UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`C.R. Bard, Inc.
`Petitioner
`v.
`Medline Industries, Inc.
`Patent Owner
`______________
`Patent No. 9,745,088
`Title: Catheter Tray, Packaging System, Instruction Insert, and Associated
`Methods
`______________
`
`DECLARATION OF RICHARD MEYST
`
`Medline Industries, Inc.
`Ex. 2001
`Page 1 of 42
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`C.R. Bard, Inc.
`Petitioner
`v.
`Medline Industries, Inc.
`Patent Owner
`______________
`Patent No. 9,745,088
`Title: Catheter Tray, Packaging System, Instruction Insert, and Associated
`Methods
`______________
`
`DECLARATION OF RICHARD MEYST
`
`Medline Industries, Inc.
`Ex. 2001
`Page 1 of 42
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`
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`1.
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`2.
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`I, Richard Meyst, declare as follows:
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`I have personal knowledge of the facts stated in this declaration, and
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`could and would testify to these facts under oath if called upon to do so.
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`I.
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`INTRODUCTION AND QUALIFICATIONS
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`3.
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`I have been retained by counsel for Patent Owner Medline Industries,
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`Inc. (“Medline”) as an expert witness in the analysis of U.S. Patent No. 9,745,088
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`(“the ʼ088 patent”).
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`4.
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`I am being compensated for my time in this case at a rate of $425 per
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`hour (plus expenses) for my review of materials and preparation of this declaration.
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`My compensation in this matter is not determined by or contingent on the outcome
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`of this case.
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`5.
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`I am willing to testify at the hearing set by the Board regarding the
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`contents of this declaration if asked to do so.
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`6.
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`I reserve the right to supplement my opinions, as well as the bases for
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`my opinions, expressed herein in light of additional materials, including other
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`evidence that may be provided to me after submission of this declaration.
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`7. My qualifications for forming the opinions set forth in this declaration
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`are summarized here and explained in more detail in my curriculum vitae, which is
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`attached as part of Exhibit A.
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`1
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`Medline Industries, Inc.
`Ex. 2001
`Page 2 of 42
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`8.
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`I have experience in the advanced design and development of a wide
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`range of successful medical technology products for the health care industry over
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`the last 40+ years. This includes extensive knowledge in product design and
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`development, product prototyping, production startup, manufacturing engineering,
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`risk analysis, strategic planning, grant preparation, and market research.
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`9.
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`I have held various engineering, development, operations and
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`management positions at CR Bard, Fenwal Division of Baxter, IMED, and other
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`healthcare and consumer product companies. For the last 25+ years, I have been an
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`owner of Fallbrook Engineering, a medical technology design and development
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`firm. Since 2003, I have been the President and Chief Executive Officer.
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`10. My product experience includes product and packaging design and
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`verification/validation including development of implantable vascular prostheses,
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`DNA amplifiers, vital signs monitoring devices, IV drug infusion pumps and
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`administration sets, medical lasers, surgical instruments, diagnostic and therapeutic
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`catheters, microprocessor based diagnostic and therapeutic instruments, blood cell
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`collection and processing, filtration devices for blood and intravenous solutions, as
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`well as stem-cell harvesting and cell expansion systems.
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`11.
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`I have been a Principal Investigator on multiple National Institute of
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`Health Small Business Innovation Research grants from the National Heart, Lung
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`and Blood Institute developing a device for the improved collection of umbilical
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`2
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`Ex. 2001
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`cord blood stem cells. 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 member
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`of the American Association of Blood Banks, the Association for the Advancement
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`of Medical Instrumentation, and the American Filtration Society. I am also a
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`member of the Medical Device Steering Committee of BIOCOM, an organization
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`focused on medical devices and life sciences. I have been a juror in the
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`UBM/Cannon Medical Design Excellence Awards competition.
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`12.
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`I received my Bachelor’s and Master’s degrees in Mechanical
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`Engineering from the University of Wisconsin, Madison. I have been awarded
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`sixteen United States patents (two of which are for a medical device thermoform
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`package), have multiple applications pending, and have been an invited speaker,
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`presenting talks at numerous scientific and medical industry meetings.
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`II.
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`PERSON HAVING ORDINARY SKILL IN THE ART (“POSITA”)
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`13.
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`In determining who would be a person of ordinary skill, I considered at
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`least the following criteria: (a) the type of problems encountered in the art; (b) prior
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`art solutions to those problems; (c) the rapidity with which innovations are made;
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`(d) the sophistication of the technology; and (e) the education level of active workers
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`in the field.
