CTNF 17/906,236 CTNF 90675 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. DETAILED ACTION 12-151 AIA 26-51 12-51 Status of Claims The present Office Action is pursuant to Applicant’s communication on 09-13-2022 ; current application filed on 09-13-2022 . This application is a 371 of PCT/JP2021/012074 03/23/2021. This application claims foreign priority to JAPAN JP2020-062166 03/31/2020. Information Disclosure Statement The information disclosure statement(s) (IDS) filed on 09-13-2022, 02-05-2026 , have been acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Patentability Summary Independent claim(s) 1, 10, 11, 12 and dependent claim(s) 2-9 is/are directed to a technical solution to a technical problem associated with calculating fluorescence intensities od one or more fluorescent beams emitted from one or more fluorescent dyes and a biological sample using an a least squares method and an autofluorescence spectrum of the biological sample. Thus, based on the aforementioned summary, the combination of limitations corresponding to the aforementioned claim(s) is/are patent eligible . Software per se Claim ( s ) 11 is/are rejected under 35 U.S.C. § 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claims 11 is/are held to encompass a computer program per se . Regarding claims 11 , claim(s) 11 is/are directed to a program. Accordingly, that aforementioned claim(s) is directed to software or computer program code to perform a function.” Thus, claim(s) 11 is/are software, making the claim encompass a computer program per se. 07-30-03-h AIA Claim Interpretation 07-30-03 AIA 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. 07-30-05 Claim(s) 1-9 and 12 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. 07-30-06 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) include the following claim and respective element limitations Claim 1 elements: “separation unit…”; [“control unit 11” : constituted by, for example, a terminal device such a personal computer , ¶59 ] Claim 12: “detection unit …”; [“12” : corresponds to, for example, the flow cytometer , ¶60 ] 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. 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 § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim (s) 1-6, 8 and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sekino (US 9,128,055) in view of Nitta (US 9,068,946) . Regarding claim(s) 1, 10, 11, Sekino An information processing device, An information processing method, A program for causing a computer comprising a separation unit that calculates, from a fluorescence signal measured from a biological sample labeled with one or more fluorescent dyes, fluorescence intensities of one or more fluorescent beams and an autofluorescent beam emitted from the one or more fluorescent dyes and the biological sample, respectively, by an arithmetic operation using a least squares method using a fluorescence spectrum reference of each of the fluorescent dyes and an autofluorescence spectrum of the biological sample (i.e., employing a weighted least squares formula in calculating ) , [21:26-39] Regarding [b], Sekino does not explicitly disclose as disclosed by Nitta : wherein in the arithmetic operation using the least squares method, an upper limit value and a lower limit value of the fluorescence intensity are set for each of the one or more fluorescent beams and the autofluorescent beam. [5:55-61 : setting an an “upper limit” and “lower limit” wavelength ] Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Sekino, including mechanism(s) [b], as taught by Nitta . One of ordinary skill would have been so motivated to employ said mechanism(s) to set an upper and lower limit for optimally unmixing spectra associated with dyed samples. [5:55-61] Regarding claim(s) 2, Sekino-Nitta as a combination discloses [a]: The information processing device according to claim 1, Nitta discloses wherein the separation unit calculates the fluorescence intensities of the fluorescent beams and the autofluorescent beam emitted from the one or more fluorescent dyes and the biological sample, respectively, by an arithmetic formula including a penalty term that sets the upper limit value and the lower limit value of the fluorescence intensity for each of the one or more fluorescent dyes and the biological sample (i.e., a penalty that mathematically sets an upper and lower limit of intensities ) . [5:55-61 : setting an an “upper limit” and “lower limit” wavelength ] Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Sekino, including mechanism(s) [a], as taught by Nitta . One of ordinary skill would have been so motivated to employ said mechanism(s) to set an upper and lower limit for optimally unmixing spectra associated with dyed samples. [5:55-61] Regarding claim(s) 4, Sekino-Nitta as a combination discloses: The information processing device according to claim 1, Nitta disclosing [a]: wherein in the arithmetic operation using the least squares method, the upper limit value and the lower limit value set for at least one of the one or more fluorescent beams and the autofluorescent beam are different from the upper limit value and the lower limit value set for another one of the one or more fluorescent beams and the autofluorescent beam, respectively (i.e., employing