UNITED STATES PATENT AND TRADEMARK OFFICE
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`PATENT TRIAL AND APPEAL BOARD
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`BAXTER INTERNATIONAL INC.
`Petitioner
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`v.
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`BECTON, DICKINSON AND COMPANY
`Patent Owner
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`_____________________
`CASE: IPR2020-00027
`U.S. PATENT NO. 10,335,584
`_____________________
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`DECLARATION OF RICHARD MEYST
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`BAXTER EXHIBIT 1002
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`PATENT TRIAL AND APPEAL BOARD
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`BAXTER INTERNATIONAL INC.
`Petitioner
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`v.
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`BECTON, DICKINSON AND COMPANY
`Patent Owner
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`_____________________
`CASE: IPR2020-00027
`U.S. PATENT NO. 10,335,584
`_____________________
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`DECLARATION OF RICHARD MEYST
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`I, Richard Meyst, 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 declaration.
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`I am also qualified to give testimony under oath. The facts and opinions listed
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`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 standard
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`consulting rate of $475/hr. My compensation in no way depends on the
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`outcome of this proceeding or the content of my opinions. I am not employed
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`by, nor receiving grant support from the Petitioner in this matter. I am
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`receiving compensation from Petitioner solely for my involvement in this
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`matter and based 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. Patent No.
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`10,335,584 (the “‘584 Patent”) (Ex. 1001) and to provide my opinions on how
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`those of skill in the art (as defined herein) would understand those documents.
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`The documents I was asked to review include those addressed in more detail
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`in the rest of this declaration. I provide my conclusions regarding the
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`disclosures of these documents below.
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`4.
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`Of particular relevance to the ‘584 Patent, I have reviewed and am familiar
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`with the following documents:
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`a. U.S. Patent No. 4,440,207 to Genatempo et al. (“Genatempo”) (Ex.
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`1006);
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`b. U.S. Patent No. 5,554,135 to Menyhay (“Menyhay”) (Ex. 1007);
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`c. U.S. Patent Publication No. 2005/0013836 to Raad (“Raad”) (Ex.
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`1016);
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`d. U.S. Patent Publication No. 2004/0111078 to Miyahara (“Miyahara”)
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`(Ex. 1009);
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`e. U.S. Patent Publication No. 2003/0153865 to Connell et al. (“Connell”)
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`(Ex. 1010);
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`f. U.S. Patent Publication No. 2006/0030827 to Raulerson et al.
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`(“Raulerson”) (Ex. 1011);
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`g. U.S. Patent No. 6,475,434 to Darouiche (“Darouiche”) (Ex. 1015); and
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`h. Needleless connectors-the way forward in the prevention of catheter-
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`related infections, A.L. Casey et al., Journal of Hospital Infection, 77-
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`81 (2002) (Ex. 1017).
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`I have also reviewed the Petition and institution decision in IPR2014-00880.
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`(Ex. 1005). I understand that the proceeding in IPR2014-00880 was instituted
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`but never reached final written decision. To the extent not explicitly
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`mentioned above, I have also reviewed any additional documents cited in this
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`declaration.
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`5.
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`I was asked to provide my opinion on the technical feasibility of and the basis
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`for combining certain aspects of certain documents. I have offered my
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`opinion on these issues in this declaration.
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`6.
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`I am not offering any conclusions as to the ultimate determinations of
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`obviousness or patentability, as I understand the Board will make in this
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`proceeding. I am simply providing my opinion on the technical aspects of the
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`documents (including, where asked, the application of what I understand
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`Petitioner asserts is the appropriate construction for this proceeding) and on
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`the reasons for combination and modification of any disclosures as well as
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`what those combinations and modifications would result in from a technical
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`perspective.
