DETAILED CORRESPONDENCE
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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/9/23, 1/10/24, 8/22/24, 1/24/25 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Status
Claims 1-6 are pending.
Drawing Objections
The drawings are objected to as failing to comply with 37 CFR 1.84(l) & (p) because the lines are not clear, clean, or well-defined, and because the characters are not of sufficient size or clarity to be distinct. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Claim Objection
Claim 2 is objected to because it includes a comma and a period at the end, where the comma should be deleted.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: the following recitations in claim 1:
“an analysis result input receiving unit configured to receive inputs…and store”
“a culture condition designation input receiving unit configured to receive input”
“a correlation evaluation unit configured to read out…and evaluate”
“correlation item presentation unit configured to display, on the display unit”
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The instant specification in [16] and Figure 1 denotes each of the “analysis result input receiving unit”, “culture condition designation input receiving unit”, “correlation evaluation unit”, and “correlation item presentation unit” as parts of a computer program. Therefore, for purposes of examination, and in accordance with 35 USC 112(f), each of the units will be interpreted as part of a general-purpose computer/processor/controller that performs the recited functions.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is rejected based on the following analysis-
Step 2A, Prong One: Identify the law of nature/natural phenomenon/abstract ideas.
Claim 1 recites the abstract ideas of “configured to receive input of designation” which is broadly being interpreted as a mental step of designation/making a choice; and “configured to read out measured values…under the designated culture condition…and evaluate a magnitude of correlation…” where these are abstract ideas of observing/evaluating and are mental processes and/or math (see [33-35] and Figure 3 where this process can be undertaken by pencil and paper or a general-purpose computer). MPEP 2106.04(a)(2)III is clear that using a computer/controller to perform the abstract idea does not preclude the steps from being considered an abstract idea.
Step 2A Prong Two: Has the abstract idea been integrated into a particular practical application?
No. After the evaluation/correlation then the evaluation result is displayed. However, just displaying the information ascertained by the abstract idea does not integrate the exception into a practical application because merely displaying is insignificant post-solution activity and not a particular practical application, similar to the alarm in Parker v. Flook. See MPEP 2106.04(d) and 2106.05(g). Additionally, that the displayed information is “based on” the evaluation result is amounts to just “apply it” and generally applying the abstract idea is not a particular practical application. See MPEP 2106.05(f).
The receiving inputs and storing of culture conditions (by the input receiving unit) associated with measured values is just insignificant extra-solution (pre-solution) activity and not a particular practical application. Receiving/storing the information could also be data gathering that is then used in the abstract idea, and data gathering to be used in the abstract idea is not a particular practical application. See MPEP 2106.05(g). Additionally, receiving and storing various information is recited at such a high level of generality that it amounts to just generally linking the abstract idea to a field of use per MPEP 2106.05(h), which is not a particular practical application. Although the receiving input of a designation is interpreted as an abstract idea, see above. If it is not, then the limitation would not result in a particular practical application for the same reasons previously discussed.
Step 2B: Does the claim recite any elements which are significantly more than the abstract idea?
The claim recites the additional elements of a display and storage unit to store culture conditions and measured values. These additional elements do not amount to significantly more as they are well-understood, routine, and conventional (WURC) in the art as evidenced by Nagoya (Translation of JP2012175946; hereinafter “Nagoya”) or Furata (Translation of WO2018193612; hereinafter “Furata”). Nagoya teaches a cell analysis device with a display and storage unit for storing measurement values and culture conditions (Nagoya; [24, 26, 32-44], Fig. 1). Furata teaches a cell analysis device with a display unit and a storage unit for storing culture conditions and measurement values (Furata; #200, [9, 18, 39, 40, 51], Fig. 2).
