IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Trial No.:
`In re Patent of:
`U.S. Patent No.:
`Issue Date:
`Serial No.:
`Filing Date:
`Title:
`
`filed electronically
`
`to be assigned
`Davies
`7,250,105
`July 31, 2007
`10/431,140
`May 7, 2003
`MEASUREMENT OF SUBSTANCES IN LIQUIDS
`
`
`
`REQUEST FOR INTER PARTES REVIEW
`OF U.S. PATENT NUMBER 7,250,105 UNDER 35 U.S.C. §§ 311-319
`
`
`
`Pharmatech Solutions, Inc. (“Requester” and “Petitioner”) respectfully
`
`requests Inter Partes Review of all claims (claims 1-3) of U.S. Patent Number
`
`7,250,105 (“the ‘105 Patent”) titled “MEASUREMENT OF SUBSTANCES IN
`
`LIQUIDS”. The ‘105 Patent was filed May 7, 2003 and issued July 31, 2007, and it
`
`has not yet expired. A copy of the ‘105 Patent is attached as Exh. 1002.1
`
`The fees set forth in 37 C.F.R. §§ 42.15(a)(1) and 42.15(a)(2) accompany
`
`this request. If any additional fee is necessary for this request to be fully
`
`considered, please charge Deposit Account No. 12-0600.
`
`
`1 A complete listing of all exhibits is set forth in Exh. 1001.
`
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`TABLE OF CONTENTS
`
`I. REAL PARTY IN INTEREST UNDER 37 C.F.R. § 42.8(b)(1) ................... 2
`
`II. GROUNDS FOR STANDING UNDER 37 C.F.R. § 42.104(a) .................... 2
`
`III. RELATED MATTERS UNDER 37 C.F.R. § 42.8(b)(2)............................... 2
`
`IV. LEAD AND BACKUP COUNSEL UNDER 37 C.F.R. § 42.8(b)(3) ............ 2
`
`V.
`
`SERVICE INFORMATION UNDER 37 C.F.R. § 42.8(b)(4) ....................... 3
`
`VI. CERTIFICATION UNDER 37 C.F.R. §§ 42.6(e)(4)(iii) and 42.105(a) ........ 3
`
`VII. STATEMENT OF PRECISE RELIEF REQUESTED UNDER
`37 C.F.R. §§ 42.22(a)(1) and 42.104(b)(1)-(2) .............................................. 3
`
`VIII. CONSTRUCTION OF CHALLENGED CLAIMS UNDER
`37 C.F.R. § 42.104(b)(2) ............................................................................... 5
`
`IX. STATEMENT OF REASONS FOR THE RELIEF REQUESTED
`UNDER 37 C.F.R. §§ 42.22(a)(2) and 42.104(b)(4), SHOWING THAT
`THERE IS A REASONABLE LIKELIHOOD THAT THE
`REQUESTER WILL PREVAIL UNDER 35 U.S.C. § 314(a) ...................... 7
`
`A.
`
`Background and Introduction .............................................................. 7
`
`B. Grounds of Rejection ........................................................................ 10
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`Ground 1 ................................................................................. 10
`
`Ground 2 ................................................................................. 16
`
`Ground 3 ................................................................................. 21
`
`Ground 4 ................................................................................. 27
`
`Ground 5 ................................................................................. 33
`
`Ground 6 ................................................................................. 34
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`7.
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`8.
`
`9.
`
`Ground 7 ................................................................................. 35
`
`Ground 8 ................................................................................. 39
`
`Ground 9 ................................................................................. 42
`
`10. Ground 10 ............................................................................... 46
`
`11. Ground 11 ............................................................................... 51
`
`12. Ground 12 ............................................................................... 56
`
`13. Ground 13 ............................................................................... 57
`
`
`
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`I. REAL PARTY IN INTEREST UNDER 37 C.F.R. § 42.8(b)(1)
`
`The real party in interest is Pharmatech Solutions, Inc. of Westlake Village,
`
`California.