an upper and lower limit associated with a least squares method) . [5:55-61 : setting an an “upper limit” and “lower limit” wavelength ] Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Sekino, including mechanism(s) [a], as taught by Nitta . One of ordinary skill would have been so motivated to employ said mechanism(s) to set an upper and lower limit for optimally unmixing spectra associated with dyed samples. [5:55-61] Regarding claim(s) 5, Sekino-Nitta as a combination discloses: The information processing device according to claim 4, Sekino discloses: wherein the at least one of the one or more fluorescent beams and the autofluorescent beam is the autofluorescent beam. [21:18-39 : intensity correction is performed on the fluorescence spectrum of cells, the autofluorescence of the cells is considered to be different for each kind of cell ] Regarding claim(s) 6, Sekino-Nitta as a combination discloses: The information processing device according to claim 2, Sekino discloses: wherein the arithmetic formula includes an autofluorescence correction parameter for setting the different upper limit values between at least one of the one or more fluorescent beams and the autofluorescent beam and another one of the one or more fluorescent beams and the autofluorescent beam (i.e., employing a correction process to autofluorescence intensities) . [21:18-39 : intensity correction is performed on the fluorescence spectrum of cells, the autofluorescence of the cells is considered to be different for each kind of cell ] Regarding claim(s) 8, Sekino-Nitta as a combination discloses: The information processing device according to claim 6, Nitta disclosing [a[: further comprising a determination unit that determines the autofluorescence correction parameter, wherein the determination unit calculates a first standard deviation of a fluorescence intensity of an autofluorescent beam emitted from an unstained biological sample by executing the arithmetic operation using the least squares method using the autofluorescence spectrum on a fluorescence signal measured from the unstained biological sample, calculates a second standard deviation of the fluorescence intensity of the autofluorescent beam emitted from the unstained biological sample by executing the arithmetic operation using the least squares method using the fluorescence spectrum reference of each of the fluorescent dyes and the autofluorescence spectrum on the fluorescence signal measured from the unstained biological sample, and determines the autofluorescence correction parameter such that the second standard deviation coincides with or approximates the first standard deviation. [13:19-67 : wherein pluralities of standard deviation and average values are employed in intensity correction process as applied to distribution of corrections ] Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Sekino, including mechanism(s) [a], as taught by Nitta . One of ordinary skill would have been so motivated to employ said mechanism(s) to set an upper and lower limit for optimally unmixing spectra associated with dyed samples. [5:55-61] Regarding claim(s) 12, Sekino discloses: An optical measurement system comprising: an excitation light source that irradiates a biological sample labeled with one or more fluorescent dyes with one or more excitation beams; [FIG 6A, 32:20-67 : irradiating light to a measurement object from a light beam source ] a detection unit that detects fluorescence signals of a fluorescent beam and an autofluorescence emitted from the biological sample by the irradiation of the one or more excitation beams; [FIG 6A, 32:20-67 : irradiating light to a measurement object from a light beam source received by an optical detector ] and a separation unit that calculates, from the fluorescence signals detected by the detection unit, fluorescence intensities of one or more fluorescent beams and an autofluorescent beam emitted from the one or more fluorescent dyes and the biological sample, respectively, by an arithmetic operation using a least squares method using a fluorescence spectrum reference of each of the fluorescent dyes and an autofluorescence spectrum of the biological sample (i.e., employing a calculation apparatus) , [24:1-5] Regarding [d], Sekino does not explicitly disclose as disclosed by Nitta : wherein in the arithmetic operation using the least squares method, an upper limit value and a lower limit value of the fluorescence intensity are set for each of the one or more fluorescent beams and the autofluorescent beam. [5:55-61 : setting an an “upper limit” and “lower limit” wavelength ] Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Sekino, including mechanism(s) [d], as taught by Nitta . One of ordinary skill would have been so motivated to employ said mechanism(s) to set an upper and lower limit for optimally unmixing spectra associated with dyed samples. [5:55-61] 07-21-aia AIA Claim (s) 3, 7, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sekino in view of Nitta (US 9,068,946) and further in view of Novo (US 2013/0346023) . Regarding claim(s) 3, Sekino-Nitta as a combination discloses: The information processing device according to claim 2, the aforementioned combination not explicitly disclosing as disclosed by Novo [a]: wherein the arithmetic