The dependent claims would undergo a similar analysis and do not appear to resolve any of the above issues and are therefore similarly rejected. Claim 2 is just receiving inputs and storing of culture conditions (by the input receiving unit) which is insignificant extra solution activity and generally linking the abstract idea to a field of use under step 2A prong 2. Claim 3 recites extracting information which is an abstract idea under step 2A prong 1, and also recites displaying which is insignificant extra solution activity under step 2A prong 2. Claims 4 and 5 are displaying a scattergram or a line/curve, where creating a scattergram would be considered an abstract idea as it is still a mental process and/or math, and approximating a correlation is an abstract idea as a mental process and/or math. Additionally, although it may take some time, it is not impossible to generate a scattergram or approximate a line/curve with pencil and paper and/or via a general-purpose computer (i.e. correlation item presentation unit- see 112(f) interpretation). Thus, the generating a scattergram or an approximation line/curve is still an abstract idea in the form of mental processes and MPEP 2106.04(a)(2)III is clear that using a computer/controller to perform the abstract idea does not preclude the steps from being considered an abstract idea. Additionally, even if this concept was not considered abstract then it would be considered just generally displaying which is insignificant extra solution activity under step 2A prong 2. Claim 6 recites that the culture condition designation input receiving unit (i.e. part of a computer per 112(f) interpretation above) reads out, displays and receives input where these processes do not integrate and have been discussed above as insignificant extra solution activity and generally linking the abstract idea to a field of use under step 2A prong 2.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6 are rejected under 35 U.S.C. 102a1 as being anticipated by Nagoya (Translation of JP2012175946; hereinafter “Nagoya”).
As to claim 1, Nagoya teaches a cell analysis device (Nagoya; [24], Fig. 1) comprising: a display unit (Nagoya; [24, 26, 43-44]); a storage unit (Nagoya; [24, 26]); an analysis result input receiving unit configured to receive inputs of a plurality of culture conditions and measured values of a plurality of items obtained by analyzing a cell cultured under each of the plurality of culture conditions with a predetermined analyzer, and store the measured values in the storage unit associating the measured values of the plurality of items with a corresponding one of the plurality of culture conditions; a culture condition designation input receiving unit configured to receive input of designation of some or all of the plurality of culture conditions; a correlation evaluation unit configured to read out measured values of a plurality of items on the cell cultured under the designated culture condition from the storage unit, and evaluate a magnitude of correlation between the measured values of two items by a predetermined method for each of all combinations of two of the plurality of items; and a correlation item presentation unit configured to display, on the display unit, a predetermined number of combinations extracted from among all the combinations based on an evaluation result by the correlation evaluation unit (Nagoya teaches a computer with various programs; Fig. 1, [24, 26]. Nagoya teaches comparing conditions such as cell type, time, and culture medium to measurement values related to morphology and also cell #/ratio; [31-45]. Nagoya teaches that a correlation is determined between the various measurement values, where a magnitude of the correlation is determined; [32-44]. The information is output to a display for a user; [24, 26, 43-44]).
As to claim 2, Nagoya teaches the cell analysis device according to claim 1, wherein the analysis result input receiving unit is further configured to receive input of image data of the cell cultured under each of the plurality of culture conditions, and store the image data in the storage unit associating the image data for each culture condition (Nagoya teaches photograph images; [26]).
As to claim 3, Nagoya teaches the cell analysis device according to claim 1, wherein when the culture condition designation input receiving unit receives input of designation of a plurality of culture conditions, the correlation item presentation unit is configured to extract the predetermined number of combinations individually for each of the plurality of culture conditions and display the result on the display unit (Nagoya teaches comparing conditions such as cell type, time, and culture medium to measurement values related to morphology and also cell #/ratio; [31-45]. Nagoya teaches that a correlation is determined between the various measurement values, where a magnitude of the correlation is determined; [32-44]).
As to claim 4, Nagoya teaches the cell analysis device according to claim 1, wherein the correlation item presentation unit is further configured to display a scatter diagram of the measured values on the display unit for the predetermined number of combinations (Nagoya teaches a graph; [22, 28, 39], Fig. 7-8).
As to claim 5, Nagoya teaches the cell analysis device according to claim 4, wherein the correlation item presentation unit is further configured to display an approximate straight line or an approximate curve representing the correlation between the measured values of two items on the scatter diagram (Nagoya teaches determining correlation coefficients which would represent a curve/line of correlation; [32-44]. Nagoya teaches a graph; [22, 28, 39], Fig. 7-8).
