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 .
Applicant’s Response
Applicant’s response, filed 04/01/2026, has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims Status
Claims 2, 3, 8, and 9 have been canceled.
Claims 1, 4-7, and 10-17 are pending.
Claims 1, 4-7, and 10-17 are examined.
Withdrawn Objections/Rejections
The objection to the Specification is withdrawn in view of the amendments submitted
The rejection of claims 1 and 4-16 under 35 USC 101 is withdrawn in view of the amendments submitted because the manufacturing of the pluripotent stem cells integrates the judicial exceptions into a practical application
The rejection of claims 1, 4, 12, and 13 under 35 USC 102(a)(1) and 102(a)(2) is withdrawn in view of the amendments submitted. A new grounds of rejection in view of Califano et al. is set forth.
Claim Objections
Claims 5-7 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.
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 limitations are: “the manufacturing apparatus is configured to manufacture the pluripotent stem cells…” in claim 1.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. This structure is recited in the Specification on pages 9-14 and Figure 3.
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
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 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 1, 4-7, 10-15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Tanabe et al. (US 2019/0338237 A1, published November 2019, Application publication of Patent 10508260 IDS reference) in view of Califano et al. (US 2024/0228965 A9, effectively filed 10/01/2020). This is a new grounds of rejection as necessitated by claim amendments.
Regarding claim 1, Tanabe et al. teaches a pluripotent stem cell manufacturing system comprising:
a manufacturing apparatus (Abstract); and
processing circuitry (paragraph [0255]) configured to:
acquire storage information for storage of a sample from a donor (paragraphs [0359], [0363]), and surviving cell number information for a number of surviving cells contained in the sample (paragraphs [0101]-[0103]), and
estimate tissue stem cell number information for a number of tissue stem cells contained in the sample, based on the storage information and the surviving cell number information (paragraphs [0104], [0109]), wherein
the processing circuitry is configured to determine, based on the tissue stem cell number information, a manufacturing process for manufacturing pluripotent stem cells from the tissue stem cells (paragraph [0272]),
the manufacturing apparatus is configured to manufacture the pluripotent stem cells from the tissue stem cells according to the manufacturing process, the pluripotent stem cells having an origin in the donor (paragraph [0372]), and
the sample comprises blood of the donor (paragraph [0078]).
Tanabe et al. does not teach the claim element of the tissue stem cells being hematopoietic stem cells, and the storage information comprising information indicative of a number of CD34 positive cells at the initial time point, a number of storage years, and/or a storage period.
However, Califano et al. teaches a method of generating multipotent stem cells. Califano et al. teaches a sample comprising blood of a donor and sample stem cells comprising hematopoietic stem cells (paragraphs [0009], [0186]). Furthermore, Califano et al. teaches information indicative of a number of CD34 positive cells at an initial time point (paragraph [0043]).
Regarding claim 4, the claim is directed to the processing circuitry being configured to determine, according to the tissue stem cell number information, a level for the number of the tissue stem cells contained in the sample, and determine, based on the determined level and a correspondence between a plurality of predetermined levels and a plurality of manufacturing processes, the manufacturing process corresponding to the determined level. Tanabe et al. teaches the system of claim 1 in view of Califano et al. Tanabe et al. also teaches determining a level for the number of tissue stem cells, and determining based on a threshold, further manufacturing amplification steps (paragraph [0105]).
Regarding claim 12, the claim is directed to the surviving cell number information comprising numerical information for the number of the surviving cells contained in the sample, numerical information for a ration of the surviving cells, image information for the sample, and/or optical spectrum information for the sample. Tanabe et al. teaches the system of claim 1 in view of Califano et al. Tanabe et la. also teaches the surviving cell number information comprising image information for the sample (paragraph [0105]).
Regarding claim 13, the claim is directed to the processing circuitry being configured to estimate the tissue stem cell number information for the number of the tissue stem cells estimated to be contained in the sample before extended cultivation. Tanabe et al. teaches the system of claim 1 in view of Califano et al. Tanabe et al. also teaches estimating the number of tissue stem cells before cultivation (paragraph [0105]).
