`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria1 Virginia 22313- 1450
`www.uspto.gov
`
`APPLICATION NO.
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`
`
`
`
` F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`
`
`
`
`CONF {MATION NO.
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`12/8 1 0,39 1
`
`06/24/2010
`
`Takahiko Tanida
`
`20249.0050USWO
`
`6139
`
`53148
`7590
`08/28/2014
`HAMRE, SCHUMANN, MUELLER & LARSON P.C.
`P.O. BOX 2902
`MINNEAPOLIS, MN 55402-0902
`
`EXAMINER
`GAKH, YELENA G
`
`PAPER NUMBER
`
`ART UNIT
`
`1797
`
`
`
`
`NOT *ICATION DATE
`
`DELIVERY MODE
`
`08/28/2014
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e—mail address(es):
`PTOMail@hsml.c0m
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`
`Applicant(s)
`Application No.
` 12/810,391 TANIDA ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventor to File)
`Office Action Summary
`
`Yelena G. Gakh, Ph.D. its“ 1797
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR1. 136( a).
`after SIX () MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1 .704(b).
`
`In no event, however, may a reply be timely filed
`
`Status
`
`1)IZI Responsive to communication(s) filed on 06/14/13.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2b)|Z| This action is non-final.
`2a)|:I This action is FINAL.
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
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`; the restriction requirement and election have been incorporated into this action.
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`4)|:| Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Exparte Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
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`5)IZI Claim(s) 1-14 is/are pending in the application.
`5a) Of the above claim(s) 7-11 is/are withdrawn from consideration.
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`is/are allowed.
`6)I:I Claim(s)
`7)|Z| Claim(s) 1-6and 12-14is/are rejected.
`8)|:I Claim(s)_ is/are objected to.
`
`
`are subject to restriction and/or election requirement.
`9)I:I Claim((s)
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`
`participating intellectual property office for the corresponding application. For more information, please see
`hit
`I/AWIIV‘LUSOIO. ovI’ atentS/init events/
`
`
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`h/index.‘$ or send an inquiry to PPI-iieedback{®usgtc.00v.
`
`Application Papers
`
`10)IZI The specification is objected to by the Examiner.
`11)|Xl The drawing(s) filed on 06/14/13 is/are: a)I:I accepted or b)lX| objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`
`12)IXI Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)IZl All
`
`b)|:l Some” c)I:l None of the:
`
`1.I:I Certified copies of the priority documents have been received.
`2.|:l Certified copies of the priority documents have been received in Application No.
`SIXI Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`
`
`3) D Interview Summary (PTO-413)
`1) D Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`4) I:I Other'
`2) I] InformatIon DIsclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mai| Date
`
`US. Patent and Trademark Office
`PTOL—326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20140820
`
`

`

`Application/Control Number: 12/810,391
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`Page 2
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`Art Unit: 1797
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`The present application is being examined under the pre—AIA first to invent provisions.
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`DETAILED ACTION
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`1.
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`RCE and amendment to the claims and drawings filed on 06/14/13 are acknowledged.
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`Claims 1—14 are pending in the application, claims 7—11 are withdrawn from consideration, and
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`claims 1—6 and 12—14 are considered on merits.
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`Response to Amendment
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`2.
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`The Declaration of Mr. Tanaka under 37 CFR 1.132 filed 06/ 14/ 13 is insufficient to
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`overcome the rejection of claims 1—6 and 12—14 based upon 35 U.S.C. 112, first and second
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`paragraphs, as set forth in the last Office action because:
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`the examiner believes that an
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`inadequate translation of the instant application from Japanese in English prevents otherwise
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`allowable application to be placed into the status for allowance.
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`First, the term “capillary” is not used in a proper manner. According to Merriam—Web ster
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`Dictionary: “Capillary 1 a : resembling a hair especially in slender elongated form <capillary
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`leaves>; b : having a very small bore <a capillary tube> 2:
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`involving, held by, or resulting from
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`surface tension <capillary water in the soil>”. The drawings do not show any capillary.
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`Analytical capillaries are characterized by their micrometer diameters. They are not flat test
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`strips having width over 6 mm. Such misuse of the well—established tem “capillary” leads to a
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`lot of confusion and improper interpretation of the disclosure. The test strips 8 demonstrated on
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`Fig. 5A and 5B are not capillaries.
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`To the examiner’s understanding the only proper use of the word "capillary" would be in
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`the context of liquid sample development in the development area of the chromatographic test
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`strip due to capillary forces.
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`If the Applicants want to represent the amount of the moving liquid in mm2 units, this can
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`be done only for the flat chromatographic test strip.
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`Regarding the term “development”, it is known in the art of chromatography. However,
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`the specification is silent regarding chromatography until para [0020], which renders the first 19
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`paragraphs unclear and indefinite. Further, “immobilizing” portion is not conventional in the
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`

