DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-10 are pending and examined herein.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “relatively large representative value and a relatively small representative value”. The metes and bounds of this limitation are unclear because “relatively large” and “relatively small” values are relative terms not defined in the art and specification.
Claim 1 recites “relatively large representative value and a relatively small representative value among representative values of all rows, which is derived based on a plurality of pixels existing in different columns in the same row in the assay region image, a standard deviation based on the representative values of all the rows, or a variation coefficient based on the representative values of all the rows”. Claim 10 recites “the processor is configured to derive a profile in the row direction based on the representative values of the respective columns”. The metes and bounds of “representative value” limitations are unclear because the criteria for selecting such values are not defined in the specification. The term representative will not be given any patentable weight.
Claims 5 and 6 recite “the processor is configured to present that the assay region may be stained”. These limitations are unclear because parent claims 1-4 do not recite any steps or structures of the apparatus that can determine the presence of a stain in the assay region. The processor is not recited as configured to perform more than one imaging of the assay region to be able to detect the presence of the stain prior to the assay development.
Claim 7 recites wherein the processor is configured to present a determination result of the main determination in a case where the abnormality is absent, and present the determination result of the main determination with reservation indicating that the assay region image has an abnormality or not present the determination result of the main determination in a case where the abnormality is present and in a case where the determination result of the main determination is positive.
It is unclear what are the assay outcomes the processor is configured to present. In particular it is unclear what is presented by the limitation of “and in a case where the determination result of the main determination is positive” because the limitation does not follow the same grammar as the preceding limitations.
The claim will be interpreted as:
outcome 1: present a determination result of the main determination in a case where the abnormality is absent (no error); and
outcome 2: present the determination result of the main determination with reservation indicating that the assay region image has an abnormality or not present the determination result of the main determination in a case where the abnormality is present (display nothing when an assay is halted);
outcome 3: present a positive result.
Claim 8 recites wherein the processor is configured to perform the main determination, and perform the abnormality determination in a case where a determination result is positive. The purpose of this limitation is unclear because there is no clear reason to perform the main determination when an abnormality is present – the presence of the abnormality actually invalidates the main determination.
Claims 2-4 and 9 are rejected because they depend from rejected claim 1.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claims 1, 3, and 8 recite “processor is configured to perform”, claims 4-7 and 9 recite “processor is configured to present”, and claim 10 recites “processor is configured to derive”.
The specification fails to disclose any specific processor elements designed to perform the recited function. Therefore, these limitations are interpreted according to common understanding that processors perform their functions according to instructions loaded into their memory.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102 (a)(2) as being anticipated by Borich et al. (IDS; U.S. Pat. No US7267799).
Regarding claim 1, Borich teaches an immunochromatographic assay apparatus comprising:
a loading part (216) in which a cartridge (206) including a carrier (306) having a spotting region on which a sample is spotted (“cartridge adapter has a sample application area”, col. 9, lines 45-46) and an assay region in which a color development state changes depending on whether the sample is positive or negative (“a visible area for control and test detection”, col. 9, line 46; test and control regions in Fig. 8B), is attachably and detachably loaded - “cartridges designed with different physical parameters to be used with the system and hence be inserted and processed”, col. 9, lines 59-61;
an imaging unit (imaging optics and CCD or CMOS imaging array, Fig. 6; col. 6, lines 35-38) that images the assay region (Fig. 8B); and
a processor (106, 618) configured to perform a main determination, which is a determination of whether the sample is positive or negative, based on an assay region image of the assay region imaged by the imaging unit (718 in Fig 7B),
wherein the assay region is a line-shaped region extending along the column direction - the test region and the control region in Fig 8A are line-shaped,
the assay region image is an image in which a plurality of pixels are two-dimensionally arranged in a matrix form - CCD or CMOS imaging array of Fig. 6 inherently capture digital images in a matrix form because of the array design,
the processor is configured to perform an abnormality determination for determining presence or absence of an abnormality in the assay region image, using, as a determination index, a variation coefficient based on the representative values of all the rows - “the pixel row and column mean channel intensities may be calculated for individual regions, as shown at step 918. As shown at step 920, the variance in row and column pixel intensities may be calculated for individual regions. These variances may be compared to threshold allowance values, as shown in step 922. If the control variance is not greater than a threshold, the test may be invalidated and halted” col. 9: lines 21-27,
determine a processing content related to the main determination based on the absence of the abnormality - “after performing the comparison to the threshold level a result is determined. The test results and other information may then be reported to a user, as shown at step 928”, col. 9, lines 32-35. The processing content related to the main determination based on the absence of the abnormality is a decision step (924) on Fig. 9, which determines whether to halt testing in the presence of the abnormality or continue with steps (926) and (928) in the absence of the abnormality.
Regarding claim 2, Borich teaches wherein the processing content includes any one of whether or not to perform the main determination or a method of presenting a determination result of the main determination.