Regarding claim 10, the claim is directed to the storage information further comprising identification information of the donor. Tanabe et al. teaches the system of claim 1 in view of Califano et al.
Tanabe et al. does not teach the claim element of identification information of the donor.
However, Califano et al. teaches storage information relating to the identity of the donor (Figures 14A and 14B).
Regarding claim 11, the claim is directed to the sample comprising umbilical blood which has been stored in an umbilical blood depository. Tanabe et al. teaches the system of claim 1 in view of Califano et al.
Tanabe et al. does not teach the claim elements of the sample comprising umbilical blood which was been stored in an umbilical blood depository.
However, Califano et al. teaches a sample comprising umbilical blood which was stored and received from the blood bank of Barcelona (paragraph [0189]).
Regarding claim 14, the claim is directed to the processing circuitry being configured to estimate the tissue stem cell number information by applying the storage information and the surviving cell number information to a trained model, the trained model being a machine learning model trained to input the storage information and the surviving cell number information and output the tissue stem cell number information. Tanabe et al. teaches the system of claim 1 in view of Califano et al.
Tanabe et al. does not teach the claim element of -applying the storage information and surviving cell number information to a trained model.
However, Califano et al. teaches a trained random forest model trained on selected reference populations to classify cells as progenitors (paragraph [0170]).
Regarding claim 17, Tanabe et al. teaches a system comprising: pluripotent stem cell manufacturing system comprising: processing circuitry (paragraph [0255]) configured to acquire storage information for storage of a sample from a donor (paragraphs [0359], [0363]), and surviving cell number information for a number of surviving cells contained in the sample (paragraphs [0101]-[0103]), and estimate tissue stem cell number information for a number of tissue stem cells contained in the sample, based on the storage information and the surviving cell number information (paragraphs [0104], [0109]).
Tanabe et al. does not teach the claim elements of training a machine learning model based on the plurality of training samples to generate a training model that inputs the storage information and the surviving cell number information and outputs the tissue stem cell number information.
However, Califano et al. teaches a trained random forest model trained on selected reference populations to classify cells as progenitors (paragraph [0170]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the trained model of Califano et al. to the system of Tanabe et al. because both Tanabe et al. and Califano et al. are directed to the generation of a multipotent stem cell (see Abstract of both). Califano discloses that algorithms are highly effective in elucidating the factors necessary to induce lineage differentiation and cellular reprogramming (paragraph [0008]). Thus, one of ordinary skill in the art would have a reasonable expectation of success of effectively generating multipotent or pluripotent stem by using the algorithms of Califano et al. to identify important factors for the cell cultures.
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Tanabe et al. in view of Califano et al., as applied to claims 1, 4-7, 10-15, and 17 in the rejection above, in view of Hirano (US 2020/0400603 A1, IDS reference). This is a new grounds of rejection as necessitated by claim amendments.
Regarding claim 15, the claim is directed to a display configured to display the tissue stem cell number information. Tanabe et al. teaches the system of claim 1 in view of Califano et al.
Neither Tanabe et al. nor Califano et al. teach the claim element of a display.
However, Hirano teaches a cell testing device configured to estimate viable cells during a prescribed period (Abstract). Hirano teaches the device comprising a display (paragraph [0034]). Hirano teaches the operation unit being provided on the display unit and the operation unit outputting results including set values of culture conditions (paragraph [0042]). Hirano teaches displaying a generated image of a result of estimating a number of cells (paragraph [0043]).
Regarding claim 16, the claim is directed to a display configured to display the manufacturing process. Tanabe et al. teaches the system of claim 1 in view of Califano et al.
Neither Tanabe et al. nor Califano et al. teach the claim element of a display.
