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 changes to Figs. 2 and 6. Sheet 2 of 11, which
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`includes Fig. 2, replaces the original sheet including Fig. 2. Sheet 5 of 11, which includes Figs. 6
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`and 7, replaces the original sheet including Figs. 6 and 7.
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`In amended Fig. 2, the phrase “detect specimen drop” on the bottom left is revised as
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`“detect adding of specimen.” In amended Fig. 2, the phrase “Specimen Amount Of Capillary”
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`on the left and the phrase “Elapsed Time After Dropping” on the bottom have been changed to
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`“Specimen Amount In Capillary” and “Elapsed Time After Adding of Specimen,” respectively.
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`Attachment: Replacement Sheets (2 sheets)
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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. 2 and 6 have been revised editorially. Claims 1-14 have been revised. Support
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`for the revisions can be found at, e.g., page 15, line 29 to page 16, line 9 of the original
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`specification and Fig. 3. Claims 1-14 remain pending in the application. Claims 7-11 remain
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`withdrawn.
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`In addition, Applicants submit herewith a 37 CFR 1.132 Declaration (hereinafter referred
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`to as “Declaration”) of Ryoko Tanaka. Mr. Tanaka holds a bachelor’s degree in bioscience and
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`biotechnology. He had over eleven-year experience in various diagnostic measurement devices.
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`Mr. Tanaka stated that he is familiar with the efforts to develop the product of the present
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`invention and the history of diagnostic measurement devices. The content of the Declaration
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`will be discussed below.
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`Applicants appreciate the courtesy shown by the Examiner in discussing this case with
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`the Applicants representative Rong Yang on May 10, 2013 regarding this application. The
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`discussions of the interview are reflected in the above amendments and the following remarks.
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`The drawings are objected to for informalities. Applicants respectfully traverse these
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`Objections to the Drawing
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`objections.
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`Fig. 6 is objected to at page 2, the first paragraph under Drawings of the Office Action,
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`because the specimen amount cannot be expressed in square millimeters. Applicants respectfully
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`traverse this objection. Page 19, lines 1-3 of the original specification provides that, in Fig. 6,
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`“the amount of the specimen in the capillary 8 is indicated as an area recognized on an image.”
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`Also, a paragraph was added before page 13, line 25 of the original specification in the last
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`Amendment to clarify that “In the present disclosure, a change of the surface area of a solution
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`stored in a solution storage portion of a test piece reflects a change of the volume of the solution
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`in the solution storage portion.” This is similar to scales on a bottle of liquid, in which a height
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`of the liquid can be used to represent the amount of the liquid in the bottle. Further, according to
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`item 1 of the Declaration, it would be clear to one skilled in the art that in Fig. 6 the area
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`Application No. 12/810,391
`Reply to Final Office Action dated 2/27/2013
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`recognized on the image in square millimeters is used to represent the amount of the specimen in
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`the capillary 8 (see, e. g., page 19, lines 1—3 of the original specification).
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`With respect to “Specimen Amount of Capillary [mm2]” in Fig. 6, the description in the
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`drawings has been revised as “Specimen Amount i_n Capillary [mm2]”. With respect to “Elapsed
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`Time after Dropping” in Fig. 6, page 18, lines 31—33 was revised as “FIG. 6 shows the
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`experimental measured values of the amount of the specimen in the capillary 8 relative to an
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`elapsed time after adding the specimen dropping’ in the last Amendment, so the description
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`“Elapsed Time after Dropping” in Fig. 6 has been revised as “Elapsed Time after Adding of
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`Specimen” to maintain consistency.
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`With respect to “Detect Specimen Drop” in Fig. 2, the step has been revised as “Detect
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`Adding of Specimen” to address the issue.
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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
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`The specification is objected to for inforrnalities. Applicants respectfully traverse these
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`objections.
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`With respect to the term “solution” in “a solution measurement method,” the term
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`“solution” is clearly defined as specimen such as blood and plasma in the original specification
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`(see, e.g., page 1, lines 19-20 of the original specification). Nevertheless, the term solution in the
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`claims has been revised editorially as “specimen” to clarify this issue. Applicants clarify that it
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`is the specimen that is measured in the specimen measurement method of claims 1—6 and 12-15.
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`With respect to the “development layer,” according to item 2 of the Declaration, this term
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`was generally known in the art. One skilled in the art would have understood how a specimen is
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`developed in a development layer.
