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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks filed August 27th, 2026. Claims 40-43, 45, 46, 49, 51, 52, 54-58, 61, 62, and 65 are pending. Claims 1-39, 44, 47, 48, 50, 53, 59, 60, 63, and 64 are canceled.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 27th, 2026 has been entered.
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 40-43, 45, 46, 49, 51, 52, 54-58, 61, 62, and 65 are rejected under 35 U.S.C. 101 because
the claimed invention is directed to an abstract idea without significantly more.
The claim(s) individually and as an ordered combination recite(s) the abstract idea of assessing a scattergram to make a determination of blood cells’ age that may be accomplished through mental steps (Step 2A, Prong 1), as well as application of mathematical concepts (the amended “…correcting a cell parameter…according to cell distribution information…” that are also abstract ideas under 35 USC 101.
Further abstract ideas are added by way of the amendments to claim 40/57 to the steps of 1) detecting…according to a first predetermined function relationship, 2) detecting…according to a first predetermined function relationship, and 3) correcting…a detection result according to…that amount to mental assessments/judgments of the data as well as being drawn to mathematical concepts by the “function relationships.”
This is seen in both the independent claim to the method of 40 and its dependents, as well as the independent claim 57 and its dependents.
It is further noted that mental steps also include steps that could be done with pencil and paper. Generating a scattergram may be accomplished through a mental step of plotting the data, and detecting cell distribution information of an aging characteristic region may be done mentally as a technician looks at the scattergram and visually assesses the data at the region of interest.
As in Step 2A, Prong 2, this judicial exception is not integrated into a practical application because while a detection result is outputted and outputted according to the cell distribution information comprises correcting a cell parameter as claimed, this is drawn to insignificant extra solution activity, wherein the claimed “outputting a detection result…comprises correcting…” is drawn to mere data outputting.
It is further noted that the amended recitation “wherein outputting a detection result according to the cell distribution information comprises correcting a cell parameter of the blood sample according to the cell distribution information…” is drawn to an additional abstract idea itself in which such outputting by correcting a cell parameter of the blood sample is drawn to mathematical concepts as seen in par. [0138]+ of Applicant’s pre-grant publication US 2021/0164885.
Further, the steps of “treating,” “irradiating,” and “acquiring” are drawn to mere data gathering and mere data gathering in a general way does not amount to significantly more than the abstract idea. See MPEP 2106.05(g).
Further, the steps of “treating,” “delivering,” and “irradiating” do not add a meaningful limitation to the method for detecting a blood sample and integrating into a practical application, wherein the “treating,” “irradiating,” and “acquiring” are drawn to data gathering steps and which are well-known, routine, and conventional.
Examiner further notes that steps of “delivering” and “irradiating” are codified by the physical infrastructure recited in the amended claim.
The provided physical infrastructure within the “delivering” step amounts to general flow architecture, a chamber, and photoelectric sensors which broadly describe well-known and conventional features in an optical flow cytometer, and do not constitute application with a particular machine as in MPEP 2106.05(b), I.
Limitations that the courts have found not to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include:
i. Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984 (see MPEP § 2106.05(f));
ii. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d));
Examiner further notes that while the claims have recited that the various steps have been done by a processor, such steps could have been done mentally and further, a general purpose computer has been recited and is not a particular machine. See MPEP 2106.05(b), I.
With respect to Step 2B, there are no additional limitations that are significantly more than the abstract idea.
This is likewise seen in the dependent claims, which provide general judgment processes that amount to mental steps afforded to the human mind in and that may be attributed to general guesswork or making an assessment of the data as based on the user’s prior experience, as well as further characterizations to the data itself that does not provide integration of a practical application nor significantly more than the abstract idea itself.
