S/N: 12/810,391
`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Inventorship:
`
`TANIDAetal.
`
`Examiner:
`
`GAKH,Yelena G.
`
`Seria] No.:
`
`12/810,39)
`
`Group Art Unit:
`
`1777
`
`Filed:
`
`Title:
`
`June 24, 2010
`
`Docket No.:
`
`20249.0050US WO
`
`SOLUTION MEASUREMENT METHOD AND SOLUTION
`MEASUREMENT APPARATUS
`
`Mail Stop RCE
`Commissioner for Patents
`P.O.Box 1450
`Alexandria, Virginia 22313-1450
`
`DECLARATION UNDER 37 C.E.R. §1.132
`
`Dear Sir:
`
`I, Ryoko Tanaka, hereby declare as follows:
`
`I received my bachelor’s degree in Department of Bioscience and Biotechnology
`
`from Okayama University, Okayama-shi, Japan in March 2002.
`
`In April 2002, I joined Panasonic Healthcare Co,Ltd, in Toon-shi, Japan, which is
`
`the assignee of the above identified application, and since then I have engaged in the
`
`research and developmentofvarious diagnostic measurement devices as a research
`
`associate in In Vitro Diagnostics Business Unit of the company.
`
`I am familiar with the efforts to develop the product of the present invention and
`
`the history of diagnostic measurement devices.
`
`I have reviewed and understand the above identified patent application and the
`
`claims therein, and have reviewed the Office Action dated February 27, 2013.
`
`
`
`
`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Inventorship:
`
`TANIDAetal.
`
`Examiner:
`
`GAKH,Yelena G.
`
`Seria] No.:
`
`12/810,39)
`
`Group Art Unit:
`
`1777
`
`Filed:
`
`Title:
`
`June 24, 2010
`
`Docket No.:
`
`20249.0050US WO
`
`SOLUTION MEASUREMENT METHOD AND SOLUTION
`MEASUREMENT APPARATUS
`
`Mail Stop RCE
`Commissioner for Patents
`P.O.Box 1450
`Alexandria, Virginia 22313-1450
`
`DECLARATION UNDER 37 C.E.R. §1.132
`
`Dear Sir:
`
`I, Ryoko Tanaka, hereby declare as follows:
`
`I received my bachelor’s degree in Department of Bioscience and Biotechnology
`
`from Okayama University, Okayama-shi, Japan in March 2002.
`
`In April 2002, I joined Panasonic Healthcare Co,Ltd, in Toon-shi, Japan, which is
`
`the assignee of the above identified application, and since then I have engaged in the
`
`research and developmentofvarious diagnostic measurement devices as a research
`
`associate in In Vitro Diagnostics Business Unit of the company.
`
`I am familiar with the efforts to develop the product of the present invention and
`
`the history of diagnostic measurement devices.
`
`I have reviewed and understand the above identified patent application and the
`
`claims therein, and have reviewed the Office Action dated February 27, 2013.
`
`
`
`
`
`S/N: 12/810,391
`
`In my opinion, one of ordinary skill in the field of diagnostic measurement
`
`devices would have recognized the following at the time the priority application (JP
`
`Application No. 2007-335425) of the present application was filed:
`
`1. An area recognized on the imagein Fig. 6 in square millimeters was used to
`
`represent the amountof the specimen based on the description on, for example,
`
`page 19, lines 1-3 of the original specification.
`
`2. The term “development layer” was commonly known in the art. On of ordinary
`
`skill would have understood that a developmentlayer of a test piece was a layer
`
`that allowed a specimento flow on the layer under capillary forces.
`
`3. A “development layer” could be formed with a porousstructure to aliow capillary
`
`effects to occur. A specimen could be developed in the developmentlayerby,for
`
`example, capillary action occurring in the porousstructure of the development
`
`layer.
`
`4. The term “immobilizing portion” was generally knownin the art. An
`
`“immobilizing portion” would have been understood as a portion including a
`
`material that allows a substance in a specimen to be bound for measurementofthe
`
`substance. For example, an antibody against the substance in the specimen would
`
`have been recognized as one type of material that could be used for immobilizing.
`
`5. An “immobilizing portion” could be formed by, for example, preparing an
`
`antibody solution, applying the antibody solution on the porousstructure, and
`
`then drying the porous structure at a room temperature.
`
`6. Areaction agent such as an antibody could be bonded to an immobilizing portion
`
`of a test piece to be able to react with a target substance in a specimen supplied to
`
`the test piece to detect the presence of the target substance in the specimen. For
`
`example, antigen-antibody, enzyme-substrate, or effector-receptor could be used
`
`as reaction agents.
`
`
`
`
`
`S/N: 12/810,391
`
`7,
`
`Onskilled in the art would have recognized that various “labeling substances”
`
`were usable for improving the detection. Example included a detectable marker,
`
`such as a color marker, for example, a gold colloid, meta! or nonmetal colloid
`
`particles, enzymes,proteins, coloring matters, fluorescent dyes, or dye particles
`such as latex.
`
`Various “substances” could be measured in a specimenbyselecting an
`
`appropriate antigen or antibody for the test piece. For example, an antibody,
`
`immunoglobulin, a hormone,a protein, a protein derivative such as an enzyme
`
`and peptide,a bacteria, a virus, Eumycete, mycoplasma,a parasite and infectious
`
`substance, chemicals, or a tumor marker were known to be detectable. These
`
`substances could be measured when reacted with specific antibodies. Specific
`
`examples of the substance included chorionic gonadotropin (hCG), corpus luteum
`
`hormone (LH), thyroid stimulating hormone,follicular forming hormone,
`
`parathyroid stimulating hormone, adrenallipid stimulating hormone,estradiol,
`
`prostate specific antigen, hepatitis B surface antigen, myoglobin, CRP, myocardial
`
`troponin, HbA 1c, albumin,or thelike.
`
`It was generally known that capillary action would take place in a capillary space
`
`as long as at least one dimension of a space is formed sufficiently small.
`
`Capillary action would not be limited to a round narrow tube. For example,
`
`capillary action could take place in a flat space that has a thickness of 0.5 mm.
`
`10.
`
`On skilled in the art would have understoodthat the term “specimen measurement
`method” meant a methodthat is used to measure a substance containedin the
`
`specimen.
`
`. It was generally knownthat, to calculate an amount ofa substance contained in a
`
`specimen from an optical property of the specimen, an image sensor could be
`
`used to measure reflectance, absorbance or luminanceofthe substance labeled at
`
`an immobilizing portion.
`
`12.
`
`It was generally knownthatan optical property of a specimen could be used to
`
`3
`
`
`
`S/N: 12/810,391
`
`calculate the amount of a specific substance contained in the specimen by a
`
`predetermined algorithm.
`
`I, the undersigned declarant, declare further that all statements made herein of my
`
`own knowledge are true andthatall statements made on information and belief are
`
`believed to be true, and further that these statements were made with the knowledgethat
`
`willful false staterients and the like so made are punishable by fine or imprisonment, or
`
`both, under section 1001 of Title 18, of the United States Code, and that such willful false
`
`statements may jeopardize the validity of the application or any patent issuing thereon.
`
`Ryoko Tanaka
`
`
`
`hune 12.2013_KeygokoSanahka
`
`
`
`
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