UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMIVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
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`'I AND1%9
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`14/479,936
`
`09/08/2014
`
`Yuki MARUYAMA
`
`20249.0116USD1
`
`1924
`
`HAMRE, SCHUMANN, MUELLER & LARSON P.C.
`PO. BOX 2902
`MINNEAPOLIS, MN 55402-0902
`
`FAN, LYNN Y
`
`PAPER NUIVIBER
`
`ART UNIT
`
`1651
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`11/06/2015
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e—mail address(es):
`PTOMail @hsml.c0m
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`
`Applicant(s)
`Application No.
` 14/479,936 MARUYAMA ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventorto File)
`Office Action Summary
`
`1651Lynn Y. Fan a?”
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR1. 136(a).
`after SIX () 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).
`
`In no event, however, may a reply be timely filed
`
`-
`-
`
`Status
`
`1)IXI Responsive to communication(s) filed on 8/7/2015.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)lX| This action is non-final.
`a)I:| This action is FINAL.
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
`
`
`; the restriction requirement and election have been incorporated into this action.
`
`4)|: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 Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`5)|XI Claim(s) M is/are pending in the application.
`5a) Of the above claim(s) 1_6 is/are withdrawn from consideration.
`6)|:l Claim(s)_ is/are allowed.
`7)IZ| Claim(s) 15 and 17- 19is/are rejected.
`
`8)IZ| Claim(s)_15 and 17is/are objected to.
`
`9)|:l Claim((s)
`are subject to restriction and/or election requirement.
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`
`participating intellectual property office for the corresponding application. For more information, please see
`htt
`://www.usoto. ov/ atents/init events,"
`h/‘index.
`
`
`
`‘3 , or send an inquiry to PF"I-Ifeedback{<‘buspto.qov.
`
`
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`11)|Z| The drawing(s) filed on 9/8/2014 is/are: a)lZl accepted or b)I:I 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).
`
`Priority under 35 U.S.C. § 119
`12)IZI Acknowledgment is made of a claim for foreign priority under 35 U.S.C. §119(a)-(d) or (f).
`Certified copies:
`
`b)I:I Some” c)I:I None of the:
`a)le All
`1.I:I Certified copies of the priority documents have been received.
`2.|Zl Certified copies of the priority documents have been received in Application No. 2009166211.
`33.le 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)
`
`
`
`3) D Interview Summary (PT0_413)
`1) E Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`—
`4) I:I Other'
`2) E InformatIon DIscIosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mai| Date
`US. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20150925
`
`

`

`Application/Control Number: 14/479,936
`
`Page 2
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`Art Unit: 1651
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`DETAILED ACTION
`
`The present application is being examined under the pre—AIA first to invent provisions.
`
`Status of the Claims
`
`1.
`
`Claims 1—14 have been canceled.
`
`Claims 15—19 are currently pending.
`
`Election/Restrictions
`
`2.
`
`Applicant’s election of Group 1, Claims 15 and 17—19, in the reply filed on 8/7/2015 is
`
`acknowledged. Because applicant did not distinctly and specifically point out the supposed errors
`
`in the restriction requirement, the election has been treated as an election without traverse
`
`(MPEP § 818.03(a)).
`
`The requirement is still deemed proper and is therefore made FINAL.
`
`Claim 16 has been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as
`
`being drawn to nonelected inventions and species, there being no allowable generic or linking
`
`claims.
`
`Claims 15 and 17—19 are being examined in this application.
`
`Claim Objections
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`3.
`
`Claims 15 and 17 are objected to because of the following informalities:
`
`Claim 15, line 3, the recitation of “apassage” is suggested to read “a passage”, and the
`
`recitation of “a measuring cell,” is suggested to read “a measuring cell; and”.
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`

