UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box I450
`Alexandria, Viry'nia 27.313-I450
`www.uspto.gov
`
`10/431,140
`
`05/07/2003
`
`Oliver W.H. Davies
`
`DDI-0045
`
`4950
`
`°W°°5
`
`759°
`"7"
`PHILIP S. JOHNSON
`JOHNSON & JOHNSON
`ONE JOHNSON '& JOHNSON PLAZA
`NEW BRUNSWICK, NJ 08933-7003
`
`NoGuERoLA, ALEXANDER STEPHAN
`
`1753
`DATE MAILED: 09/20/2005
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`PTO-90C (Rev. 10/03)
`
`LIFESCAN SCOTLAND LTD. EXHIBIT 2005
`
`LIFESCAN SCOTLAND LTD. EXHIBIT 2005
`
`

`
`Application No.
`
`Applicant(s)
`
`10/431,140
`
`DAVIES ET AL.
`
`Office Action Summary
`
`.
`
`Examine,
`
`ALEX NOGUEROLA
`
`A,, unit
`
`1753 _
`
`— The MAILING DA TE of this communication appears on the cover sheet with the conespondence address -
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE § MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`- Extensions of time may be available under the provisions of 37 CFR 1.136(3).
`In no event, however, may a reply be timely filed
`-
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above. the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will. by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1)[Z Responsive to communication(s) filed on preliminary amendment of 05/07/2003.
`
`2a)E] This action is FINAL.
`
`'
`
`2b)X This action is non-final.
`
`3)I:] Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`
`closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`4)Xl Claim(s) M is/are pending in the application.
`
`4a) Of the above claim(s) __ is/are withdrawn from consideration.
`
`5)EI Claim(s) __ is/are allowed.
`
`6)® Claim(s) E‘ is/are rejected.
`
`7)E] Claim(s)j is/are objected to.
`
`8)I:] Claim(s) j are subject to restriction and/or election requirement.
`
`Application Papers
`
`9) The specification is objected to by the Examiner.
`10)X The drawing(s) filed on 07 Ma); 2003 is/are: a)X| accepted or b)|:] objected to by the Examiner.
`
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(_a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
`11)[:l The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
`
`Priority under 35 U.S.C. § 119
`
`12)E] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`
`a)[:I All
`
`b)l:] Some * c)E] None of:
`
`1.l:l Certified copies of the priority documents have been received.
`
`2.[:l Certified copies of the priority documents have been received in Application No. _.
`
`3.[] Copies of the certified copies of the priority documents have been received in this National Stage
`
`application from the International Bureau (PCT Rule 17.2(a)).
`
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1) IX] Notice of References Cited (PTO-892)
`2) E] Notice of Draftsperson’s Patent Drawing Review (PTO-948)
`3) [XI lnforrnation Disclosure Statement(s) (PTO-1449 or PTO/SB/O8)
`Paper No(s)/Mail Date 05/07/03.
`U.S. Patent and Trademark Office
`
`4) 1] Interview Summary (PTO-413)
`Paper No(s)/Mail Date. _-
`5) CI Notice °f Informal Patent APP'i°afi°n (PTO-152)
`6) X] Other: IDS of 02/07/05.
`
`PTOL-326 (Rev. 7-05)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20050914
`
`U_/
`
`

`
`Application/Control Number: 10/431,140
`
`Page 2
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`Art Unit: 1753
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`DETAILED ACTION
`
`Double Patenting
`
`1.
`
`Claims 19 is objected to under 37 CFR 1.75 as being a substantial duplicate of
`
`claim 21. When two claims in an application are duplicates or else are so close in
`
`content that they both cover the same thing, despite a slight difference in wording, it is
`
`proper after allowing one claim to object to the other as being "a substantial duplicate of
`
`the allowed claim. See MPEP § 706.03(k).
`
`The nonstatutory double patenting rejection is based on a judicially created
`2.
`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
`unjustified or improper timewise extension of the "right to exclude" granted by a patent
`and to prevent possible harassment by multiple assignees. See In re Goodman, 11
`F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993);
`In re Longi, 759 F.2d 887, 225
`USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA
`1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington,
`418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`A timely filed terminal disclaimer in compliance with 37 CFR1.321(c) may be
`used to overcome an actual or provisional rejection based on a nonstatutory double
`patenting ground provided the conflicting application or patent is shown to be commonly
`owned with this application. See 37 CFR 1.130(b).
`Effective January 1, 1994, a registered attorney or agent of record may sign a
`terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with
`37 CFR 3.73(b).
`
`

