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 .
Specification Objections
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains the phrase “The present disclosure provides” in line 1, and it does not include the steps of the process as claimed. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). Examiner suggests amending the first sentence to read “A method of providing…”.
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 5, 8, 13 and 16 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.
Claims 8 and 16 each contain the trademark/trade names Viscopearl® D-5, CELLULOBEADS® D-5, Viscopearl® D-10 and CELLULOBEADS@ D-10. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe non-porous spherical cellulose beads and, accordingly, the identification/description is indefinite. In the interest of compact prosecution, Examiner is interpreting the claims to mean “non-porous spherical cellulose particles”.
Claims 5 and 13 both recite the limitations "the color of the artificial particles" in line 1 and “the color of the leukocytes” in line 2. There is insufficient antecedent basis for these limitations in the claims. Examiner suggests amending the claim to say “a color of the artificial particles” and “a color of the leukocytes”, respectively.
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 9-16 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 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.
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.
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 10-16 are all 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, claim 9 and its dependent claims do not amount to significantly more than the judicial exception.
As mentioned above, claim 9’s “measuring” step represents 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 10-16 are all directed to the “artificial particles” of claim 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 10-16 do not amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taki et al. in US5728582A.
Regarding claim 1, Taki discloses a method for analyzing a sample using a urine sediment analyzer (column 5, lines 3-5) (When analyzing biological components, mainly sediments in urine… white blood cells (6 to 20 µm)), comprising the steps of:
controlling the measurement accuracy of the urine sediment analyzer with artificial particles (column 6, line 6) (the following describes the calibration procedures using the suspension of reference particles) whose form as observed with a microscope is similar to the form of leukocytes as observed therewith (col 9 lines 36-38) (selection of… spherical form in conformity to the target component… size from 2 to 160 µm), for measuring a concentration of leukocytes in the sample (column 5, lines 3-5) (When analyzing biological components, mainly sediments in urine… white blood cells (6 to 20 µm)); and
analyzing the sample with the urine sediment analyzer (column 6 lines 23-24) (the number of detected particles passing through the particle detection area is measured).
Regarding claim 2, Taki discloses the method according to claim 1 (column 2 lines 45-60), wherein the artificial particles have a spherical form (column 4 lines 52-57) (the artificial particles… are used an [in] two or more forms: spherical, elliptical, and rod).
Regarding claim 3, Taki discloses the method according to claim 1 as rejected above. Taki teaches wherein the artificial particles have an average particle size of from 5 µm to 10 µm (column 5 lines 34-35) (having an average particle diameter of 8 µm).
Claim(s) 9-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Umberger et al. in WO 2021/127424 A1 (as cited in the IDS submitted on 03/05/2024).
Regarding claim 9, Umberger discloses a method (pgs. 28-29, see examples 1-2) for controlling a measurement accuracy of an analyzer that measures a concentration of particles whose form is similar to the form of leukocytes in a sample, by counting the number of the particles in the sample (pg. 2 lines 17-28) (calibration fluids including… beads sized and colored to represent white blood cells (WBCs). The counting, sizing, and stain uptake abilities of the beads allow for an assessment), the method comprising the steps of:
measuring a concentration of particles in a quality control substance comprising artificial particles whose form is similar to the form of leukocytes (pg. 3 line 2) (the beads are sized and colored to represent at least one type of blood cell), using the analyzer, to obtain a measured value (pg. 6 lines 22-23) (analyzer systems can measure the beads based on images of the beads); and
determining the measurement accuracy of the analyzer by comparing the measured value with a reference value (pg. 5 line 13) (determining whether measurements of the beads taken from the image are within tolerance of a reference size range).
Regarding claim 10, Umberger discloses the method according to claim 9 as rejected above, wherein the artificial particles have a spherical form (pg. 15 lines 12-13) (for example, FIG 1 is an image of printed and stained cellulose beads 100 [item 1000] taken on an automated hematology analyzer system). See Figure 1, item 1000, which shows a spherical artificial particle:
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Regarding claim 11, Umberger discloses the method according to claim 9 as rejected above, wherein the artificial particles have an average particle size of from 5 µm to 10 µm (pg. 29 line 11) (Cellulose beads of 10-micron size).
Regarding claim 12, Umberger discloses the method according to claim 9 as rejected above, wherein the artificial particles are made of cellulose (pg. 29 line 11) (Cellulose beads).