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`Application/Control Number: 14/479,936
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`Page 3
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`Art Unit: 1651
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`Claim 17, line 11, the recitation of “adj acent” is suggested to read “adjacent”.
`
`Appropriate correction is required.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of pre—AIA 35 USC. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(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 the invention was made.
`
`This application currently names joint inventors. In considering patentability of the claims under
`pre-AIA 35 USC. 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 pre-AIA 35 USC. 103(c) and potential pre-AIA 35
`USC. 102(e), (f) or (g) prior art under pre-AIA 35 USC. 103(a).
`
`4.
`
`Claim 15 is rejected under pre—AIA 35 USC. 103(a) as being unpatentable over
`
`Okamoto et al (JP 2007/315879 A; 12/6/2007) in view of Roblin et al (US 2008/0135419 A1;
`
`6/12/2008).
`
`The instant claims recite an analysis device, comprising: a microchannel structure
`
`rotatable about a rotation aXis of the analysis device, the microchannel structure including a
`
`passage and a measuring cell; an analysis reagent carried in the passage of the microchannel
`
`structure, the analysis reagent being in a solid and dry state, the analysis reagent comprising a
`
`combination of a polyanionic compound and a bivalent cationic compound, and one substance or
`
`one compound of the substance as an additive, wherein the substance is at least one selected
`
`

`

`Application/Control Number: 14/479,936
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`Page 4
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`Art Unit: 1651
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`from the group consisting of: succinic acid, gluconic acid, alanine, glycine, valine, histidine,
`
`maltitol, and mannitol.
`
`Okamoto teaches an analysis device comprising a rotational drive means for rotating
`
`around an aXis, and a microchannel structure includes a capillary (a passage) (Fig. 2 capillary
`
`205) and a chamber (a measuring cell) (para 0026, 0045, 0053), wherein the analysis device is
`
`useful for measuring and analyzing HDL—C (high—density lipoprotein cholesterol) (para 0036,
`
`0066).
`
`Okamoto does not teach the analysis device comprises the claimed reagent, as recited in
`
`claim 15.
`
`However, Okamoto does teach the analysis device comprises reagents necessary for
`
`analyzing HDL—C (para 0037, 0055). Roblin teaches a reagent (an analysis reagent) useful for
`
`determining the amount of cholesterol bound to high—density lipoprotein cholesterol (HDL—C)
`
`(para 0001), comprising a combination of polyanions with divalent metal salts (para 0086—0087)
`
`and an excipient (an additive) such as mannitol or glycine that is useful for stabilizing the reagent
`
`(para 0080), wherein the reagent is in a solid/dried form (para 0088).
`
`Thus, at the time of the claimed invention, it would have been obvious to one of ordinary
`
`skill in the art to incorporate the claimed reagent in the analysis device of Okamoto since the
`
`analysis device of Okamoto is useful for measuring and analyzing HDL—C, which comprises
`
`reagents necessary for analyzing HDL—C, and the reagent of Roblin is useful for determining the
`
`amount of cholesterol in HDL—C. Moreover, at the time of the claimed invention, one of ordinary
`
`skill in the art would have been motivated by the cited reference to incorporate the claimed
`
`reagent with a reasonable expectation for successfully obtaining an analysis device.
`
`

`

`Application/Control Number: 14/479,936
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`Page 5
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`Art Unit: 1651
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`5.
`
`Claims 15 and 17—19 are rejected under pre—AIA 35 U.S.C. 103(a) as being unpatentable
`
`over Okamoto et al (JP 2007/315879 A; 12/6/2007) in view of Roblin et al (US 2008/0135419
`
`A1; 6/12/2008), Saeki et al (JP 2007/078676 A; 3/29/2007) and Bibbo et al (US 6,981,794 B2;
`
`1/3/2006).
`
`The instant claims recite an analysis device, comprising: a microchannel structure
`
`rotatable about a rotation aXis of the analysis device, the microchannel structure including a
`
`passage and a measuring cell; an analysis reagent carried in the passage of the microchannel
`
`structure, the analysis reagent being in a solid and dry state, the analysis reagent comprising a
`
`combination of a polyanionic compound and a bivalent cationic compound, and one substance or
`
`one compound of the substance as an additive, wherein the substance is at least one selected
`
`from the group consisting of: succinic acid, gluconic acid, alanine, glycine, valine, histidine,
`
`maltitol, and mannitol.
`
`Okamoto teaches an analysis device comprising: a rotational drive means for rotating
`
`around an aXis (para 0026); a first chamber (a reserving cavity) disposed around the rotation aXis
`
`that allows a liquid sample to be injected thereinto (para 0037); a second chamber (an operation
`
`cavity) that is connected to the first chamber (the reserving cavity) by a capillary (a
`
`passage/connecting section) enabling application of a capillary force, wherein the second
`
`chamber (the operation cavity) contains a reagent (para 0037, 0055, 0056); a third chamber (a
`
`separating cavity) that is formed outside the second chamber (the operation cavity) and is
`
`connected to the second chamber (the operation cavity) by a capillary (a connecting passage) to
`
`apply a capillary force, wherein aggregates are produced and centrifuged in the third chamber
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`