However, Hirano teaches a display outputting information related to a cell testing process (paragraphs [0042], [0043], [0094], and the like).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the display of Hirano to the system of Tanabe et al. in view of Califano et al. because Tanabe et al. is directed to a system for introducing pluripotency inducing factors into cells to prepare pluripotent cells and supplies solutions and mediums to generate the cells (paragraph [0011]), and Hirano is directed to a cell testing system that estimates cell culture conditions (Abstract). Thus, one of ordinary skill in the art would have a reasonable expectation of success of estimating the conditions of a stem cell culture in order to generate pluripotent stem cells by combining the prior art references and one would be motivated to do so, because the system of Hirano implements viable cell count estimation with high accuracy (paragraph [0020]).
Response to Arguments
Applicant states that “The Office Action assert that Tanabe discloses […] the feature of ‘estimate tissue stem cell number information for a number of tissue stem cells contained in the sample, based on the storage information and the surviving cell number information,’ as recited by Applicant’s Claim 1. However, paragraph [0104] of Tanabe appears to discuss calculating the sized of cell masses from the reprogrammed stem cell image; and paragraph [0109] of Tanabe appears to indicate calculating the number of cell masses from the reprogrammed stem cell image. Even assuming arguendo that the ‘number of cell masses’ in Tanabe corresponds to the ‘tissue stem cell number information for a number of tissue stem cells contained in the sample’ in Claim 1, the ‘stem cell image’ in Tanabe appears to be an image of the stem cell that has been reprogrammed and cultured. As such, the ‘stem cell image’ does not (and cannot) correspond to the ‘surviving cell number information’ of Applicant’s Claim 1, which is the information for the number of surviving cells contained in the sample before reprogramming and culturing. Here, the surviving cells include stem cells and other unwanted cells.”
It is respectfully submitted that this is not persuasive. The previously cited portions in Tanabe et al. state that the system described is a stem cell production system (paragraph [0104]) and thus the extracted cell masses are extracted stem cell masses. Additionally, Tanabe et al. is directed to a pluripotent stem cell production system. The claims merely state estimating tissue stem cell number information for a number of tissue stem cells contained in the sample based on the surviving cell number information. Tanabe et al. teaches using imaging to estimate the stem cell masses extracted, which are thus surviving stem cells. Thus, it is determined that the combination of Tanabe et al. and Califano et al. renders the limitations of the instant claims obvious.
Applicant states that “Moreover, Tanabe is also silent at least with respect to the feature of the use of the storage information which comprises information indicative of a number of CD34 positive cells at an initial time point for storage of the sample, a ration of the CD34 positive cells at the initial time point, a number of storage years, and/or storage period, for calculating the size or number of the cell masses, as previously recited in dependent Claim 9 and now recited in Claim 1.”
It is respectfully submitted that a new grounds of rejection has been set forth for claim 1 in view of the amendments incorporating the limitations of previously pending dependent claim 9 into claim 1, which in the previous Office Action was rejected over Tanabe et al. in view of Califano et al.
Furthermore, with respect to claim 17, Applicant states that “Tanabe and Califano do not teach or somehow suggest a model that estimates the tissue stem cell number information based on the storage information and the surviving cell number information”.
It is respectfully submitted that this is not persuasive. Tanabe et al. teaches processing circuitry (paragraph [0255]) configured to acquire storage information for storage of a sample from a donor (paragraphs [0359], [0363]), and surviving cell number information for a number of surviving cells contained in the sample (paragraphs [0101]-[0103]), and estimate tissue stem cell number information for a number of tissue stem cells contained in the sample, based on the storage information and the surviving cell number information (paragraphs [0104], [0109]). Furthermore, Califano et al. teaches a trained random forest model trained on selected reference populations to classify cells as progenitors (paragraph [0170]). Califano discloses that algorithms are highly effective in elucidating the factors necessary to induce lineage differentiation and cellular reprogramming (paragraph [0008]). Thus, one of ordinary skill in the art would have a reasonable expectation of success of effectively generating multipotent or pluripotent stem by using the algorithms of Califano et al. to identify important factors for the cell cultures.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emilie A Smith whose telephone number is (571)272-7543. The examiner can normally be reached 9am - 5pm.
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/E.A.S./Examiner, Art Unit 1686
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685
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