Nutricia v. Massachusetts Institute of Technology

• Decision Date: 29 March 2019
• Docket Number: 096 (DK),Patent Interference 106,Technology Center 1600
• Parties: N.V. Nutricia (Inventors: Robert Johan Joseph Hageman, Patrick Joseph Gerardus Hendrikus Kamphuis, and Ladislaus Maria Broersen) Junior Party (Patent 8, 445, 458), v. Massachusetts Institute of Technology (Inventors: Richard J. Wurtman and Ingrid Richardson) Senior Party (Patent Application 11/920, 914).
• Court: United States Patent and Trademark Office. United States Patent and Trademark Office, Patent Trial and Appeal Board

N.V. Nutricia (Inventors: Robert Johan Joseph Hageman, Patrick Joseph Gerardus Hendrikus Kamphuis, and Ladislaus Maria Broersen) Junior Party (Patent 8, 445, 458), v. Massachusetts Institute of Technology

(Inventors: Richard J. Wurtman and Ingrid Richardson) Senior Party (Patent Application 11/920, 914).

Patent Interference No. 106, 096 (DK)

Technology Center 1600

United States Patent and Trademark Office, Patent Trial and Appeal Board

March 29, 2019

Attorney for Junior Party Nutricia David R. Fairbairn Alan M Koenck KINNEY & LANGE, P.A.

Attorney for Senior Party MIT Mark Cohen Craig L. Puckett PEARL COHEN ZEDEK LATZER BARATZ LLP

Before SALLY GARDNER LANE, JAMES T. MOORE, and DEBORAH KATZ Administrative Patent Judges.

JUDGMENT 37 C.F.R. § 41.127(A)

KATZ, Administrative Patent Judge.

Junior Party N. V. Nutricia ("Nutricia") was accorded benefit of the filing date, 20 June 2008, of its international application PCT/NL2008/050408. (See Declaration, Paper 1, 5:12.) Senior Party Massachusetts Institute of Technology ("MIT") was accorded benefit of the filing date, 23 May 2006, of its international application PCT/US06/19766. (See Declaration, Paper 1, 5:13.) Nutricia filed a priority statement, but did not assert a date of conception or reduction to practice earlier than the filing date, 20 June 2008, of its international application, PCT/NL2008/050408, which was accorded to it upon declaration. (See N. V. Nutricia Priority Statement, Paper 42; see Declaration, Paper 1, 5:12.) MIT was accorded benefit of an earlier filing date, 23 May 2006, upon declaration. (See Declaration, Paper 1, 5:11-13.) Therefore, Nutricia cannot assert an earlier date of invention. See 37 C.F.R. § 41.204(a)(1) ("A party may not submit evidence of its priority in addition to its accorded benefit unless it files a statement setting forth all bases on which the party intends to establish its entitlement to judgment on priority."). Accordingly, Nutricia involved claims are unpatentable under 35 U.S.C. § 102(g).^[1]

We denied Nutricia Motion 1 arguing that claims 2 and 9 of Nutricia's involved patent 8, 445, 458 do not correspond to Count 1. (See Decision on Motions, Paper 80.)

It is ORDERED that Nutricia patent 8, 445, 458, claims 1-10 be CANCELED;

It is also ORDERED that a copy of this judgment shall be entered into the administrative record of patent 8, 445, 458, application 11/920, 914;

It is further ORDERED that the parties are directed to 35 U.S.C. § 135(c) and to 37 C.F.R. § 41.205 regarding the filing of settlement agreements; and it is further ORDERED that a party seeking judicial review timely serve notice on the Director of the United States Patent and Trademark Office; 37 C.F.R. §§ 90.1 and 104.2. See also 37 C.F.R. § 41.8(b). Attention is directed to Biogen Idee MA, Inc., v. Japanese Foundation for Cancer Research, 785 F.3d 648, 654-57 (Fed. Cir. 2015) (determining that pre-AIA § 146 review was eliminated for interference proceedings declared after September 15, 2012).

DECISION ON MOTIONS 37 C.F.R. § 41.125(A)

Introduction

N.V. Nutricia ("Nutricia") is involved in this interference as the junior party based on its patent 8, 445, 458 ("the '458 patent"). Claims 1-10, all of the claims of the '458 patent, were designated as corresponding to Count 1. (See Declaration, Paper 1, 5:1-10.) Nutricia was accorded benefit of the filing date, 20 June 2008, of its international application PCT/NL2008/050408. (See Declaration, Paper 1, 5:12.)

Massachusetts Institute of Technology ("MIT") is involved based on its application 11/920, 914. All of the claims of the '914 application were designated as corresponding to Count 1. (See Declaration, Paper 1, 5:1-10.) MIT was accorded benefit of the filing date, 23 May 2006, of its international application PCT/US06/19766. (See Declaration, Paper 1, 5:13.)

Both parties claim methods comprising administering a composition to a person to treat conditions related to dementia. (See '458 patent, Ex. 2002, abstract; see '914 appl, Ex. 2001, abstract.) The compositions recited in both parties' claims include omega 3 fatty acid, uridine or a derivative thereof, and a methyl donor, such as choline. Count 1 describes the interfering subject matter and was determined to be the same as MIT claim 49.