Examiner further notes that mere physicality or tangibility of an additional element or elements is not a relevant consideration in Step 2B. As the Supreme Court explained in Alice Corp., mere physical or tangible implementation of an exception is not in itself an inventive concept and does not guarantee eligibility:
The fact that a computer “necessarily exist[s] in the physical, rather than purely conceptual, realm,” is beside the point. There is no dispute that a computer is a tangible system (in § 101 terms, a “machine”), or that many computer-implemented claims are formally addressed to patent-eligible subject matter. But if that were the end of the § 101 inquiry, an applicant could claim any principle of the physical or social sciences by reciting a computer system configured to implement the relevant concept. Such a result would make the determination of patent eligibility “depend simply on the draftsman’s art,” Flook, supra, at 593, 98 S. Ct. 2522, 57 L. Ed. 2d 451, thereby eviscerating the rule that “‘[l]aws of nature, natural phenomena, and abstract ideas are not patentable,’” Myriad, 133 S. Ct. 1289, 186 L. Ed. 2d 124, 133).
This is likewise seen, as discussed above, with respect to the blood cell analyzer of independent claim 57 and 65.
Herein, and likewise to the above discussion with respect to the method of independent cl. 40 and dependents thereof, the processor of the blood cell analyzer in cl. 57/65 carries out the abstract idea.
In addition to the processor, a reaction chamber, an optical detection device, multiple photoelectric sensors, and a delivery device are also claimed.
As above, the likewise reasoning applies under Step 2A, Prong 1 with respect to the abstract idea and the acquiring of two types of optical signals, generating a scattergram, and detecting cell distribution information.
Herein, under Step 2A, Prong 2, the claimed machine is not a particular machine as in MPEP 2106.5 (b).
The recited structures as amended herein independent claims 57 and 65 remain drawn to routine and conventional structural elements in the field for use as “data gathering” pieces and do not provide significantly more to the abstract ideas cited at-hand.
Examples of applying a judicial exception with a particular machine include Mackay Radio & Tel. Co. v. Radio Corp. of America, 306 U.S. 86,40 USPQ 199 (1939) in which a mathematical formula was employed to use standing wave phenomena in an antenna system, and the claim recited the particular type of antenna and included details as to the shape of the antenna and the conductors, particularly the length and angle at which they were arranged.
This is likewise seen in Eibel Process Co. v. Minn & Ont. Paper Co., 261 U.S. 45, 64-65 (1923) in which gravity (a law of nature or natural phenomenon) was applied by a Fourdrinier machine arranged in a particular way to optimize the speed of the machine while maintaining quality of the formed paper web.
See MPEP 2106.5 (b) I.
This section also provides that a general purpose computer that applies the judicial exception, such as an abstract idea, by use of conventional computer functions does not qualify as a particular machine (i.e. acquiring, plotting, and outputting/characterizing data).
Further, under Step 2A, Prong 2, the outputting of a detecting result and wherein the processor is configured to correct a cell parameter as claimed does not provide a particular, practical application that amounts to significantly more than the abstract idea as likewise discussed above with respect to the method. This is likewise seen with respect to the amended, recited “outputting…configured to correct…” wherein this configuration remains drawn to mere outputting which is extra-solution activity and wherein the “configured to correct a cell parameter according to…” is drawn to an additional abstract idea in the form of a mathematical concept as likewise discussed above with respect to the method of claim 40.
Further, with respect to Step 2B, the additional elements of at least one reaction chamber, an optical detection device, multiple photoelectric sensors, and a delivery device do not amount to significantly more than the abstract idea. These elements are recited at a high level of generality and are not unique or particular to analyzing blood cells, and with the abstract ideas at-hand.
Further, the remainder of the dependent claims to the method and analyzer are drawn to general calculations afforded to be carried out by mental steps and a general purpose computer that applies the abstract idea by use of conventional computer functions and does not qualify as a particular machine, such as assessing a relative amount of “aged” cells versus “non-aged” cells across the scattergram/data as given by the mental steps of such assessment discussed above and providing a basic mathematical operation of calculating a ratio to see which amount is larger between the assessed “aged” versus “non-aged” so as to provide a qualification to the scattergram/data, or with respect to the general purpose computer applying the abstract idea by conventional computer functions in characterizing and assessing data, further wherein such “judgments” and “determinations” are provided at a high level of generality.