`
`
`
`II. GROUNDS FOR STANDING UNDER 37 C.F.R. § 42.104(a)
`
`The petitioner hereby certifies that the patent for which review is sought is
`
`available for Inter Partes Review (“IPR”) and that the petitioner is not barred or
`
`estopped from requesting an IPR challenging the patent claims on the grounds
`
`identified in the petition.
`
`
`
`III. RELATED MATTERS UNDER 37 C.F.R. § 42.8(b)(2)
`
`The patent owner has sued the petitioner, alleging infringement of the ‘105
`
`Patent. Lifescan, Inc. v. Shasta Techs., LLC, 5:11-CV-04494-EJD (N.D.Cal). The
`
`‘105 Patent was first asserted through an amended complaint dated 12/10/2012.
`
`
`
`IV. LEAD AND BACKUP COUNSEL UNDER 37 C.F.R. § 42.8(b)(3)
`
`Lead counsel for the requester is William A. Rudy of Lathrop & Gage LLP,
`
`USPTO Reg. No. 34,916. Backup counsel for the requester is A. Justin Poplin of
`
`Lathrop & Gage LLP, USPTO Reg. No. 53,476.
`
`
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`V. SERVICE INFORMATION UNDER 37 C.F.R. § 42.8(b)(4)
`
`Requester may be served as follows:
`
`PATENT DOCKETING
`
`LATHROP & GAGE LLP
`
`2345 Grand Boulevard, Suite 2800
`
`Kansas City, MO 64108
`
`Requester’s lead counsel may also be contacted by phone at 816-460-5819.
`
`
`
`VI. CERTIFICATION UNDER 37 C.F.R. §§ 42.6(e)(4)(iii) and 42.105(a)
`
`Requester certifies that a copy of this request has been served in its entirety
`
`on the patent owner at the address provided for in § 42.6(e)(3). Specifically, this
`
`Request for Inter Partes Review is being served on the correspondent of record for
`
`the ‘105 Patent: Philip S. Johnson; Johnson & Johnson; One Johnson & Johnson
`
`Plaza; New Brunswick, NJ 08933.
`
`
`
`VII. STATEMENT OF PRECISE RELIEF REQUESTED UNDER
`37 C.F.R. §§ 42.22(a)(1) and 42.104(b)(1)-(2)
`
`In regard to the ‘105 Patent, Petitioner respectfully requests:2
`
`
`2 Referenced prior art accompanies this paper as set forth in Exh. 1001.
`
`Detailed proposed rejections are set forth herein in Section IX(B).
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`(1)
`
`invalidation of claim 1 under 35 U.S.C. § 103 as unpatentable over U.S. Pat.
`
`No. 5,120,420 to Nankai in view of U.S. Pat. No. 6,175,752 to Say, either
`
`alone or in further view of U.S. Pat. No. 6,258,229 to Winarta and/or U.S.
