DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-20 are currently pending and are herein under examination.
Claims 1-20 are rejected.
Claim 12 is objected.
Priority
The instant application claims domestic benefit as a 371 filing of PCT/JP2021/022635 filed 15 June 2021, which claims foreign priority to Japanese Application No. JP2020-124477 filed 21 July 2020. The claims to domestic benefit and foreign priority are not acknowledged. The PCT application submitted in Japanese is not accompanied by an English translation as required by 35 USC 371(c)(2). Because the instant application relies upon priority to the PCT application for priority to the Japanese application, foreign priority is not granted. The effective filing date for claims 1-20 is 25 July 2023.
Information Disclosure Statement
The IDSs filed 01/13/2023, 02/12/2024, 04/08/2024, 09/03/2025, 12/22/2025, 01/07/2026 and 02/25/2026 follow the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of the list of references cited from these IDSs is included with this Office Action.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 133-1 and 133-2 in FIG 13.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all 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.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. For example, clarify that the invention relates to fluorochrome and reagent databases.
Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure filed 07/25/2023 is objected to because it contains two paragraphs and recites implied language such as “An object of the present technology is to provide” and “The present technology provides”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 12 is objected to because line 5 should recite “variations[[,]] in”. Appropriate correction is required.
Claim Interpretation
35 USC 112(f)
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 limitations are described below:
Claims 1, 4-7, 10 and 15 recite an information processing device that acquires signal data, performs information processing, receives correspondence information, outputs recommendation information, searches the reagent database, acquires measurement spectrum data, performs fluorescence separation processing and outputs reagent recommendation information.
Claim 11 recites a registration processing unit that executes reagent registration processing and executes processing of notational variations.
Claim 12 recites the registration processing unit registers data.
Claim 13 recites the registration processing unit creates a new record and registers the new record.
Claim 20 recites a fluorescence signal data acquisition step of acquiring the fluorescence signal data, wherein “step” is the generic placeholder.
Claim 20 recites an information processing step of performing information processing using the fluorescence signal data, wherein “step” is the generic placeholder.
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.
These limitations are being interpreted as computer-implemented means-plus-function limitations because they are performed by a processor, as indicated in specification para. [40] and [49]. The structure for which is the algorithm that performs the claimed function (MPEP § 2181.II.B). Below are the algorithms in the instant disclosure that recite structure for the claimed functions:
Information processing device: the structure for acquiring signal data and measurement spectrum data, receiving correspondence information, and outputting recommendation information and reagent recommendation information is a generic computer processor because receiving/transmitting data is coextensive with the functions of a generic computer processor.
Information processing device: the algorithm for information processing and fluorescence separation processing includes unmixing processing, and equivalents thereof, which uses equation 2 in specification para. [203].
Information processing device: neither the specification nor the drawings disclose an algorithm for the claimed function of searching the reagent database to identify the reagent corresponding to the biomolecule in claim 7. Specification paras. [7], [10], [62-63], [67], [69] and [71] reiterate the claimed function. However, MPEP § 2181.II.B recites “simply reciting the claimed function in the specification will not be a sufficient disclosure for an algorithm which, by definition, must contain a sequence of steps.”
Registration processing unit: Figures 26 and 31-32 and specification para. [162-175] disclose algorithms for the claimed functions of the registration processing unit in claims 11-13. These algorithms, and equivalents thereof, are the structure for the registration processing unit.
Fluorescence signal data acquisition step: the structure is a generic computer processor because acquiring data is a function coextensive with a generic computer processor.
Information processing step: specification para. [214] states that the algorithm can be the unmixing process defined in para. [202-205]. The unmixing algorithm and equivalents thereof are the structure.
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 § 112
35 USC 112(a)
Claim 7 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.
Claim 7 fails to comply with the written description requirement because it does not adequately link or associate adequately described particular structure, material, or acts to perform the function recited in the claim identified to invoke 35 U.S.C. 112(f) or pre- AIA 35 U.S.C. 112, sixth paragraph. As discussed in Claim Interpretation, claim 7 recites a function for the information processing device that invoke 35 U.S.C. 112(f). Neither the specification nor the drawings disclose a sufficient algorithm that performs the recited function. Thus, in accordance with MPEP § 2181.IV, the instant specification does not provide written description support for the information processing device.
