IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`PERMA PURE L.L.C., Petitioner
`
`v.
`
`MASIMO CORP., Patent Owner
`
`DECLARATION OF ZANE N. FRUND, PH.D., MBA
`IN SUPPORT OF PETITION FOR INTER PARTES REVIEW OF
`
`U.S. Patent No. 9,861,298
`Inter Partes Review No. [Not Yet Assigned]
`
`1
`
`Perma Pure 1002
`
`

`

`I.
`
`Introduction
`
`I, Dr. Zane Frund, declare as follows:
`
`1.
`
`I have been retained by Perma Pure, L.L.C. in connection with the above-captioned
`
`Inter Partes Review (IPR) proceeding.
`
`2.
`
`I understand that this proceeding involves U.S. Pat. No. 9,861,298 (“the ‘298
`
`patent”) titled “Gas Sampling Line” by Eckerbom, et al., and more particularly, claims 1-2 and
`
`8-13 of the ‘298 patent.
`
`3.
`
`I have been asked to provide my opinions and conclusions regarding whether or not
`
`the claims at issue are invalid as obvious over certain prior art.
`
`II. Qualifications
`
`4. Among the several formal degrees I hold, are MS and PhD degrees in
`
`Chemical/Materials Engineering from the University of Pittsburgh, and a Masters in Business
`
`Administration from The Pennsylvania State University.
`
`5.
`
`For approximately the past 35+ years, I have been involved in the selection,
`
`development, testing, specification and processing of polymeric materials ─ having the
`
`appropriate permeability/permeation resistance, chemical resistance properties, and physical
`
`properties ─ for a variety of applications.
`
`6.
`
`I have also been involved extensively in the design and development of respiratory
`
`masks, gas monitoring equipment, and related devices and apparatus. Some of the products,
`
`the development of which I have participated in or supervised, include air supplying respirators
`
`in the forms of Self-Contained Breathing Apparatus for Fire Fighters, Breathing Apparatus for
`
`the US Navy, as well as the development and use of devices for the detection of oxygen, carbon
`
`
`
`2
`
`

`

`monoxide and dioxide.
`
`7.
`
` Additionally, I hold patents on protective breathing apparatus and protective
`
`clothing with the appropriate permeation/permeation to gases and vapors, as listed on my CV,
`
`attached as Exhibit A hereto.
`
`8.
`
`In addition, for nearly 20 years, I have taught courses in areas such as Materials and
`
`Polymer Science, Selection and Specification of Materials for use in Biomedical Devices, Fluid
`Dynamics (with mass transport of gases and liquids), and product design and engineering.
`
`9. My work on this case is being billed at my customary rate for consulting, of
`
`$380/hour through the TASA Group, with reimbursement for actual expenses. My
`
`compensation is not contingent on the outcome of this Inter Partes Review.
`
`III. Materials Considered
`
`10. To prepare this Declaration, I have reviewed and am familiar with the following
`
`references:
`
`a. U.S. Pat. No. 9,861,298 to Eckerbom, et al. titled “Gas Sampling Line.” It is my
`understanding that this patent, which is the subject of this Inter Partes Review, is provided as
`Ex. 1001 to this proceeding.
`
`b. U.S. Pat. No. 5,042,500 to Norlein et al. (“Norlien”), titled “Drying Sample Line.”
`It is my understanding that Norlien is prior art to the ‘298 patent and is provided as Ex. 1003 to
`this proceeding.
`
`c. “Flue Gas Dehydration Using Polymer Membranes” to Sijbesma H. et al.
`(“Sijbesma”). It is my understanding that Sijbesma is prior art to the ‘298 patent and is provided
`as Ex. 1004 to this proceeding.
`
`d. “PG Pub 2005/0171496 to Guldfeldt et al. (“Guldfeldt”). It is my understanding
`that Guldfeldt is prior art to the ‘298 patent and is provided as Ex. 1005 to this proceeding.
`
`
`
`3
`
`