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`Application/Control Number: 14/479,936
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`Page 6
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`Art Unit: 1651
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`(the separating cavity) (para 0037, 0043—0045, 0059); and a fourth chamber (a measuring
`
`passage) that is connected to the third chamber (the separating cavity) by a capillary (a
`
`connecting passage) (para 0037, 0045), wherein the capillaries are microchannel structures (para
`
`0053), and the analysis device is useful for measuring and analyzing HDL—C (high—density
`
`lipoprotein cholesterol) (para 0036, 0066).
`
`Okamoto teaches the analysis device wherein the second chamber (the operation cavity)
`
`comprises a reagent carrying section containing a reagent (Fig. 12 region 402), and the reagent
`
`carrying section protruding (interpreted to mean extend beyond or above a surface) from the
`
`operation cavity and has a clearance smaller than the clearance of the operation cavity (para
`
`0069).
`
`Okamoto does not teach the analysis device comprises the claimed reagent, as recited in
`
`claim 15.
`
`However, Okamoto does teach the analysis device comprises reagents necessary for
`
`analyzing HDL—C (para 0037, 0055). Roblin teaches a reagent (an analysis reagent) useful for
`
`determining the amount of cholesterol bound to high—density lipoprotein cholesterol (HDL—C)
`
`(para 0001), comprising a combination of polyanions with divalent metal salts (para 0086—0087)
`
`and an excipient (an additive) such as mannitol or glycine that is useful for stabilizing the reagent
`
`(para 0080), wherein the reagent is in a solid/dried form (para 0088).
`
`Thus, at the time of the claimed invention, it would have been obvious to one of ordinary
`
`skill in the art to incorporate the claimed reagent in the analysis device of Okamoto since the
`
`analysis device of Okamoto is useful for measuring and analyzing HDL—C, which comprises
`
`reagents necessary for analyzing HDL—C, and the reagent of Roblin is useful for determining the
`
`

`

`Application/Control Number: 14/479,936
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`Page 7
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`Art Unit: 1651
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`amount of cholesterol in HDL—C. Moreover, at the time of the claimed invention, one of ordinary
`
`skill in the art would have been motivated by the cited reference to incorporate the claimed
`
`reagent with a reasonable expectation for successfully obtaining an analysis device.
`
`Okamoto does not teach the analysis device wherein the operation cavity is formed next
`
`to the reserving cavity in a circumferential direction, and the device comprises a measuring cell
`
`that is formed outside the measuring passage and a capillary area that is formed inside the
`
`measuring cell, as recited in claim 17.
`
`However, Okamoto does teach the analysis device comprises a first chamber (a reserving
`
`cavity), a second chamber (an operation cavity), and a fourth chamber (a measuring passage),
`
`wherein the analysis device is used for optically analyzing a biological fluid (para 0001). Saeki
`
`teaches a rotatable analysis device comprising a microchannel configuration including a holding
`
`channel (a measuring passage) that is formed adjacent to a separation chamber (a separating
`
`cavity) in a circumferential direction and is connected to the separation chamber (the separating
`
`cavity) by a connecting passage to apply a capillary force, and a measuring cell that is formed
`
`outside the holding channel (the measuring passage) (para 0041, 0045, Fig. 5), wherein the
`
`biological fluid flows into the measuring cell by increasing the centrifugal force, the measuring
`
`cell contains a reagent, which is mixed with the biological fluid (a capillary area that is formed
`
`inside the measuring cell) (para 0059), and the analysis device is used for optically analyzing a
`
`biological fluid (para 0001).
`
`Thus, at the time of the claimed invention, it would have been obvious to one of ordinary
`
`skill in the art to form cavities next to each other in a circumferential direction as well as to
`
`incorporate a measuring cell that is formed outside a measuring passage since Okamoto and
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`