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`14.
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`In my opinion, a person of ordinary skill in the art (“POSITA”) would
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`be a person with at least a Bachelor of Science degree in Engineering, plus a
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`3
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`minimum of 2 years of experience working in the field of designing catheters,
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`catheter packaging or related medical packaging. In the alternative, the POSITA
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`would have a bachelor’s degree in an alternative field and about three years’
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`experience working in the field of designing catheters, catheter packaging or related
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`medical packaging. A POSITA would not need to be a health care practitioner that
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`would perform catheterization procedures or use the claimed products (i.e.,
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`catheterization trays), but would have learned about the procedures from those
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`skilled in catheterization procedures (e.g., a nurse).
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`III. LEGAL PRINCIPLES USED IN THE ANALYSIS
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`15.
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`I am not a patent attorney, nor have I independently researched the law
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`on patent validity. Attorneys for the Patent Owner explained certain legal principles
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`to me that I have relied upon in forming my opinions set forth in this report.
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`A.
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`Prior Art
`
`16.
`
`I understand that the law provides categories of information that
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`constitute prior art that may be used to anticipate or render obvious patent claims.
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`To be prior art to a particular patent under the relevant law, a reference must have
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`been made, known, used, published, or patented, or be the subject of a patent
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`application by another, before the priority date of the patent. I also understand that
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`the POSITA is presumed to have knowledge of the relevant prior art.
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`4
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`17.
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`I understand that the Petitioner has assumed that the various claims of
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`the ’088 patent are entitled to a June 30, 2009 priority date.
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`B.
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`Broadest Reasonable Interpretations
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`18.
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`I understand that, in Inter Partes Review, the claim terms are to be
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`given their broadest reasonable interpretation (BRI) in light of the specification. See
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`37 C.F.R. § 42.100(b). In performing my analysis and rendering my opinions, I have
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`interpreted claim terms for which I have not been provided a construction by giving
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`them the ordinary meaning they would have to a POSITA, reading the ’088 patent
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`with its earliest priority filing date (June 30, 2009) in mind, and in light of its
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`specification and file history.
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`C. Legal Standards for Obviousness
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`19.
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`I have been provided the following instructions from the Federal Circuit
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`Bar Association Model Instructions regarding obviousness, which is reproduced in
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`part below. I apply this understanding in my analysis, with the caveat that I have
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`been informed that the Patent Office will find a patent claim invalid in Inter Partes
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`Review if it concludes that it is more likely than not that the claim is invalid (i.e., a
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`preponderance of the evidence standard), which is a lower burden of proof than the
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`“clear and convincing” standard that is applied in United States district court (and
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`described in the jury instruction below):
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`4.3c OBVIOUSNESS
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`5
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`Medline Industries, Inc.
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`Even though an invention may not have been identically
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`disclosed or described before it was made by an inventor,
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`in order to be patentable, the invention must also not have
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`been obvious to a person of ordinary skill in the field of
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`technology of the patent at the time the invention was
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`made.
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`[Alleged infringer] may establish that a patent claim is
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`invalid by showing, by clear and convincing evidence, that
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`the claimed invention would have been obvious to persons
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`having ordinary skill in the art at the time the invention
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`was made in the field of [insert the field of the invention].
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`In determining whether a claimed invention is obvious,
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`you must consider the level of ordinary skill in the field
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`[of the invention] that someone would have had at the time
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`the [invention was made] or [patent was filed], the scope
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`and content of the prior art, and any differences between
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`the prior art and the claimed invention.
`
`Keep in mind that the existence of each and every element
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`of the claimed invention in the prior art does not
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`necessarily prove obviousness. Most, if not all, inventions
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`rely on building blocks of prior art. In considering whether
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`a claimed invention is obvious, you may but are not
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`required to find obviousness if you find that at the time of
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`the claimed invention [or the patent’s filing date] there was
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`a reason that would have prompted a person having
`
`ordinary skill in the field of [the invention] to combine the
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`known elements in a way the claimed invention does,
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`taking into account such factors as (1) whether the claimed
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`invention was merely the predictable result of using prior
`
`art elements according to their known function(s);
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`(2) whether the claimed invention provides an obvious
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`solution to a known problem in the relevant field;
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`(3) whether
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`the prior art
`
`teaches or suggests
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`the
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`desirability of combining elements claimed in the
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`invention; (4) whether the prior art teaches away from
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`combining elements in the claimed invention; (5) whether
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`it would have been obvious to try the combinations of
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`elements, such as when there is a design need or market
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`pressure to solve a problem and there are a finite number
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`of identified, predictable solutions; and (6) whether the
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`change resulted more from design incentives or other
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`market forces. To find it rendered the invention obvious,
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`you must find that the prior art provided a reasonable
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`expectation of success. Obvious to try is not sufficient in
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`unpredictable technologies.
