UNITED STATES PATENT AND TRADEMARK OFFICE
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`______________________
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`IN THE UNITED STATES PATENT TRIAL AND APPEAL BOARD
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`______________________
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`PRAXAIR DISTRIBUTION, INC.
`Petitioner
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`v.
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`INO THERAPEUTICS, LLC. d/b/a IKARIA, INC.
`Patent Owner
`
`______________________
`
`CASE IPR: UNASSIGNED
`U.S. PATENT NO. 8,776,794
`______________________
`
`DECLARATION OF ROBERT T. STONE, PH.D
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` 1
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`______________________
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`
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`IN THE UNITED STATES PATENT TRIAL AND APPEAL BOARD
`
`______________________
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`
`
`PRAXAIR DISTRIBUTION, INC.
`Petitioner
`
`v.
`
`INO THERAPEUTICS, LLC. d/b/a IKARIA, INC.
`Patent Owner
`
`______________________
`
`CASE IPR: UNASSIGNED
`U.S. PATENT NO. 8,776,794
`______________________
`
`DECLARATION OF ROBERT T. STONE, PH.D
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` 1
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`I, Robert T. Stone, Ph.D, do hereby declare and say:
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`1.
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`I am over the age of twenty-one (21) and competent to make this
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`declaration. I am also qualified to give testimony under oath. The facts and
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`opinions listed below are within my personal knowledge.
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`2.
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`I am being compensated for my time in this proceeding at my
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`standard consulting rate of $350.00/hr. My compensation in no way depends on
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`the outcome of this proceeding or the content of my opinions. I am not
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`employed by, nor receiving grant support from, Praxair Distribution, Inc., which
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`I refer to as “Praxair”, or any of its related companies. I am receiving
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`compensation from Praxair solely for my involvement in this matter and based
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`only on my standard hourly consulting fees.
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`3.
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`I have been asked to review certain documents, including U.S.
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`Patent No. 8,776,794 (which I refer to as the ‘794 Patent) (Ex. 1001), and to
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`provide my opinions on what those documents disclose. I was also asked to
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`review and provide opinions regarding four other U.S. Patents. Specifically, I
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`was asked to review and provide my opinions regarding U.S. Patent No.
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`8,291,904, U.S. Patent No. 8,573,209, U.S. Patent No. 8,573,210, and U.S.
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`Patent No. 8,776,795. I have provided opinions specific to those patents in
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`separate declarations. The documents I was asked to review include those
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`addressed in more detail in the rest of this declaration and in the declarations
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`related to the four other U.S. Patents I mentioned above.
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` 2
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`4.
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`Of particular relevance to the ‘794 Patent, I have reviewed and am
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`familiar with the following documents:
`
`a.
`
`U.S. Patent No. 7,114,510 to Peters et al., which is marked
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`as Ex. 1004. I refer to this document as the ‘510 Patent.
`
`b.
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`U.S. Patent No. 5,558,083 to Bathe et al., which is marked as
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`Ex. 1005. I refer to this document as the ‘083 Patent.
`
`c.
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`The figures and English-language translation of French
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`Patent Publication No. 2 917 804 to L’Air Liquide Societe Anonyme Por
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`L’Etude et L’exploitation des Procedes Georges Claude. The document I
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`relied on, which includes both the French-language version and the
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`English-language translation, is marked as Ex. 1006. I refer to this
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`document as the FR ‘804 Publication.
`
`d.
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`ISO/IEEE 11073-30300, titled “Health informatics -- Point-
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`of-care medical device communication -- Part 30300: Transport profile --
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`Infrared wireless,” an ISO/IEEE standard marked as Ex. 1007. I refer to
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`this document as the “IR Standard.”
`
`e.
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`U.S. Patent No. 6,811,533 to Lebel et al., which is marked as
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`Ex. 1008. I refer to this document as the ‘533 Patent.
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`f.
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`U.S. Patent No. 4,462,398 to Durkan et al., which is marked
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`as Ex. 1010. I refer to this document as the ‘398 Patent.
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` 3
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`
`
`
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`g.
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`A marketing brochure for the Air Liquide OptiKINOX
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`inhaled Nitric Oxide delivery system, dated 2009, which is marked as Ex.
