`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`
`
`
` FILING DATE
`
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`
`
`
`CONFIRMATIONNO.
`
`
`12/668,266
`
`01/08/2010
`
`Koji Miyoshi
`
`20249.0018USWO
`
`5008
`
`53148
`
`7590
`
`10/09/2014
`
`HAMRE, SCHUMANN,MUELLER & LARSON PC.
`P.O. BOX 2902
`MINNEAPOLIS, MN 55402-0902
`
`GAKH, YELENA G
`
`PAPER NUMBER
`
`ART UNIT
`
`1797
`
`
`
`
`
` NOTIFICATION DATE
`
`DELIVERY MODE
`
`10/09/2014
`
`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.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`Application No.
`Applicant(s)
`12/668,266
`MIYOSHI ET AL.
`
`Office Action Summary
`Examiner
`Art Unit
`AIA (First Inventorto File)
`
`
`1797Yelena G. Gakh, Ph.D. Na
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available underthe provisions of 37 CFR 1.136(a).
`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).
`Anyreply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`In no event, however, may a reply betimely filed
`
`Status
`1)L] Responsive to communication(s) filed on
`LJ A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiledon__
`2a)X] This action is FINAL.
`2b)L] This action is non-final.
`3)L] Anelection was made bythe applicant in responsetoarestriction requirementset forth during the interview on
`
`___} the restriction requirement and election have been incorporated into this action.
`4)[] Since this application is in condition for allowance exceptfor 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*
`5)KX] Claim(s) 1-3 and 5-12 is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`
`6)L] Claim(s)
`is/are allowed.
`7)X] Claim(s) 1-3 and 5-12 is/are rejected.
`8)L] Claim(s)____is/are objectedto.
`
`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
`nit Jwwwuspto.dov/patents/init_ events/poh/index.iso
`
`or send an inquiry to PPHieedback@uspto.aov.
`
`Application Papers
`10)KX] The specification is objected to by the Examiner.
`
`11)L] The drawing(s)filed on
`is/are: a)L_] 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).
`
`Priority under 35 U.S.C. § 119
`12)[] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a)L] All
`b)[-] Some** c)L] None ofthe:
`1..] Certified copies of the priority documents have been received.
`2.L] Certified copies of the priority documents have been received in Application No.
`3.L] Copies of the certified copies of the priority documents have been receivedin 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) CT] Interview Summary (PTO-413)
`1) CT] Notice of References Cited (PTO-892)
`Paper No(s)/Mail Date.
`:
`.
`4) Ol Other
`2) CT] Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20141002
`
`

`

`Application/Control Number: 12/668,266
`
`Art Unit: 1797
`
`Page 2
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`The present application is being examined underthe pre-AIAfirst to invent provisions.
`
`DETAILED ACTION
`
`1.
`
`Amendmentfiled on 08/01/14 is acknowledged. Claim 4 is cancelled. Claim 12 is new.
`
`Thus, claims 1-3 and 5-12 are pending in the application and considered on merits.
`
`Response to Amendment
`
`2.
`
`The amendmentfiled 08/01/14 is objected to under 35 U.S.C. 132(a) becauseit
`
`introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendmentshall
`
`introduce new matter into the disclosure of the invention. The added material whichis not
`
`supported by the original disclosure is as follows: “by comparing the transport speed with a
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`predetermined transport speed based on a relationship between a required quantity of the liquid
`
`sample addedanda size of the transport layer” (Claim 1) and “measuring in advance the
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`relationship between the required quantity of the liquid sample addedandthesize of the
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`transport layer” (Claim 12).
`
`Applicant is required to cancel the new matter in the reply to this Office Action.
`
`3.
`
`In response to the amendmentthe examiner maintainsall rejections with their slight
`
`modification. rejections of the claims under 35 U.S.C. 112,first and second paragraph, and
`
`establishes rejections over the prior art and objection to the specification.
`
`Information Disclosure Statement
`
`4,
`
`The Applicants apparently provided Chinese Patent Office action as NPL reference;
`
`however,it does not have English translation and it is not provided in IDS form. The examiner
`
`respectfully requests to provide both.
`
`Specification
`
`5.
`
`The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
`
`The specification shall contain a written description of the invention, and of the mannerand process of
`makingandusing it, in such full, clear, concise, and exact terms as to enable any person skilledin theart to
`
`