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`In determining whether the claimed invention was
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`obvious, consider each claim separately. Do not use
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`hindsight, i.e., consider only what was known at the time
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`of the invention [or the patent’s filing date].
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`In making these assessments, you should take into account
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`any objective evidence (sometimes called “secondary
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`considerations”) that may shed light on the obviousness or
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`not of the claimed invention, such as:
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`(a) Whether the invention was commercially successful as
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`a result of the merits of the claimed invention (rather than
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`the result of design needs or market-pressure advertising
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`or similar activities);
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`(b) Whether the invention satisfied a long-felt need;
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`(c) Whether others had tried and failed to make the
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`invention;
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`(d) Whether others invented the invention at roughly the
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`same time;
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`(e) Whether others copied the invention;
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`(f) Whether there were changes or related technologies or
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`market needs contemporaneous with the invention;
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`(g) Whether the invention achieved unexpected results;
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`(h) Whether others in the field praised the invention;
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`(i) Whether persons having ordinary skill in the art of the
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`invention expressed surprise or disbelief regarding the
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`invention;
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`(j) Whether others sought or obtained rights to the patent
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`from the patent holder; and
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`(k) Whether the inventor proceeded contrary to accepted
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`wisdom in the field.
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`Federal Circuit Bar Association Model Jury Instructions §4.3c (2014).
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`20.
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`I am also informed that the United States Patent Office supplies its
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`examining corps with a Manual of Patent Examining Procedure that provides
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`exemplary rationales that may support a conclusion of obviousness, including:
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`(a) Combining prior art elements according to known
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`methods to yield predictable results;
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`(b) Simple substitution of one known element for another
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`to obtain predictable results;
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`(c) Use of known technique to improve similar devices
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`(methods, or products) in the same way;
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`(d) Applying a known technique to a known device
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`(method, or product) ready for improvement to yield
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`predictable results;
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`(e) “Obvious to try” – choosing from a finite number of
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`identified, predictable solutions, with a reasonable
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`expectation of success;
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`(f) Known work in one field of endeavor may prompt
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`variations of it for use in either the same field or a different
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`one based on design incentives or other market forces if
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`the variations are predictable to one of ordinary skill in the
`
`art; or
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`(g) Some teaching, suggestion, or motivation in the prior
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`art that would have led one of ordinary skill to modify the
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`prior art reference or to combine prior art reference
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`teachings to arrive at the claimed invention.
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`MPEP § 2143. I apply these principles in my analysis below.
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`10
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`Medline Industries, Inc.
`Ex. 2001
`Page 11 of 42
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`IV. RELEVANT TECHNOLOGY BACKGROUND
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`21. The ’088 patent, entitled “Catheter Tray, Packaging System, Instruction
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`Insert, and Associated Methods,” discloses and claims a medical kit comprising a
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`tray with multiple compartments wherein one compartment holds multiple syringes
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`and a second compartment holds a medical assembly such as a catheter assembly.
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`The claimed inventions also include outer packaging around the medical kit for
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`shipment purposes. The ’088 patent further discloses a variety of embodiments,
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`including (but not always requiring) a single-layer tray, a specific order of placing
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`and displaying the syringes within the tray based on their order of use, staggered
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`heights of the compartments within the tray, and/or a specific placement and use
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`(within the tray’s second compartment) of a coiled tubing for use with a Foley
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`catheter. At a most basic level, the claimed inventions are a single-layer tray with
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`multiple compartments for specific medical tools.
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`22. These medical trays covered by the ’088 patent—which Medline
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`markets under the trade name “ERASE CAUTI”—are primarily intended as storage
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`containers for medical devices, specifically for long, flexible medical tools such as
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`catheters. The inventions claimed in the ’088 patent significantly increase the
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`efficiency and health of the use of catheters in medical facilities.
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`11
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`Page 12 of 42
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`A.
