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 .
Claims Status
Claims 1-17 are pending.
Claims 1-17 are examined.
Priority
The instant application claims priority to Japanese Application No. 2021-070452, filed 04/19/2021. Therefore, the Effective Filing Date (EFD) assigned to each of the claims 1-17 is the Japanese filing date of Application No. 2021-070452, filed 04/19/2021.
Information Disclosure Statement
The Information Disclosure Statements filed 04/07/2022 is in compliance with the provisions of 37 CFR 1.97 and has therefore been considered. A signed copy of the IDS document is included with this Office Action.
Drawings
The drawings filed 04/07/2022 are accepted.
Specification
The disclosure is objected to because of the following informalities:
On page 34, line 27, “process..” should read “process.”
Appropriate correction is required.
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, 2, and 4-16 are rejected under 35 U.S.C. 101 because the claimed inventions are directed to an abstract idea of mental steps, mathematic concepts, or a natural law without significantly more.
Claim 3 is eligible under 35 USC 101 because the judicial exceptions are integrated into a practical application through manufacturing of the pluripotent stem cells based on the determined process.
Claim 17 is eligible under 35 USC 101 because the claim is not directed to a judicial exception.
The MPEP at MPEP 2106.03 sets forth steps for identifying eligible subject matter:
(1) Are the claims directed to a process, machine, manufacture or composition of
matter?
(2A)(1) Are the claims directed to a judicially recognized exception, i.e. a law of nature,
a natural phenomenon, or an abstract idea?
(2A)(2) If the claims are directed to a judicial exception under Prong One, then is the
judicial exception integrated into a practical application?
(2B) If the claims are directed to a judicial exception and do not integrate the judicial
exception, do the claims provide an inventive concept?
With respect to step (1): Yes, the claims are directed to systems.
With respect to step (2A)(1): The claims are directed to abstract ideas of mental processes and mathematical concepts.
“Claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection” (MPEP 2106.04). Abstract ideas include mathematical concepts (mathematical formulas or equations, mathematical relationships and mathematical calculations), certain methods of organizing human activity, and mental processes (procedures for observing, evaluating, analyzing/judging and organizing information (MPEP 2106.04(a)(2)). Laws of nature or natural phenomena include naturally occurring principles/relations that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature (MPEP 2106(b)).
Mental processes recited in claim 1:
surviving cell number information for a number of surviving cells contained in the sample
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
Dependent claims 2, 4-7, and 12-14 recite additional steps that either are directed to abstract ideas or further limit the judicial exceptions in independent claim 1, and as such, are further directed to abstract ideas. Hence, the claims explicitly recite numerous elements that individually and in combination constitute abstract ideas. The relevant recitations are:
Claim 2: “determine, based on the tissue stem cell number information, a manufacturing process for manufacturing pluripotent stem cells from the tissue stem cells”
Claim 4: “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”
Claim 5: “adopt a manufacturing process omitting extended cultivation of the tissue stem cells if the determined level is a first level, and adopt a manufacturing process including the extended cultivation of the determined level is a level other than the first level”
Claim 6: “adopt a manufacturing process omitting extended cultivation of the tissue stem cells if the determined level is a first level, adopt a manufacturing process including the extended cultivation for a first time if the determined level is a second level lower than the first level, and adopt a manufacturing process including the extended cultivation for a second time longer than the first time if the determined level is a third level lower than the second level”
Claim 7: “determine discontinuation of manufacturing of the pluripotent stem cells if the determined level is a fourth level unsuitable for the manufacturing of the pluripotent stem cells”
Claim 12: “the surviving cell number information comprises 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”
Claim 13: “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”
Claim 14: “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”
The abstract ideas in the claims are evaluated under Broadest Reasonable Interpretation (BRI) and determined herein to each cover mental processes and mathematic concepts because the claims recite no more than analyzing a cell culture sample to calculate characteristics in order to determine a manufacturing process.
With respect to step (2A)(2): The claims must therefore be examined further to determine whether they integrate that abstract idea into a practical application (MPEP 2106.04(d)). The claimed additional elements are analyzed alone or in combination to determine if the judicial exception is integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the judicial exception, the claim fails to integrate the abstract idea into a practical application (MPEP 2106.04(d).III).
Claim 1 recites the following additional elements that are not abstract ideas:
processing circuitry
acquire storage information for storage of a sample from a donor
The step of acquiring storage information gathers the data on which the judicial exceptions are performed and is thus directed to a data gathering step. Data gathering does not impose any meaningful limitation on the abstract idea, or how the abstract idea is performed. Data gathering steps are not sufficient to integrate an abstract idea into a practical application (MPEP 2106.05(g)). The element of a system comprising processing circuitry does not specifically describe how the system is performing the steps. Hence, these are interpreted as mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application. The courts have weighed in and consistently maintained that when, for example, a memory, display, processor, machine, etc. ... are recited so generically (i.e., no details are provided) that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer (see MPEP 2106.05(f)).
