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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/18/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 06/04/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
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 is objected to because the Abstract is more than 150 words. 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 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 measurement unit and a state inference unit in claim 1; a determination unit in claim 7; a measurement target optimization inference unit in claim 9; the next step determination unit in claim 17; and a measurement step; a storing step and a state inference step in claim 19.
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 § 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.
Claims 1-8, 11-13, 15, 16, 18 and 19 are rejected under 35 U.S.C. 102a1 as being anticipated by Lang et al. (US 2013/0295596 A1 – hereafter ‘596).
‘596 discloses a process for the prediction of cell culture performance (Abstract) that includes the following limitations for claim 1:
“A state inference system”: ‘596 discloses a system ([0027]) that is used for cell culture and is being interpreted as the state inference system of the instant application.
“a measurement unit for using any of a culture medium, a culture cultured by using the culture medium, a culture medium extract extracted from the culture medium, and a culture extract extracted from the culture, as a biological sample and a target biological sample, and measuring characteristics of a plurality of biological samples including the biological sample at a certain time point and characteristic of the target biological sample being the same type as the biological sample at the certain time point”: ‘596 discloses a measurement unit such as a mass spectrometer ( [0013]; [0106]) that measures a characteristic of eh culture media at a time point. The mass spectrometer is being interpreted as the measurement unit of the instant application and would be equivalent to the measurement unit.
“a database for storing a feature amount extraction model that characterizes a distribution of input data including at least characteristic values of the plurality of biological samples acquired through the measurement unit”: ‘596 discloses a memory or database ([0178]; Fig 10) that would include a data base for storing a model (PLSDA model) characterizes the data as a distribution (Fig. 1a & b; [0108]). This would include characteristic values of the biological sample.
“a state inference unit for inferring a culture state of the culture or inferring a culture time during which the culture reaches a predetermined culture state, from the input data of the target biological sample on the basis of the feature amount extraction model.”: ‘596 discloses a program that treats the raw sample data by a first MS signal processing method ([0015]) where this is being interpreted as the equivalent structure of the state interference unit.
‘596 discloses a process for the prediction of cell culture performance (Abstract) that includes the following limitations for claim 19:
“A state inference method”: ‘596 discloses a system and method ([0027]) that is used for cell culture and is being interpreted as the state inference method of the instant application.
“a measurement step for using any of a culture medium, a culture cultured by using the culture medium, a culture medium extract extracted from the culture medium, and a culture extract extracted from the culture, as a biological sample and a target biological sample, and measuring characteristics of a plurality of biological samples including the biological sample at a certain time point and characteristic of the target biological sample being the same type as the biological sample at the certain time point”: ‘596 discloses a measurement step that uses a measurement device such as a mass spectrometer ( [0013]; [0106]) that measures a characteristic of eh culture media at a time point. The mass spectrometer is being interpreted as the measurement unit of the instant application and would be equivalent to the measurement unit.
“a storing step of storing, in a database, a feature amount extraction model that characterizes a distribution of input data including at least characteristic values of eh plurality of biological samples acquired through the measurement”: ‘596 discloses using a memory or database ([0178]; Fig 10) that would include a data base for storing a model (PLSDA model) characterizes the data as a distribution (Fig. 1a & b; [0108]). This would include characteristic values of the biological sample.
“a state inference step of inferring a culture state of the culture or inferring a culture time during which the culture reaches a predetermined culture state, from the input data of the target biological sample on the basis of the feature amount extraction model.”: ‘596 discloses the step of using a program that treats the raw sample data by a first MS signal processing method ([0015]) where this is being interpreted as the equivalent structure of the state interference unit.
For claim 2, the mass spectrometer of ‘596 is fully capable of measuring the biological sample before culturing the cells ([0029]).
For claim 3, the mass spectrometer of ‘596 takes a measurement during cell culture ([0029]).
For claim 4, ‘596 discloses that the program that processes the raw data uses this to determine a state of the culture ([0069]; [0070]).
For claim 5, ‘596 discloses that the program that processes the raw data uses this to determine a state of the culture ([0069]; [0070]) and is fully capable of taking a measure during the middle of the culturing process.