`

`Application/Control Number: 14/479,936
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`Page 8
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`Art Unit: 1651
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`Saeki both disclose a rotatable analysis device for optically analyzing a biological fluid by
`
`generating a capillary force, and Saeki discloses that the rotatable analysis device includes
`
`cavities formed next to each other in a circumferential direction, and that a measuring cell is used
`
`for measuring the number of cells (para 0041). Moreover, at the time of the claimed invention,
`
`one of ordinary skill in the art would have been motivated by the cited reference to form cavities
`
`next to each other in a circumferential direction as well as to incorporate a measuring cell that is
`
`formed outside a measuring passage, with a reasonable expectation for successfully obtaining an
`
`analysis device.
`
`The references cited above do not teach the analysis device further comprising an
`
`agitating rib extended in a radial direction in the operation cavity, the agitating rib being lower in
`
`height than an external wall of the operation cavity, as recited in claim 19.
`
`However, Saeki does teach the analysis device comprises an operation cavity where the
`
`reaction between the fluid sample and the dry reagent takes place (para 0055). Bibbo teaches a
`
`system for mixing a liquid and a dry material together to produce a homogeneous solution (col.4
`
`line 18—24), comprising vertically oriented ribs extending between inner wall and central wall (an
`
`agitating rib extended in a radial direction in the cavity, and being lower in height than an
`
`external wall of the cavity) (col.5 line 49—51, Fig. 3), wherein the ribs function to uniformly
`
`distribute the fluid, and the ribs can be oriented to flow in a variety of different paths (col.6 line
`
`22-27).
`
`Thus, at the time of the claimed invention, it would have been obvious to one of ordinary
`
`skill in the art to incorporate an agitating rib since Saeki discloses that the fluid sample and the
`
`dry reagent are mixed together in the operation cavity, and Bibbo discloses that a rib functions to
`
`

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`Application/Control Number: 14/479,936
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`Page 9
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`Art Unit: 1651
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`uniformly distribute a fluid within a chamber. Moreover, at the time of the claimed invention,
`
`one of ordinary skill in the art would have been motivated by the cited reference to incorporate
`
`an agitating rib with a reasonable expectation for successfully obtaining an analysis device.
`
`In addition, in regard to claims 17 and 18, the recitations of “that receives ...” (claim 17
`
`line 2—3), “enabling ...” (claim 17 line 5—6), “serving as ...” (claim 17 line 8—10), “configured to
`
`...” (claim 17 line 12—14), “contains ...” (claim 17 line 16—17), “wherein ...” (claim 17 line 18—
`
`21), and “configured to ...” (claim 18 line 2—4) do not recite a positive limitation (i.e., does not
`
`limit the claims to a particular structure) but only require the ability to perform, as such, these
`
`limitations are considered process or intended use limitations. Since the claims are drawn to an
`
`apparatus, it is the structural limitations of the apparatus, as recited in the claims, which are
`
`considered in determining the patentability of the apparatus itself. These recited process or
`
`intended use limitations are accorded no patentable weight to an apparatus. Furthermore, a
`
`recitation of the intended use of the claimed invention must result in a structural difference
`
`between the claimed invention and the prior art in order to patentably distinguish the claimed
`
`invention from the prior art. If the prior art structure is capable of performing the intended use,
`
`then it meets the claim. (MPEP 2112.01, 2114) Therefore, the “enzyme reagent” and “mediator”
`
`and “receives , enabling ,
`
`serving as , configured to”, and “wherein” clauses in claims 17
`
`and 18 are not considered to further limit the analysis device defined by the claims.
`
`Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created 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
`
`