35 USC 112(b)
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 1-19 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.
Claims dependent on a rejected claim are also rejected, unless otherwise noted.
Claims 1, 4-7, 10 and 15 recite method steps in a system claim. MPEP 2173.05(p) recites “[a]
single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.” These claims recite that the information processing device actively performs the following limitations rather than being configured to perform them: In claim 1, performs information processing. In claims 1, 4-5 and 7, acquires the fluorescence signal data. In claim 4, receives the correspondence information. In claim 6, outputs recommendation information. In claim 7, searches the reagent database. In claim 10, acquires measurement spectrum data and performs fluorescence separation processing. In claim 15, outputs reagent recommendation information. To overcome this rejection, clarify that the information processing device is configured to perform these steps.
Claim 5 recites the information processing device acquires fluorescence signal data from the fluorochrome database without receiving the correspondence information from the reagent database. However, in claim 1, the device acquires the data “using the correspondence information regarding the reagent in the reagent database”, indicating that the correspondence information has been received. Thus, it’s unclear whether the correspondence information is received or not in claim 5.
Claim 6 (lines 4 and 7), claim 7 (lines 2 and 3), and claim 8 (line 3) recite “the biomolecule”. It is unclear which biomolecule is being referenced because claim 6, lines 2-3, recites “at least one biomolecule”. Clarify which biomolecule is being referenced.
Claim 7, lines 6-7, recites “the fluorochromes associated with the reagent” which lacks antecedent basis. Claim 1 mentions a fluorochrome having a correspondence to a reagent, but there is no mention of fluorochromes being associated with the reagent. Provide antecedent basis.
Claim 9 recites method steps in a system claim because it requires the output unit to actively display a screen and recommendation information rather than being configured to display. See MPEP 2173.05(p). To overcome this rejection, clarify that the output unit is configured to display.
Claim 10, line 6, recites “the reagent”. It is unclear which reagent is being referenced because claim 1, line 5, recites a reagent and claim 10, lines 2-3, recites “at least one reagent”. Clarify which reagent is being referenced.
Claims 11-13 recite method steps in a system claim. See MPEP 2173.05(p). These claims recite that the registration processing unit actively performs the following limitations rather than being configured to perform them: In claim 11, executes reagent registration processing. In claim 12, registers measurement target information, a reagent, or a fluorochrome. In claim 13, creates a new record and registers the new record in the reagent/fluorochrome database. To overcome this rejection, clarify that the output unit is configured to display.
Claims 12-13 recite “measurement target information, a reagent, or a fluorochrome determined to be equivalent” and “measurement target information, a reagent, or a fluorochrome that is not determined to be equivalent”, respectively. It is unclear what these things are supposed to be equivalent to. To overcome this rejection, for example, modify claim 11 to clarify that a same fluorochrome can exist as a record in a database with different notations, wherein the different notations for the same fluorochrome are equivalent despite the notational variations.
Claim 7 recites a limitation that invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, as discussed in Claim Interpretation. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification merely reiterates the claimed function and does not recite a sequence of steps that constitute an algorithm for the claimed function. Therefore, claim 7 is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Step 1 asks whether the claims recite statutory subject matter. In the instant application, claims 1-19 recite a system and claim 20 recites a method. As such, these claims recite statutory subject matter (Step 1: YES).
Step 2A, Prong 1:
Claims that recite statutory subject matter are analyzed under Step 2A, Prong 1 to determine if they recite any concepts that equate to an abstract idea, law of nature or natural phenomena. The instant claims recite the following limitations that equate to one or more categories of judicial exception:
Claim 1 recites “performs information processing using the fluorescence signal data of the fluorochrome.”
