Application No. 12/810,391
`Reply to Final Office Action dated 2/27/2013
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`Amendments to the Drawings:
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`The attached sheets of drawings include changesto Fig. 6. Sheet 5 of 11, which includes
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`Figs. 6 and 7, replaces the original sheet including Figs. 6 and 7.
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`In amendedFig. 6, the label “Specimen Amount In Capillary” has been revised as
`“Representation of Specimen Amount in Test Piece (Strip) [mom?].”
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`Attachment: Replacement Sheet (1 sheet)
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`Application No, 12/810,391
`Reply to Final Office Action dated 2/27/2013
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`REMARKS
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`Reconsideration is requested in view of the above amendments and the following
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`remarks. Figs. 6 and claims 1 and 3 have been revised editorially. Support for the revisions can
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`be foundat, e.g., page 15, line 29 to page 16,line 9 of the original specification and Fig.3.
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`Claims 1-14 remain pending in the application. Claims 7-11 remain withdrawn.
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`Objections to the Drawing
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`The drawings are objected to because the Examiner considered the feature “capillary
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`space” not shown in the drawings. In the Response to Argument on pages 2-3 of the Office
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`Action, the Examiner argued that the term “capillary” is defined as 1: a) resembling a hair
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`especially in slender elongated form <capillary leaves>; b) having a very small bore <a capillary
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`tube>; 2: Involving, held by, or resulting from surface tension <capillary water in the soil>;” and
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`thus, the drawings did not shown any capillary as defined in the definitions.
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`Applicants respectfully disagree. In addition to items 1 and 2, the term “capillary”is
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`further defined as “3: ofor relating to capillarity” in the Merriam-Webster online dictionary
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`(referring to item 3 of the definition of “capillary,” available at: http:/Awww.merriam-
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`webster.com/dictionary/capillary), while the term “capillarity” is defined as:
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`Rise or fall of liquid in a small passage or tube, Whena glass tube of small internal
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`diameteris inserted into water, the surface water moleculesare attracted to the glass and the
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`water level in the tube rises. The narrowerthe tube, the higher the water rises. The water is said
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`to ‘wet’ the tube. Water will also be drawn into the fibres of a towel, even if the towelis in a
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`horizontal position .
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`.
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`. Capillarity is caused by the difference in attraction of the liquid molecules
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`to each other andtheattraction of the liquid molecules to those of the tube.” The definition is
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`available at: http://www.merriam-webster.com/dictionary/capillarity (emphasis added).
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`Applicants note that it is not necessary for the small capillary passage to be cylindrical. In fact, a
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`space is considered a capillary space as long as one of its dimensionsis small enough to cause an
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`observable capillary action. Therefore, Applicants respectfully contend that the “capillary
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`space”is clearly shownin the drawings.
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`Fig. 6 has been revised to address the Examiner’s concern.
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`Application No. 12/810,391
`Reply to Final Office Action dated 2/27/2013
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`Withdrawal of the objections is respectfully requested. Applicants are not conceding the
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`correctness of the objections.
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`Objections to the Specification
`The specification is objected to for informalities. With respect to the term “solution” in
`“a solution measurement method,” the term “solution”is clearly defined as a specimen such as
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`blood and plasmain the original specification (see, e.g., page 1, lines 19-20 ofthe original
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`specification). Nevertheless, the term solution in the claims has been revised editorially as
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`“specimen”to clarify this issue. Applicants clarify that it is the specimen that is measured in the
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`specimen measurement methodof claims 1-6 and 12-15. The nature of the specimen is
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`described as “such as blood and plasma”in the original specification (see, e.g., page 1, lines 19-
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`20 of the original specification).
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`With respect to the “developmentlayer,” according to item 2 of the Tanaka Declaration
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`of June 14, 2013, this term was generally known in the art. One skilled in the art would have
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`understood how a specimenis developed in a developmentlayer. Further, according to item 3 of
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`the Tanaka Declaration of June 14, 2013, one skilled in the art would have understoodthat a
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`specimen could be developed in a developmentlayer bythe action of, for example,capillarity
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`occurring in a porousstructure of the developmentlayer.
