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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5, 7-8, and 16-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 11 follows.
Regarding claim 13, the claim recites a series of steps or acts, including determining the percent fill result of the sample blood sampling capillary containing the blood sample by comparing a value generated by analysis of the 1-dimensional array to the calibration value. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of determining the percent fill result of the sample blood sampling capillary containing the blood sample by comparing a value generated by analysis of the 1-dimensional array to the calibration value sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 11 recites transmitting the percent fill of the blood sampling capillary containing the blood sample to at least one of a computer and a user interface, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The transmission of the percent fill value does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the transmitted percent fill value, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of generating first image data from the image data and convert the first image data to a first image in a first type of hue space; and generating second image data from the image data and convert the second image data to a second image in a second type of hue space which differs from the first type of hue space: and combining, into a one-dimensional array, (a) a first mask generated based on the first image in the first type of hue space and (b) a second mask generated based on the second image in the second type of hue space. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application. The claim also teaches disposing the sample blood sampling capillary into the system; capturing the image of the blood sample contained in the blood sampling capillary and converting the image to the image data. Capturing an image and converting it into image data is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the capturing and converting steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the capturing and converting steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 1, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited image sensor is a generic sensor configured to perform pre-solutional data gathering activity, and the micro-controller circuit is configured to perform the Abstract Idea and post-solution activity. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering, the calibration steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims. Any dependent ideas pertaining to abstract ideas still claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 103
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 1-5, 7-8, 16-17 and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Mohan (US10768105 – previously cited) in view of Kanda (JPH01313759A – previously cited), Ghaffari (US20150260713 – previously cited), Maxey (US 20140105446 – previously cited), Nakayama (WO 2021002105 A1 – previously cited), Hong (KR 101465933 B1 – previously cited), and Roy Chowdhury (US 20200082540 – previously cited).
In regards to claim 1 Mohan teaches a system for measuring a percent fill of a blood sampling capillary containing a blood sample, the system comprising:
a chamber configured for receiving a sample containing the blood sample (Fig7A, sample holder 600);
an illuminator arranged configured to illuminate the sample(Fig7A, light source 650);
an imaging lens aligned with the chamber and the sample(Fig 7A objective lens 670);
an image sensor (“a detector configured to image at least a portion of a channel in the sample holder”) aligned with the imaging lens, wherein the image sensor is configured to receive an image of the blood sample contained in the sample blood sampling capillary from the imaging lens and convert the image to image data (“In embodiments, a detector D may be configured to make qualitative observations or images, and in embodiments a detector D may be configured to make quantitative observations or images”);
and a programmable processor (Fig7A, programable processor 600).
Mohan fails to teach the chamber being for receiving a sample capillary and a micro-controller circuit electrically coupled to the image sensor; and at least one of a host computer or a user interface electrically coupled to the micro- controller circuit ;wherein the micro-controller circuit is configured to process the image data into a percent fill result wherein the percent fill result is to be passed to the at least one of the host computer or the user interface, wherein said processing involves use of a calibration value obtained from analyzing image data of a reference capillary having a known percentage fill of blood or a blood substitute having a red hue.
Kanda teaches a blood sample measurement device comprising a chamber for receiving a sample capillary containing a blood sample (FIG 2, Capillary holder 5). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the cuvette sample holder in Mohan for the capillary holder described in Kanda in order to allow for a smaller volume of blood to be required for use of the device. Such a modification involves the mere substitution of one known sample holder with another to yield predictable results. MPEP 2143.I
Mohan in view of Kanda fails to teach a micro-controller circuit electrically coupled to the image sensor; and at least one of a host computer or a user interface electrically coupled to the micro controller circuit; wherein the micro-controller circuit is configured to generate first image data from the image data and convert the first image data to a first image in a first type of hue space; generate second image data from the image data and convert the second image data to a second image in a second type of hue space which differs from the first type of hue space: combine, into a one-dimensional array, (a) a first mask generated based on the first image in the first type of hue space and (b) a second mask generated based on the second image in the second type of hue space and determine the percent fill of the blood sampling capillary containing the blood sample utilizing a predetermined calibration value obtained from analyzing image data of a reference capillary having a known percentage fill of blood or a blood substitute having a red hue; wherein the system is configured to transmit the percent fill of the blood sampling capillary containing the blood sample to at least one of a computer and a user interface.