`

`e. U.S. Pat. No. 8,053,030 to Gilman (“Gilman”). It is my understanding that Gilman
`is prior art to the ‘298 patent and is provided as Ex. 1006 to this proceeding.
`
`“Pervaporation, a novel technique for the measurement of vapor transmission
`f.
`rate of highly permeable films” to Nguyen Q. T. et al. (Nguyen). It is my understanding that
`Nguyen is prior art to the ‘298 patent and is provided as Ex. 1007 to this proceeding.
`
`g. PG Pub US 2009/0088656 to Levitsky et al. (Levitsky). It is my understanding
`that Levitsky is prior art to the ‘298 patent and is provided as Ex. 1008 to this proceeding.
`
`h. Prosecution History of the ‘298 Patent. It is my understanding that the
`prosecution history of the ‘298 patent is provided as Ex. 1009 to this proceeding.
`
`“Development of crosslinked poly(ether-block-amide) membrane for CO2/CH4
`i.
`separation” to Sridhar S. et al. (“Sridar”). Sridar was referenced in the prosecution history of
`the ‘298 patent. It is my understanding that Sridar is prior art to the ‘298 patent and is provided
`as Ex. 1016 to this proceeding.
`
`“Gas Transport Properties of Poly(ether-b-amide) Segmented Block
`j.
`Copolymers” to Bondar V. I., et al. (“Bondar”). Journal of Polymer Science, Polymer Physics,
`Part B, June 2000, pp. 2051-2062. Bondar was referenced in the prosecution history of the ‘298
`patent. It is my understanding that Bondar is prior art to the ‘298 patent and is provided as Ex.
`to this proceeding.
`
`k. “Encyclopedia of Polymer Science and Technology”, Vol. 6, Mark H., (1967),
`Interscience Publishers, pp. 466-467.
`
`“Mass Transfer,” Sherwood T. K., et al., Chemical Engineering Series, McGraw-
`l.
`Hill, (1975), Chapter 2 (Molecular Diffusion) and Chapter 3 (Rate Equations for Molecular
`Diffusion), pp. 8-89.
`
`m. “Diffusion in Polymers,” Crank J., et al. Academic Press, London and New York,
`Fourth Printing (1981), Chapter 2 (Simple Gases), pp. 41-73.
`
`n. “Chapter 1 Gas and Liquid Separations Using Membranes: An Overview,
`Advanced Materials for Membrane Separation,” Freeman B. D., et al., ACS Symposium
`Series, American Chemical Society, Washington DC, (2004), pp 1-23.
`
`
`
`4
`
`

`

`o. “Carbon dioxide permeability of proton exchange membranes for fuel cells,”
`Ma S. et al., Solid State Ionics, 176 (2005), pp. 2923-2927.
`
`p. “PEBAX® 1074/polyethylene glycol blend thin film composite membranes
`for CO2 separation: Performance with mixed gases,” Car A. et al., Separation and
`Purification Technology, 62 (January, 2008), pp. 110-117.
`
`q. “New High Performance Water Vapor Membranes to Improve Fuel Cell
`Balance of Plant Efficiency and Lower Costs (SBIR Phase I),” Wagener E. H., et al., DOE
`Hydrogen and Fuel Cells Program, FY 2012 Annual Progress Report, pp. 270-271.
`
`“Gas Permeation Properties of Polyvinylchloride/Polyethyleneglycol Blend
`r.
`Membranes,” Sadeghi M., et al., Journal of Applied Polymer Science, July, 2018, pp. 1093-
`1098.
`
`I have also reviewed the Petition and exhibits accompanying this IPR, the reasoning and
`
`conclusions of which with which I agree.
`
`IV. Applicable Legal Standards
`
`A. My Understanding of Claim Construction
`
`11.
`
`I understand that during an Inter Partes Review, claims of patent are to be construed
`
`under the same standard as in district court litigation. It is my understanding that the claims,
`
`specification, and file history are relevant to interpreting claim language under this standard.
`
`12.
`
`I have been advised that initially, I should assume the terms in a claim have their
`
`ordinary and customary meaning, as they would be interpreted by a person of ordinary skill in
`
`the art (“POSITA”) at the time of the invention, which I take to be on or about September, 2008.
`
`13. Having reviewed the claims at issue, I did not find any claim terms where I believed
`
`there could be reasonable differences about definitions, much less differences that might affect
`
`my analysis of such claims with respect to the prior art. Instead, it appears to me that all of the
`
`terms in the claims at issue have well understood and well defined meanings to a POSITA.
`5
`
`
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`

