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 .
Response to Arguments
Applicant’s arguments, see page 6, filed 12/08/2025, with respect to claims 1 and 12 have been fully considered and are persuasive. The minor objections of 10/21/2025 has been withdrawn.
Applicant’s arguments, see page 6, filed 12/08/2025, with respect to claims 1-15 have been fully considered and are persuasive. The 35 USC 112(b) rejection of 10/21/2025 has been withdrawn.
Applicant’s arguments, see pages 6-8, filed 12/08/2025, with respect to claims 1-5 and 7-15 have been fully considered and are persuasive. The 35 USC 101 rejection of 10/21/2025 has been withdrawn.
Applicant's arguments filed 12/08/2025 regarding the 35 USC 102 rejection have been fully considered but they are not persuasive for the following reasons.
Applicant Argument: “Turning first to claim 1, the applicant notes that, as amended, that claim 1 recites an image processing system configured to output signals which "comprise signals for implementing a gate control at a biological sample analyzer," features which were previously recited in claim 6 and which are added to claim 1 in the present amendment. In its rejections, the Office Action asserted that Kosaka teaches these signals for implementing a gate control at a biological sample analyzer were in paragraphs 148-49, 157 and 188 and in the depiction of an interrupt request in figure 28 and the depiction of a blood cell analyzing apparatus in figure 1. However, the applicant submits that none of those portions of Kosaka teaches gate control as recited in claim 1. Paragraphs 148-49 describe that when blood volume is insufficient, the analyzer described in Kosaka could switch to micro-measurement mode, and that when a sample rack is detected in a transport apparatus an interrupt signal can be generated which causes the analyzer to proceed with processing the samples in the rack. Paragraph 157 says that when sample aspiration instructions are received from the transport apparatus, a further interrupt signal can be generated for a measuring unit to perform further sample processing steps (e.g., stirring the blood sample). Paragraph 188 explains that coagulation abnormality data and specimen bar-code reading error data may be stored in conjunction with a holding position of the sample impacted by the abnormality/error. The applicant submits that none of these (or the depictions of an interrupt in figure 28 or the analyzing apparatus of figure 1) are even relevant to gate control, as none of them in any way apply gating to biological sample analysis. Indeed, the only similarity between the cited art and the recited gate control is that both can use interrupt signals. However, the interrupt signals which could be used to implement gate control would prevent analysis of a sample, not cause that analysis to proceed. Accordingly, the applicant submits that the cited art cannot properly be treated as anticipatory of amended claim 1, and so requests that the rejection of claim 1 under 35 U.S.C. § 102 be reconsidered and withdrawn.”
Examiner Response: The Examiner respectfully disagrees.
Turning to page 12 of the specification, “gate control signals” are defined as comprising the signals output by the image processing system 318, and said signals convey instructions to the analyzer. According to page 11, the output signals are based on the identified one or more characteristics and may comprise signals conveying the identified characteristics as information. In the cited art, Kosaka discloses control of aspiration/transport based on coagulation results. See Kosaka ¶199: “Accordingly, the sample dispensing section 511 is controlled to aspirate the blood sample which is determined not to have been coagulated and not to aspirate the blood sample which is determined to have been coagulated. However, the invention is not limited to this.” See also ¶202: “a configuration, in which the sample transport apparatuses 3 and 330 transmit aspiration instruction data to the blood cell analyzing apparatus 5 or the smear preparing apparatus 6 in the case of the blood sample in which blood coagulation does not occur and transmits aspiration prohibition data to the blood cell analyzing apparatus 5 or the smear preparing apparatus 6 in the case of the blood sample in which blood coagulation occurs, and the blood sample is aspirated when the measuring unit 51 receives the aspiration instruction data and the aspiration is not performed when the measuring unit receives the aspiration prohibition data, may be employed.
Page 17 of the specification states that “gate control may be performed in response to any or more of: failed identification (i.e. an unidentified or falsely identified sample or container; an unexpected identity associated with the sample or container); unacceptable sample condition (i.e. one or more quantities describing the sample condition falling outside a respective acceptable range, i.e. the amount of the biological sample; the amount of visible sedimentation and/or air bubbles; the temperature of the sample; and the age and/or transport time of the sample); unacceptable container condition (i.e. false container type; faulty container; missing or faulty container components; impermissible combinations of container components; the temperature of the container being outside a respective acceptable range).” As seen in Kosaka ¶199, “the system control apparatuses generates measuring order information including data for instructing prohibition of aspiration and transmit the measuring order information to the sample transport apparatuses 3 and 330. Moreover, the sample transport apparatuses 3 and 330 are configured to transmit aspiration instruction data to the blood cell analyzing apparatus 5 or the smear preparing apparatus 6 in the case of the blood sample for which measuring order information does not include data for instructing prohibition of aspiration, and not to transmit aspiration instruction data to the blood cell analyzing apparatus 5 or the smear preparing apparatus 6 in the case of the blood sample for which measuring order information includes data for instructing prohibition of aspiration. Due to this configuration, the sample dispensing section 511 may be controlled to aspirate the blood sample which is determined not to have been coagulated and not to aspirate the blood sample which is determined to have been coagulated.”
