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 February 3rd, 2026. Claims 40-49, 51-59, 61, 62, and 65 are pending. Claims 1-39, 50, and 60 are canceled.
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 40-49, 51-59, 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. 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, as amended, the 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.
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)).”
Examiner further directs Applicant to the discussion within the “Response to Arguments” section.
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 40-49, 51-56, 61, and 62 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 independent claim 57, 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 an aging characteristic region and the disclosure is limited to a highly general and prophetic mention of these categorical techniques. Nor is there discussion as to what constitutes “position change data” with respect to cell particle populations in scattergrams during the process from “normal” to “aging.”
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 40-49, 51-59, 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.
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.
With regard to claim 77, the recitation to determination of one/both elements by “a trained machine learning algorithm” is indefinitely defined herein.
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 77.
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.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 40-42, 44, 45, and 52-59, 61, 62, and 65 as best understood, is/are rejected under 35 U.S.C. 102a1 as being anticipated by Suzuki et al. (US 2018/0024148), hereafter Suzuki, and evidenced through Sakata et al. (USPN 5,264,369).
Suzuki discloses a blood analyzer and blood analyzing method (abstract). With regards to claims 40, 57, and 65, Suzuki discloses application by a flow cytometer system including the optical/electrical architecture as in cl. 56 to at least one reaction chamber 34 as claimed, an optical detection device 102/103/104/105 (source and three photodetectors for the three optical signals of forward, side, and fluorescence; and providing that as recited in cls. 52&53) as claimed (pars.[0081-0088], figs. 1&2; evidence by Sakata provides discussion to the known nature of the sheath flow for providing cells one by one through the orifice, lines 42-48, col. 13, figs. 1&2)) a delivery device as claimed (i.e. the source that provides a flow to the flow path from the sample preparation unit to the flow cytometric system including the flow cell (par.[0085]), and a processor 43/21/22 configured as claimed (pars.[0049,0050,0073,0074,0148,0175,0180], figs. 1&2). Further, with respect to claims 40 and 56, the methodology of claim 40 and likewise as seen with the configuration to the processor of claim 57 is seen as Suzuki discloses such optical interrogation and detection thereof to form a scattergram including forward-scattered light signals, side-scattered light signals, and fluorescence signals, and discloses assessing cell apoptosis (cell death) and outputting a detection result according to the cell distribution information (Suzuki provides for both counting of cells and their cell type according to ‘cell distribution information’ in the characteristic regions to be relatively assessed and outputting a detection result with respect to a cell parameter as in determining whether or not infection with Plasmodium (i.e. malaria-infected) has occurred in the cell(s); see as in the assessment from fig. 14A-14B; see also par.[0168,0181], and wherein the “aging characteristic region” (and given as a region that is at least a part of a region in the scattergram where the side scattered light values are smaller than a preset threshold in as much as claimed and understood herein) is given by the region in the area of regions 203-204 of fig. 14B that are separated and deviated from the upper area of 201 as previously seen in the “before apoptosis is induced” in fig.14A [and likewise seen with respect to claim 61 and 62 wherein the cited “aging characteristic region” in Suzuki constitutes the “aging characteristic region” as best understood and in as much as required herein] (pars.[0123,0125,0148,0175,0180], figs. 7A/B, 8A-D, 9A-B, 14A/B, for example). Further, with regard to the recitation in claims 40 and 57 to “outputting a detection result…comprises correcting…” Suzuki provides that in the determination result from the scattergram to malaria infection, the controller further determines whether or not the coefficient of variation calculated is less than the prescribed threshold for a given cell/cell distribution information, wherein Suzuki provides that when the coefficient of variation is less than the prescribed threshold (e.g. 10%), the controller determines that the blood is “malaria-positive”; and when the coefficient of variation is greater than or equal to the coefficient of variation, the controller outputs “malaria-positive? scatter is abnormal.” Suzuki provides an initial determination of malaria infection by the controller (i.e. given the presence of the cell distribution information being within the aging characteristic region 204-205) that is corrected by way of the coefficient of variation analysis in order to avoid false positives and provide an outputted result of the cell parameter (infection with malaria or not) with a degree of reliability thereto (pars.[0122,0123,0131,0135,0138,0142-0145,0152-0154,0186]).
