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 .
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.
1. Claims 1-5 and 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2015/0104786 to Shirasuna et al.
Shirasuna et al. teaches a cell analysis and sample screening method which includes a first dispersion unit 12 for dispersing aggregated cells using a shearing force and a second dispersing unit 16 that disperses, into single cells, aggregated cells that are remaining even after the first dispersion process. [0038]
The cells in Shirasuna et al. are dispersed for purposes of measuring cell size and cell nucleus size using a cytometer 40. [0038], [0069].
Shirasuna et al. teaches that the specimen can be epithelial cells of the uterine cervix collected from a subject. [0035]
Shirasuna et al. does not teach obtaining a dispersion condition corresponding to a type of the specimen.
It would have been obvious to one of ordinary skill in the art to disperse the cells using the first and second dispersing units to provide a predetermined dispersion condition that allows for analysis of the cells by cytometry as taught by Shirasuna et al. Such predetermined dispersion condition can be merely the use of the two dispersion units in series, as taught by Shirasuna, et al.
I.) Regarding applicant’s claim 1, as noted above Shirasuna et al. teaches and renders obvious all the elements of claim 1.
Therefore, Shirasuna et al. renders claim 1 obvious.
II.) Regarding applicant’s claim 2, as noted above Shirasuna et al. renders claim 1 obvious from which claim 2 depends.
Claim 2 recites that in the obtaining of the dispersion condition, the dispersion condition corresponding to an organ and/or site from which the specimen is derived is obtained.
As noted above, Shirasuna et al. teaches that the specimen can be epithelial cells.
Shirasuna et al. teaches that the specimen can be epithelial cells of the uterine cervix collected from a subject. [0035]
Therefore, Shirasuna et al. renders claim 2 obvious.
III.) Regarding applicant’s claim 3, as noted above Shirasuna et al. renders claim 2 obvious from which claim 3 depends.
Claim 3 recites that in the obtaining of the dispersion condition, the dispersion condition corresponding to an organ or site collected from one of uterine cervix, uterine body, oral cavity, esophagus, and bronchus, as the type of the specimen, is obtained.
As noted above, Shirasuna et al. teaches that the specimen can be epithelial cells.
Shirasuna et al. teaches that the specimen can be epithelial cells of the uterine cervix collected from a subject. [0035]
Therefore, Shirasuna et al. renders claim 3 obvious.
IV.) Regarding applicant’s claim 4, as noted above Shirasuna et al. renders claim 2 obvious from which claim 4 depends.
Claim 4 recites that in the obtaining of the dispersion condition, a first dispersion condition is obtained in a case of the specimen that contains more stratified squamous epithelial cells than simple columnar epithelial cells; and a second dispersion condition is obtained in a case of the specimen that contains more simple columnar epithelial cells than stratified squamous epithelial cells, and the second dispersion condition is a condition that has a dispersion effect higher than that of the first dispersion condition.
Shirasuna et al. does not teach a first dispersion condition is obtained in a case of the specimen that contains more stratified squamous epithelial cells than simple columnar epithelial cells; and a second dispersion condition is obtained in a case of the specimen that contains more simple columnar epithelial cells than stratified squamous epithelial cells, and the second dispersion condition is a condition that has a dispersion effect higher than that of the first dispersion condition.
Shirasuna et al. teaches that the first dispersion unit uses shearing force to effect dispersion and that the second dispersion unit uses ultrasonic vibration for effect dispersion. [0053], [0060]
The second dispersion unit further disperses the cells that were preliminary dispersed by the first dispersion unit, demonstrating that the ultrasonic vibration provides a higher dispersion that the first dispersion that uses shearing force.
It would have been obvious to one of ordinary skill in the art to modify Shirasuna et al. to use different dispersion conditions based on the dispersion characteristics of different cells, and use the ultrasonic dispersion taught by Shirasuna et al. for cells that do not disperse easily. It would further have been obvious to one skilled in the art to conduct routine engineering optimization experimentation on stratified squamous epithelial cells (layered flat cells) and columnar epithelial cells (tall, rectangular cells) to determine cells mixtures that include more stratified squamous epithelial cells can be sufficiently dispersed using shearing force and that cell mixture that include more columnar epithelial cells require the ultrasonic dispersion for analysis by cytometry.
Therefore, Shirasuna et al. renders claim 4 obvious.
