Serial No.: 12/810,394
`Examiner: Yelena G. Gakh, Ph.D.
`Reply to Office Action Mailed July 24, 2012
`Page 8 of 12
`
`REMARKS
`
`Applicants appreciate the courtesy shown by the Examiner and his supervisor in
`
`discussing this case with the Applicants’ representative, Rong Yang, on October 9, 2012.
`
`The discussions of the interview are reflected in the above amendments and the following
`
`remarks.
`
`Reconsideration is requested in viewof the above amendments and the following
`
`remarks. The specification has been revised editorially. Claims 1-5, 7 and 12 have been
`
`revised. New dependent claim 14 has been added. Support for the revisions and the new
`
`claim can be foundat, e.g., page 15, line 29 to page 16, line 9 of the original specification
`9?
`and Fig. 3. Claims 1-14 are pendingin the application.
`
`Objections to the Specification
`
`The specification is objected to due to informalities. The specification has been
`
`revised editorially to address the issues. In addition, a paragraph has been added before
`
`page 13, line 25 of the original specification to clarify that “In the present disclosure, a
`
`change of the surface area of a solution stored in a solution storage portion of a test piece
`
`reflects a change of the volumeofthe solution in the solution storage portion.” For an
`
`article that has a substantially uniform thickness, this simply reflects commonly
`
`recognized principles.
`
`With respect to the test piece, page |, line 34 to page 2, line 5 ofthe original
`
`specification provides “As shown in FIG. 14, a test piece 10 is configured by bonding a
`
`porous substrate 2 that serves as a developmentlayer for developing the specimen and a
`
`space forming portion 6 that forms a space (solution storage portion) for temporarily
`
`storing the specimen, to a PET sheet | serving as the base of the test piece 10.” Thatis,
`
`as described in paragraph [0003] in the Background Art of the original specification, a
`
`test piece includes a porous substrate serving as a development layer and a space forming
`
`portion that forms a solution storage portion.
`
`Withdrawal of objection is respectfully requested. Applicants are not conceding
`
`the correctness of the objection.
`
`

`

`Serial No.: 12/810,394
`Examiner: Yelena G. Gakh, Ph.D.
`Reply to Office Action Mailed July 24, 2012
`Page 9 of 12
`
`Objections to the Drawings
`Fig. 7 is objected to because the specimen amount cannot be expressed in mm’.
`
`The description of Fig. 7, including the paragraph bridging pages 19 and 20 ofthe
`
`original specification, has been revised editorially to clarify this issue. In addition, a
`
`paragraph has been added before page 13, line 25 of the original specification to clarify
`
`that “In the present disclosure, a change of the surface area of a solution stored in a
`
`solution storage portion of a test piece reflects a change of the volumeofthe solution in
`
`the solution storage portion.” Again this reflects a basic physical principle. Withdrawal of
`
`the objection is respectfully requested. Applicants are not conceding the correctness of
`
`the objection.
`
`Claim Rejections — 35 USC § 112
`
`Claims 1-6 and 12-13 are rejected under 35 USC 112, first paragraph and second
`
`paragraph, as failing to comply with the written description requirement, nonenabling and
`
`indefinite. Applicants respectfully traverse the rejection.
`
`Claims 1-5 and 12 have been revised to address the issues raised in the rejections.
`
`With respect to the imaging methodraised in the lack of written description requirement
`
`and nonenablementrejection, Applicants respectfully submit that the present invention is
`
`directed to a method to determine the amount of solution that has been transferred to the
`
`development layer by calculating a reduction of solution in the solution storage portion.
`
`The imaging methodis not an essential feature of the method.
`
`Withdrawalof the rejections is respectfully requested. Applicants are not
`
`conceding the correctness of the rejections.
`
`Response to Examiner’s Questions Raised in the Interview
`
`With respect to the capillary recited in claims 1, 3 and 6-7, the term is used
`
`throughout the discussion of the Best Mode for Carrying Out the Invention in the original
`
`specification. The termis defined at, e.g., page 2, lines 20-24 of the original specification,
`
`i.e., “the space forming portion 6 has a capillary 8 that serves as a solution storage
`
`portion for temporarily storing the dropped specimenand anair hole 7 that is formed on a
`
`part of the space forming portion 6” (see Figs. 14-15).
`
`