With regards to claims 41, 42, 45, 58, 59, Suzuki discloses judging as an aged sample according to cell distribution information with respect to a number of cells being greater than a first preset threshold (pars.[0135,0192], for example). With regards to claims 44, Suzuki’s determination of apoptosis in accordance with the cell distribution information as analyzed across figs. 14A/B and outputting a result that the cells are apoptotic constitutes a determination of an aging degree in as much as recited in claim 44, as it is determined that the cells are dead, which is a degree of aging. With regards to claims 54 and 55, Suzuki discloses that the aging characteristic region is at least part of a region in the scattergram where the side scattered light values are smaller than a preset threshold (noting that the threshold is completely open-ended herein), and at least a region with a small side scattered light values in the white blood cell particle population region in the scattergram (noting that “small” side scattered values in the WBC is indefinitely defined herein) (figs. 14A/B, for example and accompanying disclosure). With regard to claim 63, Examiner asserts that “the position…or the relative position of the aging characteristic region” exists to described above in Suzuki in as much as required and understood herein, wherein it is noted that such recitation has no particular bearing on the presently recited active steps of the method and purported back-end data processing utilized to assign a “position” of such region is drawn an intended use application to the data that is not afforded patentable weight. With regard to claim 64, in as much as recited and understood herein, the aging characteristic region of Suzuki is likewise said to be “located in the lower left…wherein the abscissa…and the ordinate…”.
Response to Arguments
Applicant's arguments filed February 3rd, 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 provide that the method is performed by a flow cytometer and its recited component parts that go beyond a general purpose computer.
Herein, there is no such comparison being previously made with respect to a general purpose and these presented architectural elements of a flow cytometer.
Additionally, as discussed above, these architectural elements of a flow cytometer as recited herein represent routine and conventional elements in the field of art, and their application does not amount to significantly more than the abstract idea as they are related to the “data gathering” of the methodology (and likewise with the apparatuses of cls. 57 and 65).
Applicant further asserts that one cannot generate a scattergram and detecting cell distribution information of an aging characteristic region through mental steps, and the generation of the scattergram relied upon the coordinated function of hardware components as in the photoelectric sensors, processor and memory.
As discussed above, these elements are drawn to routine and conventional infrastructure in flow cytometer for data gathering as recited in the claim to such optical signal values.
The physical infrastructure recited that is utilized for such data gathering does not preclude the scattergram itself from being drawn to an abstract idea as in a mental process and/or math.
The generating a scattergram is considered an abstract idea as it is still a mental process and/or math. Additionally, although it may take some time, it is not impossible to generate an array with pencil and paper.
Thus, the generating of a scattergram is still an abstract idea in the form of mental processes.
Examiner further asserts that a number of permutations appears immaterial to obviating a rejection under 35 USC 101 as seen through MPEP 2106.04 (a) (2) III.
Herein, it can be seen that crux of the issue is that the generating of a scattergram is drawn to something that can be accomplished through mental steps.
The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016) (holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper"). Mental processes performed by humans with the assistance of physical aids such as pens or paper are explained further below with respect to point B
Nor do the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for "anonymous loan shopping" was an abstract idea because it could be "performed by humans without a computer").
Further, mental processes recited in claims that require computers are explained further below with respect to point C (within MPEP 2106.04 (a) (2) III)
Examiner further notes then the next step of the claims to detecting cell distribution information of an aging characteristic region in the scattergram when values are less than a threshold is something that could be done mentally as an observation of the scattergram, or a comparison of values, or even math, and still remains an abstract idea.
Lastly, in the last paragraph of the claims there is provided the process of “correcting” a parameter based on the cell distribution, where this is math as discussed in the specification.
This is of particular interest as it appears that this “correcting” step is the crux of the invention, and this step itself is an abstract idea.
Applicant does not argue that the detecting step or the correcting step are not abstract ideas, and once those abstract ideas are performed then there is no integration as merely displaying the result is insignificant extra-solution (post-solution) activity.
Applicant further asserts that the correction of the cell parameter is an improvement in the field of flow cytometry as it eliminates the influence of long-term storage (more than eight hours).
Examiner asserts that in step 2A Prong Two, as required in MPEP 2106.04(d)(1) and 2106.05(a)II, we evaluate any potential improvements in technology.
However, herein Applicant is applying a conventional flow cytometer system and the improvement lies within the correction process as a data processing step, which itself is an abstract idea.
This argument is not persuasive because in order to overcome the 101 rejection, the improvement cannot be the abstract idea but must be in a particular technology (See paragraphs 4-7 of MPEP 2106.05(a)).
With regards to claims 40-49, 51-59, 61, and 62 rejected under 35 USC 112 b/2nd paragraph, Applicant traverses the rejection.
Examiner refers Applicant to the above particular discussion to the rejection of claims 40-49, 51-59, 61-62, and 65 under 35 USC 112 b/2nd paragraph.
Among other items discussed therein, it is shown that the cited “lower left region” and (similar region as provided in independent cl. 57) is indefinitely defined and not remedied by the disclosure.
Further, 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.
Lastly, Applicant’s discussion to the “simulation analysis” and/or “machine learning…” is wholly undefined and not remedied by the disclosure, wherein the disclosure offers generalized and postulated application therewith.
With regards to claims 40-42, 44, 45, 52-59, 61, and 62 rejected under 35 USC 102a1 as being anticipated by Suzuki, Applicant traverses the rejection.
Applicant asserts that Suzuki neither discloses nor teaches the aging characteristic region as defined in the claims (i.e. lower left region of a neutrophil population region…as in cl. 40).
