Case 1:21-cv-00813-JPM Document 1 Filed 06/02/21 Page 1 of 53 PageID #: 1
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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`NEW YORK UNIVERSITY
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` Plaintiff,
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` v.
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`RESMED INC.
` Defendant.
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`Case No.
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`Jury Trial Demanded
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`COMPLAINT FOR PATENT INFRINGEMENT
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`
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`Plaintiff New York University (“Plaintiff”), by and through its counsel, files this
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`Complaint against ResMed Inc. (“ResMed” or “Defendant”) for infringement of United
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`States Patent Nos. 9,867,955 (“the ‘955 patent”), 6,988,994 (“the ‘944 patent”), 9,168,344
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`(“the ‘344 patent”), 9,108,009 (“the ‘009 patent”), 9,427,539 (“the ‘539 patent”), 9,533,115
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`(“the ‘115 patent”), and 10,384,024 (“the ‘024 patent”), (collectively, the “patents-in-
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`suit”), and alleges as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for infringement of the patents-in-suit arising under the
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`patent laws of the United States, 35 U.S.C. §§ 100, et seq. Specifically, this action relates
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`to patents directed to systems and methods for diagnosing and treatment of a breathing
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`pattern of a patient, and a positive airway pressure system and method for treatment of
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`sleeping disorders in a patient.
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`PARTIES
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`2.
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`Plaintiff New York University is a research university organized as a
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`corporation under the laws of the State of New York and having a place of business at
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`550 First Avenue, New York, New York, 10016.
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`3.
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`On information and belief, Defendant ResMed Inc. is a corporation duly
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`organized and existing under the laws of the State of Delaware with its principal place
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`of business at 9001 Spectrum Center Blvd., San Diego, CA 92123.
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`4.
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`ResMed distributes, sells, and/or imports products for the entire United
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`States market and does business in every state, including Delaware, either directly or
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`indirectly.
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`JURISDICTION AND VENUE
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`5.
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`This Court has subject matter jurisdiction over this action pursuant to 28
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`U.S.C. §§ 1331 and 1338(a) because this is a patent infringement action that arises under
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`the patent laws of the United States, 35 U.S.C. §§ 100 et seq.
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`6.
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`Venue is proper in this judicial district pursuant to 28 U.S.C. §§ 1391(b),
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`(c), (d) and/or 1400(b) because, among other things, Defendant is incorporated in the
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`State of Delaware and, therefore, resides in this judicial district.
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`PERSONAL JURISDICTION OVER RESMED
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`7.
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`Plaintiff incorporates each of the preceding paragraphs as if fully set forth
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`herein.
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`8.
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`This Court has personal jurisdiction over Defendant in part because a
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`substantial part of the events giving rise to the claims alleged in this Complaint for
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`which Defendant is responsible occurred in Delaware.
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`9.
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`Specifically, Defendant’s products are used and/or sold within and
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`throughout the United States, including in Delaware. On information and belief,
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`AirSenseTM 10 AutoSetTM systems are prescribed by medical professionals practicing in
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`Delaware, sold by distributors located within Delaware, and used by patients in
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`Delaware. Each of these activities has a substantial effect within Delaware, as they
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`constitute infringement, directly and indirectly, of the patents-in-suit.
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`10. Additionally, Defendant sells other products and does business
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`throughout the United States, including Delaware.
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`11.
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`Thus, Defendant has purposefully availed itself of the privileges of
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`conducting business in Delaware and within this judicial district; has established
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`sufficient minimum contacts in Delaware and within this judicial district such that it
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`should reasonably and fairly anticipate being involved in court in Delaware and in this
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`judicial district; has purposefully directed activities at residents of Delaware and this
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`judicial district; and at least a portion of the patent infringement claims alleged herein
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`arise out of or are related to one or more of the foregoing activities.
