DETAILED ACTION
Claims 43-46 have been added.
Claims 1-6 and 37-46 are currently pending.
The rejections to claims 1-6 and 37-42 under 35 U.S.C. 101 are maintained.
The rejections to claims 1-6 and 37-42 under 35 U.S.C. 103 are maintained.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/9/25 has been entered.
Response to Arguments
Applicant's arguments filed 12/9/25 have been fully considered but they are not persuasive.
The Applicant argues on page 9 of the response in essence that: Applicant submits, however, that Adams describes calculating the ratio between a number of a first cell type and a number of a second cell type as determined in the images of the visual analyzer but does not describe a validation process of calculating the ratio between a count of identified candidates of an entity and a count of the validated candidates from within the identified candidates of the entity, as recited by claim 1
Adams discloses 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 (paragraph 240). Adams describes that a category encompasses a grouping of particles corresponding to criteria measured, detected or derived such as size, shape, texture, or color (paragraph 102). The count of a first category and the count of a second category are both counts of identified candidates of an entity because the counts are both categories of blood cells.
The Applicant argues on page 9 of the response in essence that: Del Favero does not describe or suggest invalidating a sample but rather selecting middle-range data for accuracy of the homozygous fraction calculation.
Del Favero discloses preferably a portion in which the read counts with the highest and/or the lowest value(s) are removed (paragraph 11). Removing outlier samples is invalidating the sample.
The Applicant argues on pages 9 and 10 of the response in essence that: Applicant additionally submits that while the presently claimed subject matter is directed to internal sample self-validation for optical measurements, Del Favero is concerned with statistical processing of genetic read counts from DNA sequencing. Therefore, Applicant respectfully submits that a person of ordinary skill in art, seeking a technical solution as to how to use a validation process itself as an indication of errors in an optical measurement system, and having read Adams, would not turn to Del Favero for a solution.
A skilled artisan would have been motivated to combine the removing of outlier samples as taught by Del Favero with the particle counting system of Adams because doing so would have improved the accuracy by removing outlier results. In response to Applicant's argument that Del Favero is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both Adams and Del Favero concern separating blood components classified in CPC G01N 33/49. Furthermore, the removing of outlier samples is the particular problem with which the inventor was concerned. Page 3, lines 13-17 of Applicant’s Specification states “Further alternatively or additionally, there may be an inherent problem with the sample (such as a very low count or a very high count of a certain entity, or too much time having elapsed since the sample collection was performed), which means that the computer processor is unable to perform certain measurements with a sufficient degree of accuracy, and/or which means that the computer processor should flag this to the user.”
The Applicant argues on page 11 of the response in essence that: Applicant respectfully disagrees with the rejection and with the Office Action's statement that "merely adjusting a count of particles does not provide an improvement." Applicant submits that the claimed subject matter is not merely adjusting counts; but rather it provides a technical solution to a technical problem: performing self-validation of a portion of a sample within the optical measurement unit to ensure that only a valid sample is used for measurements. This self-validation is performed internally by the optical measurement unit's processor and directly improves the accuracy, reliability, and robustness of the measurements performed by the optical measurement unit, rather than relying on external validation or post-processing. As such, the claimed method enhances the functionality of the optical measurement system itself and is analogous to other recognized patent-eligible improvements in computer-implemented measurement and control systems.
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 adjusting a count of particles within a blood sample by an optical measurement unit 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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 43-46 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
Claim 43 recites “responding to invalidating the sample based upon the ratio between the count of candidates and the count of validated candidates with at least one response selected from the group consisting 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, and instructing the user to re-collect a blood sample.” The Applicant’s Specification on page 28 states “For some applications, in response to identifying the error, the computer processor does not perform any measurements on the sample, and/or flags that the sample is invalid to the user, and/or instructs the user to repeat the sample preparation with a new test kit and/or to re-collect the blood sample.” However, the Applicant’s Specification does not state excluding any other responses to identifying the error. The transitional phrase "consisting of" excludes any element, step, or ingredient not specified in the claim. In re Gray, 53 F.2d 520 (CCPA 1931); See MPEP 2111.03. Therefore, the Applicant’s Specification fails to provide written description support for claim 43. Claims 44-46 contain similar language and are likewise rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
Claims 43-46 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 43 recites the limitation "the group" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claims 44-46 contain similar limitations and are likewise rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6 and 37-46 are rejected under 35 U.S.C. 101 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 claims recite the abstract idea of correcting blood measurements. 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).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps of “placing a blood sample within a sample chamber” and “acquiring microscopic images of the blood sample” simply append well-understood, routine and conventional activities previously known in the industry. 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.
Furthermore, the steps of “identifying, within the microscopic image, candidates of a given entity within the blood sample”, “validating at least some of the candidates as being the given entity, by performing further analysis of the candidates”, “determining a ratio between a count of the candidates of the given entity to a count of the validated candidates of the given entity” and “invalidating the sample, based upon the ratio between the count of candidates and the count of validated candidates” do not preclude the steps from being performed in the human mind. The dependent claims likewise do not preclude the steps from being performed in the human mind, and are directed to the abstract idea of correcting blood measurements.
The involvement of a generic computer processor in 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.
The claims do not provide an inventive concept as they do not provide an improvement to any type of particular machine. 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 § 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 1-6 and 37-42 are rejected under 35 U.S.C. 103 as being unpatentable over Adams et al. US Publication 2014/0273076 (hereafter “Adams”) and Del Favero et al. US Publication 2018/0171404 (hereafter “Del Favero”).