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`B. My Understanding of Obviousness
`
`14.
`
`I understand that a patent claim is invalid if the claimed invention would have been
`
`obvious to a POSITA at the time the application was filed (or, possible slightly before if it was
`
`invented before filing.). This means that even if all of the requirements of the claim cannot be
`
`found in a single prior art reference that would anticipate the claim, the claim can still be invalid.
`
`15. As part of this inquiry, I have been asked to consider the level of ordinary skill in the
`
`field that someone would have had at the time the claimed invention was made. In deciding the
`
`level of ordinary skill, I considered many factors, such as, but not limited to, the levels of
`
`education and experience of persons working in the field; the types of problems encountered in
`
`the field; and the sophistication of the technology.
`
`16.
`
`I believe that a person of ordinary skill in the art to which the ‘298 patent pertains
`
`would have at least Bachelor of Science degree in an engineering discipline, most appropriately
`
`chemical engineering or mechanical engineering, or the equivalent knowledge gained through
`
`employment or other type of degree, and 3-5 years of experience in the field.
`
`17. Based upon my experience I have a thorough understanding of the capabilities of
`
`such a POSITA, and in fact, have worked over the past several years with many personnel that
`
`would qualify as a POSITA, and continue to work with many such personnel today.
`
`C. Remaining Obviousness Concepts
`
`18.
`
`I understand that for a combination of prior art to render a patent obvious, the prior
`
`art references, when combined, must contain each and every element of the claimed invention in
`
`the same arrangement and configuration as claimed, and that there must be a motivation to
`
`combine the references to arrive at the claimed invention. I also understand that hindsight ─
`
`
`
`6
`
`

`

`constructing the invention from the references using the claimed invention as a map ─ is
`
`impermissible, and I have thus not used hindsight.
`
`19.
`
`I understand that certain objective indicia can be important evidence regarding
`
`whether a patent is obvious or nonobvious. Such indicia include: (1) commercial success of
`
`products covered by the patent claims; (2) a long-felt need for the invention; (3) failed attempts
`
`by others to make the invention; (4) copying of the invention by others in the field; (5)
`
`unexpected results achieved by the invention as compared to the closest prior art; (6) praise of
`
`the invention by others in the field; (7) the taking of licenses under the patent by others; (8)
`
`expressions of surprise by experts and those skilled in the art at the making of the invention; and
`
`(9) evidence that the patentee proceeded contrary to the accepted wisdom of the industry.
`
`20. After considering the foregoing, it is my opinion that the subject matter of claims 1-2,
`
`and 8-13 of the ‘298 patent would have been obvious to a POSITA as of the September 15, 2008
`
`filing date of the ‘298 patent, and even in the year or two leading up to that filing.
`
`V. The Prior Art and What it Teaches
`
`21. Norlien discloses an apparatus for drying a gas, such as the respiratory gas exhaled
`
`from patient, and for conducting the gas to a gas analyzer. The analyzer measures the CO2 and
`
`O2 content of the gas, among other gases. That analysis provides information about the condition
`
`of the patient. Norlien teaches that the apparatus must not change the composition of the sample
`
`gas, but for ensuring that by the time the sample reaches the gas analyzer, it is largely free of
`
`moisture. (Ex. 1003, 1:13-25).
`
`22. Norlien discloses that the drying sample line includes a patient interface adapter (14),
`
`a drying sample tube (12), and coupler (16).
`
`
`
`7
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`

