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 .
Election/Restrictions
Applicant' s election without traverse of Group I, claims 1-25 in the reply filed on 05/07/2026 is acknowledged.
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 “unit” 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: a measurement unit and an estimation unit in claim 1.
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.
Applicant’s specification, paragraph 8, teaches the measurement unit may include at least one of an image acquisition unit or a signal detection unit.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
As indicated above, claim limitation “estimation unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structures, materials, or acts for performing the entire claimed functions and to clearly link the structures, materials, or acts to the functions. Therefore, claims 1-25 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement, and under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If Applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 1-25 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding Claim 1, it is unclear what the metes and bounds of the estimation unit (lines 7+) are. In other words, it is unclear as to what information is used with the estimation unit. Lines 7+ of the claims are confusing as to the information required and it is difficult to discern the limitations with the current formatting and sentence structure. Further clarification and correction is required.
Claims 2-25 are further rejected as they depend from Claim 1.
Claim 2 recites the limitation “the cell that is commercialized” in line 5. There is insufficient antecedent basis for this limitation in the claim. It is unclear what cell this is referring to. Further clarification and correction is required.
Claim 9 recites the limitation “the cells” in line 3. It is unclear whether the cells are the cell before treatment from line 8 in claim 1 or the cell group from claim 1 or the predetermined cell from claim 1. Further correction and clarification is required.
Claims 12 and 13 are further rejected as they depend from Claim 9.
Claim 12 recites the limitation “the treated cell” in line 4. There is insufficient antecedent basis for this limitation in the claim. It is unclear what cell this is referring to. Further clarification and correction is required.
Claim 13 recites the limitation “the cell fixed to the culture vessel” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. It is unclear what cell this is referring to. Further clarification and correction is required.
Claim 14 recites the limitation "the culture control" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is the same control as claim 10 or a different control altogether. For examination purposes it is interpreted as the control from claim 10.
Claim 15 and 16 are further rejected as they depend from claim 14.
Claim 19, line 1 states “a second learner”. It is unclear what is meant by a second learner as there is no first learner in claim 19 or the depended from claim 1. Further clarification and correction is required. For examination purposes it is interpreted to depend from claim 17.
Claim Rejections - 35 USC § 102
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 1-12 and 14-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wakui (WO2018101004A1).
Regarding Claim 1, Wakui teaches the following:
A culture vessel (para 34)(a cell culture unit capable of culturing cells)
A microscope equipped with an imaging element such as a CMOS image sensor (para 34)(a measurement unit capable of measuring the cell group)
The evaluator 21 acquires the cell image output from the microscope device 10 and evaluates the state of the cells included in the acquired cell image and divides the input cell image into multiple regions of interest R, evaluates the state of the cells contained in the cell image of each region of interest R, and outputs the evaluation results for each region of interest R (para 38) and next, the predictor 22 (estimation unit) receives input of the evaluation results by the evaluator 21 of a cell image captured at a specific point in time, and outputs the state of cells in a specific region of interest at a point in time later than the specific point in time based on the evaluation results by the evaluator 21 of the surrounding region of the specific region of interest within the cell image (para 46)(the estimation unit estimates, on a basis of information regarding a cell before treatment of the cell group and at least one of information regarding a predetermined cell to reach after treatment of the cell group or a predetermined treatment condition for the cell group before treatment, a treatment condition under which the cell group is derivable to the information regarding the predetermined cell or information regarding the cell after treatment of the cell group derived by the predetermined treatment condition)
Regarding Claim 2, Wakui teaches all of the limitations of Claim 1 (see above). Wakui further teaches an operation content determination unit that acquires information on the state of the cell output from the predictor and determines the operation content for the cell based on the information on the state of the cell (the estimation unit sets the information regarding the predetermined cell and/or the predetermined treatment condition on a basis of information regarding approval of the cell that is commercialized).
Regarding Claim 3, Wakui teaches all of the limitations of Claim 1 (see above). Wakui further teaches the microscope device 10 photographs cells contained in a culture vessel and outputs cell images (the measurement unit is configured to acquire at least one of the information regarding the cell before treatment).
Regarding Claim 4, Wakui teaches all of the limitations of Claim 3 (see above). Wakui further teaches a microscope equipped with an imaging element such as a CMOS image sensor (para 34)(the measurement unit includes at least one of an image acquisition unit or signal detection unit).
