PTAB Life Sciences Report - January 2018 #2

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents.

Acclarent, Inc. v. Ford Albritton, IV

PTAB Petition: IPR2018-00268; filed December 1, 2017.

Patent at Issue: U.S. Patent No. 9,011,412 ("Apparatus, system and method for manipulating a surgical catheter and working device with a single hand," issued April 21, 2015) claims a system, comprising: a guide catheter insertable through an external body passage of a subject, said guide catheter having a substantially rigid shaft, a proximal opening, a distal opening and a lumen extending between the proximal opening and the distal opening; a handle coupled to the guide catheter, the handle having a handle opening, a handle coupling and a structure, wherein the structure is configured to allow a position of the guide catheter to be controlled by some or all of three fingers of one hand of an operator of the handle, and wherein the handle coupling is configured to couple a source of suction to the lumen; and a working device adapted to be insertable through the handle opening into the lumen of the guide catheter, wherein the structure of the handle is adapted to permit the operator to position a thumb and index finger of the hand to manipulate the working device via a portion of the working device immediately adjacent to the handle opening and to control, by one of the thumb or index finger, an amount of suction coupled to the distal opening of the lumen.

Petitioner Acclarent, Inc. is challenging the '412 patent on two grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, the '412 patent is involved in the following litigation: Dr. Ford Albritton IV v. Acclarent, Inc., Civil Action No. 3:16-cv-03340-D (N.D. Tex.).

Trans Ova Genetics, LC v. XY, LLC

PTAB Petition: IPR2018-00250; filed December 1, 2017.

Patent at Issue: U.S. Patent No. 8,652,769 ("Methods for separating frozen-thawed spermatozoa into X-chromosome bearing and Y-chromosome bearing populations," issued February 18, 2014) claims a method of producing a frozen-thawed sorted artificial insemination sample.

Petitioners Intrexon Corp. and Trans Ova Genetics, LC are challenging the '769 patent on five grounds as being obvious under 35 U.S.C. § 103(a). View the petition here.

Related Matters: According to the petition, the '769 patent is the subject of the following litigation: XY, LLC et al. v. Trans Ova Genetics, LC, No. 1:17-cv-00944 (D. Colo.). Petitioners have also filed inter partes review petitions on U.S. Patent No. 7,723,116 (IPR2018-00247 and IPR2018-00248; filed 11/30/2017; pending).

Pfizer, Inc. v. Chugai Pharmaceutical Co.

PTAB Petition: IPR2017-01357; filed May 19, 2017.

Institution of Inter Partes Review; entered December 1, 2017.

Patent at Issue: U.S. Patent No. 7,332,289 ("Method of purifying protein," issued February 19, 2008) claims a method for removing contaminant DNA in an antibody-containing sample.

Petitioner Pfizer, Inc. is challenging the '289 patent on two grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (ground 2). View the petition here. Administrative Patent Judges Grace Karaffa Obermann, Rama G. Elluru, and Jacqueline T. Harlow (author) issued a decision instituting inter partes review of whether claims 1-8 and 13 are anticipated under 35 U.S.C. § 102(b) by Shadle; and whether claims 1-8 and 13 are unpatentableunder 35 U.S.C. § 103(a) over Shadle.

Related Matters: According to the petition, Petitioner has filed a petition for inter partes review of related U.S. Patent No. 7,927,815 (IPR2017-01358; filed 05/19/2017; Instituted 12/01/2017; pending).

Pfizer, Inc. v. Chugai Pharmaceutical Co.

PTAB Petition: IPR2017-01358; filed May 19, 2017.

Institution of Inter Partes Review; entered December 1, 2017.

Patent at Issue: U.S. Patent No. 7,927,815 ("Protein purification method," issued April 19, 2011) claims a method for removing contaminant DNA in a sample containing a physiologically active protein.

Petitioner Pfizer, Inc. is challenging the '815 patent on two grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (ground 2). View the petition here. Administrative Patent Judges Grace Karaffa Obermann, Rama G. Elluru, and Jacqueline T. Harlow (author) issued a decision instituting inter partes review of whether claims 1-7 and 12 are anticipated under 35 U.S.C. § 102(b) by Shadle; and whether claims 1-7 and 12 are unpatentable under 35 U.S.C. § 103(a) over Shadle.

Related Matters: According to the petition, Petitioner has filed a petition for inter partes review of related U.S. Patent No. 7,332,289 (IPR2017-01358; filed 05/19/2017; Instituted 12/01/2017; pending).

Celltrion Inc. v. Genentech, Inc.

PTAB Petition: IPR2017-01373; filed May 9, 2017.

Institution of Inter Partes Review; entered December 1, 2017.

Patent at Issue: U.S. Patent No. 6,407,213 ("Method for making humanized antibodies," issued June 18, 2002) claims a humanized antibody variable domain comprising non-human Complementarity Determining Region (CDR) amino acid residues which bind an antigen incorporated into a human antibody variable domain, and further comprising a Framework Region (FR) amino acid substitution at a site selected from the group consisting of: 4L, 38L, 43L, 44L, 58L, 62L, 65L, 66L, 67L, 68L, 69L, 73L, 85L, 98L, 2H, 4H, 36H, 39H, 43H, 45H, 69H, 70H, 74H, and 92H, utilizing the numbering system set forth in Kabat.