`
`Application/Control Number: 10/431,140
`
`Page 3
`
`Art Unit: 1753 8
`
`3.
`
`Claim 17 is rejected under the judicially created doctrine of obviousness-type
`
`double patenting as being unpatentable over claim 1 of U.S. Patent No. 6,733,655.
`
`Althoughthe conflicting claims are not identical, they are not patentably distinct from
`
`each other because the method of claim 1 of U.S. Patent No. US 6,733,655 uses the
`
`device of claim 17 of the instant application.
`
`4.
`
`Claim 18 is rejected under the judicially created doctrine of obviousness-type
`
`double patenting as being unpatentable over claim 1 of U.S. Patent No. 6,733,655 in
`
`view of Nankai (US 5,120,420).
`
`Claim 17, from which claim 18 depends, has been
`
`addressed above. The claims of U.S. Patent No. 6,733,655 do not require the device to
`
`be configured to limit the sample liquid flow, particularly as claimed. Nankai discloses
`
`various configurations for a strip-type disposable device comprising two or more
`
`electrodes. See Figures 3, 4, 8, 10, 12, and 13. In the embodiments shown in Figures
`
`3, 4, 8, and 10 the devices are configured so that sample liquid only flows
`
`unidirectionally across the electrodes. Barring a contrary showing, n light of Nanaki, the
`
`choice of sample flow configuration, such as that claimed, will depend on where the
`
`sample inlet and the vent can be best located. An embodiment as shown in Figure 8 is
`
`suitable if sample can be more easily applied to a large area of the device, such as the
`
`top surface, rather then the thin edge. Furthermore, Nankai found that the sample
`
`rapidly reaches the electrodes with a unidirectional flow configuration. See col. 8:19-29.
`
`

`
`Application/Control Number: 10/431,140
`
`Page 4
`
`Art Unit: 1753
`
`5.
`
`Claim 19 is rejected under the judicially created doctrine of obviousness-type
`
`double patenting as being unpatentable over claim 1 of U.S. Patent No. 6,733,655.
`
`Claim 17, from which claim 19 depends, has been addressed above. Barring a contrary
`
`showing whether the working sensor parts are upstream or downstream is only intended
`
`use that does not further structurally limit the device.
`
`6.
`
`Claim 20 is rejected under the judicially created doctrine of obviousness-type
`
`double patenting as being unpatentable over claim 1 of U.S. Patent No. 6,733,655.
`
`Claim 17, from which claim 20 depends, has been addressed above. Barring a contrary
`
`showing whether the working sensor parts are upstream or downstream is only intended
`
`use that does not further structurally limit the device.
`
`7.
`
`Claim 21 is rejected under the judicially created doctrine of obviousness-type
`
`double patenting as being unpatentable over claim 1 of U.S. Patent No. 6,733,655.
`
`Claim 17, from which claim 21 depends, has been addressed above. Barring a contrary
`
`showing whether the working sensor parts are upstream or downstream is only intended
`
`use that does not further structurally limit the device.
`
`

`
`Application/Control Number: 10/431,140
`
`,
`
`V
`
`Page 5
`
`Art Unit: 1753
`
`8.
`
`Claims 22 and 23 are rejected under the judicially created doctrine of
`
`obviousness-type double patenting as being unpatentable over claim 1 of U.S. Patent
`
`No. 6,733,655. Claim 17, from which claim 22 depends, has been addressed above.
`
`Since the first and second working sensor parts are to measure the same substance
`
`and measurements obtained with these sensor parts are to be compared for errors it
`
`.
`
`would have been obvious to have the first and second working sensor parts identical as
`
`much as possible so that any difference in measurement values are due to
`
`manufacturing variability, not measurement conditions.
`
`9.
`
`Claim 24 is rejected under the judicially created doctrine of obviousness-type
`
`double patenting as being unpatentable over claim 2 of U.S. Patent No. 6,733,655.
`
`Claim 17, from which claim 24 depends, has been addressed above. Claim 2 of U.S.
`
`PatentvNo. 6,733,655 provides a measurement wait time as required.
`
`10.
`
`Claim 25 is rejected under the judicially created doctrine of obviousness-type
`
`double patenting as being unpatentable over claim 3 of U.S. Patent No. 6,733,655.
`
`Claim 17, from which claim 25 depends, has been addressed above. Claim 3 of U.S.
`
`Patent No. 6,733,655 provides additional limitations of claim 25.
`
`

