Application No. 12/810,391
`Reply to Final Office Action dated 2/27/2013
`
`Amendments to the Drawings:
`
`The attached sheets of drawings include changes to Fig. 6. Sheet 5 of 11, which includes
`
`Figs. 6 and 7, replaces the original sheet including Figs. 6 and 7.
`
`In amended Fig. 6, the label “Specimen Amount In Capillary” has been revised as
`
`“Representation of Specimen Amount in Test Piece (Strip) [m2].”
`
`Attachment: Replacement Sheet (1 sheet)
`
`
`
`

`

`Application No. 12/810,391
`Reply to Final Office Action dated 2/27/2013
`
`REMARKS
`
`Reconsideration is requested in View of the above amendments and the following
`
`remarks. Figs. 6 and claims 1 and 3 have been revised editorially. Support for the revisions can
`
`be found at, e. g., page 15, line 29 to page 16, line 9 of the original specification and Fig. 3.
`
`Claims 1-14 remain pending in the application. Claims 7-11 remain withdrawn.
`
`Objections to the Drawing
`
`The drawings are objected to because the Examiner considered the feature “capillary
`
`space” not shown in the drawings. In the Response to Argument on pages 2—3 of the Office
`
`Action, the Examiner argued that the term “capillary” is defined as 1: a) resembling a hair
`
`especially in slender elongated form <capillary leaves>; b) having a very small bore <a capillary
`
`tube>; 2: Involving, held by, or resulting from surface tension <capillary water in the soil>;” and
`
`thus, the drawings did not shown any capillary as defined in the definitions.
`
`Applicants respectfully disagree. In addition to items 1 and 2, the term “capillary” is
`
`further defined as “3: of or relating to capillarity” in the Merriam—Webster online dictionary
`
`(referring to item 3 of the definition of “capillary,” available at: http://www.merriam—
`
`webster.com/dictionary/capillary), while the term “capillarity” is defined as:
`
`Rise or fall of liquid in a small passage or tube. When a glass tube of small internal
`
`diameter is inserted into water, the surface water molecules are attracted to the glass and the
`
`water level in the tube rises. The narrower the tube, the higher the water rises. The water is said
`
`to ‘wet’ the tube. Water will also be drawn into the fibres of a towel, even if the towel is in a
`
`horizontal position .
`
`.
`
`. Capillarity is caused by the difference in attraction of the liquid molecules
`
`to each other and the attraction of the liquid molecules to those of the tube.” The definition is
`
`available at: http://www.merriam—webster.com/dictionary/capillarity (emphasis added).
`
`Applicants note that it is not necessary for the small capillary passage to be cylindrical. In fact, a
`
`space is considered a capillary space as long as one of its dimensions is small enough to cause an
`
`observable capillary action. Therefore, Applicants respectfully contend that the “capillary
`
`space” is clearly shown in the drawings.
`
`Fig. 6 has been revised to address the Examiner’s concern.
`
`

`

`Application No. 12/810,391
`Reply to Final Office Action dated 2/27/2013
`
`Withdrawal of the objections is respectfully requested. Applicants are not conceding the
`
`correctness of the objections.
`
`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
`
`blood and plasma in the original specification (see, e. g., page 1, lines 19—20 of the original
`
`specification). Nevertheless, the term solution in the claims has been revised editorially as
`
`“specimen” to clarify this issue. Applicants clarify that it is the specimen that is measured in the
`
`specimen measurement method of claims 1-6 and 12—15. The nature of the specimen is
`
`described as “such as blood and plasma” in the original specification (see, e.g., page 1, lines 19—
`20 of the original specification).
`/
`
`With respect to the “development layer,” according to item 2 of the Tanaka Declaration
`
`of June 14, 2013, this term was generally known in the art. One skilled in the art would have
`
`understood how a specimen is developed in a development layer. Further, according to item 3 of
`
`the Tanaka Declaration of June 14, 2013, one skilled in the art would have understood that a
`
`specimen could be developed in a development layer by the action of, for example, capillarity
`
`occurring in a porous structure of the development layer.
`
`With respect to the “immobilizing portion,” page 2, lines 6—9 of the original specification
`
`provides “an immobilizing portion 4 serves as a portion to be measured on which an antibody to
`
`be specifically bound to the substance to be measured is immobilized.” Further, according to
`
`item 4 of the Tanaka Declaration of June 14, 2013, the term “immobilizing portion” was
`
`generally known in the art. One skilled in the art would have understood how the immobilizing
`
`portion is formed
`
`With respect to “what specifically the immobilizing portion immobilizes,” page 2, lines
`
`6—9 of the original specification provides “an antibody to be specifically bound to the substance
`
`to be measured is immobilized.” Further, according to item 4 of the Tanaka Declaration of June
`
`14, 2013, the term “immobilizing portion” was generally known in the art. One skilled in the art
`
`would know what the immobilizing portion can be used to immobilize for example an antibody
`
`(see, e. g., page 2, lines 8—11 of the original specification.
`
`