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`BACKGROUND
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`7. My qualifications and listing of publications are detailed in my curriculum
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`vitae, which is attached as Exhibit 1004 and includes, among other things, my
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`academic credentials and my employment history. This includes a list of
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`issued patents and publications on which I am a named inventor in the
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`previous 10 years and a list of all other cases in which I have testified as an
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`expert at trial or by deposition in the previous 4 years. I am currently the
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`President and Chief Executive Officer of Fallbrook Engineering, Inc. I am an
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`engineer and consultant in the field of medical devices and related
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`technologies, including cardiovascular catheters.
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`8.
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`I received a M.S. (1972) and B.S. (1971) in mechanical engineering from the
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`University of Wisconsin, Madison. My undergraduate academic work
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`focused on design, manufacturing methods, fluid mechanics, and heat
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`transfer. My graduate academic focus was on computer-based automatic
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`controls of systems and my Master’s thesis was on concept development,
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`design, fabrication, and testing of a prototype bench-top implantable
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`mechanical human heart. Additionally, I have participated in industry
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`seminars and training programs covering design of experiments, statistical
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`analysis, biocompatibility
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`testing, sterilization method selection and
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`validation, design of plastic parts, design for manufacturability, package
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`design and testing, cellular therapy, and many others.
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`9.
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`As an engineer, designer, consultant, program manager and entrepreneur at
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`Fallbrook Engineering, Inc., I have been involved in the advanced design and
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`development of a wide range of medical technology products for the
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`healthcare industry for more than 40 years. Prior to 1989 when I became a
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`partner in Fallbrook Engineering, I held various leadership positions at
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`technology and product development companies. From 1972 to 1974, I
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`worked for United States Catheter and Instrument Corporation, a division of
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`C.R. Bard, Inc. I was a product engineer supporting Vascular Graft and
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`Cardiovascular Catheter product lines. As part of my work there, I designed,
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`implemented, and evaluated specialty test equipment and testing procedures.
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`I also implemented a program to quantify and control variables affecting
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`product quality. The work included development of multi-lumen profile
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`extrusions for use in diagnostic and therapeutic catheters
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`10. From 1974 to 1979 I worked for the Fenwal Division of Baxter Travenol Labs,
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`starting out as a senior engineer and ultimately being promoted to a program
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`manager. During that time, I was involved in the design and management of
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`human blood component products, including sterile medical disposables and
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`electronic, electro-mechanical biomedical hardware used in Cellular Therapy.
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`11. From 1983 to 1988, I worked for Imed Corp. as a manager of various design,
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`engineering and manufacturing groups. During this time, I managed the
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`design, development and manufacturing of a number of IV infusion pumps,
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`enteral feeding pumps, and associated sterile medical disposables product
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`lines.
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`12. From 1988 to 1989, I worked for Diatek Corp. as a manager of Manufacturing
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`Engineering. During this time, in addition to supporting the company’s
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`manufacturing activities, I was involved in inventing a probe cover and
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`package disposable for a next generation tympanic electronic hospital
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`thermometer.
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`13. Since 1989, I have been a partner and owner at Fallbrook Engineering. From
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`1989 to 2003, I was a Vice President, and since 2003, I have been the President
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`and Chief Executive Officer. During my time at Fallbrook Engineering, I have
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`been
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`involved
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`in providing consulting services
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`in
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`the medical,
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`pharmaceutical, biotech, electronic, and consumer product industries. The
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`consulting services include project management, product conception, design
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`and development, product prototyping, design and process validation,
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`manufacturing engineering, production startup, cost reduction, as well as
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`regulatory affairs compliance and regulatory submissions.
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`14. Over the years, I have had a consistent focus on medical devices and related
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`technologies which utilize my particular expertise in inventing, product
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`design and manufacturing methods design, fluid mechanics, drug delivery,
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`cellular therapy, high volume sterile disposables and FDA regulatory matters.