formula is expressed by the following formula (1): PNG media_image1.png 200 400 media_image1.png Greyscale in which xi (i is an integer of 1 or more) represents a fluorescence intensity of each of the one or more fluorescent beams and the autofluorescent beam, yj (j is an integer of 1 or more) represents the fluorescence signal, S represents a reference spectrum including a fluorescence spectrum reference of each of the fluorescent dyes and an autofluorescence spectrum of the biological sample, ST represents a transposed matrix of the reference spectrum S, L represents a weighting coefficient matrix, p represents a penalty coefficient, I represents a unit matrix, and pl represents the penalty term (i.e., employing a penalty term to control unmixing process within a weighted least square process) . [¶97 as applied to estimated abundances by using a weighted least squares method s depicted in ¶¶13-15] Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Sekino, including mechanism(s) [a], as taught by Novo . One of ordinary skill would have been so motivated to employ said mechanism(s) to set an upper and lower limit for optimally unmixing spectra associated with dyed samples. [5:55-61] Regarding claim(s) 7, Sekino-Nitta-Novo as a combination discloses: The information processing device according to claim 3, Novo disclosing [a]: wherein at least one of the one or more fluorescence spectrum references and the autofluorescence spectrum included in the reference spectrum S is reduced with an autofluorescence correction parameter having a value larger than 0 and smaller than 1 (i.e., requiring fractional abundances to sum to 1 1 and to be non-negative) . [¶¶58-59] Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Sekino, including mechanism(s) [a], as taught by Novo . One of ordinary skill would have been so motivated to employ said mechanism(s) to set an upper and lower limit for optimally unmixing spectra associated with dyed samples. [5:55-61] Regarding claim(s) 9, Sekino-Nitta as a combination discloses: The information processing device according to claim 1, the aforementioned combination not explicitly disclosing as disclosed by Novo [a]: wherein the least squares method is a weighted least squares method (i.e., employing a weighted least square process) . [¶97 as applied to estimated abundances by using a weighted least squares method s depicted in ¶¶13-15] Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Sekino, including mechanism(s) [a], as taught by Novo . One of ordinary skill would have been so motivated to employ said mechanism(s) to set an upper and lower limit for optimally unmixing spectra associated with dyed samples. [5:55-61] Conclusion 07-96 The prior art made of record 2 and NOT relied upon is considered pertinent to applicant's disclosure: Keenan (US 6,675,106): A method of determining the properties of a sample from measured spectral data collected from the sample by performing a multivariate spectral analysis. The method can include: generating a two-dimensional matrix A containing measured spectral data; providing a weighted spectral data matrix D by performing a weighting operation on matrix A; factoring D into the product of two matrices, C and S<T>, by performing a constrained alternating least-squares analysis of D=CS<T>, where C is a concentration intensity matrix and S is a spectral shapes matrix; unweighting C and S by applying the inverse of the weighting used previously; and determining the properties of the sample by inspecting C and S. This method can be used to analyze X-ray spectral data generated by operating a Scanning Electron Microscope (SEM) with an attached Energy Dispersive Spectrometer (EDS). Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL EZEWOKO whose telephone number is 571 272 7850. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached on 571 270 5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-7850. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MICHAEL I EZEWOKO/Primary Examiner, Art Unit 3682 Application/Control Number: 17/906,236 Page 2 Art Unit: 3682 Application/Control Number: 17/906,236 Page 3 Art Unit: 3682 Application/Control Number: 17/906,236 Page 4 Art Unit: 3682 Application/Control Number: 17/906,236 Page 5 Art Unit: 3682 Application/Control Number: 17/906,236 Page 6 Art Unit: 3682 Application/Control Number: 17/906,236 Page 7 Art Unit: 3682 Application/Control Number: 17/906,236 Page 8 Art Unit: 3682 Application/Control Number: 17/906,236 Page 9 Art Unit: 3682 Application/Control Number: 17/906,236 Page 10 Art Unit: 3682 Application/Control Number: 17/906,236 Page 11 Art Unit: 3682 Application/Control Number: 17/906,236 Page 12 Art Unit: 3682 Application/Control Number: 17/906,236 Page 13 Art Unit: 3682 Application/Control Number: 17/906,236 Page 14 Art Unit: 3682 Application/Control Number: 17/906,236 Page 15 Art Unit: 3682 Application/Control Number: 17/906,236 Page 16 Art Unit: 3682 Application/Control Number: 17/906,236 Page 17 Art Unit: 3682 Application/Control Number: 17/906,236 Page 18 Art Unit: 3682 Application/Control Number: 17/906,236 Page 19 Art Unit: 3682 Application/Control Number: 17/906,236 Page 20 Art Unit: 3682 1 Corresponding to each fractional abundance to be less than zero 2 Please see Form 892 for complete listing