`
`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.
`
`12/810,391
`
`
`
`
` FILING DATE
`
`06/24/2010
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKETNO.
`
`CONFIRMATIONNO.
`
`Takahiko Tanida
`
`20249.0050USWO
`
`6139
`
`IAMRE, SCHUMANN, MUELLER & LARSON P.C, Coxe
`HAR LLERfPCEXAMINEROM
`
`
`P.O. BOX 2902
`GAKH, YELENA G
`MINNEAPOLIS, MN 55402-0902
`
`ART UNIT
`
`PAPER NUMBER
`
`1797
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`01/05/2015
`
`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.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Status
`1)X] Responsive to communication(s)filed on 11/21/14.
`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 incorporatedinto 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) 1-14 is/are pending in the application.
`5a) Of the above claim(s) 7-11 is/are withdrawn from consideration.
`
`6)L] Claim(s)
`is/are allowed.
`7)X] Claim(s) 1-6 and 12-14 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
`or send an inquiry to PPHieedback@uspto.qoy.
`
`Application Papers
`10)KX] The specification is objected to by the Examiner.
`11)] The drawing(s)filed on 11/21/14 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).
`
`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.
`
`
`
`Applicant(s)
`Application No.
` 12/810,391 TANIDA ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventorto File)
`Office Action Summary
`
`Yelena G. Gakh, Ph.D. Na 1797
`
`-- 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
`
`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 20141229
`
`

`

`Application/Control Number: 12/810,391
`
`Art Unit: 1797
`
`Page 2
`
`The present application is being examined underthe pre-AIAfirst to invent provisions.
`
`DETAILED ACTION
`
`1.
`
`Amendmentfiled on 11/21/14 is acknowledged. Claims 1-14 are pending in the
`
`application, claims 7-11 are withdrawn from consideration, and claims 1-6 and 12-14 are
`
`considered on merits.
`
`Response to Amendment
`
`2.
`
`In response to the minor amendmentto the claims the Examiner maintainsall rejections
`
`and objections established in the previous Office action. Objection to Fig. 6 is withdrawn.
`
`Drawings
`
`3.
`
`The drawings are objected to under 37 CFR 1.83(a). The drawings must show every
`
`feature of the invention specified in the claims. Therefore, the capillary 8 must be shownor the
`
`feature(s) canceled from the claim(s). No new matter should be entered.
`
`What is shownin the drawing is not a capillary. Capillary has round cross-section and a
`
`diameter of less than 1 mm. Whatis demonstrated on Figures 5A and 5B is a portion of a small
`
`chromatographictest strip.
`
`The claimsrecite “capillary space” included in the storage specimen portion. The
`
`drawings do not show the "capillary space”.
`
`Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to
`
`the Office action to avoid abandonmentof the application. Any amended replacement drawing
`
`sheet should includeall of the figures appearing on the immediate prior version of the sheet,
`
`even if only one figure is being amended. Thefigure or figure number of an amended drawing
`
`should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure
`
`must be removedfrom the replacement sheet, and where necessary, the remaining figures must
`
`be renumbered and appropriate changes madeto the brief description of the several viewsof the
`
`drawings for consistency. Additional replacement sheets may be necessary to show the
`
`renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an
`
`application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet”
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`

`

`Application/Control Number: 12/810,391
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`Art Unit: 1797
`
`Page 3
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`pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will
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`be notified and informed of any required corrective action in the next Office action. The
`
`objection to the drawings will not be held in abeyance.
`
`Specification
`
`4,
`
`The following is a quotation of the first paragraph of 35 U.S.C. 112:
`
`The specification shall contain a written description of the invention, and of the manner and process of making
`and usingit, in such full, clear, concise, and exact terms as to enable any personskilled in the art to which it
`pertains, or with which it is most nearly connected, to make and use the same andshall set forth the best mode
`contemplated by the inventor of carrying out his invention.
`
`The specification is still objected to as not containing “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 whichit is most
`
`nearly connected, to make and use the same”’.
`
`In general, it appears that the specification is a mix of very broad statements along with
`
`specific disclosure of the invention. Becauseofthis, the terminology usedin the specification
`
`and claims, while clear for the specific examples, becomes blurring in light of the broad and
`
`general description.
`
`Specifically, the invention is presumably directed toward correct measurementof the
`
`concentration of a blood or plasma component using a test chromatographic strip comprising
`
`a capillary space for temporary storing a sample and a chromatographic layer with an
`
`immobilizing agent specific for the component under analysis; the chromatographiclayeris
`
`the one where the sample is developed.
`
`In this case the terms “developmentlayer” or
`
`“immobilizing portion” are totally clear. They become unclear for any other interpretations of
`
`the disclosure.
`
`Thus, clarification is required regarding “a solution measurement method”. Such
`
`specimen as blood and serum are notsolutions, but rather are biological liquids. Also, "a
`
`developmentlayer" is a chromatographic layer in which the sample is developed, which should
`
`be directly indicated; it is not clear, what is “a space forming portion”, and how the space can be
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`formed?
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`