This is likewise seen with the recited “aging index” which further amounts to general mental steps to be carried out within the data, along with the “characteristic correction coefficient” and “correcting a cell parameter of the sample” as it relates to general mental steps afforded to a user in providing their assessment of the data from prior experience, and "can be performed in the human mind, or by a human using a pen and paper." CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). MPEP § 2106.04(a)(2)(III) states: “As the Federal Circuit explained, ‘methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas--the ‘basic tools of scientific and technological work’ that are open to all.’’ 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)).”
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.
Claims 40-43, 45, 46, 49, 51, 52, 54-58, 61, 62, and 65 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 claim(s) 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 inventor(s), at the time the application was filed, had possession of the claimed invention. Applicant’s disclosure does not provide support for this recitation to “the aging characteristic region is in the lower left of the neutrophil population in the scattergram where side scattered optical values are less than a preset threshold.”
Claims 57-59 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 claim(s) 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 inventor(s), at the time the application was filed, had possession of the claimed invention. Applicant’s disclosure does not provide support for this recitation to “the aging characteristic region is a region of a neutrophil population region in the scattergram where side scattered optical values are less than a preset threshold.”
Claims 65 is 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 claim(s) 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 inventor(s), at the time the application was filed, had possession of the claimed invention. Applicant’s disclosure does not provide support for this recitation to “the aging characteristic region is defined as a region of the scattergram determined from simulation analysis or machine learning of position change data…”
In all three instances, Applicant’s disclosure inadequately discloses the respective “aging characteristic region.”
With regard to independent claim 40, the disclosure is absent any particular discussion to actual side scatter data and correlation and definition with respect to “lower left region of a neutrophil population region,” nor does the disclosure provide any guidance to the relatively-compared “less than a preset threshold.”
Similarly, as in independent claim 57, the disclosure is absent any particular discussion to actual side scatter data and correlation and definition with respect to “a region of a neutrophil population region,” nor does the disclosure provide any guidance to the relatively-compared “less than a preset threshold.”
Similarly, as in claim 65, the disclosure is absent any particular discussion to “simulation analysis” or “machine learning of position change…” in which the disclosure only provides the general postulation of these categorical descriptive approaches (see pars.[0095,0102,0104]).
The disclosure is absent any particular teachings to the particular steps, processes, algorithms, layers, etc…that go into such “simulation analysis” or “machine learning of position change data” to arrive at such a position of the aging characteristic region and the disclosure is limited to a highly general and prophetic mention of these categorical techniques.
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 40-43, 45, 46, 49, 51, 52, 54-58, 61, 62, and 65 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.
As seen in both of independent claims 40 and 57 (and dependents thereof), the metes and bounds of what encompasses “aging characteristic” are indefinitely defined herein each of independent claims 40, 57, and 65 (and dependents thereof), and the specification does not remedy this.
The term is not particularly defined in the specification. Examiner notes that the specification provides examples of what the term “might” mean, and additionally, Applicant’s preset values are also defined with respect to “for example” (i.e. neither element is definitively defined) (see pars. [0026-0029,0093] of Applicant’s pre-grant publication, for example). It is further noted that the specification does not set forth any particular threshold in the exemplary definitions to the aging characteristic region, nor particular definition to the recited “small side scattered light” and particular area of interest that defines the part between WBCs and ghost particle population in a scattergram.
As in claim 40, The specification does not particularly discuss or define “lower left region of a neutrophil region” and concordant side scatter values, and likewise is without particular definition or target values to the vague “lower than a preset threshold.”
This is likewise seen in independent claim 57, and as in independent claim 65 wherein, as similarly discussed above under 35 USC 112 a/1st, the specification indefinitely defines such “aging characteristic region” as it pertains to “simulation analysis or machine learning of position change data…” in which the specification merely provides general postulation thereto without any particulars in establishing the analysis or the machine learning (i.e. particular process steps, algorithms, models, layers, particular training data and the manipulation thereof to yield such models/layers).