`

`Application/Control Number: 14/479,936
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`Page 10
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`Art Unit: 1651
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`assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not
`identical, but at least one examined application claim is not patentably distinct from the reference claim(s)
`because the examined application claim is either anticipated by, or would have been obvious over, the
`reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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 CFR 1.321(c) or 1.321(d) may be used
`to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided
`the reference application or patent either is shown to be commonly owned with this application, or claims
`an invention made as a result of activities undertaken within the scope of a joint research agreement. A
`terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
`The USPTO internet Web site contains terminal disclaimer forms which may be used. Please
`visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be
`used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An
`eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon
`submission. For more information about eTerminal Disclaimers, refer to
`
`http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.j sp.
`
`6.
`
`Claim 15 is rejected on the ground of nonstatutory obviousness—type double patenting as
`
`being unpatentable over claims 1 and 5 of US. Patent No 9,134,286 (referred to as the ‘286
`
`patent) in view of Roblin et al (US 2008/0135419 A1; 6/12/2008).
`
`Claims 1 and 5 of the ‘286 patent recite an analyzing device having a microchannel
`
`structure rotatable about a rotation axis of the analysis device, the microchannel structure
`
`including an inlet (a passage) and a measurement spot (a measuring cell).
`
`The ‘286 patent does not teach the analysis device comprises the claimed reagent, as
`
`recited in claim 15.
`
`Roblin teaches a reagent (an analysis reagent) useful for determining the amount of
`
`cholesterol bound to high—density lipoprotein cholesterol (HDL—C) (para 0001), comprising a
`
`combination of polyanions with divalent metal salts (para 0086—0087) and an excipient (an
`
`additive) such as mannitol or glycine that is useful for stabilizing the reagent (para 0080),
`
`wherein the reagent is in a solid/dried form (para 0088).
`
`

`

`Application/Control Number: 14/479,936
`
`Page 11
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`Art Unit: 1651
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`Thus, at the time of the claimed invention, it would have been obvious to one of ordinary
`
`skill in the art to incorporate the claimed reagent in the analysis device of the ‘286 patent since
`
`Roblin discloses that the claimed reagent is useful for determining the amount of cholesterol in
`
`HDL—C. Moreover, at the time of the claimed invention, one of ordinary skill in the art would
`
`have been motivated by the cited reference to incorporate the claimed reagent with a reasonable
`
`expectation for successfully obtaining an analysis device.
`
`7.
`
`Claim 15 is rejected on the ground of nonstatutory obviousness—type double patenting as
`
`being unpatentable over claim 1 of US. Patent No 9,046,503 (referred to as the ‘503 patent) in
`
`view of Roblin et al (US 2008/0135419 A1; 6/12/2008).
`
`Claim 1 of the ‘503 patent recite an analyzing device having a microchannel structure
`
`rotatable about a rotation aXis of the analysis device, the microchannel structure including a
`
`connecting section (a passage) and a measurement spot (a measuring cell).
`
`The ‘503 patent does not teach the analysis device comprises the claimed reagent, as
`
`recited in claim 15.
`
`However, the ‘503 patent does teach the analysis device comprises a reagent (Claim 1).
`
`Roblin teaches a reagent (an analysis reagent) useful for determining the amount of cholesterol
`
`bound to high—density lipoprotein cholesterol (HDL—C) (para 0001), comprising a combination of
`
`polyanions with divalent metal salts (para 0086—0087) and an excipient (an additive) such as
`
`mannitol or glycine that is useful for stabilizing the reagent (para 0080), wherein the reagent is in
`
`a solid/dried form (para 0088).
`
`

