Paper 27
`Entered: August 6, 2014
`
`Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`PHARMATECH SOLUTIONS, INC.,
`Petitioner,
`
`v.
`
`LIFESCAN SCOTLAND LTD.,
`Patent Owner.
`_______________
`
`Case IPR2013-00247
`Patent 7,250,105 B1
`_______________
`
`
`Before SALLY C. MEDLEY, SCOTT E. KAMHOLZ, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`
`
`KAMHOLZ, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73(b)
`
`
`
`
`
`
`Case 3:14-cv-00274-RJC-DSC Document 19-2 Filed 09/17/14 Page 1 of 31
`
`
`Entered: August 6, 2014
`
`Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_______________
`
`PHARMATECH SOLUTIONS, INC.,
`Petitioner,
`
`v.
`
`LIFESCAN SCOTLAND LTD.,
`Patent Owner.
`_______________
`
`Case IPR2013-00247
`Patent 7,250,105 B1
`_______________
`
`
`Before SALLY C. MEDLEY, SCOTT E. KAMHOLZ, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`
`
`KAMHOLZ, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73(b)
`
`
`
`
`
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`IPR2013-00247
`Patent 7,250,105 B1
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`
`I.
`
`INTRODUCTION
`
`A. Background
`
`Pharmatech Solutions, Inc. (“Pharmatech”) filed a Petition (Paper 1,
`
`“Pet.”) to institute an inter partes review of claims 1-3 (the “challenged
`
`claims”) of U.S. Patent No. 7,250,105 B1 (Ex. 1002, “the ’105 patent”). We
`
`instituted trial for the challenged claims on the following grounds of
`
`unpatentability asserted by Pharmatech:
`
`References1
`Nankai and Schulman
`
`Basis Claims challenged
`§ 103
`1-3
`
`Winarta and Schulman
`
`§ 103
`
`1-3
`
`Decision to Institute 19 (Paper 11, “Dec.”).
`
`After institution of trial, LifeScan Scotland Ltd. (“LifeScan”) filed a
`
`Patent Owner Response (Paper 16, “Resp.”). Pharmatech filed a Reply
`
`(Paper 17, “Reply”). LifeScan did not file a motion to amend claims.
`
`Pharmatech relies upon a declaration of Joseph Wang, D.Sc.
`
`(Ex. 1024) in support of its Petition. LifeScan relies upon a declaration of
`
`John L. Smith, Ph.D. (Ex. 2008) in support of its Response.
`
`Oral argument was conducted on May 14, 2014. A transcript is
`
`entered as Paper 26 (“Tr.”).
`
`We have jurisdiction under 35 U.S.C. § 6(c). This final written
`
`decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`
`
`1 The references are: U.S. Patent No. 5,120,420 (Ex. 1003, “Nankai”), U.S.
`Patent No. 5,791,344 (Ex. 1007, “Schulman”), and U.S. Patent No.
`6,258,229 (Ex. 1005, “Winarta”).
`
` 2
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`Pharmatech has proved that claims 1-3 are unpatentable.
`
`B. The ’105 Patent
`
`The ’105 patent relates to monitoring the level of a substance in a
`
`liquid, particularly the level of glucose in blood. Ex. 1002, 1:7-10. A
`
`glucose assay is performed by inserting a test strip into a meter and then
`
`applying a drop of blood to the test strip. Id. at 5:14-25. The test strip is
`
`made from layers of various materials, built up on a plastic base and capped
`
`with a cover. Id. at 4:35-5:14. Figure 2 is reproduced below:
`
`
`
`Figure 2 illustrates one layer of the test strip, in which a pattern of carbon
`
`ink is screen-printed onto the test strip base. Id. at 4:23-24. The carbon ink
`
`forms three tracks 4, 6 (not labeled), and 8 (not labeled), along the strip, as
`
`well as a connecting bridge 10. Id. at 4:44-51. Each track has a connecting
`
`terminal 4a, 6a, 8a at one end of the strip and an electrode 4b, 6b, 8b at the
`
`other, distal, end. Id. A layer of glucose oxidase (“GOx”) is printed on the
`
`electrodes. Id. at 4:65-66. Various other layers are deposited to define the
`
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`rest of the structure, such as the precise sizes of the electrodes and a flow
`
`path for the blood. Id. at 4:54–5:14.