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`Problems With Medical Trays Before The ’088 Patent
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`23. Before Medline invented the tray claimed in the ’088 patent, several
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`problems persisted with the then-existing medical trays. One such problem occurred
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`during the shipment of flexible medical tools like catheters. During shipment,
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`storage, and unpacking, catheters were prone to damage due to their soft and flexible
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`nature. This soft and flexible nature creates the real risk that the catheter will get
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`bent, kinked, or otherwise damaged before it is used, thus resulting in the inability
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`to use it (if the damage is discovered) or creating significant complications during
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`its use (if the damage is not discovered in time).
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`24. Another major issue with trays before Medline’s inventions claimed in
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`the ’088 patent were Catheter-Associated Urinary Tract Infections (“CAUTI”).
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`CAUTIs arose when the sterility of the catheter was compromised before it was
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`inserted into the patient.
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`25. The catheter’s sterility was often compromised because of inefficient
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`and ineffective surgical trays that housed the catheter and other related medical
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`devices and supplies. Trays used before Medline’s invention were all dual-layered,
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`where the catheter and drainage bag were located in the tray’s base (lower level) and
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`the patient preparation components (e.g. syringes) were located in the upper level.
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`As a result, the practitioner was required to remove the tray’s upper layer to reach
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`the catheter in the lower layer. Due to the sterile field’s minimal space, the
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`practitioner was thus often forced to place one of the tray’s layers outside the sterile
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`area. Consequently, the catheter’s sterility was compromised and the risk of a
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`CAUTI greatly increased.
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`26. Despite these issues, clinicians and practitioners continued using the
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`same processes, practices, and tools, including dual-layered trays.
`
`B. The Improvements of the ’088 Patent’s Inventions On The Previous
`Technology
`
`27. The ’088 patent’s inventions remedied the problem with shipping,
`
`
`
`storing, and unpacking medical tools like catheters. The ’088 patent’s inventions
`
`provide a stable and protective packaging at an efficient size and shape for shipping.
`
`28. The ’088 patent’s inventions remedied the problems creating the
`
`increased risk of CAUTIs because Medline’s inventions now allow use of a single-
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`layer tray which holds the catheter and other requisite devices (e.g. syringes).
`
`Because Medline’s tray is only one layer, there is no longer the need to remove an
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`upper layer to reach the lower layer (where the catheter was previously located),
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`such as in Serany (Ex.1006). Thus, the entire tray, and all the requisite devices,
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`remain in the sterile field. Moreover, Medline’s single-layer tray allows the
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`practitioner to view all of the tray’s contents at once.
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`29. Furthermore, because the ’088 patent’s inventions come with step-by-
`
`step educational instructions, and because the ’088 patent’s tray can be organized in
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`a specific manner based on the order of use of each of the devices in the tray, the
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`catheterization procedure is simplified. Such simplification further decreases the risk
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`of issues arising from the procedure.
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`V. ADDRESSING THE SIMILARITIES AND MATERIAL DIFFERENCES BETWEEN
`THE ASSERTED ART AND THE PRIOR ART INVOLVED DURING EXAMINATION
`30. Medline’s patent portfolio (“Medline Portfolio”) is vast. As an
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`example, Petitioner’s Exhibit 1017 depicts a family tree listing all of the patents and
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`publications related to the ’088 patent. I have reviewed the most relevant prior art
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`references asserted during prosecution in the Medline Portfolio, focusing on those
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`with disclosures mirroring the challenged claims in the ’088 patent for IPR2019-
`
`00035 and IPR2019-00036, as well as the prior art asserted against the challenged
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`claims in these IPRs. My analysis of these prior art references is below. From this,
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`it is clear that the Patent Office has thoroughly considered prior art references similar
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`to those asserted here in both IPRs.
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`31. Rauschenberger (Ex.1013): It is my opinion that the tray disclosed
`
`in Rauschenberger functions in substantially the same manner as the tray in Solazzo.
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`Both trays store the catheterization components. For example, Rauschenberger
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`discloses that the “catheterization implements are placed in [the] tray” (col. 2, ll. 15-
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`16). Solazzo likewise discloses that the tray holds catheterization components,
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`including a syringe, catheter, surgical gloves, and lubricant fluid (col. 4, ll. 41-45).
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`Furthermore, both Rauschenberger’s and Solazzo’s tray function to hold lubricant
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`in a well so that the catheter can be slid into the well/lubricant in order to
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`lubricate/prepare the catheter for bodily insertion. For example, Rauschenberger
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`discloses that the catheter is rotated within the tray to spread lubricant over it (col.