`

`23. At the respiratory gas inlet end of the apparatus, patient interface adapter (14) couples
`
`drying sample tube (12) to a patient’s mouthpiece, mask, etc. At the respiratory-gas-outlet end of
`
`the apparatus, sample tube (12) couples to coupler (16), which couples the sample tube to gas
`
`analyzer (10). (Ex. 1003, 2:26-30).
`
`24. Norlien teaches that that the drying sample tube should be made of NAFION™
`
`because NAFION™ exhibits high permeability to water vapor, such that the water vapor in the
`
`exhaled gas stream will be removed from the gas stream before it reaches the gas analyzer at the
`
`other end of the drying tube. (Ex. 1003, 1:43).
`
`25.
`
`Sijbesma discloses the use of polymer membranes to remove water vapor from a
`
`gas stream. This reference considered the use of two materials ─ SPEEK (sulfonated poly(ether
`
`ether ketone)) and PEBAX® 1074 ─ because both of these materials were known to have very
`
`high water-vapor permeability and very low inert-gas flux. (Ex. 1004, Abstract and p. 264; see
`
`also, Fig. 2) Both of the materials were prepared as films and as tubular membranes structures.
`
`(p. 266).
`
`26. SPEEK is derived from the sulfonation of PEEK (Polyether Ether Ketone). To
`
`accomplish this sulfonation, PEEK resin must be dissolved into concentrated H2SO4, and
`
`subsequently dried under vacuum. Afterwards, the sulfonated resin must be redissolved in an
`
`alcohol such as methanol, cast or formed to its desired physical configuration. In 2008, PEEK
`
`resin was priced at $41-45/pound. (Ex. 13, p. 3). Subsequent processing, in order to sulfonate and
`
`convert it into a usable physical form, would increase its cost by approximately 50 to 100% thereby
`
`resulting in a cost of approximately $60-90/pound. PEBAX® 1074 was priced at approximately
`
`
`
`8
`
`

`

`$12 per pound (Ex. 26)1, making SPEEK many times more expensive. NAFION™ was priced at
`
`many times that amount, up to nearly $1400 pound. (See, e.g.; Ex. 25, p. 525, first paragraph).
`
`
`
`VI. The ‘298 Patent Claims at Issue
`
`27. The ‘298 patent discloses and claims a “gas sampling line” ─ just like Norlien ─ for
`
`conducting exhaled respiratory gases from a patient to a gas analyzer. Like Norlien, the ‘298
`
`discloses that the gas sampling line must remove water vapor from the respiratory gas sample
`
`prior to it reaching the gas analyzer. (Ex. 1001, 1:1-33).
`
`28. Rather than constructing the sample tube from NAFION™, the ‘298 patent discloses
`
`that the sample tube should be made of a polyether block amide material comprising polyether
`
`segments and polyamide segments in a ratio of polyether to polyamide from about 60:40 to about
`
`40:60, wherein the polyether segments comprise polyethyleneoxide. This same limitation
`
`appears in claims 1 and 8, which are the two independent claims in the ‘298 patent.
`
`29. The particular species of polyether block amide disclosed as being illustrative of the
`
`invention (see, Ex. 1001, Table 1, composition of “Tube no. 1” at 7:6-15) included 55%
`
`polyethyleneoxide and 45% polyamide 12. This material was (and still is) widely commercially
`
`available under the tradename PEBAX® 1074 from Arkema Inc. (Ex. 1011).
`
`
`
`VII. The Differences Between the Challenged Claims and the Prior Art
`
`30. With respect to claim 1 of the ‘298 patent, the gas sampling line comprises: a patient
`
`respiratory interface, which is what Norlien calls a patient interface adapter (14); a gas monitor
`
`
`1 From my conversations with personnel involved in the industry, I understand the price shown at
`Ex. 26 is actually higher than the price of was back in 2008.
`9
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`