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`15. My medical product experience includes, but is not limited to, product and
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`packaging design, the development of implantable vascular prostheses, DNA
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`amplifiers, vital signs monitoring devices, IV drug infusion pumps and
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`administration sets, over the needle IV catheters, self-injection training
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`devices, cardiac catheters, various balloon catheters, introducer sheaths,
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`diagnostic catheters, special purpose syringes, safety syringes, diagnostic and
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`therapeutic medical lasers and optical catheters, surgical instruments,
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`microprocessor based diagnostic and therapeutic instruments, blood cell
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`collection, separation, processing, and administration devices, filtration
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`devices for blood and intravenous solutions, stem-cell harvesting and cell
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`expansion systems.
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`16.
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`I have been a Principal Investigator on a National Institute of Health Small
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`Business Innovation Research (“SBIR”) grant from the National Heart, Lung
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`and Blood Institute developing a device for the improved collection of
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`umbilical cord blood stem cells. This product was designed to safely collect
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`cord blood without exposed sharps and in a shielded state to prevent blood
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`spatter. I served on the Board of Directors for the Society of Plastics
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`Engineers/Medical Plastics Division and am a long-time member. I am a
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`member of the American Association of Blood Banks, the Association for the
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`Advancement of Medical Instrumentation, and the American Filtration
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`Society. I have also been a long-time member of the Medical Device Steering
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`Committee of BIOCOM, the largest, most experienced leader and advocate
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`for California’s life science sector representing over 750 biotechnology,
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`pharmaceutical, digital health and medical device/diagnostic companies. I
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`have been a judge in the San Diego CONNECT capital competition for startup
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`companies. On several occasions I have been a juror in the UBM/Cannon
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`Medical Design Excellence Awards competition (“MDEA”). This annual
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`competition is the premier design awards program for the medical device
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`industry.
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`17.
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`I also have been an invited speaker, presenting technical and business talks at
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`numerous scientific and medical industry meetings and have authored articles
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`published in trade magazines.
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`18. For these reasons and because of my technical experience and training as
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`outlined in my curriculum vitae (Ex. 1004), I believe I am qualified to offer
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`technical opinions regarding the ‘584 Patent and the other documents I
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`reviewed as part of my work in this matter. I believe I am capable of opining
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`about the state of the art in these areas at various points in time from the mid-
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`2000s to the present, as I have been familiar with the academic understanding
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`of medical devices, as well as the design considerations that are to be
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`accounted for in medical devices.
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`TECHNOLOGY OVERVIEW
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`Brief History of Patient Fluid Lines
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`19. Sterile disposable tubing fluid lines have been used for numerous healthcare
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`treatment purposes for many years. These tubes allow for conveying fluids to
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`or from a patient and are often connected to indwelling cardiovascular devices
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`such as hemodialysis and peritoneal catheters, central venous line catheters,
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`urine drainage catheters placed into the patient’s bladder and many other
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`devices. Patient fluid lines are single use devices that are packaged and
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`sterilized. Aseptic technique is used to place these devices in the patient, or
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`to connect to these lines, as any microbial contamination can lead to the
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`patient becoming infected and even the development of life-threatening
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`peritonitis or sepsis.
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`20. Access to these fluid lines previously was done by using a sterile needle on a
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`syringe or tubing set to penetrate a rubber stopper which was a part of the
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`disposable tube set. The rubber stopper and other connection components
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`were prepped with an antiseptic solution to minimize the chance of microbial
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`contamination. However, the use of needles led to accidental needle sticks of
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`healthcare workers, raising the risk of infection. To prevent accidental needle
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`sticks, needless connectors of various designs were developed and sold in the
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`early 1990s. While this new type of connector eliminated needle sticks, they
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`were sometimes hard to clean and disinfect prior to use which led to patient
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`contamination and infections. As demonstrated above and herein, by 2005, it
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`was well-known in the industry to use anti-microbials to clean patient tubing
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`connections, and that such cleaning dramatically reduced the risk of
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`infections.