`
`Pat. No. 5,672,256 to Yee;
`
`(2)
`
`invalidation of claim 1 under § 103 as unpatentable over Nankai (‘420) in
`
`view of U.S. Pat. No. 5,791,344 to Schulman, either alone or in further view
`
`of Winarta (‘229) and/or Yee (‘256);
`
`(3)
`
`invalidation of claim 1 under § 103 as unpatentable over Nankai (‘420) in
`
`view of Ramakant Khazanie, Statistics in a World of Applications (1997)
`
`(“Khazanie”), either alone or in further view of Winarta (‘229) and/or Yee
`
`(‘256);
`
`(4)
`
`invalidation of claim 1 under § 103 as unpatentable over Nankai (‘420) in
`
`view of William Lichten, Data and Error Analysis in the Introductory
`
`Physics Laboratory (1996) (“Lichten”), either alone or in further view of
`
`Winarta (‘229) and/or Yee (‘256);
`
`(5)
`
`invalidation of claim 1 under § 103 as unpatentable as set forth above in
`
`grounds (1) through (4), further in view of U.S. Pat. No. 6,540,891 to
`
`Stewart;
`
`(6)
`
`invalidation of claim 1 under § 103 as unpatentable as set forth above in
`
`grounds (1) through (4), further in view of U.S. Pat. No. 5,004,998 to Horii;
`
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`(7)
`
`invalidation of claim 1 under § 103 as unpatentable over Winarta (‘229) in
`
`view of Say (‘752);
`
`(8)
`
`invalidation of claim 1 under § 103 as unpatentable over Winarta (‘229) in
`
`view of Horii (‘998);
`
`(9)
`
`invalidation of claim 1 under § 103 as unpatentable over Winarta (‘229) in
`
`view of Schulman (‘344);
`
`(10)
`
`invalidation of claim 1 under § 103 as unpatentable over Winarta (‘229) in
`
`view of Yee (‘256) and Khazanie;
`
`(11)
`
`invalidation of claim 1 under § 103 as unpatentable over Winarta (‘229) in
`
`view of Lichten;
`
`(12)
`
`invalidation of claim 2 under § 103 as unpatentable as set forth above in
`
`grounds (1) through (11); and
`
`(13)
`
`invalidation of claim 3 under § 103 as unpatentable as set forth above in
`
`grounds (1) through (11).
`
`
`
`VIII. CONSTRUCTION OF CHALLENGED CLAIMS UNDER 37 C.F.R. §
`42.104(b)(2)
`
`The patent owner has asserted that “proportion” and “proportional” in the
`
`claims should be construed as “correlated to”. See Lifescan’s Opening Markman
`
`Brief (Doc. 240) at pp. 8-12, Lifescan, Inc. v. Shasta Techs., LLC, 5:11-cv-04494-
`
`EJD (N.D.Cal) (attached hereto as Exh. 1012).
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`Unlike in litigation, where claim scope is determined based on, inter alia,
`
`the specification, prosecution history, and prior art, claims must be given their
`
`broadest reasonable scope at the USPTO. See, e.g., Atlantic Thermoplastics Co.,
`
`Inc. v. Faytex Corp., 970 F.2d 834, 846 (Fed. Cir. 1992) (“This court…
`
`distinguishes treatment of claims for patentability before the PTO from treatment
`
`of claims for validity before the courts. This court permits the PTO to give claims
`
`their broadest reasonable meaning when determining patentability. During
`
`litigation determining validity or infringement, however, this approach is
`
`inapplicable. Rather the courts must consult the specification, prosecution history,
`
`prior art, and other claims to determine the proper construction of the claim
`
`language. Thus…this court treats claims differently for patentability as opposed to
`
`validity and infringement.”) (internal citations omitted). Accordingly, because the
`
`USPTO’s use of the patent owner’s construction for reexamination is of no
`
`consequence to an analysis of claim scope in litigation, and because the Petitioner
`
`is prohibited by 35 U.S.C. § 311(b) from challenging the existing claim limitations
`
`under 35 U.S.C. §§ 101 or 112 in this proceeding, the USPTO is urged to adopt
`
`the patent owner’s broad construction for “proportion” and “proportional” as
`
`“correlated to” in this proceeding.
`
`
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`IX. STATEMENT OF REASONS FOR THE RELIEF REQUESTED
`UNDER 37 C.F.R. § 42.22(a)(2) and 42.104(b)(4), SHOWING THAT THERE
`IS A REASONABLE LIKELIHOOD THAT THE REQUESTER WILL
`PREVAIL UNDER 35 U.S.C. § 314(a)
`
`A. Background and Introduction
`
`The ‘105 Patent claims a method of measuring the concentration of a
`
`substance in a sample liquid, and requires specific structure for a disposable test
`
`strip and method steps performed by a meter.