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`connector, which is what Norlien calls a coupler (16); and a gas sampling tube adapted to
`
`conduct respiratory gases, which is what Norlien calls a drying sample tube (12).
`
`31. Hence, the first three elements of claim 1 appear to be explicitly and clearly disclosed
`
`in Norlien, in the same arrangement as in the claim.
`
`32. The fourth element of claim 1 of the ‘298 patent differs from Norlien. Specifically,
`
`the fourth element of claim 1 discloses that the sample tube is made from “a polyether block
`
`amide material comprising polyether segments and polyamide segments in a ratio of polyether to
`
`polyamide from about 60:40 to about 40:60, wherein the polyether segments comprise
`
`polyethyleneoxide,” (i.e.; a material of which PEBAX® 1074 is an example). Norlien, however,
`
`does not teach a sample tube made from such material, but instead, teaches that the sample tube
`
`is made from a different polymeric hydrophilic material; namely, NAFION™. NAFION™ was
`
`one of the most expensive such materials available at the time for medical use.
`
`33. A POSITA looking for a less costly alternative to NAFION™ out of which to make
`
`Norlien’s sampling tube would have been motivated to look for other, less expensive medical
`
`grade polymers that could dry a gas stream, and would have found that Sijbesma taught a far less
`
`expensive alternative than NAFION™.
`
`34. Sijbesma discloses the use of polymer membranes for the specific purpose of
`
`removing water vapor from a gas stream. This reference considered the use of two materials ─
`
`SPEEK (sulfonated poly(ether ether ketone)) and PEBAX® 1074 ─ because both of these
`
`materials were known to have very high water-vapor permeability and very low inert-gas flux,
`
`where the inert gas was, inter alia, CO2. (Ex. 1003, Abstract and pp. 263-264; see also, Fig. 2;
`
`Introduction, and Section 4.4 listing inert gases).
`
`
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`1
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`

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`35. Both of the materials were prepared as films and as well as tubular structures. (p.
`
`266). Further, medical grade tubing made from PEBAX® 1074 was well known in the art. (Ex.
`
`1006, generally and at 4:17-49). I have been unable to locate anything indicating medical grade
`
`SPEEK was available in 2008 at all.
`
`36. While both NAFION™ and PEBAX® 1074 were functional equivalents ─ both were
`
`well known for use to remove water vapor from a gas stream ─ PEBAX® 1074 was significantly
`
`less expensive, often selling for a small fraction of the price of NAFION™. (Ex. 1013).
`
`37. A POSITA looking for an economical alternative to NAFION™, and with Sijbesma’s
`
`two options before him or her, would have selected PEBAX® 1074 over SPEEK for further
`
`evaluation for use as a respiratory tube in the arrangement of Norlien, because, as explained above,
`
`a typical SPEEK respiratory tube would have cost many times the price of a PEBAX® 1074
`
`respiratory tube. Further, I have not found anything indicating that SPEEK was even commercially
`
`available in medical grade form in the 2007-2008 time frame.
`
`38. Thus, a POSITA looking for an economical alternative to NAFION™, and with
`
`Sijbesma’s two options before him or her, would have selected PEBAX® 1074 over SPEEK for
`
`further evaluation for use as a respiratory tube in the arrangement of Norlien.
`
`39. The substitution of PEBAX® 1074 for NAFION™ would have been essentially a
`
`trivial matter and indeed, medical grade tubing made out of PEBAX® 1074 was already widely
`
`known in the prior art. (Exs. 1004, see also, Ex. 1006, generally, and at 4:16-45, teaching tubular
`
`medical grade catheters made from PEBAX® 1074; Ex. 1005, generally, and ¶81, Table 1).
`
`
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`1
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`40. What’s more, PEBAX® 1074 was known to be used in both medical applications and
`
`in industrial applications such as that described in Sijbesma. (Exs. 1003; 1004 (Table 1); 1006,
`
`generally, and at 4:17-44; 1017, p. 2, top paragraph).
`
`41. Finally, the permeability values given in Ex. 1004 (Sijbesma, Table 6, p. 270), and
`
`Ex. 1015(Ma, p. 2925, Fig. 2) when converted to common units, indicate that PEBAX® 1074 had
`
`lower permeability to CO2 (122 Barrer) than would NAFION™ (257 or 130 Barrer, at 100% and
`
`50% relative humidity, respectively.).
`
`42. Hence, a POSITA would have found the substitution a simple matter of using a lower
`
`cost and functionally equivalent materiel to do exactly what it was designed and known to do –
`
`remove moisture from a gas stream.
`
`43.
`
`I have also been advised of the arguments made in the file history, and more
`
`particularly, in the patentee’s appeal brief. (Ex. 1022). I have reviewed this appeal brief as
`
`well.
`
`44. One issue that arose during prosecution and appeal pertained to patentee’s argument
`
`that all PEBAX® 1074 films were known to be highly permeable to CO2. Patentee argued that
`
`since CO2 is one of the gases being monitored, PEBAX® 1074 would not have been an
`
`acceptable material for use in a gas sampling line for conducting respiratory gases, and that its
`
`successful use in Patentee’s gas sampling line was an unexpected result.
`
`45. The Examiner argued that Sridar (Ex. 1016) teaches that CO2 permeance depends on
`
`the grade of PEBAX® 1074, and that by increasing the cross-linking of a compositionally “in-
`
`range” grade of PEBAX® 1074 (grade 1657), its permeability to CO2 would decrease.
`
`
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`1
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`46. According to the patentee, this cross-linking step would reduce the ability of
`
`PEBAX® 1074 to remove moisture from the gas stream, and thus, would render the Norlien tube
`
`inoperable for its intended purpose of drying the gas stream. (Ex. 1022, pp. 8-9).
`
`47. This argument makes no sense to me – the entire cross linking argument is a red
`
`herring, because no cross linking would be required, necessary, or even contemplated to begin
`
`with and there would be no reason or purpose to do so.
`
`48. Specifically, NAFION™, like PEBAX® 1074, is also somewhat permeable to CO2.
`
`Indeed, the prior art had recognized that relatively significant amounts of CO2 would permeate
`
`through NAFION™. (See Ma et al., Ex. 1015, generally, and specifically at 2924-2925 and Fig.
`
`2).
`
`49. However, this fact did not discourage the prior art from turning to NAFION™ for
`
`respiratory tubes, and it would not have discouraged the use of PEBAX® 1074 for the same
`
`reasons.
`
`50. More specifically, it was well known in the art, and Ma itself explains, that the
`
`permeability of NAFION™ to CO2 depends upon a variety of factors, such as thickness of the
`
`membrane to be used, humidity, flow rates, and a number of other factors. (Ex. 1015, generally,
`
`and p. 2925).
`
`51. Indeed, the amount of CO2 absorbed by a sampling tube made of either
`
`NAFION™ or PEBAX® 1074 depends heavily upon the parameters of the sampling tube
`
`and its environment, such as temperature, and, significantly, the thickness of the membrane.
`
`The prior art specifically recognized that NAFION™ was permeable to CO2, but that
`
`permeation is “almost solely dependent on membrane hydration and thickness” (emphasis
`
`
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`1
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`

