`
`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
`
`05/02/2014
`
`HAMRE, SCHUMANN,MUELLER & LARSON PC.
`P.O. BOX 2902
`MINNEAPOLIS, MN 55402-0902
`
`GAKH, YELENA G
`
`PAPER NUMBER
`
`ART UNIT
`
`1777
`
`
`
`
`
` NOTIFICATION DATE
`
`DELIVERY MODE
`
`05/02/2014
`
`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.
`
`Examiner
`Art Unit
`AIA (First Inventor toFile)
`Yelena G. Gakh, Ph.D.
`1777
`No
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address--
`Period for Reply
`
`Office Action Summary
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING DATE OF
`THIS GOMMUNICATION.
`Extensions of time may be available under the 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).
`Any reply 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 be timely filed
`
`-
`-
`
`
`
`Disposition of Claims*
`5) Claim(s) 1-77 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`is/are withdrawn from consideration.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)K] Claim(s) 1-11 is/are rejected.
`8)X] Claim(s) 9 is/are objected to.
`
`9)L] Claim(s)
`are subjectto 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
`nito:/www. usote.gov/natenis/init events/
`b/index.js
`
`
`
` or send an inquiry to PPHfeecback@uspte.dov.
`
`Status
`1)X] Responsive to communication(s) filed on 05/17/12.
`] A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filedon__
`2a)L] This action is FINAL.
`2b)X] This action is non-final.
`3)L] An election was made bythe applicant in responseto a restriction requirementset forth during the interview on
`; the restriction requirement and election have been incorporatedinto this action.
`4)L] Sincethis application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordancewith the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Application Papers
`10)X] The specification is objected to by the Examiner.
`
`11) The drawing(s) filed on
`is/are: a)[_] 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)X] 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.) 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)
`1) X Notice of References Cited (PTO-892)
`.
`.
`2) Xx] 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
`
`3) TC Interview Summary (PTO-413)
`Paper No(s)/Mail Date.
`4 O Other:
`—
`ther:
`.
`)
`
`.
`
`Part of Paper No./Mail Date 20140428
`
`

`

`Application/Control Number: 12/668,266
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`Art Unit: 1777
`
`Page 2
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`The present application is being examined underthe pre-AJAfirst to invent provisions.
`
`DETAILED ACTION
`
`1.
`
`Amendmentto the specification and claims filed on 05/17/12 is acknowledged. Claims
`
`1-11 are pending in the application and considered on merits.
`
`Examiner’s Note: the examiner appreciates the Applicants’ amendment, whichclarifies the
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`language of the specification and claims.
`
`Response to Amendment
`
`2.
`
`In response to the amendment the examiner modifies 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
`
`3.
`
`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
`
`4,
`
`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 manner and process of
`making andusingit, in such full, clear, concise, and exact terms as to enable any person skilled 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 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”.
`
`In particular, it is not clear from the specification, first, why the development(transport)
`
`speed should be determined,if it does not depend on the amount of the added sample at a
`
`specific volume of the sample? Thatis - if it is known that 5 wL is needed for performing
`
`

`

`Application/Control Number: 12/668,266
`
`Art Unit: 1777
`
`Page 3
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`reaction in the reaction part, why the developments speed needs to be determinedto add the
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`amountto 5 wL?
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`It is also not clear, how the transport (development) speed depends on the amountof the
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`added sample? It appears from Fig. 2 that this dependence is quite empirical and is not
`
`predictable. Therefore, the empirical correlation between the volumeof the added sample and
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`the speed ofits transport should be known upfrontin order to calculate the amount of the sample
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`which is required depending on the transport speed.
`
`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 examiner did 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 sample is taken into accountin these
`
`equations.
`
`5.
`
`The disclosure is objected to because of the following informalities:
`
`the flow rate of
`
`nitrocellulose membraneis given in sec/4cm units (page 9 [0032]). These are not proper units
`for the flow rate. Theflow 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
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`on a membrane cannot be measured with one dimension of the distance (mm/s), since the speed
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`will also depend on the width ofthe flow.
`
`Appropriate correction is required.
`
`6.
`
`Claim 9 is objected to because of the following informalities:
`
`it appears that the word
`
`“among” should be replaced with “along”. Appropriate correction is required.
`
`Claim Objections
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`