`

`Application/Control Number: 12/810,391
`
`Art Unit: 1797
`
`Page 4
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`Furthermore,it is not clear, how the amountof the solution can be optically measured?
`
`For example, in the paper by Lancasteret al., “Quantitative Ultraviolet Measurements on Wetted
`
`TLC Plates Using a Charge-Coupled Device Camera” (White Rose Research Online, published
`
`in J. Chromat. A, 2008) the authors state: “This paper presentsthe first study of the UV imaging
`
`of spots on thin-layer chromatographic plates whilst still wet with solvent.” In light of this the
`
`question arises whether imaging takes place for the wet TLC plate with structural elements
`
`disclosed in the specification, such as a capillary storage space and “immobilization layer”, orit
`
`discloses something else?
`
`The examinerfails to understand, what specifically is being imaged — the wet portion of
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`the immobilization layer?
`
`These steps of the methodare notclear:
`
`“By using this image, the adding of the specimen onthetest piece 10 is detected, in order
`to detect the adding of the specimen, an imageat the point of the capillary 8 is recognized
`in the image of FIG. 3. A space forming portion 6 forming the space of the capillary 8 is
`made of a transparent material such as a PET sheet, so that an imageof the capillary 8
`can be obtained through the space forming portion 6.” (page 17). What then is imaged?
`A capillary? A capillary comprising the solution?
`
`Further, a labeling compoundis disclosed. What type of labeling compoundthisis?
`
`The specification appears to miss some important and essential description of e.g. the
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`nature of the specimen, description of the developing portion as a chromatographiclayer,
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`description of the nature of immobilizing layer, 1.e. what specifically the immobilizing layer
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`immobilizes?; what type of labeling compoundis disclosed?
`
`On page 19 the specification indicates e.g. that “the specimen hasa light absorbing
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`property”. How this can be concluded if the nature of the specimenis not clear? If the specimen
`
`is a transparentliquid, then this statementis not correct.
`
`The examiner respectfully requests the Applicants to provide exact and concise
`
`description of the experiment for which they obtained the data. If these are blood or plasma
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`samples in which specific proteins are supposed to be measured with the test apparatus claimed,
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`this should be absolutely clearly disclosed in the specification. Then immobilization layer
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`should be disclosed as containing specifically binding antibodies, the labeling agents should be
`
`indicated.
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`

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`Application/Control Number: 12/810,391
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`Art Unit: 1797
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`Page 5
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`Also, the steps of imaging the capillary itself, along with imaging chromatographically
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`developing area should be clearly disclosed.
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`The examiner does not understand, whatis the “area of the specimen” in the capillary?
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`The specimen in the capillary can have a certain volume, which can be defined by the length of
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`the capillary occupied by the specimenif the capillary internal diameter is known. It is not clear,
`
`whatthe "area of the specimen" might be.
`
`In general, the specification lacks a clear disclosure of the invention with too many
`
`unclear and indefinite terms, which partially is due to an imperfect translation of original
`
`Japanese documentinto English.
`
`It is difficult for the examiner to guess what the Applicants are trying to disclose,
`
`especially since such expressionsas “the area of the specimen in the capillary” is just technically
`
`unclear, while being the mostessential feature of the invention.
`
`Since it is not clear, what“the area of the specimenin the capillary” mightbe, it is not
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`clear, how the amountof the specimenis calculated.
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`Also, it is not clear, what is the “optical property of the immobilization portion”? The
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`immobilization portion is a part of the test piece. What type of optical property is measured from
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`this test piece and how the substance is measured? This is not clear.
`
`The examiner believes that further amendmentof the specification is required for
`
`clarification purposes.
`
`5.
`
`The following is a quotation of the first paragraph of 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
`and usingit, in such full, clear, concise, and exact terms as to enable any personskilled in the art to which it
`pertains, or with which it is most nearly connected, to make and use the same andshall set forth the best mode
`contemplated by the inventor of carrying out his invention.
`
`6.
`
`Claims 1-6 and 12-14 are rejected under 35 U.S.C. 112,first paragraph, as failing to
`
`comply with the written description requirement. The claim(s) contains subject matter which
`
`wasnot 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.
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`

