DETAILED ACTION
Claims 4, 5, 40, 41 and 43-46 have been cancelled.
Claims 1-3, 6, 37-39 and 42 are currently pending.
The rejections to claims 1-3, 6, 37-39 and 42 under 35 U.S.C. 101 are maintained.
Response to Arguments
Applicant’s arguments with respect to the 35 U.S.C. 103 rejections of claims 1-3, 6, 37-39 and 42 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 7/11/26 with respect to the 35 U.S.C. 101 rejections of claims 1-3, 6, 37-39 and 42 have been fully considered but they are not persuasive.
The Applicant argues on pages 11 and 12 of the response in essence that: Claim 1 as amended requires a computer processor of an optical measurement unit to operate upon acquired microscope images to identify stained objects having irregular shapes as debris or contaminating bodies and to exclude such debris from the validated candidates, to compute a candidate-to-validated-candidate ratio, to evaluate that ratio against maximum and minimum thresholds to determine whether an error is present, and to control the apparatus in response- halting measurements, flagging invalidity to a user, or instructing re-collection. Identifying irregularly shaped stained objects within microscope images and controlling the instrument's downstream operation based on a threshold-evaluated ratio are not acts that can be practically performed in the human mind.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the recitations to hardware involve no more than a generic computer performing generic computer functions that are well understood, routine and conventional activities previously known in the industry. The recitation of a computer processor in the claims does preclude the steps from practically being performed in the human mind. See MPEP 2106.05(d)). Placing blood within a sample chamber and acquiring microscopic images are well understood, routine and conventional activities previously known in the industry. The Applicant's Background describes obtaining microscopic images of a blood sample within a sample carrier as predating the Applicant’s claimed invention.
The Applicant argues on page 12 of the response in essence that: Additionally, the amended claims are integrated into a practical application. Contrary to the Office Action's characterization, the amended claims do not "correct blood measurements". Rather, they perform an internal self-validation that detects an error condition-by evaluating whether the ratio between initially identified candidates and subsequently validated candidates exceeds a maximum threshold or falls below a minimum threshold-and, in response, invalidates the sample and takes a concrete corrective action. This improves the functioning of the optical measurement unit itself by enabling it to autonomously recognize when debris, sample-preparation faults, or instrument faults have corrupted the analysis and to prevent unreliable measurements from being reported. That is a specific technological improvement to the operation of the measurement apparatus, not an abstract concept implemented on a generic computer.
The claims do not provide an inventive concept as they do not provide an improvement to any type of particular machine. Applicant contends that the claims provide an improvement by providing self-validation of a portion of the sample for being used in measurements. However, merely identifying a sample as invalid does not provide an improvement to the optical measurement unit. Thus, even when viewed as a whole, nothing in the claim adds significantly more (i.e., an inventive concept) to the abstract idea.
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.
Claim 1-3, 6, 37-39 and 42 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The flow chart in MPEP 2106, Subject Matter Eligibility Test For Products and Processes, will be referenced to establish that the subject matter is ineligible.
Step 1: claims 1 and 6 recite a method and claims 37 and 42 recite an apparatus. Claims 1, 6, 37 and 42 fall under one of the four recognized statutory categories.
Step 2A Prong One: However, claims 1, 6, 37 and 42 are further directed to the abstract idea of correcting blood measurements. See MPEP 2106.04(a)(2). The claimed invention is similar to other claims in which the Federal Circuit has found directed to ineligible subject matter. See Illumina, Inc. v. Ariosa Diagnostics, Inc., 952 F.3d 1367 (Fed. Cir. 2020) (Claims directed to diagnosing Down's Syndrome were found ineligible). Furthermore, the claims do not preclude the limitations from being performed in the human mind. The limitations are mental processes that can be performed by a human using pen and paper.