`
`The patent owner repeatedly tried to patent just the test strip set forth in the
`
`claims of the ‘105 Patent (i.e., without accompanying method steps), but was
`
`entirely unsuccessful. For example, in parent patent 6,733,655, claim 23 (pending
`
`on 4/22/2002) was substantially identical to the test strip set forth in method claims
`
`1-3 of the ‘105 Patent, but only claimed the test strip. See 4/22/2002 Amendment
`
`at p. 2 in application 09/521,163 (attached hereto as Exh. 1013). It was rejected
`
`under 35 U.S.C. § 102 as being anticipated by Yee (US 5,672,256) on 7/31/2002,
`
`and was subsequently withdrawn by an amendment dated 5/6/2003. See 7/31/2002
`
`Rejection at p. 3 in application 09/521,163 and 5/6/2003 Amendment at p. 2 in
`
`application 09/521,163 (attached hereto as Exhs. 1014 and 1015). No claims to the
`
`test strip were issued in the related ‘655 Patent without method steps. See ‘655
`
`Patent at 7:11 to 8:21 (attached hereto as Exh. 1016). Claim 17 (pending on
`
`6/9/2006) in the file history of the ‘105 Patent was also substantially identical to
`
`the test strip set forth in the issued method claims of the ‘105 Patent, and it also
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`only claimed the test strip. See 6/9/2006 Amendment at p. 3 in application
`
`10/431,140 (attached hereto as Exh. 1018). It was rejected as being anticipated by
`
`Fujiwara (US 6,004,441) on 8/9/2006, and the patent owner withdrew the claim by
`
`an amendment dated 1/10/2007. See 8/9/2006 Rejection at pp. 2-4 in application
`
`10/431,140 and 1/10/2007 Amendment at p. 2 in application 10/431,140 (attached
`
`hereto as Exhs. 1019 and 1020). Again, no claims to the test strip were issued
`
`without method steps. See ‘105 Patent at 6:52 to 8:12 (Exh. 1002). Finally, in child
`
`application 11/772,714, claim 17 (pending on 7/2/2007) was also substantially
`
`identical to the test strip set forth in the issued method claims of the ‘105 Patent,
`
`and it too only claimed the test strip. See 7/2/2007 Amendment at p. 3 in
`
`application 11/772,714 (attached hereto as Exh. 1021). It was rejected as being
`
`anticipated by Winarta (‘229) and obvious in view of Nankai (‘420) on 10/2/2009,
`
`and the entire ‘714 Application abandoned on 4/2/2010. See 10/2/2009 Rejection at
`
`p. 8 in application 11/772,714 and Notice of Abandonment in application
`
`11/772,714, attached hereto as Exhs. 1022 and 1023).
`
`The claims of the ‘105 Patent were purportedly allowed because, according
`
`to the examiner, the prior art of record failed to teach using prior art test strips for
`
`“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
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`giving an indication of an error if said difference parameter is greater than a
`
`predetermined threshold.” See 8/9/2006 Office Action at p. 8, attached hereto as
`
`Exh. 1019.
`
`A further review of the file history, however, also shows that the examiner
`
`withdrew rejections based on U.S. Pat. No. 5,120,420 to Nankai once the applicant
`
`amended the claims to require: (a) the second working sensor part to be
`
`downstream from said first working sensor part; (b) the reference sensor part to be
`
`upstream from the first and second working sensor parts; and (c) the reference
`
`sensor and the first and second working sensor parts to be arranged such that the
`
`sample liquid is constrained to flow substantially unidirectionally across the
`
`reference sensor part and the first and second working sensor parts. See 3/2/2006
`
`Office Action at pp. 3-5; 6/9/2006 Amendment at p. 3; 8/9/2006 Rejection at pp. 2-
`
`6, attached hereto as Exhs. 1017, 1018, and 1019.
`
`But as set forth in detail below, neither the measuring, comparing, and
`
`indicating an error steps, nor the arrangement of sensors on the test strip, properly
`
`provides patentability. And none of the other claim limitations (either alone or in
`
`combination) provide patentability. Of the prior art references set forth above in
`
`Section VII regarding claims 1-3, only Nankai (‘420), Yee (‘256), Schulman
`
`(‘344), and Horii (‘998) were cited during prosecution of the ‘105 Patent, and the
`
`examiner did not cite and combine those references as set forth herein.