V.) Regarding applicant’s claim 5, as noted above Shirasuna et al. renders claim 2 obvious from which claim 5 depends.
Claim 5 recites that the dispersing of the cells aggregated and contained in the specimen includes applying ultrasonic vibration to the specimen, and in the obtaining of the dispersion condition, a first dispersion condition is obtained when the specimen is a tissue of uterine cervix, and a second dispersion condition having a processing time for applying the ultrasonic vibration to the specimen longer than that of the first dispersion condition is obtained when the specimen is a tissue of uterine body.
Shirasuna et al. does not teach and in the obtaining of the dispersion condition, a first dispersion condition is obtained when the specimen is a tissue of uterine cervix, and a second dispersion condition having a processing time for applying the ultrasonic vibration to the specimen longer than that of the first dispersion condition is obtained when the specimen is a tissue of uterine body.
Shirasuna et al. teaches the specimen is a biological sample of epithelial cells and glandular cells of the uterine cervix.
It would have been obvious to one of ordinary skill in the art to apply the testing methods of Shirasuna et al. to other types of cancer cells in other samples, including tissue of a uterine body.
As noted above, Shirasuna et al. teaches ultrasonic vibration.
It would have been obvious to one of ordinary skill in the art to modify Shirasuna et al. to conduct routine engineering optimization experimentation and use a dispersion condition when the specimen is a tissue of uterine cervix, and a second dispersion condition having a processing time for applying the ultrasonic vibration to a specimen longer than that of the first dispersion condition when the specimen is another type of sample, including a tissue of uterine body, with the ultrasonic vibration time optimized to obtain a desired dispersion for cytometry analysis.
Therefore, Shirasuna et al. renders claim 5 obvious.
VI.) Regarding applicant’s claim 7, as noted above Shirasuna et al. renders claim 1 obvious from which claim 7 depends.
Claim 7 recites that the dispersing of the cells includes applying a shearing force to the specimen, thereby dispersing the aggregated cells.
Shirasuna et al. teaches the first dispersion processing part 11 is configured to perform a first dispersion process of mechanically applying a shearing force to aggregated cells in the specimen. [0038].
Therefore, Shirasuna et al. renders claim 7 obvious.
VII.) Regarding applicant’s claim 8, as noted above Shirasuna et al. renders claim 1 obvious from which claim 8 depends.
Claim 8 recites that the dispersing of the cells includes applying ultrasonic vibration to the specimen, thereby dispersing the aggregated cells.
Shirasuna et al. teaches the second dispersion processing part 16 is configured to disperse aggregated cells by applying ultrasonic vibration to the specimen. [0040]
Therefore, Shirasuna et al. renders claim 8 obvious.
VIII.) Regarding applicant’s claim 9, as noted above Shirasuna et al. renders claim 1 obvious from which claim 9 depends.
Claim 9 recites that the dispersing of the cells includes: first dispersion processing of applying a shearing force to the specimen, thereby dispersing the aggregated cells; and second dispersion processing of applying ultrasonic vibration to the specimen after the first dispersion processing, thereby dispersing the aggregated cells.
As noted above, Shirasuna et al. teaches that the first dispersion unit is configured to perform a first dispersion process of mechanically applying a shearing force to aggregated cells in the specimen, and that the second dispersion unit is configured to disperse aggregated cells by applying ultrasonic vibration to the specimen.
Therefore, Shirasuna et al. renders claim 9 obvious.
IX.) Regarding applicant’s claim 10, as noted above Shirasuna et al. renders claim 9 obvious from which claim 10 depends.
Claim 10 recites in the obtaining of the dispersion condition, the first dispersion processing has a dispersion condition that is identical between a case where the specimen is a tissue of uterine cervix and a case where the specimen is a tissue of uterine body, and the second dispersion processing has a dispersion condition that is different between a case where the specimen is a tissue of the uterine cervix and a case where the specimen is a tissue of the uterine body.
Shirasuna et al, does not teach that the first dispersion processing has a dispersion condition that is identical between a case where the specimen is a tissue of uterine cervix and a case where the specimen is a tissue of uterine body, and the second dispersion processing has a dispersion condition that is different between a case where the specimen is a tissue of the uterine cervix and a case where the specimen is a tissue of the uterine body.
