DETAILED ACTION
Claims 16-35 are pending for examination.
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 .
Priority
Acknowledgment is made of applicant's claim under US PRO 62/357096 filed on 6/30/2016.
Double Patenting
The non-statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper time-wise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. A non-statutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g In re Berg, 140F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528,163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on non-statutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(l) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms.Thefiling date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AI A/25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-l.jsp.
Claims 16-35 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 16-19, 21, 23-29, 31 and 33-39 of U.S. Patent No. 12,462,373. Although the claims at issue are not identical because the present invention claims a broader invention, while claiming there will be at least three color components of a fragment of the image, than the claimed evaluating dispensation of a fluidic substance in the US Patent.
However, they are not patentably distinct from each other because they both claim capturing an image of at least a portion of a fluid receptacle; obtaining color components of a fragment of the image; generating a comparison value based on one or more of the color components of the fragment of the image; and performing a comparison of the comparison value and a threshold; and determining whether to generate a flag for the fluid receptacle based on the comparison of the comparison value and the threshold
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 16, 22-26 and 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over Pugia, US 2010/0239137 A1 (Pugia), in view of Badawy et al, US 2016/0055653 A1 (Badawy).
Regarding Claim 16, Pugia discloses a method for evaluating dispensation of a fluidic substance in an automated analysis instrument, the method comprising:
capturing, using an image capturing device, an image of at least a portion of a fluid receptacle; obtaining at least three color components of a fragment of the image (Pugia [0034] – The processor 110 may process image data received from the camera 106. For example, the processor 110 may determine the color response associated with regions of the images received from the camera 106. The processor 110 may determine, for example, the red-green-blue color values of pixels within digital images received from the camera 106. The processor 110 may determine from the two-dimensional image received from the camera 106 a color response associated with an area of reacted reagent and/or a background area of unreacted reagent; see Claim 24 - the processor determines a plurality of respective third color responses corresponding to the second subset of the plurality of test areas, calibrates the plurality of respective third color responses according to the first color response, and generates a second plurality of respective results according to the plurality of respective third color responses);
generating a comparison value based on the color components of the fragment of the image; and performing a comparison of the comparison value and a threshold (Pugia [0043] – The assay 104 may have a dry reagent that defines test areas 210 a-1 of reacted reagent and a background area 202 of reagent that has not been exposed to the sample. In a typical test with the assay 104, the color of the test area 210 a-1 may change according to a reaction between the sample and the reagent. The color response of the test area 210 a-1 in contrast with the color of the background area 202 may indicate the result of the test; [0061] – The information presented in the graph 602 may be used to assess the result of the test for which the assay 104 is being used. For example, the calibrated second color response may be compared to a known value and/or known threshold associated with a positive or negative result of the test); and
However, Pugia does not explicitly disclose determining whether to generate a flag for the fluid receptacle based on the comparison of the comparison value and the threshold
Badawy teaches determining whether to generate a flag for the fluid based on the comparison of the comparison value and the threshold (Badawy [0017] – In step 115, for each ROI 101, the current frame is compared with the TC set in step 113. The points that are similar to or darker than the TC are considered. If the considered points are changed a lot compared with the RF, for example if the differences from the reference frame are greater than a threshold, they are defined as potential points; [0018] - Because of the lighting change (or reflection) in the environment, some potential points may not be related to a leak. Therefore, in step 116 we will filter them out by comparing with the reference frame difference (RFD). Even though there is no leak at the time that the RFD is obtained in step 114, we still can see some difference in the image. This is because of the background lighting change or some reflection by the floor. If there is a leak, the amount of frame difference should be much larger than the reference frame difference. For each region of interest, if the amount of potential points is larger than the frame difference according to a metric by a threshold, and if the area occupies a certain percentage of the whole region, the server determines that there is a leak in that ROI in step 117. If any ROI is determined to have a leak in step 117, the server generates an alarm in step 118).
Therefore, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to modify Pugia to generate a flag for the fluid based on the comparison of the three color components, as taught by Badawy. One would be motivated as the flag would provide an indicator that fluid is present.