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`1011.
`
`h.
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`A document titled “Guidance Document for Premarket
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`Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric
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`Oxide Analyzer and Nitrogen Dioxide Analyzer,” issued January 24,
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`2000 by the U.S. Department of Health and Human Services, Food and
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`Drug Administration, which is marked as Exhibit 1012. I refer to this
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`document as the FDA guidance document.
`
`i.
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`U.S. Patent No. 4,308,865 to Hay, which is marked as Ex.
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`1013. I refer to this document as the ‘865 Patent.
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`j.
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`A drug label from the Center for Drug Evaluation Research,
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`Application Number: NDA 20845, INOMAX®, Final Printed Labeling
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`which is marked as Exhibit 1014. I refer to this as the INOMAX Label.
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`5.
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`I provide my conclusions regarding the disclosures of the
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`documents I reviewed as applied to the ‘794 Patent below.
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`6.
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`I was also asked to provide my opinion on the technical feasibility
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`of combining certain aspects of certain documents. I have offered my opinion
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`on the feasibility of these combinations in this declaration. I have also offered
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`my opinions about what a person of skill in the art would understand about
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`certain aspects of the resulting combinations of documents.
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` 4
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`7.
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`I am not offering any conclusions as to the ultimate determinations
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`I understand the Patent Trial and Appeals Board will make in this proceeding.
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`Specifically, I am not offering opinions on ultimate issues of validity or claim
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`construction. I am simply providing my opinion on the technical aspects of the
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`documents and on the combinability of the concepts disclosed in those
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`documents from a technical perspective.
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`BACKGROUND
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`8.
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`A copy of my curriculum vitae is attached to this declaration as Ex.
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`1003.
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`9.
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`I received my B.S. in Electrical Engineering from Virginia
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`Polytechnic Institute and State University in 1977, my M.S. in Electrical
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`Engineering from Virginia Polytechnic Institute and State University in 1979,
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`and my Ph.D. in Electrical Engineering from Stanford University in 1981. My
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`studies focused on electronics and signal processing.
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`10.
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`I have over thirty years of academic and industry experience in the
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`field of medical electronics systems and instrumentation. I have extensive
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`experience in the design of medical devices designed to communicate with
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`remote computers, such as for control and monitoring of the delivery of
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`treatment. I have experience designing the hardware interfaces of those
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`systems, as well as designing the software executed on treatment delivery
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`devices and control and monitoring hardware. I am presently the CEO and
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` 5
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`
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`Founder of Medical Design Solutions, Inc., which is a consulting firm focusing
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`on all aspects of medical device research and development.
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`11. While employed at Nellcor Puritan Bennett, Inc., where I was
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`Manager of Electronic Research from 1983 to 1989, I was the Lead Program
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`Manager for the development of a patient monitoring system which allowed
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`remote monitoring of in-hospital patients via a wireless network. That and
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`virtually all of my work at Nellcor involved embedded systems level
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`programming and application programming.
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`12. While employed at Natus Medical from 1991 to 1996, I designed
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`an infant breath analyzer that was utilized in conjunction with both voluntary
`
`and mechanical ventilators. That work involved analyzing and selecting gas
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`sensors, including CO2, NO, and O2 sensors, and integrating them into
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`respiratory systems. I later participated in the design of ventilators during my
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`employment at Pacific Consultants from 1997 to 2003.
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`13. During the period of time from 2000 through 2008, I was involved
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`in and supervised the development of a remotely operated and remotely
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`powered implantable pumping system for weight control. This system had
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`some of the safety and battery concerns implicated by the patents I was asked to
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`review as part of my engagement in this case.
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`14. Moreover, beginning in 2007 and continuing through the present, I
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`have been involved in and have overseen the development of remote patient
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` 6
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`
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`monitoring systems related to providing remote patients with telemedicine
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`services. Such systems implicate several of the device-to-device
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`communications issues at issue in the patents I have been asked to review as
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`part of my engagement in this matter. These systems also relate to the
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`considerations around ensuring that when medication is delivered to patients,
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`verification delivery of the appropriate amount of medication is critical to
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`patient wellbeing and medication efficacy.
