Showing all posts written by Daniel Fullerton
Mr. Fullerton specializes in intellectual property law, with a focus on patent preparation and prosecution in the medical device field. During law school, Mr. Fullerton worked as a clinical intern for the USC Intellectual Property and Technology Law Clinic, where he worked on various copyright and other intellectual property matters for individuals and non-profits.
Boston Scientific Corporation (“Boston Scientific”) filed a petition with the Patent Trial and Appeal Board on April 10, 2015 requesting inter partes review of U.S. Patent No. 6,266,563 (“the ’563 Patent”). The petition states that the ’563 Patent is owned by the UAB Research Foundation. The petition has been assigned Case No. IPR2015-01038.
The ’563 Patent is entitled “Method and Apparatus for Treating Cardiac Arrhythmia,” and lists as inventors Bruce H. KenKnight, Raymond E. Ideker, Robert S. Booker, III, and Stephen J. Hahn. The ’563 Patent states that it “relates to methods and an implantable apparatus for treating cardiac arrhythmia, particularly ventricular fibrillation.” Figure 1 from the ’563 Patent is shown below.
The petition seeks review of all twenty of the ’563 Patent’s claims “as obvious under 35 U.S.C. § 103 based on U.S. Patent No. 5,181,511 (‘Nickolls’), U.S. Patent No. 5,433,729 (‘Adams’), and the knowledge of a person of ordinary skill in the art.”
The petition states that the ’563 Patent has been asserted by the Board of Trustees of the University of Alabama at Birmingham and the UAB Research Foundation against Boston Scientific and Cardiac Pacemakers, Inc. in a lawsuit filed on September 22, 2014 in the U.S. District Court for the Northern District of Alabama. The complaint alleges that Boston Scientific and Cardiac Pacemakers, Inc., a wholly owned subsidiary of Boston Scientific, infringe the ’563 Patent by making, using, offering to sell or selling cardiac resynchronization therapy defibrillators (“CRT-Ds”), “including but not limited to the Incepta, Enrgen, Cognis, and Livian CRT-Ds . . . .”
The petition also states that Boston Scientific previously filed a petition requesting inter partes review of the ’563 Patent, alleging that all twenty claims were invalid as anticipated under 35 U.S.C. § 102(b) by U.S. Patent No. 5,797,967 to KenKnight. The prior petition was filed on March 23, 2015, and was assigned Case No. IPR2015-00918.
Tissue Transplant Technology Ltd. and Human Biologics of Texas Ltd. (“the Petitioners”) recently filed a petition with the Patent Trial and Appeal Board requesting inter partes review of U.S. Patent No. 8,597,687 (“the ’687 Patent”). The petition states that the ’687 Patent is owned by MiMedx Group, Inc. (“MiMedx”). According to the USPTO Assignment Database, the ’687 Patent was assigned to MiMedx by Surgical Biologics, LLC. on May 10, 2013.
The ’687 Patent is entitled “Methods For Determining The Orientation Of A Tissue Graft,” and the sole listed inventor is John Daniel. The ’687 Patent states that it “relates generally to tissue allografts and, in particular, to placental membrane tissue grafts (amnion and chorion) and methods of preparing, preserving, and medical uses for the same.” Figure 5 from the ’687 Patent is shown to the right.
The petition seeks review of all seven of the ’687 Patent’s claims. The petition discloses that the ’687 Patent has been asserted by MiMedx against the Petitioners in a lawsuit filed on May 16, 2014 in the U.S. District Court for the Western District of Texas. The first amended complaint, filed on June 26, 2014, alleges that the Petitioners infringe the ’687 Patent, as well as U.S. Pat. No. 8,709,494 by making, using, offering to sell or selling the SteriShield™ and/or Cygnus Solo™ tissue graft products.
On May 15 and 16, 2014, Boston Scientific Corporation and Boston Scientific Scimed, Inc. (collectively, “Boston Scientific”) filed a total of five petitions with the Patent Trial and Appeal Board requesting inter partes review of three U.S. Patents. The first petition (the ’759 Petition) seeks review of U.S. Patent No. 8,142,413 (“the ’413 Patent”). The second and third petitions (the ’760 Petition and the ’761 Petition) seek review of U.S. Patent No. 8,048,032 (“the ’032 Patent”). The fourth and fifth petitions (the ’762 Petition and the ’763 Petition) seek review of U.S. Patent No. 8,292,850 (“the ’850 Patent”). The petitions state that “all three patents are closely related and directed generally to the same subject matter,” and request that the petitions be assigned to the same Board.