Claim 6 recites “outputs recommendation information of the reagent corresponding to the biomolecule by the information processing”
Claim 7 recites “searches the reagent database on a basis of the biomolecule to identify the reagent corresponding to the biomolecule”
Claim 8 recites “wherein the recommendation information of the reagent includes information regarding the reagent associated with a combination of the biomolecule and a fluorochrome corresponding to the biomolecule acquired by the information processing.”
Claim 10 recites “performs fluorescence separation processing on the measurement spectrum data using the fluorescence spectrum data of the fluorochrome as the information processing”
Claim 11 recites “executes reagent registration processing … execute integration processing of notational variations of the measurement target information, the reagent, or the fluorochrome”
Claim 12 recites “registers measurement target information, a reagent, or a fluorochrome determined to be equivalent although having notational variations, in an existing record in the reagent database or the fluorochrome database”
Claim 13 recites “creates a new record for measurement target information, a reagent, or a fluorochrome that is not determined to be equivalent”
Claim 20 recites “An information processing method executed by using a fluorochrome database that holds fluorescence signal data of a fluorochrome, wherein the fluorescence signal data is associated with measuring instrument information, and a reagent database that holds correspondence information regarding a correspondence between a reagent and the fluorochrome, the information processing method comprising: a fluorescence signal data acquisition step of acquiring the fluorescence signal data of the fluorochrome corresponding to the reagent from the fluorochrome database using the correspondence information regarding the reagent in the reagent database identified on a basis of input measurement target information; and an information processing step of performing information processing using the fluorescence signal data of the fluorochrome.”
Limitations reciting a mental process.
Claims 1, 6-8, 10-13 and 20 contain limitations recited at such a high level of generality that they equate to a mental process because they are similar to the concepts of collecting information, analyzing it, and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), which the courts have identified as concepts that can be practically performed in the human mind. The paragraphs below discuss the broadest reasonable interpretation (BRI) of the limitations in these claims that recite a mental process.
Claim 1 recites information processing using fluorescence signal data which is so generically recited that it includes analyzing the signal data. Alternatively, claim 1 includes performing the limitations of claim 10 of fluorescence separation processing, which includes performing calculations using the weighted least squares method recited in specification para. [202-204]. Claims 6 and 8 include a mental process of determining a recommendation as a result of processing information. Claim 7 includes a mental process of evaluating data in a database.
Claim 11 recites reagent registration processing and integration processing which includes writing down on pen and paper different names of the same reagent found in a database. Claim 12 recites registering data determined to be equivalent which includes making a mental process of realization. Claim 13 recites creating a record which includes writing down information on pen and paper.
Claim 20 recites acquiring data from a database using information relating a reagent to a fluorophore which includes searching for and collecting data from a database. Claim 20 recites information processing using the fluorescence signal data which is so generically recited that is includes processing the data in the human man. Alternatively, it includes performing a weighted least squares method as recited in specification para. [202-204].
Limitations reciting a mathematical concept.
Claims 1, 10 and 20 recite limitations that equate to a mathematical concept because they are like the concepts of organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)), which the courts have identified as mathematical concepts. The paragraphs below discuss the broadest reasonable interpretation (BRI) of the limitations in these claims that recite a mathematical concept.
Claims 1, 10 and 20 recite information processing using fluorescence signal data. Specification para. [202-204] recite that information processing includes an unmixing process performed by a weighted least squares equation, which requires a mathematical equation and calculation.
As such, claims 1-20 recite an abstract idea (Step 2A, Prong 1: YES).
Additional Elements:
Once limitations have been identified that recite a judicial exception, the claims are evaluated for additional elements. The additional elements are then analyzed under Step 2A, Prong 2 then Step 2B. The instant claims recite the following additional elements:
Claim 1 recites “An information processing system comprising: a fluorochrome database that holds fluorescence signal data of a fluorochrome, wherein the fluorescence signal data is associated with measuring instrument information; a reagent database that holds correspondence information regarding a correspondence between a reagent and the fluorochrome; and an information processing device that acquires the fluorescence signal data of the fluorochrome corresponding to the reagent from the fluorochrome database using the correspondence information regarding the reagent in the reagent database identified on a basis of input measurement target information”
Claim 2 recites “wherein the fluorescence signal data includes fluorescence spectrum data.”