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`12. Accordingly, this Court has personal jurisdiction over Defendant who, on
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`information and belief: (1) has committed acts of patent infringement, individually, in
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`active concert or jointly in the State of Delaware and in this judicial district; (2) has
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`substantial, regularly conducted and systematic business contacts in the State of
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`Delaware and in this judicial district; (3) owns, manages, and markets products in the
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`State of Delaware and in this judicial district; and (4) enjoys substantial income from the
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`sale of products in the State of Delaware and in this judicial district.
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`BACKGROUND
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`The Patents-in-Suit
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`13. David M. Rapoport, M.D. is the foremost expert in sleep technology.
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`14. Dr. Rapoport has an undergraduate degree in Physics from Massachusetts
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`Institute of Technology, an MD from Albert Einstein College of Medicine, Internal
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`Medicine training at the Roosevelt Hospital, and a Pulmonary Fellowship at New York
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`University Medical Center/Bellevue.
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`15. Dr. Rapoport has been involved in clinical research in Sleep Medicine for
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`over 30 years and currently serves as Director of the Sleep Medicine Research Program
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`at Mount Sinai.
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`16. Dr. Rapoport holds multiple U.S. and European patents for improvements
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`on nasal CPAP.
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`17. Dr. Rapoport is also the founder and President of the Foundation for
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`Research in Sleep Disorders and is a member of the Board of Directors of the American
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`Sleep Apnea Association.
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`United States Patent No. 9,867,955
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`18. U.S. Patent No. 9,867,955, entitled “System and method for diagnosis and
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`treatment of a breathing pattern of a patient,” (attached as Exhibit 1), was duly and
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`legally issued on January 16, 2018.
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`19.
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`The ‘955 patent will expire on March 21, 2024, per the 35 U.S.C. § 154(b)
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`patent term adjustment.
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`20.
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`The inventors named on the ‘955 patent are David M. Rapoport and
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`Robert G. Norman.
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`21.
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`The ’955 patent covers a system including a sensor and a processing
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`arrangement.
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`22.
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`The claims of the ’955 patent are valid, enforceable, and not expired.
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`23.
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`The ’955 patent ultimately claims priority to U.S. Application No.
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`10/642,459, filed August 14, 2003, now U.S. Patent No. 6,988,994.
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`24. All rights, title and interests in the ’955 patent are owned by and assigned
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`to New York University.
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`United States Patent No. 6,988,994
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`25. U.S. Patent No. 6,988,994, entitled “Positive airway pressure system and
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`method for treatment of sleeping disorder in patient,” (attached as Exhibit 2), was duly
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`and legally issued on January 24, 2006.
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`26.
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`The ‘994 patent will expire on September 5, 2023.
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`27.
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`The inventors named on the ‘994 patent are David M. Rapoport and
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`Robert G. Norman.
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`28.
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`The claims of the ‘994 patent are valid, enforceable, and not expired.
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`29. All rights, title and interests in the ’994 patent are owned by and assigned
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`to New York University.
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`United States Patent No. 9,168,344
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`30. U.S. Patent No. 9,168,344, entitled “System and method for diagnosis and
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`treatment of a breathing pattern of a patient,” (attached as Exhibit 3), was duly and
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`legally issued on October 27, 2015.
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`31.
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`The ’344 patent will expire on August 14, 2023.
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`32.
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`The inventors named on the ’344 patent are David M. Rapoport and
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`Robert G. Norman.
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`33.
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`The ’344 patent covers a system including a sensor and a processing
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`arrangement.
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`34.
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`The claims of the ’344 patent are valid, enforceable, and not expired.
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`35.
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`The ’344 patent ultimately claims priority to U.S. Application No.
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`10/642,459, filed August 14, 2003, now U.S. Patent No. 6,988,994.
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`36. All rights, title and interests in the ’344 patent are owned by and assigned
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`to New York University.