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`Application/Control Number: 12/810,391
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`Page 3
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`Art Unit: 1797
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`field of chromatography, unless this is an immunoassay test strip. This is also not disclosed in
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`the appropriate paragraphs.
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`Regarding the term “capillary”. Again, the existence of capillary forces in the
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`chromatographic test strip is well known. However, it is not the test strip itself that can be called
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`a “capillary”. “Capillary space” is not a term of the specification. The examiner did not raise an
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`issue relate to the capillary forces. Capillary forces act in the test strip. The issue was raised
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`regarding the term “capillary” which was used for a portion of the test strip, which is not correct.
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`Regarding the expression “specimen measurement method”, there is no such expression
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`in the specification. The specification discloses “solution measurement method”, which is not a
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`clear and definite expression, since it is not apparent, which solution is meant in the
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`specification.
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`In fact, all the statements made by Mr. Tanaka are clear and definite. The problem is that
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`the specification itself lacks such clarity and definiteness.
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`The examiner strongly advices the Applicants to rewrite the specification so that it would
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`correctly reflect the essence of the invention, taking into account a poor translation of the
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`specification in English. Since the subject matter is disclosed in the specification, this will not
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`introduce new matter, but rather will make it clear and easy to understand.
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`3.
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`In response to the amendment the examiner modifies objection to the drawings, maintains
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`objection to the specification and modifies rejection of the claims under 35 U.S.C. 112, first and
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`second paragraphs.
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`Drawings
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`4.
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`The drawings are objected to under 37 CFR 1.83(a). The drawings must show every
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`feature of the invention specified in the claims. Therefore, the capillary 8 must be shown or the
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`feature(s) canceled from the claim(s). No new matter should be entered.
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`What is shown in the drawing is not a capillary. Capillary has round cross—section and a
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`diameter of less than 1 mm. What is demonstrated on Figures 5A and 5B is a portion of a small
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`chromatographic test strip.
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`The claims recite “capillary space” included in the storage specimen portion. The
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`drawings do not show the "capillary space".
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`

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`Application/Control Number: 12/810,391
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`Page 4
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`Art Unit: 1797
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`Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to
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`the Office action to avoid abandonment of the application. Any amended replacement drawing
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`sheet should include all of the figures appearing on the immediate prior version of the sheet,
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`even if only one figure is being amended. The figure or figure number of an amended drawing
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`should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure
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`must be removed from the replacement sheet, and where necessary, the remaining figures must
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`be renumbered and appropriate changes made to the brief description of the several views of the
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`drawings for consistency. Additional replacement sheets may be necessary to show the
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`renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an
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`application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet”
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`pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will
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`be notified and informed of any required corrective action in the next Office action. The
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`objection to the drawings will not be held in abeyance.
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`5.
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`Drawing 6 is still objected. The amount of the specimen cannot be expressed in mmz.
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`The area of the test strip where the specimen is present only reflects the amount of the specimen,
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`but is not its measurement, unless the third dimension (the thickness of the test strip) is
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`considered to be zero.
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`The examiner suggests renaming y—axis as "representation of specimen amount in test
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`piece (strip) [mm2]).” This will be technically correct, and it is exactly how it is indicated in the
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`Declaration.
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`Specification
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`6.
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`The following is a quotation of the first paragraph of 35 U.S.C. 112:
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`The specification shall contain a written description of the invention, and of the manner and process of making
`and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it
`pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode
`contemplated by the inventor of carrying out his invention.
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`The specification is still objected to as not containing “contain a written description of the
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`invention, and of the manner and process of making and using it, in such full, clear, concise, and
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`exact terms as to enable any person skilled in the art to which it pertains, or with which it is most
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`nearly connected, to make and use the same”.
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`