Petitioner Pfizer, Inc. is challenging the '213 patent on seven grounds as being obvious under 35 U.S.C. § 103(a). View the petition here. Administrative Patent Judges Sheridan K. Snedden, Zhenyu Yang (author), and Robert A. Pollock issued a decision instituting inter partes review of whether claims 1-7 and 12 are anticipatedunder 35 U.S.C. § 102(b) by Shadle; and whether claims 1-7 and 12 are unpatentable under 35 U.S.C. § 103(a) over Shadle.

Related Matters: According to the petition, Petitioner has filed a petition for inter partes review of the same claims of the '213 patent based on different art references. The '213 patent is also the subject of inter partes reviews IPR2016-01693 (Mylan Pharmaceuticals Inc.; filed 08/30/2016; terminated by settlement before institution 03/10/2017); IPR2016-01694 (Mylan Pharmaceuticals Inc.; filed 08/30/2016; terminated by settlement before institution 03/10/2017). According to the Institution of Inter Partes Review, the '213 patent is the subject of inter partes reviews IPR2017-01488 (Pfizer, Inc.; filed 05/25/2017; pending); IPR2017-01489 (Pfizer, Inc.; filed 05/25/2017); IPR2017-02031 (Boehringer Ingelheim Pharmaceuticals, Inc.; filed 08/31/2017); IPR2017-02032 (Boehringer Ingelheim Pharmaceuticals, Inc.; filed 08/31/2017); IPR2017-02139 (Samsung Bioepis Co., Ltd.; filed 09/29/2017; pending); and IPR2017-02139 (Samsung Bioepis Co., Ltd.; filed 09/29/2017; pending).

Trans Ova Genetics, LC v. XY, LLC

PTAB Petition: IPR2018-00249; filed December 4, 2017.

Patent at Issue: U.S. Patent No. 6,372,422 ("Multiple sexed embryo production system for mammals," issued April 16, 2002) claims a method of producing multiple, sexed embryos from a non-human female mammal.

Petitioners Intrexon Corp. and Trans Ova Genetics, LC are challenging the '422 patent on six grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (grounds 2-5). View the petition here.

Related Matters: According to the petition, the '422 patent is the subject of the following litigation: XY, LLC et al. v. Trans Ova Genetics, LC, No. 1:17-cv-00944 (D. Colo.). Petitioners have filed separate inter partes review petitions on U.S. Patent No. 7,723,116 (IPR2018-00247 and IPR2018-00248; filed 11/30/2017; pending) and U.S. Patent No. 8,652,769 (IPR2018-00250; filed 12/01/2017; pending).

KVK-Tech, Inc. v. Shire PLC

PTAB Petition: IPR2018-00290; filed December 11, 2017.

Patent at Issue: U.S. Patent No. 8,846,100 ("Controlled dose drug delivery system," issued September 30, 2014) claims a pharmaceutical composition comprising: (a) an immediate release bead comprising at least one amphetamine salt; (b) a first delayed release bead comprising at least one amphetamine salt; and (c) a second delayed release bead comprising at least one amphetamine salt; wherein the first delayed release bead provides pulsed release of the at least one amphetamine salt and the second delayed release bead provides sustained release of the at least one amphetamine salt; wherein the second delayed release bead comprises at least one amphetamine salt layered onto or incorporated into a core; a delayed release coating layered onto the amphetamine core; and a sustained release coating layered onto the delayed release coating, wherein the sustained release coating is pH-independent; and wherein the first delayed release bead and the second delayed release bead comprise an enteric coating.

Petitioners KVK-Tech, Inc. and Abhai LLC are challenging the '938 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (grounds 2 and 3). View the petition here.

Related Matters: According to the petition, Petitioners concurrently filed an inter partes review petition on related U.S. Patent No. 9,173,857 (IPR2018-00293; filed 12/11/2017; pending).

KVK-Tech, Inc. v. Shire PLC

PTAB Petition: IPR2018-00293; filed December 11, 2017.

Patent at Issue: U.S. Patent No. 9,173,857 ("Controlled dose drug delivery system," issued November 3, 2015) claims a method for treating attention deficit hyperactivity disorder (ADHD) which comprises: administering to a patient in need thereof, a pharmaceutical composition comprising: (a) an immediate release bead comprising at least one amphetamine salt; (b) a first delayed release bead comprising at least one amphetamine salt; and (c) a second delayed release bead comprising at least one amphetamine salt; wherein the first delayed release bead provides pulsed release of the at least one amphetamine salt and the second delayed release bead provides sustained release of the at least one amphetamine salt; wherein the second delayed release bead comprises at least one amphetamine salt layered onto or incorporated into a core; a delayed release coating layered onto the amphetamine core; and a sustained release coating layered onto the delayed release coating, wherein the sustained release coating is pH-independent; and wherein the first delayed release bead and the second delayed release bead comprise an enteric coating.

Petitioners KVK-Tech, Inc. and Abhai LLC are challenging the '938 patent on three grounds as being anticipated under 35 U.S.C. § 102(b) (ground 1) or as obvious under 35 U.S.C. § 103(a) (grounds 2 and 3). View the petition here.

Related Matters: According to the petition, Petitioners concurrently filed an inter partes review petition on related U.S. Patent No. 8,846,100 (IPR2018-00290; filed 12/11/2017; pending).