All three patents are entitled “Coaxial Guide Catheter For Interventional Cardiology Procedures,” and list as inventors Howard Root, Greg Sutton, Jeffrey M. Welch, and Jason M. Garrity. According to the patents, the ’850 Patent issued from an application that was a divisional of the application that issued as the ’413 Patent, which was a divisional of the application that issued as the ’032 Patent.
The ’413, ’032, and ’850 Patents state that they relate to “methods and apparatus for increasing backup support for catheters inserted into the coronary arteries from the aorta.” Figure 7 from the patents is shown below:
The ’759 Petition seeks review of claims 1, 4, 9, 10, and 13 of the ’413 Patent on various grounds. The ’760 Petition seeks review of claims 1-4, 8, 11, 13, and 17 of the ’032 Patent on various grounds, and the ’761 Petition seeks review of claims 1-4, 8, 11, and 13 of the ’032 Patent on alternative grounds. The ’762 Petition seeks review of claims 1-4, 8, 12, 14, and 18 of the ’850 Patent on various grounds, and the ’763 Petition seeks review of claims 1-4, 8, 12-14, and 18 of the ’850 Patent on alternative grounds.
The petitions disclose that one or more claims of the ’413, ’032, and ’850 Patents have been asserted against Boston Scientific by Vascular Solutions, Inc. (“VSI”) in a lawsuit originally filed on May 16, 2013 in the U.S. District Court for the District of Minnesota. VSI’s first amended complaint, filed on May 28, 2013, alleges that Vascular Solutions is the owner by assignment of the ’413, ’032, and ’850 Patents. The complaint further alleges that “VSI’s cause of action arises directly from Boston Scientific’s infringing actions by manufacturing, marketing and selling the infringing Guidezilla™ product in the State of Minnesota. . . .”
On April 25, 2014, Medtronic, Inc. and Medtronic Vascular, Inc. (“Medtronic”) filed a second petition (the ’695 Petition) with the Patent Trial and Appeal Board requesting inter partes review of U.S. Patent No. 5,593,417 (“the ’417 Patent”). Medtronic concurrently filed a motion requesting joinder of the ’695 Petition and Medtronic’s previously filed first petition requesting inter partes review of the ’417 Patent (the ’100 Petition).
The ’417 Patent is entitled “Intravascular Stent With Secure Mounting Means,” and lists a single inventor, Valentine J. Rhodes. The ’417 Patent states that it relates to “expandable grafts and methods of use for opening restrictions therein, e.g., revascularizing stenotic arteries.” Figures 1-3 from the ’417 Patent are shown below:
The ’695 Petition seeks review of claims 1, 2, 9, 10, and 13 of the ’417 Patent, the same claims challenged by the ’100 Petition. The ’695 Petition discloses that one or more claims of the ’417 Patent have been asserted against Medtronic by Endotach LLC (“Endotach”) in a lawsuit filed in the U.S. District Court for the Northern District of California. Endotach’s first amended complaint, filed on October 22, 2013, alleges that Acacia Patent Acquisition LLC assigned its rights in the ‘417 Patent to Endotach. The complaint further alleges that “at least the Endurant AAA Stent Graft and Endurant II AAA Stent Graft. . .” infringe “at least claims 1, 2, and 13 of the ’417 Patent. . . .” On April 24, 2014, the lawsuit was stayed by order of the court pending final resolution of the inter partes review proceedings.
According to the ’695 Petition, Endotach is also asserting the ’417 Patent against Cook Medical Inc. in Endotach LLC v. Cook Medical Inc., No. 1:13-cv-1135 (S.D. Ind.) and W.L. Gore & Associates, Inc. in Endotach LLC v. W.L. Gore & Associates, Inc., No. 3:12-cv-00308 (N.D. Fla.).
The ’469 Patent is entitled “Audio Instructions for Appliances,” and the sole listed inventor is Stephen J. Brown. The ’469 Patent states that it relates to “communication systems for remote monitoring of individuals, and in particular to a networked system for remotely monitoring individuals and for communicating information to the individuals through the use of script programs.” Figure 5 from the ’469 Patent is shown below:
The petition seeks review of all 22 of the ’469 Patent’s claims. The petition discloses that the ’469 Patent has been asserted by Robert Bosch Healthcare Systems, Inc. (“Bosch Healthcare”) against Cardiocom, LLC (“Cardiocom”), a wholly-owned subsidiary of Medtronic, in a lawsuit filed in the U.S. District Court for the Eastern District of Texas. The complaint, filed on April 26, 2013, states the ’469 Patent is assigned to Bosch Healthcare. The complaint alleges that the “Cardiocom Telehealth system, which includes, but is not limited to, the Commander Flex Device, the Commander Device, the Telescale Device, the LinkView Device, the Attentiv Device, the NetResponse product, the TeleResponse product, and the Omnivisor Management System” infringes the ’469 Patent and five other patents.
