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 “Objection”, in the Remarks filed 06/25/2026, with respect to the objections to the specification have been fully considered and are persuasive. Objections to the specification have been withdrawn.
Applicant's arguments, see “Rejection Under 35 U.S.C. § 112(b)”, filed 06/25/2026, with respect to the rejections of claims 5, 8, 13, and 16, have been fully considered and are persuasive. Rejection Under 35 U.S.C. § 112(b) of claims 5, 8, 13, and 16 have been withdrawn.
Applicant's arguments, see “Rejection Under 35 U.S.C. § 102”, filed 06/25/2026, with respect to the rejections of claims 1-3 and 9-16 have been fully considered and are persuasive. Rejection Under 35 U.S.C. § 102 of claims 1-3 and 9-16 have been withdrawn.
Applicant's arguments, see “Rejection Under 35 U.S.C. § 103”, filed 06/25/2026, with respect to the rejections of claims 4-8 have been fully considered and are persuasive. Rejection Under 35 U.S.C. § 103 of claims 4-8 have been withdrawn.
Applicant's arguments, see “Rejection Under 35 U.S.C. § 101”, filed 06/25/2026, with respect to the rejections of claims 9-16 have been fully considered but are not persuasive. Rejection Under 35 U.S.C. § 101 of claims 10-12 and 14-16 have been withdrawn in light of the cancellation of those claims; the rejection of claims 9 and 13 are maintained.
Applicant asserts that the recitation in claim 9 of “measuring a concentration of particles in a quality control substance comprising artificial particles whose form is similar to the form of leukocytes, using the analyzer, to obtain a measured value” is not mere data gathering because it requires operating an analyzer.
Examiner respectfully submits that the operation of an analyzer does not change that this “measuring…” step amounts to mere data collection. MPEP 2106.05(g) provides examples of activities that the courts have found to be insignificant extra-solution activity under “Mere Data Gathering”. From these, example vi describes “assessing or measuring data derived from an ultrasound scan, to be used in a diagnosis”; “from an ultrasound scan” implies the operation of an analyzer. Therefore, the ”measuring…” step still amounts to mere data gathering, despite requiring an analyzer.
Applicant further asserts that, in the Step 2A analysis, the recitations of claim 9 was not treated as a whole. Applicant asserts that, as a whole, the subject matter of claim 9 improves operability and convenience due to the inclusion of artificial particles because artificial particles are ethically sourced, safe, and stable.
Examiner respectfully submits that the use of artificial particles does not constitute an improvement to the operability or convenience of the technology or technical field in question because the use of artificial particles in the technology or technical field is well-known. MPEP 2106.05(a)(II) provides examples that the courts have indicated may not be sufficient to show an improvement to technology; examples ii-iii show that “Using well-known standard laboratory techniques to detect…” and “Gathering and analyzing information using conventional techniques and displaying the result”, respectively, are not sufficient to show an improvement to technology. In this case, the use of artificial particles in measuring a quality control substance are well-known and conventional; Umberger et al. (WO 2021/127424A1) teaches of using spherical cellulose particles that are 10 µm in size to calibrate blood analyzers, and Taki et al. (US 5728582A) teaches of using spherical artificial particles to calibrate a urine sediment analyzer. See MPEP 2106.05(d). Therefore, the inclusion of artificial particles does not amount to an improvement of the technology or technical area.
Applicant further asserts the method of claim 9 improves the functioning of a technology or technical field because it provides a previously unavailable quality control method that confirms the measurement accuracy of leukocytes and therefore provides a practical application of the judicial exception.
Examiner respectfully submits that quality control methods that confirming the measurement accuracy of leukocytes were available prior to the effective filing date of the instant application: Umberger et al. (WO 2021/127424A1) teaches of using spherical cellulose particles that are 10 µm in size to calibrate blood analyzers, and Taki et al. (US 5728582A) teaches of using spherical artificial particles to calibrate a urine sediment analyzer. See MPEP 2106.05(d). See MPEP 2106.05(a)(II).
Applicant asserts that as a whole claim 9 recites significantly more than the judicial exception because “measuring a concentration of particles in a quality control substance comprising artificial particles whose form is similar to the form of leukocytes, using the analyzer, to obtain a measured value… wherein the artificial particles are non-porous spherical cellulose particles having an average particle size of from 5 µm to 10 µm” is not well understood, routine, and conventional.
Examiner respectfully submits that the limitations of claim 9 are well-understood, routine, and conventional in the art: Umberger et al. (WO 2021/127424A1) teaches of using spherical cellulose particles that are 10 µm in size to calibrate blood analyzers, and Taki et al. (US 5728582A) teaches of using spherical artificial particles to calibrate a urine sediment analyzer. See MPEP 2106.05(d).
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 1, 5, 9, 13 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.
Regarding claim 1, the limitation “controlling the measurement accuracy of the urine sediment analyzer” is unclear. There is no claimed measurement recited so it is unclear to what the measurement accuracy refers to and what is being controlled.
Regarding claim 1, the limitation “similar to the form of leukocytes observed therewith” is unclear. The term “similar” is relative and the specification does provide not a standard. While the specification at para. [0035] describes an analyzer that determines “whether or not the degree of similarity between the forms of both is equal to or higher than a certain value,” neither the claims nor the specification defines that “certain value” or otherwise establishes a boundary.
Regarding claim 1, the limitation “the form of leukocytes” is unclear. Leukocytes are not uniform so it’s not clear as to what aspect of leukocytes meets the term “form”. The specification at para. [0026] identifies “polymorphonuclear granulocytes, monocytes and lymphocytes,” which differ in size and morphology.