Claim 3 recites “wherein the measuring instrument information includes at least one of a model name of a measuring instrument, a laser light wavelength, or a detection wavelength range of a detector.”
Claim 4 recites “wherein the information processing device receives the correspondence information from the reagent database, and acquires the fluorescence signal data of the fluorochrome corresponding to the reagent from the fluorochrome database using the received correspondence information.”
Claim 5 recites “wherein the information processing device acquires the fluorescence signal data of the fluorochrome corresponding to the reagent from the fluorochrome database without receiving the correspondence information from the reagent database.”
Claim 6 recites “wherein the measurement target information includes a name, an abbreviation, or a number of at least one biomolecule, the correspondence information includes information indicating a correspondence between the biomolecule and the reagent, and the information processing device ...”
Claim 7 recites “wherein the information processing device … acquires, from the fluorochrome database, the fluorescence signal data of the fluorochrome associated with the measuring instrument information among a plurality of the fluorochromes associated with the reagent.”
Claim 9 recites “further comprising an output unit that displays a screen prompting an input of the measurement target information, wherein the output unit also displays the recommendation information of the reagent.”
Claim 10 recites “wherein the measurement target information includes a name, an abbreviation, or a number of at least one reagent, the fluorescence signal data includes fluorescence spectrum data, the information processing device acquires measurement spectrum data acquired by irradiating a particle, labeled with the reagent, with excitation light, and the information processing device ...”
Claim 11 recites “further comprising a registration processing unit that … wherein the registration processing unit is configured to ...”
Claim 12 recites “wherein the reagent database or the fluorochrome database includes an integration processing data table that is referred to for executing the integration processing of notational variations, and the registration processing unit ...”
Claim 13 recites “wherein the registration processing unit ... registers the new record in the reagent database or the fluorochrome database”
Claim 14 recites “wherein a name of at least one of a reagent, a biomolecule, or a fluorochrome and/or at least one of a reactive organism, a host organism, an isotype of an antibody, a size, a price, or a sales company is registered in the reagent database.”
Claim 15 recites “wherein the information processing device outputs reagent recommendation information on a basis of information of the price and/or the sales company in the reagent database.”
Claim 16 recites “wherein the fluorochrome database includes at least one of information regarding a measurement target or the measuring instrument information.”
Claim 17 recites “wherein the information regarding the measurement target includes at least one of a target organism or a degree of expression of a biomolecule.”
Claim 18 recites “wherein the measuring instrument information includes at least one of a number or wavelengths of excitation light sources of a measuring instrument, a number, types, or exposure gains of detectors included in the measuring instrument, or a flow rate in a sample flow channel included in the measuring instrument.”
Claim 19 recites “wherein the fluorochrome database is configured such that information regarding a fluorochrome acquired through a network is addable.”
These above recited additional elements are analyzed below under both Step 2A, Prong 2 and Step 2B:
Step 2A, Prong 2:
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). The judicial exception is not integrated into a practical application because the claims do not recite additional elements that reflect an improvement to a computer, technology, or technical field (MPEP § 2106.04(d)(1) and 2106.5(a)), require a particular treatment or prophylaxis for a disease or medical condition (MPEP § 2106.04(d)(2)), implement the recited judicial exception with a particular machine that is integral to the claim (MPEP § 2106.05(b)), effect a transformation or reduction of a particular article to a different state or thing (MPEP § 2106.05(c)), nor provide some other meaningful limitation (MPEP § 2106.05(e)). Rather, the claims include limitations that equate to an equivalent of the words “apply it” and/or to instructions to implement an abstract idea on a computer (MPEP § 2106.05(f)), insignificant extra-solution activity (MPEP § 2106.05(g)), and field of use limitations (MPEP § 2106.05(h)). The paragraphs below discuss the additional elements recited above in the instant claims.