Step 2A Prong Two: Additional elements include a blood sample chamber, a microscope and a computer processor. Analyzing images of blood under a microscope is commonplace in the art. The Applicant's Background describes obtaining microscopic images of a blood sample within a sample carrier as predating the Applicant’s claimed invention. The involvement of a generic computer components does not provide additional elements that are sufficient to amount to significantly more than the judicial exception because the recitations to hardware involve no more than a generic computer performing generic computer functions that are well understood, routine and conventional activities previously known in the industry. That is, other than reciting “by a processor,” nothing in the claim precludes the steps from practically being performed in the human mind. See MPEP 2106.05(d)).
Step 2B: The claims do not provide an inventive concept as they do not provide an improvement to any type of particular machine. Adjusting a count of particles within a blood sample by an optical measurement unit does not provide an improvement to the optical measurement unit. Merely automating or otherwise making efficient traditional methods do not constitute an inventive concept. Therefore claims 1-3, 6, 37-39 and 42 are non-statutory.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 6, 37-39 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Adams et al. US Publication 2014/0273076 (hereafter “Adams”) and Ye US Publication 2023/0071301 (hereafter “Ye”).
Referring to claims 1 and 37, Ye discloses a method comprising:
placing a blood sample within a sample chamber (paragraph 59, Referring also to FIG. 9, in particular, the detection device 300 is provided with a flow chamber 301, through which the cells pass one by one);
acquiring microscopic images of the blood sample (paragraph 59, In the laser irradiation direction, a diaphragm 304, a collecting lens 305, a flare eliminating diaphragm 306, and a forward scattered light detector 307 are sequentially arranged, and the forward scattered light signal is collected by the forward scattered light detector 307)); and
using a computer processor of an optical measurement unit (paragraph 61, The analysis device 400 may be implemented a processor):
identifying, within the microscopic image, candidates of a given entity within the blood sample (paragraph 35, Step 103, generating a first scattergram based on the forward scattered light information and the fluorescence information to obtain characteristic information of platelets, namely information that characterizing the platelets);
validating at least some of the candidates as being the given entity, by performing further analysis of the candidates (paragraph 37, Step 105, acquiring a real count value for the platelets based on the characteristic information of the platelets and the characteristic information of the white blood cell fragments obtained in the above two steps, by means of a specific algorithm or processing), the further analysis comprising identifying stained objects having irregular shapes as debris or contaminating bodies and excluding the debris or contaminating bodies from the validated candidates (paragraph 39, In another example, scattered points representing the characteristic information of the white blood cell fragments on the first scattergram are determined based on the characteristic information of the white blood cell fragments obtained in Step 104) (paragraph 28, White blood cell fragments, also known as fragmented white blood cells, are white blood cells with cell membranes that are broken completely or partially);
invalidating the sample based upon in response to the count of candidates and the count of validated candidates indicating an error, wherein the counts indicate the error when the ratio exceeds a maximum threshold or is below a minimum threshold (paragraph 62, The determining unit 401 is configured to acquire a count value for the white blood cell fragments based on the characteristic information of the white blood cell fragments and to determine whether the count value for the white blood cell fragments exceeds a threshold value) (paragraph 50, In the above method, the characteristic cells falling within the predetermined characteristic region may also be marked, removed, or reported by an alarm prompt); and
in response to invalidating the sample, performing at least one of: not performing any measurements on the sample, flagging to a user that the sample is invalid, instructing the user to repeat a sample preparation with a new test kit, or instructing the user to re- collect a blood sample (paragraph 62, The alarm unit 402 is configured to determine whether to output an alarm prompt based on the determination result of the determining unit 401. For example, when the determining unit 401 determines that the count value for the white blood cell fragments exceeds the threshold value, the alarm unit 402 will output an alarm prompt) (paragraph 40, The prompting may be implemented in a form of text, sound, light, or pop-up window).
While Ye discloses invalidating the sample, Ye does not disclose expressly invalidating the sample based upon the ratio.