`
`A user begins a glucose measurement by inserting the terminal end of
`
`the test strip into a meter device; the connecting bridge completes a circuit
`
`upon insertion to turn on the device. Id. at 5:16-18. The device applies a
`
`voltage between the reference terminal 4a and terminal 6a, and also between
`
`the reference terminal 4a and terminal 8a. Id. at 5:19-22. A drop of blood is
`
`deposited at the distal end of the strip, and the blood is drawn by capillary
`
`action over electrode 4b for the reference sensor part and electrodes 6b and
`
`8b for the working sensor parts. Id. at 5:23-26. The blood thereby comes
`
`into contact with the GOx printed on the electrodes, and the GOx reacts with
`
`glucose in the blood to release electrons.
`
`The resulting electric currents through carbon tracks 4 and 6 are
`
`proportional to both the surface area of the electrode covered by GOx and
`
`the amount of glucose in the blood sample. Id. at 1:27-38. Because the
`
`GOx surface area is known, the electric current is indicative directly of the
`
`amount of glucose in the blood. Id. The currents are measured by the meter
`
`device after a predetermined time. Id. at 5:26-27. The current
`
`measurements are compared to one another, and if they differ by more than
`
`10%, an error message is displayed so that the user will know to repeat the
`
`test. Id. at 5:27-30. If they are within 10% of each other, the measured
`
`currents are summed and converted into a glucose level, which is then
`
`displayed. Id. at 5:30-33. Regarding arrangement of the sensor parts, the
`
`’105 patent discloses that it is “preferred that both working sensor parts are
`
`downstream of the reference sensor part.” Id. at 3:56-58.
`
`The challenged claims are reproduced below:
`
` 4
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`1. A method of measuring the concentration of
`a substance in a sample liquid comprising the steps
`of:
`providing a measuring device said device
`comprising:
`a first working sensor part for generating
`charge carriers
`in proportion
`to
`the
`concentration of said substance in the
`sample liquid;
`a second working sensor part downstream
`from said first working sensor part also
`for generating
`charge
`carriers
`in
`proportion to the concentration of said
`substance in the sample liquid wherein
`said first and second working sensor
`parts are arranged such that, in the
`absence of an error condition,
`the
`quantity of said charge carriers generated
`by said first working sensors part are
`substantially identical to the quantity of
`said charge carriers generated by said
`second working sensor part; and
`a reference sensor part upstream from said
`first and second working sensor parts
`which reference sensor part is a common
`reference for both the first and second
`working sensor parts, said reference
`sensor part and said first and second
`working sensor parts being arranged such
`that the sample liquid is constrained to
`flow substantially unidirectionally across
`said reference sensor part and said first
`and
`second working
`sensor parts;
`wherein said first and second working
`sensor parts and said reference sensor
`part are provided on a disposable test
`strip;
`
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`applying the sample liquid to said measuring
`device;
`measuring an electric current at each working
`sensor part proportional to the concentration
`of said substance in the sample liquid;
`comparing the electric current from each of the
`working
`sensor parts
`to establish a
`difference parameter; and
`giving an
`indication of an error
`difference parameter
`is greater
`predetermined threshold.
`
`if said
`than a
`
`
`
`in claim 1
`2. The method as claimed
`comprising measuring the current at each working
`sensor part after a predetermined time following
`application of the sample.
`
`
`3. The method as claimed in claim 1 wherein
`the substance to be measured is glucose, and each
`of the working sensor parts generates charge
`carriers in proportion to the concentration of
`glucose in the sample liquid.