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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 Declaration, the term “immobilizing portion” was generally known in the art. One
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`skilled in the art would have understood how the immobilizing portion is formed.
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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 Examiner’s question regarding “what specifically is being imaged” in the
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`following paragraph cited on page 4 of the Office Action, as clearly illustrated in Figs. 2 and 7-8,
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`a test piece including a capillary space comprising a specimen (see, e. g., page 28, lines 1-12 of
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`the original specification) and an immobilizing portion (see, e.g., page 15, lines 21—27 of the
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`specification) is imaged.
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`With respect to the “type of labeling compound,” page 2, lines 5-8 of the original
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`specification provides “a labeling portion 3 is provided which is coated with a labeling substance
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`to be specifically bound to the substance to be measured in the specimen.” Further, according to
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`item 7 of the Declaration, it was generally known to one skilled in the art that different labeling
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`substances could be used to form the labeling portion.
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`With respect to questions raised in the last paragraph on page 4 of the Office Action, the
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`nature of the specimen is described as “such as blood and plasma” in the original specification
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`(see, e. g., page 1, lines 19-20 of the original specification).
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`With respect to the “development layer,” as discussed above, this term was generally
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`known in the art. Further, according to item 3 of the Declaration, one skilled in the art would
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`have understood that a specimen could be developed in a development layer caused by, for
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`example, capillarity occurring in a porous structure of the development layer.
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`With respect to the nature of “the immobilizing layer [sic—immobilizing portion]”, page 2,
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`lines 6—9 of the original specification provides “an immobilizing portion 4 serves as a portion to
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`be measured on which an antibody to be specifically bound to the substance to be measured is
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`immobilized.” Further, according to items 4 and 5 of the Declaration, the term “immobilizing
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`portion” was generally known in the art. One skilled in the art would know the nature of the
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`immobilizing portion.
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`With respect to “what specifically the immobilizing layer [sic-immobilizing portion]
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`immobilizes,” page 2, lines 6—9 of the original specification provides “an antibody to be
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`specifically bound to the substance to be measured is immobilized.” Further, according to item 4
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`of the Declaration, the term “immobilizing portion” was generally known in the art. One skilled
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`in the art would know what the immobilizing portion can be used to immobilize for example an
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`antibody (see, e. g., page 2, lines 8—11 of the original specification.
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`With respect to the question regarding the description that “the specimen has a light
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`absorbing property” in the first paragraph on page 5 of the Office Action, in an illustrative
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`Application No. 12/810,391
`Reply to Final Office Action dated 2/27/2013
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`example, the specimen can be blood (see, e. g., page 1, line 22 of the original specification).
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`Blood has a light absorbing property and thus the description that “the specimen has a light
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`absorbing property” is understandable.
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`With respect to the “specific proteins,” the specific “binding antibodies,” and the
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`“labeling agents” questioned in the second paragraph on page 5 of the Office Action, according
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`to items 6, 7 and 8 of the Declaration, it was generally known to one skilled in the art which
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`substances in the specimen could be measured, which antibodies could be used to form an
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`immobilizing portion and which labeling agents could be used. Thus, the discussion in the
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`specification is sufficient.
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`With respect to the steps of imaging the capillary itself questioned in the third paragraph
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`on page 5 of the Office Action, the steps of imaging a specimen storage portion having a
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`capillary space is clearly described at page 15, line 29 to page 19, line 19 of the original
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`specification and Fig. 2. For example, one of the steps is described as follows:
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`. First, the test piece 10 is set in the stage 12 before the specimen is
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`dropped. When the detection switch 15 detects that the test piece 10 has been set,
`the measurement start 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. By using this
`image, the dropping of the specimen on the test piece 10 is detected. In order to
`detect the dropping of the specimen, an image at 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
`image of the capillary 8 can be obtained through the space forming portion 6.
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`See page 15, line 30 to page 16, line 9 of the original specification.
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`With respect to the steps of imaging the development area questioned in the third
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`paragraph on page 5 of the Office Action, the steps of imaging an immobilizing portion clearly
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`are described at page 15, lines 21-26 of the original specification and Fig. 2.
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`With respect to the “area of the specimen” questioned in the fourth paragraph on page 5
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`of the Office Action, according to item 9 of the Declaration, one skilled in the art would know
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`that a capillary space enclosed by the specimen storage portion had a very thin thickness, and the
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`capillary action would cause the specimen to be drawn naturally into the capillary space and fill
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`the thickness of the capillary space.