Adams discloses determining a ratio between a count of the candidates of the given entity to a count of the validated candidates of the given entity (paragraph 240, In step 88 of FIG. 9, the concentration of particles in the first category or subcategory can be then calculated by processor 18, as depicted in FIG. 5 or 6, at least in part by applying the proportionate ratio to the single count (e.g. step 84 of FIG. 9) obtained from the particle counter);
invalidating the sample based upon in response to the ratio between the count of candidates and the count of validated candidates indicating an error (paragraph 241, As illustrated in FIG. 10B, the particle count from the analyzer of this disclosure can be used to correct inaccurate particle counts associated with at least one detection range used by the particle counter, such as particle concentration, volume and/or size) (paragraph 249, As another example, microcytic red cells, cell fragments, artifacts, and even electronic noise may be mistakenly counted as platelets, resulting in an inaccurately high count of PLTs).
Before the effective filing date of the claimed invention, it would have obvious to a person of ordinary skill in the art to use a ratio between two counts to detect an error. The motivation for doing so would have been to improve the accuracy of the counts. Therefore, it would have been obvious to combine Adams with Ye to obtain the invention as specified in claims 1 and 37.
Referring to claims 2 and 38, Ye discloses wherein:
identifying, within the microscopic image, candidates of a given entity within the blood sample comprises identifying, within the microscopic image, platelet candidates within the blood sample (paragraph 35, Step 103, generating a first scattergram based on the forward scattered light information and the fluorescence information to obtain characteristic information of platelets, namely information that characterizing the platelets);
validating at least some of the candidates as being the given entity, by performing the further analysis of the candidates comprises validating at least some of the platelet candidates as being platelets, by performing further analysis of the candidates (paragraph 37, Step 105, acquiring a real count value for the platelets based on the characteristic information of the platelets and the characteristic information of the white blood cell fragments obtained in the above two steps, by means of a specific algorithm or processing).
Adams discloses invalidating the sample comprises invalidating the sample based upon a ratio between the count of platelet candidates and the count of validated platelet candidates (paragraph 53, The system may be useful, for example, in characterizing particles in biological fluids, such as detecting and quantifying erythrocytes, reticulocytes, nucleated red blood cells, platelets and white blood cells, including white blood cell differential counting, categorization and subcategorization and analysis).
Referring to claims 3 and 39, Ye discloses wherein:
identifying, within the microscopic image, candidates of a given entity within the blood sample comprises identifying, within the microscopic image, white blood cell candidates within the blood sample (paragraph 35, Step 103, generating a first scattergram based on the forward scattered light information and the fluorescence information to obtain characteristic information of platelets, namely information that characterizing the platelets. In an embodiment, the blood cells can be classified into at least three types of white blood cells, red blood cells, and platelets);
validating at least some of the candidates as being the given entity, by performing further analysis of the candidates comprises validating at least some of the white blood cell candidates as being white blood cells, by performing further analysis of the candidates (paragraph 37, Step 105, acquiring a real count value for the platelets based on the characteristic information of the platelets and the characteristic information of the white blood cell fragments obtained in the above two steps, by means of a specific algorithm or processing); and
invalidating the sample comprises invalidating the sample based upon on the count of white blood cell candidates and the count of validated white blood cell candidates (paragraph 62, The determining unit 401 is configured to acquire a count value for the white blood cell fragments based on the characteristic information of the white blood cell fragments and to determine whether the count value for the white blood cell fragments exceeds a threshold value) (paragraph 50, In the above method, the characteristic cells falling within the predetermined characteristic region may also be marked, removed, or reported by an alarm prompt).
Adams discloses invalidating the sample comprises invalidating the sample based upon on the ratio between the count of white blood cell candidates and the count of validated white blood cell candidates (paragraph 53, The system may be useful, for example, in characterizing particles in biological fluids, such as detecting and quantifying erythrocytes, reticulocytes, nucleated red blood cells, platelets and white blood cells, including white blood cell differential counting, categorization and subcategorization and analysis).