`
`
`II. DISCUSSION
`
`A. Claim Construction
`
`In an inter partes review, claim terms in an unexpired patent are
`
`interpreted according to their broadest reasonable construction in light of the
`
`specification of the patent in which they appear. 37 C.F.R. § 42.100(b);
`
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48756, 48766 (Aug. 14,
`
`2012). Also, claim terms are given their ordinary and customary meaning,
`
`as would be understood by one of ordinary skill in the art in the context of
`
`the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257
`
` 6
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`(Fed. Cir. 2007). Any special definition for a claim term must be set forth in
`
`the specification with reasonable clarity, deliberateness, and precision. In re
`
`Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`
`
`
`We construed several claim terms as follows:
`
`1. “Proportion” and “proportional to” as “correlated to” (Dec. 8);
`
`2. “Downstream” as “further along a stream from its source” (id. at
`
`8-9); and
`
`3. “Substantially unidirectionally” as “along, or nearly along, one
`
`direction” (id. at 9).
`
`The parties do not contest these constructions (Tr. 4:9-12, 16:1-21),
`
`and we maintain them.
`
`B. Obviousness over Nankai and Schulman
`
`Pharmatech argues that claims 1-3 are unpatentable under
`
`35 U.S.C. § 103(a) over Nankai in combination with Schulman. Pet. 16-21.
`
`LifeScan responds, both arguing that Pharmatech has not demonstrated the
`
`obviousness of the claims (Resp. 17-21, 26-43), and presenting objective
`
`evidence of nonobviousness. Resp. 45-49.
`
`We undertake the four factual inquiries of an obviousness analysis:
`
`determining the scope and content of the prior art; ascertaining the
`
`differences between the prior art and the claims at issue; resolving the level
`
`of ordinary skill in the pertinent art; and assessing objective evidence of
`
`nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966).
`
`1. The level of skill in the pertinent art
`
`“The person of ordinary skill in the art is a hypothetical person who is
`
`presumed to know the relevant prior art.” In re GPAC Inc., 57 F.3d 1573,
`
` 7
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`1579 (Fed. Cir. 1995). This person is of ordinary creativity, not merely an
`
`automaton, and is capable of combining teachings of the prior art. KSR Int’l
`
`Co. v. Teleflex Inc., 550 U.S. 398, 420-21 (2007).
`
`LifeScan argues that one of ordinary skill in the relevant art is a
`
`person having a Bachelor’s degree in chemistry or electrical engineering, or
`
`an equivalent degree in a related field, such as physics or chemical
`
`engineering, and also having five years of experience working in the field of
`
`electrochemical glucose sensors. Resp. 13-14 (citing Ex. 2008 ¶ 13).
`
`Pharmatech does not dispute this proposed definition. The definition is
`
`reasonable, and we adopt it for purposes of this decision.
`
`2. Scope and content of the prior art
`
`a. Overview of Nankai
`
`Nankai describes disposable biosensors for measuring, e.g., glucose
`
`concentration in blood. Ex. 1003, 3:65-68. Figure 12 of Nankai is
`
`reproduced below:
`
`
`
` 8
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`Figure 12 shows a glucose sensor having base plate 1 on which is
`
`formed lead 3 and corresponding counter electrode 5, and leads 21, 22, and
`
`23, and corresponding measurement electrodes 41, 42, and 43. Id. at 8:5-10.
`
`Spacer 7 overlies the base plate, and space 8 cut out from the spacer
`
`provides a conduit for a blood sample to flow from introducing port 10 to
`
`the measurement and counter electrodes. Id. at Abstr., 8:15-18. Cover 9
`
`provides discharge ports 11, 12, and 13, through which air leaves space 8 as
`
`it is displaced by the flowing blood. The measurement electrodes are coated
`
`with GOx. Id. at 5:1, 8:11-14. During use, blood enters through the
`
`introducing port and flows along the main conduit of space 8, with portions
`
`of the sample entering successive branches along the main conduit. Id. at
`
`8:25-27. A current measurement is made at each sensor, and the
`
`measurements are averaged to give a final result. Id. at 8:42-46. The shape
`
`or arrangement of sensors may vary. Id. at 8:50-52.