`added) (Ex. 1015, p. 2926, left col.), so much so that its CO2 permeability could vary by
`
`multiple orders of magnitude. (Ex. 1015, Conclusion section).
`
`52. A POSITA interested in a less costly material for the sampling tube of Norlien, and
`
`seeing that PEBAX® 1074 could dry a gas stream and was thus functionally equivalent to the
`
`NAFION™, would immediately go to the usual, customary next step that any designer of
`
`any such system would do.
`
`53. Specifically, the POSITA would be well aware that the design of any particular
`
`apparatus out of any material would involve using well known equations based upon the
`
`particular requirements of any system to determine the proper parameters for the system design.
`
`This is no different than a bridge builder using mechanical equations to figure out how long and
`
`thick the steel should be for a given load and length of bridge, or an aircraft manufacturer using
`
`equations to figure out how thick the aluminum should be to manufacture the aircraft to ensure it
`
`is safe.
`
`54. Thus, having identified PEBAX® 1074 as a lower cost material for drying gas, the
`
`designer attempting to design a respiratory tube that passes CO2 while removing moisture
`
`would then use well known basic equations to design the respiratory tube, in exactly the
`
`same manner, whether the tube was to be made from NAFION™, PEBAX® 1074, or any other
`
`hydrophilic material.
`
`55. At Ex. B to my report here, I have performed these calculations for both NAFION™
`
`PEBAX® 1074 and for using parameters of what the ‘298 patent describes at col. 7 as “well
`
`known” gas sampling tubes of the day. (Ex. 1001, 7:1-40). I have also used certain
`
`parameters, such as flow rates, that are typical in a respiratory tube application, and my
`
`calculations thus represent essentially the very same design process that would be followed by
`1
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`