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`Application/Control Number: 12/810,391
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`Page 5
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`Art Unit: 1797
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`In general, it appears that the specification is a mix of very broad statements along with
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`specific disclosure of the invention. Because of this, the terminology used in the specification
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`and claims, while clear for the specific examples, becomes blurring in light of the broad and
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`general description.
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`Specifically, the invention is presumably directed toward correct measurement of the
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`concentration of a blood or plasma component using a test chromatographic strip comprising
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`a capillary space for temporary storing a sample and a chromatographic layer with an
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`immobilizing agent specific for the component under analysis; the chromatographic layer is
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`the one where the sample is developed.
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`In this case the terms “development layer” or
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`“immobilizing portion” are totally clear. They become unclear for any other interpretations of
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`the disclosure.
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`Thus, clarification is required regarding “a solution measurement method”. Such
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`specimen as blood and serum are not solutions, but rather are biological liquids. Also, "a
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`development layer" is a chromatographic layer in which the sample is developed, which should
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`be directly indicated; it is not clear, what is “a space forming portion”, and how the space can be
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`formed?
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`Furthermore, it is not clear, how the amount of the solution can be optically measured?
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`For example, in the paper by Lancaster et al., “Quantitative Ultraviolet Measurements on Wetted
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`TLC Plates Using a Charge—Coupled Device Camera” (White Rose Research Online, published
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`in J. Chromat. A, 2008) the authors state: “This paper presents the first study of the UV imaging
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`of spots on thin—layer chromatographic plates whilst still wet with solvent.” In light of this the
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`question arises whether imaging takes place for the wet TLC plate with structural elements
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`disclosed in the specification, such as a capillary storage space and “immobilization layer”, or it
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`discloses something else?
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`The examiner fails to understand, what specifically is being imaged — the wet portion of
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`the immobilization layer?
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`These steps of the method are not clear:
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`“By using this image, the adding of the specimen on the test piece 10 is detected, in order
`to detect the adding 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
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`

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`Application/Control Number: 12/810,391
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`Page 6
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`Art Unit: 1797
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`can be obtained through the space forming portion 6.” (page 17). What then is imaged?
`A capillary? A capillary comprising the solution?
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`Further, a labeling compound is disclosed. What type of labeling compound this is?
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`The specification appears to miss some important and essential description of e.g. the
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`nature of the specimen, description of the developing portion as a chromatographic layer,
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`description of the nature of immobilizing layer, i.e. what specifically the immobilizing layer
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`immobilizes?; what type of labeling compound is disclosed?
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`On page 19 the specification indicates e. g. that “the specimen has a light absorbing
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`property”. How this can be concluded if the nature of the specimen is not clear? If the specimen
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`is a transparent liquid, then this statement is not correct.
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`The examiner respectfully requests the Applicants to provide exact and concise
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`description of the experiment for which they obtained the data. If these are blood or plasma
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`samples in which specific proteins are supposed to be measured with the test apparatus claimed,
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`this should be absolutely clearly disclosed in the specification. Then immobilization layer
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`should be disclosed as containing specifically binding antibodies, the labeling agents should be
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`indicated.
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`Also, the steps of imaging the capillary itself, along with imaging chromatographically
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`developing area should be clearly disclosed.
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`The examiner does not understand, what is the “area of the specimen” in the capillary?
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`The specimen in the capillary can have a certain volume, which can be defined by the length of
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`the capillary occupied by the specimen if the capillary internal diameter is known. It is not clear,
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`what the "area of the specimen" might be.
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`In general, the specification lacks a clear disclosure of the invention with too many
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`unclear and indefinite terms, which partially is due to an imperfect translation of original
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`Japanese document into English.
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`It is difficult for the examiner to guess what the Applicants are trying to disclose,
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`especially since such expressions as “the area of the specimen in the capillary” is just technically
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`unclear, while being the most essential feature of the invention.
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`Since it is not clear, what “the area of the specimen in the capillary” might be, it is not
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`clear, how the amount of the specimen is calculated.
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`