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`U.S. PATENT NO. 10,335,584
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`21. The ‘584 Patent is titled “Patient Fluid Line Access Valve Antimicrobial
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`Cap/Cleaner.” The ‘584 Patent issued from an application filed on February
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`11, 2016, and claims priority to U.S. Application No. 14/159,959 (“the ‘959
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`Application”) filed on January 21, 2014 and U.S. Application No. 11/281,711
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`(“the ‘711 Application”) filed on November 17, 2005. (Ex. 1001, Cover).
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`The ‘959 Application issued as U.S. Patent No. 9,283,367 (“the ‘367 Patent”).
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`The ‘711 Application issued as U.S. Patent No. 8,740,864 (“the ‘864 Patent”).
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`22. The ‘584 Patent is generally directed to a device for antiseptically cleaning
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`and maintaining what it refers to as a “patient fluid line access valve” or a
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`patient tube such as a catheter. (Ex. 1001, 1:49-50). The ‘584 Patent
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`accomplishes this by providing a cap/cleaning device 10 which threadingly
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`attaches to the patient line access valve A (as shown in Fig. 1 reproduced
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`below). (Ex. 1001, 1:59–61; 2:15–17, Fig 1).
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`23. The ‘584 Patent relies upon a threading engagement between the cap and the
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`line to advance the face of the line (A8 above) into the interior of the cap 10.
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`The ‘584 Patent further shows that cleaning end 16 is covered by lid 20 which
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`may be removed to expose wet pad 22. (Ex. 1001, 2:35–36, 40–44; Fig. 2).
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`The cap of the ‘584 Patent may be made of any number of known plastic
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`materials. (Ex. 1001, 2:29-33). The use of these plastics was well known in
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`the medical device field. Another illustration of the claimed mechanical cap
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`is depicted below in annotated figure 10b, showing lid 78a in green, threading
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`18 in red, sponge 80 in orange, and cap 78 in blue.
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`24. During treatment of a patient, the patient fluid line described by the ‘584
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`Patent (e.g., a catheter) is left in the patient’s body while an access valve
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`remains external to the body, accessible by the patient, by medical
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`professionals, and to the environment. In this access valve, there is a septum
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`into which a male luer may be inserted to administer fluids to the patient or
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`withdraw fluids from the patient. The disinfecting cap of the ‘584 Patent is
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`threadingly attached to the access valve when the patient is not being treated,
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`protecting the face and inhibiting bacterial contamination of the patient’s
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`access valve. This patient line disinfecting cap is, at its essence, a threaded
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`cap with an antiseptic-soaked sponge within the cap.
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`25.
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`I understand that the ‘864 Patent was previously challenged at the Patent
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`Office. (Ex. 1005). I have been asked to apply the claim constructions of
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`“external threads on the access portion proximate the septum” and “length”
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`that the board preliminarily adopted and the construction of “access portion”
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`that the Patent Owner proposed in the earlier proceeding. These claim
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`constructions are as follows:
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`Term
`“external threads on the
`access portion proximate
`the septum”
`“length”
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`“access portion”
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`Construction
`This term requires the external threads to be located
`on the access portion very near the end face as
`compared to other parts of the access portion.
`“Length” refers to a measurement from one end of a
`thread to the other end of that thread.
`This term refers to the exposed surface of the septum
`and the exposed surface of the housing that surrounds
`the septum.
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`LEVEL OF SKILL IN THE ART
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`26.
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`I was asked to provide my opinion about the experience and background a
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`person of ordinary skill in the art (“POSA”) of the ‘584 Patent would have
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`had as of November 17, 2005.
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`27. With respect to the ‘584 Patent, a POSA as of November 17, 2005 would have
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`had an undergraduate degree or equivalent thereof in mechanical engineering
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`or biomedical engineering with at least three years of experience in product
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`design with experience in, for example, catheters, medical ports, and other
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`patient fluid line access valve caps. Additional graduate education might
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`substitute for experience and vice-versa. A POSA would have had knowledge
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`of design considerations known in the industry and would have been familiar
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`with then existing products and solutions, and would have understood how to
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`search available literature for relevant publications.
