DETAILED ACTION
Applicant' s arguments, filed 04/22/2025 have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 12/08/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-2, 4-5, 7, 9-17, and 19-20 are the current claims hereby under 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 .
Claim Objections
Claim 20 is objected to because of the following informalities:
Claim 20 line 1 it appears that “Method” should recite “The method”
Appropriate correction is required.
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 13 and 19-20 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 13 recites “wherein actuating the sample aspirator comprises controlling the sample aspirator to aspirate a part of the sample through the sample aspirator tube” which appears to define what “actuating the sample aspirator” entails however no such actuation of the sample aspirator has been set forth in the claims and thus it is unclear how this actuating of the sample aspirator relates to the rest of the claimed system. For the purposes if this examination, the limitation will be interpreted as describing the function of the sample aspirator but not requiring the actuating of the sample aspirator.
Claim 19 recites “filling the sample through the lumen of the sample aspirator tube into the measurement chamber” it is unclear what the recitation of “filling the sample” is meant to convey. For the purposes of this examination, the limitation will be interpreted as “aspirating the sample through the lumen of the sample aspirator tube into the measurement chamber to fill the measurement chamber”.
Claim 20 is rejected by virtue of its dependence on claim 19.
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.
Claim 1-2, 4-5, 7, 9-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ebbesen US Patent Application Publication Number US 2024/0241106 A1 hereinafter Ebbesen in view of Watson US Patent Application Publication Number US 2004/0005245 A1 hereinafter Watson and further in view of Takemoto US Patent Application Publication Number US 2018/0348243 A1 hereinafter Takemoto and evidenced by US Patent Application Publication Number US 2006/0139453 A1 hereinafter Spinelli and Lee US Patent Application Publication Number US 2012/0268237 A1 hereianfter Lee
Regarding claim 1, Ebbesen discloses a measurement apparatus (Abstract), comprising:
an arrangement for supporting a measurement of a liquid sample contained in a container (Paragraph 0067: the blood gas analyzer and inlet structure), the arrangement comprising:
a measurement support equipment (Paragraph 0067: the blood gas analyzer and inlet structure; Fig. 1 reference 1);
a detection system adapted to acquire object information about the container arranged in a region of interest, the container being held by a user's hand in the region of interest, in order to acquire information about the container (Paragraphs 0069-0070: the sensors for detecting a presence, position, and/or orientation of the handheld sample container); and
a processor (Paragraphs 0068: a controller) adapted:
to analyze the object information, in order to obtain an analysis result (Paragraphs 0069-0070: the presence, position and/or orientation of the container); and
to control the measurement support equipment based on the analysis result (Paragraph 0073: display instruction to the user to push the container closer to the analyzer and instruction to adjust the angle of the container),
wherein the detection system (Paragraphs 0069-0070: the sensors) comprises:
a camera system adapted to acquire images of the region of interest as the object information (Paragraph 0023: the at least one sensor may be a camera or vision based system),
wherein the processor is adapted to analyze at least one image of the images including detecting a position of the container and detecting a type of the container, in order to obtain the analysis result (Paragraphs 0023 and 0069-0070: the images may be analyzed to determine the kind, or type, of blood sample container being present at the inlet structure and the position of the container),
wherein the measurement support equipment comprises a sample input system adapted to allow input of the sample for the measurement, which sample input system is arranged in said region of interest (Paragraph 0067: the inlet structure; Figs 1-3: references 12a-e),
wherein the sample input system includes a sample aspirator including a sample aspirator tube having a lumen through which the sample can be conveyed towards a measurement chamber (Paragraphs 0067-0069 and 0071: the inlet structure and aspiration point, which is interpreted to be the tip of the tube or needle which penetrates the sample container to aspirate the sample, and the inlet through which the blood sample enters the measurement chamber Fig. 1 references 6, 12a and 12b), and
the measurement apparatus (Abstract) further comprising:
the measurement chamber (Paragraphs 0067 and 0071; The measurement chamber; Fig. 1 reference 2);