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`2, ll. 31-33). Similarly, Solazzo states that the tray can contain “catheter lubricating
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`wells” which hold lubricant, which is applied to the catheter when the catheter is slid
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`into the wells (col. 4, ll. 21-25). Unlike Solazzo, however, Rauschenberger discloses
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`a “drainage bag” that collects urine from the catheter. Ex. 1013, 2:55-56.
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`32. Misra (Ex.2006): It is my opinion that Misra and Solazzo disclose
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`similar limitations. Both disclose a tray with multiple compartments that can hold
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`syringes and a catheter. For example, Misra discloses that there are dividers in each
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`of two compartments (col. 5, ll. 46-50). Solazzo similarly discloses that the tray has
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`a “divider wall creating two separate compartments” (col. 2, ll. 61-63). Moreover,
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`Misra discloses that a compartment can hold “a number of small items such as
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`syringes” and separately a catheter. Ex.2006, 5:25-30, 5:51-53. Solazzo likewise
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`discloses that the tray can hold a syringe and a Foley catheter. Ex. 1005, 4:41-45.
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`Unlike Solazzo, however, Misra discloses catheter wires that are coiled (i.e., a coiled
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`medical device). Ex.2006, 5:25-30.
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`33. Busch (Ex.2007): It is also my opinion that Busch and Solazzo disclose
`
`similar limitations. Both Busch and Solazzo disclose a tray with multiple
`
`compartments. For example, Busch discloses that each item in the tray can “rest[] in
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`its respective compartment” in the tray (paragraph [0030]). Solazzo similarly
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`discloses that the tray has a “divider wall creating two separate compartments” (col.
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`2, ll. 61-63). Additionally, both Busch and Solazzo disclose a medical assembly
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`within the tray. Busch, for example, discloses a “prepared kit” that includes medical
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`utensils like syringes, anesthesia, and skin preparation solutions (paragraph 0032).
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`Solazzo discloses that the tray holds, inter alia, syringes and catheters (col. 4, ll. 41-
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`45).
`
`34. Bickelhaupt (Ex.2022): It is further my opinion that Bickelhaupt and
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`Solazzo disclose similar
`
`limitations. Both disclose a
`
`tray with multiple
`
`compartments, a catheter, and a syringe with inflation fluid. For example,
`
`Bickelhaupt discloses two compartments (col. 5, ll. 50-57). Solazzo similarly
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`discloses that the tray has a “divider wall creating two separate compartments” (col.
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`2, ll. 61-63). Furthermore, Bickelhaupt discloses a catheter contained in one of the
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`compartments (col. 5, ll. 57-59). Solazzo similarly discloses a catheter (col. 4, ll. 41-
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`45). As well, Bickelhaupt discloses a syringe “used for inflating the balloon” (col.
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`8, 16-18). Similarly, Solazzo discloses an “inflation syringe” (col. 4, ll. 41-45).
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`Unlike Solazzo, however, Bickelhaupt’s catheters are coiled and appear to be for
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`optical procedures as opposed to urological procedures.
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`Ex. 2001
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`VI. THE PRIOR ART DOES NOT RENDER THE CHALLENGED CLAIMS OBVIOUS
`35.
`I agree with the arguments set forth in the Patent Owner’s Preliminary
`
`Responses (“POPRs”) for IPR2019-00035 and IPR2019-00036. I provide additional
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`details regarding these arguments below. It should be noted that my opinions below
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`are applicable to both POPRs.
`
`A.
`
`It would not have been obvious to a POSITA to modify Solazzo to
`include the closed-system Foley catheter assembly described in
`Serany (and/or as further modified by Disston)
`
`36. As Patent Owner explains in both POPRs, Solazzo describes an
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`“ergonomic urological catheterization/irrigation tray.” This is, in fact, the title of
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`Solazzo’s patent. The tray is touted as having “a shape that will fit between the legs
`
`of a patient” and “has a contoured or terraced recess so as to create a tapered
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`wall/bottom arrangement,” which makes it “easier to rest atop upper leg areas when
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`the patient is seated.” Ex.1005, 1:7-13. The shape of the tray can be seen in the
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`figures from Solazzo reproduced below. (Figures 1, 2, 5 and 6 are respective top,
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`bottom, side and front views of Solazzo’s tray.)