`

`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 including a 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.
`
`With respect to the “type of labeling compound,” page 2, lines 5—8 of the original
`
`specification provides “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.” Further, according to
`
`item 7 of the Tanaka Declaration of June 14, 2013, it was generally known to one skilled in the
`
`art that different labeling substances could be used to form the labeling portion.
`
`With respect to the question regarding the description that “the specimen has a light
`
`absorbing property” in the first paragraph on page 5, in an illustrative example, the specimen can
`
`be blood (see, e. g., page 1, line 22 of the original specification). Blood has a light absorbing
`
`property and thus the description that “the specimen has a light absorbing property” is
`
`understandable.
`
`With respect to the “specific proteins,” the specific “binding antibodies,” and the
`
`“labeling agents,” according to items 6, 7 and 8 of the Tanaka Declaration of June 14, 2013, it
`
`was generally known to one skilled in the art which substances in the specimen could be
`
`measured, which antibodies could be used to form an immobilizing portion and which labeling
`
`agents could be used. Thus, the discussion in the specification is sufficient.
`
`With respect to the steps of imaging the capillary 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 described as follows:
`
`. First, the test piece 10 is set in the stage 12 before the specimen is
`.
`.
`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.
`
`See page 15, line 30 to page 16, line 9 of the original specification.
`
`10
`
`
`
`
`
`

`

`Application No. 12/810,391
`Reply to Final Office Action dated 2/27/2013
`
`With respect to the steps of imaging the development area, the steps of imaging an
`
`immobilizing portion clearly are described at page 15, lines 21-26 of the original specification
`
`and Fig. 2.
`
`With respect to the “area of the specimen,” according to item 9 of the Tanaka Declaration
`
`of June 14, 2013, one skilled in the art would know that a capillary space enclosed by the
`
`specimen storage portion had a very thin thickness, and the capillary action would cause the
`
`specimen to be drawn naturally into the capillary space and fill the thickness of the capillary
`
`space.
`
`For at least these reasons, the specification is understandable and provides definite and
`
`adequate support for the claims. Applicants respectfully request withdrawal of the objections.
`
`Applicants are not conceding the correctness of the objections.
`
`Claim Rejections 35 USC § 112
`
`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. Applicants respectfully traverse this rejection.
`
`With respect to the term “capillary space,” in View of the description of the capillary in
`
`the specification, the term “capillary space” is readily understood by one skilled in the art.
`
`With respect to “the amount of the specimen is not determined directly from two images,
`
`but rather is a special process disclosed in paragraph [0056] and Fig. 7,” Applicants respectfully
`
`contend that “taking image of the test strip to calculate the amount of the specimen flowing to
`
`developing portion” is not an essential step of the specimen measurement method. Thus, the fact
`
`that taking images is not included in claim 3 does not negate the fact that the description of this
`
`application clearly allows persons of ordinary skill in the art to recognize that he or she invented
`
`what is claimed.
`
`For at least these reasons, the specification provides adequate support for claims 1-6 and
`
`12—14. Applicants respectfully request withdrawal of the rejection. Applicants are not
`
`conceding the correctness of the objections.
`
`Claims 1—6 and 12—14 are rejected under 35 USC. 112, first paragraph, as being non-
`
`enabling. Applicants respectfully traverse this rejection.
`
`11
`
`
`
`
`
`