the sample input port through which the sample aspirator tube is traversable (Considered to be at least suggested by: Fig. 3 appears to illustrate the inlet structure 12a/b being outside of the rectangular port, Fig 4 seems to illustrate that the container is pressed into this port to achieve the desired aspiration depth as recited in paragraph 0072. Additionally Fig. 1 illustrates the inlet structure 112a/b extending beyond the wall of the device. This depiction is considered sufficient to at least suggest an input port through which the aspirator tube is traversable. Ebbesen further recites a displaceable part 12e of the inlet structure but fails to disclose how this element is displaceable. Figs 1 and 2 appear to suggest that the displaceable part 12e is configured to rotate to change the angle at which the inlet parts 12a/b are presented. This is suggested in at least Fig. 1 where inlet elements 12a and 12b are shown at two separate angles, each of the other figures refers to 12a and 12b being in the same location so their illustration at two different angles in combination with the recitation of a displaceable part and the appearance of the displaceable part 12e in Fig. 2 is considered to at least suggest that the inlet system is configured to rotate to some degree)
the measurement chamber being adapted to be filled with the sample through the lumen of the sample aspirator tube and comprising at least one sensor unit adapted to measure at least one analyte in the sample (Paragraphs 0067 and 0071: the measurement chamber is filled via the inlet structure and contains a plurality of analyte sensors for sensing analytes in the blood sample),
Ebbesen fails to further disclose the arrangement wherein the measurement support equipment further comprises a sample input port closure configured to open and close a sample input port through which the sample aspirator tube is traversable to be accessible in the region of interest and wherein to control the measurement support equipment based on the analysis result comprises actuating the sample input port closure, and wherein to actuate the sample input port closure comprises to control the sample input port closure to open the sample input port based on the analysis result.
Watson teaches a pathology distribution system for automated sample container processing and distribution (Abstract). Thus Watson falls within the same field of endeavor as Applicant’s invention.
Watson teaches a system configured to control the measurement support equipment based on the analysis result comprises controlling the sample input system (Paragraphs 0120-0125 and 0190; Fig. 5-6C reference 86 and the arrows). Watson teaches an axially traversable aspiration system controlled by the analysis result of an image system.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the input system of Ebbesen to include actuatable components which are movable in response to an analysis result and traverse through the input port into the container rather than press the container into the aspiration system as taught by Watson because configuring the system of Ebbesen to make the aspiration system traversable through the input port into the container rather than having the user press the container farther into the device would provide the benefit of reducing potential user error which could damage the system or result in invalid measurements being taken. The user may damage the system by pressing the container too far in, at the wrong angle, or with too much force and may result in invalid measurements if the user does not press the container in far enough resulting in improper aspiration. Additionally, such a configuration would improve the usability of the device as all the user has to do is hold the container still in a specific area.
Ebbesen in view of Watson fails to further disclose the arrangement wherein the measurement support equipment further comprises a sample input port closure configured to open and close a sample input port through which the sample aspirator tube is traversable to be accessible in the region of interest and wherein to control the measurement support equipment based on the analysis result comprises actuating the sample input port closure, and wherein to actuate the sample input port closure comprises to control the sample input port closure to open the sample input port based on the analysis result
Takemoto teaches an analysis unit which analyzes a specimen collected from a subject (Abstract). Thus, Takemoto falls within the same field of endeavor as Applicant’s invention.
Takemoto teaches a container set unit which is openable and closable from a front surface of an apparatus body (Paragraph 0109; Figs. 2 and 3 reference 111). Fig. 3 illustrates that the internal portion of the device is accessible when the set unit is open and enclosed when the set unit is closed.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to construct Ebbesen in view of Watson with an openable and closable sample input port closure as taught by Takemoto such that the input port depicted in in Figs. 3-10 of Ebbesen has an openable and closable door, or sample input port closure, such that the aspiration tube and measurement equipment are contained within the device body in the closed position and are accessible and able to traverse through the opening in the open position as taught by Takemoto because such a construction would protect the internals of Ebbesen in view of Watson when not in use and prevent buildups of dust or other matter on the aspiration member which may cause clogs or inaccurate measurements.