`
`b. Overview of Schulman
`
`Schulman describes an implantable sensor used to monitor blood
`
`glucose continuously by GOx-mediated current measurements. Ex. 1007,
`
`3:17-28, 4:20-30, 7:35-37. Two or more sensors may be used to confirm the
`
`correctness of the measurement. Id. at 4:46-50. The readings from two
`
`sensors are compared, and if they are not within 10% of one another, the
`
`system requests sensor recalibration (id. at 11:16-22, 20:50-54), and issues
`
`an error message advising the user to check the sensors. Id. at 21:9-13.
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`3. Differences between the claimed subject matter and the
`prior art
`
`a. Petitioner’s Case-in-Chief
`
`Pharmatech argues that Nankai discloses all limitations of claim 1
`
`except (a) the position of the reference sensor part “upstream” of the first
`
`and second working sensor parts; (b) the step of comparing the electric
`
`current from each of the working sensor parts to establish a difference
`
`parameter; and (c) the step of giving an indication of an error if the
`
`difference parameter is greater than a predetermined threshold. Pet. 16-21.
`
`With regard to limitation (a), Pharmatech points to Nankai’s teaching
`
`that the arrangement of the sensors may vary. Id. at 16 (citing Ex. 1003,
`
`8:47-52). Pharmatech argues that the ’105 patent discloses that the sensors
`
`may be arranged “as convenient” and does not identify any benefit or
`
`unexpected result from the claimed arrangement. Id. (citing Ex. 1002,
`
`3:36-58). Pharmatech cites evidence, from the testimony of Dr. Wang, that
`
`a person of ordinary skill in the art would have known that there was a finite
`
`number of ways to arrange a reference sensor part in relation to a working
`
`sensor part and that repositioning the reference sensor part upstream from
`
`the working sensor parts, as opposed to downstream from the working
`
`sensor parts, would have been obvious to try. Id. at 16, 19 (citing
`
`Ex. 1024 ¶ 25).
`
`With regard to limitation (b), Pharmatech argues that Schulman
`
`discloses taking multiple measurements in order to identify errors and that
`
`modifying Nankai to include this step would have been nothing more than
`
`the application of a known technique to improve a similar device with
`
`predictable results. Id. at 16-17, 21; Ex. 1024 ¶¶ 27-28. With regard to
`
`
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`limitation (c), Pharmatech argues that Schulman discloses giving an error
`
`indication if the difference parameter exceeds a predetermined threshold.
`
`Pet. 17 (citing Ex. 1007, 3:17-28; Ex. 1024 ¶¶ 27-28); see also Reply 3
`
`(citing Ex. 1007, 21:32-36 (disclosing generating a signal only if sensor
`
`signals are within a prescribed amount of one another); id. at 22:20-23
`
`(disclosing generating an error message if they are not within the prescribed
`
`amount)).
`
`b. Patent Owner’s Response
`
`LifeScan presents several arguments in response to Pharmatech’s
`
`challenge. We address them in turn.
`
`(1) Position of Nankai’s reference sensor part
`relative to working sensor parts
`
`LifeScan argues that Nankai’s test strip provides a reference sensor
`
`part downstream of the working sensor parts, rather than upstream as
`
`claimed. Resp. 17. This is not in dispute. See Pet. 11:2-3; see also section
`
`II.B.2.a, supra (Nankai Fig. 12 showing that reference electrode 5 is
`
`downstream of working electrodes 41, 42, 43).