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`United States Patent No. 9,108,009
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`37. U.S. Patent No. 9,108,009, entitled “System and method for diagnosis and
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`treatment of a breathing pattern of a patient,” (attached as Exhibit 4), was duly and
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`legally issued on August 18, 2015.
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`38.
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`The ’009 patent will expire on August 14, 2023.
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`39.
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`The inventors named on the ’009 patent are David M. Rapoport and
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`Robert G. Norman.
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`40.
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`The ’009 patent covers a system including a sensor and a processing
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`arrangement.
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`41.
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`The claims of the ’009 patent are valid, enforceable, and not expired.
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`42.
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`The ’009 patent ultimately claims priority to U.S. Application No.
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`10/642,459, filed August 14, 2003, now U.S. Patent No. 6,988,994.
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`43. All rights, title and interests in the ’009 patent are owned by and assigned
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`to New York University.
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`United States Patent No. 9,427,539
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`44. U.S. Patent No. 9,427,539, entitled “System and method for diagnosis and
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`treatment of a breathing pattern of a patient,” (attached as Exhibit 5), was duly and
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`legally issued on August 30, 2016.
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`45.
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`The ‘539 patent will expire on February 27, 2035.
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`46.
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`The inventors named on the ‘539 patent are David M. Rapoport and
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`Robert G. Norman.
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`47.
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`The ‘539 patent covers a system including a sensor and a processing
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`arrangement.
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`48.
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`The claims of the ’539 patent are valid, enforceable, and not expired.
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`49.
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`The ’539 patent ultimately claims priority to U.S. Application No.
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`10/642,459, filed August 14, 2003, now U.S. Patent No. 6,988,994.
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`50. All rights, title and interests in the ’539 patent are owned by and assigned
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`to New York University.
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`United States Patent No. 9,533,115
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`51. U.S. Patent No. 9,533,115, entitled “System and method for diagnosis and
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`treatment of a breathing pattern of a patient,” (attached as Exhibit 6), was duly and
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`legally issued on January 3, 2017.
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`52.
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`The ‘115 patent will expire on February 27, 2035.
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`53.
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`The inventors named on the ‘115 patent are David M. Rapoport and
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`Robert G. Norman.
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`54.
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`The ‘115 patent covers a system including a sensor and a processing
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`arrangement.
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`55.
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`The claims of the ’115 patent are valid, enforceable, and not expired.
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`56.
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`The ’115 patent ultimately claims priority to U.S. Application No.
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`10/642,459, filed August 14, 2003, now U.S. Patent No. 6,988,994.
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`57. All rights, title and interests in the ’115 patent are owned by and assigned
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`to New York University.
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`United States Patent No. 10,384,024
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`58. U.S. Patent No. 10,384,024, entitled “System and method for diagnosis and
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`treatment of a breathing pattern of a patient,” (attached as Exhibit 7), was duly and
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`legally issued on August 20, 2019.
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`59.
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`The ‘024 patent will expire on January 3, 2031.
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`60.
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`The inventors named on the ‘024 patent are David M. Rapoport and
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`Robert G. Norman.
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`61.
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`The ‘024 patent covers a system including a sensor and a processing
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`arrangement.
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`62.
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`The claims of the ’024 patent are valid, enforceable, and not expired.
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`63.
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`The ’024 patent ultimately claims priority to U.S. Application No.
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`10/642,459, filed August 14, 2003, now U.S. Patent No. 6,988,994.
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`64. All rights, title and interests in the ’024 patent are owned by and assigned
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`to New York University.
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`AirSenseTM 10 AutoSetTM
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`65. On information and belief, ResMed manufactures, sells and distributes the
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`AirSenseTM 10 AutoSetTM series of positive airway pressure machines throughout the
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`United States. See generally ResMed Air Solutions product brochure,
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`https://document.resmed.com/en-us/documents/products/machine/aircurve-
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`series/product-brochure/1018639_ras-overview_brochure_anz_eng.pdf, attached as
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`Exhibit 8.
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`66.