When a term is not understood or defined properly by the specification, the plain meaning is given under BRI (broadest reasonable interpretation), however, in the context of blood samples this is extremely difficult and vague to assign. Given that the specification is highly ambiguous and as it is impractically possible to fall back on a dictionary definition of what is meant by ‘aged blood’ as seen through Applicant’s use of “aging characteristic,” the claims are indefinitely defined herein.
Further, as in cl. 40, Examiner asserts that the recitation to “wherein aging…means… have changed due to the blood sample having been stored for more than eight hours” not remedy the prior-discussed issues and the metes and bounds of what constitutes an “aging characteristic region” remain indefinitely defined. This does not define the aging characteristic region within the scattergram (i.e. particular value/range to side scattered light and/or fluorescent light to provide a particular region of interest within the scattergram that coincides with an “aging characteristic region”), nor does the specification provide clarity to the metes and bounds afforded to this recitation.
This is likewise seen in the recitation in claim 57 “wherein aging…means…” and within claim 65.
It likewise follows from that this that the dependent claims are further indefinitely defined in connection therewith, and which includes lack of particular metes and bounds with respect to the preset thresholds sought and what constitutes the particular regions of the scattergram (metes and bounds to the WBC region, what is a “small” side scatter therewith), and what particularly defines the region between the WBC population and the ghost particle population for the intended “aging characteristic region…” Clarification is required.
Examiner further asserts that the figures (including that of figure 4 which is highlighted in Applicant’s remarks on page 18 for the amended recitation to the region defining the aging characteristic region) is/are insufficient as they present a stylized, figurative depiction without any concordant data thereto wherein the figure itself is without defined X and Y-axes to ascertain quantitative data therefrom, and the proffered idea that “they can determine the aging characteristic region from the scattergram described above” is wholly unfounded and unpersuasive.
Further, with regards to independent claims 40 and 57, as amended, the determining of the aging index and characteristic coefficient by the two “determining” steps are indefinitely understood herein.
The recitations “…the characteristic aging index is used to indicate an aging time….” and “…the characteristic correction coefficient is used to indicate a correction degree…” present unclear metes and bounds to the methodology sought by way of the vague and indefinite “used” language.
Does Applicant intend that these determined index and correction coefficient are applied in a particular manner, as in the “correcting” step? If so, the active step(s) that constitute the respective “used to indicate an aging time” and “used to indicate a correction degree” need to be particularly specified.
Otherwise, does Applicant intend these recitations to be drawn to “for” recitations that are nothing more than descriptive to the index/correction coefficient?
Claim 65 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.
The metes and bounds of the claim are indefinitely defined as the “aging characteristic region is defined as…from simulation analysis or machine learning of position change data” is wholly undefined.
This is similarly discussed above in the body of the initial rejection of the claim set.
Claim 65 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.
The written description fails to disclose the algorithm(s) for performing the claimed specific determinations.
See MPEP 2181, Section II, B:
For a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function, or else the claim is indefinite under 35 U.S.C. 112(b). See Net MoneyIN, Inc. v. Verisign. Inc., 545 F.3d 1359, 1367, 88 USPQ2d 1751, 1757 (Fed. Cir. 2008). See also In re Aoyama, 656 F.3d 1293, 1297, 99 USPQ2d 1936, 1939 (Fed. Cir. 2011) (“[W]hen the disclosed structure is a computer programmed to carry out an algorithm, ‘the disclosed structure is not the general purpose computer, but rather that special purpose computer programmed to perform the disclosed algorithm.’”) (quoting WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391 (Fed. Cir. 1999)).
In cases involving a special purpose computer-implemented means-plus-function limitation, the Federal Circuit has consistently required that the structure be more than simply a general purpose computer or microprocessor and that the specification must disclose an algorithm for performing the claimed function. See, e.g., Noah Systems Inc. v. Intuit Inc., 675 F.3d 1302, 1312, 102 USPQ2d 1410, 1417 (Fed. Cir. 2012); Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239.
