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 .
Claim Objections
Claim 16, and therefore, claims 17–28 which depend therefrom or are also subject to the same issues, are objected to because of the following informalities: both “said” and “the” are used to refer back to antecedent basis thereby impacting readability of the claims, and therefore only “the” should be recited in the claims to refer back to antecedent basis. Appropriate correction is required.
Claim 22 is further objected to for the following informalities: lines 3 and 4 both recite “axis of the duct,” but should instead recite “axis of the sampling duct.” Appropriate correction is required.
Claims 27 and 28 are further objected to for the following informalities: both claims recite “a predetermined number of repetitions [at least – claim 27 only] of step (D),” however, claim 16 from which these claims depend already recite “a predefined number of bubble elimination cycles by one or more repetitions of said step (D),” therefore, claims 27 and 28 should clearly refer back to this antecedent basis by reciting for example “the predefined number of bubble elimination cycles.” Appropriate correction is required.
Claim 29 and therefore claim 30 which depends therefrom is objected to for the following informalities: line 5 recites “to perform an analysis of the image with to detect a presence” which is incorrect grammar regarding the “with to” phrase. Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are “a device for capturing images,” and “a device for analyzing the sample” in claim 16.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 16, and therefore claims 17–28 which depend therefrom, 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. Specifically, claim 16 recites in lines 12–13 “repeating … if necessary, also step (A),” however it is unclear and indefinite what constitutes the repeating being “necessary.” As it is indefinite what is considered “necessary,” this limitation has not been examined at this time.
Claim 25 is further rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite because the claim recites “the presence of a bubble is detected … preferably if …” which is unclear and indefinite whether the “preference” is a required or optional limitation in the claim. For the purposes of examination, this limitation has been treated as optional.
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 16–22 and 25–28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without a practical application or significantly more.
Regarding claim 16, this claim recites the following limitations which are found to be abstract ideas not reciting a practical application or significantly more:
(A) drawing the liquid sample from a container with the syringe; (B) operating said image capture device to capture one or more images of the syringe at an area of the syringe where the liquid sample was drawn; (abstract idea as organizing human activity by managing personal behavior or relationships or interactions between people" including and following rules or instructions, as given in MPEP 2106.04(a)(2)(II)(C), as a medical professional would be drawing a liquid sample and operating a camera in the process of interacting with medical patients for medical diagnostics)
(C) performing an analysis of the image with said computer to detect a presence of bubbles in the liquid sample; (abstract idea as organizing human activity by a mental process as a human mind is capable of discerning edge regions from a pixelated image, where the pixel differences are above a particular threshold);
(D) if the presence of one or more bubbles is detected in said step (C), performing one or more bubble elimination cycles and repeating at least said step (B) and said step (C) thereafter, and if necessary, also said step (A) prior to said steps (B) and (C); (abstract idea as organizing human activity by “managing personal behavior or relationships or interactions between people" including and following rules or instructions, as given in MPEP 2106.04(a)(2)(II)(C), as a medical professional would be tapping a syringe to remove bubbles in the course of drawing samples)
and (E) if a bubble is not detected in said step (C), or if a predefined number of bubble elimination cycles by one or more repetitions of said step (D) have been carried out, delivering the liquid sample from the syringe to the device for analyzing the sample to carry out the analysis of the liquid sample (abstract idea as managing personal behavior or relationships or interactions between people" including and following rules or instructions, as given in MPEP 2106.04(a)(2)(II)(C), as a medical professional would be transferring an extracted sample to an analysis device in medical lab for obtaining medical test results for a patient).
Claim 16 further recites additional elements: an analysis system comprising: a sampling device, provided with at least one syringe having a duct for drawing the sample, and a plunger movable in the duct; a device for capturing images; a computer provided with a software application for image analysis; and a device for analyzing the sample. To the extent the “sampling device,” “syringe having a duct,” “plunger movable in the duct,” “device for capturing images,” “computer” and “device for analyzing the sample” have any patentable weight due to being recited in the preamble, these limitations, while not being abstract ideas and are additional elements, nonetheless are not sufficient to recite a practical application of the abstract ideas recited in claim 1 as they amount to mere generic computer elements and thus amount to no more than a recitation of the words "apply it" (or an equivalent) or are no more than mere instructions to implement an abstract idea or other exception on a computer. see MPEP §2106.05(f).