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`37. As illustrated in these figures, the tray in Solazzo includes a flange 15
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`(highlighted purple) that “extends outwardly from opposing side walls 7 and 9 and
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`acts in part so that a patient may have flange 15 rest on front upper portions of the
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`patient’s legs when in a seated position.” Ex.1005, 3:66-4:3. Solazzo further
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`describes “folding wings” that can be folded or unfolded as necessary to provide
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`additional tray support during a catheterization procedure. Ex.1005, 2:52-60. For
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`example, during such a procedure, the wings can be unfolded “so as to be in a
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`substantially horizontal orientation and extending outwardly from the tray for
`
`resting on front upper positions of legs.” Ex.1005, 2:2:52-60.
`
`38.
`
`In order to comfortably fit between the patient’s legs, Solazzo discloses
`
`that the recessed portion 3 of its tray has a “generally trapezoidal footprint.” This
`
`trapezoidal recessed portion 3 is shown
`
`in orange
`
`in Figure 3 at
`
`right.
`
`Specifically, the back 13 of the tray “has
`
`a width that is significantly less than the
`
`width of the front 5.” Ex.1005, 3:58-66.
`
`As also shown in Figures 3, 5 and 6, the
`
`back end 13 of the tray recess starts out
`
`shallow and narrow, and then expands in both dimensions so that at the other end of
`
`the tray the recessed area is at its deepest and widest.
`
`39. Solazzo explains the benefits of this configuration and sizing with
`
`respect to male catheterization procedures:
`
`“A patient requiring an urological procedure may be positioned with tray 1 at
`back 13 below the scrotum and penis with flange 15 preventing the back
`portion of tray 1 from sliding or dropping downwardly between the patient’s
`legs by resting the front upper portions of the legs while support wings 21 and
`23 will perform a similar function for the front portion of the tray.”
`
`Ex.1005, 4:26-33.
`
`19
`
`Medline Industries, Inc.
`Ex. 2001
`Page 20 of 42
`
`
`
`40. This passage – and the others before it – clearly indicate that the tray in
`
`Solazzo is intended to be fully engaged with the patient’s upper leg area and genitals
`
`during the catheterization procedure. And, it is clear that the only way to comfortably
`
`(for the patient) achieve that full engagement is through proper sizing and selective
`
`contouring.
`
`41.
`
`In stark contrast to the tray disclosed in Solazzo, Serany discloses a
`
`catheter tray that is disposed above a larger box 10 containing a closed-system Foley
`
`catheter assembly, which includes a Foley catheter
`
`48, drainage tubing 49 and a drainage bottle 46.
`
`Ex.1006, 3:23-44. This assembly is illustrated at
`
`right. See Ex.1006, FIG. 6. As shown, even in its
`
`collapsed position, the closed-system catheter
`
`assembly consumes most of the box 10 due to the
`
`protruding tubing and the dimension of the drainage bottle 46. The box 10 and the
`
`tray 12 share substantially the same width and length dimensions, which allow the
`
`tray 12 to sit atop the box and fully cover its contents. See e.g., Ex.1006, FIG. 5
`
`(shown below). But, in order to accommodate the closed-system Foley catheter
`
`assembly, the box 10 in Serany is much deeper than that of the tray 12.
`
`
`
`
`20
`
`Medline Industries, Inc.
`Ex. 2001
`Page 21 of 42
`
`
`
`
`
`
`42.
`
`In certain Grounds of the POPRs, Petitioner proposes replacing the
`
`drainage bottle 46 in Serany with the
`
`drainage bag 10 disclosed in Disston. The
`
`tray 2 in Disston contains the drainage
`
`bag 10 but, as shown in Figure 1
`
`(excerpted and reproduced at right), the
`
`bag 10 has a substantially rectangular
`
`shape and the tray 2 is similarly shaped in order to accommodate this bag 10.
`
`43. None of the closed-system Foley catheter assemblies asserted by
`
`Petitioner have a shape or size that could easily be accommodated by Solazzo’s
`
`contoured / ergonomically designed
`
`tray. Neither assembly would fit into
`
`the trapezoidal shaped recess 3
`
`where Solazzo’s catheter 120 is
`
`illustrated as being stored. See
`
`Ex.1005, FIG. 8 (reproduced at left).
`
`It is therefore my opinion that, if
`
`Solazzo is modified to include either
`
`21
`
`Medline Industries, Inc.