For a computer-implemented means-plus-function claim limitation invoking 35 U.S.C. 112(f) the Federal Circuit has stated that “a microprocessor can serve as structure for a computer-implemented function only where the claimed function is ‘coextensive’ with a microprocessor itself.” EON Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 622, 114 USPQ2d 1711, 1714 (Fed. Cir. 2015), citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1316, 97 USPQ2d 1737, 1747 (Fed. Cir. 2011). “‘It is only in the rare circumstances where any general-purpose computer without any special programming can perform the function that an algorithm need not be disclosed.’” EON Corp., 785 F.3d at 621, 114 USPQ2 at 1714, quoting Ergo Licensing, LLC v. CareFusion 303, Inc., 673 F.3d 1361, 1365, 102 USPQ2d 1122, 1125 (Fed. Cir. 2012). “‘[S]pecial programming’ includes any functionality that is not ‘coextensive’ with a microprocessor or general purpose computer.” EON Corp., 785 F.3d at 623, 114 USPQ2d at 1715 (citations omitted). “Examples of such coextensive functions are ‘receiving’ data, ‘storing’ data, and ‘processing’ data—the only three functions on which the Katz court vacated the district court’s decision and remanded for the district court to determine whether disclosure of a microprocessor was sufficient.” 785 F.3d at 622, 114 USPQ2d at 1714. Thus, “[a] microprocessor or general purpose computer lends sufficient structure only to basic functions of a microprocessor. All other computer-implemented functions require disclosure of an algorithm.” Id., 114 USPQ2d at 1714
To claim a means for performing a specific computer-implemented function and then to disclose only a general purpose computer as the structure designed to perform that function amounts to pure functional claiming. Aristocrat, 521 F.3d 1328 at 1333, 86 USPQ2d at 1239. In this instance, the structure corresponding to a 35 U.S.C. 112(f) claim limitation for a computer-implemented function must include the algorithm needed to transform the general purpose computer or microprocessor disclosed in the specification. Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239; Finisar Corp. v. DirecTV Group, Inc., 523 F.3d 1323, 1340, 86 USPQ2d 1609, 1623 (Fed. Cir. 2008); WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1349, 51 USPQ2d 1385, 1391 (Fed. Cir. 1999); Rain Computing, Inc. v. Samsung Electronics America Co., 989 F.3d 1002, 1007-8, 2021 USPQ2d 284 (Fed. Cir. 2021).
The corresponding structure is not simply a general purpose computer by itself but the special purpose computer as programmed to perform the disclosed algorithm. Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239. Thus, the specification must sufficiently disclose an algorithm to transform a general purpose microprocessor to the special purpose computer. See Aristocrat, 521 F.3d at 1338, 86 USPQ2d at 1241. (“Aristocrat was not required to produce a listing of source code or a highly detailed description of the algorithm to be used to achieve the claimed functions in order to satisfy 35 U.S.C. § 112 ¶ 6. It was required, however, to at least disclose the algorithm that transforms the general purpose microprocessor to a ‘special purpose computer programmed to perform the disclosed algorithm.’” (quoting WMS Gaming, 184 F.3d at 1349, 51 USPQ2d at 1391.)) An algorithm is defined, for example, as “a finite sequence of steps for solving a logical or mathematical problem or performing a task.” Microsoft Computer Dictionary, Microsoft Press, 5th edition, 2002. Applicant may express the algorithm in any understandable terms including as a mathematical formula, in prose, in a flow chart, or “in any other manner that provides sufficient structure.” Finisar, 523 F.3d at 1340, 86 USPQ2d at 1623; see also Intel Corp. v. VIA Techs., Inc., 319 F.3d 1357, 1366, 65 USPQ2d 1934, 1941 (Fed. Cir. 2003); In re Dossel, 115 F.3d 942, 946-47, 42 USPQ2d 1881, 1885 (Fed. Cir.1997); Typhoon Touch Inc. v. Dell Inc., 659 F.3d 1376, 1385, 100 USPQ2d 1690, 1697 (Fed. Cir. 2011); In re Aoyama, 656 F.3d at 1306, 99 USPQ2d at 1945.