Regarding claim 13, Umberger discloses the method according to claim 9 as rejected above, wherein the color of the artificial particles as observed with the microscope is similar to the color of the leukocytes as observed therewith (pg. 3 line 2) (the beads are sized and colored to represent at least one type of blood cell). See also figure 6, which shows artificial particles that are similar in color to leukocytes (colorless or grey) as observed under a microscope:
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Claim(s) 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Umberger et al. in WO 2021/127424 A1 (as cited in the IDS submitted on 03/05/2024), as evidenced by Kobo Products Inc. (Non-Patent Literature, “Microspheres North American Program”).
Regarding claim 14, Umberger discloses the method according to claim 9 as rejected above. Umberger discloses that their 10 µm cellulose beads are sourced from Kobo Products Inc. (pg. 14 line 21-22). According to Kobo Product’s North American catalog, the source of these 10 µm cellulose beads is most likely CELLULOBEADS® D-5 (Non-Patent Literature, “Microspheres North American Program”, Kobo Products Inc., see pg. 2). Applicant describes CELLULOBEADS® as being “non-porous, spherical cellulose particles” (paragraph [18] of specification). Therefore, Umberger discloses wherein the artificial particles have a non-porous structure (pg. 29 line 11) (Cellulose beads of 10-micron size).
Regarding claim 15, Umberger teaches the method of claim 9 as rejected above, wherein the artificial particles are non-porous (see claim 14 rejection) spherical cellulose particles having an average particle size of from 5 µm to 10 µm (pg. 29 line 11) (Cellulose beads of 10-micron size). See also Figure 1, item 1000, which shows a spherical cellulose particle:
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Regarding claim 16, Umberger teaches the method of claim 9 as rejected above, wherein the artificial particles are non-porous (see claim 14 rejection) spherical cellulose particles (pg. 29 line 11) (Cellulose beads of 10-micron size). See also Figure 1, item 1000, which shows a spherical cellulose particle (see above). Note that Examiner is interpreting the body of claim 16 to mean “non-porous spherical cellulose particles”.
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.
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.
Claim(s) 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Taki et al. (US5728582A) in view of Umberger et al. (WO2021127424A1).
Regarding Claim 4, Taki discloses the method according to claim 1 as rejected above. Taki teaches the use of several synthetic artificial polymers (column 4, lines 52-54) (Material for the artificial particles includes a copolymer of polystyrene, styrene and divinylbenzene, polyvinyl toluene, silica gel…). Taki teaches of the use of radical species to functionalize the surface of the particles (column 4 lines 65-66) (Types of functional radicals used include the sulfonic acid group… hydroxyl… chloro…).
Taki does not disclose wherein the artificial particles are made of cellulose.
In the analogous art of using artificial particles to calibrate the measurement of leukocyte content in a biological sample, Umberger discloses artificial particles made of cellulose (pg. 29 line 11) (Cellulose beads). Umberger teaches that cellulose has the advantage of being easily stained without a functionalization/derivatization step (pg. 15 line 3) (The cellulose beads' hydrophilic properties allow the beads to absorb stain).
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the synthetic polymer particles of Taki to instead use the cellulose particles of Umberger because it would lead to the predictable outcome of having artificial particles that absorb stains without any functionalization step with a reasonable chance of success. See MPEP 2143(I)(G).
Regarding Claim 5, Taki discloses the method according to claim 1 as rejected above.
Taki does not specifically disclose wherein the color of the artificial particles as observed with the microscope is similar to the color of the leukocytes as observed therewith.
In the analogous art of using artificial particles to calibrate the measurement of leukocyte content in a biological sample, Umberger discloses the use of beads that are similar in color to leukocytes as observed with a microscope (pg. 3 line 2) (the beads are sized and colored to represent at least one type of blood cell). See also figure 6, which shows artificial particles that are similar in color to leukocytes (off-white or grey) as observed under a microscope:
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It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the artificial particles of Taki with the coloration of Umberger because it would lead to the predictable outcome of more accurately mimicking the color of white blood cells with a reasonable chance of success. See MPEP 2143(I)(G).
Claim(s) 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Taki et al. (US5728582A) in view of Umberger et al. (WO2021127424A1), as evidenced by Kobo Products Inc. (Non-Patent Literature, “Microspheres North American Program”).