`Ex. 2001
`Page 22 of 42
`
`
`
`of the closed-system Foley catheter assemblies described in Serany and/or Disston,
`
`then Solazzo’s tray would need to be completely re-designed.
`
`44. For example, the back 13 end of the tray would need to be widened to
`
`accommodate the rectangular shaped bottle 48 / bag 10 of Serany and/or Disston.
`
`Furthermore, the front end 5 of the tray would also need to be widened to
`
`accommodate the dimensions of the bottle 48 / bag 10. Widening this back area 13
`
`would change the shape of the tray from trapezoidal to more rectangular in nature.
`
`Widening in this manner also means that the tray will no longer be able to be placed
`
`comfortably between a patient’s legs in the manner described by Solazzo. The
`
`previous v-shape tray matched the v-shape contours of the patient’s body defined
`
`when the patient’s legs are spread. This feature would no longer be present in the
`
`modified version of Solazzo and would significantly alter or altogether eliminate its
`
`ergonomic shape.
`
`45. Similarly, the recess 3 of Solazzo’s tray would need to be deeper to
`
`accommodate a closed-system Foley catheter assembly. If the shallow portions of
`
`the tray are deepened, then there becomes less of a contour or distinction between
`
`the once-shallow back end 13 and the deeper front end 5. Changing these particular
`
`dimensions changes (1) the ergonomic nature of the tray, and (2) the draining
`
`functionality.
`
`22
`
`Medline Industries, Inc.
`Ex. 2001
`Page 23 of 42
`
`
`
`46. Keeping the contouring but changing the overall depth of the recess 3
`
`presents another set of problems. For example, this modification to the recess 3 may
`
`result in Solazzo’s tray becoming too tall to fit – or comfortably fit – beneath the
`
`patient’s genitals as described in Solazzo. See Ex.1005, 4:26-33.
`
`47. With the above modifications required to accommodate a closed-
`
`system Foley catheter assembly, it is my opinion that Solazzo’s tray will no longer
`
`achieve its intended goal of being fully and comfortably engaged with the patient
`
`during catheterization. The ergonomic features touted in Solazzo would essentially
`
`be rendered useless. This significant re-design would undoubtedly deter a POSITA
`
`from attempting to incorporate a closed-system Foley catheter assembly into
`
`Solazzo’s tray, and would undoubtedly render Solazzo’s tray unsatisfactory for its
`
`intended purpose and would also change its principle of operation.
`
`48.
`
` It is also my opinion that the drainage features of Solazzo’s tray are of
`
`critical importance. Solazzo specifically provides a tray for an open system. Its Foley
`
`catheter 120 is indeed an open catheter,
`
`and not
`
`the closed-system Foley
`
`catheter assemblies described in Serany
`
`and Disston. Because of the open nature
`
`of Foley catheters, fluid is evacuated
`
`and must be captured and disposed of.
`
`23
`
`Medline Industries, Inc.
`Ex. 2001
`Page 24 of 42
`
`
`
`Solazzo’s tray allows for fluid to be captured in recess 3 and the drain 19 (highlighted
`
`purple) disposed at the deepest end of the tray allows the fluid to be emptied from
`
`the tray. Ex.1005, Title, 4:10-20. The contoured or “terraced” bottom 11 (highlighted
`
`blue and green) of Solazzo’s tray has dual functionality – i.e., to provide the
`
`ergonomic features previously described, and to enable rapid and efficient fluid
`
`drainage. The contoured/terraced bottom 11 and drain 19 in Solazzo are illustrated
`
`at right.
`
`49. As explained in the Preliminary Responses, the bottom 11 of the tray is
`
`terraced so that it includes a shallow end 11b (highlighted green) and a deep end 11a
`
`(highlighted blue). Ex.1005, FIG. 2, 3:61-66. And, naturally, the drain 19
`
`(highlighted purple) is disposed at the deep end of the tray so that fluid flows towards
`
`the drain 19. Ex.1005, 4:10-20. Solazzo explains that the Foley catheter “evacuate[s]
`
`the bladder of its contents, urine and/or clots” into the tray (Ex.1005, 4:26-33) and
`
`then the drain 19 further discards these fluids from the tray (Ex.1005, 4:10-20). In
`
`one embodiment of Solazzo, the drain 19 is part of a “drainage well” that receives
`
`overflow fluids from another section of the tray called an “irrigation well,” and then
`
`discards those overflow fluids from the tray. Ex.1005, 4:10-20, 5:13-15. This flow-
`
`over functionali
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