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`The AirSenseTM 10 AutoSetTM series is indicated for the treatment of
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`sleeping disorders and is a complete system. Further, the AirSenseTM 10 AutoSetTM is a
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`positive airway pressure system, providing air pressure to a patient’s airways. Id.
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`67.
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`The AirSenseTM 10 AutoSetTM system contains the AutoRampTM feature
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`with sleep onset detection. The AutoRampTM starts by delivering a low pressure; once
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`the AutoRampTM detects that the patient is asleep, it increases the pressure to the
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`prescribed level. Id. at 7.
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`68.
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`Further, the AirSenseTM 10 AutoSetTM system detects when a patient is
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`asleep and adjusts the treatment pressure accordingly. See ResMed sleep blog,
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`https://www.resmed.com/en-us/sleep-apnea/sleep-blog/fall-asleep-faster-with-
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`lower-cpap-pressure/, attached as Exhibit 9.
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`69.
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`The AirSenseTM 10 AutoSetTM system also has the AutoSet algorithm,
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`which continually monitors each patient’s unique breathing pattern and assesses each
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`breathing event to determine and deliver the ideal pressure to treat the event. See Apnea
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`board, http://www.apneaboard.com/wiki/index.php/CPAP_Algorithms, attached as
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`Exhibit 10.
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`Notice of the Patents-in-Suit
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`70.
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`ResMed has had notice and been aware of the patents-in-suit, when
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`Plaintiff sent correspondence on June 1, 2021, which was received on June 2, 2021, to
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`the Chief Executive Officer of ResMed informing him of the existence of these patents
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`and the infringement of same by ResMed. See Notice letter, attached as Exhibit 11.
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`71.
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`Plaintiff’s letter instructed ResMed to immediately cease and desist from
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`engaging in any further conduct that would lead to infringing activity. On information
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`and belief, ResMed has not altered its conduct in response to the letter from Plaintiff.
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`72.
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`ResMed has thus induced infringement of the patents-in-suit in violation
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`of 35 USC § 271(b) by providing to the public, at a minimum, the AirSenseTM 10
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`AutoSetTM CPAP product and product specifications and directions which provide
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`instructions on how to use the AirSenseTM 10 AutoSetTM in a manner that directly
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`infringes the patents-in-suit.
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`PATENT INFRINGEMENT
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`Count I: Infringement of United States Patent No. 9,867,955
`by ResMed
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`73.
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`Plaintiff incorporates each of the preceding paragraphs as if fully set forth
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`herein.
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`74. On information and belief, and without authority, consent, right, or
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`license, ResMed makes, uses, sells, offers to sell and/or imports positive airway
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`pressure devices in the United States. In doing so, ResMed infringes one or more claims,
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`including claims 1-6, 8, 11-12, 16-26, and 30-31 of the ’955 patent under § 271(a), either
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`literally or under the doctrine of equivalents, by making, using, offering to sell, selling
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`and/or importing the AirSenseTM 10 AutoSetTM systems, and/or by actively inducing
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`infringement by others under § 271(b) and/or contributing to infringement under §
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`271(c) by providing to the public, at a minimum, the AirSenseTM 10 AutoSetTM system
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`specifications and directions, which provide instructions on how to use the AirSenseTM
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`10 AutoSetTM systems in a manner that infringes directly the ’955 patent.
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`75.
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`ResMed commits acts of patent infringement through the manufacture,
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`use, offer for sale, sale and/or importation of at least ResMed’s AirSenseTM 10
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`AutoSetTM systems that include the AutoSet TM algorithm and AutoRampTM features,
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`including, but not limited to, the AirSenseTM 10 AutoSetTM series of systems.
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`76.