`the POSITA, whether he or she selected NAFION™, PEBAX® 1074, or any other material for
`
`the respiratory tube. That is, the calculations represent what a POSITA would immediately do
`
`once identifying PEBAX® 1074 as a potential lower cost replacement for NAFION™.
`
`56. As some of these parameters (e.g.; Permeability Coefficient for NAFION™,
`
`thickness of standard respiratory tubes) vary slightly across available sources, I have performed
`
`the calculations across the range, or, where appropriate, used an average value.
`
`57. My calculations show that depending upon which of the several accepted values for
`
`the parameters and environment of respiratory tubes is used, the POSITA contemplating making
`
`a Norlien type respiratory tube from PEBAX® 1074 would have found that PEBAX® 1074 was
`
`an excellent lower cost substitute for NAFION™.
`
`58. Specifically, if PEBAX® 1074 were substituted for the NAFION™ of Norlien, the
`
`resulting respiratory tube would have equivalent or even less CO2 permeation than the one
`
`composed of NAFION™. (Ex. B).
`
`59.
`
`In the case where certain parameters (e.g. gas flow rate, tube length, wall thickness)
`
`are assumed to have other typical values that tend to diminish the performance of PEBAX® 1074
`
`more than that of NAFION™, my calculations show that the PEBAX® 1074 might in fact be
`
`subject to higher CO2 permeability. However, in these scenarios, my calculations indicate that
`
`the PEBAX® 1074 would absorb about 0.004-0.005 percent more CO2 than NAFION™, yet the
`
`accuracy of typical gas meters of the day was approximately 5% (Ex. 1014, p.2, right column) -
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`meaning the difference in CO2 absorbed between the two materials would be approximately
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`three orders of magnitude below the detection threshold of the gas meter.
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`60.
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`In short, the idea that cross linking would make a material such as PEBAX® 1074
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`inoperable to remove moisture is a red herring because no POSITA would suggest cross linking.
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`Instead, a POSITA would see a less expensive material, available in tubular form and known to
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`remove moisture from a gas stream, and, just as the case for NAFION™, go through the typical
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`design process to design the respiratory tube from PEBAX® 1074. The POSITA would then
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`immediately see that the normal, usual design process yielded a PEBAX® 1074 tube that
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`performed just as well, if not better, than NAFION™, but would be significantly less costly.
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`61. The POSITA would then adopt the design using the PEBAX® 1074 – cross-linking
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`would never arise.
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`62. By way of example, I note that Table 8 of Sijbesma shows permeability for values
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`PEBAX® 1074, but notes the PEBAX® 1074 membrane being used is 5 micrometers thick.
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`Typical widely available respiratory tubes at time the ‘298 patent was filed, according the ‘298
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`patent itself, had a thickness of approximately 0.75 millimeters (Ex. 1001, 7:1-40). That is, the
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`respiratory tubes would be approximately one hundred fifty times thicker than the membranes of
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`Sijbesma. This fact alone would reduce the amount of CO2 permeating into the tube wall by a
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`factor of 150.
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`63.
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`In fact, if the mere fact that a very thin membrane, many times if not orders of
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`magnitude thinner than a respiratory tube and used in an environment with different humidity,
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`flow rates, etc., might leak too much CO2 would discourage the use of PEBAX® 1074 in a
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`respiratory tube, then it would have identically discouraged the use of NAFION™, because
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`NAFION™ also, under many different conditions, leaks significant CO2 – even more than
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`PEBAX® 1074. (Ex. 1015, p. 2925; Ex. B hereto).
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`64. Even if a POSITA did not perform the normal design process, and simply, upon
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`identifying a less costly material, just tried using it, that POSITA would have seen that the new
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`respiratory tube performed just as well or better than the old one, and hence, would not need to
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`engage in any cross linking. This trial and error process is frequently utilized in the design of
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`systems, and is called the Edisonion process.
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`65.
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`Indeed, this is exactly what Sijbesma did. When process simulations indicated the
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`importance, in the application being studied, for a “membrane material with very high water
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`vapor permeabilities combined with very low inert gas [e.g.; CO2] fluxes,” Sijbesma turned to
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`PEBAX® 1074 and another material as options.
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`66. A POSITA faced with Norlien and looking a lower cost alternative to NAFION™
