University of Western Australia v. Academisch Ziekenhuis Leiden

Decision Date29 April 2016
Docket NumberPatent Interference 106,007 (RES)
PartiesUniversity of Western Australia, Junior Party v. Academisch Ziekenhuis Leiden, Senior Party (Patent 8, 455, 636, Inventors: Stephen Donald Wilton, Sue Fletcher and Graham McClorey), (Application 11/233, 495, Inventors: Garrit-Jan Boudewijn van Ommen, Judith Christina Theodora van Deutekom, Johannes Theodorus den Dunnen and Annemieke Aartsma-Rus). Technology Center No. 1600
CourtUnited States Patent and Trademark Office. United States Patent and Trademark Office, Patent Trial and Appeal Board

Attorney for University of Western Australia: R. Danny Huntington, Esq. Sharon E. Crane, Esq. Steven P O’Connor, Esq. William B. Raich, Esq. Finnegan Henderson, Farabow, Garrett & Dunner, LLP

Attorney for Academisch Ziekenhuis Leiden: Timothy M. Murphy, Esq. Kathleen M. Williams, Esq. Elizabeth N. Spar, Esq. Brandon T. Scruggs, Esq. Sunstein Kann Murphy & Timbers, LLP

Before: RICHARD E. SCHAFER, SALLY GARDNER LANE, and DEBORAH KATZ, Administrative Patent Judges

JUDGMENT - MOTIONS - 37 CFR § 41.127

SCHAFER, Administrative Patent Judge.

In view of the DECISION ON MOTIONS (Paper 472), it is-

ORDERED that judgment be entered against junior party University of Western Australia (UWA) and inventors Stephen Donald Wilton, Sue Fletcher and Graham McClorey;

FURTHER ORDERED that claims 1-43 (all claims) of UWA's involved patent 8, 455, 636, be cancelled (35 U.S.C. 135(a) (2010));

FURTHER ORDERED that judgment be entered against senior party Academisch Ziekenhuis Leiden (AZL) and inventors Garrit-Jan Boudewijn van Ommen, Judith Christina Theodora van Deutekom, Johannes Theodorus den Dunnen and Annemieke Aartsma-Rus as to claims 15, 76, 78-80, 82, 84, 86, 88-90, 97, 98, and 100-103 of AZL involved application 11/233, 495;

FURTHER ORDERED that claims 15, 76, 78-80, 82, 84, 86, 88-90, 97, 98, and 100-103 of AZL involved application 11/233, 495 be FINALLY REFUSED (35 U.S.C. 135(a));

FURTHER ORDERED that a copy of this judgment be entered in the Administrative Record of:

(1) Patent 8, 455, 636; and
(2) Application 11/233, 495;

FURTHER ORDERED that a party seeking judicial review timely promptly serve notice on the Director of the United States Patent and Trademark Office (37 C.F.R. § 41.8(b)) and file a copy of the notice in the record of this interference.; and

FURTHER ORDERED that attention is directed to Biogen Idec MA, Inc., v. Japanese Foundation for Cancer Research, 758 F.3d 647 (Fed. Cir. 2015) cert. denied 2016 WL 1078942 (March 21, 2016).

NOTICE: "Any agreement or understanding between parties to an interference, including any collateral agreements referred to therein, made in connection with or in contemplation of the termination of the interference, shall be in writing and a true copy thereof filed in the Patent and Trademark Office before the termination of the interference as between the said parties to the agreement or understanding." 35 U.S.C. 135(c); see also Bd.R. 205 (settlement agreements).

Decision - Motions - 37 CFR § 41.125(a)

This interference is between University of Western Australia (UWA) Patent 8, 455, 636 and Academisch Ziekenhuis Leiden (AZL) Application 11/233, 495.

I.

The parties have presented the following motions for decision:

(1) UWA Motion 4 to exclude certain AZL evidence. Paper 455
(2) UWA Motion 1 asserting that AZL's claims are unpatentable under 35 U.S.C. § 112(a) because the claims are broader than supported by the written description and/or an enabling disclosure. Paper 210.
(3) UWA Motion 2 asserting that AZL's claims are unpatentable under 35 U.S.C. § 112(b) as indefinite. Paper 211.
(4) UWA Motion 3 seeking the declaration of an additional interference between UWA U.S. Patent No. 8, 455, 636 AZL Application No. 14/248, 279. Paper 212.
(5) AZL Motion 1 asserting that certain of UWA claims are unpatentable over prior art. Paper 181
(6) AZL Motion 2 to deny UWA the accorded benefit date of is Australian Application AU 2004903474. Paper 26.
(7) AZL Motion 3 asserting that certain of UWA's claims are unpatentable under 35 U.S.C. § 101 in view of Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107 (2013). Paper 27.
(8) AZL Motion 4 (Responsive) to add two additional claims to its application. Paper 241.
II.