Ghaffari teaches a micro-controller circuit electrically coupled to the image sensor (Fig 5 teaches a sensor connected to a microcontroller); and at least one of a host computer or a user interface electrically coupled to the micro-controller unit ([0052] The entire system is connected through a USB port to a laptop where software collects and analyzes data from the system)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have substitute the programmable processor (Fig 7A part 710) in Mohan in view of Kanda for the micro-controller unit and host computer described in Ghaffari. Doing so would allow for the device to be used in environments where no power is available (Ghaffari [0172]).
Mohan in view of Kanda further in view of Ghaffari fails to teach a system wherein the micro-controller circuit is configured to generate first image data from the image data and convert the first image data to a first image in a first type of hue space; generate second image data from the image data and convert the second image data to a second image in a second type of hue space which differs from the first type of hue space: combine, into a one-dimensional array, (a) a first mask generated based on the first image in the first type of hue space and (b) a second mask generated based on the second image in the second type of hue space and determine the percent fill of the blood sampling capillary containing the blood sample utilizing a predetermined calibration value obtained from analyzing image data of a reference capillary having a known percentage fill of blood or a blood substitute having a red hue; wherein the system is configured to transmit the percent fill of the blood sampling capillary containing the blood sample to at least one of a computer and a user interface.
Maxey teaches a system wherein a micro-controller circuit processes image data into a percent fill result wherein the percent fill result is passed to the at least one of a host computer or the user interface (Maxey [0029]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the microprocessor of Mohan in view of Kanda further in view of Ghaffari to carry out the fill level determining process of Maxey. Doing so would merely combining known prior art elements according to known methods to yield the predictable result of identifying the fill percent of the capillary tube inserted into the system. MPEP 2143.I
Mohan in view of Kanda in view of Ghaffari further in view of Maxey fails to teach a system wherein said processing involves use of a calibration value obtained from analyzing image data of a reference capillary having a known percentage fill of blood or a blood substitute having a red hue.
Nakayama teaches processing involving use of a calibration value obtained from analyzing image data of a reference capillary having a known percentage fill of reference liquid ([0051] zero point and span calibration are performed). It would have been obvious to a person of ordinary skill in the art to modify the processor of Mohan in view of Kanda in view of Ghaffari further in view of Maxey to use the calibration method of Nakayama to calibrate the threshold volume by performing span calibration (would include a blood capillary full to 100%). Doing so would merely be combining prior art elements according to known methods in order to yield the predictable result of calibrating the system. MPEP 2143.I
Mohan in view of Kanda in view of Ghaffari further in view of Maxey in view of Nakayama fail to teach wherein a system wherein the micro-controller circuit is configured to generate first image data from the image data and convert the first image data to a first image in a first type of hue space; generate second image data from the image data and convert the second image data to a second image in a second type of hue space which differs from the first type of hue space: combine, into a one-dimensional array, (a) a first mask generated based on the first image in the first type of hue space and (b) a second mask generated based on the second image in the second type of hue space.
Hong teaches generating first image data from the image data and convert the first image data to a first image in a first type of hue space (“a color object in an image includes the steps of receiving a source image by an image processing apparatus, RGB normalizing a source image, converting a normalized RGB image into a YCbCgCr image, and generating a first temporary image, converting the normalized RGB image into an HSV image to generate a second temporary image in which the object is detected” Hong Page 2); and generating second image data from the image data and convert the second image data to a second image in a second type of hue space which differs from the first type of hue space (“a color object in an image includes the steps of receiving a source image by an image processing apparatus, RGB normalizing a source image, converting a normalized RGB image into a YCbCgCr image, and generating a first temporary image. Converting the normalized RGB image into an HSV image to generate a second temporary image in which the object is detected” Hong Page 2). Hong also teaches , (a) a first mask generated based on the first image in the first type of hue space and (b) a second mask generated based on the second image in the second type of hue space created using binarization (“Generating the first temporary image may include converting the normalized RGB image into a YCbCgCr image, extracting an object having a threshold value or more in each color difference channel of Cb, Cg, and Cr in the YCbCgCr image, extracting the object, And Cr; performing binarization on at least one of the images; and performing combining for each image when the binarized images are a plurality of images.” Hong Page 1, Paragraph 13).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the microprocessor of Mohan in view of Kanda in view of Ghaffari further in view of Maxey in view of Nakayama to carry out the image analysis technique described in Hong. Doing so would allow for the detection that is efficient and has a low computational complexity (Hong Translation Page 3, Paragraph 6, Hong Translation Page 5, Paragraph 6).