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., signals for implementing gate control, particularly wherein implementation of gate control causes “that analysis to proceed”) are not recited in the rejected claim(s). The claim merely requires “implementing the gate control at a biological sample analyzer,” which covers both analysis to proceed and analysis to not proceed (see pg. 12). Kosaka clearly recites, “the sample dispensing section 511 [of blood cell analyzing apparatus 5] may be controlled to aspirate the blood sample which is determined not to have been coagulated and not to aspirate the blood sample which is determined to have been coagulated.” Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In view of the above arguments, and the excerpts from the specification below, Kosaka clearly anticipates the structure and function of the claimed method, even if the term ‘gate control’ isn’t explicitly recited.
Further, Applicant amended claim 6 to recite “wherein the signals for implementing the gate control at the biological sample analyzer comprise signals which convey instructions to the biological sample analyzer that a yet to be started analysis is to be prevented,” while reciting in the arguments, “the interrupt signals which could be used to implement gate control would prevent analysis of a sample, not cause that analysis to proceed.”
Applicant's arguments filed 12/08/2025 regarding the 35 USC 103 rejection have been fully considered but they are not persuasive, in light of the 35 USC 102 argument above.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 and 6-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kosaka (US 2010/0027868 A1).
Consider claim 1, Kosaka discloses an image processing system configured to:
receive at least one captured image (FIGs. 16, 20 #S142, #S152 Taking image captured by camera 225a) depicting:
a) at least a portion of a biological sample,
b) at least a portion of a container containing the biological sample, or
both a) and b) (FIGs. 16, 20, 17-18 image #100);
process the received image to identify one or more characteristics of
i) the biological sample,
ii) the container, or
both i) and ii) (FIGs. 16, 20; ¶28-29; “FIG. 17 is a schematic diagram for illustrating a process of detecting a width of an image of the sample container,”; ¶99; “the system control apparatus 7 performs image processing of the images captured by and output from the cameras 225a and 225b to determine whether a blood sample in a storing container is coagulated and to detect a volume of the blood sample in the sample container.”; ¶120-130; Blood Volume Detecting Operation of System Control Apparatus 7; ¶131-142; Blood Coagulation Determining Operation of System Control Apparatus 7); and
output signals based on the identified one or more characteristics for result handling (¶120-130; Blood Volume Detecting Operation of System Control Apparatus 7; ¶131-142; Blood Coagulation Determining Operation of System Control Apparatus 7; ¶146-147 Measuring order Transmitting Operation of System Control Apparatus 7; ¶156),
wherein the one or more characteristics comprise a pre-analytic sample condition of the biological sample (FIG. 16 blood volume; FIG. 21 presence or absence of coagulation; ¶142; “When determining the presence or absence of blood coagulation, the CPU 71a associates a determination result with the measuring order having the specimenID of the blood sample as a target of image processing and stores the result in the hard disk 71d (Step S1510),”),
wherein the result handling comprises gate control, and wherein the signals output by the image processing system based on the identified one or more characteristics comprise signals for implementing the gate control at a biological sample analyzer (¶154-156, 157; “As described above, regarding a blood sample, which is determined to have been coagulated and of which measuring order information is not generated, the sample container 8 containing the blood sample is stopped at an aspiration position, and then is transported from the aspiration position without the issue of aspiration instruction data. Regarding a blood sample, which is determined not to have been coagulated and of which measuring order information is generated, the sample container 8 is stopped at the aspiration position, and then aspiration instruction data is issued. This blood sample is aspirated by the measuring unit 51 as described later, and then is transported from the aspiration position after the aspiration completion notification signal is issued.”; ¶199-202; Other embodiments, “a configuration, in which the sample transport apparatuses 3 and 330 transmit aspiration instruction data to the blood cell analyzing apparatus 5 … in the case of the blood sample in which blood coagulation does not occur and transmits aspiration prohibition data to the blood cell analyzing apparatus 5 … in the case of the blood sample in which blood coagulation occurs, and the blood sample is aspirated when the measuring unit 51 receives the aspiration instruction data and the aspiration is not performed when the measuring unit receives the aspiration prohibition data, may be employed.”).