`

`Application/Control Number: 12/668,266
`
`Art Unit: 1777
`
`Page 4
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`7.
`
`The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
`
`Claim Rejections - 35 USC § 112
`
`The specification shall contain a written description of the invention, and of the manner and process of
`making andusingit, in such full, clear, concise, and exact terms as to enable any person skilled 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 by the inventorof carrying out his invenThe examinerrespectfully
`reminds the Applicants that according to MPEP §2163:
`
`8.
`
`Claims 1-11 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 was not described 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 undergoesa 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.
`
`However, the specification does not provide an adequate disclosure of performing the
`
`claimed method, as it is demonstrated above.
`
`While the transport speed of the sample can be calculated by optical imaging,it is not
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`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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`depend on the material used for the transport layer? Does it depend on the amountof the
`
`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.
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`

`

`Application/Control Number: 12/668,266
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`Art Unit: 1777
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`Page 5
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`In fact, the specification does not provide any ways to measure the amountof the sample
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`to be added based onits transport rate.
`
`The examinerfailed to find any disclosure of the subject matter recited in claim 4:
`
`The measuring method using a biosensor according to Claim 3, wherein the insufficient quantity
`of the added liquid sample is detected by comparing a maximum transport speed calculated
`from a relationship between a required quantity of the liquid sample added and a size of the
`transport layer, with the detected transport speed.
`
`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 whatis claimed.” Jn 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
`possessionat that time ofthe 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)). Whenever the 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 of its 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., Pfaffv. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647
`(1998); Regents of the University of California v. 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
`USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compoundby “whatever characteristics
`sufficiently distinguish it’).
`tion.
`
`

`

`Application/Control Number: 12/668,266
`
`Art Unit: 1777
`
`Page 6
`
`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 claimsparticularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`10.
`
`Claims 1-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second
`
`paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject
`
`matter which the inventor or 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.
`
`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.
`
`Claim Rejections - 35 USC § 103
`
`11.
`
`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which formsthe basis forall
`
`obviousnessrejections set forth in this Office action:
`
`(a) A patent may not be obtained thoughthe invention is not identically disclosed or described as
`set forth in section 102 ofthistitle, 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 obviousat
`the time the invention was madeto 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.
`
`12.
`
`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 underpre-
`
`AIA 35 U.S.C. 103(a) are summarized as follows:
`
`1. Determining the scope and contents of the prior art.
`2. Ascertaining the differences between the prior art and the claimsat issue.
`3. Resolving the level of ordinary skill in the pertinent art.
`
`

`

`Application/Control Number: 12/668,266
`
`Art Unit: 1777
`
`Page 7
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`4. Considering objective evidence present in the application indicating obviousnessor
`nonobviousness.
`13.
`This application currently namesjoint inventors. In considering patentability of the
`
`claims under pre-AIA 35 U.S.C. 103(a), the examiner presumesthat the subject matter of the
`
`various claims was commonly ownedat 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 ownedat the
`
`time a later invention was madein order for the examiner to consider the applicability of pre-
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`AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-ATA
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`35 U.S.C. 103 (a).
`
`14.
`
`Claims 1-3 and 5-11 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 claim ] Tatsuhiko teaches the following:
`
`PROBLEM TO BE SOLVED: Toeliminate effect of the errors, generated both from the
`difference of expansion rate, when measurement of absorbance is implemented by expandingtest
`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 analysislight is irradiated to the reagent
`immobilizing section concerned 11, after detecting expansion rate, at which the test solution is
`expanded on the test piece 7, from reflected light received at a first photodiode 4 and a second
`photodiode 5, an onset time of irradiation 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 amountof the added sample,see e.g.
`
`para [0011].
`
`Regarding claims 2 and 3 while Tatsuhiko doesnot 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
`
`reference position downstream the end portion of the transport layer, see para [0016]-[0017].
`
`

`

`Application/Control Number: 12/668,266
`
`Art Unit: 1777
`
`Page 8
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`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].
`
`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
`
`photodiodes provide pixels.
`
`15.|Applicant’s arguments with respect to claims 1-11 have been considered but are moot
`
`because the arguments do not apply to any of the references being usedin the current rejection.
`
`Response to Arguments
`
`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, Vickie Kim can be reached on 571-272-0579. 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 1777
`
`4/30/2014
`
`