Regarding claim 1, the limitation “leukocytes observed therewith” is unclear since it’s unclear whether a step of observing leukocyte is positively recited.
Regarding claim 5, the limitation “similar to a color of the leukocytes” is unclear. The term “similar” in claim 5 is a relative term which renders the claim indefinite. The term “similar” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the specification at para. [0035] describes an analyzer that determines “whether or not the degree of similarity between the forms of both is equal to or higher than a certain value,” neither the claims nor the specification defines that “certain value” or otherwise establishes a boundary.
Regarding claim 9, the limitation “the measurement accuracy” is unclear. There is no claimed measurement of the analyzer recited so it is unclear to what the measurement accuracy refers to and what is being controlled.
Regarding claim 9, the limitation “similar to the form of leukocytes observed therewith” is unclear. The term “similar” is relative and the specification does provide not a standard. While the specification at para. [0035] describes an analyzer that determines “whether or not the degree of similarity between the forms of both is equal to or higher than a certain value,” neither the claims nor the specification defines that “certain value” or otherwise establishes a boundary.
Regarding claim 9, the limitation “the form of leukocytes” is unclear. Leukocytes are not uniform so it’s not clear as to what aspect of leukocytes meets the term “form”. The specification at para. [0026] identifies “polymorphonuclear granulocytes, monocytes and lymphocytes,” which differ in size and morphology.
Regarding claim 13, the limitation “similar to a color of the leukocytes” is unclear. The term “similar” in claim 13 is a relative term which renders the claim indefinite. The term “similar” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the specification at para. [0035] describes an analyzer that determines “whether or not the degree of similarity between the forms of both is equal to or higher than a certain value,” neither the claims nor the specification defines that “certain value” or otherwise establishes a boundary.
Regarding claim 13, the limitation “leukocytes as observed therewith” is unclear since it’s unclear whether a step of observing leukocyte is positively recited.
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, 5, 9, 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims will be analyzed below according to MPEP 2106.
Inquiry 1: Is the claim directed to a statutory category of invention (process, machine, manufacture, or composition of matter)?
Yes, the claim is directed to a process.
Inquiry 2A Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, claim 1 recites “controlling the measurement accuracy… with artificial particles… leukocytes as observed therewith”. The act of “controlling the measurement accuracy” is something that can be performed in the human mind and/or with pen and paper by simply observing the artificial particles and the leukocytes and controlling the measurement accuracy by writing down the parameters of the analyzer to be controlled; alternatively this could be done by observing the artificial particles and the leukocytes and counting everything by eye and marking the differences in the counts on paper to control the measurement accuracy.
Claim 5 is dependent on claim 1 and therefore also recites an abstract idea.
Claim 9 recite(s) “determining the measurement accuracy of the analyzer by comparing the measured value with a reference value”. Determining is a mental process that can be performed in the human mind. Thus, it is an abstract idea.
Claim 13 is dependent on claim 9 and is therefore also drawn to an abstract idea.
Inquiry 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
No, this judicial exception is not integrated into a practical application.
There is nothing prior to the “controlling” step of claim 9, but the “analyzing” step that occurs after the judicial exception amounts to mere data-gathering and does not integrate the judicial exception into a practical application. See MPEP 2106.05(g).
Before the judicial exception, claim 9 recites a step for “measuring a concentration of particles in a quality control substance comprising artificial particles whose form is similar to the form of leukocytes, using the analyzer, to obtain a measured value.” This amounts to mere data gathering and does not integrate the judicial exception into a practical application. See MPEP 2106.05(g).
Dependent claims 5 and 13 are directed to the “artificial particles” in the data-gathering step that prefaces the judicial exception. Limiting the identity of the artificial particles does not change that the “measuring” step amounts to mere data gathering. See MPEP 2106.05(g). Therefore, the dependent claims also do not incorporate the judicial exception into a practical application.
Inquiry 2B: Does the claim recite additional limitations that amount to significantly more than the judicial exception?
No, claims 1, 5, 9, and 13 do not amount to significantly more than the judicial exception.
As mentioned above, claim 1’s “analyzing” step and claim 9’s “measuring” step represent mere data gathering, which does not amount to significantly more than the judicial exception. Furthermore, the concept of measuring a concentration of particles in a quality control substance and using artificial particles to calibrate an analytical instrument is well-understood, routine, and conventional in the arts, and it does not amount to an improvement in the technological field; Umberger et al. (WO 2021/127424A1) teaches of using artificial particles to calibrate blood analyzers, and Taki et al. (US 5728582A) teaches of using artificial particles to calibrate a urine sediment analyzer. See MPEP 2106.05(d) and 2106.04(d)(1).
Dependent claims 5 and 13 is directed to the “artificial particles” of claims 1 and 9, which are well-understood, routine, and conventional (WURC) in the arts; Umberger et al. (WO 2021/127424A1) teaches of using spherical cellulose particles that are 10 µm in size to calibrate blood analyzers, and Taki et al. (US 5728582A) teaches of using non-porous spherical artificial particles to calibrate a urine sediment analyzer. See MPEP 2106.05(d). Furthermore, because the particles are WURC in the arts, they do not represent an improvement of the technical field. See MPEP 2106.04(d)(1). Applicant’s specification supports this by pointing out that these artificial particles are commercially available products (see paragraphs [11] and [19]) (commercially available product of artificial particles and it is preferred to use… Viscopearl® … or CELLULOBEADS®… which is non-porous, spherical cellulose particles… average particle size of 5 µm). Therefore, the dependent claims 5 and 13 do not amount to significantly more than the judicial exception.
Conclusion
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/H.D.C./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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