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`Application/Control Number: 12/810,391
`
`Art Unit: 1797
`
`Page 6
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`The scopeof the claims differs from that disclosed in the Detailed Disclosure of two
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`embodiments.
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`First, there is not “capillary space” disclosed in the specification. The specification
`
`discloses capillary 8, which, first, does not correspond to the term “capillary space”, and, second,
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`is not a capillary according to the definition, since what is depicted on Fig. 5A, 5B is nota
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`capillary.
`
`Therefore, the claim language does not correspondto the specification.
`
`Further, the image of the specimen storage portion cannot show an amountof the
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`specimen stored in the specimen storage portion. It only can represent an amountof the
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`specimen.
`
`The amountof the specimen is not determineddirectly from two images, but rather is a
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`special process disclosed in para [0056] referring to Fig. 7. This calculation of the specimen
`
`amountis not reflected in the claims.
`
`In particular:
`
`[0061] Further, in the present embodiment, the amount of the specimen in the capillary 8 is
`determined by binarization and histogram processing. Any methods may be used as long as an
`area is determined by image processing.
`
`However,as it is clear from Fig. 7, determining an area is not a direct process, as the shape of the
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`moving specimen is not a rectangle.
`
`Further, claim 3 does not recite essential steps of taking imageofthe test strip to calculate the
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`amount of the specimen flowing to developing portion, according to the second embodiment.
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`In fact, to the examiner’s understanding there are four embodiments, with only two reflected in
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`the claims.
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`Moreover, the language of the claims does not correspond to the disclosed embodiments.
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`Furthermore, the Detailed Disclosure is directed toward analysis of a blood or serum
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`sample for specific proteins, with immobilization area comprising specific antibodies, whichis
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`not reflected in the claims and changes their scope.
`
`The examiner respectfully reminds the Applicants that according to MPEP §2163:
`
`"2163.02. Standard for Determining Compliance with Written Description Requirement:
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`

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`Application/Control Number: 12/810,391
`
`Art Unit: 1797
`
`Page 7
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`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)). 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 shows possession 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 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 distinguishit’).
`
`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.”
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`7.
`
`Claims 1-6 and 12-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA),
`
`first paragraph, because the specification, while being enabling for the method of determining
`
`concentration of specific components of blood or serum, which can be specifically bound by the
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`binding agents in the immobilization area of the chromatographic developing part of thetest
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`strip and for the test strip, and in which the imagesare taken fortest strip before and after
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`developmentof the blood sample in the developing area, does not reasonably provide
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`enablement for any other method. The specification does not enable any personskilled in the art
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`to whichit pertains, or with whichit is most nearly connected, to practice the invention
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`

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`Application/Control Number: 12/810,391
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`Art Unit: 1797
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`Page 8
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`commensurate in scope with these claims. First, the solution cannot be developed, if the
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`“developing area” is not a chromatographic area. Second, the sample cannot be immobilized,if
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`it does not have components which can be immobilized in the area by a specific binding. Third,
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`the amountof the solution cannot be measuredas the area rather than volume,if the test strip has
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`a noticeable depth.
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`Claims 3 and 4 are additionally rejected, because the claims omit essential methods steps
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`of taking imagesof the developing portion of the test strip (piece), without which the methodis
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`not enabled. Taking imagesof the storage portion is the only way to measuretheinitial and final
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`amounts of the specimen in the storage portion. The Applicants did not provide any guidance for
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`any other way of measuring this amount.
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`8.
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`The following is a quotation of the second paragraph of 35 U.S.C. 112:
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`The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the
`subject matter which the applicant regards as his invention.
`
`9.
`
`Claims 1-6 and 12-14 are rejected under 35 U.S.C. 112, second paragraph, as being
`
`indefinite for failing to particularly point out and distinctly claim the subject matter which
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`applicant regards as the invention.
`
`The preambles of claims 1 and 3 raise the questions regarding the expression “a test
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`piece”, “a developmentlayer’, “immobilization portion”, etc. It is not clear, what these
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`definitions are related to. “A test piece” can be any test apparatus. While the claimsare read in
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`light of the specification, they have to be clear on their own.
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`Therefore, the specific limitations should be recited in the claims to make them clear. If
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`the Applicants prefer the expression “a test piece” instead of conventional“test strip’, this will
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`be fine if they add the word “chromatographic”, whichis in any case a necessary condition for
`
`practicing the method. Moreover, this will explain the term “developmentlayer”.
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`Further, the examiner believes that the limitation for the specimen being blood or plasma
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`should be recited in the preamble of the claim, because this will direct interpretation of the
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`recited subject matter in the right direction from the beginning.
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`Further, “immobilizing portion” is an unclear expression, since it is not apparent, as to
`
`what this immobilizes, and how it immobilizes. If the claim in the preamble recites a
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`chromatographictest strip (in fact, an immunoassaytest strip) for testing a blood or serum
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`