Mohan in view of Kanda in view of Ghaffari further in view of Maxey in view of Nakayama in view of Hong fails to teach a 1-dementional array made from a combination of the masks. Roy Chowdhury teaches a method and system that takes an image plane and linearizes it into a 1-dimensional array (Roy Chowdhury [0016]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the software steps defined in Hong with the linearizing system in Roy Chowdhury to convert the combined mask into a 1-dimentional array. Doing so would minimize the computational time complexity (Roy Chowdhury, Paragraph 0031).
In regards to claim 2, Modified Mohan teaches the system of claim 1, further comprising: a white light LED (“For example, light source 654 may be white light or light sources such as but not limited to light emitting diodes”, Mohan col 68, lines 45-47)
In regards to claim 3, Modified Mohan teaches the system of claim 1, further comprising: an aperture structure aligned with the imaging lens and the imaging sensor wherein the aperture structure is disposed between the imaging lens and the image sensor, the aperture structure restricting a ray cone of the image of the blood in the sample capillary to decrease image distortion and aberrations caused by the imaging lens. (aperture 694, Mohan col 66, line 11) (See annotated FIG. bellow)
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In regards to claim 4 modified Mohan teaches the system of claim 1. Modified Mohan fails to teach a microcontroller circuit that controls the illuminator. Ghaffari teaches an LED controlled by a microcontroller (Fig 5C shows LED to DAC to microcontroller).It would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Modified Mohan to have the microprocessor layout of Ghaffari. Doing so would allow all of the electronic components of the device to be controlled by the microprocessor allowing for the user to control the system from one host computer (Ghaffari paragraph 0160).
In regards to claim 5, modified Mohan teaches the system of claim 1, wherein the micro-controller circuit is further configured to select out pixels of the image of the blood sample contained in the blood sampling capillary whose values lie in a particular range of hue (Hong Page 2 paragraphs 13-14 masks are created from selected pixels in specific hues).
In regards to claim 7, modified Mohan teaches the system of claim 1, wherein at least one of: the first type of hue space is a YCbCr format color space; and the second type of hue space is a HSV format color space (“Converting the normalized RGB image into an HSV image to generate a second temporary image in which the object is detected, and finally detecting the object by combining the first temporary image and the second temporary image” Hong Page 2, Paragraph 1).
In regards to claim 8, modified Mohan teaches the system of claim 1, wherein: the first type of hue space is a YCbCr format color space; and the second type of hue space is a HSV format color space (“Converting the normalized RGB image into a YCbCgCr image and generating a first temporary image in which an object is detected in the YCbCgCr image”, Hong Page 2).
In regards to claim 16 modified Mohan teaches the system of claim 1, wherein the known percentage fill is one hundred percent (100%) (Nakayama [0051] span calibration would include a sample on the upper limit of the measurement range).
In regards to claim 17 modified Mohan teaches the system of claim 1, further comprising the reference capillary (Nakayama [0051]).
In regards to claim 24 modified Mohan teaches the system of claim 1, wherein the micro-controller circuit is further configured to generate the first mask and the second mask based on a selected hue range, wherein: pixels lying within the selected hue range are set to 1 in the first mask and the second mask; and pixels outside the selected hue range are set to 0 in the first mask and the second mask (“performing binarization on at least one of the images; and performing combining for each image when the binarized images are a plurality of images.” Hong Page 1, Paragraph 13).
In regards to claim 25 modified Mohan teaches the system of claim 1, wherein the blood substitute comprises at least one of a red dye or a red epoxy. Modified Mohan teaches that the capillary has a known percentage fill of blood not blood substitute (see arguments for claim 1).
In regards to claim 26 modified Mohan teaches the system of claim 1, wherein the blood substitute comprises an ultraviolet- curable epoxy and a red dye powder. Modified Mohan teaches that the capillary has a known percentage fill of blood not blood substitute (see arguments for claim 1).