Regarding claim 6, Taki discloses the method according to claim 1 (column 2 lines 45-60). Taki teaches the use of particles with concavities and convexities to enable functionalization and staining of the surface (column 4 lines 57-59) (The particles surfaces are provided with concavities and convexities to ensure efficient bonding with functional radicals).
Taki does not disclose wherein the artificial particles have a non-porous structure.
In the analogous art of using artificial particles to calibrate the measurement of leukocyte content in a biological sample, Umberger discloses that their 10 µm cellulose beads (pg. 29 line 11) (Cellulose beads of 10-micron size) are sourced from Kobo products (pg. 14 line 21-22) (manufactured by Kobo Products, Inc., South Plainfield, N.J., USA). According to Kobo Product’s North American catalog, the source of these 10 µm cellulose beads is most likely CELLULOBEADS® D-5 (Non-Patent Literature, “Microspheres”, see pg. 2). Applicant describes CELLULOBEADS® as being “non-porous, spherical cellulose particles” (paragraph [18] of specification). Therefore, the cellulose beads disclosed by Umberger are non-porous.
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to substitute the artificial particles of Taki (concavities/convexities) with the artificial particles of Umberger (non-porous) because both may be used to calibrate the measurement of leukocytes with a reasonable chance of success. See MPEP 2143(I)(B).
Regarding claim 7, Taki discloses the method according to claim 1 as rejected above. Taki discloses the use of artificial particles that are spherical in form (column 4 lines 52-57) (the artificial particles… are… spherical, elliptical, and rod). Taki discloses the use of particles with concavities and convexities to enable functionalization and staining of the surface (column 4 lines 57-59) (The particles surfaces are provided with concavities and convexities to ensure efficient bonding with functional radicals). Taki teaches the use of synthetic artificial polymers (column 4, lines 52-54) (Material for the artificial particles includes a copolymer of polystyrene…). Taki teaches the use of artificial particles with an average particle size of 8 µm (column 5 lines 34-35) (having an average particle diameter of 8 µm).
Taki does not specifically disclose wherein the artificial particles are non-porous cellulose particles.
In the analogous art of using artificial particles to calibrate the measurement of leukocyte content in a biological sample, Umberger discloses the use of non-porous (see claim 14 and 6 rejections above) cellulose particles having an average particle size of 10 µm (pg. 29 line 11) (Cellulose beads of 10-micron size). Umberger teaches of using particles that are sized to represent leukocytes (pg. 3 line 2) (the beads are sized and colored to represent at least one type of blood cell). Umberger teaches that cellulose has the advantage of being easily stained without a functionalization or derivatization step (pg. 15 line 3) (The cellulose beads' hydrophilic properties allow the beads to absorb stain).
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the artificial particles of Taki (concavities/convexities, spherical, non-cellulose) with the artificial particles of Umberger (non-porous, spherical, cellulose) because it would lead to the predictable outcome of having good stain uptake with a reasonable chance of success. See MPEP 2143(I)(G).
Regarding claim 8, Taki discloses the method according to claim 1 (column 2 lines 45-60). Taki discloses the use of artificial particles that are spherical in form (column 4 lines 52-57) (the artificial particles… are… spherical, elliptical, and rod). Taki teaches the use of particles with concavities and convexities to enable functionalization and staining of the surface of the particles (column 4 lines 57-59) (The particles surfaces are provided with concavities and convexities to ensure efficient bonding with functional radicals).
Taki does not disclose wherein the artificial particles are non-porous cellulose particles.
In the analogous art of using artificial particles to calibrate the measurement of leukocyte content in a biological sample, Umberger discloses the use of non-porous (see claim 14 and 6 rejections above) cellulose beads (pg. 29 line 11) (Cellulose beads). Umberger teaches that cellulose has the advantage of being easily stained without a functionalization/derivatization step (pg. 15 line 3) (The cellulose beads' hydrophilic properties allow the beads to absorb stain).
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the artificial particles of Taki (beads with ‘concavities and convexities’, synthetic) with the artificial particles of Umberger (beads that are non-porous, cellulose) because it would lead to the predictable outcome of having good stain uptake without a functionalization step with a reasonable chance of success. See MPEP 2143(I)(G).
Conclusion
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/H.D.C./Examiner, Art Unit 1758
/CHRISTINE T MUI/
Primary Examiner, Art Unit 1797
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