The petition further states that there is a second patent infringement lawsuit “involving related patents,” and also that several of the related patents are also being challenged in USPTO proceedings. The complaint for this second case, filed by Bosch Healthcare against Cardiocom on July 24, 2012 in the Northern District of California, is available here.
Indiana University Research & Technology Corporation (IURTC) filed a lawsuit against AngioDynamics, Inc. alleging infringement of U.S. Patent No. 6,719,717 (“the ‘717 Patent”). The lawsuit was filed on December 18, 2013 in the Southern District of Indiana. The ‘717 Patent is entitled “Thrombectomy Treatment System and Method.”
The ‘717 Patent states that it “relates generally to a thrombectomy treatment system and method, and more particularly to a percutaneous thrombectomy system and method providing reinfusion of treated blood that is free of blood clots.” Figure 1 from the ‘717 Patent is shown below:
The complaint alleges that AngioDynamics infringes the ‘717 Patent by “having made, importing into the United States, and/or using, selling, and/or offering for sale in the United States,” its AngioVac Cannula and Circuit products.
According to its website, IURTC is a “not-for-profit agency that assists IU faculty and researchers in realizing the commercial potential of their discoveries.” According to its website, AngioDynamics is headquartered in Albany, New York, and has products that include radiofrequency ablation and NanoKnife® systems, vascular access products, angiographic products and accessories, dialysis products, angioplasty products, drainage products, thrombolytic products, embolization products, venous products and targeted renal therapy products.
Last week, Mirowski Family Ventures, LLC filed a lawsuit against Boston Scientific Corp. and its wholly-owned subsidiaries Cardiac Pacemakers, Inc., Guidant LLC, and Guidant Sales LLC. According to the complaint, the defendants breached exclusive license agreements to patents relating to implantable cardioverter defibrillators and cardiac resynchronization therapy. The complaint also asserts claims for breach of the implied covenant of good faith and fair dealing, unjust enrichment, constructive fraud, disgorgement of profits, and negligence.
The NIH describes an implantable cardioverter defibrillator as an implantable device, similar to a pacemaker, that “uses electrical pulses or shocks to help control life-threatening arrhythmias, especially those than can cause sudden cardiac arrest.”
The lawsuit seeks over $570 million in damages for the defendants’ actions. The lawsuit was initially filed on September 10, 2013 in the Circuit Court For Montgomery County, and was subsequently removed by the defendants to the U.S. District Court for the District of Maryland.
On August 5, 2013, TriVascular, Inc. filed a petition with the Patent Trial and Appeal Board requesting inter partes review of U.S. Patent No. 6,007,575 owned by named inventor Dr. Shaun L.W. Samuels.
The ’575 Patent is entitled “Inflatable Intraluminal Stent and Method for Affixing Same Within the Human Body.” The ’575 Patent states that it relates to “[a]n inflatable intraluminal stent for attachment to the interior surface of a tubular structure within the human body” featuring “a cuff having an inflatable chamber and a friction-enhancing outer surface” that “engages the interior surface of the tubular structure without penetration when the inflatable cuff is in an inflated condition.” Figure 1 from the ’575 Patent is shown below:
The petition seeks review of all 24 of the ’575 Patent’s claims. The petition discloses that the ’575 Patent has been asserted by Dr. Samuels against TriVascular in a lawsuit filed in the U.S. District Court for the Northern District of California. The complaint, filed on May 17, 2013, alleges that TriVascular’s “Ovation Prime™ Abdominal Stent Graft System” infringes the ’575 Patent.
On June 27, 2013, NuVasive, Inc. filed two petitions with the Patent Trial and Appeal Board requesting inter partes review of Warsaw Orthopedic, Inc.’s U.S. Patent No. 8,444,696.