`
`Application/Control Number: 10/431,140
`Art Unit: 1753
`
`'
`
`‘
`
`Page 6
`
`11.
`
`Claim 26 is rejected under the judicially created doctrine of obviousness-type
`
`double patenting as being unpatentable over claim 1 of U.S. Patent No. 6,733,655.
`
`Although the conflicting claims are not identical, they are not patentably distinct from
`
`each other because the method of claim 1 of U.S. Patent No. US 6,733,655 uses the
`
`device of claim 26 of the instant application.
`
`12.
`
`Claim 27 is rejected under the judicially created doctrine of obviousness-type
`
`double patenting as being unpatentable over claim 1 of U.S. Patent No. 6,733,655 in
`
`view of Nankai (US 5,120,420).
`
`Claim 26, from which claim 27 depends, has been
`
`addressed above. The claims of U.S. Patent No. 6,733,655 do not require the device to
`be configured to limit the sample liquid flow, particularly as claimed. Nankai discloses
`
`various configurations for a strip-type disposable device comprising two or more
`
`electrodes. See Figures 3, 4, 8, 10, 12, and 13. In the embodiments shown in Figures
`
`3, 4, 8, and 10 the devices are configured so that sample liquid only flows
`
`unidirectionally across the electrodes. Barring a contrary showing, n light of Nanaki, the
`
`choice of sample flow configuration, such as that claimed, will depend on where the
`
`sample inlet and the vent can be best located. An embodiment as shown in Figure 8 is
`
`suitable if sample can be more easily applied to a large area of the device, such as the
`
`top surface, rather then the thin edge. Furthermore, Nankai found that the sample
`
`rapidly reaches the electrodes with a unidirectional flow configuration. See col. 8:19-29.
`
`

`
`Application/Control Number: 10/431,140
`
`Page 7
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`Art Unit: 1753
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`13.
`
`Claim 28 is rejected under the judicially created doctrine of obviousness-type
`
`double patenting as being unpatentable over claim 1 of U.S. Patent No. 6,733,655.
`
`Claim 27, from which claim 28 depends, has been addressed above. Barring a contrary
`
`showing whether the working sensor parts are upstream or downstream is only intended
`
`use that does not further structurally limit the device.
`
`14.
`
`Claim 29 is rejected under the judicially created doctrine of obviousness-type
`
`double patenting as being unpatentable over claim 1 of U.S. Patent No. 6,733,655.
`
`Claim 26, from which claim 29 depends, has been addressed above. Barring a contrary
`
`showing whether the working sensor parts are upstream or downstream is only intended
`
`use that does not further structurally limit the device.
`
`15.
`
`Claims 30 and 31 are rejected under
`
`the judicially created doctrine of
`
`obviousness-type double patenting as being unpatentable over claim 1 of U.S. Patent
`
`No. 6,733,655. Claim 26, from which claim 30 depends, has been addressed above.
`
`Since the first and second working sensor parts are to measure the same substance
`
`and measurements obtained with these sensor parts are to be compared for errors it
`
`would have been obvious to have the first and second working sensor parts identical as
`
`much as possible so that any difference in measurement values are due to
`
`manufacturing variability, not measurement conditions.
`
`