As to claim 6, Nagoya teaches the cell analysis device according to claim 1, wherein the culture condition designation input receiving unit is configured to read out the culture condition stored in the storage unit, display the read-out culture condition on the display unit, and receive input of selection of the culture condition displayed on the display unit (Nagoya teaches comparing conditions such as cell type, time, and culture medium to measurement values related to morphology and also cell #/ratio; [31-45]. Nagoya teaches that a correlation is determined between the various measurement values, where a magnitude of the correlation is determined; [32-44]. The information is output to a display for a user; [24, 26, 43-44]).
Claims 1-6 are rejected under 35 U.S.C. 102a2 as being anticipated by Hegarty et al (US 20230068250; hereinafter “Hegarty”).
As to claim 1, Hegarty teaches a cell analysis device (Hegarty; [16]) comprising: a display unit (Hegarty; [16]); a storage unit (Hegarty; [16]); an analysis result input receiving unit configured to receive inputs of a plurality of culture conditions and measured values of a plurality of items obtained by analyzing a cell cultured under each of the plurality of culture conditions with a predetermined analyzer, and store the measured values in the storage unit associating the measured values of the plurality of items with a corresponding one of the plurality of culture conditions; a culture condition designation input receiving unit configured to receive input of designation of some or all of the plurality of culture conditions; a correlation evaluation unit configured to read out measured values of a plurality of items on the cell cultured under the designated culture condition from the storage unit, and evaluate a magnitude of correlation between the measured values of two items by a predetermined method for each of all combinations of two of the plurality of items; and a correlation item presentation unit configured to display, on the display unit, a predetermined number of combinations extracted from among all the combinations based on an evaluation result by the correlation evaluation unit (Hegarty teaches a computer with a processor that performs various functions; [16]. Hegarty teaches cellular conditions of pH, oxygen, nutrients/media, and also measurement values of cell status such as healthy or infected, where the status is associated and correlated with the condition; [17]. Hegarty teaches various correlations, and specifically teaches a pre-correlation in which various conditions are used to train a database which uses various regressions to develop a pattern recognition that correlates the conditions with the measured values; [41-51]. Hegarty teaches that PCA analysis can help differentiate which culture conditions affect cells and then plats the variance on a scatterplot; [74]. Hegarty also develops best fit via linear discriminant analysis; [41]. Hegarty teaches displaying the results; [16, 46, 74]).
As to claim 2, Hegarty teaches the cell analysis device according to claim 1, wherein the analysis result input receiving unit is further configured to receive input of image data of the cell cultured under each of the plurality of culture conditions, and store the image data in the storage unit associating the image data for each culture condition (Hegarty teaches IR spectra images; [8-10]).
As to claim 3, Hegarty teaches the cell analysis device according to claim 1, wherein when the culture condition designation input receiving unit receives input of designation of a plurality of culture conditions, the correlation item presentation unit is configured to extract the predetermined number of combinations individually for each of the plurality of culture conditions and display the result on the display unit (Hegarty teaches cellular conditions of pH, oxygen, nutrients/media, and also measurement values of cell status such as healthy or infected, where the status is associated and correlated with the condition; [17]. Hegarty teaches various correlations, and specifically teaches a pre-correlation in which various conditions are used to train a database which uses various regressions to develop a pattern recognition that correlates the conditions with the measured values; [41-51]. Hegarty teaches that PCA analysis can help differentiate which culture conditions affect cells and then plats the variance on a scatterplot; [74]. Hegarty also develops best fit via linear discriminant analysis; [41]. Hegarty teaches displaying the results; [16, 46, 74]).
As to claim 4, Hegarty teaches the cell analysis device according to claim 1, wherein the correlation item presentation unit is further configured to display a scatter diagram of the measured values on the display unit for the predetermined number of combinations Hegarty teaches various correlations, and specifically teaches a pre-correlation in which various conditions are used to train a database which uses various regressions to develop a pattern recognition that correlates the conditions with the measured values; [41-51]. Hegarty teaches that PCA analysis can help differentiate which culture conditions affect cells and then plats the variance on a scatterplot; [74], Fig. 4, 9, 12. Hegarty also develops best fit via linear discriminant analysis; [41]).