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`15. Virtually all of my work experience since that time has included
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`application programming. In 2007 through 2009, I developed a home-based
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`wireless patient monitoring system that would communicate with a central
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`server i.e. a computer configured to service multiple clients or remote
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`computers.
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`16.
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`I am competent to make this declaration based upon my personal
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`knowledge and technical expertise in the area of medical device design,
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`including design of therapy delivery devices that communicate with remote
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`control or monitoring systems.
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`LEVEL OF SKILL IN THE ART
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`17.
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`I understand that one of the relevant factors in this proceeding is
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`the level of skill in the pertinent art. I understand that the pertinent date for this
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`determination is date of alleged invention. For purposes of this declaration, I
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`have been asked to assume that the date of invention for the ‘794 Patent is
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` 7
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`
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`January 6, 2011. I have been asked to make this assumption even though I
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`understand new matter was added to the disclosure of the ‘794 Patent after
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`January 6, 2011.
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`18.
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`In my opinion, a person of ordinary skill in the art as of January 6,
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`2011 would have had a bachelor’s degree in electrical engineering, computer
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`science, computer engineering, or the equivalent, and would have had at least
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`two years’ experience in biomedical engineering designing medical gas delivery
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`or monitoring systems.
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`BACKGROUND OF THE TECHNOLOGY
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`19. Much of the background of the technology at issue in the ‘794
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`Patent can be gleaned from reviewing prior patents that are incorporated by
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`reference in the ‘794 Patent. Specifically, the ‘510 Patent (Ex. 1001 at 7:47-49)
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`describes known valves for use on gas cylinders, and the ‘083 Patent (Ex. 1001
`
`at 10:4-7) describes known gas delivery modules for delivering gas from a
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`cylinder to a ventilator. A brief discussion of these patents serves as a
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`technology background for the pertinent technology in the ‘794 Patent.
`
`The ‘510 Patent
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`20. The application that issued as the ‘510 Patent was filed on
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`November 15, 2001, claiming priority to a provisional application that was filed
`
`on November 17, 2000. The ‘510 Patent itself issued on October 6, 2006, more
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`than four years before the filing of the earliest application that led to the ‘794
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` 8
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`
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`Patent. INO Therapeutics, Inc., the patent owner of the ‘794 Patent, is one of
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`the assignees listed on the face of the ‘510 Patent. I further understand that the
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`term “iNO” (as used, for example, in the name of the assignee of the ‘510
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`Patent) is an abbreviation for the phrase “inhaled nitric oxide.”
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`21. Valves for affixing to cylinders of gas were well known in the art
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`as of 2006, as evidenced by the ‘510 Patent. Specifically, it was known to
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`provide a valve having a “valve body 14 [that] includes a threaded inlet port 18
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`which screws onto the outlet port of the cylinder 12. The valve body 14 also
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`includes an outlet port 20. The valve body 14, the outlet port 20, and the inlet
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`port 18 may be modified for specific uses, cylinder sizes, or gases.” (Ex. 1004
`
`at 2:43-51). When rotated, a valve handle of such known valves opened or
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`closed the valve itself, permitting or prohibiting gas to flow through. (See, e.g.,
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`Ex. 1004 at 6:21-22). This valve handle is an example of a valve actuator
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`because when it is turned by a user, the valve itself is actuated (i.e., opened or
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`closed).
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`22. As referenced in the ‘510 Patent, it was known prior to the earliest
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`priority date of the ‘794 Patent to provide a valve with electronics contained in
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`the handle thereof to track usage and “enable logging and billing.” (Ex. 1004 at
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`1:9-15). More specifically, known valves included so-called “smart handles” in
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`which “several electronic devices [] mounted in the handle, including a
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`processor 23, a timer 21, a reset button 27, an open/closed sensor 28, a battery
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` 9
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`
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`25, a display 26, and an electronic memory device 22…” (Ex. 1004 at Abstract,
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`2:58-61). Thus, before January 6, 2011, it was known to include electronics,
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`such as processors, memory devices, and LCD displays, in “smart handles” of
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`valves used to control delivery of gas to patients.
