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 .
Status of Claims
The claim set submitted on 12 MARCH 2026 is acknowledged.
In the claim set, Claims 1, 3-5, 8-11, 14 and 15 are ‘Currently Amended’ and Claims 2 , 4, 6, 7, 12 and 13 are ‘Previously Presented’.
Current pending claims are Claims 1-15 and are considered on the merits below.
Response to Amendment
Applicant’s arguments, see REMARKS, filed 12 MARCH 2026, with respect to the objection the specification /abstract have been fully considered and are persuasive. The objection to the specification / abstract has been withdrawn.
Applicant’s arguments with respect to claim(s) 1-15 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.
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.
Claim 1 is 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.
In the instant claim, Claim 1 has been amended to recited ‘hemotologically analyzing the analyte mixture’. It is unclear as to what ‘hemotologically analyzing’ is or what steps are to be performed in a hematological analysis. There is no clarification as to what this analysis entails. For examiner purposes, as long as blood is analyzed ; it undergoes hematological analysis.
Depend Claims 2-15 are also rejected under 112(b) as being dependent upon Claim 1.
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 and 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Instant Claim 1 recites :
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Step 1: The claim recites at least one step or act. Thus, the claim is to a method, which is one of the statutory categories of invention (Step 1: YES).
Step 2A Prong One: The claim recites a judicial exception. The limitation of monitoring the initial mixture, wherein monitoring the initial mixture comprises obtaining a first blood parameter of a first blood component of the initial mixture and determining a first combination scheme based on the first blood parameter is an abstract idea. This is similar to a look up table and would be considered an evaluation (mental step) and therefore an abstract idea and falls within the mathematical concept and mental process groupings in the 2019 PEG, and a law of nature. Determining and adding according to a combination scheme for a provision are both abstract ideas in the form of mental processes. In addition, once the step ‘based on the first blood parameter, determining a first combination scheme’ ; it merely a step that has been applied. At this point, the hmatoloigcally analyzing step is not applied so the only application is the ‘adding a first volume…’ step.
Step 2A Prong Two: The claim as a whole integrates the recited judicial exception into a practical application of the exception; No. Once the first combination scheme is determined a first reagent and second reagent according to that first combination scheme are added to the mixture. There is stated with a high level of generality and it is merely applied. What type of reagents and at what volumes? This would amount to merely adding the words “apply it” (or an equivalent) with the judicial exception or mere instructions to implement an abstract idea MPEP 2106.05(f) OR generally linking the use of the judicial exception to a particular technological environment or field of use 2106.05(h).
Step 2B: does the claim recite any elements which are significantly more than the abstract idea? This does not appear to have ‘significantly’ more; all steps in the method are well-understood routine and convention (WURC).
Further the monitoring comprising obtaining a first blood parameter would be considered data gathering, and insignificant extra solution activity and not to amount to significantly more.
All steps in Claim 1 are WURC and anticipated a prior art.
The dependent claims, Claims 2-10, do not solve the issues of above and are rejected by INSTITUT, GB1 560 729 below.
The claim is ineligible.
In addition, instant Claim 11 recites :
Step 1: The claim recites at least one step or act. Thus, the claim is to a method, which is one of the statutory categories of invention (Step 1: YES).
Step 2A Prong One: The claim recites a judicial exception. The limitation of measuring a “quality parameter” and the first determining step , then a second determining step if a condition is satisfied is an abstract idea and falls within the mathematical concept and mental process groupings in the 2019 PEG, and a law of nature. This claim identifies the recited exception as an abstract idea. Determining and comparing(whether or not the parameter falls within a criteria) are both abstract ideas in the form of mental processes. These steps are data gathering to be used in the abstract idea and are insignificant extra solution activities. This limitation sets forth a judicial exception and can be performed by a human using mental steps or basic critical thinking which is an abstract idea, MPEP 2106.040 (a)(2)(III).
This judicial exception is not integrated into a practical application because the elements of steps a-d do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea. While there is a step of performing a cbc and steps in claim 1, these step do anything with the findings of the parameter. Therefore there is no application of the abstract ideas much less a particular practical application.