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`Application/Control Number: 12/810,391
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`Page 7
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`Art Unit: 1797
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`Also, it is not clear, what is the “optical property of the immobilization portion”? The
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`immobilization portion is a part of the test piece. What type of optical property is measured from
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`this test piece and how the substance is measured? This is not clear.
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`The examiner believes that further amendment of the specification is required for
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`clarification purposes.
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`7.
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`The following is a quotation of the first paragraph of 35 USC. 112:
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`Claim Rejections - 35 USC § 112
`
`The specification shall contain a written description of the invention, and of the manner and process of making
`and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it
`pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode
`contemplated by the inventor of carrying out his invention.
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`8.
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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. The claim(s) contains subject matter which
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`was not described in the specification in such a way as to reasonably convey to one skilled in the
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`relevant art that the inventor(s), at the time the application was filed, had possession of the
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`claimed invention.
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`The scope of the claims differs from that disclosed in the Detailed Disclosure of two
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`embodiments.
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`First, there is not “capillary space” disclosed in the specification. The specification
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`discloses capillary 8, which, first, does not correspond to the term “capillary space”, and, second,
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`is not a capillary according to the definition, since what is depicted on Fig. 5A, 5B is not a
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`capillary.
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`Therefore, the claim language does not correspond to the specification.
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`Further, the image of the specimen storage portion cannot show an amount of the
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`specimen stored in the specimen storage portion. It only can represent an amount of the
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`specimen.
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`The amount of the specimen is not determined directly from two images, but rather is a
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`special process disclosed in para [0056] referring to Fig. 7. This calculation of the specimen
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`amount is not reflected in the claims.
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`In particular:
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`

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`Application/Control Number: 12/810,391
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`Page 8
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`Art Unit: 1797
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`[0061] Further, in the present embodiment, the amount of the specimen in the capillary 8 is
`determined by binarization and histogram processing. Any methods may be used as long as an
`area is determined by image processing.
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`However, as it is clear from Fig. 7, determining an area is not a direct process, as the shape of the
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`moving specimen is not a rectangle.
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`Further, claim 3 does not recite essential steps of taking image of the test strip to calculate the
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`amount of the specimen flowing to developing portion, according to the second embodiment.
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`In fact, to the examiner’s understanding there are four embodiments, with only two reflected in
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`the claims.
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`Moreover, the language of the claims does not correspond to the disclosed embodiments.
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`Furthermore, the Detailed Disclosure is directed toward analysis of a blood or serum
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`sample for specific proteins, with immobilization area comprising specific antibodies, which is
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`not reflected in the claims and changes their scope.
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`The examiner respectfully reminds the Applicants that according to MPEP §2163z
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`"2163.02. Standard for Determining Compliance with Written Description Requirement:
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`The courts have described the essential question to be addressed in a description requirement
`issue in a variety of ways. An objective standard for determining compliance with the written
`description requirement is, “does the description clearly allow persons of ordinary skill in the art
`to recognize that he or she invented what is claimed.” In re Gosteli, 872 F.2d 1008, 1012, 10
`USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-
`64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an
`applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date
`sought, he or she was in possession of the invention, and that the invention, in that context, is
`whatever is now claimed. The test for sufficiency of support in a parent application is whether the
`disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had
`possession at that time of the later claimed subject matter.” Ralston Purina Co. v. Far-Mar-Co.,
`Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d
`1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)). Whenever the issue arises, the fundamental
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`factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the
`art that, as of the filing date sought, applicant was in possession of the invention as now claimed.
`See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir.
`1991). An applicant shows possession of the claimed invention by describing the claimed
`invention with all of its limitations using such descriptive means as words, structures, figures,
`diagrams, and formulas that fully set forth the claimed invention. Lockwood v. American Airlines,
`Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in
`a variety of ways including description of an actual reduction to practice, or by showing that the
`invention was “ready for patenting” such as by the disclosure of drawings or structural chemical
`formulas that show that the invention was complete, or by describing distinguishing identifying
`characteristics sufficient to show that the applicant was in possession of the claimed invention.
`
`