Regarding Claim 5, Wakui teaches all of the limitations of Claim 4 (see above). Wakui further teaches a phase-contrast image is output from the imaging element as a cell image (para 34)(the image acquired by the image acquisition unit is a non-stained image.
Regarding Claim 6, Wakui teaches all of the limitations of Claim 5 (see above). As the limitations of claim 5 were met by the non-stained image and claim 6 provides no further limitations regarding the non-stained image, only the non-selected limitation to meet claim 5, the device of Wakui meets the limitations of claim 6.
Regarding Claim 7, Wakui teaches all of the limitations of Claim 5 (see above). Wakui further teaches a phase-contrast image is output from the imaging element as a cell image (para 34)(the non-stained image includes at least one of a bright field image, phase difference image, a polarized image, or an image that is identified from information learned from the non-stained image or the fluorescence image and is pseudo-stained for each cell feature).
Regarding Claim 8, Wakui teaches all of the limitations of Claim 4 (see above). Wakui further teaches a microscope equipped with an imaging element such as a CMOS image sensor (para 34)(the image acquisition unit acquires an image from at least one of a CMOS, a signal processing sensor, or an event detection sensor).
Regarding Claim 9, Wakui teaches all of the limitations of Claim 1 (see above). Wakui further teaches the control unit 23 controls the entire cell image evaluation device 30 (para 61), which does sort the cells on a basis of the predetermined treatment condition of the treatment condition estimated by the estimation unit.
Regarding Claim 10, Wakui teaches all of the limitations of Claim 1 (see above). Wakui further teaches the control unit 23 controls the entire cell image evaluation device 30 (para 61) and a cell image evaluation device and a cell image evaluation program that can grasp how cells to be cultured will change in the future and can perform operations on the cells, such as passaging and medium replacement, at the appropriate time (para 12)(a control unit that performs control to culture the cell on a basis of the predetermined treatment condition of the treatment condition estimated by the estimation unit).
Regarding Claim 11, Wakui teaches all of the limitations of Claim 1 (see above). Wakui further teaches the control unit 23 controls the entire cell image evaluation device 30 (para 61) and a cell image evaluation device and a cell image evaluation program that can grasp how cells to be cultured will change in the future and can perform operations on the cells, such as passaging and medium replacement, at the appropriate time (para 12)(a control unit that performs control to sort and culture the cell on a basis of the predetermined treatment condition of the treatment condition estimated by the estimation unit).
Regarding Claim 12, Wakui teaches all of the limitations of Claim 9 (see above). Wakui further teaches the control unit controls the entire cell image evaluation device 20 (para 61) which if the quality of the cells falls below a preset reference value and is poor, the user may be prompted to undergo genetic testing (para 79)(the control unit sets a threshold value for the estimated treatment condition or the information regarding the treated cell, and performs processing of stopping the production of the cell and/or re-collecting the cell depending on the threshold value or depending on information specified by a user).
Regarding Claim 14, Wakui teaches all of the limitations of Claim 9 (see above). Wakui further teaches In the cell image evaluation device of the present invention, the operations performed on the cells are preferably subculture, medium exchange, medium change, drug addition, picking, or genetic testing (para 27)(the control controls physiological environment).
Regarding Claim 15, Wakui teaches all of the limitations of Claim 14 (see above). As the limitations of claim 14 were met by the physiological environment and claim 15 provides no further limitations regarding the physiological environment, only the non-selected limitation to meet claim 14, the device of Wakui meets the limitations of claim 15.
Regarding Claim 16, Wakui teaches all of the limitations of Claim 14 (see above). Wakui further teaches In the cell image evaluation device of the present invention, the operations performed on the cells are preferably subculture, medium exchange, medium change, drug addition, picking, or genetic testing (para 27)(the control of the physiological environment includes control of culture solution).
Regarding Claim 17, Wakui teaches all of the limitations of Claim 1 (see above). Wakui further teaches a learning feature is obtained by arranging the evaluation results of each region of interest R in region ER11 in order from the evaluation result in the upper left to the evaluation result in the lower right, and the evaluation result of a specific region of interest SR12 in region ER12 is obtained as the learning class corresponding to this learning feature (para 51)(a first learner that learns relevance between the cell treated under the treatment condition estimated by the estimation unit and information regarding therapy using the cell as input information)
Regarding Claim 18, Wakui teaches all of the limitations of Claim 17 (see above). Wakui further teaches the relationship between the learning feature amounts and the learning classes is machine-learned by the predictor (para 51)(the estimation unit estimates information regarding therapy of the cell after treatment of the cell group derived by the treatment condition on a basis of the first learner and the information regarding the cell before treatment).