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`For example, claim 1 of the ’955 patent covers:
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`A positive airway pressure system for delivery of a flow of breathable gas
`at a positive treatment pressure with respect to ambient air pressure
`delivered to an entrance of a patient’s airways in order to assist in treating
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`a sleeping disorder in a patient, the positive airway pressure system
`comprising:
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`a flow generator which supplies a positive treatment pressure flow
`of breathable gases to the entrance of a tube, the tube directing the flow of
`breathable gases to the airway of a patient to provide the patent with the
`positive treatment pressure flow of breathable gases;
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`a flow sensor located in a flow path of the positive treatment
`pressure flow of breathable gases, the flow sensor measuring data
`corresponding to the flow of breathable gases directed to the patient and
`indicative of the patient’s breathing patterns; and
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`a processing arrangement which receives the measured data
`corresponding to the flow of breathable gases from the flow sensor and
`analyzes the data to determine the patient’s breathing patterns,
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`the processing arrangement also determines whether to alter
`the pressure supplied to the airway of the patient based, at least in
`part, on the determined breathing patterns of the patient,
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`wherein the processing arrangement applies a greater
`positive treatment pressure in an asleep state and a lesser positive
`treatment pressure in an awake state,
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`wherein when the processor determines that the patient has
`transitioned between at least an awake state and an asleep state, the
`processing arrangement automatically controls the flow generator to
`increase a positive treatment pressure supplied to the entrance of the
`tube using a ramp system.
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`77.
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`The AirSenseTM 10 AutoSetTM systems meet the claim element for “[a]
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`positive airway pressure system for delivery of a flow of breathable gas at a positive
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`treatment pressure with respect to ambient air pressure delivered to an entrance of a
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`patient’s airways in order to assist in treating a sleeping disorder in a patient…” The
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`AirSenseTM 10 AutoSetTM system is a positive airway pressure system that delivers a
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`flow of breathable gas to an entrance of a patient’s airways to treat a sleeping disorder,
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`as shown by the product brochure. See Exhibit 8, https://document.resmed.com/en-
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`us/documents/products/machine/aircurve-series/product-brochure/1018639_ras-
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`overview_brochure_anz_eng.pdf.
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`78.
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`The AirSenseTM 10 AutoSetTM systems meet the claim element for “a flow
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`generator which supplies a positive treatment pressure flow of breathable gases to the
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`entrance of a tube, the tube directing the flow of breathable gases to the airway of a
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`patient to provide the patent with the positive treatment pressure flow of breathable
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`gases.” As shown by the user guide, The AirSenseTM 10 AutoSetTM system uses a flow
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`generator (blower) to supply the positive treatment pressure flow of breathable gases
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`through a tube attached to a mask. See Exhibit 12, AirSenseTM 10 user guide, p. 19,
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`https://document.resmed.com/en-us/documents/products/machine/airsense-
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`series/user-guide/airsense-10-device-with-humidifier_user-guide_amer_eng.pdf; see
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`also https://www.resmed.com/en-us/sleep-apnea/cpap-products/cpap-masks/.
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`79.
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`The AirSenseTM 10 AutoSetTM systems meet the claim element for “a flow
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`sensor located in a flow path of the positive treatment pressure flow of breathable gases,
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`the flow sensor measuring data corresponding to the flow of breathable gases directed
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`to the patient and indicative of the patient’s breathing patterns,” as shown by the user
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`guide indicating the presence of a flow sensor. See Exhibit 12, p. 19.
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`80.
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`The AirSenseTM 10 AutoSetTM systems meet the claim element for “a
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`processing arrangement which receives the measured data corresponding to the flow of
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`breathable gases from the flow sensor and analyzes the data to determine the patient’s
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`breathing patterns…” As shown by the product brochure, the AirSenseTM AutosetTM
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`algorithm (processing arrangement) receives the measured data corresponding to the
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`flow of breathable gases from the flow sensor and analyzes the data to determine the
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`patient’s breathing patterns. See Exhibit 8, https://document.resmed.com/en-
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`us/documents/products/machine/aircurve-series/product-brochure/1018639_ras-
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`overview_brochure_anz_eng.pdf; see also Exhibit 10,
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`http://www.apneaboard.com/wiki/index.php/CPAP_Algorithms.