The ’696 Patent is entitled “Anatomic Spinal Implant Having Anatomic Bearing Surfaces.” The ’696 Patent relates to “an interbody spinal implant having a structural configuration that provides for maintaining the normal anatomic relationship of two adjacent vertebrae of the spine.” Figure 1 from the ’696 Patent is shown below:
The ‘696 Patent has 19 issued claims. The first petition (IPR2013-00395) seeks review of claims 1-6, and the second petition (IPR2013-00396) seeks review of claims 7-12. The petitions also identify a lawsuit between NuVasive and Warsaw Orthopedic that is currently pending in the Southern District of California, and state that Warsaw Orthopedic has asked the Court for permission to add the ’696 Patent to that lawsuit. Warsaw’s original complaint in that lawsuit, filed on August 17, 2012, alleges infringement by NuVasive of U.S. Patent Nos. 8,021,430 and 5,676,146.
Respironics, Inc., a subsidiary of Koninklijke Philips N.V., filed a petition last Friday with the Patent Trial and Appeal Board requesting inter partes review of ZOLL Medical Corporation’s U.S. Patent No. 6,681,003 to Linder et. al. The petition identifies Koninklijke Philips as a real party-in-interest.
The ‘003 patent is entitled “Data Collection and System Management for Patient-Word Medical Devices.” The ‘003 patent relates to “a method and system of monitoring information received from a patient-word medical device.”
The petition seeks review of nine of the patent’s 35 issued claims. Eight of these nine claims identified in the petition have been asserted by ZOLL Medical against Respironics in a lawsuit filed in the U.S. District Court of Delaware. The amended complaint, filed on January 9, 2013, alleges that Respironics’s “patient medical monitoring and treatment systems and methods” including positive airway pressure devices, infringe the ‘003 patent.
Carticept Medical, Inc. announced today that it received 510(k) clearance from the United States Food and Drug Administration for its Navigator® Delivery System (DS), a computer-controlled injection system. The press release states that the Navigator DS automatically prepares intra-articular injections and records treatment data. The FDA 510(k) Summary is available here.
According to the press release, the Navigator DS addresses issues of patient safety and office workflow through computer-controlled preparation, delivery and recordkeeping of medications.
Carticept Medical, Inc. is based in Alpharetta, Georgia. The press release is available here. Carticept Medical’s website is available here, and information about the Navigator DS product is available here.
Harbor MedTech, Inc., announced today FDA clearance for its first product, Architect™, which it describes as an advanced collagen matrix for treatment of skin wounds. In the press release, Harbor MedTech President and Founder Jerry Mezger states that:
[T]he FDA has cleared Architect™ for treating a wide variety of serious skin wounds, including diabetic foot ulcers, venous leg ulcer, pressure ulcers, and many other trauma or surgery related skin wounds[.]
According to the press release, shipments of the device will begin in April. Harbor MedTech is a medical device company based in Irvine, California. Harbor MedTech’s press release is available here.
St. Jude Medical, Inc. issued a press release today announcing the first patient implant in a clinical trial of the company’s AMPLATZER™ Cardiac Plug (ACP), a device designed to prevent stroke in patients with non-valvular atrial fibrillation. According to the press release, the ACP is
[a] self-expanding occlusion device constructed from nitinol mesh, and delivered via catheter [and] is designed to completely seal the [left atrial appendage (LAA)] (a tubular-shaped, muscular appendage connected to the left atrium of the heart) at its opening, and minimize blood clots from forming in the LAA and migrating into the bloodstream.
The press release states that the trial will compare the safety and efficacy of the device to the traditional treatment option of using long-term, blood-thinning medication.
Interventional cardiology medical device company AngioLight announced today that it has formed a partnership with Medical Technologies Innovation Asia (MTIA). According to AngioLight’s press release, MTIA will perform safety, animal and clinical studies of AngioLight’s diagnostic catheter in exchange for equity in AngioLight. AngioLight’s newly appointed president, Gary Saxton, will oversee the partnership.
In the press release, AngioLight’s president states:
While the worldwide market potential for our device is clear, we see a uniquely high growth opportunity in China, where the patient need exists and an advancing healthcare system is moving towards improved standards of care. Our collaboration with MTIA will allow us to capitalize on this opportunity with expert, on-the-ground resources who can help move our technology through the development phase and into the hands of physicians.
According to the press release, AngioLight has developed a light-based diagnostic catheter to improve proper stent sizing and placement. AngioLight is based in Medford, Massachusetts. MTIA is a medical device company headquartered in Hong Kong, with manufacturing and sales facilities throughout China. AngioLight’s press release is available here.