The processing system of claims 1-19 comprises an information processing device, an output unit display, a registration processing unit, a fluorochrome database, and a reagent database. There are no limitations that these components require anything other than a generic computer and/or generic computing system. Therefore, these limitations equate to mere instructions to implement an abstract idea on a generic computer, which the courts have established does not render an abstract idea eligible in Alice Corp. 573 U.S. at 223, 110 USPQ2d at 1983.
Claims 1, 4-5, 7, 10 and 15 recite an information processing unit that acquires fluorescence signal data, receives correspondence information, and outputs reagent recommendation information. These limitations also invoke computers as a tool to performing an existing process such as receiving, storing, and transmitting data (MPEP 2106.05(f)(2)).
Claim 13 recites an integration processing unit that registers a new record in a database, which equates to invoking a computer as a tool to performing an existing process of storing data (MPEP 2106.05(f)(2)).
Claim 9 recites an output unit that displays a screen prompting an input which equates to significant extra-solution activity of necessary data gathering because the input measurement target information is used to collect the fluorescence signal data used for the abstract idea of information processing in claim 1.
Claim 9 recites an output unit that displays recommendation information, which equates to insignificant extra-solution activity of necessary data outputting.
Claims 1-3, 6, 10, 12, 14, 16 and 18 recite limitations that further limit data stored in the databases and thus equate to field of use limitations (MPEP 2106.05(h)) and invoke a computer as a tool for an existing process of storing data (MPEP 2106.05(f)(2)).
As such, claims 1-20 are directed to an abstract idea (Step 2A, Prong 2: NO).
Step 2B:
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). These claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these claims recite additional elements that equate to instructions to apply the recited exception in a generic way and/or in a generic computing environment (MPEP § 2106.05(f)) and to well-understood, routine and conventional (WURC) limitations (MPEP § 2106.05(d)). The paragraphs below discuss the additional elements recited above in the instant claims.
The processing system of claims 1-19 comprises an information processing device, an output unit display, a registration processing unit, a fluorochrome database, and a reagent database. There are no limitations that these components require anything other than a generic computer and/or generic computing system. Therefore, these limitations equate to instructions to implement an abstract idea on a generic computing environment, which the courts have established does not provide an inventive concept in Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).
Claims 1, 4-7, 10 and 15 recite an information processing unit that acquires fluorescence signal data, receives correspondence information, outputs recommendation information, and outputs reagent recommendation information. Claim 13 recites an integration processing unit that registers a new record in a database. Claim 9 recites an output unit that displays recommendation information and displays a screen prompting an input. These limitations equate to receiving/transmitting data over a network, which the courts have established as WURC limitation of a generic computer in buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014).
Claims 1-3, 6, 10, 12, 13-14, 16 and 18-19 recite storing data in a database. These limitations equate to storing information in memory, which the courts have established as a WURC function of a generic computer in Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015).
When these additional elements are considered individually and in combination, they do not provide an inventive concept. These limitations recite mere instructions to implement an abstract idea on a generic computer and invoke computers as a tool to performing an existing process of receiving, transmitting, and storing data. Therefore, these additional elements do not transform the claimed judicial exception into a patent-eligible application of the judicial exception and do not amount to significantly more than the judicial exception itself (Step 2B: No).
As such, claims 1-20 are not patent eligible.
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.
(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 1-10 and 19-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ren et al. (“Ren”; US Patent on IDS filed 02/12/2024; US 2018/0231452 A1).
The bold and italicized text below are the limitations of the instant claims, and the italicized text serves to map the prior art onto the instant claims.
Claim 1:
An information processing system comprising:
Ren discloses a system comprising a flow cytometer and a controller/processor 190 with memory 195 (FIG 1).
a fluorochrome database that holds fluorescence signal data of a fluorochrome, wherein the fluorescence signal data is associated with measuring instrument information;
Flow cytometer data such as spectral characteristics of a fluorochrome label and flow cytometer configuration data is stored in memory [31] [66]. Spectral characteristics include emission spectrum data stored in a database or label library [67]. Flow cytometer configuration data includes data such as model of flow cytometer, color and wavelength of lasers, and identities of detectors in the flow cytometer (measuring instrument information) [35].
a reagent database that holds correspondence information regarding a correspondence between a reagent and the fluorochrome; and
Each reagent includes fluorochrome labels attached to a detector molecule [9]. Figure 4J shows a label library database that includes fluorochrome labels associated with a reagent description which are specific for a marker [74].