Dependent claims 8-11 are directed to limitations limiting the data gathered and thus are directed to data gathering steps. Dependent claims 15 and 16 are directed to generic computer elements.
None of these dependent claims recite additional elements, alone or in combination, which would integrate a judicial exception into a practical application.
Lastly, the claims have been evaluated with respect to step (2B): Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims lack a specific inventive concept. Under said analysis, Applicant is reminded that the judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). Identifying whether the additional elements beyond the abstract idea amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they provide significantly more than the judicial exception (MPEP 2106.05.A i-vi).
With respect to the instant claims, the additional elements described above do not rise to the level of significantly more than the judicial exception. As set forth in the MPEP at 2106.05(d)(I), determinations of whether or not additional elements (or a combination of additional elements) may provide significantly more and/or an inventive concept rests in whether or not the additional elements (or combination of elements) represents well-understood, routine, conventional activity. Said assessment is made by a factual determination stemming from a conclusion that an element (or combination of elements) is widely prevalent or in common use in the relevant industry, which is determined by either a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to claim 1: The additional elements of a system comprising processing circuitry and acquire storage information for storage of a sample from a donor do not rise to the level of significantly more than the judicial exceptions. With regard to the system, as exemplified in the MPEP at 2106.05(f) with reference to Alice Corp. 573 US at 223, 110 USPQ2d at 1983 “claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible”. Therefore, the device constitutes no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than the abstract idea (see MPEP 2105(b)I-III). As stated in the MPEP at 2106.05(d).II, with reference to Mayo, 566 U.S. at 79, 101 USPQ2d at 1968, steps of determining the level of a biomarker, such as ratios of CD34 positive cells, is a well-understood, routine, and conventional activity. As such, it is recognized that these additional limitations are routine, well understood, and conventional in the art. These limitations do not improve the functioning of a computer, or comprise an improvement to any other technical field, they do not require or set forth a particular machine, they do not affect a transformation of matter, nor do they provide a non-conventional or unconventional step. As such, these limitations fail to rise to the level of significantly more.
With respect to claim 8: The additional elements of the sample comprises blood of the donor, and the tissue stem cells are hematopoietic stem cells do not rise to the level of significantly more than the judicial exceptions. As stated in the Specification on page 15, line 8 of the Specification of the instant application, umbilical blood banks have been instituted for the transplantation of hematopoietic stem cells and approximately 10,000 samples are stored in a frozen state in Japan. As such, it is recognized that these additional limitations are routine, well understood, and conventional in the art. These limitations do not improve the functioning of a computer, or comprise an improvement to any other technical field, they do not require or set forth a particular machine, they do not affect a transformation of matter, nor do they provide a non-conventional or unconventional step. As such, these limitations fail to rise to the level of significantly more.
With respect to claim 9: The additional element of the storage information comprises information indicative of a number of CD34 positive cells at an initial time point for storage of the sample, a ratio of the CD34 positive cells at the initial time point, a number of storage years, and/or a storage period does not rise to the level of significantly more than the judicial exception. As stated in the MPEP at 2106.05(d).II, with reference to Mayo, 566 U.S. at 79, 101 USPQ2d at 1968, steps of determining the level of a biomarker, such as ratios of CD34 positive cells, is a well-understood, routine, and conventional activity. As such, it is recognized that these additional limitations are routine, well understood, and conventional in the art. These limitations do not improve the functioning of a computer, or comprise an improvement to any other technical field, they do not require or set forth a particular machine, they do not affect a transformation of matter, nor do they provide a non-conventional or unconventional step. As such, these limitations fail to rise to the level of significantly more.
With respect to claim 10: The additional element of identification information of the donor does not rise to the level of significantly more than the judicial exception. As stated in the Specification on page 15, line 8 of the Specification of the instant application, umbilical blood banks have been instituted for the transplantation of hematopoietic stem cells and approximately 10,000 samples are stored in a frozen state in Japan. As such, it is recognized that these additional limitations are routine, well understood, and conventional in the art. These limitations do not improve the functioning of a computer, or comprise an improvement to any other technical field, they do not require or set forth a particular machine, they do not affect a transformation of matter, nor do they provide a non-conventional or unconventional step. As such, these limitations fail to rise to the level of significantly more.