`

`Application/Control Number: 12/810,391
`
`Art Unit: 1797
`
`Page 9
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`specimen regarding the presence of a compoundofinterest, which is immobilized in the
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`immobilization portion comprising specific reagents for immobilizing the compoundofinterest,
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`then the whole subject matter of the claim becomes muchclearer.
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`Moreover, claim | recites the steps of obtaining images of the specimen storage portion
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`“showing” amounts of the specimen. This is not correct. The images do not show the amounts
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`of the specimen. They rather represent the amounts; however, obtaining the amounts requires
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`calculations. In regards to this the following rejection is applicable.
`
`10.
`
`Claims 1-6 and 12-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-ATA),
`
`second paragraph, as being incomplete for omitting essential steps, such omission amounting to a
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`gap between the steps. See MPEP § 2172.01. The omitted steps are: calculation of the specimen
`
`amount based on the images.
`
`The amountof the specimen is not determined directly from two images, but rather is a
`
`special process disclosed in para [0056] referring to Fig. 7.
`
`In particular:
`
`[0061] Further, in the present embodiment, the amountof the specimen in the capillary 8 is
`determined by binarization and histogram processing. Any methods may be used as long as an
`area is determined by image processing.
`
`However,asit is clear from Fig. 7, determining an areais not a direct process, as the
`
`shape of the moving specimenis nota rectangle.
`
`This step is one of the most essential steps of the method.
`
`Furthermore,it is not clear, what is the “optical property” of the specimen, and howit is
`
`related to the concentration of the substance in the specimen? Blood is a very complex specimen
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`with thousands of various compounds. The claim is completely silent as to what the
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`immobilizing portion is; whether it comprises reagents which specifically bind the substance in
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`the specimen to be analyzed, and whether these are changesin the optical properties of the
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`unboundand boundreagents?
`
`The claim omits someessential steps which rendersit unclear and indefinite.
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`Further, claim 3, besides have the same issues as claim 1, does not recite essential steps of taking
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`imageofthetest strip to calculate the amountof the specimen flowing to developing portion, according to
`
`the second embodiment.
`
`

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`Application/Control Number: 12/810,391
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`Art Unit: 1797
`
`Page 10
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`11.
`
`Applicant's arguments filed 11/21/14 have been fully considered but they are not
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`Response to Arguments
`
`persuasive.
`
`Regarding objection to the drawings. The Applicants refer to "capillarity" based on action
`
`of capillary forces. The examineris well aware of this fact. However, “capillary space” is not
`
`disclosed in the specification as the space in which the capillary forces act. Furthermore, the
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`wholetest strip covered with chromatographic mediumis a “capillary space”, since TLC is based
`
`on capillary forces. Thus, this definition is not clear anyway.
`
`Regarding objection to the specification. While the Applicants define blood or plasma as
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`“solutions”, this is quite a confusing definition, and Abstract and Summary of the Invention do
`
`not reflect this definition.
`
`Regarding the term “development layer’, the Examinerspecifically indicated thatit is
`
`knownin the art of chromatography; however, the word “chromatography” is not mentioned in
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`the specification before paragraph [0020], and thus it is difficult to understand whatit refersto.
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`Therefore, the word chromatography should be mentioned in the beginning ofthe specification.
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`Immobilizing portion is knownin the art of immunoassay test strips. However, these words are
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`absent from the specification. It is not clear, what “a capillary space” is. What is depicted on
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`Fig. 2 and 7-8 is not the capillary space.
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`Again, the Applicants refer to the terminology conventional for immunoassayteststrips;
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`however, the specification is silent regarding this field. Outside the context of immunoassaytest
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`strips the terminologyis unclear and confusing.
`
`The Examiner suggests the Applicants to define the field from the beginning in order to
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`remove this ambiguity. Since the specification does disclose this subject matter, it will not
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`introduce new matter.
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`Defining “immobilizing portion” as the portion in which an antibody is immobilized
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`limits immobilizing portion to this definition. However, antibody immobilized in immobilizing
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`portion is not disclosed from the beginning of the specification, which renders this term unclear.
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`The “capillary space” is not defined in the specification. If this is the space in which the
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`capillary forces act, then this should be the whole test strip covered with TLC medium.
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`