`

`Application/Control Number: 12/668,266
`
`Art Unit: 1797
`
`Page 3
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`whichit pertains, or with which it is most nearly connected, to make and use the same, and shall set forth
`the best mode contemplated by the inventor of carrying out his invention.
`
`The specification does not contain “a written description of the invention, ... in such full,
`
`clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or
`
`with whichit is most nearly connected, to make and use the same”.
`
`It is not clear, how the transport (development) speed depends on the amountofthe
`
`added sample? Fig. 2 is not quite clear. Why the development speed becomesconstantat the
`
`amountof 5 pL, and whyit is almost zero for the amount of about 2 L? Does it depend on the
`
`absorbing properties of the test strip? Why 5 uL is such a critical amount? Moreover,it is not
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`clear, whether, if the amount added would be only about 2 uL, the speed would be close to zero?
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`The specification does not provide such disclosure for the first embodiment.
`
`For the second embodimentit is disclosed that “Arrival time with respect to the quantity
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`of the liquid sample added is measured in advance, and then the measured value is compared
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`with the arrival time T1 calculated by the transport speed V1, so that the reduced transport speed
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`is interpreted as an insufficient quantity of the liquid sample with respect to the required additive
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`quantity.” However,it is not clear, how the amount of the sample is correlated with the time and
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`the speed ofits transportation. The examinerdid not find any correlation between these
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`parameters disclosed in the specification.
`
`The examiner further does not quite understand equations provided in paragraphs [0038]
`
`and [0041]. It is not clear, where the amount of the added sampleis taken into accountin these
`
`equations.
`
`6.
`
`The disclosure is objected to because of the following informalities:
`
`the flow rate of
`
`nitrocellulose membraneis given in sec/cm units (page 9 [0032]). These are not proper units for
`the flow rate. The flow rates are measured in mL/min/cm”,see e.g. MembraneFilters, page 4.
`
`The sameis true for speed measured in mm/s (page 10). The flow speed of the moving flow on a
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`membrane cannot be measured with one dimension ofthe distance (mm/s), since the speed will
`
`also depend on the width of the flow.
`
`Appropriate correction is required.
`
`Claim Rejections - 35 USC § 112
`
`

`

`Application/Control Number: 12/668,266
`
`Art Unit: 1797
`
`Page 4
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`7.
`
`The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
`
`The specification shall contain a written description of the invention, and of the mannerand process of
`making andusing it, in such full, clear, concise, and exact terms as to enable any personskilled in the art to
`whichit pertains, or with which it is most nearly connected, to make and use the same, and shall set forth
`the best mode contemplated bythe inventorof carrying out his invenThe examiner respectfully
`reminds the Applicants that according to MPEP §2163:
`
`8.
`
`Claims 1-3 and 5-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA),
`
`first paragraph,as failing to comply with the written description requirement. The claim(s)
`
`contains subject matter which wasnotdescribed in the specification in such a way as to
`
`reasonably convey to one skilled in the relevant art that the inventor(s), at the time the
`
`application wasfiled, had possession of the claimed invention.
`
`The claimsrecite:
`
`a measuring method using a biosensor, the biosensor including a supply part to which a
`constant quantity of a liquid sample is added,a transport layer in which the liquid sample
`is carried, and a reaction part in which the liquid sample undergoes a reaction, the method
`comprising:
`
`when measuring a concentration of an object to be analyzed contained in the liquid
`sample,
`detecting a transport speed at which the liquid sampleis carried in the transport
`layer; and
`detecting an insufficient quantity of the liquid sample addedto the supply part,
`
`based on the transport speed by comparing the transport speed with a predetermined
`
`transport speed based on a relationship between a required quantity of the liquid sample
`
`added anda size of the transport layer.
`
`However, the specification does not provide an adequate disclosure of performing the
`
`claimed method,as it is demonstrated above. Thelast step is just not disclosed in the
`
`specification.
`
`While the transport speed of the sample can be calculated by optical imaging, it is not
`
`clear, how it is related to the amount of the sample. The disclosure does not provide any such
`
`relation, and as it can be seen from Fig. 2, the correlation is complex and empirical. It is also not
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`clear, how the graph of Fig. 2 is obtained. Is it obtained empirically? Does this correlation
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`

