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 .
Remarks
In response to communications sent August 10, 2023, claim(s) 1-6 are pending in this application; of these claims 1 and 6 are in independent form.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The Examiner compared a machine translation of the Japanese foreign priority document to the instant U.S. patent application and determined that there are the same number of figures. In addition, there are corresponding paragraphs between the instant application and the foreign priority document. Nevetherless the Examiner will search for intervening references in the absence of a certified translation.
Drawings
The drawing(s) filed on August 10, 2023 are accepted by the Examiner.
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.
The following title is suggested: “CELL MANAGEMENT SYSTEM AND CELL MANAGEMENT METHOD FOR DETERMINING SUBJECT CONSISTENCY”.
Information Disclosure Statement
The Information Disclosure Statement(s) is/are acknowledged and the references contained therein have been considered by the Examiner. This includes the Information Disclosure Statements(s) filed on: August 10, 2023 and September 1, 2026.
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:
“analysis apparatus configured to acquire…” in claim 1 (described on page 13 line 12 to page 14 line 23, which describes elements 20, 21, 22, and 23 in Figure 6).
“determination apparatus… configured to determine… in claim 1 (described on page 18 line 15 to page 19 line 12 which describes elements 50, 51, and 52 in Figure 7).
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) “determine consistency”. This judicial exception is not integrated into a practical application because the additional element of an analysis apparatus is necessary pre-solution activity to carry out the abstract mental process. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because it is well-understood, routine, and conventional to acquire information from DNA; this is based on the precedential case, Genetic Techs. Ltd., 818 F.3d at 1377; 118 USPQ2d at 1546.
1. A cell management system, comprising:
an analysis apparatus configured to acquire a first identification code from a processing sample from which a cell used for treatment is produced, or from a processed product based on the processing sample, and to acquire a second identification code from a reference sample (an additional element beyond the abstract idea, but the additional element is necessary pre-solution activity to carry out the abstract mental process; it is well-understood, routine, and conventional to acquire information from DNA; this is based on the precedential case, Genetic Techs. Ltd., 818 F.3d at 1377; 118 USPQ2d at 1546); and
a determination apparatus, based on the first identification code and the second identification code, configured to determine consistency of a subject from whom the processing sample is obtained and a subject from whom the reference sample is obtained (mental process of evaluation, performable in the human mind as a comparison of identification codes).
2. The cell management system according to claim 1, wherein the analysis apparatus acquires at least one of a short tandem repeat sequence, a multi-locus minisatellite sequence, a single-locus minisatellite sequence, and a mitochondrial DNA sequence, as the first identification code and the second identification code (an additional element that is necessary pre-solution activity; it is well-understood, routine, and conventional to acquire information from DNA; this is based on the precedential case, Genetic Techs. Ltd., 818 F.3d at 1377; 118 USPQ2d at 1546).
3. The cell management system according to claim 1, wherein
the analysis apparatus acquires a plurality of the first identification codes from a plurality of the processed products (an additional element that is necessary pre-solution activity; it is well-understood, routine, and conventional to acquire information from DNA; this is based on the precedential case, Genetic Techs. Ltd., 818 F.3d at 1377; 118 USPQ2d at 1546), and
the determination apparatus determines the consistency, based on the first identification codes based on the processed products, and the second identification code (mental process of evaluation, performable in the human mind as a comparison of identification codes).
4. The cell management system according to claim 1, wherein the processing sample and the reference sample are different types of samples obtained from a same subject (an additional element that is necessary pre-solution activity; it is well-understood, routine, and conventional to acquire information from DNA; this is based on the precedential case, Genetic Techs. Ltd., 818 F.3d at 1377; 118 USPQ2d at 1546).
5. The cell management system according to claim 1, wherein the processing sample and the reference sample are same type of samples obtained from a same subject on different tests (an additional element that is necessary pre-solution activity; it is well-understood, routine, and conventional to acquire information from DNA; this is based on the precedential case, Genetic Techs. Ltd., 818 F.3d at 1377; 118 USPQ2d at 1546).
6. A cell management method, comprising:
acquiring a processing sample from which a cell used for treatment is produced (an additional element beyond the abstract idea, but the additional element is necessary pre-solution activity to carry out the abstract mental process; it is well-understood, routine, and conventional to acquire information from DNA; this is based on the precedential case, Genetic Techs. Ltd., 818 F.3d at 1377; 118 USPQ2d at 154;
acquiring a reference sample (an additional element beyond the abstract idea, but the additional element is necessary pre-solution activity to carry out the abstract mental process; it is well-understood, routine, and conventional to acquire information from DNA; this is based on the precedential case, Genetic Techs. Ltd., 818 F.3d at 1377; 118 USPQ2d at 154;
acquiring a first identification code from the processing sample, or from a processed product based on the processing sample (an additional element beyond the abstract idea, but the additional element is necessary pre-solution activity to carry out the abstract mental process; it is well-understood, routine, and conventional to acquire information from DNA; this is based on the precedential case, Genetic Techs. Ltd., 818 F.3d at 1377; 118 USPQ2d at 154;
acquiring a second identification code from a reference sample (an additional element beyond the abstract idea, but the additional element is necessary pre-solution activity to carry out the abstract mental process; it is well-understood, routine, and conventional to acquire information from DNA; this is based on the precedential case, Genetic Techs. Ltd., 818 F.3d at 1377; 118 USPQ2d at 154; and
based on the first identification code and the second identification code, determining consistency of a subject from whom the processing sample is obtained and a subject from whom the reference sample is obtained (mental process of evaluation, performable in the human mind as a comparison of identification codes).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20170199211 A1 (“Ghouze”).