As to claim 5, Hegarty teaches the cell analysis device according to claim 4, wherein the correlation item presentation unit is further configured to display an approximate straight line or an approximate curve representing the correlation between the measured values of two items on the scatter diagram Hegarty teaches various correlations, and specifically teaches a pre-correlation in which various conditions are used to train a database which uses various regressions to develop a pattern recognition that correlates the conditions with the measured values; [41-51]. Hegarty teaches that PCA analysis can help differentiate which culture conditions affect cells and then plats the variance on a scatterplot; [74], Fig. 4, 9, 12. Hegarty also develops best fit via linear discriminant analysis; [41]).
As to claim 6, Hegarty teaches the cell analysis device according to claim 1, wherein the culture condition designation input receiving unit is configured to read out the culture condition stored in the storage unit, display the read-out culture condition on the display unit, and receive input of selection of the culture condition displayed on the display unit (Hegarty; [16, 46, 74]).
Claim 1 is rejected under 35 U.S.C. 102a2 as being anticipated by Li et al (US 20210301245; hereinafter “Li”).
As to claim 1, Li teaches a cell analysis device (Li; Fig. 1) comprising: a display unit; a storage unit; an analysis result input receiving unit configured to receive inputs of a plurality of culture conditions and measured values of a plurality of items obtained by analyzing a cell cultured under each of the plurality of culture conditions with a predetermined analyzer, and store the measured values in the storage unit associating the measured values of the plurality of items with a corresponding one of the plurality of culture conditions; a culture condition designation input receiving unit configured to receive input of designation of some or all of the plurality of culture conditions; a correlation evaluation unit configured to read out measured values of a plurality of items on the cell cultured under the designated culture condition from the storage unit, and evaluate a magnitude of correlation between the measured values of two items by a predetermined method for each of all combinations of two of the plurality of items; and a correlation item presentation unit configured to display, on the display unit, a predetermined number of combinations extracted from among all the combinations based on an evaluation result by the correlation evaluation unit (Li teaches a system that includes a computer that can store and display data; [85], Fig. 1. Li teaches that the computer performs various operations including determining a correlation of cell conditions such as medium to a number of cells or cell morphology; [55, 36]).
Claim 1 is rejected under 35 U.S.C. 102a1/a2 as being anticipated by Furata (Translation of WO2018193612; hereinafter “Furata”).
As to claim 1, Furata teaches a cell analysis device (Furata; #10, [9], Fig. 2)comprising: a display unit (Furata; #30, Fig. 2, [9]); a storage unit (Furata; #200, [18], Fig. 2); an analysis result input receiving unit configured to receive inputs of a plurality of culture conditions and measured values of a plurality of items obtained by analyzing a cell cultured under each of the plurality of culture conditions with a predetermined analyzer, and store the measured values in the storage unit associating the measured values of the plurality of items with a corresponding one of the plurality of culture conditions; a culture condition designation input receiving unit configured to receive input of designation of some or all of the plurality of culture conditions; a correlation evaluation unit configured to read out measured values of a plurality of items on the cell cultured under the designated culture condition from the storage unit, and evaluate a magnitude of correlation between the measured values of two items by a predetermined method for each of all combinations of two of the plurality of items; and a correlation item presentation unit configured to display, on the display unit, a predetermined number of combinations extracted from among all the combinations based on an evaluation result by the correlation evaluation unit (Furata teaches an analysis system with a computer that includes various correlation programs; [18, 19], Fig. 2. Furata teaches a user inputting various comparison features; [24]. Furata teaches cells are cultured with various conditions and stimulus where measurement values such as differentiation, morphology and number are each associated with the conditions; [17]. Furata calculates various measurements over time [21] and compares/evaluates different cells and stimulus/conditions [24, 40, 36] where the comparison/evaluation results in a correlation of the measured values with the various stimulus/conditions [25, 49, 54-57]. Furata teaches that the magnitudes can be compared [49] and the results are output [30, 51]; Fig. 4, 7. Furata teaches a graphical lasso method; [51]).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Xu (EP2450698; hereinafter “Xu”) teaches cell index with correlations of the number of cells and morphology to various conditions.
Conclusion
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/Benjamin R Whatley/Primary Examiner, Art Unit 1798