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`23. The electronics referred to in the ‘510 Patent are positioned in a
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`“compartment formed by the handle 16 and cover 24 in the preferred
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`embodiment.” (Ex. 1004 at 3:3-5). In my opinion, the ‘510 Patent discloses
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`that the electronics contained in this “compartment” include the valve memory
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`referenced with numeral 22. (Ex. 1004 at 3:3-29). Because the handle is an
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`actuator and the cover 24 is a cap on the handle, the electronics in the
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`“compartment” are disposed between an actuator and a cap of the valve.
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`24. Known “smart handles” included “sensors for sensing the opening
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`and closing of the valve, a timer for timing the duration over which the valve is
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`opened, and an electronic memory device which records the pertinent
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`information.” (Ex. 1004 at 1:34-35, 1:43-52). The ‘510 Patent further describes
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`the operation of known smart handles:
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`When the valve handle 16 is turned to open or close the valve, the
`proximity sensor 28 triggers the processor 23 to instruct the
`memory device 22 to log the event, including date, time, and
`whether the event was an opening or a closing of the valve. This
`information
`is stored
`in a non-volatile,
`read-only-memory
`(NVROM) in the memory device 22.
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`
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`10
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`
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`(Ex. 1004 at 6:21-27). Accordingly, known “smart handles” provided the
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`capability of detecting the open time and close time of the valve, and stored that
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`data in memory within the smart handle. This could be achieved, according to
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`the ‘510 Patent, using “at least two timers 21, one of which is a calendar, and
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`the other of which is an event timer.” (Ex. 1004 at 3:9-11).
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`25. This data, once determined as described, could be stored by a valve
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`processor 23 in valve memory 22 to record the time and date of events. (Ex.
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`1004 at 3:38-58, 6:21-32). This data could later be transmitted from the valve
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`memory 22 to external devices as needed. (See Ex. 1004 at 6:33-7:15). In
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`addition to the timing data regarding valve opening and closing, known “smart
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`handles” could store gas data used to assist in therapy itself, such as Born On
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`Date and Batch number to assign patient IDs to cylinders and identify control
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`cylinders for blinded trials. (Ex. 1004 at 7:36-47).
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`26. Known “smart handles” also included data ports or transceivers
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`(short for “transmitter-receiver”) in communication with valve processors and
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`valve memory devices through which data stored in the valve memory could be
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`communicated from the smart handle to a remote computer device. (Ex. 1004 at
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`6:33-55). The ‘510 Patent discloses that this communication of data can be
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`achieved with either wired or wireless transceivers. (Ex. 1004 at 6:64-7:4).
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`Specifically, the ‘510 Patent discloses portable iButtons, which operate
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`according to a single-conductor communication protocol (Ex. 1004 at 6:37-46),
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`
`11
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`
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`or a direct data downloading protocol to download data through one-wire port
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`22 onto a computer or printer (Ex. 1004 at 6:47-57). It also discloses that data
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`can be periodically transmitted from the handle to a remote device using a
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`wireless transmitter. (Ex. 1004 at 7:1-4).
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`27. Such data ports also enabled the transfer of “initialization
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`parameter data,” from a remote computer device to the memory device of a
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`smart handle. (Ex. 1004 at 5:65-6:2). This initialization parameter data could
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`include the following parameters:
`
`• Born on date (date when cylinder was filled)
`• Cylinder serial number
`• Gas lot number
`• Set the timers (which may include a calendar timer and an event timer)
`• Clear the log registers
`• Additional area may be available for recording specific notes or
`information relative to a specific treatment or lot.
`
`(Ex. 1004 at 5:45-56). In known smart handles, both the “distributor who is
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`filling and supplying the filled cylinder” and the “user (such as the hospital)”
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`could add data to the valve memory through the data port. (Ex. 1004 at 5:57-
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`6:2).
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`
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`12
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`
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`28. Accordingly, prior to January 6, 2011, it was well-known to
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`transmit and receive data about the gas to and from a valve memory device in a
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`smart handle using a transceiver in the smart handle.