`
`Application/Control Number: 10/431,140
`
`Page 8
`
`Art Unit: 1753
`
`16.
`
`Claim 32 is rejected under the judicially created doctrine of obviousness-type
`
`double patenting as being unpatentable over claim 3 of U.S. Patent No. 6,733,655.
`
`Claim 26, from which claim 32 depends, has been addressed above. Claim 3 of U.S.
`
`Patent No. 6,733,655 provides additional limitations of claim 32.
`
`17.
`
`Claim 33 is rejected under the judicially created doctrine of obviousness-type
`
`double patenting as being unpatentable over claim 1 of U.S. Patent No. 6,733,655.
`
`Although the conflicting claims are not identical, they are not patentably distinct from
`
`each other because the method of claim 1 of U.S. _Patent No. US 6,733,655 meets the
`
`limitations claim 33 of the instant application.
`
`18.
`
`Claim 34 is rejected under the judicially created doctrine of obviousness-type
`
`double patenting as being unpatentable over claim 2 of U.S. Patent No. 6,733,655.
`
`Claim 33, from which claim 34 depends, has been addressed above. Claim 2 of U.S.
`
`Patent No. 6,733,655 provides a measurement wait time as required.
`
`19.
`
`Claim 35 is rejected under the judicially created doctrine of obviousness-type
`
`double patenting as being unpatentable over claim 3 of U.S. Patent No. 6,733,655.
`
`Claim 33, from which claim 35 depends, has been addressed above. Claim 3 of U.S.
`
`Patent No. 6,733,655 provides additional limitations of claim 35.
`
`

`
`Application/Control Number: 10/431,140
`
`Page 9
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`Art Unit: 1753
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`Claim Objections
`
`20.
`
`Claim 17 is objected to because of the following informality: in line 7 “as” should
`
`be -- a --. Appropriate correction is required.
`
`Claim Rejections - 35 usc § 102
`
`21.
`
`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
`
`form the basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless —
`
`(b) the invention was patented or described in a printed publication in this or a foreign country or in public
`use or on sale in this country, more than one year prior to the date of application for patent in the United
`States.
`
`22.
`
`Claims 17, 25, 26, and 32 are rejected under 35 U.S.C. ‘102(b) as being
`
`anticipated by Nankai (US 5,120,420) (“Nanaki").
`
`Addressing claim 17, Nankai discloses a device for measuring the concentration
`
`of a substance in as ample liquid; the device comprising
`a first working sensor part (41) for generating charge carriers in proportion to the
`
`concentration of the substance in the sample liquid (col. 8255-61 and col. 5243-53);
`
`a second working sensor part (42) also for generating charge carriers in
`
`proportion to the concentration of the substance in the sample liquid (col. 921-5); and
`
`

`
`Application/Control Number: 10/431,140
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`Page 10
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`Art Unit: 1753
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`a reference sensor part (5) which is a- common reference for both the first and
`
`second working sensor parts (Figure 13), wherein the first and second working sensor
`
`parts and the reference sensor part are provided on a disposable test strip (Figure 13).
`
`Addressing claims 25 and 32, the device of Figure 13 of Nankai is a glucose
`
`sensor. See col. 8:53-54-65.
`
`Addressing claim 26, Nankai discloses a test member for measuring the
`
`concentration of a substance in a sample liquid comprising
`
`a base member (1);
`
`two working sensor parts (41,42) provided on the base member;
`
`a reference sensor part (5) which is a common reference for each working
`
`sensor part, each working sensor part being arranged in use to generate charge carriers
`
`in proportion to the concentration of the substance in the sample liquid (col. 8:55-61 and
`
`col. 5:43-53).
`
`Claim Rejections - 35 USC § 103
`
`23.
`
`The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`

`
`Application/Control Number: 10/431,140
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`Page 11
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`Art Unit: 1753
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`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which theinvention was made.
`
`24.
`
`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148
`
`USPQ 459 (1966),
`
`that are applied for establishing a background for determining
`
`obviousness under 35 U.S.C. 103(a) are summarized as follows:
`
`:"‘.°°!°.-‘
`
`Determining the scope and contents 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.
`Considering objective evidence present
`in the application indicating
`obviousness or nonobviousness.
`
`25.
`
`This application currently names joint inventors.
`
`In considering patentability of
`
`the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of
`
`the various claims was commonly owned at the time any inventions covered therein
`
`were made absent any evidence to the contrary. Applicant is advised of the obligation
`
`under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was
`
`not commonly owned at the time a later invention was made in order for the examiner to
`
`consider the applicability of 35 U.S.C. 103(c)‘and potential 35 U.S.C. 102(e), (f) or (g)
`
`prior art under 35 U.S.C. 103(a).
`
`26.
`
`Claims 18-24 and 27-31 are rejected under 35 . U.S.C. 103(a) as being
`
`unpatentable over Nankai (US 5,120,420) (“Nanaki").
`
`Addressing claims 18 and 20, Nankai discloses a device for measuring the
`
`concentration of a substance in a sample liquid; the device comprising
`
`a first working sensor part (41) for generating charge carriers in proportion to the
`
`