`
`(2) Criticality of positioning reference sensor part
`upstream
`
`LifeScan argues that it would not have been obvious to reposition
`
`Nankai’s reference sensor part to be upstream of the working sensor parts,
`
`because there is criticality in positioning the reference sensor part upstream.
`
`Resp. 17-18 (citing Ex. 2008 ¶ 43); Resp. 37 (citing Ex. 2008 ¶ 77).
`
`LifeScan argues that positioning the reference sensor part downstream of the
`
`working sensor parts, as Nankai does, would result in the reference sensor
`
`part being covered incompletely in the event an insufficient blood sample is
`
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`applied. Id. If the reference sensor part is covered incompletely, it will give
`
`an unreliable baseline potential, which would then cause measurements
`
`relative to the working sensor parts to be erroneous. Id. at 18. Nankai then
`
`would average those erroneous readings and not detect the error. Id. In
`
`contrast, if an inadequate sample is applied to a device in which the
`
`reference electrode is upstream, it will be instead one of the working
`
`electrodes that is covered incompletely. Ex. 2008 ¶ 38. That electrode will
`
`give a reading that differs significantly from the other working electrode. Id.
`
`If that difference exceeds the threshold, the error will be detected and an
`
`inaccurate measurement avoided. Id. LifeScan argues that Pharmatech’s
`
`expert, Dr. Wang, does not address this criticality in his testimony. Id. at 50.
`
`The criticality of a claimed feature may be demonstrated by showing
`
`that the specific feature claimed achieves unexpected results compared to the
`
`generic prior art. In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990)
`
`(addressing criticality of a claimed range within a broader prior-art range).
`
`Without such a showing, the advantage is no more than a new benefit of an
`
`old method, and cannot, by itself, render the method again patentable. Id.
`
`LifeScan’s argument is unpersuasive, because it does not explain how
`
`the advantage it identifies is an unexpected consequence of how the
`
`reference sensor part and the working sensor parts are positioned relative to
`
`one another. Whichever sensor part is furthest downstream is the one most
`
`likely to be covered incompletely when a sample of inadequate volume is
`
`applied. See Ex. 2008 ¶¶ 38, 43. LifeScan does not offer any credible
`
`evidence to suggest that it is unexpected that a downstream working sensor
`
`part, covered incompletely by the dregs of an inadequate sample, will report
`
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`a current measurement with a detectible discrepancy from the other, fully
`
`covered working sensor part.
`
`(3) Disclosure in Nankai of multiple measurements
`
`LifeScan argues that Nankai simply averages its multiple
`
`measurements, instead of comparing them to a difference parameter.
`
`Resp. 18-19 (citing Ex. 2008 ¶ 44); Resp. 37. LifeScan argues that Nankai’s
`
`blind averaging would give inaccurate results if one of more of Nankai’s
`
`working sensor parts were not completely filled with sample. Id. at 19.
`
`This argument is unpersuasive, because Pharmatech relies on
`
`Schulman, not Nankai, for disclosing the comparison of multiple
`
`measurements to a difference parameter. See Pet. 16-17, 21. Pharmatech
`
`argues that it would have been obvious to apply this comparison technique
`
`to measurements made using Nankai’s test strip. Id. How Nankai itself
`
`performs the comparison is irrelevant.
`
`(4) Adequate sample size
`
`LifeScan argues that Nankai fails to address the detection of an
`
`inadequately sized sample. Resp. 20-21 (citing Ex. 2008 ¶¶ 46-48).
`
`LifeScan argues that the ’105 patent is directed to avoiding the incomplete
`
`coverage problem by minimizing sample size. Id. at 21 (citing Ex. 1002,
`
`2:51-55). According to LifeScan, Nankai gives no consideration to this
`
`problem because it uses sample sizes so much larger than those disclosed in
`
`the ’105 patent (five microliters or more, compared to two microliters or
`
`less), that samples were guaranteed to cover all the electrodes fully. Id. at
`
`20-21. LifeScan acknowledges that the challenged claims do not place any
`
`limitations on the sample size, but argues that Nankai’s failure to appreciate
`
`the problem of inadequate sample size is evidence that one of ordinary skill
`
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`in the art, attempting to solve the problem the ’105 patent’s inventors
`
`confronted, would not have considered Nankai. Id. at 21 (citing Ex. 2008
`
`¶ 48).