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`29. The ‘510 Patent does not appear to specify the kinds of gas its
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`valve can be used to deliver. Claims 1 to 4 of the ‘510 Patent, however, are
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`specifically directed to methods of tracking the use of gas for medical
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`treatments. (Ex. 1004 at claims 1-4). The ‘510 Patent also explains, in setting
`
`up the problems it sought to solve, that “[s]ome medical treatments involve the
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`use of gases that are inhaled by the patient.” (Ex. 1004 at 1:15-16). It refers to
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`the gases addressed in its disclosure as “[p]harmaceutical gases, dispensed by
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`prescription” (Ex. 1004 at 1:20-21) and states that “[t]he cylinder may contain
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`pharmaceutical gas or other gases” (Ex. 1004 at 2:41-42). Based on these
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`disclosures and on the fact that the ‘510 Patent is assigned to INO Therapeutics,
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`it is my opinion that a person of skill in the art, reading the entirety of the ‘510
`
`Patent, would understand that one of the pharmaceutical gases that can be
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`dispensed using the disclosed smart handle is nitric oxide (also abbreviated as
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`“NO”).
`
`The ‘083 Patent
`
`30. The application that issued as the ‘083 Patent was filed on
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`November 22, 1993. The ‘083 Patent issued on September 24, 1996, more than
`
`14 years before the filing of the earliest application that led to the ‘794 Patent.
`
`
`13
`
`
`
`It is titled “Nitric Oxide Delivery System.” Like the ‘510 Patent, INO
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`Therapeutics LLC, the patent owner of the ‘795 Patent, is also the assignee of
`
`the ‘083 Patent.
`
`31. The ‘083 Patent is generally directed to a “flow transducer that
`
`senses the flow of gas from the gas delivery system and uses that information
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`with a selective algorithm to provide an operator selectable concentration of NO
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`to the patient.” (Ex. 1005 at 2:20-24). It discloses a system for delivering gas
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`from, for example, a cylinder 10 using various elements to regulate the
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`concentration and flow of the gas. (Ex. 1005 at 3:45-47). Accordingly, in gas
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`delivery systems known long before the filing of the ‘794 Patent, a central
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`processing unit (“CPU”) would receive signals from an input device indicative
`
`of the concentration the user desires to administer, and would receive signals
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`from various transducers indicative of the flow rate gas and concentration of the
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`gas. (Ex. 1005 at 5:60-6:4).
`
`32.
`
`In known systems, an input device was provided to enable the user
`
`to input patient data, such as “the desired concentration of NO that is to be
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`administered to the patient.” (Ex. 1005 at 6:29-30). This input device could
`
`include a display in the form of a touch screen. (Ex. 1005 at 6:32). Thus, in
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`known gas delivery systems, the user could set the desired NO concentration to
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`be administered to the patient. (Ex. 1005 at 6:40-42). It was also known that in
`
`such delivery systems, if the actual NO concentration being delivered to the
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`
`14
`
`
`
`patient differed from a value set by the user, the CPU could generate an alarm
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`and/or shut a shutoff valve to prevent further gas delivery. (Ex. 1005 at 8:1-12).
`
`33. Moreover, in systems known prior to January 6, 2011, a CPU that
`
`performed certain control functions received an input from a sensor that
`
`“sense[d] the concentration of NO in the supply cylinder 10 so that the user
`
`[could] verify that the proper supply [was] being utilized…” (Ex. 1005 at 6:5-
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`8). Systems prior to January 6, 2011 also contemplated a CPU receiving data
`
`about the actual concentration of gas in a supply cylinder from other sources.
`
`(Ex. 1005 at 6:11-15). Accordingly, it was known to rely on a CPU to help
`
`verify that a gas source contained the correct concentration of gas for a
`
`particular patient.
`
`34. Known gas delivery systems (such as the one described in the ‘083
`
`Patent) were capable of being connected to two different cylinders of gas at the
`
`same time. (Ex. 1005 at 8:38-65; Fig. 2). In such systems, the CPU controlled
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`the flow of gas from both cylinders as was appropriate given the type of gas in
`
`both cylinders and the specific needs of the patient.
`
`THE ‘794 PATENT
`
`35. The ‘794 Patent was filed against the backdrop of the state of the
`
`art based on at least the prior art discussed above. Indeed, the ‘794 Patent
`
`incorporates both prior art references discussed above by reference. (Ex. 1001
`
`at 7:47-49 (‘510 Patent), 10:4-7 (‘083 Patent)).