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`With respect to the “immobilizing portion,” page 2, lines 6-9 of the original specification
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`provides “an immobilizing portion 4 serves as a portion to be measured on which an antibody to
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`be specifically bound to the substance to be measured is immobilized.” Further, according to
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`item 4 of the Tanaka Declaration of June 14, 2013, the term “immobilizing portion” was
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`generally knownin the art. One skilled in the art would have understood how the immobilizing
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`portion is formed
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`With respect to “what specifically the immobilizing portion immobilizes,” page 2,lines
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`6-9 of the original specification provides “an antibody to be specifically boundto the substance
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`to be measured is immobilized.” Further, according to item 4 of the Tanaka Declaration of June
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`14, 2013, the term “immobilizing portion” was generally known in the art. One skilled in the art
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`would know what the immobilizing portion can be used to immobilize for example an antibody
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`(see, e.g., page 2, lines 8-11 of the original specification.
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`Application No. 12/810,391
`Reply to Final Office Action dated 2/27/2013
`With respect to Examiner’s question regarding “what specifically is being imaged,” as
`clearly illustrated in Figs. 2 and 7-8, a test piece includinga capillary space comprising a
`specimen (see,e.g., page 28, lines 1-12 of the original specification) and an immobilizing portion
`(see, e.g., page 15, lines 21-27 of the specification) is imaged.
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`With respectto the “type of labeling compound,” page2, lines 5-8 of the original
`specification provides “a labeling portion 3 is provided which is coated with a labeling substance
`to be specifically boundto the substance to be measured in the specimen.” Further, according to
`item 7 of the Tanaka Declaration of June 14, 2013, it was generally known to one skilled in the
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`art that different labeling substances could be used to form the labeling portion.
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`With respectto the question regarding the description that “the specimen hasa light
`absorbing property” in the first paragraph on page 5,in anillustrative example, the specimen can
`be blood(see, e.g., page 1, line 22 of the original specification). Blood hasalight absorbing
`property and thus the description that “the specimenhasa light absorbing property”is
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`understandable.
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`With respect to the “specific proteins,” the specific “binding antibodies,” and the
`“labeling agents,” accordingto items 6, 7 and 8 of the Tanaka Declaration of June 14, 2013, it
`was generally knownto oneskilled in the art which substances in the specimen could be
`measured, which antibodies could be used to form an immobilizing portion and whichlabeling
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`agents could be used. Thus, the discussion in the specification is sufficient.
`With respect to the steps of imaging thecapillary itself, the steps of imaging a specimen
`storage portion having a capillary space are clearly described at page 15, line 29 to page 19,line
`19 of the original specification and Fig. 2. For example, one of the steps is describedas follows:
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`... First, the test piece 10 is set in the stage 12 before the specimenis
`dropped. Whenthe detection switch 15 detects that the test piece 10 has beenset,
`the measurementstart signal is outputted from the error AMP 32 to turn on the
`light source 21 and the image sensor controller 26 is driven to image the test piece
`10. This imaging operation obtains an image shown in FIG. 3. Byusingthis
`image, the dropping of the specimen onthe test piece 10 is detected. In orderto
`detect the dropping of the specimen, an image atthe pointof 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 PETsheet, so that an
`imageof the capillary 8 can be obtained through the space forming portion6.
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`See page 15, line 30 to page 16,line 9 of the original specification.
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`Application No. 12/810,391
`Reply to Final Office Action dated 2/27/2013
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`With respectto the steps of imaging the developmentarea, the steps of imaging an
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`immobilizing portion clearly are described at page 15, lines 21-26 of the original specification
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`and Fig.2.
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`With respectto the “area of the specimen,” according to item 9 of the Tanaka Declaration
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`of June 14, 2013, one skilled in the art would know that a capillary space enclosed by the
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`specimen storage portion had a very thin thickness, and the capillary action would cause the
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`specimen to be drawnnaturally into the capillary space andfill the thickness of the capillary
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`space.
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`Forat least these reasons, the specification is understandable and provides definite and
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`adequate support for the claims. Applicants respectfully request withdrawal of the objections.
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`Applicants are not conceding the correctness of the objections.
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`Claim Rejections 35 USC § 112
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`Claims 1-6 and 12-14 are rejected under 35 U.S.C. 112, first paragraph,as failing to
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`comply with the written description requirement. Applicants respectfully traverse this rejection.
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`With respectto the term “capillary space,” in view of the description of the capillary in
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`the specification, the term “capillary space” is readily understood by one skilled in theart.