As to claim 1, Ghouze teaches a cell management system, comprising:
an analysis apparatus (Ghouze Para [0111]: analytical instrument) configured to acquire a first identification code (Ghouze Para [0111]: a database record) from a processing sample (Ghouze Para [0111]: from a processing sample subject chemical, biochemical, or molecular analysis) from which a cell used for treatment is produced (Ghouze Para [0111]: a patient sample), or from a processed product based on the processing sample (Ghouze Para [0111]: a therapeutic material), and to acquire a second identification code from a reference sample (Ghouze Para [0111]: a second biomarker signature is stored in the patient’s database record); and
a determination apparatus, based on the first identification code and the second identification code, configured to determine consistency of a subject from whom the processing sample is obtained and a subject from whom the reference sample is obtained (Ghouze Para [0111]: “Prior to administration of the therapeutic material the first biomarker signature of the original patient sample and the second signature of the therapeutic material are checked to verify a match between the two signatures confirming that the patient sample and the processed material are both derived from the same patient”).
As to claim 2, Ghouze teaches the cell management system according to claim 1, wherein the analysis apparatus acquires at least one of a short tandem repeat sequence (Ghouze Para [0112]: short tandem repeats), a multi-locus minisatellite sequence (this element is claimed in the alternative and does not need to be mapped; nevertheless see Ghouze Para [0112]: genetic fingerprinting and DNA profiling), a single-locus minisatellite sequence (Ghouze Para [0112]: Variable Number Tandem Repeats, abbreviated VNTR), and a mitochondrial DNA sequence (this element is claimed in the alternative and does not need to be mapped), as the first identification code and the second identification code (Ghouze Para [0112]: “assign a patient identity to a processed therapeutic material by matching the STR signature of the original patient sample and the therapeutic material”).
As to claim 3, Ghouze teaches the cell management system according to claim 1, wherein
the analysis apparatus acquires a plurality of the first identification codes from a plurality of the processed products (see the mapping of the independent claim combined with Ghouze Para [0031]: “parallel processing of a plurality of biological cellular samples” emphasis added) , and
the determination apparatus determines the consistency, based on the first identification codes based on the processed products, and the second identification code (Ghouze Para [0112]: “assign a patient identity to a processed therapeutic material by matching the STR signature of the original patient sample and the therapeutic material” emphasis added).
As to claim 4, Ghouze teaches the cell management system according to claim 1, wherein the processing sample and the reference sample are different types of samples (Ghouze Para [0042]: different types of samples) obtained from a same subject (Ghouze Para [0048]: the donor is also the patient in autologous cell therapy).
As to claim 5, Ghouze teaches the cell management system according to claim 1, wherein the processing sample and the reference sample are same type of samples (Ghouze Figure 2; a progression of sample measurements) obtained from a same subject on different tests (Ghouze Para [0048]: the donor is also the patient in autologous cell therapy).
As to claim 6, Ghouze teaches a cell management method, comprising:
acquiring a processing sample (Ghouze Para [0111]: from a processing sample subject chemical, biochemical, or molecular analysis) from which a cell used for treatment is produced (Ghouze Para [0111]: a patient sample);
acquiring a reference sample (Ghouze Para;
acquiring a first identification code (Ghouze Para [0111]: a database record) from the processing sample (Ghouze Para [0111]: a therapeutic material), or from a processed product based on the processing sample (Ghouze Para [0111]: a therapeutic material);
acquiring a second identification code from a reference sample (Ghouze Para [0111]: a second biomarker signature is stored in the patient’s database record); and
based on the first identification code and the second identification code, determining consistency of a subject from whom the processing sample is obtained and a subject from whom the reference sample is obtained (Ghouze Para [0111]: “Prior to administration of the therapeutic material the first biomarker signature of the original patient sample and the second signature of the therapeutic material are checked to verify a match between the two signatures confirming that the patient sample and the processed material are both derived from the same patient.”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Roseti, L., et al. "A novel DNA profiling application for the monitoring of cross-contamination in autologous chondrocyte implantation." European Review for Medical & Pharmacological Sciences 17.6 (2013): 820. (Year: 2013)
US 20220389490 A1: pertinence is the authentication of samples from a subject
US 20180181709 A1: pertinence is the bioinformatics-based triage of autologous transplants; see summary of the invention
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jesse P Frumkin whose telephone number is (571)270-1849. The examiner can normally be reached Monday - Friday, 10-5 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia Wise can be reached at (571) 272-2249. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JESSE P FRUMKIN/Primary Examiner, Art Unit 1685 September 15, 2026
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