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`Additionally, the requester presents five new prior art references that provide basis
`
`for invalidating the patent claims: Say (‘752), Winarta (‘229), Khazanie, Lichten,
`
`and Stewart (‘891); each is discussed below in Section IX(B) at Grounds 1-13.
`
`Finally, the patent owner may attempt to argue secondary considerations of
`
`nonobviousness, such as commercial success. However, there is no nexus between
`
`the patent claims and the success of the product marketed under the ‘105 Patent. So
`
`secondary considerations do not support patentability, and clearly do not overcome
`
`the strong showing of obviousness made herein. See Wyers v. Master Lock Co.,
`
`616 F.3d 1231, 1246 (Fed. Cir. 2010) (“Moreover, secondary considerations of
`
`nonobviousness… simply cannot overcome a strong prima facie case of
`
`obviousness.”).
`
`Accordingly, the challenged claims are invalid. Detailed rejections appear
`
`below in Section IX(B) (i.e., at Grounds 1-13), and this paper makes the required
`
`showing that there is a reasonable likelihood that the Requester will prevail.
`
`
`
`B. Grounds of Rejection
`
`1. Ground 1
`
`Claim 1 is invalid under 35 U.S.C. § 103 as obvious over Nankai (‘420) in
`
`view of Say (‘752), either alone or in further view of Winarta (‘229) and/or Yee
`
`(‘256). As set forth in the claim chart below, Nankai (‘420) discloses a test strip (or
`
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`“measuring device”) that includes all of the features of the measuring device of
`
`claim 1, except it does not explicitly place the reference sensor upstream of the
`
`working sensor parts. However, such configuration is merely an unpatentable
`
`rearrangement of parts. According to the ‘105 Patent, the sensor parts may be
`
`arranged in various configurations “as convenient”, and no benefit or unexpected
`
`result is set forth for placing the reference sensor upstream of both working sensor
`
`parts. See ‘105 Patent at 3:36-58. Further, Nankai (‘420) specifically teaches that
`
`the shape and arrangement of the sensors may vary. See Nankai (‘420) at 8:47-52.
`
`So the claimed arrangement would be one of a finite number of identified,
`
`predictable solutions having a reasonable expectation of success (and thus obvious
`
`to try). Wang Dec., ¶20, 23, attached hereto as Exh. 1024.
`
`Nankai (‘420) also discloses applying the sample liquid to the measuring
`
`device. See Nankai (‘420) at 8:25-30. Nankai further teaches that multiple
`
`measurements should be taken and averaged together. See Nankai (‘420) at 8:11-
`
`14 and 30-46.
`
`Say (‘752) discloses that when readings are taken from multiple electrodes,
`
`they should be compared to one another to identify errors. See Say (‘752) at 39:26-
`
`46; 40:11 and 14-16. Incorporating this into Nankai (‘420) would be nothing more
`
`than the use of a known technique to improve similar devices/methods in the same
`
`way, and the results would be predictable. Wang Dec., ¶22-23. When the
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`comparison in Say (‘752) reveals that the difference in readings is outside a
`
`predetermined threshold level, the patient is alerted that the sensor is defective. See
`
`Say (‘752) at 39:26-46; 40:11. Alerting users of the Nankai (‘420) device of
`
`defects would have been obvious in light of the teachings of Say (‘752). Wang
`
`Dec., ¶ 22-23. This would be nothing more than the use of a known technique to
`
`improve similar devices/methods in the same way, and the results would be
`
`predictable. Wang Dec., ¶22-23.
`
`Any deficiency in the arrangement of sensor parts is met by Winarta (‘229)
`
`and/or Yee (‘256). Winarta (‘229) discloses placing the reference sensor part R
`
`upstream from the working sensor parts W, Wo and unidirectional flow as claimed.