Applicant’s specification is devoid of the algorithm(s) required for performing the functions as in claim 65. Examiner notes the general and prophetic discussion in pars. [0093,0095,01020104], for example.
However, no algorithm(s), models, particular process steps, layers, particular data training and model development thereof, etc…is/are defined for the recited functions in the claims, nor are the particulars of such “simulation analysis” “trained machine learning algorithm,” defined wherein the disclosure amounts to a general, prophetic discussion thereof that is drawn to categorical disclosure to field of “simulation analysis” and machine learning at large and is without any particulars to that which has been developed and found for the present application and its sought functionalities as in claim 65.
The claims go beyond a general purpose computer and are not coextensive with the computer as defined in the MPEP passages cited above. Therefore, the claims are indefinite and rejected under 35 USC 112b/2nd.
Response to Arguments
Applicant's arguments filed August 27th, 2026 have been fully considered but they are not persuasive.
With regards to claims 40-49, 51-59, and 61-64 rejected under 35 USC 101, Applicant traverses the rejection.
Initially, Examiner reasserts those remarks and discussion found in the body of the action with respect to the updated rejection of the claims under 35 USC 101 as amended.
Applicant asserts that the claims have been amended to obviate the prior-discussed issues.
Examiner asserts that the amended step of “detecting, by the processor, cell distribution information of an aging characteristic region…” remains drawn to an abstract idea as this can be done mentally as an observation of the scattergram, or a comparison of values, or even math. The added recitations to the “aging characteristic region” and its manner of determination are not particularly pertinent here (and this will be further discussed in terms of the rejections of the claims under 35 USC 112 b/2nd) and the recited steps remains drawn to an abstract idea in a mental judgment/assessment of data or math.
As in both of amended independent claims 40 and 57, this is likewise seen with the added steps of 1) determining a characteristic aging index….according to a first predetermined function relationship… and 2) 1) determining a characteristic aging index….according to a first predetermined function relationship… in which both steps are drawn to further abstract ideas themselves in a mental judgment/assessment of data or math as it pertains to the ‘first/second predetermined function relationship.’
Lastly, the added step of “Correcting the cell parameter…” is also drawn to a further abstract idea as this amounts to a mental judgement/assessment of the data or a mathematical application with the data.
The step of “outputting, by a display device, a detection result…” is pertinent to Step 2A, Prong 2, wherein such outputting according to the cell distribution information and the aging time or aging degree is drawn to insignificant extra solution activity, wherein the claimed “outputting a detection result…comprises correcting…” is drawn to mere data outputting and does not afford a practical application to the abstract ideas at-hand. And likewise seen in dependent cl. 41 that is likewise drawn to extra-solution activity and does not afford a practical application to the abstract ideas at-hand.
Applicant’s further discussion to various sections of the specification as providing support for the amendments is noted, however, the issues at-hand are drawn to 35 USC 101 and with respect to Step 2A, Prong 1 (the abstract idea(s)), Step 2A, Prong 2 (abstract idea integrated into a practical application), and Step 2B (Significantly more than the abstract idea) in which the purported support for the presented amendments herein is not pertinent to this end.
Further discussion is provided below as it pertains to well as inadequate description in the disclosure and the lack of clarity and unclear metes and bounds to various recitations of the claims under both of 35 USC 112 a/1st and 35 USC 112 b/2nd.
To the extent the cited portions attempt to set forth a “practical application” of the abstract idea(s) under Step 2A, Prong 2 it is noted that in all portions discussed therewith the offered “practical application” is drawn to the abstract idea(s) themselves and is not a technical improvement as outlined in MPEP 2106.04(a), 2106.05(a) paragraphs 4-7.
The offered “improvement” in more accurate data to the cell parameter is drawn to an improvement that is the abstract ideas themselves.