Alternatively, the instant specification at para. [63] defines correspondence information as a name or abbreviation of a fluorochrome included in a reagent. As such, the fluorochrome label stored in memory in Figures 4I-4J also constitutes a reagent database that hold correspondence information because the labels have names and are part of a named reagents.
an information processing device that acquires the fluorescence signal data of the fluorochrome corresponding to the reagent from the fluorochrome database using the correspondence information regarding the reagent in the reagent database identified on a basis of input measurement target information and
Emission spectrum data for a panel of labels is retrieved from the database (fluorescence signal data of the fluorochrome corresponding to the reagent from the fluorochromes database) by selecting the name of the label as seen in Figure 4F (using the correspondence information regarding the reagent in the reagent database) [36]. The emission spectrum data is retrieved based on the configuration data such as input marker [36], selection of input target species (Figure 4A), or selection of a desired input label (Figure 4F) (identified on a basis of input measurement target information). Ren also recites “a list of available labels and corresponding data may be provided or retrieved based on wavelengths of the lasers in the flow cytometer and the filter windows of the detectors in the flow cytometer” [36].
performs information processing using the fluorescence signal data of the fluorochrome.
After emission spectrum data is retrieved, labels are assigned markers, wherein the assignments are evaluated based on spillover and other criteria [37-38] [72] (Figure 4H).
Claim 2:
Emission spectrum data of fluorochrome labels is stored in memory [36] (Figure 2).
Claim 3:
Flow cytometer configuration data includes data such as model of flow cytometer, color and wavelength of lasers, and identifies of detectors in the flow cytometer [35].
Claim 4:
A label is retrieved by the processor 433, then emission spectrum data is retrieved for each label 435 a,b [67]. Each fluorochrome label has a name and is associated with a reagent stored in a database (Figure 4l). Thus, the name of a label is the correspondence information. See instant specification para. [63] regarding this interpretation.
Claim 5:
A user can input emission spectrum data associated with a label into the computer system, which necessities the processor of the computer system acquiring the emission spectrum data [76].
Claim 6:
Marker section 443 allows selection of markers such as CD3 (measurement target information) (FIG 4H) [71]. Figure 4H shows markers associated with labels (correspondence information). Ren recite “when a marker is selected for assignment, a visual indicator will appear for each fluorochrome for which a commercial embodiment of a reagent including the selected marker and the fluorochrome is known” [71] (outputs recommendation information of the reagent corresponding to the biomolecule). Figure 4J shows markers associated with reagents.
Claim 7:
Figure 4I shows a marker CD25 being unassigned from label APC-H7, resulting in the computer system searching through a catalog to identify commercially available labels from the selected marker and are highlighted [73]. Figure 4J shows a plurality of commercially available reagents for each marker, which is associated with a cytometer model [74]. Each label has a corresponding emission spectrum that is retrievable by the processors [7] [36].
Claim 8:
Figure 4I and 4J show a marker such as CD3 associated with a fluorophore label PE, wherein a user can select from different reagents containing the marker and label. The reagents are recommendations [76].
Claim 9:
Figure 4B shows target species input in a display. Figured 4I and 4J show reagent recommendation.
Claim 10:
Input information includes names of fluorochrome labels and reagents (measurement target information includes a name of at least one reagent) [60] (FIG 4E). Emission spectrum data for each fluorochrome is retrieved from a database (fluorescence spectrum data) [36]. The emission spectrum data is derived from a flow cytometer (irradiating a particle, labeled with the reagent, with exciting light) [4] [21-22] [27]. Label spillover can be corrected using spectral overlap values (fluorescence separation processing on the measurement spectrum data) [44].
Claim 19:
Data inputted into the displays screens 430-450, such as fluorochrome labels, is saved into a database [75].