As noted above, Shirasuna et al. teaches the specimen is a biological sample of epithelial cells and glandular cells of the uterine cervix. [0039]
It would have been obvious to one of ordinary skill in the art to apply the testing methods of Shirasuna et al. to other types of cancer cells in other samples, including tissue of a uterine body.
It would have been obvious to one or ordinary skill in the art to modify Shirasuna et al. to conduct routine engineering optimization experimentation and determine useful different dispersion conditions for different samples including tissue of uterine cervix and tissue of the uterine body as necessary to provide a suitable dispersion for cytometry analysis.
Therefore, Shirasuna et al. renders claim 10 obvious.
X.) Regarding applicant’s claim 11, as noted above Shirasuna et al. renders claim 7 obvious from which claim 11 depends.
Claim 11 recites that the dispersion condition in the applying of the shearing force to the specimen includes at least one of a processing time, and a speed of a member that applies the shearing force.
It would have been obvious to one of ordinary skill in the art to apply the shearing force in Shirasuna et al. for a sufficient period of time to achieve a desired dispersion.
Therefore, Shirasuna et al. renders claim 11 obvious.
XI.) Regarding applicant’s claim 12, as noted above Shirasuna et al. renders claim 8 obvious from which claim 11 depends.
Claim 12 recites that the dispersion condition in the applying of the ultrasonic vibration to the specimen includes at least one of a processing time, a frequency of vibration, and an intensity of the ultrasonic vibration.
It would have been obvious to one of ordinary skill in the art to apply the ultrasonic vibration in Shirasuna et al. for a sufficient period of time to achieve a desired dispersion.
Therefore, Shirasuna et al. renders claim 12 obvious.
XII.) Regarding applicant’s claim 13, as noted above Shirasuna et al. renders claim 1 obvious from which claim 13 depends.
Claim 13 recites further comprising staining the cells.
Shirasuna et al. teaches staining cells. [0066]
Therefore, Shirasuna et al. renders claim 13 obvious.
2. Claim 6 is rejected under 35 USC 103 as being unpatentable over Shirasuna et al. as applied to claim 2 and further in view of Japanese Patent Application Publication No. JP2016001184 to Clark et al. (cited by applicant).
I.) Regarding applicant’s claim 6, as noted above Shirasuna et al. renders claim 2 obvious from which claim 6 depends.
Claim 6 recites that the obtaining of the dispersion condition includes: obtaining, by an information reading part, specimen information regarding the specimen; and obtaining, on the basis of the obtained specimen information, the dispersion condition corresponding to the organ and/or site from which the specimen is derived.
Shirasuna et al. does not teach obtaining, by an information reading part, specimen information regarding the specimen; and obtaining, on the basis of the obtained specimen information, the dispersion condition corresponding to the organ and/or site from which the specimen is derived.
Clark et al. teaches cell analysis that includes a bar code or other means for identifying a cartridge, a cell sample source, or both within the device. A bar code or other means of identifying the cartridge may be used to facilitate sample identification, patient safety, or both. Such identification means may be adapted to interact with a data storage system, an automated cell processing system, an assay, a personal digital assistant (PDA), or various combinations thereof. [0027]
It would have been obvious to one of ordinary skill in the art to modify Shirasuna et al. to provide information regarding specimens as taught by Clark et al. and obtaining, on the basis of the obtained specimen information, the dispersion condition corresponding to the organ and/or site from which the specimen is derived, based on prior analysis of similar analyzed sample type.
Therefore, Shirasuna et al. in view of Clark et al. renders claim 6 obvious.
3. Claims 14 and 15 stand rejected under 35 USC 103 as being unpatentable over Shirasuna et al.
I.) Regarding applicant’s claim 14, claim 14 recites a cell analysis method for analyzing proliferative capacity of each cell contained in a specimen, the cell analysis method comprising: preparing a sample by the sample preparation method according to claim 1; detecting optical information from the cell in the sample; and analyzing a measurement item regarding the proliferative capacity of the cell, on the basis of the detected optical information.
As noted above, Shirasuna et al. renders claim 1.
Shirasuna et al. teaches extracting target cells from a population of cells derived from an epithelial tissue on the basis of N/C ratio representing a relative size of a nucleus to a cytoplasm; determining a threshold according to a proportion of the target cells in the population; classifying the target cells into at least a first group and a second group by difference of amount of DNA; and evaluating a pathology of the epithelial tissue by comparing a ratio of numbers of cells between the first and second groups with the threshold determined. (claim 14)
Evaluating the pathology of the epithelial tissue is interpreted as analyzing a measurement item regarding the proliferative capacity of the cell.