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`Application/Control Number: 10/431,140
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`Page 12
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`Art Unit: 1753
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`concentration of the substance in the sample liquid (col. 8:55-61 and col. 5243-53);
`
`a second working sensor part (42) also for generating charge carriers in
`
`proportion to the concentration of the substance in the sample liquid (col. 921-5); and
`
`a reference sensor part (5) which is a common reference for both the first and
`
`second working sensor parts (Figure 13), wherein the first and second working sensor
`
`parts and the reference sensor part are provided on a disposable test strip (Figure 13).
`
`In the embodiment of Figure 13 the sample flows in parallel from inlet 10 over the
`
`working electrodes and then the counter electrode to discharge ports 11 and 12. See
`
`col. 8:65-68. However, Nankai discloses several other configurations for a strip-type
`
`disposable device comprising two or more electrodes. See Figures 3, 4, 8, 10, and 12.
`
`In the embodiments shown in Figures 3, 4, 8, and 10 the devices are configured so that
`
`sample liquid only flows unidirectionally across the electrodes. Barring a contrary
`
`showing, n light of the other embodiments of Nanaki,
`
`the choice of sample flow
`
`configuration, such as that claimed, will depend on where the sample inlet and the vent
`
`can be best located. An embodiment as shown in Figure 8 is suitable if sample can be
`
`more easily applied to a large area of the device, such as the top surface, rather then
`
`the - thin edge.
`
`Furthermore, Nankai found that
`
`the sample rapidly reaches the
`
`electrodes with a unidirectional flow configuration. See col. 8:19-29. For claim 20, note
`
`that with a flow configuration as shown in Figure 8 the working sensor parts will
`
`inherently be downstream of one another.
`
`

`
`Application/Control Number: 10/431,140
`
`Page 13
`
`Art Unit: 1753
`
`Addressing claims 19 and 21, Nankai discloses a device for measuring the
`
`concentration of a substance in a sample liquid; the device comprising
`
`a first working sensor part (41) for generating charge carriers in proportion to the
`
`concentration of the substance in the sample liquid (col. 8:55-61 and col. 5:43-53);
`
`a second working sensor part (42) also for generating charge carriers in
`
`proportion to the concentration of the substance in the sample liquid (col. 921-5); and
`
`a reference sensor part (5) which is a common reference for both the first and
`
`second working sensor parts (Figure 13), wherein the first and second working sensor
`
`parts and the reference sensor part are provided on a disposable test strip (Figure 13).
`
`Although the working sensor parts in Figure 3 are intended to be upstream (port
`
`10 is an inlet port and ports 11 and 12 are discharge ports — col. 8:65-68), whether the
`
`working sensor parts are upstream or downstream of the reference sensor part is only
`
`intended use that does not further structurally limit the device. The discharge ports
`
`could be used as sample inlets.
`
`Addressing claims 22 and 23, Nankai discloses a device for measuring the
`
`concentration of a substance in a sample liquid; the device comprising
`
`a first working sensor part (41) for generating charge carriers in proportion to the
`concentration of the substance in the sample liquid (col. 8:55-61 and col. 5:43-53);
`
`a second working sensor part (42) also for generating charge carriers in
`
`proportion to the concentration of the substance in the sample liquid (col. 921-5); and
`
`