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`28.
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`I believe that based on my experiences outlined above, I can opine today about
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`what those of skill in the art would have known and understood as of
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`November 17, 2005.
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`OVERVIEW OF THE PRIOR ART REFERENCES
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`Menyhay
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`29. As part of my work in this proceeding, I was asked to review U.S. Patent No.
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`5,554,135 to Menyhay (“Menyhay”) (Ex. 1007). Menyhay describes a sterile
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`medical injection port and cover method and apparatus consisting of an
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`external port cover that is open on one end and closed on the other end. (Ex.
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`1007, Abstract).
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`30. The interior of the cover is configured with a set of spiraling screw threads
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`which mate with corresponding screw threads located on the exterior surface
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`of an external medical fluid injection port. (Ex. 1007, Abstract, 4:10-12, 4:19-
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`21). Within the cover, there is a closed frangible breakable plastic vessel
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`containing a combination of liquid antiseptic, bactericidal and virucidal
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`agents. (Ex. 1007, Abstract, 4:13-15). A porous sponge is located proximal
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`to the liquid container. (Ex. 1007, Abstract, 4:17-18). As the port cover is
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`screwed into place over the injection port, it first creates a sealed chamber
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`(Ex. 1007, 4:22-24) and then an inwardly projecting point of the cover comes
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`into contact with the frangible container and causes the container to rupture,
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`dispensing the contents of the container (the various antiseptic, bactericidal,
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`and virucidal solutions) into the interior of the port cover which are then
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`soaked up by the sponge. (Ex. 1007, Abstract, 4:24-27). As tightening
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`continues, the antiseptically treated sponge contacts the latex membrane of
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`the port, bathing it with the liquid soaked up by the sponge, cleaning the face
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`of the port. (Ex. 1007, Abstract, 4:27-30). The assembly within the cover
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`stays bathed in antiseptic until the cover is removed and discarded when the
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`port is needed again. (Ex. 1007, 4:30-32). After use, a new sterile cover is
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`obtained and screwed onto the injection port. (Ex. 1007, 4:39-40).
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`31. Menyhay states that the cap or cover may be a cylinder that is open on one end
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`and includes screw threads 15 on the inside. (Ex. 1007, 6:38-40, Fig. 2). A
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`rubberized O-ring 14 is provided proximal to the open end of cylinder 10.
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`(Ex. 1007, 6:41-43, Fig. 2). The frangible liquid containing capsule 11 is
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`located inside cylinder 10 near sponge 12. Capsule 11 is filled with povidone
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`iodine and isopropyl alcohol (a known antiseptic, bactericidal and virucidal
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`solution). (Ex. 1007, 6:44-49, Fig. 2). External liquid injection port 19 has
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`septum 18 made of resealable rubber material. (Ex. 1007, 6:53-58, Fig. 2).
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`Screw threads 17 are on the exterior of port 19 which mate with screw threads
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`15 on the interior of cover 10 so that port 19 may be screwed into cover 10
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`(like a bolt into a nut). (Ex. 1007, 6:53-58, Fig. 2).
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`32. As the cap 10 is screwed over the port 19 the O-ring creates a seal on the open
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`end of the cap to create a liquid tight enclosure that will ultimately contain the
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`antiseptic solution. (Ex. 1007, 6:59-61). Further tightening of the threads
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`ruptures the container 11 holding the antiseptic solution, which is then soaked
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`up by the sponge 12. (Ex. 1007, 6:61-66, Fig. 2). Since the wet sponge is in
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`direct contact with the port (due to the threading advancement of the port into
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`the cap), antiseptic liquid flows to the rubber membrane and bathes the port
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`in an antiseptic, bactericidal and virucidal solution. (Ex. 1007, 6:67-7:3). The
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`port cover needs no maintenance while applied which results in a decreased
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`risk of contamination and infection and longer life of the injection port itself.