Referring to claims 6 and 42, Ye discloses a method comprising:
placing a blood sample within a sample chamber (paragraph 59, Referring also to FIG. 9, in particular, the detection device 300 is provided with a flow chamber 301, through which the cells pass one by one);
acquiring microscopic images of the blood sample (paragraph 59, In the laser irradiation direction, a diaphragm 304, a collecting lens 305, a flare eliminating diaphragm 306, and a forward scattered light detector 307 are sequentially arranged, and the forward scattered light signal is collected by the forward scattered light detector 307)); and
using a computer processor of an optical measurement unit (paragraph 61, The analysis device 400 may be implemented a processor):
identifying, within the microscopic image, white blood cell candidates within the blood sample (paragraph 35, Step 103, generating a first scattergram based on the forward scattered light information and the fluorescence information to obtain characteristic information of platelets, namely information that characterizing the platelets. In an embodiment, the blood cells can be classified into at least three types of white blood cells, red blood cells, and platelets);
validating at least some of the white blood cell candidates as being given types of white blood cells, by performing further analysis of the white blood cell candidates (paragraph 37, Step 105, acquiring a real count value for the platelets based on the characteristic information of the platelets and the characteristic information of the white blood cell fragments obtained in the above two steps, by means of a specific algorithm or processing), the further analysis comprising identifying stained objects having irregular shapes as debris or contaminating bodies and excluding the debris or contaminating bodies from the white blood cell candidates validated as being the given types of white blood cells (paragraph 39, In another example, scattered points representing the characteristic information of the white blood cell fragments on the first scattergram are determined based on the characteristic information of the white blood cell fragments obtained in Step 104) (paragraph 28, White blood cell fragments, also known as fragmented white blood cells, are white blood cells with cell membranes that are broken completely or partially);
invalidating the sample in response to the count of white blood cell candidates and the count of the white blood cell candidates validated as being given types of white blood cells indicating an error, wherein the counts indicate the error when the ratio exceeds a maximum threshold or is below a minimum threshold (paragraph 62, The determining unit 401 is configured to acquire a count value for the white blood cell fragments based on the characteristic information of the white blood cell fragments and to determine whether the count value for the white blood cell fragments exceeds a threshold value) (paragraph 50, In the above method, the characteristic cells falling within the predetermined characteristic region may also be marked, removed, or reported by an alarm prompt); and
in response to invalidating the sample, performing at least one of: not performing any measurements on the sample, flagging to a user that the sample is invalid, instructing the user to repeat a sample preparation with a new test kit, or instructing the user to re- collect a blood sample (paragraph 62, The alarm unit 402 is configured to determine whether to output an alarm prompt based on the determination result of the determining unit 401. For example, when the determining unit 401 determines that the count value for the white blood cell fragments exceeds the threshold value, the alarm unit 402 will output an alarm prompt) (paragraph 40, The prompting may be implemented in a form of text, sound, light, or pop-up window).
While Ye discloses invalidating the sample, Ye does not disclose expressly invalidating the sample based upon the ratio.
Adams discloses determining a ratio between a count of the white blood cell candidates to a count of the white blood cell candidates validated as being the given types of white blood cells (paragraph 240, In step 88 of FIG. 9, the concentration of particles in the first category or subcategory can be then calculated by processor 18, as depicted in FIG. 5 or 6, at least in part by applying the proportionate ratio to the single count (e.g. step 84 of FIG. 9) obtained from the particle counter); and
invalidating the sample, based upon the ratio between the count of the white blood cell candidates and the count of the white blood cell candidates validated as being given types of white blood cells (paragraph 241, As illustrated in FIG. 10B, the particle count from the analyzer of this disclosure can be used to correct inaccurate particle counts associated with at least one detection range used by the particle counter, such as particle concentration, volume and/or size) (paragraph 249, As another example, microcytic red cells, cell fragments, artifacts, and even electronic noise may be mistakenly counted as platelets, resulting in an inaccurately high count of PLTs).
Before the effective filing date of the claimed invention, it would have obvious to a person of ordinary skill in the art to use a ratio between two counts to detect an error. The motivation for doing so would have been to improve the accuracy of the counts. Therefore, it would have been obvious to combine Adams with Ye to obtain the invention as specified in claims 6 and 42.
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 PETER K HUNTSINGER whose telephone number is (571)272-7435. The examiner can normally be reached Monday - Friday 8:30 - 5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benny Q Tieu can be reached at 571-272-7490. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER K HUNTSINGER/Primary Examiner, Art Unit 2682
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