Ebbesen in view of Watson further in view of Takemoto fails to explicitly teach the arrangement wherein to control the measurement support equipment based on the analysis result comprises actuating the sample input port closure, and wherein to actuate the sample input port closure comprises to control the sample input port closure to open the sample input port based on the analysis result
However, this difference of the sample input port closure being configured to automatically open and close on the basis of an analysis result determined from images is not considered to be a patentable difference. This is because the automation, i.e. use of computers, to perform otherwise known methods is not an unobvious variation from the teachings of prior art wherein automation was not performed. In other words, broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (see In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958)). In the present case, the opening and closing of the door is considered a known manual activity such as is evidenced by Takemoto Figs. 3, 22, and 24-25 and paragraphs 0109 which describe the container set unit, or door, as being openable and closable by pushing a button or manually closing the door. The automation of such as task based on image analysis is not considered to be a patentable difference because the automation of opening and closing doors based on image analysis is well known as evidenced by at least Spinelli which teaches an automated door actuatable based on image analysis of a camera’s field of view (Spinelli: Paragraphs 0021-0027) and Lee which also teaches the automatic control of a door based on identified object in a camera’s field of view (Lee: Paragraphs 0012-0016). Since Ebbesen already performs the required video analysis (Ebbesen: Paragraphs 0023 and 0069-0070: the images may be analyzed to determine the kind, or type, of blood sample container being present at the inlet structure and the position of the container), and Ebbesen in view of Watson, further in view of Takemoto teaches that such an input port closure may be present, the automation of the opening and closing of such an input port closure based on the results of the image analysis is considered to be an unobvious variation from the teachings of prior art
Regarding claim 2, Ebbesen in view of Watson further in view of Takemoto and evidenced by Spinelli and Lee teaches the measurement apparatus according to claim 1. Modified Ebbesen further discloses the arrangement wherein the measurement support equipment is controlled without requiring the user touching anything except the container (Paragraph 0073; Figs. 3-5: the user only touches the container and adjusts it according to the output instructions).
Regarding claim 4, Ebbesen in view of Watson further in view of Takemoto and evidenced by Spinelli and Lee teaches the measurement apparatus according to claim 1. Modified Ebbesen further discloses the arrangement wherein the measurement support equipment further comprises at least one of: an optical and/or acoustical output device (Paragraphs 0027 and 0046: the output device may be a monitor to display images and/or a loudspeaker).
Modified Ebbesen further suggests a sample aspirator positioner configured to adjust the sample aspirator tube in at least one of a position and an orientation in Figs. 1 and 2 and paragraph 0072 which disclose a displaceable part which appears to be rotatable as described in the above rejection of claim 1.
Watson teaches a sample aspirator positioner configured to adjust the sample aspirator tube in at least one of a position and an orientation (Paragraphs 0120-0125 and 0190; Fig. 5-6C reference 86 and the arrows). Watson teaches an axially traversable aspiration system controlled by the analysis result of an image system.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the input system of Ebbesen to include actuatable components which are movable in response to an analysis result and traverse into the container rather than press the container into the aspiration system as taught by Watson because configuring the system of modified Ebbesen to make the aspiration system traversable into the container rather than having the user press the container farther into the device would provide the benefit of reducing potential user error which could damage the system or result in invalid measurements being taken. The user may damage the system by pressing the container too far in, at the wrong angle, or with too much force and may result in invalid measurements if the user does not press the container in far enough resulting in improper aspiration. Additionally, such a configuration would improve the usability of the device as all the user has to do is hold the container still in a specific area.
Regarding claim 5, Ebbesen in view of Watson further in view of Takemoto and evidenced by Spinelli and Lee teaches the measurement apparatus according to claim 1. Modified Ebbesen further discloses the arrangement wherein to control the measurement support equipment based on the analysis result comprises at least one of:
indicating information on an optical and/or acoustical output device (Paragraph 0072: displaying instructions);
actuating the sample aspirator (Paragraph 0074: aspirating the sample);
Modified Ebbesen fails to further disclose the control of the measurement equipment comprising: actuating a sample aspirator positioner, in order to adjust the sample aspirator tube in at least one of a position and an orientation.
Watson teaches a sample aspirator positioner configured to adjust the sample aspirator tube in at least one of a position and an orientation (Paragraphs 0120-0125 and 0190; Fig. 5-6C reference 86 and the arrows). Watson teaches an axially traversable aspiration system controlled by the analysis result of an image system.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the input system of Ebbesen to include actuatable components which are movable in response to an analysis result and traverse into the container rather than press the container into the aspiration system as taught by Watson because configuring the system of modified Ebbesen to make the aspiration system traversable into the container rather than having the user press the container farther into the device would provide the benefit of reducing potential user error which could damage the system or result in invalid measurements being taken. The user may damage the system by pressing the container too far in, at the wrong angle, or with too much force and may result in invalid measurements if the user does not press the container in far enough resulting in improper aspiration. Additionally, such a configuration would improve the usability of the device as all the user has to do is hold the container still in a specific area.