Consider claim 2, Kosaka discloses the claimed invention wherein the one or more characteristics comprise a unique ID of the container containing the biological sample (FIG. 2 ¶55 barcode, specimenID).
Consider claim 3, Kosaka discloses the claimed invention configured to identify a plurality of characteristics of the container which, when combined, uniquely identify the container (FIG. 2 ¶55; 8b, 9a).
Consider claim 6, Kosaka discloses the claimed invention wherein the signals for implementing the gate control at the biological sample analyzer comprise signals which convey instructions to the biological sample analyzer that a yet to be started analysis is to be prevented (¶199, 202; “the aspiration is not performed when the measuring unit receives the aspiration prohibition data”).
Consider claim 7, Kosaka discloses a server comprising the claimed invention (¶90).
Consider claim 8, Kosaka discloses a biological sample analyzer comprising the claimed invention (FIG. 1, ¶6, ¶53).
Consider claim 9, Kosaka discloses the claimed invention further comprising one or more of:
a sample handler (¶53, 54, FIG. 1; sample putting apparatus 2, ¶79, 163-164; FIG. 11 511);
a measurement module configured to measure a parameter of the biological sample (¶78; measuring unit 51);
a display configured to display the measured parameter of the biological sample (¶160, FIGs. 21-24, 33); and
an image capture device configured to capture the image (FIG. 5 cameras 225a, 225b).
Consider claim 10, Kosaka discloses a biological sample handler comprising the image processing system of the claimed invention (FIG. 1 ¶54 sample putter 2, 51; FIG. 11 sample dispensing section 511 of 51; ¶75, 110, 120).
Consider claim 11, Kosaka discloses the claimed invention further comprising an image capture device configured to capture the image (FIG. 5 cameras 225a, 225b).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Kosaka as applied to claims 1-3 and 6-11 above, and further in view of Fradkin (US 2021/0213486 A1).
Consider claim 4, Kosaka discloses the claimed invention wherein processing the received image to identify the one or more characteristics comprising the pre-analytic sample condition of the biological sample comprises detecting one or more sample handling errors (Kosaka ¶174, 189 FIG. 33 error information 493, 494).
Kosaka fails to specifically disclose wherein processing the received image to identify the one or more characteristics comprising the pre-analytic sample condition of the biological sample comprises detecting one or more sample handling errors.
In related art, Fradkin discloses wherein processing the received image to identify the one or more characteristics comprising the pre-analytic sample condition of the biological sample comprises detecting one or more sample handling errors (Fradkin ¶4, 27).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the detection of one or more sample handling errors of Fradkin into the analysis method of Kosaka to evaluate the one or more characteristics comprising the pre-analytic sample condition of the biological sample with high accuracy (Kosaka ¶141). As stated by Fradkin, “it is necessary to examine fluid or other (e.g., lyophilized) samples for the presence of various attributes, such as particles, bubbles or stains. Undesired particles or other attributes can originate from a number of different sources, such as the environment, incorrect handling or storage (Fradkin ¶4).”
Consider claim 5, Kosaka fails to specifically disclose wherein processing circuitry is configured to execute an image recognition algorithm to identify faults in the container or in one of its components.
In related art, Fradkin discloses wherein processing circuitry is configured to execute an image recognition algorithm to identify faults in the container or in one of its components (Fradkin ¶27, 54).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the detection of faults in the container or in one of its components of Fradkin into the analysis method of Kosaka to evaluate the one or more characteristics comprising the pre-analytic sample condition of the biological sample with high accuracy (Kosaka ¶141). As stated by Fradkin, “As another example, a container attribute may be the presence of one or more chips or cracks, the presence of one or more specific types of chips or cracks, the presence of one or more deformities on the container, the presence of a deformity on a specific part of the container (e.g., the plunger, flange, etc.)… (Fradkin ¶27)” Further, “it is necessary to examine fluid or other (e.g., lyophilized) samples for the presence of various attributes, such as particles, bubbles or stains. Undesired particles or other attributes can originate from a number of different sources, such as the environment, incorrect handling or storage, or byproducts/residuals of forming, packaging, or filling (Fradkin ¶2).”