Referring to claims 1 and 37, Adams discloses a method comprising:
placing a blood sample within a sample chamber (paragraph 85, As used herein, typically a phlebotomist collects the blood sample from the subject, the blood is generally drawn into a test tube typically containing an anticoagulant (e.g., EDTA, sometimes citrate) to stop it from clotting);
acquiring microscopic images of the blood sample (paragraph 85, In certain embodiments, the blood sample may be viewed on a slide prepared with a sample of the patient's blood under a microscope (a blood film, or peripheral smear)); and
using a computer processor of an optical measurement unit (paragraph 181, processor 18 of FIG. 5):
identifying, within the microscopic image, candidates of a given entity within the blood sample (paragraph 237, In step 82, a sample (e.g. sample 12 of FIG. 6) is provided onto a particle counter (e.g. particle counter 15 of FIG. 6), which has a detection criteria which are met by at least two categories or subcategories of particles which are desired to be distinguished. The results from the particle counter encompass these categories or subcategories within a single count in step 84 of FIG. 9);
validating at least some of the candidates as being the given entity, by performing further analysis of the candidates (paragraph 238, In step 86, the sample is provided onto the analyzer (such as a visual analyzer) to determine a proportionate ratio of the first category or subcategory of particles to the second category or subcategory of particles);
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); and
correcting the sample based upon the ratio between the count of candidates and the count of validated candidates (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).
Adams does not disclose expressly invalidating the sample.
Del Favero discloses invalidating the sample (paragraph 11, preferably a portion in which the read counts with the highest and/or the lowest value(s) are removed).
Before the effective filing date of the claimed invention, it would have obvious to a person of ordinary skill in the art to invalidate the sample. The motivation for doing so would have been to improve accuracy by removing outlier results. Therefore, it would have been obvious to combine Del Favero with Adams to obtain the invention as specified in claims 1 and 37.
Referring to claims 2 and 38, Adams 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;
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 platelet candidates as being platelets, by performing further analysis of the candidates; and
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).
Del Favero discloses invalidating the sample (paragraph 11, preferably a portion in which the read counts with the highest and/or the lowest value(s) are removed).
Referring to claims 3 and 39, Adams 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;
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; and
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).
Del Favero discloses invalidating the sample (paragraph 11, preferably a portion in which the read counts with the highest and/or the lowest value(s) are removed).
Referring to claims 4 and 40, Adams discloses wherein correcting the sample comprises correcting the sample based a ratio of the count of validated candidates to the count of candidates exceeding a maximum threshold (paragraph 241, In some embodiments, the first category and/or subcategory of particles is present in the sample at a concentration above an upper limit of a detection range applicable to the first category and/or subcategory of particles).
Del Favero discloses invalidating the sample (paragraph 11, preferably a portion in which the read counts with the highest and/or the lowest value(s) are removed).
Referring to claims 5 and 41, Adams discloses wherein correcting the sample comprises correcting the sample based a ratio of the count of validated candidates to the count of candidates being less than minimum threshold (paragraph 242, In some embodiments, the first category and/or subcategory of particles is present in the sample below a lower limit of a detectable range of some parameter).
Del Favero discloses invalidating the sample (paragraph 11, preferably a portion in which the read counts with the highest and/or the lowest value(s) are removed).
Referring to claims 6 and 42, Adams discloses a method comprising:
placing a blood sample within a sample chamber (paragraph 85, As used herein, typically a phlebotomist collects the blood sample from the subject, the blood is generally drawn into a test tube typically containing an anticoagulant (e.g., EDTA, sometimes citrate) to stop it from clotting);
acquiring microscopic images of the blood sample (paragraph 85, In certain embodiments, the blood sample may be viewed on a slide prepared with a sample of the patient's blood under a microscope (a blood film, or peripheral smear)); and
using a computer processor of an optical measurement unit (paragraph 181, processor 18 of FIG. 5):
identifying, within the microscopic image, white blood cell candidates within the blood sample (paragraph 237, In step 82, a sample (e.g. sample 12 of FIG. 6) is provided onto a particle counter (e.g. particle counter 15 of FIG. 6), which has a detection criteria which are met by at least two categories or subcategories of particles which are desired to be distinguished. The results from the particle counter encompass these categories or subcategories within a single count in step 84 of FIG. 9) (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);
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 238, In step 86, the sample is provided onto the analyzer (such as a visual analyzer) to determine a proportionate ratio of the first category or subcategory of particles to the second category or subcategory of particles);
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
correcting 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).
Adams does not disclose expressly invalidating the sample.
Del Favero discloses invalidating the sample (paragraph 11, preferably a portion in which the read counts with the highest and/or the lowest value(s) are removed).
Before the effective filing date of the claimed invention, it would have obvious to a person of ordinary skill in the art to invalidate the sample. The motivation for doing so would have been to improve accuracy by removing outlier results. Therefore, it would have been obvious to combine Del Favero with Adams to obtain the invention as specified in claims 6 and 42.
Referring to claims 6 and 42, Adams discloses responding to invalidating the sample based upon the ratio between the count of candidates and the count of validated candidates with at least one response selected from the group consisting 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, and instructing the user to re-collect a blood sample.
Conclusion
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.
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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