Step 2A Prong Two: The claim as a whole integrates the recited judicial exception into a practical application of the exception; No. After whether both ‘in accordance …is satisfied or not satisfied’; nothing else is done. There does not appear to have any additional steps which are significantly more than the abstract idea.
Step 2B: does the claim recite any elements which are significantly more than the abstract idea? This does not appear to have ‘significantly’ more; all steps in the method are WURC. All steps are disclosed and taught by INSTITUT, GB1 560 729. Further the monitoring comprising obtaining a first blood parameter would be considered data gathering, and insignificant extra solution activity and not to amount to significantly more.
All steps in Claim 11 are WURC and anticipated a prior art. In a method of method for assessing one or more parameters, this is recited at a high level of generality such that it amount to insignificant presolution activity, e.g. mere data gathering is necessary to use to re-assess (compare). Since it is claimed at a high level of generality, there is no meaningful limitation claimed, such as a particular or unconventional machine or transformation of a particular article.
The claim is ineligible.
Dependent claims 12 and 13 only arbitrary define thresholds, which are WURC in comparison and determination of valid parameters or levels for preparation of a blood sample for hematology.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over GB 1 560 729, INSTITUT.
Applicant’s invention is directed towards a method.
Regarding Claim 1, the reference INSTITUT discloses a method of analyzing a blood sample, Claim 1, the method comprising:
combining a blood sample with an initial volume of a first reagent for provision of to form an initial mixture, Claim 1, sample contacted with staining composition, the first reagent comprising a staining and/or lysing reagent, Claim 1, hypotonic staining composition;
monitoring the initial mixture, wherein monitoring the initial mixture comprises obtaining measuring a first blood parameter of a first blood component of the initial mixture, Claim 1, pH of the mixture is measured to a particular pH;
based on the first blood parameter, determining a first combination scheme based on the first blood parameter configured to convert the initial mixture into an analyte mixture suitable for analysis, Claim 9, the pH is adjusted; [[and]]
adding a first volume of the first reagent and/or a first volume of a second reagent to the initial mixture according to the first combination scheme for provision of a to form the analyte [[first]] mixture, Claim 6, 9 and 10, mixing of staining compositions in appropriate proportions by addition of basic or acid reagent, adjust ratio,
the second reagent comprising a staining and/or lysing reagent, Claim 10, staining composition amount/ratio is adjusted; and
analyzing the analyte mixture, Example 2, page 8 line 34-59, Claim 11.
The INSTITUT reference discloses the claimed invention, but is silent in regards to specific hematologically analyzing the mixture.
In Example 2, page 8 line 34-59, the counting of basophils are counted. While the reference does not specifically disclose hematologically analyzing, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the step of counting of basophils to be a hematological analysis as this help diagnose a particular disease base on the number of white blood cells and the monitor blood disorder, infections and clotting issues.