`
`
`15
`
`
`
`36. The ‘793 Patent is generally related to a “gas delivery system for
`
`administering therapy gas and methods of administering therapy gas.” (Ex.
`
`1001 at 1:16-18). The Background section of the ‘794 Patent sets forth the state
`
`of the art and the alleged problems that allegedly needed to be solved. (Ex.
`
`1001 at 1:22-46). In describing the pre-existing technology, the ‘794 Patent
`
`concedes that known devices tracked data about gas therapy:
`
`Known gas delivery devices may include a computerized system
`for tracking patient information, including information regarding
`the type of gas therapy, concentration of gas to be administered and
`dosage information for a particular patient.
`
`(Ex. 1001 at 1:29-33).
`
`37. One of the problems the ‘794 Patent identifies with such known
`
`tracking systems is that they allegedly did not communicate with other devices:
`
`these computerized systems often do not communicate with other
`components of gas delivery devices, for example, the valve that
`controls the flow of the gas to the computerized system and/or
`ventilator for administration to the patient
`
`(Ex. 1001 at 1:33-37). The ‘794 Patent also states that “in known systems, the
`
`amount of gas utilized by a single patient is often difficult or impossible to
`
`discern, leading to possible overbilling for usage.” (Ex. 1001 at 1:37-39).
`
`38.
`
`In my experience, medical devices long before January 6, 2011
`
`were able to perform both tasks identified as being weaknesses. Specifically, I
`
`am aware of delivery devices that could communicate with other devices during
`
`delivery of therapy. As an example, intravenous medication delivery devices
`
`
`
`16
`
`
`
`and ventilators were frequently in communication with central monitoring
`
`systems in Intensive Care Units (ICUs) to allow--and indeed to insure--allowing
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`accurate, computer based monitoring of drug or therapy delivery by medical
`
`staff.
`
`39.
`
`I am also aware of systems that tracked the amount of a drug
`
`delivered to a patient during treatment. Since this is of critical importance, in
`
`many clinical applications (such as dialysis applications), the amount of therapy
`
`drug delivered to a patient is closely monitored. This was true long before
`
`January 6, 2011.
`
`40. Notwithstanding the fact that the problems the ‘794 Patent
`
`identified had well-known solutions prior to January 6, 2011, the ‘794 Patent
`
`describes what it characterizes as an unfulfilled need:
`
`There is a need for a gas delivery device that integrates a
`computerized system to ensure that patient information contained
`within the computerized system matches the gas that is to be
`delivered by the gas delivery device. There is also a need for such
`an integrated device that does not rely on repeated manual set-ups
`or connections and which can also track individual patient usage
`accurately and simply.
`
`(Ex. 1001 at 1:40-46).
`
`41. The ‘794 Patent purports to satisfy these needs with what it
`
`describes as a “gas delivery device.” (Ex. 1001 at Abstract). Giving examples
`
`of each of the three sub-components of the overall system, the ‘794 Patent states
`
`that the gas delivery device includes a “valve assembly with a valve and
`
`
`17
`
`
`
`circuit.” (Ex. 1001 at Abstract). It further describes that the gas delivery device
`
`may send “wireless optical line-of-sight signals to communicate [] gas data to a
`
`control module.” (Ex. 1001 at Abstract). Finally, examples of the gas delivery
`
`mechanism include “a ventilator and a breathing circuit. (Ex. 1001 at Abstract).
`
`42. The ‘794 Patent states that “the therapy gas may comprise nitric
`
`oxide (NO),” but does not limit its disclosure to systems for delivering NO.
`
`(Ex. 1001 at 1:52-53). Instead, it states that “[t]he gas delivery devices and
`
`systems described herein may be utilized with medical devices such as
`
`ventilators and the like to delivery [sic] gas to a patient.” (Ex. 1001 at 2:1-4).
`
`43.