`
`Application/Control Number: 10/431,140
`Art Unit: 1753
`
`‘-
`
`Page 14
`
`a reference sensor part (5) which is a common reference for both the first and
`
`second working sensor parts (Figure 13), wherein the first and second working sensor
`
`parts and the reference sensor part are provided on a disposable test strip (Figure 13).
`
`Nankai arguably discloses the sensor parts having the same area in Figure 13.
`
`In any event, since the first and second working sensor parts are to measure the same
`
`substance and the average of the measurements obtained with these sensor parts is to
`
`be used to calculate the substance concentration it would have been obvious to have
`
`the first and second working sensor parts identical as much as possible so that any
`
`difference
`
`in measurement values
`
`are due
`
`to manufacturing variability,
`
`not
`
`measurement conditions.
`
`Addressing claim 24, Nankai discloses a device for measuring the
`
`concentration of a substance in a sample liquid; the device comprising
`
`a first working sensor part (41) for generating charge carriers in. proportion to the
`
`concentration of the substance in the sample liquid (col. 8:55-61 and col. 5:43-53);
`
`a second working sensor part (42) also for generating charge carriers in
`
`proportion to the concentration of the substance in the sample liquid (col. 921-5); and
`
`a reference sensor part (5) which is a common reference for both the first and
`
`second working sensor parts (Figure 13), wherein the first and second working sensor
`parts and the reference sensor part are provided on a disposable test strip (Figure 13).
`
`Although the discussion of the embodiment in Figure 13 does not mention a
`
`measurement delay after applying the sample, Nankai does disclose such a delay for
`
`