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`(Ex. 1007, Abstract). Menyhay also states, “[t]he present invention can be
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`used not only to cover but also to aseptically cleanse the surface of an injection
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`port simply by being firmly attached thereto.” (Ex. 1007, 7:4-6).
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`Genatempo
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`33. As part of my work in this proceeding, I was asked to review U.S. Patent No.
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`4,440,207 to Genatempo et al. (“Genatempo”) (Ex. 1006).
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`34. Genatempo describes an antibacterial/antimicrobial cap for providing a non-
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`contaminated environment to house a patient connection valve, medical port
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`opening or connector, such as those used in peritoneal dialysis. (Ex. 1006,
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`Abstract, 1:6-14, 1:64-67, claim 1, claim 7). Genatempo’s cap can also be
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`used with other medical connectors which would benefit from an antiseptic
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`engagement. (Ex. 1006, 2:4-7, 2:19-20). The cap creates a desirous
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`environment in the interior of the cap and around the exterior of the connector
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`by incorporating a liquid antiseptic into an absorbent material which lines a
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`portion of interior of the cap and which comes into direct contact with the
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`connector. (Ex. 1006, 1:59-2:15, Abstract, claim 11).
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`35. A secure liquid tight connection of the cap to the connector is achieved by the
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`use of a threaded engagement of complementary threaded portions on the
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`inside surface of the cap and on the outside surface of the connector. (Ex.
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`1006, 2:21-27, claim 3). Additionally, certain features may be added to the
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`cap cavity to prevent over advancement of the connector into the cap,
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`potentially reducing the risk of damaging the threads. (Ex. 1007, 3:47-51).
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`The connector exterior and threaded portions are coated by the liquid
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`antiseptic when connected through (1) direct contact with the liquid infused
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`absorbent, (2) by migration of the liquid from the absorbent materials to the
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`exterior surfaces of the connector, or (3) by both methods. (Ex. 1006, 1:59-
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`63, 3:40-45).
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`36. The antiseptic solution of Genatempo is pre-positioned within the cap where
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`it is impregnated into the absorbent material. (Ex. 1006, 2:36-38). The
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`protective cap interior is secured and isolated from the outside environment
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`through the sealing of the cap cavity by a removable, peelable water vapor
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`19
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`BAXTER EXHIBIT 1002
`Page 19 of 58
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`barrier lid. (Ex. 1006, 2:63-66, 3:1-3). This lid ensures an acceptable shelf
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`life by keeping the volatile antiseptic solution, such as povidone iodine, from
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`evaporating and further ensures external contaminates do not interfere with
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`the solution. (Ex. 1006, 3:1-5). The cap housing is made from a non-porous
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`thermoplastic which may be injection moldable. (Ex. 1006, 3:19-22, claim
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`10). The cap may be configured to include interior ribs which can be welded
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`to the absorbent material. (Ex. 1006, 3:16-19, claim 2). Additionally, the cap
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`may include exterior gripping fins to allow the user to securely hold the device
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`while assembling the cap to the valve/connector. (Ex. 1006, 2:58-61). The
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`absorbent material may be a plastic made of a polyether-based polyurethane
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`material or similar material, known plastics suitable for manufacture in the
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`medical device field. (Ex. 1006, claim 8).
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`Raad
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`37. As part of my work in this proceeding, I was asked to review U.S. Patent
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`Publication No. 2005/00013836 to Raad (“Raad”) (Ex. 1016).
`
`38. Raad states that it discloses a way of reducing microbial organisms from
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`indwelling medical devices (like dialysis catheters), medical equipment and
`
`other surfaces. (Ex. 1016, ¶3). Raad discloses the use of solutions that
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`comprise alcohol and an antimicrobial agent in accomplishing this goal. (Ex.
