Application/Control Number: 12/810,391
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`Art Unit: 1777
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`Page 2
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`DETAILED ACTION
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`1,
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`Amendmentto the claims and specification filed on 11/08/12 is acknowledged.
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`Examiner’s Comments:
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`A, the Office does not require anymore submitting the clean copies of the amended documents.
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`B, claims 7-11 should be indicated as withdrawn from consideration on the basis of restriction
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`requirements as directed toward withdrawn apparatus invention (claims 7-11).
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`Claim 14 is new. Thus, claims 1-14 are pending in the application, claims 7-11 are
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`withdrawn from consideration, and claims 1-6 and 12-14 are considered on merits.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 amendmentfiled 11/08/12 is objected to under 35 U.S.C. 132(a) becauseit
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`introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendmentshall
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`introduce new matter into the disclosure of the invention. The added material whichis not
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`supported by the original disclosure is as follows: “obtaining a first image ofa first amount of
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`solution stored in the solution storage portion of the test piece; obtaining a second image of a
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`second amountof solution stored in the solution storage portion, where the first amount of
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`solution is greater than the second amountof solution”.
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`Applicantis required to cancel the new matter in the reply to this Office Action.
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`3.
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`In response to the amendment the examiner maintains andslightly modifies objections
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`and rejections established in the previous Office action.
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`The examineralso corrects a typo regarding objection to the drawings.
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`Drawings
`The drawings are objected to because specimen amount cannotbe expressed in mm”,asit
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`4,
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`is depicted on Fig. 6. Moreover,it is not clear, whatis a “specimen amount ofcapillary’? Also,
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`whatis “elapsed time after dropping? “Dropping” occurs when something falls down.
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`Also, expression “detect specimen drop” in Fig. 2 is unclear. Is it supposed to mean
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`“specimen deposition’’?
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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 abandonmentof the application. Any amended replacement drawing
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`Application/Control Number: 12/810,391
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`sheet should includeall of the figures appearing on the immediate prior version of the sheet,
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`even if only one figure is being amended. Thefigure 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 removedfrom the replacement sheet, and where necessary, the remaining figures must
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`be renumbered and appropriate changes madeto the brief description of the several viewsof 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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`Specification
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`5.
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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 usingit, 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 shallset forth the best mode
`contemplated by the inventor of carrying out his invention.
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`The examiner appreciates the Applicants’ amendments to paragraphs [0012] and [0015].
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`However,the specification is still objected to as not containing “contain a written description of
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`the invention, and of the manner and process of making and usingit, in such full, clear, concise,
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`and exact terms as to enable any person skilled in the art to which it pertains, or with whichit is
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`most nearly connected, to make and use the same”’.
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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. Becauseofthis, the terminology usedin 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 measurementof the
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`concentration of a blood or plasma componentusingatest strip comprising a capillary space for
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`temporary storing a sample and a chromatographic layer with an immobilizing agent specific for
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`the component underanalysis; the chromatographic layer is the one where the sample is
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`Application/Control Number: 12/810,391
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`Art Unit: 1777
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`Page 4
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`developed. In this case the terms “developmentlayer” or “immobilizing portion” are totally
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`clear. They become unclear for any other interpretations of the disclosure.
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`Thus, clarification is required regarding “a solution measurement method”. First,it
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`appearsthat it is not a solution that is being measured, but rather a substancein the solution;
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`second, "a development layer" is a chromatographic layer in which the sample is developed,
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`which should be directly indicated; third, "an immobilizing portion" does not immobilize the
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`solvent - it rather immobilizes the substance to be tested and presumably contains the specifically
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`binding agent. All this is absent from the disclosure, which thus becomesunclear and indefinite.
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`Furthermore,it is not clear, how the amountof the solution can be optically measured?
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`For example, in the paper by Lancasteret 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’, orit
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`discloses something else?
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`The examinerfails 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 methodare notclear:
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`“By using this image, the adding of the specimen onthetest piece 10 is detected, in order
`to detect the adding of the specimen, an imageat 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.” (page 17). What then is imaged?
`A capillary? A capillary comprising the solution?
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`Further, a labeling compoundis disclosed. Whattype of labeling compoundthisis?
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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 chromatographiclayer,
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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 compoundis disclosed?