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`Application/Control Number: 12/810,391
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`Art Unit: 1797
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`Page 11
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`The examiner inquired what was being measuredin light of the reference by Lancasteret
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`al., “Quantitative Ultraviolet Measurements on Wetted TLC Plates Using a Charge-Coupled
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`Device Camera” (White Rose Research Online, published in J. Chromat. A, 2008). The authors
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`state: “This paper presents the first study of the UV imaging of spots on thin-layer
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`chromatographic plates whilststill wet with solvent.” Since the authors indicate that this is the
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`first paper on UV imaging of the spots on TLC plate, the examiner wonders, whetherthis is
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`exactly the same methodof imaging that is used by the Applicants. That is — whatis specifically
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`imaged on thetest strip? Is this the specimen of blood or serum, whichis colored?
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`Regarding the disclosure related to immobilizing portion, the description of the
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`immobilizing portion should be providedthefirst time it occurs, i.e. on page 1, para [0002].
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`Regarding the specimen havinga light absorbing property, this is also not clear, since the
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`specification discloses “a substance to be measuredis read by using the optical property after
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`being immobilized at a predetermined point”. "A substance" is not "a specimen”. Thus, it
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`becomesunclear, as to what which specific property is disclosed in the specification.
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`Regarding “the area of specimen”, the examiner once more indicates that the term “the
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`capillary space” is not properly used in the disclosure. Whatis disclosed is a thin-layer
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`chromatographic test strip in which capillary forces act; however, this is not “a capillary space”
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`or “a capillary”.
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`The Applicants’ arguments are not convincing. The specification is written in ambiguous
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`and indefinite language, with Dr. Tanaka’s Declaration required for providing a necessary
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`clarification for the specification. This should not be the case. According to 35 U.S.C. 112,first
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`paragraph,the specification should “contain a written description of the invention, and of the
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`manner and process of making and usingit, in such full, clear, concise, and exact termsas to
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`enable any person skilled in the art to which it pertains, or with whichit is most nearly
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`connected, to make and use the same andshall set forth the best mode contemplated by the
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`inventor of carrying out his invention.”
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`Regarding rejections of the claims under 35 U.S.C. 112,first and second paragraphs, it
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`appears from the Applicants’ argumentsthatall the method steps, including “taking imageofthe
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`test strip to calculate the amount of the specimen” recited in the claims “are not essential” for
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`

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`Application/Control Number: 12/810,391
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`Art Unit: 1797
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`Page 12
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`performing the method. This raises the question, as to what the Applicants consideras their
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`invention.
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`The Examiner explicitly indicated all the flaws in the claim language.
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`The Applicants’ reluctance to amend the specification and the claims in orderto clarify
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`the disclosure and makeit in accordance with MPEPrequirements delays the prosecution of the
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`case and does not moveit toward the status for allowance.
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`Conclusion
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`THIS ACTION IS MADEFINAL. Applicant is reminded of the extension of time
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`policy as set forth in 37 CFR 1.136(a).
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`A shortenedstatutory period for reply to this final action is set to expire THREE
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`MONTHSfrom the mailing date of this action. In the eventa first reply is filed within TWO
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`MONTHSof the mailing date of this final action and the advisory action is not mailed until after
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`the end of the THREE-MONTHshortened statutory period, then the shortened statutory period
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`will expire on the date the advisory action is mailed, and any extension fee pursuant to 37
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`CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event,
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`however, will the statutory period for reply expire later than SIX MONTHSfrom the mailing
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`date of this final action.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to Yelena G. Gakh, Ph.D. whose telephone numberis (571)272-
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`1257. The examiner can normally be reached on 9:30am-6:30pm.
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`

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`Application/Control Number: 12/810,391
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`Art Unit: 1797
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`Page 13
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`If attempts to reach the examiner by telephoneare unsuccessful, the examiner’s
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`supervisor, Heidi Kelley can be reached on 571-270-1831. The fax phone numberfor the
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`organization where this application or proceeding is assigned is 571-273-8300.
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`Information regarding the status of an application may be obtained from the Patent
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`Application Information Retrieval (PAIR) system. Status information for published applications
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`maybe obtained from either Private PAIR or Public PAIR. Status information for unpublished
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`applications is available through Private PAIR only. For more information about the PAIR
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`system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR
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`system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would
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`like assistance from a USPTO Customer Service Representative or access to the automated
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`information system, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
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`/Yelena G. Gakh, Ph.D./
`Primary Examiner, Art Unit 1797
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`12/30/2014
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`