`
`This argument is unpersuasive because, as LifeScan acknowledges,
`
`the claims do not limit the sample size, and LifeScan does not identify any
`
`other limitation in the claims to which the sample-size argument relates.
`
`Consequently, the claims encompass subject matter that this argument does
`
`not reach. See In re Lintner, 458 F.2d 1013, 1015 (CCPA 1972) (“Claims
`
`which are broad enough to read on obvious subject matter are unpatentable
`
`even though they also read on nonobvious subject matter.”); In re
`
`Muchmore, 433 F.2d 824, 826 (CCPA 1970) (affirming obviousness
`
`rejection where claim “reads on both obvious and unobvious subject
`
`matter.”).
`
`This argument also is not persuasive because, when considering the
`
`rationale for combining references, “the problem examined is not the
`
`specific problem solved by the invention but the general problem that
`
`confronted the inventor before the invention was made.” In re Kahn, 441
`
`F.3d 977, 988 (Fed. Cir. 2006). The rationale for combining references may
`
`be different from the inventor’s specific reasons or goals for making the
`
`invention. Id. In the present case, the general problem confronting the
`
`inventors of the ’105 patent was one of improving accuracy of the test strips.
`
`Ex. 1002, 1:15-18 (“the accuracy . . . is very important since an inaccurate
`
`reading could lead to the wrong level of insulin being administered which
`
`could be very harmful”). Pharmatech’s rationale for combining Nankai and
`
`Schulman—that one of ordinary skill in the art would have recognized that
`
`Schulman’s multisensor comparison method could improve the accuracy of
`
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`Nankai’s multisensor test strip (Pet. 17)—addresses the same general
`
`problem.
`
`(5) Whether Schulman discloses a disposable test
`strip
`
`LifeScan argues that Schulman does not disclose a test strip having
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`the claimed structure. Resp. 30. Specifically, LifeScan argues that
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`Schulman does not disclose a test strip which has two working sensor parts
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`and a common reference sensor part. Id. LifeScan also argues that
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`Schulman does not disclose applying sample liquid to the test strip. Id.
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`Specifically, LifeScan argues that Schulman’s device is implanted in the
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`body and is, therefore, in continuous contact with sample. Id. LifeScan
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`describes Schulman’s arrangement as “not related” to test strips that are used
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`for intermittent measurements. Id. LifeScan also argues that Schulman uses
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`the term “sensor” differently from how the term is used in the ’105 patent.
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`Resp. 28-29. According to LifeScan, the term “sensor,” or more
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`specifically, “sensor part,” is used in the ’105 patent to refer to a single
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`electrode on a test strip, whereas a “sensor” in Schulman is an entire
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`assembly of several electrodes and other structure. Id. at 29 (citing
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`Ex. 1002, claims 1-3; Ex. 1007, 7:28-30; Ex. 2008 ¶ 59).
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`These arguments are unpersuasive, because Pharmatech does not rely
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`on Schulman for any of these disclosures. Pharmatech relies on Schulman
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`simply for the limited disclosure that multiple measurements of a sample can
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`be made, compared to establish a difference parameter, and rejected if the
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`difference exceeds a threshold. Pet. 16-17, 21; Reply 3; see id. at 6 (“the
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`proposed [challenges] do not rely upon the specific sensor of Schulman”).
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`That Schulman happens to disclose this technique in the context of
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`continuous monitoring by an implanted electrode, instead of intermittent
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`monitoring by a disposable electrode, is of no moment.