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`Application/Control Number: 12/668,266
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`Art Unit: 1797
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`Page 5
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`dependon the material used for the transport layer? Does it depend on the amountof the
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`sample? Is this a prophetic example?
`
`The specification does not provide correct units for the flow rate, and thusit is not clear,
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`what is measured.
`
`In fact, the specification does not provide any ways to measure the amountof the sample
`
`to be added based onits transport rate.
`
`The examinerfailed to find any disclosure of the subject matter recited in claim 12:
`
`The measuring method using a biosensor according to Claim 1, further comprising: measuring
`in advance the relationship between the required quantity of the liquid sample added
`andthe size of the transport layer.
`
`Therefore, the claimed subject matter is not adequately disclosed by the specification.
`
`"2163.02. Standard for Determining Compliance with Written Description Requirement:
`
`The courts have described the essential question to be addressed in a description requirement
`issue in a variety of ways. An objective standard for determining compliance with the written
`description requirementis, “does the description clearly allow persons of ordinary skill in the art
`to recognize that he or she invented what is claimed.” In re Gosteli, 872 F.2d 1008, 1012, 10
`USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-
`64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an
`applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date
`sought, he or she wasin possession of the invention, and that the invention,in that context, is
`whatever is now claimed. Thetest for sufficiency of support in a parent application is whether the
`disclosure of the application relied upon “reasonably conveysto the artisan that the inventor had
`possession at that time of the later claimed subject matter.” Ralston Purina Co. v. Far-Mar-Co.,
`Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d
`1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)). Wheneverthe issue arises, the fundamental
`factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the
`art that, as of the filing date sought, applicant was in possession of the invention as now claimed.
`See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir.
`1991). An applicant showspossession of the claimed invention by describing the claimed
`invention with all ofits limitations using such descriptive means as words, structures, figures,
`diagrams, and formulas that fully set forth the claimed invention. Lockwood v. American Airlines,
`Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in
`a variety of ways including description of an actual reduction to practice, or by showing that the
`invention was“ready for patenting” such as by the disclosure of drawingsor structural chemical
`formulas that show that the invention was complete, or by describing distinguishing identifying
`characteristics sufficient to show that the applicant was in possession of the claimed invention.
`See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647
`(1998); Regents of the University of California vy. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d
`1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharmaceutical, 927 F.2d 1200, 1206, 18
`
`

`

`Application/Control Number: 12/668,266
`
`Art Unit: 1797
`
`Page 6
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`USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by “whatever characteristics
`sufficiently distinguishit’).
`tion.
`
`The Applicants did not “show possession of the claimed invention by describing the
`
`claimed invention with all of its limitations using such descriptive means as words, structures,
`
`figures, diagrams, and formulasthat fully set forth the claimed invention.”
`
`9.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph:
`
`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter which the applicant regardsas his invention.
`
`10.
`
`Claims 1-3 and 5-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIJA),
`
`second paragraph,as being indefinite for failing to particularly point out and distinctly claim the
`
`subject matter which the inventoror a joint inventor, or for pre-AIA the applicant regards as the
`
`invention.
`
`Claim 1 recites the step of “detecting an insufficient quantity of the liquid sample added
`
`to the supply part, based on the transport speed”. It is not clear, how this insufficient amountis
`
`detected. It is not clear, how the relationship between the quantity of the liquid sample and the
`
`size of the transport layer is determined, since it depends on the properties of the transport layer
`
`and its material.
`
`Since the specification discloses determining the transport speed just by detecting the
`
`time of transport from one point to another, the examiner interprets these claims exactly in terms
`
`of these parameters.
`
`11.
`
`The text of those sections of Title 35, U.S. Code not included in this action can be found
`
`Claim Rejections - 35 USC § 103
`
`in a prior Office action.
`
`12.
`
`Claims 1-3 and 5-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable
`
`over Tatsuhiko (JP2006-162496, computer translation of the JP application provided in IDS).
`
`Regarding claims 1 and 12 Tatsuhiko teaches the following:
`
`PROBLEM TO BE SOLVED: Toeliminate effect of the errors, generated both from the
`difference of expansion rate, when measurementof absorbance is implemented by expanding test
`
`

`

`Application/Control Number: 12/668,266
`
`Art Unit: 1797
`
`Page 7
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`solutions and from the situation after completion of expansion, due to the absorbance value not
`being stabilized.
`SOLUTION: In the device optically analyzing the reaction of the test solution and the analysis
`light, a reagent immobilizing section 11 immobilizing the test solution expanded ona test piece 7
`stuck spottedly with the test solution is prepared; and the analysis light is irradiated to the reagent
`immobilizing section concerned 11, after detecting expansion rate, at which the test solution is
`expanded onthetest piece 7, from reflected light received at a first photodiode 4 and a second
`photodiode 5, an onset time ofirradiation is established for the analysis light that optically
`analyzes reaction of the test solution and the analysis light, based on the expansion rate
`concerned. (Abstract).
`
`While the computer translation of the JP document does not provide a completely clear
`
`description of the details of the invention, it can be concluded that the transport speed (expansion
`
`rate) of the sample is determined in order to correct the amount of the added sample,see e.g.
`
`para [0011]. Expansion rate obviously inherently dependson the size of the transport layer, and
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`thus it would have been obviously to preliminary determine this dependence in orderto useit for
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`correcting the amount of added sample.
`
`Regarding claims 2 and 3 while Tatsuhiko does not specifically disclose imaging device
`
`and using pixels, photodiodes are conventionally used for imaging optics, and this it would have
`
`been obviousfor a routineer in the art to use pixels for determining the transport speed.
`
`Regarding claims 5 and 6 the speedis detected by optical device using an arbitrary
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`reference position downstream the endportion of the transport layer, see para [0016]-[0017].
`
`Regarding claims 7-11 the arrival time is calculated based on the reference position and
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`the transport speed detected by optical device and the arrival of the liquid samples at the
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`downstream end is confirmed by optical measurements, as disclosed in para [0030]-[0034].
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`Asit was indicated above, while the computertranslation does not provide specifically
`
`the terms “image” and “pixels”, scanning is conventionally performed by imaging optics, and pin
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`photodiodes provide pixels.
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`13.
`
`Applicant's arguments filed 08/01/14 have been fully considered but they are not
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`Response to Arguments
`
`persuasive.
`
`Regarding Chinese Office action,it is not clear, what does it mean that the documentis
`
`provided “for Examiner’s convenience’? What type of convincethis is for the examiner,if the
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`