Claim 20:
An information processing method executed by using a fluorochrome database that holds fluorescence signal data of a fluorochrome, wherein the fluorescence signal data is associated with measuring instrument information:
Figure 1 shows a system comprising a flow cytometer and a controller/processor 190 with memory 195. Flow cytometer data such as spectral characteristics of a fluorochrome label and flow cytometer configuration data is stored in memory [31] [66]. Flow cytometer configuration data includes data such as model of flow cytometer, color and wavelength of lasers, and identities of detectors in the flow cytometer (measuring instrument information) [35]. Spectral characteristics include emission spectrum data stored in a database or label library [67].
and a reagent database that holds correspondence information regarding a correspondence between a reagent and the fluorochrome, the information processing method comprising:
Each reagent includes fluorochrome labels attached to a detector molecule [9]. Figure 4J shows a label library that includes fluorochrome labels associated with a reagent description which are specific for a marker [74].
Alternatively, the instant specification at para. [63] defines correspondence information as a name or abbreviation of a fluorochrome included in a reagent. As such, the fluorochrome label spectral characteristics stored in memory constitute a reagent database that holds correspondence information because the labels have names and are part of a reagent.
a fluorescence signal data acquisition step of acquiring the fluorescence signal data of the fluorochrome corresponding to the reagent from the fluorochrome database using the correspondence information regarding the reagent in the reagent database identified on a basis of input measurement target information; and
Emission spectrum data for a panel of labels is retrieved from the database (fluorescence signal data of the fluorochrome) by selecting the name of the label as seen in Figure 4F (using the correspondence information regarding the reagent in the reagent database) [36]. The emission spectrum data is retrieved based on the configuration data such as input marker [36], selection of input target species (Figure 4A), or selection of a desired input label (Figure 4F) (identified on a basis of input measurement target information).
Ren recites “a list of available labels and corresponding data may be provided or retrieved based on wavelengths of the lasers in the flow cytometer and the filter windows of the detectors in the flow cytometer” [36].
an information processing step of performing information processing using the fluorescence signal data of the fluorochrome.
After emission spectrum data is retrieved labels are assigned markers, wherein the assignments are evaluated based on spillover, and other criteria [37-38] [72] (Figure 4H).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 11-12, 14 and 16-18 are rejected under 35 USC 103 for being unpatentable over Ren et al. (“Ren”; US Patent on IDS filed 02/12/2024; US 2018/0231452 A1) in view of Kervizic (“Master data management, how to match and merge records to unify your data”; published online 2019).
The limitations of claim 1 have been taught above in section 35 USC 102 by Ren and are applied here under 35 USC 103.
The bold and italicized text below are the limitations of the instant claims, and the italicized text serves to map the prior art onto the instant claims.
Claims 11-12:
Ren discloses a processor for performing methods of their invention [31] (FIG 1). Ren populates a list of reagents on a display screen 450 when designing a reagent panel for particular markers (executes reagent registration processing) (FIG 4I-4J). FIGs 4I and 4J show the fluorochrome and reagent databases.
However, Ren does not integrate notational variations of target input, reagents, or fluorochromes, or disclose that the databases have an integration processing data table.
Kervizic discloses master data management (MDM) detailing how to match and merge records to unify data, resulting in a single source of truth (SSOT) for different entities (pg. 1). Soft merging creates an association between different records, allowing records to be grouped (pg. 18, para. 3-4, such as record for a same product with differing names (pg. 7, para. 2) (pg. 8, para. 3) (integration processing of notational variations) (equivalent although having notational variations in an existing record). A table is used for the association (integration processing data table) (pg. 19, para. 1) When these teachings are taken together, they suggest product names with different notional variations can be merged using an association key.
It would have been prima facie obvious to modify the computing system of Ren that contains a reagent database by incorporating an MDM strategy as taught by Kervizic to create a SSOT for the components of the reagent database. Motivation for doing so is taught by Kervizic who recites that MDM is used to achieve clean results and data (pg. 2, para. 1), and one issue in databases is when the same entity has different names (pg. 7, para. 2) (pg. 8, para. 3). Thus, one of skill would want to have a consistent naming scheme for reagents in the instance where there are notational variations across companies. There would have been a reasonable expectation of success because Kervizic teaches that MDM is applicable to products (pg. 2, para. 1), such as the reagents/fluorochromes of Ren.