Further, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, the above recited additional elements from claim 16 do not add significantly more (also known as an “inventive concept”) to the exception. Rather, the additional elements disclosed above perform well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP § 2106.05(d).
Therefore, independent claim 16 is directed towards an abstract idea without a practical application or significantly more.
Regarding claims 17–22, the limitations are merely directed towards further abstract ideas, specifically mental processes, as the human mind is capable of:
detecting a variation of a characteristic of pixels of the image along a direction intersecting the liquid sample in the syringe (claim 17);
detecting the variation of the characteristic when the characteristic:
of each pixel is related to color and/or brightness of the pixel (claim 18);
is related to a gray level of the pixel (claim 19);
detecting said variation along at least two directions distinct and, preferably, parallel to each other and/or the operation of detecting the variation between the characteristic of pixels arranged at the intersection points between a line transverse to, preferably orthogonal to, these at least two directions, and said two directions (claim 20);
detecting variation along the directions set forth in claim 20, and where the directions are substantially perpendicular and/or parallel to an axis of the sampling duct of said syringe (claim 21); and
evaluating a difference between a value of the characteristic in pairs of pixels, a first pixel of each pair being arranged along a first direction parallel to an axis of the duct, a second pixel of each pair being arranged along a second direction parallel to the axis of the duct, and distinct from the first direction, the pixels of each pair also being arranged on the same line perpendicular to said first and second directions (claim 22).
Regarding claim 25, the limitations are merely directed towards further abstract ideas, specifically mental processes, as the human mind is capable of detecting the presence of a bubble if the variation of said characteristic between different pixels along a direction exceeds a predefined threshold, where the human mind just by looking at a photo of a syringe would understand a bubble to be present by the different pixel colors in the image along the outline of the bubble.
Regarding claim 26, the limitations are merely directed towards further abstract ideas, specifically organizing human activity by “managing personal behavior or relationships or interactions between people" as a medical professional would press on a syringe to result in “the liquid sample is compressed by said plunger to promote bubble elimination” in the process of collecting and analyzing a lab sample for a medical test for a patient.
Regarding claim 27, the limitations are merely directed towards further abstract ideas, specifically organizing human activity by “managing personal behavior or relationships or interactions between people" as a medical professional would following a predetermined number of repetitions at least of step (D) of bubble elimination, the bubbles have not been removed, system operations are interrupted (stop trying to use the same sample due to a fatal problem with the syringe sample), in the process of collecting and analyzing a lab sample for a medical test for a patient.
Regarding claim 28, the limitations are merely directed towards further abstract ideas, specifically mental processes as the human mind is capable of, after a predetermined number of repetitions of step (D) of bubble elimination, the bubbles have not been eliminated, a volume of bubbles is estimated), so that the actual amount of liquid in the syringe is calculated (human mind can estimate the volume of a bubble, and subtract it from the overall volume to arrive at the actual amount of liquid). The claimed “the liquid sample is delivered to the device for analyzing the sample, so that the device for analyzing the sample is operable to perform sample analysis according to the calculated actual amount of liquid in the syringe” is directed towards abstract ideas, specifically organizing human activity by “managing personal behavior or relationships or interactions between people" as a medical professional would deliver a liquid sample to an analysis device in the process of collecting and analyzing a lab sample for a medical test for a patient.
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 (i.e., changing from AIA to pre-AIA ) 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)(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.
Claim 29 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Brown et al., US Patent Application Publication No. US 2022/0059203 A1 (herein “Brown”).
Regarding claim 29, Brown teaches an analysis system, comprising (Brown Abstract, determining the volume of a liquid in a container using an apparatus):
a sampling device equipped with at least one syringe having a duct for drawing a liquid sample, and a plunger movable in the duct (Brown ¶36, apparatus used with a syringe with cylinder (duct) for containing a liquid with an opening where the plunger that extends through the opening for slidable disposition (movable) and an end with a fluid exit port);
an image capture device (Brown ¶39, camera 34); and
a computer equipped operable to perform an analysis of the image with to detect a presence of bubbles in the liquid sample (Brown ¶¶37 and 76, CPU programmed with software that performs, among other things, analysis of a picture (image) taken by the camera of the syringe, to determine the volume of the liquid in the syringe and whether there are air bubbles present in the syringe).