`

`Application/Control Number: 12/668,266
`
`Art Unit: 1797
`
`Page 8
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`Office action is not translated? Furthermore, according to the Duty of Disclosure, the Applicants
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`should provide all material pertinent to the application, with correspondingtranslation of foreign
`
`documents. This documentis the most relevant to the instant application.
`
`Regarding objection to the specification, Fig. 2 is not quite clear. Why the development
`
`speed becomesconstant at the amount of 5 wL, and whyit is almost zero for the amount of about
`
`2 wL. In fact, it is not clear, why the transport speed should depend on the amount added, rather
`
`than on the absorbing properties of the transport layer? According to Fig. 2 if 2 wL are added,
`
`they will not moveat all. Howisit possible?
`
`If there is clogging, then how the transport speed will be determined? It definitely is not
`
`defined by the amountof the added liquid, but rather by the cloggingitself, no matter how much
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`sample will be added.
`
`Regarding equation in para [0037], the examiner inquired, how the amountofthe liquid
`
`wasrepresented in the equation? How can the amountofthe liquid be determined,if it is not a
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`part of the equation?
`
`Regarding the units, the examiner explained above, howthe flow rate of a flowing fluid
`
`is defined. The flow rate is supposed to include the volume ofthe fluid, which is omitted in the
`
`instant specification. How the portion of the sample can affect the units in which the flow rate is
`
`defined? After all, a sample is a portion of something. The unit of mm/s is not appropriate for
`
`any liquid sample.
`
`Regarding rejection of the claims under 35 U.S.C. 112,first paragraph,it is not clear,
`
`which relationship the Applicants refer to, since the examinerdid not find any empirical
`
`relationship expressed in any formula; furthermore, the correctness of the relationship is tested
`
`by checking the units used for the parameters of the relation. In this case the units for the flow
`
`rate are a priori incorrect.
`
`Regarding rejection of the claims overthe prior art, it is not clear, what Applicants
`
`arguments are.
`
`In general, the Applicants arguments are not convincing, and the rejection is made
`
`FINAL.
`
`

`

`Application/Control Number: 12/668,266
`
`Art Unit: 1797
`
`Page 9
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`Conclusion
`
`THIS ACTION IS MADEFINAL. Applicant is reminded of the extension of time
`
`policy as set forth in 37 CFR 1.136(a).
`
`A shortenedstatutory period for reply to this final action is set to expire THREE
`
`MONTHSfrom the mailing date of this action. In the eventafirst reply is filed within TWO
`
`MONTHSof the mailing date of this final action and the advisory action is not mailed until after
`
`the end of the THREE-MONTHshortened statutory period, then the shortened statutory period
`
`will expire on the date the advisory action is mailed, and any extension fee pursuant to 37
`
`CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event,
`
`however, will the statutory period for reply expire later than SIX MONTHSfrom the mailing
`
`date of this final action.
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Yelena G. Gakh, Ph.D. whose telephone numberis (571)272-
`
`1257. The examiner can normally be reached on 9:30am-6:30pm.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Heidi Kelley can be reached on 571-270-1831. The fax phone numberfor the
`
`organization where this application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of an application may be obtained from the Patent
`
`Application Information Retrieval (PAIR) system. Status information for published applications
`
`maybe obtained from either Private PAIR or Public PAIR. Status information for unpublished
`
`applications is available through Private PAIR only. For more information about the PAIR
`
`system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR
`
`system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would
`
`like assistance from a USPTO Customer Service Representative or access to the automated
`
`information system, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/Yelena G. Gakh, Ph.D./
`Primary Examiner, Art Unit 1797
`
`10/6/2014
`
`