Regarding claim 7, Ebbesen in view of Watson further in view of Takemoto and evidenced by Spinelli and Lee teaches the measurement apparatus according to claim 1. Modified Ebbesen further discloses the arrangement wherein to analyze the at least one image includes in real time detecting an orientation of the container (Paragraphs 0023 and 0034: the vison-based system may detect an object’s orientation).
Regarding claim 9, Ebbesen in view of Watson further in view of Takemoto and evidenced by Spinelli and Lee teaches the measurement apparatus t according to claim 1. Modified Ebbesen further discloses the arrangement wherein the analysis result further includes: an incorrect arrangement of the container, including at least one of an incorrect positioning and an incorrect orientation of the container (Paragraphs 0023 and 0034: the sensors may detect the orientation of the container; Paragraphs 0073-0075: the sensors can detect if the user is having difficulties in advancing the handheld container and may instruct them on how to change the position or orientation).
Modified Ebbesen fails to further disclose the analysis including an error related to the container.
Watson teaches an analysis of a container may include a variety of error conditions (Paragraphs 0077-0082 and 0113: the image analyzer analyses the container and may output a variety of errors based on certain conditions).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the error output of Watson into the arrangement of modified Ebbesen because the error output of Watson may allow the arrangement of modified Ebbesen to notify the user if an incompatible container is being presented, if the sample is incompatible or insufficient, and/or if the identifying information is unable to be read. Such messages may prompt the user to take corrective actions.
Regarding claim 10, Ebbesen in view of Watson further in view of Takemoto and evidenced by Spinelli and Lee teaches the measurement apparatus according to claim 4. Modified Ebbesen further discloses the arrangement wherein in case that the measurement support equipment comprises the optical and/or acoustical output device (Paragraphs 0027 and 0046: the output device may be a monitor to display images and/or a loudspeaker), the information indicated by the optical and/or acoustical output device comprises at least one of:
the at least one image (Not explicitly disclosed by Ebbesen but not required by the claim);
the information about the container (Not explicitly disclosed by Ebbesen but not required by the claim);
an error message (Not explicitly disclosed by Ebbesen but not required by the claim);
information regarding the sample (Paragraph 0071: information from the analyte sensors which analyze the sample is presented);
a warning message (Not explicitly disclosed by Ebbesen but not required by the claim);
a waiting message (Fig. 6, 9, and 10: the text above the image displays a waiting time);
an information message (Fig. 6, 9, and 10: the text above the image displays a waiting time);
information regarding a state of a measurement workflow (Fig. 6, 9, and 10: the text above the image displays a waiting time and the current step of aspirating or measuring).
Regarding claim 11, Ebbesen in view of Watson further in view of Takemoto and evidenced by Spinelli and Lee teaches the measurement apparatus according to claim 4. Modified Ebbesen further discloses the arrangement wherein in case that the measurement support equipment comprises the optical and/or acoustical output device (Paragraphs 0027 and 0046: the output device may be a monitor to display images and/or a loudspeaker), the information indicated by the optical and/or acoustical output device comprises a demand to the user, including at least one of:
indicating that the container should be moved to allow loading the sample into a measurement chamber (Figs. 3-5 and 7-9: the instructions display how to move the container to allow the system to aspirate the sample into the measurement chamber; Paragraph 0075: the instructions help the user obtain sufficient penetration depth to reach the aspiration point to allow the sample to be transported to the measurement chamber);
indicating that the container should by moved such that the sample aspirator tube is connected with the container (Not explicitly disclosed by Ebbesen but not required by the claim);
indicating that the container should be moved such that the sample aspirator tube is arranged in contact with the sample inside the container (Figs. 3-5 and 7-9: the instructions display how to move the container to allow the system to aspirate the sample; Paragraph 0075: the instructions help the user obtain sufficient penetration depth to reach the aspiration point); and
indicating that the container should be removed (Figs. 6 and 10: the instructions include removing the container; Paragraph 0074: the instructions to remove the container).