Regarding Claim 19, Wakui teaches all of the limitations of Claim 1 (see above). Wakui further teaches three areas is learned (multiple learners, including a second learner) by machine learning, but the predictor 22 can also learn the correspondence between the evaluation results of many other areas. As above, the learning feature is obtained by arranging the evaluation results of each region of interest R in a region in order from the evaluation result in the upper left to the evaluation result in the lower right, and the evaluation result of a specific region of interest is obtained as the learning class corresponding to this learning feature (para 51)(a second learner that learns relevance between the information regarding the cell before treatment and the treatment condition by using, as input information, the information regarding the cell before treatment, the treatment condition estimated by the estimation unit, and the cell before treatment treated under the treatment condition).
Regarding Claim 20, Wakui teaches all of the limitations of Claim 19 (see above). Wakui further teaches the relationship between the learning feature amounts and the learning classes is machine-learned by the predictor (para 51)(the estimation unit estimates a treatment condition under which the cell group is derivable to the information regarding the predetermined cell on a basis of the second learner and the information regarding the cell before treatment).
Regarding Claim 21, Wakui teaches all of the limitations of Claim 1 (see above). Wakui further teaches the device to evaluates the state of cells contained in each region of interest (para 13)(the information regarding the cells before treatment includes at least one of a configuration, a state, a number, a proportion, a type, an increase rate, a survival rate, genetic information, or information regarding a molecule of the cell before treatment).
Regarding Claim 22, Wakui teaches all of the limitations of Claim 21 (see above). As the limitations of claim 21 were met by the state and claim 22 provides no further limitations regarding the state, only the non-selected limitation to meet claim 21, the device of Wakui meets the limitations of claim 22.
Regarding Claim 23, Wakui teaches all of the limitations of Claim 1 (see above). Wakui further teaches the device to evaluates the state of cells contained in each region of interest (para 13)(the information regarding the cell after treatment includes at least one of a configuration, a state, a number, a proportion, an increase rate, a survival rate, a response rate, a recurrence rate, or a side effect of the cell after treatment).
Regarding Claim 24, Wakui teaches all of the limitations of Claim 1 (see above). Wakui further teaches the predictor 22 may also be configured to accept input of predicted dates and times, such as one day and two days later, and predict and output the state of the cells at the predicted dates and times (para 77)(the treatment condition includes a culture condition related to at least one of a stimulating factor or a number of culture days).
Regarding Claim 25, Wakui teaches all of the limitations of Claim 1 (see above). Regarding claim 25, these limitations are directed to the material worked upon by the apparatus, all the structural limitations of the claim has been disclosed by Wakui and the apparatus of Wakui is capable of working on peripheral blood mononuclear cell fraction collected from a patient or donor. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Wakui (see MPEP §2115).
Claim Rejections - 35 USC § 103
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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wakui (WO2018101004A1) in view of Kajihara et al. (WO2017199651A1).
Wakui teaches all of the limitations of Claim 9 (see above). Wakui does not teach the control unit treats the cell fixed to the culture vessel via a light-selective linker in such a manner that the cells are sorted by optical control.
Kajihara teaches a biomaterial analyzer comprising: a solid-state image sensor; and molecules capable of binding to biomaterials, immobilized on the light-receiving surface of the solid-state image sensor via a stimulus-degradable linker (page 4, para 2). Kajihara further teaches a molecule 603 capable of binding to a biomolecule is immobilized on the spectral layer 102 stacked on the solid-state image sensor 101 via a polymer 601 and a photodegradable linker 602 (page 13, para 2) and image sensor 101 can be used to perform various analyses, such as analyzing cells using images, for example, sorting cells based on the number of captured cells, cell size, or cell type using multiple fluorescence detections (page 15, para 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Wakui with the photodegradable linker and usage of sorting cells according to Kajihara. One would have been motivated to make this modification as it would improve cell purity, recovery rate, and other factors (page 2, para 2).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.E.L./Examiner, Art Unit 1796
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
Prosecution Insights