`

`Serial No.: 12/810,394
`Examiner: Yelena G. Gakh, Ph.D.
`Reply to Office Action Mailed July 24, 2012
`Page 10 of 12
`
`With respect to the space forming portion, the term is used in the discussion of the
`
`Best Mode for Carrying Out the Invention tn the original specification. The term is
`
`defined at, e.g., page 2, lines 2-4 of the original specification, 1e., “a space forming
`
`portion 6... [forms] a space (solution storage portion) for temporarily storing the
`
`specimen” (see Figs. 14-15).
`
`With respect to the labeling portion, the term is used in the discussion of the Best
`
`Mode for Carrying Out the Invention in the original specification. The termis definedat,
`
`e.g., page 2, lines 5-8 of the original specification, 1.e., “On the porous substrate 2, a
`
`labeling portion 3 is provided which is coated with a labeling substance to be specifically
`
`bound to the substance to be measured in the specimen. . .” (see Figs. 14-15) and page2,
`
`line 26-29” of the original specification,i.e., “The substance to be measured tn the
`
`specimen ts labeled in the labeling portion 3 and is developed bycapillarity in the porous
`
`substrate 2 along with the specimen.”
`
`With respect to fluctuations, in the illustrative example as shownin Fig. 4, the
`
`“fluctuation in the image sensor output” means that the image sensor output varies along
`
`the imaging extraction line B-B’ (see, e.g., page 17, lines 17-19 of the original
`
`specification and Fig. 4). Page 17, lines 5-15 of the original specification provides a
`
`reason for the fluctuation in the image sensor output, 1.e., “since a labeling substanceis
`
`applied to a labeling portion 3, light is absorbed and the image sensor output decreases.
`
`A porous substrate 2 is made of a white material or a material not absorbinglight, so that
`
`light is reflected on the porous substrate 2 and the image sensor output increases. The
`
`space forming portion 6 is made of a transparent resin and thus hardlyaffects the image
`
`sensor output. An air hole 7 is provided by forming a through hole on the space forming
`
`portion 6 and thuslight partially reflects on the edge of the air hole 7.” Inthis illustrative
`
`example, the fluctuation in the image sensor output helps locate the specimen in the
`
`capillary 8 (see, e.g., page 20, lines 18-21 of the original specification and Fig. 4).
`
`With respect to the air hole 7, the term is used in the discussion of the Best Mode
`
`for Carrying Out the Inventionin the original specification. The term is definedat, e.g.,
`
`page 2, lines 22-26 of the original specification, 1.e., “an air hole 7... is formed on a part
`
`of the space forming portion 6. By dropping (adding) the specimento the capillary 8, the
`
`

`

`Serial No.: 12/810,394
`Examiner: Yelena G. Gakh, Ph.D.
`Reply to Office Action Mailed July 24, 2012
`Page 11 of 12
`
`capillary 8 is filled with the specimen to the edge of the air hole 7” (see Figs. 14-15). As
`
`shown in Figs. 3-4, SA-B, 7-8 and 14-15, the air hole 7 is labeled clearly differently from
`
`the space forming portion6.
`
`With respect to the “convex region,” the specification has been revised to clarify
`
`that the convex regionrefers to “a convex region (2) of the image sensor output
`
`appearing on the corresponding end of the test piece 10.” That is, the “convex region”is
`
`used to refer to the shape of a portion of the image sensor output as shown at the bottom
`
`of Fig. 4.
`
`With respect to “the capillary 8 on the test piece 10 is located in the longer
`
`direction,” page 17, lines 23-24 of the specification has been revised to clarify that this
`
`sentence meansthat the specimen in the capillary 8 in the longer direction onthe test
`
`piece 10 is located. With respect to the “longer direction,” page 16, line 34 to page 17,
`
`line 4 of the original specification provides that “an image extraction line B-B’ is set
`
`substantially at the center of the width direction .
`
`.
`
`. in the longitudinal direction (also
`
`called a longer direction) of the test piece” (see Fig. 4). That is, the longitudinal direction
`
`of the test piece along the image extraction line B-B’ ts called the longerdirection.
`
`With respect to “locating,” the paragraph bridging pages 16 and 17 of the
`
`specification has beenrevised to clarify that it is to locate the spectmen in the capillary 8,
`
`instead of to locate the capillary 8 itself (see Figs. 3 and 4).
`
`

`

`Serial No.: 12/810,394
`Examiner: Yelena G. Gakh, Ph.D.
`Reply to Office Action Mailed July 24, 2012
`Page 12 of 12
`
`In viewofthe above, favorable reconsideration in the formof a notice of
`
`allowanceis respectfully requested. Anyquestions regarding this communication can be
`
`directed to the undersigned attorney, James A. Larson, Reg. No. 40,443, at (612) 455-
`
`3805.
`
`
`
`| 53148
`eee
`
`Respectfully submitted,
`
`HAMRE, SCHUMANN, MUELLER &
`LARSON,P.C.
`P.O. Box 2902-0902
`Minneapolis, MN 55402-0902
`(612) 455-3800
`
`
`Dated: November 8, 2012
`
`JAL/DPM/CY
`
`By: _/James A. Larson/
`James A. Larson
`Reg. No. 40,443
`
`