`
`I understand that the material related to hypoxic respiratory failure
`
`in the ‘794 Patent, which is a continuation of a continuation-in-part of the ‘904
`
`Patent, was new matter. (Ex. 1001 at 2:9-12; 15:33-67). This added material
`
`generally relates to the use of inhaled nitric oxide to treat a condition called
`
`hypoxic respiratory failure. The INOMAX label reference discloses that iNO
`
`can be used to treat hypoxic respiratory failure in its as-approved form in 2000.
`
`44. Figs. 1 and 3 of the ‘794 Patent, reproduced below for reference,
`
`provide detail about the system described in the ‘794 Patent.
`
`
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`18
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`
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`
`
` lt:::::::E:::::
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`‘:-
`
`
`
`
`
`
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`19
`19
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`
`
`45.
`
`In the ‘794 Patent, the gas delivery system is referred to as numeral
`
`10. Numeral 100 refers to the valve assembly, numeral 200 refers to the control
`
`module, and numeral 400 refers to a ventilator. (Ex. 1001 at 6:7-17). These
`
`three sub-components of the gas delivery system are used to deliver gas from
`
`gas source 50 to a patient labeled in Fig. 1 as “PATIENT.” (Ex. 1001 at 6:13-
`
`17).
`
`46. The valve assembly 100 includes a valve 107 that controls the flow
`
`of gas. (Ex. 1001 at 6:8). It also includes an actuator “disposed on the valve
`
`
`
`20
`
`
`
`107 [that] is rotatable around the valve 107 for opening and closing the valve
`
`107.” (Ex. 1001 at 6:33-35). The actuator contains a sensor to sense whether
`
`the actuator is turned on or off. (Ex. 1001 at 7:43-47). The ‘794 Patent
`
`concedes that such sensors were known, noting that they are described in the
`
`‘510 Patent. (Ex. 1001 at 7:47-49).
`
`47.
`
`It is clear from reading the ‘794 Patent that the actuator described
`
`therein is a manually operable actuator that, when rotated by the hand of the
`
`operator, opens or closes the valve 107. First, the fact that no motor is
`
`described, and instead a sensor is used to detect when the actuator has “been
`
`rotated” to the opened or closed position, indicates the actuator is hand-
`
`operable. (Ex. 1001 at 7:43-8:8). Second, the ‘794 Patent discusses the use of
`
`alarms “to alert the user to turn off the valve or, more specifically, the actuator
`
`114 when the dose has been delivered.” (Ex. 1001 at 14:28-31). Third, the ‘794
`
`Patent describes that “[c]oordinating delivery of the gas may include turning on
`
`the actuator 114 of the valve 107.” (Ex. 1001 at 16:45-48). Accordingly, the
`
`‘794 Patent covers manually operable actuators to open and close the valve that
`
`controls delivery of therapy gas.
`
`48. The valve described in the ‘794 Patent also includes a circuit 150
`
`that contains many sub-circuits illustrated in Fig. 4. (Ex. 1001 at 6:8, 6:43-56).
`
`The valve circuit 150 includes a transceiver 120 and is in communication with a
`
`valve display 132 visible from the exterior of the valve. (Ex. 1001 at 6:43-56).
`
`
`21
`
`
`
`49. Finally, the valve includes a data input 108 “used to transfer data
`
`from the valve memory 134 to other devices or to input data to the valve
`
`memory 134.” (Ex. 1001 at 7:3-7). The ‘794 Patent gives the example that gas
`
`data about the gas in the cylinder 50 may be communicated to the valve and
`
`used by the circuit 150, through data input 108, from a bar code scanned with a
`
`scanning device connected to the data input 108. (Ex. 1001 at 7:12-20). With
`
`regard to the content of the data, the ‘794 Patent states:
`
`Gas data may include information regarding the gas composition
`(e.g., NO, O2, NO2, CO, etc.), concentration, expiration date, batch
`and lot number, date of manufacturing and other information. Gas
`data may be configured to include one or more types of
`information.
`
`(Ex. 1001 at 7:20-25).