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`Application/Control Number: 12/810,391
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`Art Unit: 1777
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`Page 5
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`On page 19 the specification indicates e.g. that “the specimen hasa light absorbing
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`property”. How this can be concluded if the nature of the specimenis not clear? If the specimen
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`is a transparentliquid, then this statementis 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 documentinto English.
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`It is difficult for the examiner to guess what the Applicantsare 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 mostessential feature of the invention.
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`Since it is not clear, what “the area of the specimen in the capillary” mightbe, it is not
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`clear, how the amountof the specimenis calculated.
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`The examinerbelieves that further amendmentof the specification is required for
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`clarification purposes.
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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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`Claim Rejections - 35 USC § 112
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`The specification shall contain a written description of the invention, and of the manner and process of making
`and usingit, in suchfull, clear, concise, and exact terms as to enable any personskilled in the art to which it
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`Application/Control Number: 12/810,391
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`Art Unit: 1777
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`Page 6
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`pertains, or with which it is most nearly connected, to make and use the same and shallset forth the best mode
`contemplated by the inventor of carrying out his invention.
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`7.
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`Claims 1-6 and 12-14 are rejected under 35 U.S.C. 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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`wasnot described in the specification in such a way as to reasonably conveyto one skilled in the
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`relevantart that the inventor(s), at the time the application wasfiled, had possession of the
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`claimed invention.
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`The claimsrecite “obtaining a first image of a first amount of solution stored in the
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`solution storage portion of the test piece; obtaining a second image of a second amountof
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`solution stored in the solution storage portion, where the first amountof solution is greater than
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`the second amountofsolution”. The examinerfailed to find these expressionsin the
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`specification and is not quite sure, as to what they might mean. Asfar as the examiner could
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`understand the specification, these were supposed to be imagesof the capillary in which the
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`amountof the sample decreases dueto its transferring by the capillary forces into the
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`chromatographic development area, which comprises immobilizing layer with specific binding
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`agents.
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`Further, the claims recite "a solution measurement method", while the specification is
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`directed toward measuring the concentration of the compoundin the solution; moreover, the
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`claim recites a solution, while the Detailed Disclosure is directed toward analysis of a blood or
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`serum sample for specific proteins, with immobilization area comprising specific antibodies.
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`The examiner respectfully reminds the Applicants that according to MPEP §2163:
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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 requirementis, “does the description clearly allow persons of ordinary skill in the art
`to recognize that he or she invented whatis claimed.” Jn 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 wasin possession of the invention, and that the invention, in that context, is
`whatever is now claimed. Thetest for sufficiency of support in a parent application is whether the
`disclosure of the application relied upon “reasonably conveysto the artisan that the inventor had
`possessionat 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
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`Application/Control Number: 12/810,391
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`Art Unit: 1777
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`1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)). Whenever the issue arises, the fundamental
`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 showspossession 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 drawingsor 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.
`See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647
`(1998); Regents of the 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 compoundby “whatever characteristics
`sufficiently distinguish it’).
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`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,
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`figures, diagrams, and formulasthat fully set forth the claimed invention.”
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`8.
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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 ofthe test strip
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`and for the test strip, in which the storage portion is a shallow microchannel, rather than the
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`capillary, and in which the imagesare taken for the microchannel before and after development
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`of the blood sample in the developing area, does not reasonably provide enablement for any
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`other method. The specification does not enable any person skilled in the art to which it pertains,
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`or with which it is most nearly connected, to practice the invention commensurate in scope with
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`these claims. First, the solution cannot be developed,if the “developing area” is not a
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`chromatographic area. Second, the sample cannot be immobilized, if it does not have
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`components which can be immobilized in the area by a specific binding. Third, the amount of
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`the solution cannot be measuredasthe area rather than volume, if the microchannel in whichit is
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`stored is not shallow and has a noticeable depth. In this case the imaging of the surface of the
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`microchannelwill not give the proper output for the amountof the sample, as it does not take
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`into account the depth of the channel. This is specifically the case for the capillary which usually
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`is a round narrow tube.
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`9.
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`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 claimsparticularly pointing out and distinctly claiming the
`subject matter which the applicant regardsas his invention.
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`10.