Regarding Claim 22, Pugia, in combination, further discloses the method of claim 16, wherein: the method comprises, for each of a plurality of fragments of the image: obtaining at least three color components of that fragment of the image; and generating a comparison value for that fragment based on the color components of that fragment of the image; the method comprises performing a set of comparisons by, for each of the plurality of fragments of the image, performing a comparison of the comparison value for that fragment and the threshold (Pugia [0057] – The two-dimensional image 500 may be subdivided in the x-direction into a plurality of columns 502. The processor 110 may determine an average red-green-blue value for each column 502 of constant pixel width; [0034] – The processor 110 may process image data received from the camera 106. For example, the processor 110 may determine the color response associated with regions of the images received from the camera 106. The processor 110 may determine, for example, the red-green-blue color values of pixels within digital images received from the camera 106. The processor 110 may determine from the two-dimensional image received from the camera 106 a color response associated with an area of reacted reagent and/or a background area of unreacted reagent; [0043] – The assay 104 may have a dry reagent that defines test areas 210 a-1 of reacted reagent and a background area 202 of reagent that has not been exposed to the sample. In a typical test with the assay 104, the color of the test area 210 a-1 may change according to a reaction between the sample and the reagent. The color response of the test area 210 a-1 in contrast with the color of the background area 202 may indicate the result of the test; [0061] – The information presented in the graph 602 may be used to assess the result of the test for which the assay 104 is being used. For example, the calibrated second color response may be compared to a known value and/or known threshold associated with a positive or negative result of the test);
However, Pugia does not explicitly disclose determining whether to generate the flag for the fluid receptacle based on the comparison of the comparison value and the threshold comprises determining whether to generate the flag for the fluid receptacle based on each comparison from the set of comparisons.
Badawy teaches determining whether to generate the flag for the fluid based on the comparison of the comparison value and the threshold comprises determining whether to generate the flag for the fluid based on each comparison from the set of comparisons (Badawy [0017] – In step 115, for each ROI 101, the current frame is compared with the TC set in step 113. The points that are similar to or darker than the TC are considered. If the considered points are changed a lot compared with the RF, for example if the differences from the reference frame are greater than a threshold, they are defined as potential points; [0018] - Because of the lighting change (or reflection) in the environment, some potential points may not be related to a leak. Therefore, in step 116 we will filter them out by comparing with the reference frame difference (RFD). Even though there is no leak at the time that the RFD is obtained in step 114, we still can see some difference in the image. This is because of the background lighting change or some reflection by the floor. If there is a leak, the amount of frame difference should be much larger than the reference frame difference. For each region of interest, if the amount of potential points is larger than the frame difference according to a metric by a threshold, and if the area occupies a certain percentage of the whole region, the server determines that there is a leak in that ROI in step 117. If any ROI is determined to have a leak in step 117, the server generates an alarm in step 118).
Therefore, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to modify Pugia to generate a flag based on color comparisons of fluid in an image, as taught by Badawy. One would be motivated as the flag/alert would notify a system/user of the presense of a type of liquid/fluid of interest.
Regarding Claim 23, Pugia, in combination, further discloses the method of claim 16, wherein the method comprises determining the threshold based on a type for the fluidic substance (Pugia [0028] – The assay 104 may be any diagnostic test medium suitable for detecting the presence or absence of a compound and/or for determining a characteristic of a biological sample by a reaction with a dry reagent that affects the reflectance of the dry reagent).
Regarding Claim 24, Pugia, in combination, further discloses the method of claim 16, wherein the color components of the fragment of the image comprise a red color component, a green color component, and a blue color component (Pugia [0053] – the processor 110 may determine from the one or more two-dimensional images a first color response from the background area 202. The first color response may be a corresponding red-green-blue value).