Applicant’s argument that the scattergram in Suzuki at fig. 14B is different from that of Applicant’s claim is unpersuasive as Suzuki’s fig. 14b has not been particularly and solely relied upon for the recitations of claim 40.
As commensurately claimed, Suzuki provides for the claimed “treating…” , “irradiating…”, “acquiring…”, “detecting…”, and “outputting…” as best understood herein.
As discussed above, the recitation to the “detecting cel distribution information of an aging characteristic region…” is indefinitely defined as the “aging characteristic region” is indefinitely defined. To this end, and as discussed below, Suzuki commensurately provides for such detecting concordant with an “aging characteristic region” in as much as required and understood herein.
Suzuki discloses such optical interrogation and detection thereof to form a scattergram including forward-scattered light signals, side-scattered light signals, and fluorescence signals, and discloses assessing cell apoptosis (cell death) and outputting a detection result according to the cell distribution information (Suzuki provides for both counting of cells and their cell type according to ‘cell distribution information’ in the characteristic regions to be relatively assessed and outputting a detection result with respect to a cell parameter as in determining whether or not infection with Plasmodium (i.e. malaria-infected) has occurred in the cell(s); see as in the assessment from fig. 14A-14B; see also par.[0168,0181], and wherein the “aging characteristic region” (and given as a region that is at least a part of a region in the scattergram where the side scattered light values are smaller than a preset threshold in as much as claimed and understood herein) is given by the region in the area of regions 203-204 of fig. 14B that are separated and deviated from the upper area of 201 as previously seen in the “before apoptosis is induced” in fig.14A [and likewise seen with respect to claim 61 and 62 wherein the cited “aging characteristic region” in Suzuki constitutes the “aging characteristic region” as best understood and in as much as required herein] (pars.[0123,0125,0148,0175,0180], figs. 7A/B, 8A-D, 9A-B, 14A/B, for example).
Applicant asserts that Suzuki neither discloses nor teaches that region 203 or 204 can be used to judge whether the blood sample has been stored for more than eight hours after the blood sample is collected as fresh.
Examiner asserts that Applicant’s arguments are not commensurate in scope with the claims.
The claimed methodology does not provide a temporal analysis involving an initial marking/measurement at a time 0 when a fresh sample is collected and ascertaining when that sample has been stored for more than eight hours from a scattergram.
Further, with regard to the recitation in claims 40 and 57 to “outputting a detection result…comprises correcting…” Suzuki provides that in the determination result from the scattergram to malaria infection, the controller further determines whether or not the coefficient of variation calculated is less than the prescribed threshold for a given cell/cell distribution information, wherein Suzuki provides that when the coefficient of variation is less than the prescribed threshold (e.g. 10%), the controller determines that the blood is “malaria-positive”; and when the coefficient of variation is greater than or equal to the coefficient of variation, the controller outputs “malaria-positive? scatter is abnormal.” Suzuki provides an initial determination of malaria infection by the controller (i.e. given the presence of the cell distribution information being within the aging characteristic region 204-205) that is corrected by way of the coefficient of variation analysis in order to avoid false positives and provide an outputted result of the cell parameter (infection with malaria or not) with a degree of reliability thereto (pars.[0122,0123,0131,0135,0138,0142-0145,0152-0154,0186]).
Examiner further asserts that apoptic bodies fully corresponds with an aging blood sample in as much as recited and required herein wherein apoptic bodies refer to cell death that is clearly connected to aging.
Likewise, as discussed above, such region in Suzuki is coincident with the “aging characteristic region” in as much as recited and understood herein, and likewise with respect to being in a region where the side scattered light values are smaller than a preset threshold in as much as recited and understood herein wherein, as discussed above, the metes and bounds of this region including this amended provision are indefinitely defined.
The remaining dependent claims are maintained as rejected with respect to Suzuki for the reasons discussed above in the body of the action as there are no such deficiencies with respect to Suzuki in independent claims 40 and 57.
Newly-added claim 65 is rejected as likewise discussed with respect to independent claim 57. Examiner further notes that the claims are drawn to a device and there are no active steps, processes, algorithms required with respect to the “simulation analysis” or “machine learning…” wherein such recitations are a product of describing the aging characteristic region.
Further, with respect to independent claims 57 and 65 (and dependents thereof), it is seen that Suzuki utilizes a flow cytometer system (pars.[0081-0088], fig. 1). Evidentiary reference to Sakata is provided with respect to the delivery by the sheath one-by-one through the orifice (and further noting such step is only required by the method of independent cl. 40, as claims 57 and 65 are drawn to an apparatus with a delivery device for such a functionality).
As such claims 40-42, 44, 45, 52-59, 61, and 62 are maintained rejected for the reasons discussed above and those provided in the body of the action.
Conclusion
THIS ACTION IS MADE FINAL. 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 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