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`81.
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`The AirSenseTM 10 AutoSetTM systems meet the claim element for “the
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`processing arrangement also determines whether to alter the pressure supplied to the
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`airway of the patient based, at least in part, on the determined breathing patterns of the
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`patient…” As explained by the product brochure, the AirSenseTM AutoRampTM
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`processing arrangement determines whether to alter the pressure supplied to the
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`airway of the patient based, at least in part, on the determined breathing patterns of the
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`patient. See Exhibit 8, https://document.resmed.com/en-
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`us/documents/products/machine/aircurve-series/product-brochure/1018639_ras-
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`overview_brochure_anz_eng.pdf.
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`82.
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`The AirSenseTM 10 AutoSetTM systems meet the claim element for
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`“wherein the processing arrangement applies a greater positive treatment pressure in
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`an asleep state and a lesser positive treatment pressure in an awake state…” The
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`AirSenseTM AutoRampTM processing arrangement applies a greater positive treatment
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`pressure when the patient is asleep, and a lesser pressure when the patient is awake. Id.
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`83.
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`The AirSenseTM 10 AutoSetTM systems meet the claim element for
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`“wherein when the processor determines that the patient has transitioned between at
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`least an awake state and an asleep state, the processing arrangement automatically
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`controls the flow generator to increase a positive treatment pressure supplied to the
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`entrance of the tube using a ramp system.” The AutoRampTM processing arrangement
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`increases the pressure through a ramp system once the processor determines that the
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`patient has transitioned from an awake state to an asleep state. Id.
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`84.
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`Since the AirSenseTM 10 AutoSetTM systems meet each and every claim
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`limitation, ResMed is directly infringing one or more claims of the ’955 patent in
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`violation of 35 U.S.C. § 271(a).
`
`85.
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`ResMed, acting without authority, consent, right, or license of the ’955
`
`patent, has induced, and continues to induce, medical professionals and patients to
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`administer and use the AirSenseTM 10 AutoSetTM systems, which directly infringe one or
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`more claims of the ’955 patent resulting in conduct that constitutes, at a minimum,
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`patent infringement under 35 U.S.C. § 271(b) and 35 U.S.C. § 271(c). More specifically,
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`patients and medical professionals directly infringe (literally and/or under the doctrine
`
`of equivalents) at least claims 1-6, 8, 11-12, 16-26, and 30-31 of the ’955 patent by using
`
`the AirSenseTM 10 AutoSetTM systems, resulting in conduct that constitutes, at a
`
`minimum, patent infringement under 35 U.S.C. § 271(a).
`
`86. At least since the date of receipt of the notice letter, see Exhibit 11, ResMed
`
`knew of the ’955 patent, knowingly induced the use by medical professionals and
`
`patients of the AirSenseTM 10 AutoSetTM systems by keeping these products in the
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`market place and the stream of commerce, and possessed a specific intent to encourage
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`direct infringement of the ’955 patent, due to the failure to remove these goods from the
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`stream of commerce.
`
`87.
`
`ResMed possessed, and continues to possess, specific intent to induce
`
`infringement by providing to the public, at a minimum, product specifications and the
`
`option to purchase and/or use the AirSenseTM 10 AutoSetTM systems, which directly
`
`infringe the ’955 patent.
`
`88.
`
`ResMed has actively induced and encouraged, and continues to actively
`
`induce and encourage, medical professionals to prescribe the AirSenseTM 10 AutoSetTM
`
`systems, and patients to use the AirSenseTM 10 AutoSetTM systems, by marketing,
`
`promoting and advertising the infringing use of the AirSenseTM 10 AutoSetTM systems.