Additional Disclosures Included are: Claim 2: wherein the method according to claim 1, wherein the method further comprises outputting a first reagent indicator indicative of the first combination scheme, Claim 9.; Claim 3: wherein the method according to claim 1, wherein the obtaining measuring the first blood parameter of the first blood component of the initial mixture comprises obtaining image data and/or sensor data of the initial mixture, Claim 9, pH is obtained, Claims 1 and 9, and determining the first blood parameter based on the image data and/or the sensor data, Claim 9.; Claim 4: wherein the method according to [[any]] claim 1, wherein the monitoring the initial mixture comprises monitoring via image capturing and/or via [[an]] optical diffraction tomography and/or via a turbidity sensor and/or via a modified liquid sensor and/or via a porous mirror and/or via a spectrophotometer and/or via an electro/impedance measuring unit, page 2, line 11-12, line 28-30.; Claim 5: wherein the method according to claim 1, wherein the combining the blood sample with the initial volume of the first reagent comprises mixing the blood sample with the initial volume of the first reagent for provision of to form the initial mixture, Claims 1 and 7.; Claim 6: wherein the method according to claim 1, wherein the first blood parameter is indicative of a red blood cell content in the initial mixture and/or a white blood cell content in the initial mixture and/or a platelet content in the initial mixture and/or a lipid content in the initial mixture, page 2 line 28-34.; Claim 7: wherein the method according to claim 1, wherein the initial volume of the first reagent is in the range from 0.5 to 20 times a volume of the blood sample in the initial mixture, Claim 1, 3-6. ; Claim 8: wherein the method according to claim 1, wherein the first reagent is a staining and/or and lysing reagent, Claim 1, 4-6.; Claim 9: wherein the method according to claim 1, wherein the second reagent is a staining and/or and lysing reagent, Claim 3-5.; Claim 10: wherein the method according to claim 1, wherein the first combination scheme is configured to convert the initial mixture to the analyte mixture having achieve full red blood cell lysis and strong suitable white blood cell and/or platelet staining. ; Claim 11: wherein the method according to claim 1, the method further comprising:
obtaining measuring a quality parameter of the [[first]] analyte mixture prior to the hematologically analyzing the analyte mixture, Claim 1; and determining whether the quality parameter satisfies a quality criterion, wherein a determination that the quality criterion is satisfied is indicative of the initial mixture being successfully converted to the analyte mixture suitable for analysis, and a determination that the quality criterion is not satisfied is indicative of the initial mixture being unsuccessfully converted to the analyte mixture suitable for analysis, Claim 1, 9 and 10, in accordance with a determination that the quality criterion is satisfied, performing the hematological analysis of the analyte mixture comprising a complete blood count (CBC) analysis of the [[first]] analyte mixture, page 8, line 52-59, Claim 19, 22, and
in accordance with a determination that the quality criterion is not satisfied, determining a second combination scheme configured to convert the initial mixture to the analyte mixture suitable for analysis and adding a second volume of the first reagent and/or a second volume of the second reagent to the [[first]] analyte mixture according to the second combination scheme for provision of a second to form a modified analyte mixture, Claims 9 and 10. ; Claim 12: wherein the method according to claim 11, wherein the quality parameter is indicative of a degree of red blood cell lysis and wherein the quality criterion is satisfied if the quality parameter is larger than a first lysis threshold, page 8, line 52-59, Example 2. ; Claim 13: wherein the method according to claim 11, wherein the quality parameter is indicative of a degree of white blood cell lysis and/or platelet lysis and wherein the quality criterion is satisfied if the quality parameter is larger than a second lysis threshold, Claim 1.
Applicant’s invention is directed to a computer program product.
Regarding Claim 14, the INSTITUT reference discloses the claimed invention of the method of Claim 1, see Rejection of Claim 1 above, but is silent in regards to a computer program comprising a nontransitory computer readable medium.
However, INSTITU does teach a method of classifying a blood sample using the method above in Claim 1.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the claimed invention of INSTITUT to have a computer program product comprising a nontransitory computer readable medium, having thereon a computer program comprising program instructions, the computer program being loadable into a data processing unit configured to execute the steps according to claim 1 when the computer program is run by the data processing unit so that the method can be performed automatically rather than manually or by hand, and by providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art, In reVenner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958) .
Applicant’s invention is directed towards a system.
Regarding Claim 15, the reference INSTITUT discloses a system for continuously monitoring and adjusting a reagent for point of care hematology, Claim 27, the system comprising:
a hematology analyzer, page 2, line 11-12, line 28-30; and
a reservoir for accommodating a reagent, Claim 27, 28; [[and]]
a cell measurement component for accommodating a blood sample, Claim 27 and 28;
wherein the system is configured to perform the method according to claim 1, Claim 27-38.
However, INSTITU does teach a method of classifying a blood sample using the method above in Claim 1, but is silent in regards to a controller.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the claimed invention of INSTITUT to have a controller, so that the method can be performed automatically rather than manually or by hand, and by providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art, In reVenner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958) .
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 CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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, LYLE ALEXANDER can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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