With respect to Step 2A, Prong 1 and Step 2B Examiner does not see particular discussions therewith.
To this end, Examiner refers Applicant the prior discussion on the record and that found above wherein the claims remain to recite a number of abstract ideas and wherein the remaining portions of the claim and in an ordered combination with the dependent claims does not provide to recite significantly more than the abstract ideas at-hand.
With regards to claims 40-49, 51-59, 61, and 62 under 35 USC 112a/1st, and 35 USC 112 b/2nd, Applicant traverses the rejections.
Examiner acknowledges Applicant’s showings on pages 23-27.
Examiner maintains the rejections for likewise reasons as discussed previously and above in the body of the action.
None of the offered disclosure provides adequate disclosure to the cited elements.
What is offered is general and prophetic discussion thereto.
For example, “Based on the applicant’s creative efforts, it has been found through research and analysis that the cell distribution of a specific region in the scattergram correlates with the aging of samples.”
This does not particularly define what this “specific region” is, nor does it provide the particular correlation as it relates to “aging of samples.”
The subsequent discussion is similarly prophetic and without particulars thereto. Discussion of various circles drawn on diagrammatic illustration of fig. 4 and the discussion to “the aging characteristic region is a region determined on a white blood cell particular population region in the scattergram” provides inadequate disclosure to the “aging characteristic region” as claimed as well as with respect to the added recitations to the first/second predetermined function relationship utilized therewith for the recited “characteristic correction coefficients.”
Examiner asserts that “the aging characteristic region is a region determined on a white blood cell particular population region in the scattergram” remains to both be unsupported/inadequately disclosed and without clear metes and bounds (35 USC 112 a/1st, 35 USC 112 b/2nd, respectively).
The added amendment to “is a region determined based on a white blood cell particle population region in the scattergram…” is drawn to a recitation that speaks to a manner in which the “aging characteristic region” is determined and does not itself particularly define the “aging characteristic region.”
Further, the specification is without adequate disclosure and particular discussion to what this “aging characteristic region” is in terms of the white blood cell population “in which a portion of white blood cell particles related to an aging of the blood sample appears as the blood sample ages over time.”
Discussion in pars.[0105-0109] are inadequate and do not particularly define the various named “regions.” The discussion is general and prophetic and without particular bounds thereto and particular values/ranges thereof to side scatter values and forward scatter values that define such sought region.
The discussion is predicated on vague and relative terms not particularly defined (“small signal values,” “smaller than a preset threshold,” “close to a ghost particle population,” “at least a part of a region between the white blood cell particle population and the ghost particle population.”).
The specification does not offer any particular values to these elements in defining clear metes and bounds as to the claimed “aging characteristic region.”
Applicant’s showings of the diagrammatic depictions in figures 4 and 5 (i.e. they are without particular values to the axes, and the specification does not provide particular experimental data therefrom) are nothing more than conjecture and do not offer any particular or definitive support.
It follows, that the designation to various circles in the figures does not afford adequate and clear support to the recited “aging characteristic region” as claimed.
The specification does not particularly discuss what defines “an edge region of the white blood cell particle population in the scattergram…” (cls. 54,55)
This is likewise seen with respect to cl. 65. Examiner has previously reviewed par.[0104] as seen in the prior Office Action, and the disclosure therein is generalized and prophetic without any particulars to the position of the aging characteristic region being determined by “simulation analysis” and “machine learning.”
This is likewise maintained with respect to claim 65 and its rejection under 35 USC 112 b/2nd paragraph in which the disclosure does not make clear the corresponding algorithm(s), equations, etc…that provide for ascertain such a position of the aging characteristic region by way of “simulation analysis” or “machine learning.”
Examiner further notes the added rejection under 35 USC 112 b/2nd paragraph with respect to independent claims 40 and 57 with respect to the “usage” of the determined aging index and correction coefficient as particularly discussed above in the body of the action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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/NEIL N TURK/ Primary Examiner, Art Unit 1798