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`LifeScan’s arguments that (a) Schulman’s measurement of oxygen
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`depletion is not “in proportion” to the glucose concentration
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`(Resp. 31-32, 37); (b) Schulman does not disclose a second sensor making
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`an independent measurement (id. at 32-33); (c) Schulman does not compare
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`the currents from its two sensors with one another directly because they
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`measure different things (id. at 34, 37-38); and (d) Schulman does not
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`disclose a single measuring device with multiple sensor parts (id. at 34-36,
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`38) each are unpersuasive for the same reason.
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`(6) “Fundamental technique” of measuring
`glucose.
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`LifeScan disputes our initial determination that Nankai, Schulman,
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`and the ’105 patent use the same “fundamental technique” for measuring
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`glucose oxidase (“GOx”)-mediated electrical current. Resp. 30-31 (citing
`
`Dec. 13). LifeScan argues that Schulman measures current resulting from
`
`oxygen reduction, not from a GOx-mediated oxidation of glucose followed
`
`by oxidation of a mediator. Resp. 31 (citing Ex. 2008 ¶ 68).
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`This argument is unpersuasive because LifeScan does not explain its
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`relevance to the combinability of Nankai and Schulman. We also disagree
`
`with LifeScan’s assertion. Schulman measures a GOx-mediated electrical
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`current in the sense that the oxygen reduction it measures results from
`
`consumption of the oxygen by GOx to oxidize glucose in the blood. Ex.
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`1007, 3:35-62. We pointed out this similarity—the use of GOx and current
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`measurements by each of Nankai, Schulman, and the ’105 patent—to
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`explain why we were not persuaded by LifeScan’s Preliminary Response
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`argument that Schulman is non-analogous to single-use test strip
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`technologies. Dec. 12-13 (citing Paper 10, 28).
`
`(7) Combination of Nankai and Schulman
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`LifeScan argues that there is no evidence supporting a rationale to
`
`combine Nankai and Schulman and that, instead, the evidence shows that
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`one of ordinary skill would have been led away from the combination.
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`Resp. 38-43.
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`LifeScan argues that Schulman’s glucose calculation method, which
`
`involves subtracting an oxygen depletion signal from a background oxygen
`
`signal to obtain a glucose result, is less accurate than the claimed method of
`
`comparing two glucose results. Id. at 40-41 (citing Ex. 2008 ¶ 83).
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`This argument is unpersuasive for the reason discussed above in
`
`subsection (5): Pharmatech relies on Schulman not for disclosure of the
`
`particular glucose measurement method, but rather only for disclosure of
`
`making multiple measurements and signaling an error if a difference
`
`parameter between the measurements exceeds a threshold. LifeScan does
`
`not credibly explain why it would not have been reasonable for one of
`
`ordinary skill in the art to have taken away from Schulman only this limited
`
`teaching. See EWP Corp. v. Reliance Universal Inc., 755 F.2d 898, 907
`
`(Fed. Cir. 1985) (“A reference must be considered for everything it teaches
`
`by way of technology and is not limited to the particular invention it is
`
`describing and attempting to protect.”).
`
`LifeScan identifies other purported disadvantages of Schulman’s
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`glucose measurement method, including errors that would be introduced by
`
`the local generation of hydrogen peroxide and local deficit of oxygen.
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`Resp. 41-42 (citing Ex. 2008 ¶¶ 84-85). These arguments are unpersuasive
`
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`for the same reason, because they depend on the incorporation of disclosure
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`from Schulman beyond that which Pharmatech argues.
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`LifeScan argues that Schulman was less concerned with accuracy of
`
`individual measurements, because the continuous operation of the sensor
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`would, instead, permit error detection by comparison of results over time.
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`Id. at 42 (citing Ex. 2008 ¶ 88). Again, this argument is unpersuasive
`
`because it is not responsive to the challenge as Pharmatech has framed it.