Therefore, Shirasuna et al. renders claim 14 obvious.
II.) Regarding applicant’s claim 15, as noted above Shirasuna et al. renders claim 14 obvious from which claim 15 depends.
Claim 15 recites that the measurement item includes a measurement item to be analyzed on the basis of a size of the cell, a size of a cell nucleus of the cell, and a DNA content of the cell, which are obtained from the optical information detected from the cell in the sample.
Shirasuna et al. teaches measuring the size of cells, the size of the cell nucleus and the amount of DNA in cells. [0069]
Therefore, Shirasuna et al. renders claim 15 obvious.
4. Claims 16 and 20 are rejected under 35 USC 103 as being unpatentable over Shirasuna et al.
As noted above, Shirasuna et al. teaches a cell analysis and sample screening method which includes a first dispersion unit 12 for dispersing aggregated cells using a shearing force and a second dispersing unit 16 that into single cells, aggregated cells that are remaining even after the first dispersion process. [0038]
The cells in Shirasuna et al. are dispersed for purposes of measuring cell size and cell nucleus size using a cytometer 40. [0038], [0069].
Shirasuna et al. teaches a microprocessors and controllers, including a preparation control unit 28
Shirasuna et al. does not teach obtaining a dispersion condition corresponding to a type of the specimen.
It would have been obvious to one of ordinary skill in the art to modify Shirasuna et al. to disperse the cells using the first and second dispensing units to a predetermined dispersion condition that allows for analysis of the cells by cytometry as taught by Shirasuna et al. Such predetermined dispersion condition can be merely the use of a dispersion condition determined to be useful or optimum by previous use of the method of Shirasuna et al.
It would further have been obvious to one of ordinary skill in the art to modify Shirasuna et al. to provide a controller to obtain dispersion condition corresponding to a type of the specimen and control the dispersion processing part so as to perform a dispersion process on the specimen according to the obtained dispersion condition, for purposes of automating the processing and analysis.
I.) Regarding applicant’s claim 16, as noted above Shirasuna et al, renders all the limitations of claim 16 obvious.
Therefore, Shirasuna et al, renders claim 16 obvious.
II.) Regarding applicant’s claim 20, as noted above Shirasuna et al. renders claim 16 obvious from which claim 20 depends.
Claim 20 recites that the dispersion processing part includes: a first dispersion processing part configured to apply a shearing force to the specimen, thereby dispersing the aggregated cells; and a second dispersion processing part configured to apply ultrasonic vibration to the specimen, thereby dispersing the aggregated cells, and the controller is programmed to cause the first dispersion processing part and the second dispersion processing part to operate under the dispersion condition corresponding to the specimen.
As noted above, Shirasuna et al. a first dispersion unit that applies shearing force to disperse cell aggregates and a second dispersion unit that applies ultrasonic vibrations to disperse cells.
Shirasuna et al. does not teach that the dispersion processing part includes: a first dispersion processing part configured to apply a shearing force to the specimen, thereby dispersing the aggregated cells; and a second dispersion processing part configured to apply ultrasonic vibration to the specimen, thereby dispersing the aggregated cells, and the controller is programmed to cause the first dispersion processing part and the second dispersion processing part to operate under the dispersion condition corresponding to the specimen.
It would have been obvious to modify the dispersion processing part in Shirasuna et al. to include: a first dispersion processing part configured to apply a shearing force to the specimen, thereby dispersing the aggregated cells; and a second dispersion processing part configured to apply ultrasonic vibration to the specimen, thereby dispersing the aggregated cells, and program the controller to cause the first dispersion processing part and the second dispersion processing part to operate under the dispersion condition corresponding to the specimen.
Therefore, Shirasuna et al. renders claim 20 obvious.
5. Claims 17-19 are rejected under 35 USC 103 as being unpatentable over Shirasuna et al. as applied to claim 16 and further in view of Clark et al.
I.) Regarding applicant’s claim 17, as noted above Shirasuna et al. renders claim 16 obvious from which claim 17 depends.