`

`Application/Control Number: 14/479,936
`
`Page 12
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`Art Unit: 1651
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`Thus, at the time of the claimed invention, it would have been obvious to one of ordinary
`
`skill in the art to incorporate the claimed reagent in the analysis device of the ‘503 patent since
`
`the ‘503 patent discloses that the analysis device comprises a reagent, and Roblin specifically
`
`discloses that the claimed reagent is useful for determining the amount of cholesterol in HDL—C.
`
`Moreover, at the time of the claimed invention, one of ordinary skill in the art would have been
`
`motivated by the cited reference to incorporate the claimed reagent with a reasonable expectation
`
`for successfully obtaining an analysis device.
`
`8.
`
`Claim 15 is rejected on the ground of nonstatutory obviousness—type double patenting as
`
`being unpatentable over claim 1 of US. Patent No 8,865,472 (referred to as the ‘472 patent) in
`
`view of Roblin et al (US 2008/0135419 A1; 6/12/2008).
`
`Claim 1 of the ‘472 patent recite an analytical device rotatable about a rotation aXis,
`
`comprising a microchannel structure (a passage) and a measurement cell with a capillary area.
`
`The ‘472 patent does not teach the analysis device comprises the claimed reagent, as
`
`recited in claim 15.
`
`Roblin teaches a reagent (an analysis reagent) useful for determining the amount of
`
`cholesterol bound to high—density lipoprotein cholesterol (HDL—C) (para 0001), comprising a
`
`combination of polyanions with divalent metal salts (para 0086—0087) and an excipient (an
`
`additive) such as mannitol or glycine that is useful for stabilizing the reagent (para 0080),
`
`wherein the reagent is in a solid/dried form (para 0088).
`
`Thus, at the time of the claimed invention, it would have been obvious to one of ordinary
`
`skill in the art to incorporate the claimed reagent in the analysis device of the ‘472 patent since
`
`

`

`Application/Control Number: 14/479,936
`
`Page 13
`
`Art Unit: 1651
`
`Roblin discloses that the claimed reagent is useful for determining the amount of cholesterol in
`
`HDL—C. Moreover, at the time of the claimed invention, one of ordinary skill in the art would
`
`have been motivated by the cited reference to incorporate the claimed reagent with a reasonable
`
`expectation for successfully obtaining an analysis device.
`
`9.
`
`Claim 15 is rejected on the ground of nonstatutory obviousness—type double patenting as
`
`being unpatentable over claims 1 and 2 of US. Patent No 8,709,346 (referred to as the ‘346
`
`patent) in view of Roblin et al (US 2008/0135419 A1; 6/12/2008).
`
`Claims 1 and 2 of the ‘346 patent recite an analytical device rotatable about a rotation
`
`aXis, comprising a joint structure (a passage) to apply a capillary force (utilizing a
`
`microstructure) and a measurement cell.
`
`The ‘346 patent does not teach the analysis device comprises the claimed reagent, as
`
`recited in claim 15.
`
`Roblin teaches a reagent (an analysis reagent) useful for determining the amount of
`
`cholesterol bound to high—density lipoprotein cholesterol (HDL—C) (para 0001), comprising a
`
`combination of polyanions with divalent metal salts (para 0086—0087) and an excipient (an
`
`additive) such as mannitol or glycine that is useful for stabilizing the reagent (para 0080),
`
`wherein the reagent is in a solid/dried form (para 0088).
`
`Thus, at the time of the claimed invention, it would have been obvious to one of ordinary
`
`skill in the art to incorporate the claimed reagent in the analysis device of the ‘346 patent since
`
`Roblin discloses that the claimed reagent is useful for determining the amount of cholesterol in
`
`HDL—C. Moreover, at the time of the claimed invention, one of ordinary skill in the art would
`
`