`
`89. Upon information and belief, ResMed knows that the AirSenseTM 10
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`AutoSetTM systems are especially made or adapted for use in infringing the ′955 patent,
`
`that the AirSenseTM 10 AutoSetTM systems are not staple articles or commodities of
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`commerce, and that the AirSenseTM 10 AutoSetTM systems are not suitable for
`
`substantial noninfringing use, resulting in conduct that constitutes, at a minimum,
`
`patent infringement under 35 U.S.C. § 271(c). More specifically, patients or medical
`
`professionals directly infringe (literally and/or under the doctrine of equivalents) at
`
`least claims 1-6, 8, 11-12, 16-26, and 30-31 of the ’955 patent by using the AirSenseTM 10
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`AutoSetTM systems, resulting in conduct that constitutes, at a minimum, patent
`
`infringement under 35 U.S.C. § 271(a).
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`90.
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`ResMed’s foregoing actions constitute and/or will constitute infringement
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`of the ’955 patent, active inducement of infringement of the ’955 patent, and
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`contribution to the infringement by others of the ’955 patent.
`
`91.
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`Plaintiff reserves the right to assert additional claims of the ’955 patent
`
`that ResMed infringes.
`
`92.
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`Plaintiff has been damaged as a result of ResMed’s infringing conduct.
`
`ResMed is, thus, liable to Plaintiff in an amount that adequately compensates for its
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`infringement, which, by law, cannot be less than a reasonable royalty, together with
`
`interest and costs as fixed by this Court under 35 U.S.C. § 284.
`
`Count II Infringement of United States Patent No. 6,988,994
`by ResMed
`
`
`
`93.
`
`Plaintiff incorporates each of the preceding paragraphs as if fully set forth
`
`herein.
`
`94. On information and belief, and without authority, consent, right, or
`
`license, ResMed makes, uses, sells, offers to sell and/or imports positive airway
`
`pressure systems in the United States. In doing so, ResMed infringes one or more
`
`claims, including claims 1, 6-7, 10-14, 19-20, 23-30, and 32 of the ‘994 patent under §
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`271(a), either literally or under the doctrine of equivalents, by making, using, offering to
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`sell, selling and/or importing the AirSenseTM 10 AutoSetTM series, and/or by actively
`
`inducing infringement by others under § 271(b) by providing to the public, at a
`
`minimum, the AirSenseTM 10 AutoSetTM product specifications and directions, which
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`provide instructions on how to use the AirSenseTM 10 AutoSetTM series in a manner that
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`directly infringes the ’994 patent.
`
`95.
`
`ResMed commits acts of patent infringement through the manufacture,
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`use, offer for sale, sale and/or importation of at least the AirSenseTM 10 AutoSetTM line
`
`of systems that include the AutoSet TM algorithm and AutoRampTM feature, including,
`
`but not limited to, the AirSenseTM 10 AutoSetTM series.
`
`96.
`
`For example, claim 1 of the ’994 patent covers:
`
`A positive airway pressure system for treatment of a sleeping disorder in a
`patient, comprising:
`
`
`a generator supplying airflow and applying a pressure to an airway
`of a patient;
`
` a
`
` sensor measuring data corresponding to patient’s breathing
`patterns; and
`
` a
`
` processing arrangement analyzing the breathing patterns to
`determine whether the breathing patterns are indicative of one of the
`following patient’s states: (i) a regular breathing state, (ii) a sleep disorder
`breathing state, (iii) a REM sleep state and (iv) a troubled wakefulness state,
`the processing arrangement adjusting the applied pressure as a function of
`the patient’s state,
`
`wherein, when the breathing patterns indicate one of states (i)
`and (ii) and (iii), the processing arrangement controls the generator
`to adjust the pressure to a first value and
`
`wherein, when the breathing patterns indicate state (iv), the
`processing arrangement controls the generator to adjust the pressure
`to a second value.
`
`
`97.