`
`See Winarta (‘229) at 5:59 to 6:10, 7:11-42, FIG. 2. Incorporating this into Nankai
`
`(‘420) would be nothing more than the use of a known technique to improve
`
`similar devices/methods in the same way, and the results would be predictable.
`
`Wang Dec., ¶40-41. Yee (‘256) discloses that the arrangement of electrodes does
`
`not affect their characteristics. See Yee (‘256) at 2:11-13. This further confirms
`
`that it would be obvious to place the reference sensor upstream of the working
`
`sensor parts, as set forth in claim 1. Wang Dec., ¶42-43.
`
`A claim chart showing application of Nankai (‘420), Say (‘752), Winarta
`
`(‘229), and Yee (‘256) to claim 1 follows:
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`Claim 1 of ‘105 Patent Nankai (‘420) in view of Say (‘752), either alone or in
`further view of Winarta (‘229) and/or Yee (‘256)
`The combination of references provides the claimed
`method.
`
`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
`
`Nankai (‘420) provides a measuring device at FIG. 12.
`
`Nankai (‘420): a first working sensor part 43 for
`generating charge carriers in proportion to the
`concentration of said substance in the sample liquid.
`
`Nankai (‘420) at 8:4-14, FIG. 12.
`
`
`Nankai (‘420): a second working sensor part 42
`downstream from the first working sensor part 43 also
`for generating charge carriers in proportion to the
`concentration of said substance in the sample liquid.
`
`Nankai (‘420) at 8:4-14, FIG. 12.
`
`
`Nankai (‘420): said first and second working sensor
`parts 43, 42 are arranged such that, in the absence of an
`error condition, the quantity of said charge carriers
`generated by said first working sensors part 43 are
`substantially identical to the quantity of said charge
`carriers generated by said second working sensor part
`42.
`
`This is inherent in Nankai (‘420), as its first and second
`working sensor parts 43, 42 are constructed in the same
`manner, include the same reagent, and are the same size.
`See Nankai (‘420) at 8:4-46, FIG. 12.
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`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
`
`Nankai (‘420): a reference sensor part 5 which is a
`common reference for both the first and second working
`sensor parts 43, 42.
`
`Nankai (‘420) at 8:4-52, 4:55-57, FIG. 12.
`
`While Nankai (‘420) does not explicitly show the
`reference sensor part 5 being upstream from the first and
`second working sensor parts 43, 42, such arrangement is
`merely an unpatentable rearrangement of parts, and in
`any case would be one of a finite number of identified,
`predictable solutions having a reasonable expectation of
`success (and thus obvious to try).
`
`Any deficiency in the arrangement of sensor parts is met
`by Winarta (‘229) and/or Yee (‘256). Winarta (‘229)
`discloses placing the reference sensor part R upstream
`from the working sensor parts W, Wo as claimed.
`Winarta (‘229) at 5:59 to 6:10, 7:11-42, FIG. 2.
`Incorporating this into Nankai (‘420) would be nothing
`more than the use of a known technique to improve
`similar devices/methods in the same way, and the results
`would be predictable. Yee (‘256) discloses that the
`arrangement of electrodes does not affect their
`characteristics. Yee (‘256) at 2:11-13. This further
`confirms that it would be obvious to place the reference
`sensor upstream of the working sensor parts, as set forth
`in claim 1.
`Nankai (‘420): said reference sensor part 5 and said
`first and second working sensor parts 43, 42 being
`arranged such that the sample liquid is constrained to
`flow substantially unidirectionally across said reference
`sensor part 5 and said first and second working sensor
`parts 43, 42.
`
`Nankai (‘420) at 8:4-29, FIG. 12.
`
`Any deficiency in the arrangement of sensor parts is met
`by Winarta (‘229) and/or Yee (‘256). Winarta (‘229)
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`parts;
`
`wherein said first and
`second working sensor
`parts and said reference
`sensor part are provided
`on a disposable test
`strip;
`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 if said
`difference parameter is
`greater than a
`predetermined
`threshold.