`

`Application/Control Number: 12/810,391
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`Page 9
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`Art Unit: 1797
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`See, e.g., Pfaflv. Wells Elecs., Inc., 525 US. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647
`(1998); Regents ofthe University of California v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d
`1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharmaceutical, 927 F.2d 1200, 1206, 18
`USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by “whatever characteristics
`sufficiently distinguish it”).
`
`The Applicants did not show “possession of the claimed invention by describing the
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`claimed invention with all of its limitations using such descriptive means as words, structures,
`
`figures, diagrams, and formulas that fully set forth the claimed invention.”
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`9.
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`Claims 1—6 and 12—14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre—AIA),
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`first paragraph, because the specification, while being enabling for the method of determining
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`concentration of specific components of blood or serum, which can be specifically bound by the
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`binding agents in the immobilization area of the chromatographic developing part of the test
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`strip and for the test strip, and in which the images are taken for test strip before and after
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`development of the blood sample in the developing area, does not reasonably provide
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`enablement for any other method. The specification does not enable any person skilled in the art
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`to which it pertains, or with which it is most nearly connected, to practice the invention
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`commensurate in scope with these claims. First, the solution cannot be developed, if the
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`“developing area” is not a chromatographic area. Second, the sample cannot be immobilized, if
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`it does not have components which can be immobilized in the area by a specific binding. Third,
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`the amount of the solution cannot be measured as the area rather than volume, if the test strip has
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`a noticeable depth.
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`Claims 3 and 4 are additionally rejected, because the claims omit essential methods steps
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`of taking images of the developing portion of the test strip (piece), without which the method is
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`not enabled. Taking images of the storage portion is the only way to measure the initial and final
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`amounts of the specimen in the storage portion. The Applicants did not provide any guidance for
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`any other way of measuring this amount.
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`10.
`
`The following is a quotation of the second paragraph of 35 U.S.C. 112:
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`The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the
`subject matter which the applicant regards as his invention.
`
`