`
`The AirSenseTM 10 AutoSetTM systems meet the claim element for “A
`
`positive airway pressure system for treatment of a sleeping disorder in a patient”
`
`because ResMed makes, uses, sells, offers to sell and/or imports the AirSenseTM 10
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`Case 1:21-cv-00813-JPM Document 1 Filed 06/02/21 Page 19 of 53 PageID #: 19
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`
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`AutoSetTM system for treatment of a sleeping disorder. See Exhibit 8,
`
`https://document.resmed.com/en-us/documents/products/machine/aircurve-
`
`series/product-brochure/1018639_ras-overview_brochure_anz_eng.pdf
`
`98.
`
`The AirSenseTM 10 AutoSetTM systems meet the claim element for “a
`
`generator supplying airflow and applying a pressure to an airway of a patient,” as
`
`evidenced by product schematics within the user guide showing the presence of a flow
`
`generator (blower). See Exhibit 12, p. 19, https://document.resmed.com/en-
`
`us/documents/products/machine/airsense-series/user-guide/airsense-10-device-
`
`with-humidifier_user-guide_amer_eng.pdf.
`
`99.
`
`The AirSenseTM 10 AutoSetTM systems meet the claim element for “a
`
`sensor measuring data corresponding to patient’s breathing patterns,” as evidenced by
`
`product schematics within the user guide showing the presence of a sensor. Id.
`
`100. The AirSenseTM 10 AutoSetTM systems meet the claim element for “a
`
`processing arrangement analyzing the breathing patterns to determine whether the
`
`breathing patterns are indicative of one of the following patient’s states: (i) a regular
`
`breathing state, (ii) a sleep disorder breathing state, (iii) a REM sleep state and (iv) a
`
`troubled wakefulness state, the processing arrangement adjusting the applied pressure
`
`as a function of the patient’s state,” as evidenced by the AutoSetTM algorithm and
`
`AutoRampTM features which analyze the patient’s breathing patterns. See Exhibit 8,
`
`https://document.resmed.com/en-us/documents/products/machine/aircurve-
`
`series/product-brochure/1018639_ras-overview_brochure_anz_eng.pdf
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`101. The AirSenseTM 10 AutoSetTM systems meet the claim element for “
`
`wherein, when the breathing patterns indicate one of states (i) and (ii) and (iii), the
`
`processing arrangement controls the generator to adjust the pressure to a first value…”
`
`When the breathing patterns indicate one of states (i) (a regular breathing state) and (ii)
`
`(a sleep disorder breathing state) and (iii) (a REM sleep state), the AirSenseTM AutosetTM
`
`algorithm (processing arrangement), through its AutoRampTM feature, controls the
`
`generator to adjust the pressure to a first value, i.e. the prescribed treatment pressure
`
`level. Id.; see also Exhibit 9, https://www.resmed.com/en-us/sleep-apnea/sleep-
`
`blog/fall-asleep-faster-with-lower-cpap-pressure/
`
`102. The AirSenseTM 10 AutoSetTM systems meet the claim element for
`
`“wherein, when the breathing patterns indicate state (iv), the processing arrangement
`
`controls the generator to adjust the pressure to a second value.” When the breathing
`
`patterns indicate a troubled wakefulness state (state iv), the AirSenseTM 10 AutoSetTM
`
`AutoSetTM algorithm (processing arrangement), and/or the AutoRampTM feature,
`
`controls the generator to adjust the pressure to a second value, i.e. it decreases the
`
`pressure upon waking up. Id.
`
`103. Since the AirSenseTM 10 AutoSetTM systems meet each and every claim
`
`limitation, ResMed is directly infringing one or more claims of the ’994 patent in
`
`violation of 35 U.S.C. § 271(a).
`
`104. ResMed, acting without authority, consent, right, or license of the ’994
`
`patent, has induced, and continues to induce, medical professionals and patients to
`
`administer and use the AirSenseTM 10 AutoSetTM systems, which directly infringe one
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`Case 1:21-cv-00813-JPM Document 1 Filed 06/02/21