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`With respect to “the amount of the specimen is not determined directly from two images,
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`but rather is a special process disclosed in paragraph [0056] and Fig. 7,” Applicants respectfully
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`contend that “taking image of the test strip to calculate the amount of the specimen flowing to
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`developing portion”is not an essential step of the specimen measurement method. Thus, the fact
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`that taking imagesis not included in claim 3 does not negate the fact that the description of this
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`application clearly allows persons of ordinary skill in the art to recognize that he or she invented
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`whatis claimed.
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`Forat least these reasons, the specification provides adequate support for claims 1-6 and
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`12-14. Applicants respectfully request withdrawal of the rejection. Applicants are not
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`conceding the correctness of the objections.
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`Claims 1-6 and 12-14 are rejected under 35 U.S.C. 112, first paragraph, as being non-
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`enabling. Applicants respectfully traverse this rejection.
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`Application No. 12/810,391
`Reply to Final Office Action dated 2/27/2013
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`With respect to the “developmentlayer,” the “immobilizing portion,” and using a
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`“capillary area” to represent a volumeof a specimen, as discussed above, these terms are
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`generally known in the art. According to items 3, 5 and 9 of the Tanaka Declaration of June 14,
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`2013, one skilled in the art would have understood and known how to make the development
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`layer and the immobilizing portion, and how to form the capillary space without undue
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`experimentation.
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`Forat least these reasons, claims 1-6 and 12-14 are enabling. Applicants respectfully
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`request withdrawal of the rejection. Applicants are not conceding the correctness of the
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`rejection.
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`Claims3 and 4 are rejected under 35 U.S.C. 112, second paragraph, because the claims
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`omit essential methods steps of taking images of the developing portion of thetest strip (piece).
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`Applicants respectfully traverse this rejection. In fact, Applicants hereby clarify that taking
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`images of the developing portion of the test strip (piece) is not an essential methodstep of the
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`specimen measurement method. Withdrawalof this rejection is respectfully requested.
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`Claims 1-6 and 12-14 are rejected under 35 U.S.C. 112, second paragraph, as being
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`indefinite. Applicants respectfully traverse this rejection.
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`With respect to the “developmentlayer,” the “immobilizing portion,” and the “species to
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`be measured,” these terms can be interpreted in light of the specification. Because the usages of
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`these terms were commonin the art and these terms were generally known inthe art, these terms
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`are definite to those skilled in theart.
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`Forat least these reasons, claims 1-6 and 12-14 are definite. Withdrawal of the rejection
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`is respectfully requested.
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`Claims 1-6 and 12-14 are rejected under 35 U.S.C. 112, second paragraph,as being
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`incomplete for omitting an essential step. Applicants respectfully traverse this rejection.
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`Applicants respectfully contend that the amount of specimen is not determined directly from two
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`imagesis not an essential step of the specimen measurement method.
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`With respect to how to calculate an amountof the substance from the optical property of
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`a specimen, and how the amountof the substanceis related to the optical property of the
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`Application No. 12/810,391
`Reply to Final Office Action dated 2/27/2013
`specimen, a substance to be measuredis read by using the optical property of the specimen after
`the specimen is immobilized at a predetermined point, and the concentration (amount) of the
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`substance is measured(see,e.g., page 2, lines 23-27 of the original specification). An illustrative
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`example is described at page 15, line 29 to page 19, line 19 of the original specification and Fig.
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`2. Further, according to items 11 and 12 of the Tanaka Declaration of June 14, 2013, one skilled
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`in the art would know howto calculate an amount of a substance from the optical property of the
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`specimen and how the optical property of the specimen related to the amount of the substance.
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`Withdrawalof the rejection is respectfully requested.
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`In view of the above, favorable reconsideration in the form of a notice of allowanceis
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`respectfully requested. Any questions regarding this communication can be directed to the
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`undersigned attorney, Douglas P. Mueller, Reg. No. 30,300, at (612) 455-3804.
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`53148
`PATENTTRADEMARK OFFICE
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`Respectfully submitted,
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`HAMRE, SCHUMANN, MUELLER &
`LARSON,P.C.
`P.O. Box 2902
`Minneapolis, MN 55402-0902
`(612) 455-3800
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`Dated: November21 2014 By:
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`Douglas P. Mueller
`Reg. No. 30,300
`DPM/CY
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