The involved subject matter

The subject matter claimed by the parties relates to "exon skipping." Exon skipping is a molecular biology technique that may be useful for ameliorating or eliminating the effects of certain genetic mutations. Those mutations may result in a shift in the reading frame during protein formation resulting in a non-functional or partially functional protein. The exon skipping technique, in effect, hides certain pre-mRNA exons from the mRNA formation machinery. As a result, the hidden exon is removed along with introns during the splicing to form mRNA. The exon skipping is said to be caused by the binding of an oligonucleotide that includes a nucleobase sequence that is complementary to a portion of a particular pre-mRNA exon. The complimentary oligonucleotide is referred to as an antisense oligonucleotide or "AON." Both the exon to be discarded and the AON are chosen to restore an open reading frame allowing for the formation of a more complete and more functional protein.

Specifically, the parties' invention is directed to AONs selected to cause skipping of exon 53 of the pre-mRNA associated with the gene responsible for the formation of the protein dystrophin. The absence of dystrophin prevents skeletal muscle development and causes the myopathies of muscular dystrophy. In people suffering from Duchenne muscular dystrophy (DMD), the mutation in the dystrophin gene essentially precludes the formation of any functional dystrophin. By skipping, and thus removing, exon 53 during the formation of mRNA, a reading frame is said to be restored, resulting in the formation of a partially functional dystrophin protein.

III.

UWA Motion 4 to exclude certain testimony

UWA moves to exclude the testimony of Dr. Erik Sontheimer (Exs. 1012, 1067 and 1186) and certain portions of the testimony of Dr. van Deutekom (Ex. 1125). We dismiss the motion.

With respect to Dr. Sontheimer, UWA challenges the admissibility of all three of his declarations on the basis that he is not qualified as an expert in the field under Fed.R.Evid. 702.

The prerequisite to filing a miscellaneous motion to exclude evidence is the timely service of objections to that evidence on the opponent. SO ¶ 151. Objections to evidence must be served within five business days of service of the evidence. 37 C.F.R. § 41.155(b)(1). Where an objection to evidence is served, the proponent of the evidence has ten business days to file supplemental evidence. 37 C.F.R. § 41.155(b)(2). The purpose of supplemental evidence is to allow the proponent an opportunity to cure the alleged evidentiary defect. SO ¶ 155.3. If an objection is not timely made, the objection is waived. SO ¶ 155.1.2. A motion to exclude evidence must identify where in the record the objection was originally made. 37 C.F.R. § 41.155(c); SO ¶ 155.2.2.

AZL filed three declarations by Dr. Sontheimer-Exhibits 1012, 1067 and 1186-on November 18, 2014, December 23, 2014, and February 17, 2015, respectively. As the basis for its motion to exclude, UWA identifies its objections, served February 24, 2015 (Ex. 2150). UWA Motion 4, Paper 455, 1:7-10. UWA never objected to the first and second Sontheimer declarations (Exs. 1012 and 1067). Ex. 2150. Thus, the objections as to those declarations were untimely and considered to have been waived. 37 C.F.R. § 41.155(b)(1); SO ¶ 155.1.2.

With respect to the third Sontheimer declaration (Ex. 1186), the objection on its face appears to have been timely. However, we fail to see why the objection to Dr. Sonetheimer's expertise could not have been made in response to the filing of his first declaration and CV (Ex. 1013). It is apparent from Dr. Sontheimer's cross-examination, that UWA had significant questions as to his expertise that could have formed the basis for a timely objection. The failure to timely give notice of its objections precluded AZL from timely filing supplemental evidence with respect to at least the first two Sontheimer declarations and possibly following a modified course with respect to the third. Under these circumstances, we decline to consider the exclusion of Dr. Sontheimer's third declaration. However, in evaluating Dr. Sontheimer's testimony, we will consider UWA's arguments on his expertise in evaluating the weight to be give his testimony.

UWA also seeks to exclude ¶¶ 4-18 of Dr. van Deutekom's testimony (Ex. 1125). That testimony is directed to Dr. Sontheimer's credentials. UWA Motion 4, Paper 455, 1:5-6. UWA posits two bases for exclusion: (1) under Fed.R.Evid. 403, the value of her testimony is substantially outweighed by unfair prejudice and needless presentation of cumulative evidence and (2) as hearsay under Fed. R. Evid.. 801 and 802.

With respect to the first basis, the Board is fully capable of weighing any probative value of her testimony against any unduly prejudicial effect. Additionally, her testimony on the point, in light of the extensive record developed in this proceeding, is not so extensive that it is excessively cumulative.

With respect to hearsay challenge, UWA did not raise hearsay as a basis to object to Dr. van Deutekom's testimony in its objections. Ex. 2150. Thus, its objection to admissibility on this ground is considered untimely.

UWA's motion to exclude is dismissed as to Exhibits 1012, 1067 and 1186 and denied with respect paragraphs 4 to 18 of Exhibit 1125.

IV.

UWA Motion 1 - Unpatentability under 35 U.S.C. § 112(a)

A.

UWA Motion 1 argues that AZL's involved claims are unpatentable because AZL's...

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