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 (i.e., changing from AIA to pre-AIA ) 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 16–22 and 26–28 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al., US Patent Application Publication No. US 2022/0059203 A1 (herein “Brown”) in view of Takarabe et al., US Patent Application Publication No. US 2016/0052266 A1 (herein “Takarabe”).
Regarding claim 16, with deficiencies of Brown noted in square brackets [], Brown teaches a method for analysis of a liquid sample with an analysis system comprising (Brown Abstract, determining the volume of a liquid in a container using an apparatus): a sampling device, provided with at least one syringe having a duct for drawing the sample, and a plunger movable in the duct (Brown ¶36, apparatus used with a syringe with cylinder for containing a liquid with an opening where the plunger that extends through the opening for slidable disposition (movable) and an end with a fluid exit port); a device for capturing images (Brown ¶39, camera 34); a computer provided with a software application for image analysis (Brown ¶¶37 and 76, CPU programmed with software that performs, among other things, analysis of a picture (image) taken by the camera of the syringe); and a device for analyzing the sample (Brown ¶¶37 and 76, CPU programmed with software that performs analysis on the picture of the syringe sample to determine the volume of the liquid in the syringe and whether there are air bubbles present in the syringe); wherein the method comprises the steps of (Brown ¶24, fig. 5, flowchart delineating the operations of the software of the apparatus):
(A) drawing the liquid sample from a container with the syringe (Brown ¶76, nurse or medical practitioner is directed to draw medicine into a syringe, cap the syringe and place it on a tray, then press a button to indicate that the syringe is ready for analysis);
(B) operating said image capture device to capture one or more images of the syringe at an area of the syringe where the liquid sample was drawn (Brown ¶76, camera 34 takes a picture 84 of the syringe 30, where ¶44 and fig. 2a, teaches the camera has a view (thus captures an image of the area) of the syringe including the liquid in the syringe);
(C) performing an analysis of the image with said computer to detect a presence of bubbles in the liquid sample (Brown ¶76, the software scans (85) said picture and the software analyzes the data to determine among other things, the presence of air or air bubbles present in the syringe);
(D) if the presence of one or more bubbles is detected in said step (C), performing one or more bubble elimination cycles, and repeating at least said step (B) and said step (C) thereafter, and if necessary, also said step (A) prior to said steps (B) and (C) (Brown ¶76, fig. 5, step 90 analyzing for whether there are air bubbles, and if the “YES” path followed, then repeating step 81 which is to “tap the syringe to remove bubbles” and then proceed to repeat steps 82–90 again including taking a picture of the syringe at step 84 (capture one or more images (B)), and step 85 scanning the picture for presence of air bubbles (performing an analysis (C))); and
(E) if a bubble is not detected in said step (C), or if [a predefined number] of bubble elimination cycles by one or more repetitions of said step (D) have been carried out, delivering the liquid sample from the syringe to the device for analyzing the sample to carry out the analysis of the liquid sample (Brown ¶76, fig. 5, at step 90 analyzing for whether there are air bubbles, and a YES path is followed, then the syringe is tapped to remove the bubbles (resulting in the further step 90 returning a NO result, then in this sequence, step 85 is analyzing the liquid sample (delivered earlier by the medical professional in step 82 in placing the syringe back on the tray) and the analysis determines the size and volume of the liquid from the image).
While Brown teaches that the tap syringe to remove bubbles step can be repeated, Brown does not explicitly teach repeating it a predefined number of times.
Takarabe teaches a predefined number of times (Takarabe fig. 8, ¶52, a counter value n1 keeping track of how many times a bubble removal operation has been performed is compared against a predefined number N1 of times to perform the bubble removal operation).