Regarding Claim 25, Pugia, in combination, further discloses the method of claim 16, wherein the fluidic substance is selected from: a body fluid sample; a reagent; and a mixture of a body fluid sample and a reagent (Pugia [0028] – The assay 104 may be any diagnostic test medium suitable for detecting the presence or absence of a compound and/or for determining a characteristic of a biological sample by a reaction with a dry reagent that affects the reflectance of the dry reagent. The assay 104 may include a reagent, that when reacted, with biological urine sample, may detect glucose, creatinine, albumin, protein, occult blood, urobilinogen, pH, ketone, specific gravity, bilirubin, leukocyte, nitrite, and the like).
With regard to claims 26 and 32-35, the claim limitations are essentially the same as claims 16 and 22-25, respectively, but in a different embodiment. Therefore, the rational used to reject claims 16 and 22-25 is applied to claims 26 and 32-35.
Claims 17, 18, 21, 27, 28 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Pugia and Badawy, in view of Orla-Jensen, US 2018/0304293 A1 (OJ).
Regarding Claim 17, Pugia, in combination, further discloses the method of claim 16, wherein the method comprises determining, based on the fluidic substance, a subset of color components of the fragment of the image to use in generating the comparison value (Pugia [0011] – The processor determines, from the two-dimensional image, a first color response from the background area and a second color response from the test area or vice versa. The processor calibrates the second color response according to the first color response and generates a result of the test according to the second color response).
However, Pugia does not explicitly disclose generating the comparison value based on one or more of the color components of the fragment of the image is performed by generating the comparison value based on the subset of color components of the fragment of the image determined based on the fluidic substance
OJ teaches generating the comparison value based on one or more of the color components of the fragment of the image is performed by generating the comparison value based on the subset of color components of the fragment of the image determined based on the fluidic substance (OJ [0053] – The retroreflective properties of the fluid may result in the color captured by the camera 412 to have more red light than blue light, which may indicate a higher sphericity of the fluid. If the color captured by the camera 412 appears to have more equal levels of red light and blue light or higher levels of blue light than red light, the controller 408 may determine the sphericity of the fluid is lower).
Therefore, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to modify Pugia to generate a comparison value based on color components and the fluidic substance, as taught by OJ. One would be motivated as the different colors can assist a system to determine the position and the type of substance.
Regarding Claim 18, Pugia, in combination, further discloses the method of claim 17, wherein the subset of color components of the fragment of the image is two color components of the fragment of the image (Pugia [0034] – The processor 110 may process image data received from the camera 106. For example, the processor 110 may determine the color response associated with regions of the images received from the camera 106. The processor 110 may determine, for example, the red-green-blue color values of pixels within digital images received from the camera 106; [0045] – The first field of view 204 a may encompass a first subset 210 a-f of test areas 210 a-1).
Regarding Claim 21, Pugia and Badawy teach the method of claim 16, as outlined above.
However, Pugia does not explicitly disclose generating the comparison value based on the color components of the fragment of the image comprises generating the comparison value as a difference between the first color component and the second color component.
OJ teaches generating the comparison value based on the color components of the fragment of the image comprises generating the comparison value as a difference between the first color component and the second color component (OJ [0053] – The retroreflective properties of the fluid may result in the color captured by the camera 412 to have more red light than blue light, which may indicate a higher sphericity of the fluid. If the color captured by the camera 412 appears to have more equal levels of red light and blue light or higher levels of blue light than red light, the controller 408 may determine the sphericity of the fluid is lower).
Therefore, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains to modify Pugia to calculate a difference between color components, as taught by OJ. One would be motivated as the different colors can assist a system to determine the position and type of substance.
With regard to claims 27, 28 and 31, the claim limitations are essentially the same as claims 17, 18 and 21, respectively, but in a different embodiment. Therefore, the rational used to reject claims 17, 18 and 21 is applied to 27, 28 and 31.
Allowable Subject Matter
Claims 19, 20, 29, 30 are objected to as being dependent upon a rejected base claim but would be allowable if it were to overcome the double patent rejection and rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMIR SHAHNAMI whose telephone number is (571)270-0707. The examiner can normally be reached Monday - Friday 8:00 am to 4:00 pm.
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/AMIR SHAHNAMI/Primary Examiner, Art Unit 2483
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