With respect to claim 11: The additional element of the sample comprises umbilical blood which has been stored in an umbilical blood depository does not rise to the level of significantly more than the judicial exception. As stated in the Specification on page 15, line 8 of the Specification of the instant application, umbilical blood banks have been instituted for the transplantation of hematopoietic stem cells and approximately 10,000 samples are stored in a frozen state in Japan. As such, it is recognized that these additional limitations are routine, well understood, and conventional in the art. These limitations do not improve the functioning of a computer, or comprise an improvement to any other technical field, they do not require or set forth a particular machine, they do not affect a transformation of matter, nor do they provide a non-conventional or unconventional step. As such, these limitations fail to rise to the level of significantly more.
With respect to claim 15: The additional element of a display configured to display the tissue stem cell number information does not rise to the level of significantly more than the judicial exception. As exemplified in the MPEP at 2106.05(f) with reference to Alice Corp. 573 US at 223, 110 USPQ2d at 1983 “claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible”. Therefore, the device constitutes no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than the abstract idea (see MPEP 2105(b)I-III). As such, it is recognized that these additional limitations are routine, well understood, and conventional in the art. These limitations do not improve the functioning of a computer, or comprise an improvement to any other technical field, they do not require or set forth a particular machine, they do not affect a transformation of matter, nor do they provide a non-conventional or unconventional step. As such, these limitations fail to rise to the level of significantly more.
With respect to claim 16: The additional element of a display configured to display the manufacturing process does not rise to the level of significantly more than the judicial exception. As exemplified in the MPEP at 2106.05(f) with reference to Alice Corp. 573 US at 223, 110 USPQ2d at 1983 “claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible”. Therefore, the device constitutes no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than the abstract idea (see MPEP 2105(b)I-III). As such, it is recognized that these additional limitations are routine, well understood, and conventional in the art. These limitations do not improve the functioning of a computer, or comprise an improvement to any other technical field, they do not require or set forth a particular machine, they do not affect a transformation of matter, nor do they provide a non-conventional or unconventional step. As such, these limitations fail to rise to the level of significantly more.
The claims have all been examined to identify the presence of one or more judicial exceptions. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether the additional limitations integrate the judicial exception into a practical application. Each additional limitation in the claims has been addressed, alone and in combination, to determine whether those additional limitations provide an inventive concept which provides significantly more than those exceptions. Individually, the limitations of the claims and the claims as a whole have been found lacking.
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 1-4, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Tanabe et al. (US 2019/0338237 A1, published November 2019, Application publication of Patent 10508260 IDS reference).
Regarding claim 1, Tanabe et al. teaches a 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]).
Regarding claim 2, the claim is directed to the processing circuitry being configured to determine, based on the tissue stem cell number information, a manufacturing process for manufacturing pluripotent stem cells from the tissue stem cells. Tanabe et al. teaches the system of claim 1. Tanabe et al. teaches determining a manufacturing process for the cell cultures based on the image data of the cell number information (paragraph [0272]).
Regarding claim 3, the claim is directed to a manufacturing apparatus 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. Tanabe et al. teaches the system of claim 2. Tanabe et al. also teaches manufacturing pluripotent stem cells from the culture according to a plan, and the pluripotent stem cells having an origin in a donor (paragraph [0372]).
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 2. 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. 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. Tanabe et al. also teaches estimating the number of tissue stem cells before cultivation (paragraph [0105]).
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 8-11, 14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Tanabe et al., as applied to claims 1-4, 12, and 13 in the 102 rejection above, in view of Califano et al. (US 2024/0228965 A9, effectively filed 10/01/2020).
Regarding claim 8, the claim is directed to the sample comprising blood of the donor, and the tissue stem cells being hematopoietic stem cells. Tanabe et al. teaches the system of claim 1. Tanabe et al. also teaches the sample comprising blood of the donor (paragraphs [0363], [0365]).
Tanabe et al. does not teach the claim element of the tissue stem cells being hematopoietic stem cells.
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]).
Regarding claim 9, the claim is directed to the storage information comprising information indicative of a number of CD34 positive cells at an initial time point for storage of the sample, a ratio of the CD34 positive cells at the initial time point, a number of storage years, and/or a storage period. Tanabe et al. teaches the system of claim 8 in view of Califano et al.
Tanabe et al. does not teach the claim element of 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. information indicative of a number of CD34 positive cells at an initial time point (paragraph [0043]).
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 9 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 8 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.
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., as applied to claims 1-4, 12, and 13 in the 102 rejection, in view of Hirano (US 2020/0400603 A1, IDS reference).
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.
Tanabe et al. does not 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 2.
Tanabe et al. does not 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. 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]).
Conclusion
No claims are allowed.
Claim 5-7 appear to be free from the prior art.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D Riggs can be reached at (571)270-3062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.A.S./Examiner, Art Unit 1686
/LARRY D RIGGS II/Supervisory Patent Examiner, Art Unit 1686
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