`
`discloses placing the reference sensor part R upstream
`from the working sensor parts W, Wo and unidirectional
`flow as claimed. Winarta (‘229) at 5:59 to 6:10, 7:11-42,
`FIG. 2. Incorporating this into Nankai (‘420) would be
`nothing more than the use of a known technique to
`improve similar devices/methods in the same way, and
`the results would be predictable. Yee (‘256) discloses
`that the arrangement of electrodes does not affect their
`characteristics. Yee (‘256) at 2:11-13. This further
`confirms that it would be obvious to place the reference
`sensor upstream of the working sensor parts and have
`unidirectional flow, as set forth in claim 1.
`Nankai (‘420): said first and second working sensor
`parts 43, 42 and said reference sensor part 5 are
`provided on a disposable test strip.
`
`Nankai (‘420) at 8:37, FIG. 12.
`
`Nankai (‘420) at 8:25-30.
`
`Using Patent Owner’s construction of “proportional”
`(i.e., correlated to), Nankai (‘420) measures an electric
`current at each working sensor part proportional to the
`concentration of said substance in the sample liquid.
`Nankai (‘420) at 8:11-14, 8:30-46.
`
`Say (‘752) discloses that when readings are taken from
`multiple electrodes, they should be compared to one
`another to identify errors. See Say (‘752) at 39:26-46,
`40:11, 40:14-16. Incorporating this into Nankai (‘420)
`would be nothing more than the use of a known
`technique to improve similar devices/methods in the
`same way, and the results would be predictable.
`When the comparison in Say (‘752) reveals that the
`difference in readings is outside a predetermined
`threshold level, the patient is alerted that the sensor is
`defective. See Say (‘752) at 39:26-46 and 40:11.
`Alerting users of the Nankai (‘420) device of defects
`would have been obvious in light of the teachings of Say
`
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`(‘752). This would nothing more than the use of a
`known technique to improve similar devices/methods in
`the same way, and the results would be predictable.
`
`
`
`2. Ground 2
`
`Claim 1 is invalid under 35 U.S.C. § 103 as obvious over Nankai (‘420) in
`
`view of Schulman (‘344), either alone or in further view of Winarta (‘229) and/or
`
`Yee (‘256). As set forth in the claim chart below, Nankai (‘420) discloses a test
`
`strip (or “measuring device”) that includes all of the features of the measuring
`
`device of claim 1, except it does not explicitly place the reference sensor upstream
`
`of the working sensor parts. However, such configuration is merely an
`
`unpatentable rearrangement of parts. According to the ‘105 Patent, the sensor parts
`
`may be arranged in various configurations “as convenient”, and no benefit or
`
`unexpected result is set forth for placing the reference sensor upstream of both
`
`working sensor parts. See ‘105 Patent at 3:36-58. Further, Nankai (‘420)
`
`specifically teaches that the shape and arrangement of the sensors may vary. See
`
`Nankai (‘420) at 8:47-52. So the claimed arrangement would be one of a finite
`
`number of identified, predictable solutions having a reasonable expectation of
`
`success (and thus obvious to try). Wang Dec., ¶25, 28.
`
`Nankai (‘420) also discloses applying the sample liquid to the measuring
`
`device. See Nankai (‘420) at 8:25-30. Nankai further teaches that multiple
`
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`measurements should be taken and averaged together. See Nankai (‘420) at 8:11-
`
`14 and 30-46.
`
`Schulman (‘344) teaches that multiple measurements should be taken to
`
`identify errors. See Schulman (‘344) at 3:17-28. Incorporating this into Nankai
`
`(‘420) would be nothing more than the use of a known technique to improve
`
`similar devices/methods in the same way, and the results would be predictable.
`
`Wang Dec., ¶27-28. Schulman
`
`(‘344)
`
`further discloses comparing
`
`the
`
`measurements to establish a difference parameter, and then giving an indication of
`
`an error if the difference parameter is greater than a predetermined threshold. See
`
`Schulman (‘344) at 3:17-28. Alerting users of the Nankai (‘420) device of errors
`
`would have been obvious in light of the teachings of Schulman (‘344). Wang Dec.,
`
`¶27-28. This would be nothing more than the use of a known technique to improve
`
`similar devices/methods in the same way, and the results would be predictable.