Claim 14:
Ren shows in Figure 4J company name, BD, associated with the listed reagents in the database.
Claims 16 and 18:
Ren teaches that flow cytometer data such as spectral characteristics of a fluorochrome label and flow cytometer configuration data is stored in memory [31] [66]. Flow cytometer configuration data includes data such as model of flow cytometer, color and wavelength of lasers, and identities of detectors in the flow cytometer (measuring instrument information) [35].
Claim 17:
Ren shows in Figure 4J associated measurement target, human, associated with the fluorochrome and marker. Figure 4B shows the marker with associated degree of expression.
Claim 13 is rejected under 35 USC 103 for being unpatentable Ren et al. (“Ren”; US Patent on IDS filed 02/12/2024; US 2018/0231452 A1) in view of Kervizic (“Master data management, how to match and merge records to unify your data”; published online 2019), as applied above to claim 11, and in further view of Holt (“The powerful SQL UPSERT”; published online 2015).
The limitations of claim 1 have been taught above in section 35 USC 102 by Ren and are applied here under 35 USC 103. The limitations of claim 11 have been taught above by Ren and Kervizic.
The bold and italicized text below are the limitations of the instant claims, and the italicized text serves to map the prior art onto the instant claims.
Claim 13:
Ren inputs fluorochrome labels, which are retrieved from a database (FIG 4A-4J). However, Ren does not create and register a new record of a label when the inputted label is not found in the database. Holt discloses the upsert database operation (title), which adds an entity into a database if the entity does not already exist in the database (pg. 1, para. 1). It would have been prima facie obvious to have updated the fluorochrome database of Ren by creating and adding a new fluorochrome not already present in the database, as taught by Holt. Motivation for doing so is to generate a record for a fluorochrome that has no record, which is the point of a database, particularly one used to sell reagents. There would have been a reasonable expectation of success to generate such a record because Holt discloses the database operations for doing so. It also requires adding more tables in the database.
Claim 15 is rejected under 35 USC 103 for being unpatentable over Ren et al. (“Ren”; US Patent on IDS filed 02/12/2024; US 2018/0231452 A1) in view of Kervizic (“Master data management, how to match and merge records to unify your data”; published online 2019), as applied above to claims 11-12 and 14, and in further view of Stax (“Customer decision making criteria and the importance of price”; published online 2016).
The limitations of claim 1 have been taught above in section 35 USC 102 by Ren and are applied here under 35 USC 103. The limitations of claims 11-12 and 14 have been taught in the rejection above by Ren and Kervizic.
The bold and italicized text below are the limitations of the instant claims, and the italicized text serves to map the prior art onto the instant claims.
Claim 15:
Ren discloses generating recommendations of reagents from a reagent database (FIG 4I-4J) [74] [76]. However, the recommendation is not based on price or sales company in the reagent database.
Stax evaluated customer decision making criteria and the importance of price (title) (pg. 1, para. 1). Price is the most influential decision driver when purchasing a product (pg. 3, last para.). It would have been prima facie obvious to have modified the reagent recommendations of Ren to include price as taught by Stax because price is the most important purchasing influence (see Stax at pg.). The reagent database in FIG 4J of Ren is used to order reagents. There would have been a reasonable expectation of success because FIG 4J of Ren could be modified to include price of the listed recommended reagents.
Conclusion
No claims are allowed.
Notable, but not relied upon, prior art includes Kapinksy (WO 2014/144826 A1) for panel design in flow cytometry with antibody-dye conjugate database [3] [74] [95] (FIG 1).
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Noah A. Auger whose telephone number is (703)756-4518. The examiner can normally be reached M-F 7:30-4:30 EST.
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/N.A.A./Examiner, Art Unit 1687
/KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685
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