`
`1016, Abstract). Raad further discloses “methods for reducing microbial
`
`
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`20
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`BAXTER EXHIBIT 1002
`Page 20 of 58
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`organisms from a surface comprising: a) obtaining an antimicrobial solution
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`of the invention as set forth above; and b) contacting the surface with the
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`antimicrobial solution, whereby said contacting reduces microbial organisms
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`from the surface.” (Ex. 1016, ¶39). Contact time can be as little as 15 minutes
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`or less and up to 4 hours or less. (Ex. 1016, ¶40).
`
`39. The solution of Raad may be applied to a surface, “wherein the surface is the
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`surface of a medical device, indwelling catheter, organic surface or inorganic
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`surface.” (Ex. 1016, claim 26). Additionally, Raad discloses many uses of
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`its solution, including cleaning of a generic catheter, a hemodialysis catheter,
`
`a urinary catheter, and a peritoneal catheter, all of which are specific devices
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`which may rely upon a needless connector cap. Numerous other types of
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`surfaces encountered in a healthcare setting are also listed. (Ex. 1016, claim
`
`27).
`
`Miyahara
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`40. As part of my work in this proceeding, I was asked to review U.S. Patent
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`Publication No. 2004/0111078 to Miyahara (“Miyahara”) (Ex. 1009).
`
`41. Miyahara describes a medical fluids connector system for making sterile
`
`connections. (Ex. 1009, Cover). Miyahara discloses a male type connector
`
`having a tube connecting portion at a rear end. (Ex. 1009, ¶36). Further, the
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`system includes a female type connector that mates with the male type
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`
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`21
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`BAXTER EXHIBIT 1002
`Page 21 of 58
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`connector. (Ex. 1009, ¶36). Miyahara also discloses a protective cap for the
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`patient side connector (a connector that is on a tubing connected to a catheter
`
`that is placed in the patient for up to a half year). (Ex. 1009, ¶36, Abstract).
`
`When used in a peritoneal dialysis system the male type connector may be on
`
`the patient side and the female connector is on the side connected to the
`
`dialysis circuit. (Ex. 1009, ¶¶12-13)
`
`42. The protective cap has a substantially cylindrical shape with a closed first end.
`
`(Ex. 1009, ¶¶12-13). The cap is capable of connecting and disconnecting
`
`with/from a male type connector. (Ex. 1009, ¶¶12-13). Within this protective
`
`cap is an inner cap 3 that includes a ring-shaped element that supports a
`
`sponge like disinfectant-impregnated member that participates in ensuring the
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`system makes sterile connections. (Ex. 1009, ¶¶12-13, 35). The disinfectant
`
`can be Isodine (brand name of povidone-iodine) or a similar bactericidal
`
`solution. (Ex. 1009, ¶42).
`
`43. During use of the system described by Miyahara, inner cap 3 with the
`
`disinfectant is automatically transferred from the male connector to the female
`
`connector at appropriate times to place the disinfectant at the most strategic
`
`location to provide a sterile connection. (Ex. 1009, ¶¶36-37). The design of
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`the system also allows for a new fresh disinfectant inner cap to be
`
`
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`22
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`BAXTER EXHIBIT 1002
`Page 22 of 58
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`automatically added whenever a new connection is made or broken. (Ex.
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`1009, ¶¶13).
`
`44. The mechanical interface between the male and female connector includes
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`numerous features that, when combined with manual insertion and rotation of
`
`the connectors, automate the transfer of the inner cap from location to
`
`location. (Ex. 1009, ¶¶55-57). Molded-in guide grooves and guide
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`protrusions, snap fits, channels, blocking surfaces combined with user actions
`
`such as axial motions and component rotations cause the guide protrusion to
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`slide along the guide groove 13, “so that the male type connector is pulled into
`
`an inside of the protective cap by a driving force resulting from a screw action
`
`by the inclined portion of the guide groove....” (Ex. 1009, ¶¶16). When this
`
`occurs, blocking features limit further rotation “of the male type connector, so
`
`that a force in the axis direction acts on the inner cap so as to separate the
`
`inner cap from the male type connector, resulting in the release of the
`
`engagement between the inner cap and the male type connector, and the inner
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`cap assumes a state of being retained by the inner cap retaining portion of the
`
`outer cylinder.” (Ex. 1009, ¶¶17).