Regarding claim 12, Ebbesen in view of Watson further in view of Takemoto and evidenced by Spinelli and Lee teaches the measurement apparatus according to claim 5. Modified Ebbesen fails to further disclose the arrangement wherein to actuate the sample aspirator positioner comprises at least one of: controlling the sample aspirator positioner to move the sample aspirator tube to a predetermined loading position; controlling the sample aspirator positioner to move the sample aspirator tube to a parking position.
Watson teaches an arrangement wherein to actuate the sample aspirator positioner comprises at least one of: controlling the sample aspirator positioner to move the sample aspirator tube to a predetermined loading position (Paragraphs 0122; Fig. 6B: the sample aspiration and dispensing means is lowered into the sample to aspirate the sample. The position at which the aspiration is performed is considered a “predetermined loading position”); controlling the sample aspirator positioner to move the sample aspirator tube to a parking position (Paragraphs 0119-0121; Figs. 5 and 6A: the position of the sample aspiration and dispensing means above the tube prior to be lowered is considered a “parking position”).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to modify the arrangement of modified Ebbesen to include a parking position and a predetermined position for the sample aspiration tube as taught by Watson because such positions may be used to indicate to the user what step in the process is occurring and/or that the arrangement is prepared to receive a sample. Placing the sample aspiration tube in the “parking position” may be a retracted state as taught by Watson and may mean that the input means of Ebbesen is retracted or otherwise positioned such that it is not accessible to the user to indicate the device is off or not ready for aspiration. Such a positioning may prevent premature container insertion which may contaminate the aspiration means. Additionally, implementing the movement to a “predetermined location” as taught by Watson may mean that the input means of modified Ebbesen is extended or otherwise presented and accessible to the user to indicate that the device is ready to receive a sample. Ebbesen appears to be well suited for such a modification as Ebbesen teaches a displaceable part as part of the input system (Ebbesen: Paragraph 0072; Fig. 2) and further appears to suggest that the inlet structure may be positioned in different orientations in Fig. 1 references 12a and b appear to suggest that the inlet structure may be rotated to change its orientation.
Regarding claim 13, Ebbesen in view of Watson further in view of Takemoto and evidenced by Spinelli and Lee teaches the measurement apparatus according to claim 5. Modified Ebbesen further discloses the arrangement wherein actuating the sample aspirator comprises controlling the sample aspirator to aspirate a part of the sample through the sample aspirator tube (Paragraphs 0073-0074: the arrangement aspirates the sample through the inlet structure).
Regarding claim 14, Ebbesen in view of Watson further in view of Takemoto and evidenced by Spinelli and Lee teaches the measurement apparatus according to claim 1. Modified Ebbesen further discloses the arrangement wherein the analysis of the image further includes at least one of detecting and decoding at least one label on at least one of the container and on a container cap (Paragraphs 0045 and 0060-0061: the sensor may read a barcode or QR code on the container), wherein the measurement support equipment is controlled further based on the detected at least one label (Paragraph 0045: the instructions are adapted to a specific characteristic of the handheld container).
Regarding claim 15, Ebbesen in view of Watson further in view of Takemoto and evidenced by Spinelli and Lee teaches the measurement apparatus according to claim 14. Modified Ebbesen fails to further disclose the arrangement wherein the label comprises information regarding at least one of: a patient; a date; a user; an information regarding the sample.
Watson teaches the arrangement wherein the label comprises information regarding at least one of: a patient; a date; a user; an information regarding the sample (Paragraphs 0034, 0084, 0113 and claim 11: the bar code is used for sample identification means and is uniquely associated with each patient).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the barcode on the sample including information related to the same and patient as taught by Watson because including information related to the sample and/or patient in the barcode as taught by Watson would allow the system to automatically adjust for a particular test type based on the same and associate the produced data to a given patient. This would reduce the amount of information required to be manually input and would allow the system to synchronize with record keeping software more easily.
Regarding claim 16, Ebbesen in view of Watson further in view of Takemoto and evidenced by Spinelli and Lee teaches the measurement apparatus according to claim 14. Modified Ebbesen further discloses the arrangement wherein the label being configured as at least one of: text; bar code; QR code; color coded information (Paragraphs 0045 and 0060-0061: the sensor may read a barcode or QR code on the container).
Regarding claim 17, Ebbesen in view of Watson further in view of Takemoto and evidenced by Spinelli and Lee teaches the measurement apparatus according to claim 1. Modified Ebbesen further discloses the arrangement wherein at least one of the following is satisfied:
the camera system includes at least one 2D detector array sensitive for at least one of infrared and visible and ultraviolet light (Paragraph 0023: the at least one sensor of the sensor system may be a camera which detects visible light).