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`Application/Control Number: 12/810,391
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`Page 10
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`Art Unit: 1797
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`11.
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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 for failing to particularly point out and distinctly claim the subject matter which
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`applicant regards as the invention.
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`The preambles of claims 1 and 3 raise the questions regarding the expression “a test
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`piece”, “a development layer”, “immobilization portion”, etc. It is not clear, what these
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`definitions are related to. “A test piece” can be any test apparatus. While the claims are read in
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`light of the specification, they have to be clear on their own.
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`Therefore, the specific limitations should be recited in the claims to make them clear. If
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`the Applicants prefer the expression “a test piece” instead of conventional “test strip”, this will
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`be fine if they add the word “chromatographic”, which is in any case a necessary condition for
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`practicing the method. Moreover, this will explain the term “development layer”.
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`Further, the examiner believes that the limitation for the specimen being blood or plasma
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`should be recited in the preamble of the claim, because this will direct interpretation of the
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`recited subject matter in the right direction from the beginning.
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`Further, “immobilizing portion” is an unclear expression, since it is not apparent, as to
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`what this immobilizes, and how it immobilizes. If the claim in the preamble recites a
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`chromatographic test strip (in fact, an immunoassay test strip) for testing a blood or serum
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`specimen regarding the presence of a compound of interest, which is immobilized in the
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`immobilization portion comprising specific reagents for immobilizing the compound of interest,
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`then the whole subject matter of the claim becomes much clearer.
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`Moreover, claim 1 recites the steps of obtaining images of the specimen storage portion
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`“showing” amounts of the specimen. This is not correct. The images do not show the amounts
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`of the specimen. They rather represent the amounts; however, obtaining the amounts requires
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`calculations. In regards to this the following rejection is applicable.
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`12.
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`Claims 1—6 and 12—14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre—AIA),
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`second paragraph, as being incomplete for omitting essential steps, such omission amounting to a
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`gap between the steps. See MPEP § 2172.01. The omitted steps are: calculation of the specimen
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`amount based on the images.
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`The amount of the specimen is not determined directly from two images, but rather is a
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`special process disclosed in para [0056] referring to Fig. 7.
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`Page 11
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`Art Unit: 1797
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`In particular:
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`[0061] Further, in the present embodiment, the amount of the specimen in the capillary 8 is
`determined by binarization and histogram processing. Any methods may be used as long as an
`area is determined by image processing.
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`However, as it is clear from Fig. 7, determining an area is not a direct process, as the
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`shape of the moving specimen is not a rectangle.
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`This step is one of the most essential steps of the method.
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`Furthermore, it is not clear, what is the “optical property” of the specimen, and how it is
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`related to the concentration of the substance in the specimen? Blood is a very complex specimen
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`with thousands of various compounds. The claim is completely silent as to what the
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`immobilizing portion is; whether it comprises reagents which specifically bind the substance in
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`the specimen to be analyzed, and whether these are changes in the optical properties of the
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`unbound and bound reagents?
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`The claim omits some essential steps which renders it unclear and indefinite.
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`Further, claim 3, besides have the same issues as claim 1, does not recite essential steps of taking
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`image of the test strip to calculate the amount of the specimen flowing to developing portion, according to
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`the second embodiment.
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`13.
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`Applicant's arguments filed 06/14/13 have been fully considered but they are not
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`Response to Arguments
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`persuasive.
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`The examiner appreciates the Applicants’ efforts to clarify the subject matter of the
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`invention and their amendment to the specification, claims, and drawings.
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`Objection to the drawings. Regarding expressing the amount of the specimen in mmz,
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`this is just not the right measurement for the amount of any compound. It does not correspond to
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`any metric system. This is not the same as the scale on the bottle, since the scale on the bottle
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`measures the volume and is in the units of volume, rather than the area.
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`Moreover, according to Declaration of Mr. Tanaka, the area represents the amount, rather
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`than is a direct measurement of the amount. The examiner suggested the proper language for the
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`drawing.
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`Art Unit: 1797
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`Furthermore, what is depicted on Figure 6 is not a capillary. A capillary is a very narrow
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`(less than 0.5 mm in diameter) tube with a circle cross—section.
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`Objection to the specification. Blood and plasma are not solutions. Rather, they are
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`biological fluids. The examiner suggests the Applicants to amend the specification to disclose
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`specimen of blood or plasma form the very beginning, including the Abstract and the Summary
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`of the Invention.
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`Development layer is known in the art of chromatography, which is not mentioned in the
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`specification before paragraph [0020], which renders the first nineteen paragraphs unclear.
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`Therefore, the word chromatography should be mentioned in the beginning of the specification.
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`Immobilizing portion is known in the art of immunoassay test strips. However, these words are
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`absent from the specification. It is not clear, what “a capillary space” is. What is depicted on
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`Fig. 2 and 7—8 is not the capillary space.
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`The examiner inquired what was being measured in light of the reference by Lancaster et
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`al., “Quantitative Ultraviolet Measurements on Wetted TLC Plates Using a Charge—Coupled
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`Device Camera” (White Rose Research Online, published in J. Chromat. A, 2008). The authors
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`state: “This paper presents the first study of the UV imaging of spots on thin—layer
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`chromatographic plates whilst still wet with solvent.” Since the authors indicate that this is the
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`first paper on UV imaging of the spots on TLC plate, the examiner wonders, whether this is
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`exactly the same method of imaging that is used by the Applicants. That is — what is specifically
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`imaged on the test strip? Is this the specimen of blood or serum, which is colored?
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`Regarding the disclosure related to immobilizing portion, the description of the
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`immobilizing portion should be provided the first time it occurs, i.e. on page 1, para [0002].
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`Regarding the specimen having a light absorbing property, this is also not clear, since the
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`specification discloses “a substance to be measured is read by using the optical property after
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`being immobilized at a predetermined point”. "A substance" is not "a specimen". Thus, it
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`becomes unclear, as to what which specific property is disclosed in the specification.
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`Regarding “the area of specimen”, the examiner once more indicates that the term “the
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`capillary space” is not properly used in the disclosure. What is disclosed is a thin—layer
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`chromatographic test strip in which capillary forces act; however, this is not “a capillary space”
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`or “a capillary”.
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`Application/Control Number: 12/810,391
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`Page 13
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`Art Unit: 1797
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`Regarding rejections of the claims under 35 U.S.C. 112, first and second paragraphs, the
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`rejections are modified.
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`The examiner also appreciates submitting Declaration by Mr. Tanaka. The Declaration
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`itself is