`
`Connell
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`45. As part of my work in this proceeding, I was asked to review U.S. Patent
`
`Publication No. 2003/0153865 to Connell et al. (“Connell”) (Ex. 1010).
`
`
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`23
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`BAXTER EXHIBIT 1002
`Page 23 of 58
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`46. Connell describes a connector and a cap incorporating a disinfectant for
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`medical connections, such as in Peritoneal Dialysis (PD), that need to be
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`performed in a sterile or aseptic fashion. (Ex. 1010, ¶¶14-15, Fig. 2).
`
`Connell’s system can also be used with infusion therapy, or any medical fluid
`
`transfer activity that needs to be germ free. The disinfectant is contained
`
`within the cap such that it is safe and easy for the patient to use. (Ex. 1010,
`
`¶66). Connell includes a cap 12 and a connector 10 that may be made of
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`medical grade plastics. (Ex. 1010, ¶¶14-15, 68, Fig. 2).
`
`
`
`47. Additionally, some components may be made of compliant materials such as
`
`elastomeric rubber, silicon rubber and synthetic elastomers. In some cases,
`
`the rigid plastic components are instead made of medical grade metals such
`
`as stainless steel or aluminum. (Ex. 1010, ¶¶68-69). A cavity or void space
`24
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`BAXTER EXHIBIT 1002
`Page 24 of 58
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`16 is created within the cap/body to contain a liquid disinfectant which is
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`securely maintained within the space by an elastomeric seal 18 compressed
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`within the void space. (Ex. 1010, ¶¶71-72, Fig. 1A). The seal may also be
`
`impregnated with a disinfectant to add an additional level of disinfection to
`
`the process. (Ex. 1010, ¶¶71-72).
`
`
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`48. Seal 18 may be secured in place by an adhesive or by heat sealing in place.
`
`(Ex. 1010, ¶74). An alternative seal consists of a thin puncturable/frangible
`
`film 18 that is sealed about the cavity 16 to contain the liquid antiseptic. (Ex.
`
`1010, ¶74). This membrane/film is torn or otherwise breached by actions
`
`taken by the patient when using the device (e.g., screwing the pieces together
`
`as set forth below), releasing the disinfectant to flow to other portions of the
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`cap. (Ex. 1010, ¶74).
`
`49. The disinfectant of Connell can be any type of solution capable of
`
`substantially sterilizing upon direct contact the plastic, rubber or metal
`
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`25
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`BAXTER EXHIBIT 1002
`Page 25 of 58
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`components. (Ex. 1010, ¶76). One such disinfectant is povidone iodine; other
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`suitable alternatives include iodine-containing antimicrobials and betadine
`
`(i.e., the brand name of povidone-iodine), and may include any disinfectant
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`know to a POSA. (Ex. 1010, ¶76). In some cases, these materials may be
`
`sterilized by irradiation, autoclave or ethylene oxide gas. (Ex. 1010, ¶76).
`
`50.
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`Internal and external threads allow two separate members of the invention to
`
`move along the central axis of the body 14 inward and outward relative to the
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`body 14 of cap 12. (Ex. 1010, ¶77). Various thread geometries are employed
`
`to control and limit relative motion. (Ex. 1010, ¶78).
`
`51. A tip protector 42 that covers body 14 and shell 36 is applied at the factory
`
`and serves multiple functions. (Ex. 1010, ¶78, Fig. 2). It acts as a microbial
`
`barrier keeping bacteria and other harmful airborne contaminants from
`
`coming into the body 14 of the cap 10 prior to use. (Ex. 1010, ¶¶87-88, Fig.
`
`2). The tip p
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