`

`Application/Control Number: 14/479,936
`
`Page 14
`
`Art Unit: 1651
`
`have been motivated by the cited reference to incorporate the claimed reagent with a reasonable
`
`expectation for successfully obtaining an analysis device.
`
`10.
`
`Claim 15 is rejected on the ground of nonstatutory obviousness—type double patenting as
`
`being unpatentable over claim 1 of US. Patent No 8,667,833 (referred to as the ‘833 patent) in
`
`view of Roblin et al (US 2008/0135419 A1; 6/12/2008).
`
`Claim 1 of the ‘833 patent recite an analyzing device having a microchannel structure
`
`rotatable about a rotation aXis of the analysis device, the microchannel structure including an
`
`inlet (a passage) and a measurement spot (a measuring cell).
`
`The ‘833 patent does not teach the analysis device comprises the claimed reagent, as
`
`recited in claim 15.
`
`Roblin teaches a reagent (an analysis reagent) useful for determining the amount of
`
`cholesterol bound to high—density lipoprotein cholesterol (HDL—C) (para 0001), comprising a
`
`combination of polyanions with divalent metal salts (para 0086—0087) and an excipient (an
`
`additive) such as mannitol or glycine that is useful for stabilizing the reagent (para 0080),
`
`wherein the reagent is in a solid/dried form (para 0088).
`
`Thus, at the time of the claimed invention, it would have been obvious to one of ordinary
`
`skill in the art to incorporate the claimed reagent in the analysis device of the ‘833 patent since
`
`Roblin discloses that the claimed reagent is useful for determining the amount of cholesterol in
`
`HDL—C. Moreover, at the time of the claimed invention, one of ordinary skill in the art would
`
`have been motivated by the cited reference to incorporate the claimed reagent with a reasonable
`
`expectation for successfully obtaining an analysis device.
`
`

`

`Application/Control Number: 14/479,936
`
`Page 15
`
`Art Unit: 1651
`
`11.
`
`Claim 15 is rejected on the ground of nonstatutory obviousness—type double patenting as
`
`being unpatentable over claims 1, 5 and 9 of US. Patent No 8,596,150 (referred to as the ‘150
`
`patent) in view of Roblin et al (US 2008/0135419 A1; 6/12/2008).
`
`Claims 1, 5 and 9 of the ‘ 150 patent recite an analytical device rotatable about a rotation
`
`aXis, comprising a passage and a measurement cell, wherein the passage and the measurement
`
`cell have a microchannel structure.
`
`The ‘ 150 patent does not teach the analysis device comprises the claimed reagent, as
`
`recited in claim 15.
`
`Roblin teaches a reagent (an analysis reagent) useful for determining the amount of
`
`cholesterol bound to high—density lipoprotein cholesterol (HDL—C) (para 0001), comprising a
`
`combination of polyanions with divalent metal salts (para 0086—0087) and an excipient (an
`
`additive) such as mannitol or glycine that is useful for stabilizing the reagent (para 0080),
`
`wherein the reagent is in a solid/dried form (para 0088).
`
`Thus, at the time of the claimed invention, it would have been obvious to one of ordinary
`
`skill in the art to incorporate the claimed reagent in the analysis device of the ‘ 150 patent since
`
`Roblin discloses that the claimed reagent is useful for determining the amount of cholesterol in
`
`HDL—C. Moreover, at the time of the claimed invention, one of ordinary skill in the art would
`
`have been motivated by the cited reference to incorporate the claimed reagent with a reasonable
`
`expectation for successfully obtaining an analysis device.
`
`

`

`Application/Control Number: 14/479,936
`
`Page 16
`
`Art Unit: 1651
`
`12.
`
`Claim 15 is rejected on the ground of nonstatutory obviousness—type double patenting as
`
`being unpatentable over claims 1, 2, 4 and 5 of US. Patent No 8,415,140 (referred to as the ‘ 140
`
`patent) in view of Roblin et al (US 2008/0135419 A1; 6/12/2008).
`
`Claims 1, 2, 4 and 5 of the ‘ 140 patent recite an analyzing device having a microchannel
`
`structure rotatable about a rotation aXis of the analysis device, the microchannel structure
`
`including a connecting channel (a passage) and a measurement spot (a measuring cell).
`
`The ‘ 140 patent does not teach the analysis device comprises the claimed reagent, as
`
`recited in claim 15.
`
`Roblin teaches a reagent (an analysis reagent) useful for determining the amount of
`
`cholesterol bound to high—density lipoprotein cholesterol (HDL—C) (para 0001), comprising a
`
`combination of polyanions with divalent metal salts (para 0086—0087) and an excipient (an
`
`additive) such as mannitol or glycine that is useful for stabilizing the reagent (para 0080),
`
`wherein the reagent is in a solid/dried form (para 0088).
`
`Thus, at the time of the claimed invention, it would have been obvious to one of ordinary
`
`skill in the art to incorporate the claimed reagent