`
`Application/Control Number: 10/431,140
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`another embodiment. See Figure 5:54-59.
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`It would have been obvious to one with
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`ordinary skill in the art at the time of the invention to provide a measurement delay also
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`in the embodiment of Figure 13 because this will allow the enzyme or reagent to
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`substantially react with the analyte. This is commonly referred to in the art as an
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`incubation period.
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`Addressing claim 27, Nankai discloses a test member for measuring the
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`concentration of a substance in a sample liquid comprising
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`a base member (1);
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`two working sensor parts (41 ,42) provided on the base member;
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`a reference sensor part (5) which is a common reference for each working
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`sensor part, each working sensorpart being arranged in use to generate charge carriers
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`in proportion to the concentration of the substance in the sample liquid (col. 8:55-61 and
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`col. 5:43-53).
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`In the embodiment of Figure 13 the sample flows in parallel from inlet 10 over the
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`working electrodes and then the counter electrode to discharge ports 11 and 12. See
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`col. 8:65-68. However, Nankai discloses several other configurations for a strip-type
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`disposable device comprising two or more electrodes. See Figures 3, 4, 8, 10, and 12.
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`In the embodiments shown in Figures 3, 4, 8, and 10 the devices are configured so that
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`sample liquid only flows unidirectionally across the electrodes. Barring a contrary
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`showing, n light of the other embodiments of Nanaki,
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`the choice of sample flow
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`configuration, such as that claimed, will depend on where the sample inlet and the vent
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`Application/Control Number: 10/431,140
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`1
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`can be best located. An embodiment as shown in Figure 8 is suitable if sample can be
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`more easily applied to a large area of the device, such as the top surface, rather then
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`the thin edge.
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`Furthermore, Nankai
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`found that
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`the sample rapidly reaches the
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`electrodes with a unidirectional flow configuration. See col. 8:19-29. For claim 20, note
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`that with a flow configuration as shown in Figure 8 the working sensor parts will
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`inherently be downstream of one another.
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`Addressing claim 28, Nankai discloses a test member for measuring the
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`concentration of a substance in a sample liquid comprising
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`a base member (1);
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`two working sensor parts (41 ,42) provided on the base member;
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`a reference sensor part (5) which is a common reference for each working
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`sensor part, each working sensor part being arranged in use to generate charge carriers
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`in proportion to the concentration of the substance in the sample liquid (col. 8:55-61 and
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`col. 5:43-53).
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`Although the working sensor parts in Figure 3 are intended to be upstream (port
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`10 is an inlet port and ports 11 and 12 are discharge ports — col. 8:65-68), whether the
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`working sensor parts are upstream or downstream of the reference sensor part is only
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`intended use that does not further structurally limit the device. The discharge ports
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`could be used as sample inlets.
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`'
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`Addressing claim 29, Nankai discloses a test member for measuring the
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`concentration of a substance in a sample liquid comprising
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`a base member (1 );
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`two working sensor parts (41 ,42) provided on the base member;
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`a reference sensor part (5) which is a common reference for each working
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`sensor part, each working sensor part being arranged in use to generate charge carriers
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`in proportion to the concentration of the substance in the sample liquid (col. 8255-61 and
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`col. 5:43-53).
`
`Although the working sensor parts in Figure 3 are intended to be upstream (port
`10 is an inlet port and ports 11 and 12 are discharge ports — col. 8:65-68), whether the
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`working sensor parts are upstream or downstream of the reference sensor part is only
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`intended use that does not further structurally limit the device. The discharge ports
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`could be used as sample inlets.
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`Addressing claims 30 and 31, Nankai discloses a test member for measuring the
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`concentration of a substance in a sample liquid comprising
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`a base member (1);
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`two working sensor parts (41.42) provided on the base member;
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`a reference sensor part (5) which is a common reference for each working
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`sensor part, each working sensor part being arranged in use to generate charge carriers
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`in proportion to the concentration of the substance in the sample liquid (col. 8:55-61 and
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`col. 5:43-53).
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`Nankai arguably discloses the sensor parts having the same area in Figure 13.
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`In any event, since the first and second working sensor parts are to measure the same
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`substance and the average of the measurements obtained with these sensor parts is to
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`be used to calculate the substance concentration it would have been obvious to have
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`the first and second working sensor parts identical as much as possible so that any
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`difference
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`in measurement values
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`are due to manufacturing variability,
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`not
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`measurement conditions.
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`27.
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`Claims 33-35 are rejected under 35 U.S.C. 103(a) as being unpatentable over
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`Nankai (US 5,120,420) (“Nanaki”) in view of Horii (US 5,004,998) ("Horii").
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`Addressing claim 33, Nankai discloses a device as set forth in claim 17. See the
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`rejection under 35 U.S.C. 102(b) above. The “applying” and “measuring" steps of claim
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`33 are just using the measuring device as intended. Nankai does not mention
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`“comparing the electric current from each of the working sensor parts to establish a
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`difference parameter; and giving an indication of an error of said difference parameter is
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`greater than a predetermined threshold.” Although,
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`it should be noted that Nankai
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`averages the measurement values from working sensor parts (col. 921-5) and discloses
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`determining the coefficient of variation for a lot of 30 sensors (col. 9:5-7).
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`I
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`Horii discloses a measurement device comprising several of
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`the same
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`electrochemical sensors.
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`Horii
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`further discloses using an average value of the
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`measurement values from these sensors for computing the concentration of the
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`substance of interest and also comprising the measurement values from the sensors to
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`judge whether any of the sensors are abnormal. See the abstract and Figures 1 and 2.
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`it would have been obvious to also compare the measured values from the sensor parts
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`‘of Nankai to see if they are too different because this will indicate whether one of the
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`sensor parts is not function correctly and so whether its measurement value should be
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`excluded from the calculation of the substance concentration.
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`Addressing claim 34, although the discussion of the embodiment in Figure 13
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`does not mention a measurement delay after applying the sample, Nankai does
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`disclose such a delay for another embodiment. See Figure 5:54-59.
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`it would have
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`been obvious to one with ordinary skill invthe art at the time of the invention to provide a
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`measurement delay also in the embodiment of Figure 13 because this will allow the
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`enzyme or reagent to substantially react with the substance. This is commonly referred
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`to in the art as an incubation period.
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`Addressing claim 35, the device of Figure 13 of Nankai is a glucose sensor. See
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`col. 8:53-54-65.
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`Specification
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`28.
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`This application does not contain an abstract of the disclosure as required by 37
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`CFR 1.72(b). An abstract on a separate sheet is required.
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`It should be 150 words or
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`less. MPEP 608.01 (b).
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`Official action issued by the Patent Office of the Russian Federation
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`29.
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`Several claims appear to have been rejected over WO 99/58709 in the Official
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`action issued by the Patent Office of the Russian Federation. Independent claims 17
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`and 26 require the working sensor parts to generate charge carriers in proportion to the
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`concentration of the substance in the sample liquid.
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`In WO 99/58709 electrode 5 is a
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`working electrode and electrode 5a is a “dummy” electrode it is the same as electrode 5
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`except that it does not have a material such as enzyme that reacts with the substance
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`of interest in the sample. See page 9:3-14. Thus, the signals from the dummy
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`electrode arise from spurious reactions and indicate background noise not a
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`concentration of the substance in the sample liquid.
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`Application/Control Number: 10/431,140
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`30.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to ALEX NOGUEROLA whose telephone number is (571) 272-
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`1343. The examiner can normally be reached on M-F 8:30 - 5:00.
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`If attempts to reach the