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`Application No. 12/810,391
`Reply to Final Office Action dated 2/27/2013
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`For at least these reasons, the specification is understandable. Applicants respectfully
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`request withdrawal of the objections. Applicants are not conceding the correctness of the
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`objections.
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`Claim Rejections 35 USC § 112
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`Claims 1-6 and 12—14 are rejected under 35 USC. 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 respect to “obtaining a first image of the specimen storage portion showing a first
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`amount of specimen stored in the specimen storage portion of the test piece,” the original
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`specification describes “FIG. 5A is an image of a state of the capillary 8 immediately after the
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`specimen is dropped. At this point, the capillary 8 is filled with a specimen X” (see page 15, line
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`29 to page 16, line 9, and page 18, lines 18—21 of the original specification, and Figs. 3 and Fig.
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`5A.).
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`With respect to “obtaining a second image of the specimen storage portion showing a
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`second amount of specimen stored in the specimen storage portion, where the first amount of
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`specimen is greater than the second amount of specimen,” the original specification describes
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`“FIG. 5B shows a state of the capillary 8 after a predetermined time since the specimen X has
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`been dropped. The dropped specimen X develops on the porous substrate 2 and thus the amount
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`of the specimen X decreases in the capillary 8.” (see page 15, line 29 to page 16, line 9, and page
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`18, lines 21-25 of the original specification, and Figs. 3 and Fig. 5B.).
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`With respect to the “solution measurement method,” the claims now are directed to
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`specimen measurement methods. Further, according to item 10 of the Declaration, one skilled in
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`the art would recognize that the term “specimen measurement method” meant a specimen
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`measurement method that was used to measure a substance contained in the specimen.
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`For at 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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`Application No. 12/810,391
`Reply to Final Office Action dated 2/27/2013
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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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`With respect to the comments that “the storage portion is a shallow microchannel, rather
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`than the capillary” on page 7 and the “round narrow tube” at page 8, line 2 of the Office Action,
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`Applicants respectfully submit that capillary action takes place as long as at least one dimension
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`of a space is formed sufficiently small and would not be limited to a round narrow tube. The
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`capillary space in the present invention is a thin space with only one dimension small enough to
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`cause the capillary effect.
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`With respect to the “development area [sic—development layer],” the “immobilizing
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`portion,” and using a “capillary area” to represent a volume of a specimen, as discussed above,
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`these terms are generally known in the art. According to items 3, 5 and 9 of the Declaration, one
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`skilled in the art would have understood and known how to make the development layer and the
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`immobilizing portion, and how to form the capillary space without undue experimentation.
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`For at 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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`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 “development layer,” 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 common in the art and these terms were generally known in the art, these terms
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`are definite to those skilled in the art.
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`With respect to how to calculate an amount of the substance from the optical property of
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`a specimen, and how the amount of the substance is related to the optical property of the
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`specimen, a substance to be measured is read by using the optical property after being
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`immobilized at a predetermined point, and the concentration (amount) of the substance to be
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`measured 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 Declaration, one skilled in the art would know
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`Application No. 12/810,391
`Reply to Final Office Action dated 2/27/2013
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`how to calculate an amount of a substance from the optical property of the specimen and how the
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`optical property of the specimen related to the amount of the substance.
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`For at least these reasons, claims 1-6 and 12—14 are definite. Withdrawal of the rejection
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`is respectfully requested. Applicants are not conceding the correctness of the rejection.
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`With respect to “what these biological fluids are tested for” in the Response to
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`Arguments at page 9, line 1 of the Office Action, in one illustrative embodiment, the specimen is
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`tested to obtain concentration (amount) of a substance in the specimen (see, e.g., page 15, lines
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`25—27 of the original specification).
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`In view of the above, favorable reconsideration in the form of a notice of allowance is
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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—3 804.
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`53148
`PATENTMEWOFHCE
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`Dated: June 14 2013
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`Respectfully submitted,
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`HAMRE, SCHUMANN, MUELLER &
`LARSON, p.c.
`PO. Box 2902
`Minnea olis, MN 55402—0902
`(612) 4 5—3800
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`By:
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`ouglas P. Mueller
`Reg. No. 30,300
`DPM/CY/cxr
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`l4
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