The parties filed motions during this preliminary, non-priority phase of the interference. Senior Party MIT filed three motions: Motion 1 arguing that it should be accorded the benefit of a provisional application (Paper 44); Motion 2 arguing that Nutricia's involved claims are unpatentable under 35 U.S.C. § 112, first paragraph (Paper 45); and Motion 3 arguing that Nutricia's involved claims are unpatentable under 35 U.S.C. § 102(b) (Paper 46).

MIT's motions are moot because Nutricia did not assert a priority date earlier than MIT's accorded benefit date. Specifically, Nutricia filed a priority statement, but did not assert a date of conception or reduction to practice earlier than the filing date, 20 June 2008, of its international application, PCT/NL2008/050408, which was accorded to it upon declaration. (See N. V. Nutricia Priority Statement, Paper 42; see Declaration, Paper 1, 5:12.) MIT was accorded benefit of an earlier filing date, 23 May 2006, upon declaration. (See Declaration, Paper 1, 5:11-13.) Nutricia cannot assert a date of invention earlier than 20 June 2008 in a priority phase of the interference. See 37 C.F.R. § 41.204(a)(1) ("A party may not submit evidence of its priority in addition to its accorded benefit unless it files a statement setting forth all bases on which the party intends to establish its entitlement to judgment on priority."). Accordingly, Nutricia cannot win on priority and its claims involved in the interference will be canceled under 35 U.S.C. § 135(a).^[1] The motions filed by MIT, asserting an even earlier priority date and that Nutricia's claims are unpatentable under different statutes are, therefore, moot and we DISMISS them.^[2]

Junior Party Nutricia filed Motion 1, arguing that claims 2 and 9 of its involved '458 patent do not correspond to Count 1. (Paper 26.) Claims not corresponding to Count 1 are not involved in the interference and will not be canceled under 35 U.S.C. § 135(a). Therefore, we take up Nutricia Motion 1, to determine which of its claims will be canceled when judgment is entered. For the reasons that follow, we DENY Nutricia Motion 1.

Nutricia Motion 1

Nutricia argues that claims 2 and 9 of its involved '458 patent should not be designated as corresponding to Count 1 and thus, are not involved in the interference. (See Nutricia Motion 1, Paper 26, 1:7-10.) "A claim corresponds to a count if the subject matter of the count, treated as prior art to the claim, would have anticipated or rendered obvious the subject matter of the claim." 37 C.F.R. § 41.207(b)(2). Thus, it is Nutricia's burden to persuade us that Count 1 would not anticipate or render obvious claim 2 or claim 9 of its involved '458 patent. See 37 C.F.R. § 41.208(b)("To be sufficient, a motion must provide a showing, supported with appropriate evidence, such that, if unrebutted, it would justify the relief sought. The burden of proof is on the movant."); see also 37 C.F.R. § 41.121(b).

Count 1 is claim 49 of MIT's involved '914 application and recites:

A method of increasing an amount of a synaptic membrane of a neural cell or brain cell of a subject comprising

administering to said subject in need of such treatment a therapeutically effective amount of a composition having:

(a) an omega-3 fatty acid, an omega-6 fatty acid, or a combination thereof;

(b) uridine, an acyl derivative thereof, a uridine phosphate or a CDP22 choline; and

(c) a choline salt,

wherein uridine, an acyl derivative thereof, a uridine phosphate or CDP-choline is dosed to provide a range of 10 to 500 mg of uridine per day and choline is dosed in a range of 100 mg to 10 g per day.

(Declaration, Paper 1, 4:12-26.)

Claim 2

We consider Nutricia's arguments regarding claim 2 first.

Nutricia's claim 1 recites:

A method for the prevention or delay of the onset of dementia in a person having characteristics of a prodromal dementia patient comprising administering to the person a composition comprising:

(a) one or more ɷ-3 fatty acids selected from DHA, DPA and EPA,

(b) a uridine selected from the group of uridine, deoxyuridine, uridine phosphates, uracil and acylated uridine derivatives, and

(c) a methyl donor.

(N.V. Nutricia Clean Copy of Involved Claims, Paper 6, 3:1-9.)

Nutricia's claim 2 recites:

The method according to claim 1, wherein the characteristics comprise two or more of:

a level of more than 350 ng Total-tau per liter cerebrospinal fluid (CSF);

a weight ratio of abeta-42/Phospho-tau-181 of less than 6.5 in CSF;

presence of medial temporal lobe (MTL) atrophy, existing of volume loss of hippocampus, entorhinal cortex, or amygdala evidenced on Magnetic Resonance Imaging (MRI);

presence of fronto-temporal lobe (FTL) atrophy evidenced on MRI with qualitative ratings or quantitative volumetry;

a level of more than 25 pg F2-iso-prostane (F2-IsoP isoprostane 8, 12- iso iPF2alpha-VI) per mL CSF; reduced glucose metabolism in bilateral temporal parietal areas of the brain, as is detectable by Positron Emission Tomography (PET);

reduced glucose metabolism in the posterior cingulate cortex, as is detectable by PET;

impaired blood flow in the brain as measurable by applying Single-Photon Emission Computed Tomography (SPECT), for example by applying the radioisotope 99mTc-HMPAO);

impaired glucose metabolism in the brain as measurable by applying SPECT;

abnormalities in the histology of the medial or inferior temporal lobes as can be determined by MRI or in the rate of glucose utilisation;

abnormalities in

...