Therefore, taking the teaching of Brown and Takarabe together as a whole, it would have been obvious to a person having ordinary skill in the art (herein “PHOSITA”) before the effective filing date of the claimed invention to have modified the repeating of the removing bubbles from the syringe step of Brown to be performed a predefined number of times as disclosed by Takarabe at least because doing so would balance the competing demands of eliminating as many bubbles as possible while not incurring an intolerable delay (rendering poor usability) to the ultimate functioning/intended result of a device due to the time required for the bubble reduction process. See Takarabe ¶¶7 and 9–10.
Regarding claim 17, Brown teaches wherein said step (C) comprises detecting a variation of a characteristic of pixels of the image along a direction intersecting the liquid sample in the syringe (Brown ¶53, an air bubble is discerned and measured by how the colors of light are not transposed before being viewed by the camera, where ¶¶48–49 teach that the amount of pixels having transposed colors (characteristic of pixels) is calculated to find the volume occupied by the liquid versus that volume occupied by the air bubble, the pixels are counted from the inside edge of the left cylinder wall 35 in fig. 2a showing the intersection of the hashed colors against the plane of the left cylinder wall 35).
Regarding claim 18, Brown teaches wherein said characteristic of each pixel is related to color and/or brightness of the pixel (Brown ¶49, fig. 2a, pixels of color are counted to determine presence of liquid and air bubbles).
Regarding claim 19, Brown teaches wherein said characteristic is related to a gray level of the pixel (Brown ¶47, intensity (gray level) used as a distinguishing value in the pixels in addition to color hue).
Regarding claim 20, Brown teaches comprising the operation of detecting said variation along at least two directions distinct and, preferably, parallel to each other and/or the operation of detecting the variation between the characteristic of pixels arranged at the intersection points between a line transverse to, preferably orthogonal to, these at least two directions, and said two directions (Brown ¶¶46–49, fig. 2a, given the broadest scope of the claim to be the parallel directions limitation as the two limitations provided only require one to meet the scope of the claim under the “and/or” recitation, two colors are used for detecting the liquid (and therefore air bubble) amount, the two colors being side by side (parallel) in the direction of intersecting the syringe cylinder).
Regarding claim 21, Brown teaches wherein said directions are substantially perpendicular and/or parallel to an axis of the sampling duct of said syringe (Brown ¶46, figs. 2a and 3f, the light colors change (variation) at a dividing line that is parallel to the syringe column, forming two parallel columns of respective light colors).
Regarding claim 22, Brown teaches wherein said step (C) comprises the operation of evaluating a difference between a value of the characteristic in pairs of pixels, a first pixel of each pair being arranged along a first direction parallel to an axis of the duct, a second pixel of each pair being arranged along a second direction parallel to the axis of the duct, and distinct from the first direction, the pixels of each pair also being arranged on the same line perpendicular to said first and second directions (Brown ¶¶46–48, figs. 2a and 3f, the light colors change (variation) at a dividing line that is parallel to the syringe column, forming two parallel columns of respective light colors, where step 85 in fig. 5 evaluates the picture of the syringe to determine the volume of liquid and presence of air bubble (mapping to the claimed step “C”), and in this process, to determine the inner width of the syringe cylinder, counts the number of pixels from a pixel (first pixel of a pair) located at the inside edge of the left cylinder wall 35, to a pixel (second pixel of a pair) located in the inside edge of the right cylinder wall 35, where the left and right sides are directions distinct but both parallel to the length-wise axis of the syringe cylinder, but along a perpendicular width-wise line).
Regarding claim 26, with deficiencies of Brown noted in square brackets [], Brown teaches wherein in said step (D), if at least one bubble elimination cycle is performed, the liquid sample is compressed by [said plunger] to promote bubble elimination (Brown fig. 5, ¶76, medical practitioner taps the syringe to promote air bubble elimination which would compress the sample). Brown does not explicitly teach but Takarabe teaches by said plunger (Takarabe figs. 6a and 6b, reference number 140, ¶¶39–42, during a bubble removal operation, flexible member 140 deforms and is released (acting as a plunger)).