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`would have done the exact same thing, and would have found the PEBAX® 1074 to be an
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`excellent substitute.
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`67. The fact that Sijbesma ultimately found that a layer of PEBAX® 1074 that was a few
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`micrometers thick (Ex. 1004, p. 266, Section 4.2), and used at Sijbesma’s conditions of air flow,
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`humidity, etc., might allow too much CO2 to traverse the membrane for his application does not
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`change the result. Instead, when a POSITA did the same thing as Sijbesma, and identified
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`PEBAX® 1074 as a water absorbing alternative out of which to make the Norlien tube, the
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`POSITA would have found PEBAX® 1074 was an excellent, lower cost substitute for
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`NAFIONTM performing as well or better. (Ex. B hereto).
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`68. This is because the flow rates, etc. in the respiratory tube environment are different,
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`and the thickness of a respiratory tube is two orders of magnitude greater than in Sijbesma’s
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`application. Thus, when a POSITA tried PEBAX® 1074 in a respiratory tube, he would have
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`found it to be an excellent, lower cost alternative, equivalent to, or better than, NAFIONTM in its
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`ability to pass the CO2 while removing moisture from the gas stream.
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`69.
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`In short, regarding the last element of claim 1 requiring that the “CO2 component,”
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`largely pass the tube “without being absorbed,” whether PEBAX® 1074 or NAFION™ were used
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`makes absolutely no difference. Neither material would be perfect, either material would absorb
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`some small amount of CO2, that amount would be negligible in both cases, the PEBAX® 1074
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`would perform either better than, or essentially the same as, the NAFION™ and either would
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`result in the same “accurate reading at the gas monitor” as the claims specify. (Ex. B hereto).
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`Thus, the two materials are in fact functionally equivalent for respiratory tubes.
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`70. Hence, if a POSITA found PEBAX® 1074 less costly, there would be no reason not to
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`substitute it into the Norlien arrangement.
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`71. The notion that a POSITA would not use PEBAX® 1074 because it is too permeable
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`to CO2 is like saying that a POSITA in the aerospace engineering field would never make an
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`airplane out of aluminum, because the prior art household aluminum foil was known to bend and
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`tear easily. Of course, the designer would have to account, for example, for the thickness of the
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`aluminum used, number of layers, etc., – thereby resulting in aluminum being widely used in
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`modern day aircraft.
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`72.
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`I understand another argument was made by the patentee in its appeal – the
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`supposedly surprising result that PEBAX® 1074 would absorb not only water vapor, but liquid
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`water. (Ex. 1021, p 8).
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`73. The claims say nothing about this, so it would appear to have little relevance to the
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`matter. However, this property was anything but surprising, as the prior art was well aware that
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`PEBAX® 1074 was highly absorbent of liquid water. (Ex. 1006, 4:16-44).
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`74. The difference between claims 2, 12, 13 (all dependent on claim 1) and Norlien is,
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`like claim 1, simply the material from which the sample tube is made. More particularly, claims
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`2 and 12 recite that the polyamide segments is selected from at least polyamide 12. Claim 13
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`narrows the acceptable range for the amount of polyamide from 40-60 to 40-50 of the polyether
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`block amide. Once again, a polymer satisfying the limitations of claims 2, 12, and 13 is
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`PEBAX® 1074. Thus, the same combination of the same two references would meet the
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`limitations of all of these claims.
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`75.
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`Independent claim 8 is a method claim that recites conducting respiratory gases
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`through a tube comprised of a polyether block amide having the same composition as recited in
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`claim1, and also includes the limitation pertaining to preserving CO2. Like claims 1, 2, 12, and
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`13, the only difference between claim 8, and the prior art as represented by Norlien, is