Modified Ebbesen fails to explicitly disclose the measurement apparatus wherein the sample input port closure is controlled to open the sample input port further based on at least one of a predetermined measurement configuration and a measurement workflow.
This limitation is considered to be rendered obvious over the teachings of Ebbesen in view of Watson further in view of Takemoto and evidenced by Spinelli and Lee. This is because the automation, i.e. use of computers, to perform otherwise known methods is not an unobvious variation from the teachings of prior art wherein automation was not performed. In other words, broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (see In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958)). In particular, the opening of the sample input port based on at least one of a predetermined measurement configuration and a measurement workflow is considered to be the automation of an previous manual activity. In particular, as taught by Takemoto, the opening of an input port closure may be performed manually based on a measurement workflow (Takemoto Figs. 24-26, 33, and 38-40: the various steps of opening and closing the door which take place at certain points during a measurement workflow, or a predetermined measurement configuration). As evidenced by Spinelli and Lee, the automatic control of doors is known in the art and thus the automatic control of the doors based on a measurement workflow, or a predetermined measurement configuration is considered to be an obvious automation of a previous manual process.
Regarding claim 19, Ebbesen in view of Watson further in view of Takemoto and evidenced by Spinelli and Lee teaches the measurement apparatus according to claim 1. Modified Ebbesen further discloses a method of supporting a measurement of a liquid sample contained in a container and measuring the liquid sample (Abstract), the method using an arrangement according to claim 1 (Modified Ebbesen as presented in the above rejection of claim 1), the method comprising:
acquiring, by the camera system, images of the region of interest in which the container is arranged held by a user's hand, in order to acquire information about the container (Paragraphs 0069-0070: the sensors for detecting a presence, position, and/or orientation of the handheld sample container; Paragraph 0023: the at least one sensor may be a camera or vision based system);
analyzing at least one image of the images, in order to obtain an analysis result (Paragraphs 0023 and 0069-0070: the images may be analyzed to determine the position of the container); and
controlling the measurement support equipment based on the analysis result (Paragraph 0073: display instruction to the user to push the container closer to the analyzer and instruction to adjust the angle of the container),
wherein analyzing the at least one image includes detecting a position of the container and detecting a type of the container, in order to obtain the analysis result (Paragraphs 0023 and 0069-0070: the images may be analyzed to determine the kind, or type, of blood sample container being present at the inlet structure and the position of the container),
filling the sample through the lumen of the sample aspirator tube into the measurement chamber; measuring the at least one analyte in the sample using the least one sensor unit within the measurement chamber (Paragraphs 0067 and 0071: the measurement chamber is filled via the inlet structure and contains a plurality of analyte sensors for sensing analytes in the blood sample),
Ebbesen fails to further disclose the method comprising wherein to control the measurement support equipment based on the analysis result comprises actuating the sample input port closure, wherein to actuate the sample input port closure comprises to control the sample input port closure to open the sample input port based on the analysis result
Watson teaches a pathology distribution system for automated sample container processing and distribution (Abstract). Thus Watson falls within the same field of endeavor as Applicant’s invention.
Watson teaches a system configured to control the measurement support equipment based on the analysis result comprises controlling the sample input system (Paragraphs 0120-0125 and 0190; Fig. 5-6C reference 86 and the arrows). Watson teaches an axially traversable aspiration system controlled by the analysis result of an image system.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the input system of Ebbesen to include actuatable components which are movable in response to an analysis result and traverse through the input port into the container rather than press the container into the aspiration system as taught by Watson because configuring the system of Ebbesen to make the aspiration system traversable through the input port into the container rather than having the user press the container farther into the device would provide the benefit of reducing potential user error which could damage the system or result in invalid measurements being taken. The user may damage the system by pressing the container too far in, at the wrong angle, or with too much force and may result in invalid measurements if the user does not press the container in far enough resulting in improper aspiration. Additionally, such a configuration would improve the usability of the device as all the user has to do is hold the container still in a specific area.
Ebbesen in view of Watson fails to further disclose the method wherein to control the measurement support equipment based on the analysis result comprises actuating the sample input port closure, wherein to actuate the sample input port closure comprises to control the sample input port closure to open the sample input port based on the analysis result
Takemoto teaches an analysis unit which analyzes a specimen collected from a subject (Abstract). Thus, Takemoto falls within the same field of endeavor as Applicant’s invention.