`

`
`
`Application No. 12/810,391
`Reply to Final Office Action dated 2/27/2013
`
`With respect to the “development layer,” the “immobilizing portion,” and using a
`
`“capillary area” to represent a volume of a specimen, as discussed above, these terms are
`
`generally known in the art. According to items 3, 5 and 9 of the Tanaka Declaration of June 14,
`
`2013, one skilled in the art would have understood and known how to make the development
`
`layer and the immobilizing portion, and how to form the capillary space without undue
`
`experimentation.
`
`For at least these reasons, claims 1-6 and 12-14 are enabling. Applicants respectfully
`
`request withdrawal of the rejection. Applicants are not conceding the correctness of the
`
`rejection.
`
`Claims 3 and 4 are rejected under 35 U.S.C. 112, second paragraph, because the claims
`
`omit essential methods steps of taking images of the developing portion of the test strip (piece).
`
`Applicants respectfully traverse this rejection. In fact, Applicants hereby clarify that taking
`
`images of the developing portion of the test strip (piece) is not an essential method step of the
`
`specimen measurement method. Withdrawal of this rejection is respectfully requested.
`
`Claims 1—6 and 12—14 are rejected under 35 U.S.C. 112, second paragraph, as being
`
`indefinite. Applicants respectfully traverse this rejection.
`
`With respect to the “development layer,” the “immobilizing portion,” and the “species to
`
`be measured,” these terms can be interpreted in light of the specification. Because the usages of
`
`these terms were common in the art and these terms were generally known in the art, these terms
`
`are definite to those skilled in the art.
`
`For at least these reasons, claims 1—6 and 12—14 are definite. Withdrawal of the rejection
`
`is respectfully requested.
`
`Claims 1—6 and 12-14 are rejected under 35 U.S.C. 112, second paragraph, as being
`
`incomplete for omitting an essential step. Applicants respectfully traverse this rejection.
`
`Applicants respectfully contend that the amount of specimen is not determined directly from two
`
`images is not an essential step of the specimen measurement method.
`
`With respect to how to calculate an amount of the substance from the optical property of
`
`a specimen, and how the amount of the substance is related to the optical property of the
`
`12
`
`

`

`Application No. 12/810,391
`Reply to Final Office Action dated 2/27/2013
`
`specimen, a substance to be measured is read by using the optical property of the specimen after
`
`the specimen is immobilized at a predetermined point, and the concentration (amount) of the
`
`substance is measured (see, e. g., page 2, lines 23-27 of the original specification). An illustrative
`
`example is described at page 15, line 29 to page 19, line 19 of the original specification and Fig.
`
`2. Further, according to items 11 and 12 of the Tanaka Declaration of June 14, 2013, one skilled
`
`in the art would know how to calculate an amount of a substance from the optical property of the
`
`specimen and how the optical property of the specimen related to the amount of the substance.
`
`Withdrawal of the rejection is respectfully requested.
`
`In View of the above, favorable reconsideration in the form of a notice of allowance is
`
`respectfully requested. Any questions regarding this communication can be directed to the
`
`undersigned attorney, Douglas P. Mueller, Reg. No. 30,300, at (612) 455—3804.
`
`53148
`PATENTTRADEMARKOFHCE
`
`Respectfully submitted,
`
`HAMRE, SCHUMANN, MUELLER &
`LARSON, p.c.
`P.O. BOX 2902
`Minneapolis, MN 55402—0902
`(612) 455—3800
`
`
`
`Dated: November!” 2014 By:
`
`Douglas P. Mueller
`Reg. No. 30,300
`DPM/CY
`
`13
`
`
`
`