For claim 6, ‘596 discloses the following limitations:
“wherein the measurement unit measures characteristics of the plurality of biological samples and the target biological sample in the middle of being used in a culturing process along a timeline”: The mass spectrometer of’596 is fully capable of measuring the sample in the middle of the culturing process.
“the state inference unit infers a culture state of the culture or infers the culture time, on the basis of the feature amount extraction model, in which the characteristic values of the plurality of biological samples are characterized at each measurement time for the characteristic values, from the characteristic values of the target biological sample at each measurement time for the characteristic values.”: ‘596 discloses that the signal processing method obtains profiles of the data and evaluates the pre-treated and raw profiles ([0029]).
For claim 7, ‘596 discloses using a partially least squares-discriminant analysis (PLS-DA; [0016]) that is being interpreted as the determination unit of the instant application. This analysis determines a state of the biological sampled based on inference of the culture state ([0035]).
For claim 8, ‘596 discloses using a partially least squares-discriminant analysis (PLS-DA; [0016]) that is being interpreted as the determination unit of the instant application. This analysis determines a state of the biological sampled based on inference of the culture state ([0035]).
For claim 11, ‘596 discloses the following limitations:
“the state inference unit infers a culture state of the culture or infers the culture time, on the basis of the feature amount extraction model that uses the characteristic values of the plurality of biological samples and culture parameters related to culturing conditions of a culturing process using he biological samples, as the input data, and characterizes distributions of the characteristic values and the culture parameters.”: ‘596 discloses that the signal processing method obtains profiles of the data and evaluates the pre-treated and raw profiles ([0029]).
For claim 12, ‘596 discloses using a partially least squares-discriminant analysis (PLS-DA; [0016]) that is being interpreted as the determination unit of the instant application. This analysis determines a state of the biological sampled based on inference of the culture state ([0035]).
For claim 13, ‘596 discloses the measurement system is a mass spectrometer ([0013]) and the values measured are a mass spectrum ([0029]).
For claim 15, ‘596 discloses that the system determines desirable characteristics such as productivity and growth ([0054]) where this is being interpreted as the yield of the culture.
For claim 16, ‘596 discloses the following limitations:
“wherein the measurement unit measures characteristics of the culture at a certain time point”: The mass spectrometer of’596 is fully capable of measuring the sample in the middle of the culturing process.
“the state inference unit uses measurement results obtained from the measurement unit as the input data, and infers which culture state among a plurality of types of culture states the culture will reach by culturing, from the input data on the basis of the feature amount extraction model.”: ‘596 discloses that the signal processing method obtains profiles of the data and evaluates the pre-treated and raw profiles ([0029]).
For claim 18, ‘596 discloses using a partially least squares-discriminant analysis (PLS-DA; [0016]) that is being interpreted as the determination unit of the instant application. This analysis determines a state of the biological sampled based on inference of the culture state ([0035]).
Therefore, ‘596 meets the limitations of claims 1-8, 11-13, 15, 16, 18 and 19.
Allowable Subject Matter
Claims 9, 10, 14 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: For claim 9, the prior art fails to teach or fairly suggest a state inference system where the stat inference system includes a measurement target optimization inference unit for inferring an additive to be added to the culture medium on the basis of an inference result of the culture state or an inference result of the culture time obtained by the state inference unit.
Claim 10 would be allowable for the same reasons as claim 9.
For claim 14, the prior art fails to teach or fairly suggest where the measurement unit is an impedance measurement apparatus and the characteristics values measured by the measurement unit are impedances of the plurality of biological samples and the target biological sample.
For claim 17, the prior art fails to teach or fairly suggest a next step determination unit that determines a next processing step for the culture according to the type of a culture state of the culture inferred by the state inference unit.
The closest prior art is Lang et al. (US 2013/0295596 A1) discloses a system for the prediction of cell culture performance, but does not teach or suggest the limitations of claims 9, 10, 14 and 17.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The closest prior art is Paul et al. (US 2020/0377844 A1) which discloses a system for predicting the conditions of cells.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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