`
`50. The ‘794 Patent also discusses the capability for the valve
`
`transceiver 120 to communicate with CPU transceiver 220. (Ex. 1001 at 8:12-
`
`15). In the preferred embodiment of the ‘794 Patent, the valve transceiver 120
`
`communicates with the CPU transceiver 220 using “wireless optical line-of-
`
`sight” communications. (Ex. 1001 at 8:27-30). This optical line of sight is
`
`illustrated with numeral 300 in Fig. 1. (Ex. 1001 at 6:7-10). In this
`
`embodiment, “the CPU transceiver 220 is positioned directly above the valve
`
`transceiver 120” to provide an optical line of sight between the devices. (Ex.
`
`1001 at 9:43-45).
`
`
`
`22
`
`
`
`51. The control module 200 of Fig. 1 also includes a delivery module
`
`260 that “regulat[es] the flow of gas from the gas source 50 to the ventilator
`
`400.” (Ex. 1001 at 9:65-67). The ‘794 Patent concedes that the delivery
`
`module 260 is conventional and known in the prior art, citing to the ‘083 Patent
`
`as containing a description of the “detailed method of how the delivery module
`
`delivers the gas to the ventilator circuit.” (Ex. 1001 at 10:4-7). The ‘794 Patent
`
`discloses that “the delivery module 260 can detect and regulate the flow of gas
`
`from the gas source 50 to the ventilator 400.” (Ex. 1001 at 10:24-26).
`
`52. The ventilator 400 includes a breathing circuit 410 with an
`
`inspiratory limb 412 and an expiratory limb 414, each in fluid communication
`
`with the ventilator 400. (Ex. 1001 at 10:12-15). According to the ‘794 Patent,
`
`the “inspiratory limb 412 carries gas to the patient and the expiratory limb 414
`
`carries gas exhaled by the patient to the ventilator 400.” (Ex. 1001 at 10:18-20).
`
`53. With regard to the control module 200, the ‘794 Patent discloses
`
`that the user can enter patient information, such as identity, type/concentration
`
`of gas to be administered, dose of gas to be administered, or other patient data.
`
`(Ex. 1001 at 11:39-45). Such data allegedly provides a safety benefit, as it
`
`enables the control module to “detect[] a non-confirming drug or gas source, an
`
`expired drug or gas, incorrect gas type, incorrect gas concentration and the like.
`
`In addition, embodiments of the gas delivery system described herein also
`
`improve efficiency of gas therapy.” (Ex. 1001 at 11:55-59).
`
`
`23
`
`
`
`54. More specifically, the ‘794 Patent discloses that a gas provider
`
`prepares a gas delivery device by filling a gas source 50 with gas and attaching
`
`a valve assembly 100 to the gas source. (Ex. 1001 at 11:63-12:1). Gas data
`
`may then be stored in the valve, either by the gas supplier or manufacturer or at
`
`the medical facility. (Ex. 1001 at 12:4-10). This may be achieved, for example,
`
`by scanning a bar code with a bar code scanner connected to the data port, as
`
`discussed above.
`
`55. Thereafter, the gas cylinder can be positioned such that a line-of-
`
`sight is established between the valve transceiver and the CPU transceiver. (Ex.
`
`1001 at 12:10-13). The gas data can then communicate from the valve to the
`
`CPU via the optical line-of-sight, and the CPU compares the gas data from the
`
`valve to the patient information. (Ex. 1001 at 12:13-18). According to the ‘794
`
`Patent, “[i]f the gas data and the patient information match, then gas is
`
`administered to the patient” through the ventilator. (Ex. 1001 at 12:29-32).
`
`Alternatively, if the gas data does not match the patient data, an alarm is
`
`emitted. (Ex. 1001 at 12:32-33).
`
`56. The ‘794 Patent gives several examples of the kinds of
`
`comparisons that can be made by the CPU to determine whether to either
`
`deliver gas to a patient or emit an alarm. First, it discloses comparing the gas
`
`expiration date, stored in the valve, with the current date to determine whether
`
`the gas has expired. (Ex. 1001 at 12:64-13:9). Second, it discloses comparing
`
`
`24
`
`
`
`gas concentration data stored in the valve with a concentration of gas to be
`
`administered to the patient. (Ex. 1001 at 13:10-31).
`
`57. The ‘794 Patent also includes discussions of various well-known
`
`techniques for preserving power in battery-operated systems. It states that in
`
`“embodiments in which the power source 130 includes a batte
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