`
`Wang Dec., ¶27-28.
`
`Any deficiency in the arrangement of sensor parts is met by Winarta (‘229)
`
`and/or Yee (‘256). Winarta (‘229) discloses placing the reference sensor part R
`
`upstream from the working sensor parts W, Wo and unidirectional flow as claimed.
`
`See Winarta (‘229) at 5:59 to 6:10, 7:11-42, FIG. 2. Incorporating this into Nankai
`
`(‘420) would be nothing more than the use of a known technique to improve
`
`similar devices/methods in the same way, and the results would be predictable.
`
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`Wang Dec., ¶40-41. Yee (‘256) discloses that the arrangement of electrodes does
`
`not affect their characteristics. See Yee (‘256) at 2:11-13. This further confirms
`
`that it would be obvious to place the reference sensor upstream of the working
`
`sensor parts, as set forth in claim 1. Wang Dec., ¶42-43.
`
`A claim chart showing application of Nankai (‘420), Schulman (‘344),
`
`Winarta (‘229), and Yee (‘256) to claim 1 follows:
`
`Claim 1 of ‘105 Patent Nankai (‘420) in view of Schulman (‘344), either alone
`or in further view of Winarta (‘229) and/or Yee (‘256)
`The combination of references provides the claimed
`method.
`
`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
`
`Nankai (‘420) provides a measuring device at FIG. 12.
`
`Nankai (‘420): a first working sensor part 43 for
`generating charge carriers in proportion to the
`concentration of said substance in the sample liquid.
`
`Nankai (‘420) at 8:4-14, FIG. 12.
`
`
`Nankai (‘420): a second working sensor part 42
`downstream from the first working sensor part 43 also
`for generating charge carriers in proportion to the
`concentration of said substance in the sample liquid.
`
`Nankai (‘420) at 8:4-14, FIG. 12.
`
`
`Nankai (‘420): said first and second working sensor
`parts 43, 42 are arranged such that, in the absence of an
`
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`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,
`
`error condition, the quantity of said charge carriers
`generated by said first working sensors part 43 are
`substantially identical to the quantity of said charge
`carriers generated by said second working sensor part
`42.
`
`This is inherent in Nankai (‘420), as its first and second
`working sensor parts 43, 42 are constructed in the same
`manner, include the same reagent, and are the same size.
`See Nankai (‘420) at 8:4-46, FIG. 12.
`
`Nankai (‘420): a reference sensor part 5 which is a
`common reference for both the first and second working
`sensor parts 43, 42.
`
`Nankai (‘420) at 8:4-52, 4:55-57, FIG. 12.
`
`While Nankai (‘420) does not explicitly show the
`reference sensor part 5 being upstream from the first and
`second working sensor parts 43, 42, such arrangement is
`merely an unpatentable rearrangement of parts, and in
`any case would be one of a finite number of identified,
`predictable solutions having a reasonable expectation of
`success (and thus obvious to try).
`
`Any deficiency in the arrangement of sensor parts is met
`by Winarta (‘229) and/or Yee (‘256). Winarta (‘229)
`discloses placing the reference sensor part R upstream
`from the working sensor parts W, Wo as claimed.
`Winarta (‘229) at 5:59 to 6:10, 7:11-42, FIG. 2.
`Incorporating this into Nankai (‘420) would be nothing
`more than the use of a known technique to improve
`similar devices/methods in the same way, and the results
`would be predictable. Yee (‘256) discloses that the
`arrangement of electrodes does not affect their
`characteristics. Yee (‘256) at 2:11-13. This further
`confirms that it would be obvious to place the reference
`sensor upstream of the working sensor parts, as set forth
`
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`
`said reference sensor
`part and