Takemoto teaches a container set unit which is openable and closable from a front surface of an apparatus body (Paragraph 0109; Figs. 2 and 3 reference 111). Fig. 3 illustrates that the internal portion of the device is accessible when the set unit is open and enclosed when the set unit is closed.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to construct Ebbesen in view of Watson with an openable and closable sample input port closure as taught by Takemoto such that the input port depicted in in Figs. 3-10 of Ebbesen has an openable and closable door, or sample input port closure, such that the aspiration tube and measurement equipment are contained within the device body in the closed position and are accessible and able to traverse through the opening in the open position as taught by Takemoto because such a construction would protect the internals of Ebbesen in view of Watson when not in use and prevent buildups of dust or other matter on the aspiration member which may cause clogs or inaccurate measurements.
Ebbesen in view of Watson further in view of Takemoto fails to explicitly teach the method wherein to control the measurement support equipment based on the analysis result comprises actuating the sample input port closure, wherein to actuate the sample input port closure comprises to control the sample input port closure to open the sample input port based on the analysis result
However, this difference of controlling the sample input port closure to automatically open on the basis of an analysis result determined from images is not considered to be a patentable difference. This is because the automation, i.e. use of computers, to perform otherwise known methods is not an unobvious variation from the teachings of prior art wherein automation was not performed. In other words, broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art (see In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958)). In the present case, the opening and closing of the door is considered a known manual activity such as is evidenced by Takemoto Figs. 3, 22, and 24-25 and paragraphs 0109 which describe the container set unit, or door, as being openable and closable by pushing a button or manually closing the door. The automation of such as task based on image analysis is not considered to be a patentable difference because the automation of opening and closing doors based on image analysis is well known as evidenced by at least Spinelli which teaches an automated door actuatable based on image analysis of a camera’s field of view (Spinelli: Paragraphs 0021-0027) and Lee which also teaches the automatic control of a door based on identified object in a camera’s field of view (Lee: Paragraphs 0012-0016). Since Ebbesen already performs the required video analysis (Ebbesen: Paragraphs 0023 and 0069-0070: the images may be analyzed to determine the kind, or type, of blood sample container being present at the inlet structure and the position of the container), and Ebbesen in view of Watson, further in view of Takemoto teaches that such an input port closure may be present, the automation of the opening and closing of such an input port closure based on the results of the image analysis is considered to be an unobvious variation from the teachings of prior art
Regarding claim 20, Ebbesen in view of Watson further in view of Takemoto and evidenced by Spinelli and Lee teaches the method according to claim 19. Modified Ebbesen further discloses a method wherein the measurement support equipment is controlled based on the analysis result without requiring the user touching anything except the container (Paragraph 0073; Figs. 3-5: the user only touches the container and adjusts it according to the output instructions; Paragraph 0045: the display of instructions is modified according to the type of container, or analysis result.).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are not found to be persuasive.
In particular, Applicant argues that the closed loop control of the sample input port closure provides a non-obvious patentable distinction over Ebbesen, Watson , and Takemoto because none of the cited references contemplate automatic door control based on the image analysis. Applicant argues that the recited control of the sample input port closure is more than a mere automation of a manual task but is an intelligent control loop that provides conditional access to prevent incorrect container introduction.
Applicant’s arguments are not found to be persuasive because they are not commensurate in scope with the claimed invention. In particular, the control of the sample input port closure is recited as being “based on” the analysis result, the analysis result includes the detection of a position of the container and the type of the container. There are no recitations drawn towards intelligent door control such that inappropriate container types cannot be introduced, the system, as claimed, merely requires a type of container and its position to be identified then to open the door. As such, the door operation is considered to be an automatization of a previously performed manual activity. Additionally, even if such functionality of opening the door only when certain criteria are met were to be recited, the teachings of Spinelli and Lee provide evidence that door control based on certain criteria being met in an image is known in the art. The automatic control of the door is not considered to be recited in such a manner to render it as more than a mere automation of a previously performed manual task.
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.
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/MATTHEW ERIC OGLES/ Examiner, Art Unit 3791
/JASON M SIMS/ Supervisory Patent Examiner, Art Unit 3791
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