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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 claimsrecite terms which are not well defined in the specification, such as
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`“developmentlayer’, “immobilizing portion’, “solution to be measured” — measured for what?
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`Moreover, the amendedclaimsrecite obtaining first and second “imagesof the amount of
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`the solution” stored in the storage portion area. Howis it possible to obtain the image of the
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`amount of the solution? The image may beobtained for the capillary - or, rather, microchannel,
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`whichstores the solution.
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`Further, how is it possible to compare an area with a volume?
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`Whatis the “optical property of the solution’? How is it possible to calculate an amount
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`of the substance from this data? Howis it related to the “optical property of the solution’’?
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`Theclaimsstill are written in unclear and indefinite form, and before the examiner can
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`search the claims regarding the prior art, it is necessary to clarify their subject matter.
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`11.
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`Applicant's arguments filed 11/08/12 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 amendmentto the specification and claims.
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`However, the disclosureis still in the format which precludes the examiner from a
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`thorough search of the claimed subject matter in the priorart.
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`The examiner respectfully requests the Applicants to provide a short and concise
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`explanation of their experiment, i.e. a) what type of solutions they are dealing with — are these
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`biological fluids, such as blood or plasma? If this is the case — these are not the solutions perse,
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`but rather the biological fluids; b) what these biological fluids are tested for? For the presence of
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`specific compounds? In other words — what for the method is developed? If the biological fluids
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`are tested for the presence of specific compounds, and these are the compoundsthat are
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`immobilized in the chromatographic developmentlayer — this hasto be clearly indicated.
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`The major question — how is it possible to determine the amountofthe fluid by the area,
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`rather than by volume? This is the main question that the Applicants should concisely elaborate.
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`In their arguments the Applicants have quite an extensive discussion of “labeling”, which
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`is totally absent from the claims. “Labeling” is another issue that has to be clarified. Whatis
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`labeled, for what purpose, howit is used, etc. The “labeling” subject matter is totally absent
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`from the claims.
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`Again, the examiner respectfully requests the Applicants to exactly and concisely
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`describe their experiments using the drawings submitted in the application, with all samples,
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`compoundsandlabels fully defined.
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`Also, as it was indicated above, the Applicants should answer the question regarding
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`expressing the amountof the “solution” as the area, since conventionally the amount of a
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`solution is measured as a volume. Howisit possible to have solution defined by the area is not
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`clear to the examiner, especially when the solution starts to flowing from the capillary, which is
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`three-dimensional. This also hasto be fully explained.
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`The specification and claims require an extensive amendmentin order to becomeclear
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`and definite. If there is a patentable subject matter, a person of ordinary skill in the art needs to
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`understand what should be donein order to perform the method.
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`Conclusion
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`Applicant's amendmentnecessitated the new ground(s) of rejection presented in this
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`Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a).
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`Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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`A shortenedstatutory period for reply to this final action is set to expire THREE
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`MONTHSfrom the mailing date of this action. In the eventafirst reply is filed within TWO
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`MONTHSof the mailing date of this final action and the advisory action is not mailed until after
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`Application/Control Number: 12/810,391
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`Art Unit: 1777
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`Page 10
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`the end of the THREE-MONTHshortened statutory period, then the shortened statutory period
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`will expire on the date the advisory action is mailed, and any extension fee pursuant to 37
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`CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event,
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`however, will the statutory period for reply expire later than SIX MONTHSfrom the date of this
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`final action.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to Yelena G. Gakh, Ph.D. whose telephone numberis (571)272-
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`1257. The examiner can normally be reached on 9:30am-6:30pm.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Vickie Kim can be reached on 571-272-0579. The fax phone numberfor the
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`organization where this application or proceeding is assigned is 571-273-8300.
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`Information regarding the status of an application may be obtained from the Patent
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`Application Information Retrieval (PAIR) system. Status information for published applications
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`maybe obtained from either Private PAIR or Public PAIR. Status information for unpublished
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`applications is available through Private PAIR only. For more information about the PAIR
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`system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR
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`system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would
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`like assistance from a USPTO Customer Service Representative or access to the automated
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`information system, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
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`/Yelena G. Gakh, Ph.D./
`Primary Examiner, Art Unit 1777
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`2/21/2013
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`