PTAB

IPR2023-00726

Mom Enterprises LLC v. Vieth Elaine

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Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Vitamin D Compositions and Method of Administration to a Human Being
  • Brief Description: The ’958 patent discloses a method for delivering a vitamin D composition by applying a single drop to an object, such as a spoon or pacifier, for a human, particularly an infant, to lick or suck off. The patent claims the method of delivery, not the composition itself.

3. Grounds for Unpatentability

Ground 1: Obviousness over Core References - Claims 1 and 5 are obvious over Harder, Wolf, and European Pharmacopoeia.

  • Prior Art Relied Upon: Harder (a 2003 book chapter on childcare), Wolf (a 1970 medical journal article), and European Pharmacopoeia Supplement 4.3 (a 2003 quality standard).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the combination of references taught every limitation of claims 1 and 5. Harder taught the claimed method: administering one drop of Vigantol oil (a commercial vitamin D product) to an infant by placing it "from the tip of a spoon" to be licked off. Harder also identified the oil's excipient as "medium-chain triglycerides." Wolf disclosed the specific concentration of vitamin D in Vigantol oil, which Petitioner’s expert calculated to be 505.04 mcg/ml, falling within claim 1’s range of 9 to 9000 mcg/ml. The European Pharmacopoeia, an official standard, defined the "medium-chain triglycerides" taught by Harder as being composed of fatty acids with 8 to 10 carbon atoms (within the claimed 6-12 range) and having at least 95% C8-C10 triglycerides, meeting the limitation of claim 5. Petitioner asserted the "adheres" limitation was an inherent property of applying a viscous oil drop to a spoon tip as taught by Harder.
    • Motivation to Combine: A Person of Ordinary Skill in the Art (POSITA) analyzing the well-known Vigantol oil product would combine these references to obtain a complete understanding of its composition, dosage, and administration method. Harder and Wolf are German publications describing the product's use; a POSITA would consult the governing European Pharmacopoeia to understand the precise definition and quality standards for its ingredients, namely the medium-chain triglycerides.
    • Expectation of Success: A POSITA would have a high expectation of success, as the combination merely involved assembling publicly available information about a single, long-standing commercial product to arrive at its known composition and method of use.

Ground 2: Obviousness over Core References and Blass - Claim 3 is obvious over Harder, Wolf, European Pharmacopoeia, and Blass.

  • Prior Art Relied Upon: Harder, Wolf, European Pharmacopoeia Supplement 4.3, and Blass (a 1999 journal article on sucrose-induced analgesia in newborns).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground added Blass to the combination from Ground 1 to teach the limitations of dependent claim 3, which specifies the object is a "woman's nipple or the external surface of a pacifier." Blass taught a method of delivering a liquid supplement (sucrose) to infants by dipping a pacifier into the liquid and allowing the infant to suck it off.
    • Motivation to Combine: A POSITA would be motivated to modify the spoon-delivery method taught by Harder to improve its efficacy for infants. Recognizing that a spoon is not a natural object for an infant to suck on, a POSITA would look to known alternative delivery methods. Blass taught using a pacifier, which leverages an infant's natural sucking reflex, thereby providing an obvious and predictable improvement to ensure the complete dose is administered.

Ground 3: Obviousness over Core References and Gartner - Claim 4 is obvious over Harder, Wolf, European Pharmacopoeia, and Gartner.

  • Prior Art Relied Upon: Harder, Wolf, European Pharmacopoeia Supplement 4.3, and Gartner (a 2003 Pediatrics journal article).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground added Gartner to the combination from Ground 1 to teach the specific vitamin D concentration range of 150 to 450 mcg/ml recited in dependent claim 4. Gartner, published by the American Academy of Pediatrics, provided updated guidelines that lowered the recommended daily vitamin D intake for infants to 200 IU.
    • Motivation to Combine: A POSITA formulating a vitamin D supplement would be motivated to align the product's dosage with the most current recommendations from a respected authority like the American Academy of Pediatrics to ensure safety and efficacy. Modifying the concentration of Vigantol oil (disclosed by Wolf at ~505 mcg/ml) to deliver the 200 IU dose recommended by Gartner was an obvious adjustment. Petitioner’s expert calculated that a one-drop dose providing 200 IU would require a concentration of 151.51 mcg/ml, falling squarely within the range claimed in claim 4.

4. Arguments Regarding Discretionary Denial

  • Petitioner argued against discretionary denial under both 35 U.S.C. §325(d) and Fintiv.
  • Under §325(d), Petitioner asserted that its primary references—Harder, Wolf, European Pharmacopoeia, and Gartner—were never before the Examiner. While the Examiner considered Blass, it was not in view of the new references that supply the key teachings the Examiner previously found missing from the art of record.
  • Under the Fintiv factors, Petitioner contended that the parallel district court case was in its early stages, with a trial date set 19 months in the future and well after the statutory deadline for a Final Written Decision. Petitioner further eliminated overlap by stipulating that it would not pursue the same grounds or prior art in the district court if the IPR is instituted.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1, 3, 4, and 5 of the ’958 patent as unpatentable under 35 U.S.C. §103.