Therefore, taking the teaching of Brown and Takarabe together as a whole, it would have been obvious to a PHOSITA before the effective filing date of the claimed invention to have modified the removing bubbles from the syringe step of Brown to be performed by a flexible member as a plunger as disclosed by Takarabe at least because doing so would balance the competing demands of eliminating as many bubbles as possible while not incurring an intolerable delay (rendering poor usability) to the ultimate functioning/intended result of a device due to the time required for the bubble reduction process. See Takarabe ¶¶7 and 9–10.
Regarding claim 27, Brown does not explicitly teach, but Takarabe teaches wherein if following a predetermined number of repetitions at least of step (D) of bubble elimination, the bubbles have not been removed, system operations are interrupted (Takarabe fig. 8, ¶¶52–54, if the number of bubble removal operations performed is equal to a value N1, then the bubble removal sequence is ended (system operations are interrupted) and printing is performed).
Therefore, taking the teaching of Brown and Takarabe together as a whole, it would have been obvious to a PHOSITA before the effective filing date of the claimed invention to have modified the repeating of the removing bubbles from the syringe step of Brown to be performed a predefined number of times before interrupting operations as disclosed by Takarabe at least because doing so would balance the competing demands of eliminating as many bubbles as possible while not incurring an intolerable delay (rendering poor usability) to the ultimate functioning/intended result of a device due to the time required for the bubble reduction process. See Takarabe ¶¶7 and 9–10.
Regarding claim 28, with deficiencies of Brown noted in square brackets [], Brown teaches wherein if after [a predetermined] number of repetitions of step (D) of bubble elimination, the bubbles have not been eliminated (Brown ¶76, fig. 5, the repeating of the step 81 involving tapping the syringe to remove bubbles is repeated per decision at step 90 which is disclosed as being repeated when a harmful amount of air is detected, which could involve not all bubbles being removed, but at least the harmful amount having been removed), a volume of bubbles is estimated, so that the actual amount of liquid in the syringe is calculated (Brown ¶76, step 85 determines the volume of liquid (actual amount of liquid) in the syringe), the liquid sample is delivered to the device for analyzing the sample, so that the device for analyzing the sample is operable to perform sample analysis according to the calculated actual amount of liquid in the syringe (Brown ¶76, syringe is returned to the tray of the analysis machine for analysis of proper dosage in the syringe (sample analysis)).
While Brown teaches that the remove bubbles step can be repeated, Brown does not explicitly teach a predetermined number of repetitions.
Takarabe teaches a predetermined number of repetitions (Takarabe fig. 8, ¶52, a counter value n1 keeping track of how many times a bubble removal operation has been performed is compared against a predefined number N1 of times to perform the bubble removal operation).
Therefore, taking the teaching of Brown and Takarabe together as a whole, it would have been obvious to a PHOSITA before the effective filing date of the claimed invention to have modified the repeating of the removing bubbles from the syringe step of Brown to be performed a predefined number of times as disclosed by Takarabe at least because doing so would balance the competing demands of eliminating as many bubbles as possible while not incurring an intolerable delay (rendering poor usability) to the ultimate functioning/intended result of a device due to the time required for the bubble reduction process. See Takarabe ¶¶7 and 9–10.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Brown in view of Takarabe as set forth above regarding claim 17 from which claim 25 depends, further in view of Rusch et al., US Patent Application Publication No. US 2017/0206637 A1 (herein “Rusch”).
Regarding claim 25, with deficiencies of Brown noted in square brackets [], Brown teaches wherein, during said step (C), the presence of a bubble is detected if the variation of said characteristic between different pixels along a direction exceeds [a predefined threshold], preferably if the variation of said characteristic along a direction perpendicular to an axis of the duct exceeds a predefined threshold (Brown ¶¶ 46 and 53, air bubbles are detected to be present and thus discerned and measured by detecting the colors of light to not be transposed (no variation of characteristic between pixels for respective colors)).
Brown does not explicitly teach, where Rusch teaches a predefined threshold (Rusch ¶¶55–56, defining lines between boundary areas within a syringe are detected via color and intensity data in an image exceeding a threshold).
