expectation of success because the modifications involved combining well-known nutritional components and adjusting their dosages for their known and intended purposes.

Ground 2: Obviousness over MPR Combination - Claims 1-10 are obvious over MPR in view of Bischoff-Ferrari and Koletzko.

  • Prior Art Relied Upon: MPR (Monthly Prescribing Reference, Apr. 2010), Bischoff-Ferrari (a 2008 journal article), and Koletzko (a 2008 journal article).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner asserted that MPR, a standard drug reference guide, discloses commercially available prenatal vitamin products that collectively teach all 16 ingredients recited in claim 1. The disclosed products contained most ingredients in amounts that were identical to or encompassed the claimed amounts. Key differences identified by Petitioner were the lower Vitamin D content (200-420 IU) and a different DHA range (250-300 mg) in the products listed in MPR compared to the claimed amounts.
    • Motivation to Combine: As an alternative to Bentley, Petitioner argued a POSA would start with the established formulations in MPR and be motivated to optimize them. A POSA would increase the Vitamin D dose to about 1000 IU based on the teachings of Bischoff-Ferrari for the same reasons as in Ground 1. A POSA would also be motivated to adjust the DHA amount to 200 mg, consistent with Koletzko’s recommendation, as this lower (but sufficient) dose would advantageously reduce the overall size of the dosage form, thereby improving patient compliance.
    • Expectation of Success: A POSA would have a high expectation of success in making these modifications, as it constituted the routine optimization of known supplements to achieve predictable benefits in a well-understood field.
  • Additional Grounds: Petitioner asserted additional obviousness challenges based on combinations including McCullough (as an alternative to Bischoff-Ferrari for increasing Vitamin D) and Edwards (WO 2009/151457), which was cited to teach soft-gel and liquid gelcap dosage forms for dependent claims 2 and 3.

4. Key Claim Construction Positions

  • Petitioner argued for a construction of the term "about", which modifies every ingredient amount in independent claim 1.
    • Proposed Construction: Based on the patent’s own specification, Petitioner proposed that "about" means "an amount or range closely above and/or closely below the stated amount or range that does not manifestly alter the therapeutic effect of the specific ingredient."
    • Relevance: This construction was central to Petitioner’s argument that ingredient amounts disclosed in the prior art were close enough to the claimed amounts to support a prima facie case of obviousness. For example, it supported the argument that a disclosed value of 25 mg of magnesium in MPR rendered a claim to "about 20 mg" obvious.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-10 of Patent 8,183,227 as unpatentable under 35 U.S.C. § 103.