Claims 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kosaka as applied to claims 1-3 and 6-11 above, and further in view of Cowan (US 2017/0290993 A1), in further view of Tucker (US 2019/0224406 A1).
Consider claim 16, Kosaka discloses wherein preventing the yet to be started analysis comprises (Kosaka ¶199, 202; controlled to not aspirate).
However, Kosaka fails to specifically disclose physically locking out or ejecting the container with an actuator of the biological sample analyzer.
In related art, Cowan discloses wherein preventing the yet to be started analysis comprises physically locking out or ejecting the container (Cowan ¶141, 221).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the physical lockout or ejection of Cowan into the analysis of Kosaka to prevent aspiration of coagulated blood samples (Kosaka ¶199, 202).
In related art, Tucker discloses physically locking out or ejecting the container with an actuator of the biological sample analyzer (Tucker ¶70).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the actuator of Tucker into the analysis of Kosaka, as modified by Cowen, to eject the container from the port without guidance or effort from the operator (Tucker ¶70; Cowan ¶141, 221).
Allowable Subject Matter
Claims 12-13, 15, and 17 are allowed.
The following is an examiner’s statement of reasons for allowance:
Kosaka (US 2010/0027868 A1) discloses that “the measuring unit 250 includes a sample dispensing section 251, a measuring sample preparing section 252, an optical detecting section 253, a signal processing circuit 254, a rack transport section 255, bar-code readers 256 and 257, a horizontal rotation mechanism 258, a sample container tilting mechanism 259 and a controller 260 (¶163).” Kosaka further discloses that the “measuring sample preparing section 512 is provided with a mixing container (not shown) to mix and stir the blood sample dispensed by the sample dispensing section 511, a reagent and a diluents and prepare a measuring sample (¶80).” An optical sensor exposes the measuring sample to light to obtain a side scattered light signal, a forward-scattered light signal and a fluorescent signal (¶81).
Fradkin (US 2021/0213486 A1) discloses a robotic system for performing pattern recognition-based inspection of pharmaceutical containers. In a case where a container holds a sample, “the controller first causes robotic arm 110 to agitate (e.g., shake, invert, etc.) container 114, shortly before imaging. After the initial image(s) is/are captured, the controller causes robotic arm 110 to manipulate end effector 112 such that container 114 is positioned in a series of different orientations (¶24).” The controller then determines where the container itself, or the sample within the container, should be rejected (¶25). The controller may reject a given sample if it fails to satisfy one or more criteria, for example, if detected bubbles (caused by agitation) exceed a threshold (¶30).
Dupoteau (US 8,852,505 B2) discloses that “an essential condition for the correct functioning” of blood sample analyzers is that the blood tubes have been previously correctly stirred during a stirring phase which precedes analysis (Col. 1 lines 34-36). In an example, Dupoteau specifies that “The number of inversions to be effected is generally between 10 and 20 to obtain correct stirring. Stirring may be effected by a succession of partial inversions (FIG. 7) or by a succession of full inversions, the amplitude of movement then being up to 180° (Col. 6 lines 43-48).”
Neither Kosaka, Fradkin, nor Dupoteau, neither alone nor in combination, discloses an image processing method comprising:
receiving a captured image depicting
a) at least a portion of a biological sample,
b) at least a portion of a container containing the biological sample, or
both a) and b);
processing the received image to identify one or more characteristics of:
i) the biological sample,
ii) the container, or
both i) and ii); and
outputting signals based on the identified one or more characteristics for result handling,
wherein the one or more characteristics comprise a pre-analytic sample condition of the biological sample;
receiving one or more additional images, each of the one or more additional images depicting at least a component of the container;
processing the one or more additional images to identify movement of the container during processing of the biological sample by a biological sample analyzer;
receiving process data, the process data defining movement or actuations of an agitator of the biological sample analyzer during a mixing process; and
evaluating the mixing process by correlating the movement of the container to the process data defining movement or actuations of the agitator of the biological sample analyzer.
Accordingly, the features identified, in combination with other claim limitations, are neither suggested nor discussed by the prior art of record.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2019/0360999 A1 discloses a method for analyzing a body fluid sample from a sampler.
US 2020/0365241 A1 discloses systems for managing biopsy specimens.
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 ASHLEY HYTREK whose telephone number is (703)756-4562. The examiner can normally be reached M-F 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Steve Koziol can be reached at (408)918-7630. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHLEY HYTREK/Examiner, Art Unit 2665
/Stephen R Koziol/Supervisory Patent Examiner, Art Unit 2665