In regards to claim 27 modified Mohan teaches the system of claim 1, further comprising at least one of the computer and the user interface (Ghaffari [0052] The entire system is connected through a USB port to a laptop where software collects and analyzes data from the system).
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Mohan (US10768105) in view of Kanda (JPH01313759A), Ghaffari (US20150260713), Maxey (US 20140105446), Nakayama (WO 2021002105 A1), Hong (KR 101465933 B1), and Roy Chowdhury (US 20200082540 – previously cited) as applied to claim 1, further in view of Xiong (US 20090263013 A1).
In regards to claim 20 modified Mohan teaches the system of claim 1. Modified Mohan fails to teach a system wherein the micro-controller circuit is further configured to at least one of: perform an erosion operation on the one-dimensional array to reduce noise; and perform a dilation operation on the one-dimensional array to reduce noise. Xiong teaches using an erosion dilation process to reduce noise in image data ([0025]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Mohan to perform an erosion and dilation process on the one-dimensional array. Doing so would help reduce noise in the one-dimensional array data.
In regards to claim 21 modified Mohan teaches the system of claim 1. Modified Mohan fails to teach a system wherein the micro-controller circuit is further configured to both: perform an erosion operation on the one-dimensional array to reduce noise; and perform a dilation operation on the one-dimensional array to reduce noise. Xiong teaches using an erosion-dilation process to reduce noise in image data ([0025]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Mohan to perform an erosion and dilation process like Xiong on the one-dimensional array. Doing so would help reduce noise in the one-dimensional array data.
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Mohan (US10768105) in view of Kanda (JPH01313759A), Ghaffari (US20150260713), Maxey (US 20140105446), Nakayama (WO 2021002105 A1), Hong (KR 101465933 B1), and Roy Chowdhury (US 20200082540) as applied to claim 1, further in view of Ghosh (US 20050177315 A1).
In regards to claim 22 modified Mohan teaches the system of claim 1. Modified Mohan fails to teach a system wherein in being configured to combine the first mask and the second mask into the one-dimensional array, the micro-controller circuit is configured to sum the first mask and the second mask pixel by pixel. Ghosh teaches summing binary masks pixel by pixel column wise ([0057]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Mohan to perform to perform the mask summing method of Ghosh. Doing so would merely be combining prior art methods according to known methods in order to sum the two binarized masks.
In regards to claim 23 modified Mohan teaches the system of claim 22, wherein in being configured to sum the first mask and the second mask pixel by pixel, the micro-controller circuit is configured to sum the first mask and the second mask column-wise into the one-dimensional array (Ghosh [0057]).
Examiner’s Note
In regards to claims 18 and 28, none of the prior art teaches or suggests, either alone or in combination, a device comprising a micro-controller circuit configured to multiply (a) a difference between (i) a blood start location determined from the image of the blood sample contained in the blood sampling capillary and (ii) a blood end location determined from the image of the blood sample contained in the blood sampling capillary by (b) the predetermined calibration value, in combination with the other claimed elements.
Claims 18-19 and 28 contain no prior art rejections, however they are not in condition for
allowance due to their rejections under 35 U.S.C. 101.
Response to Arguments
Applicant's arguments filed 09/25/2025 in regards to the 35 U.S.C. 101 rejections have been fully considered and they are not persuasive. Applicant’s only argument is that the amendments to the claims have obviated the rejection. This is not persuasive as no reasons are provided as to why the amendments have obviated the rejection. Merely transmitting data to a computer/user interface is not enough to integrate the judicial exception into a practical application as it is considered post-solutional activity.
Applicant’s arguments, see pages 8-10 of remarks, filed 09/25/2025, with respect to the rejection(s) of claim(s) 1-4 and 16-17 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Mohan (US10768105 – previously cited) in view of Kanda (JPH01313759A – previously cited), Ghaffari (US20150260713 – previously cited), Maxey (US 20140105446 – previously cited), Nakayama (WO 2021002105 A1 – previously cited), Hong (KR 101465933 B1 – previously cited), and Roy Chowdhury (US 20200082540 – previously cited).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY EPPERT whose telephone number is (571)270-0818. The examiner can normally be reached M-F 7:30-5:00 EST.
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/LUCY EPPERT/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791