Claim 17 recites an information reading part configured to read specimen information regarding the specimen, wherein the controller is programmed to obtain the dispersion condition corresponding to an organ and/or site from which the specimen is derived, on the basis of the specimen information read by the information reading part.
Shirasuna et al. does not teach information reading part configured to read specimen information regarding the specimen, wherein the controller is programmed to obtain the dispersion condition corresponding to an organ and/or site from which the specimen is derived, on the basis of the specimen information read by the information reading part.
As noted above, teaches cell analysis that includes a bar code or other means for identifying a cartridge, a cell sample source, or both within the device. A bar code or other means of identifying the cartridge may be used to facilitate sample identification, patient safety, or both. Such identification means may be adapted to interact with a data storage system, an automated cell processing system, an assay, a personal digital assistant (PDA), or various combinations thereof. [0027]
It would have been obvious to modify Shirasuna et al. to include an information reading part configured to read specimen information regarding the specimen as taught by Clark et al. and having the controller programmed to obtain the dispersion condition corresponding to an organ and/or site from which the specimen is derived, on the basis of the specimen information read by the information reading part.
Therefore, Shirasuna et al. renders claim 17 obvious.
II.) Regarding applicant’s claim 18, as noted above Shirasuna et al. renders claim 17 obvious from which claim 18 depends.
Claim 18 recites that the controller is programmed to obtain the dispersion condition corresponding to the organ or site collected from one of uterine cervix, uterine body, oral cavity, esophagus, and bronchus, as the type of the specimen, on the basis of the specimen information read by the information reading part.
As noted above, Shirasuna et al. teaches the specimen is a biological sample of epithelial cells and glandular cells of the uterine cervix. [0039]
It would have been obvious to modify Shirasuna et al. to program the controller to obtain the dispersion condition corresponding to the organ or site collected from one of uterine cervix, uterine body, oral cavity, esophagus, and bronchus, as the type of the specimen, on the basis of the specimen information read by the information reading part.
Therefore, Shirasuna et al. renders claim 18 obvious.
III.) Regarding applicant’s claim 19, as noted above Shirasuna et al. renders claim 18 obvious from which claim 19 depends.
Claim 19 recites that the controller is programmed to when the specimen is a tissue of the uterine cervix, obtain a first dispersion condition and control the dispersion processing part so as to perform a dispersion process on the specimen according to the obtained first dispersion condition, and when the specimen is a tissue of the uterine body, obtain a second dispersion condition having a processing time for applying ultrasonic vibration to the specimen longer than that of the first dispersion condition, and control the dispersion processing part so as to perform a dispersion process on the specimen according to the obtained second dispersion condition.
As noted above, Shirasuna et al. teaches the specimen is a biological sample of epithelial cells and glandular cells of the uterine cervix. [0039]
Shirasuna et al. does not teach that the controller is programmed to when the specimen is a tissue of the uterine cervix, obtain a first dispersion condition and control the dispersion processing part so as to perform a dispersion process on the specimen according to the obtained first dispersion condition, and when the specimen is a tissue of the uterine body, obtain a second dispersion condition having a processing time for applying ultrasonic vibration to the specimen longer than that of the first dispersion condition, and control the dispersion processing part so as to perform a dispersion process on the specimen according to the obtained second dispersion condition.
It would have been obvious to modify Shirasuna et al. to program the controller to when the specimen is a tissue of the uterine cervix, obtain a first dispersion condition and control the dispersion processing part so as to perform a dispersion process on the specimen according to the obtained first dispersion condition, and when the specimen is a tissue of the uterine body, obtain a second dispersion condition having a processing time for applying ultrasonic vibration to the specimen longer than that of the first dispersion condition, and control the dispersion processing part so as to perform a dispersion process on the specimen according to the obtained second dispersion condition.
Therefore, Shirasuna et al. renders claim 19 obvious.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
European Patent Application Publication No. EP2735872 to Ebi et al. teaches analyzing epithelial cells of the uterine cervix, and cells at other sites, such as the oral cavity can be used as the cells to be analyzed for cancer.
Nagase et al. (“Uterine body cancer mass screening at Tokai University Hospital,” Toki J. Exp. Clin. Med., Vol. 29. No. 2, pp. 43-48, 2004) teaches about uterine body cancer.
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/M.S.G./Examiner, Art Unit 1798
/JILL A WARDEN/Supervisory Patent Examiner, Art Unit 1798