Therefore taking the teachings of Brown and Rusch together as a whole, it would have been obvious to a PHOSITA before the effective filing date of the claimed invention to have modified the inverted color detection to discern air bubbles taught in Brown to include a threshold that is established prior to the image analysis to determine different regions in a syringe as disclosed in Rusch at least because doing so would allow for designing for specific criteria indicating defects with a syringe. See Rusch ¶¶6–8 and 55.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Brown in view of Takarabe as set forth above regarding claim 17 from which claim 23 depends, further in view of Korean patent publication no. KR 101588648 B1 by inventor Kim Young-Sub (with reference to the provided machine English language translation, herein “Young”).
Regarding claim 23, Brown teaches in which step (C) comprises the step (Brown ¶76, the software scans (85) said picture and the software analyzes the data to determine among other things, the presence of air or air bubbles present in the syringe), but does not teach the remainder of the claim. Young teaches defining a function Z = f(X, Y), wherein X and Y are coordinates of the pixels of the image in a reference system defined by two directions orthogonal to each other in a plane of the image, and Z is a value of the characteristic of the pixel placed at the X and Y coordinates of the image, and of evaluating the variation of Z as a function of X and/or Y (Young page 4, in equation (2), given as:
PNG
media_image1.png
200
400
media_image1.png
Greyscale
, ψ is a mapping for each pixel given by X and Y coordinates (thus a function of X and Y where fi is the claimed Z function), as a color value for a color variation, where x and y are the x and y axis in an image, thus orthogonal to each other in the image plane).
Therefore taking the teachings of Brown as modified above and Young together as a whole, it would have been obvious to a PHOSITA before the effective filing date of the claimed invention to have modified the image analysis taught in Brown to include the mapping function as disclosed in Young at least because doing so would allow for high-speed object detection and tracking. See Young bottom of page 5.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Brown as set forth above regarding claim 29 from which claim 30 depends, further in view of Gentalen et al., US Patent Application Publication No. US 2023/0010104 A1 (herein “Gentalen”).
Regarding claim 30, while Brown teaches a sampling device (Brown figs. 1a–1b, ¶37, including tray 25 which samples are placed on for imaging), Brown does not explicitly teach where Gentalen teaches is an autosampler (Gentalen ¶¶171–174, samples are loaded from an autosampler via an inlet to an enrichment channel where they are imaged for analysis).
Therefore taking the teachings of Brown and Gentalen together as a whole, it would have been obvious to a PHOSITA before the effective filing date of the claimed invention to have modified the sampling device taught in Brown to include an autosampler as disclosed in Gentalen at least because doing so would allow for additional analysis stages that may not be able to be safely accessed manually, thus benefitting from an automatic movement of samples between stages. See Gentalen ¶¶173–175, 141–142, UV processing (ultraviolet light known to be harmful to eyes) and mass spectrometry processing (using high voltages) of the sample performed automatically.
Allowable Subject Matter
Claim 24 is allowable over the prior art, and would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and to overcome any indicated objections or rejections noted above for the independent and intervening claims. Claim 24 is allowable over the prior art for the following reasons: the closest cited art includes Young in combination with Brown and Takarabe, as applied in claim 23. However, claim 24 which depends from claim 23, additionally recites a specific evaluation of a slope of a segment of a line intersecting the variation function Z at specific points with specific values (same X coordinates and different Y coordinates), wherein the X coordinate is in a direction parallel to an axis of the syringe duct. While Young teaches a variation function based on X and Y coordinates in an image being analyzed for the presence of a particular object (similar to the claim’s analysis for the presence of a bubble “object” in an image), Young does not, whether considered alone or in a combination obvious to a person having ordinary skill in the art teach or suggest the slope analysis of the function at the two specifically claimed points, especially considering the points relationship to the direction parallel to an axis of the syringe duct. Therefore, claim 24 is allowable over the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gibbons et al., US 2012/0309636 A1, directed towards image analysis of an image of a sample.
Pearson et al., US 2023/0139131 A1, directed towards image analysis of a syringe by way of illuminating the syringe with multiple colors of light.
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MICHELLE M. KOETH
Primary Examiner
Art Unit 2671
/MICHELLE M KOETH/ Primary Examiner, Art Unit 2671
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