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`LifeScan argues that Schulman’s device has not been commercialized,
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`and also that Dr. Smith never had any reason to consider implantable
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`monitors in the course of decades of work seeking to improve disposable test
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`strips. Id. at 43 (citing Ex. 2008 ¶¶ 86, 88-90). These arguments are
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`unpersuasive, because they do not address why one of ordinary skill in the
`
`art would have been dissuaded from adapting the disclosure from Schulman
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`that Pharmatech cites.
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`4. Objective evidence of nonobviousness
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`LifeScan argues that Pharmatech’s copying of LifeScan’s test strips
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`demonstrates nonobviousness of claims 1-3. Resp. 45-49 (citing Ex. 2008
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`¶¶ 92-95). LifeScan argues that Pharmatech’s “GenStrip” test strip is similar
`
`to LifeScan’s commercial strip. Id. at 46-48. LifeScan argues, and
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`Pharmatech does not dispute in its Reply, that use of either a LifeScan test
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`strip or a Pharmatech test strip with LifeScan’s “One Touch Ultra” meter, to
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`measure blood glucose, falls within the scope of claims 1-3. Id. at 47-48
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`(citing Ex. 2008 ¶¶ 92, 95). Pharmatech argues that its copying is not
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`probative of obviousness because at least some level of copying was
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`necessary to make its test strips operable with LifeScan’s meter device, and
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`because evidence of copying, without more, is not persuasive of
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`nonobviousness. Reply 14 (citing Cable Elec. Products, Inc. v. Genmark,
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`Inc., 770 F.2d 1015, 1028 (Fed. Cir. 1985), overruled on other grounds by
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`Midwest Indus., Inc. v. Karavan Trailers, Inc., 175 F.3d 1356, 1359 (Fed.
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`Cir. 1999)).
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`5. Analysis
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`Nankai discloses a test strip having the structure recited in claim 1,
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`expect for the position of the reference sensor part being upstream from the
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`two working sensor parts. Supra at section II.B.2.a. Nankai’s disclosure
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`that the arrangement of its sensors may vary (Ex. 1003, 8:50-52) provides
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`adequate reason for one of ordinary skill in the art to have repositioned the
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`reference sensor part, in view of Dr. Wang’s unrebutted2 testimony
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`(Ex. 1024 ¶ 25) that positioning the reference sensor part upstream of the
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`working sensor parts was one of a finite number of possibilities and would
`
`have been obvious to try. See KSR, 550 U.S. at 417 (arrangement of prior-
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`art elements that yields no more than expected results is obvious); In re
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`Kuhle, 526 F.2d 553, 555 (CCPA 1975) (particular placement of electrical
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`contact an obvious matter of design choice absent showing of an unexpected
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`result). As discussed above in section II.B.3.b(2), we are unpersuaded that
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`there is criticality in the positioning of the reference sensor, because
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`LifeScan has not explained how any benefits flowing from the claimed
`
`position are unexpected.
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`The combination of Nankai with Schulman similarly is reasonable.
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`Schulman’s teachings about the need to compare independent concentration
`
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`2 Dr. Smith acknowledges Dr. Wang’s testimony but does not respond to it
`directly. See Ex. 2008 ¶ 42.
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`measurements, and signal an error if they diverge, transcend the particular
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`sensor systems for which they are implemented. We agree with Pharmatech,
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`and credit Dr. Wang’s testimony, that one of ordinary skill in the art, seeking
`
`to improve the accuracy of a multisensor test strip such as Nankai’s, would
`
`have had reason to use Schulman’s comparison and error techniques. See
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`Pet. 17; Ex. 1024 ¶ 27.
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`LifeScan’s arguments to the contrary, discussed above in sections
`
`II.B.3.b(5)-(7), dwell on technical details of Schulman’s sensor assemblies,
`
`not on the more general discussion of the need to detect divergence between
`
`redundant measurements in order to signal error. See, e.g., Ex. 1007,
`
`3:21-24 (calling for a “prescribed degree
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