Specifically, the reference teaches a method presented in Fig. 9 flow diagram, wherein the method performs the following functional steps: “Acquire raw image pixel data” (902), “Calculate mean channel intensities” (918), “Calculate variance” (920), “If not > threshold, invalidate and halt testing” (924), and “Report value” (928). The step “Report value” is presenting a determination result of the main determination; and the step “If not > threshold, invalidate and halt testing” decides whether or not to perform the main determination.
Regarding claim 3, Borich teaches wherein the processor is configured to perform the main determination to present the main determination result in a case where the abnormality is absent - Fig. 9, flow path steps 902 -> 920 -> 928, or not to perform the main determination in a case where the abnormality is present - Fig. 9, flow path branch with steps 902 -> 920 -> 924.
Regarding claim 4, Borich teaches wherein the processor is configured to present that the main determination is not performed in a case where the main determination is not performed.
Specifically, Borich teaches that “Data may be transferred in its raw format for secondary analysis along with the pre-processed data. The data may include, in addition to the test results and image, information identifying the user, time of test, location, error status, and/or environmental conditions at time of test” (col. 8, lines 15-19). The transfer of the error status is equivalent to presenting that the main determination is not performed in a case where the main determination is not performed.
Regarding claims 5-6 and 8, Borich fails to specifically teach the limitations of these claims: (a) wherein the processor is configured to present that the assay region may be stained in a case where the abnormality is present, (b) wherein the processor is configured to present that the assay region may be stained in a case where the abnormality is present, and (c) wherein the processor is configured to perform the main determination, and perform the abnormality determination in a case where a determination result is positive.
However, these limitations are drawn to intended use of the system and therefore the prior art only needs to be capable of performing the recited intended use. So long as the imager and computer processor of Borich are capable of taking images and executing appropriate commands, the system of Borich reads on the claims.
Regarding claim 7, Borich teaches wherein the processor is configured to (see claim interpretation in 112(b) above):
present a determination result of the main determination in a case where the abnormality is absent - normal run without errors; Fig. 9, flow path steps 902 -> 920 -> 928, and
not present the determination result of the main determination in a case where the abnormality is present - Fig. 9, flow path steps 902 -> 920 -> 924; and
present a positive result – a test without errors/abnormalities reports any result, positive or negative, in step “Report value” (928) (Fig. 9, flow path steps 902 -> 920 -> 928).
As such, the processor of Borich is configured to present all three listed above assay outcomes.
Regarding claim 9, Borich teaches wherein the processor is configured to present a determination result of the main determination in a case where the abnormality is absent. Specifically, in the absence of any abnormality/error the processor of Borich is configured to present the result of the main determination in step “Report value” (928) (Fig. 9, flow path steps 902 -> 920 -> 928).
Regarding claim 10, Borich teaches immunochromatographic assay apparatus according to claim 1, wherein the imaging unit is an image sensor that images an observation region including the assay region to output an observation image including the observation region, the observation image is an image in which a plurality of pixels are two-dimensionally arranged in a matrix form, and the processor is configured to derive a profile in the row direction based on the representative values of the respective columns in the observation image, and extract the assay region image corresponding to the assay region from the observation image based on the derived profile.
Specifically, the imaging unit is an image sensor - the reader module (104) (Fig. 1) with imaging optics (608) and CCD or CMOS imaging array (Fig. 6; col. 6, lines 35-38) that images the observation region – “image shown in FIG. 8A is acquired by the CMOS or CCD detector” (col. 8, lines 62-63) including the assay region – the test and control zones/regions (Fig. 8B).
The observation image is an image in which a plurality of pixels are two-dimensionally arranged in a matrix form – the CCD or CMOS imaging array of Fig. 6 inherently capture digital images in a 2D matrix form because this is how modern imaging arrays capture digital images.
Finally, the processor is configured to extract the assay region image corresponding to the assay region from the observation image - Borich teaches that “test and control regions can then be isolated and analyzed” (col. 8, lines 65-66) from the image shown in FIG. 8A (acquired by the CMOS or CCD detector).
Borich does not specifically teach deriving a profile in the row direction based on the representative values of the respective columns in the observation image, and extracting the assay region image corresponding to the assay region from the observation image based on the derived profile. However, this limitation is drawn to intended use of the system and therefore the prior art only needs to be capable of performing the recited intended use. So long as the computer processor of Borich are capable of extracting the assay region image corresponding to the assay region from the observation image, the system of Borich reads on the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander Volkov whose telephone number is (571) 272-1899. The examiner can normally be reached M-F 9:00AM-5:00PM (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached on (571) 272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER ALEXANDROVIC VOLKOV/Examiner, Art Unit 1677
/REBECCA M GIERE/Primary Examiner, Art Unit 1677