DETAILED ACTION
Response to Arguments
Applicant's arguments filed with respect to rejections under 35 U.S.C. §112 have been fully considered but they are not persuasive. The rejections is centered on lacking description for the limitation “estimates the features by using a trained model”. Adding “wherein the features are at least one of signal strength and distribution” does not provide description of “estimates the features by using a trained model”, therefore the rejection still set forth.
Applicant's arguments filed with respect to rejections under 35 U.S.C. §102 have been fully considered but they are moot because the new ground of rejection does not rely on matter specifically challenged in the argument
Claim Interpretations - 35 USC § 112(f)
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: a separation unit, a generation unit, a processing unit in claims 1-16
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth para.
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.
Claim(s) 13- 14 is(are) rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 13 recites computer-implemented functions including, among other limitations, “estimates the features by using a trained model.”
Applicant(s) is/are respectfully reminded, for computer-implemented functional claims, “examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter.” MPEP § 2161.01(I).
As an initial matter, the Examiner notes that claim(s) 13 is(are) an originally-filed claim. However, originally-filed claim(s) 13 does(do) not disclose how to “estimates the features by using a trained model” and so does not provide the necessary written description support for pending claim 13. Accord Ariad, 598 F.3d at 1349 (indicating original claim language does not necessarily satisfy the written description requirement for the claimed subject matter). That is to say, originally-filed claim 13 itself(themselves) does(do) not provide an algorithm that performs the function “estimates the features by using a trained model” in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter.
Furthermore, Applicant’s specification does not describe an algorithm that performs the function “estimates the features by using a trained model” in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter. For example, Applicant’s specification discloses “The information processing device according to (12), wherein the correction unit estimates the features by using a trained model .” Spec. [0166]. However, such disclosure is not an algorithm (e.g., the necessary steps and/or flowcharts) that performs the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter.
Applicant is also reminded, “if the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention including how to program the disclosed computer to perform the claimed function, a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, for lack of written description must be made.” MPEP § 2161.01(I).
Therefore, because an algorithm for the function “estimates the features by using a trained model” is not disclosed in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter, and in accordance with MPEP § 2161.01, claim 13 is rejected for lack of written description.
Dependent claims 14-15 fail to cure this deficiency of claim 13 (set forth directly above) and are rejected accordingly.
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.
(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.
Claim(s) 1-4, 8-12, 15-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by SAKAI ( US 20120056103).
Regarding claim 1, SAKAI teaches an information processing device( [0015], computing apparatus) including:
a separation unit that separates a fluorescence image obtained ( [0004], true intensity of fluorescence emitted from a desired fluorochrome) by observing a specimen labeled with one or more fluorescent dyes ( [0011], microparticles multiply labeled with a plurality of fluorochromes) into a fluorescence component image containing one or more fluorescence components and an autofluorescence component image containing one or more autofluorescence components([0012], a simple staining spectrum obtained from the microparticle labeled with one of the fluorochromes and an autofluorescence spectrum obtained from the microparticle that is not labeled with any one of the fluorochromes) ;
a generation unit that generates an autofluorescence component correction image using a reference spectrum of each of one or more autofluorescent substances included in the specimen and using the autofluorescence component image( [0012], fluorescence intensity of each of the fluorochromes and the autofluorescence intensity can be computed by approximating a measured spectrum obtained by collecting detection values of the photodetectors with a linear sum of a simple staining spectrum ); and
a processing unit that processes the fluorescence component image based on the autofluorescence component correction image([0012], By performing computation while taking into account the autofluorescence component of the microparticle, the autofluorescence component that varies from subpopulation to subpopulation can be accurately computed and, therefore, the occurrence of a measurement error caused by a variation in the autofluorescence intensity from subpopulation to subpopulation can be prevented); and
an evaluation unit that evaluates performance of separation between the fluorescence component image and the autofluorescence component image performed by the separation unit ( [0013], The constraint condition can be that each of the computed fluorescence intensity of each of the fluorochromes and the autofluorescence intensity is higher than or equal to a predetermined minimum value).
Regarding claim 2, SAKAI teaches the information processing device according to claim 1, wherein the processing unit generates a fluorescence component correction image obtained by correcting the fluorescence component image using the autofluorescence component correction image([0012], By performing computation while taking into account the autofluorescence component of the microparticle, the autofluorescence component that varies from subpopulation to subpopulation can be accurately computed and, therefore, the occurrence of a measurement error caused by a variation in the autofluorescence intensity from subpopulation to subpopulation can be prevented) .
Regarding claim 3, SAKAI teaches the information processing device according to claim 1, wherein the generation unit generates the autofluorescence component correction image by summing a result of multiplying the autofluorescence component image and the reference spectrum for each of the autofluorescent substances(( [0012], fluorescence intensity of each of the fluorochromes and the autofluorescence intensity can be computed by approximating a measured spectrum obtained by collecting detection values of the photodetectors with a linear sum of a simple staining spectrum ).
Regarding claim 4, SAKAI teaches the information processing device according to claim1, wherein the processing unit generates region information indicating a region labeled with the fluorescent dye from the autofluorescence component correction image, and processes the fluorescence component image using the generated region information([0061], the information regarding the computed autofluorescence intensity of each of the subpopulations may be displayed in a two-dimensional correlation diagram (a cytogram) and may be presented to a user. Thus, the user can select a desired subpopulation (perform gating) or identify the type of microparticle and the state of the microparticle in accordance with the level of the autofluorescence intensity).
Regarding claim 8, SAKAI teaches the information processing device according to claim 1, wherein the generation unit further generates a fluorescence component correction image by using a reference spectrum of each of the one or more fluorescent dyes and the fluorescence component image([0012], a simple stainning spectrum obtained from the microparticle labeled with one of the fluorochromes).
Regarding claim 9, SAKAI teaches the information processing device according to claim 8, further including an evaluation unit that evaluates at least one of: measurement accuracy of a measurement system that acquires the fluorescence image([0012], the autofluorescence component that varies from subpopulation to subpopulation can be accurately computed) ; component image and the autofluorescence component image performed by the separation unit[0013], By performing the computation … the occurrence of a measurement error and a decrease in the population in a two-dimensional correlation diagram (a cytogram) caused by a negative computed value of the fluorescence intensity of the fluorochrome can be prevented); and staining performance of a fluorescent reagent panel including the one or more fluorescent dyes, based on the fluorescence component correction image and the autofluorescence component correction image([0015], The fluorescence intensity computing apparatus includes a measurement unit configured to emit light onto microparticles multiply labeled with a plurality of fluorochromes having fluorescence wavelength ranges that overlap each other, excite the fluorochromes, and receive fluorescence generated by the excited fluorochromes using photodetectors having different reception wavelength ranges).
Regarding claim 10, SAKAI teaches the information processing device according to claim 8, further including: an image generation unit that generates a spectral intensity ratio image representing a ratio between spectral intensity of each pixel in the fluorescence component correction image and spectral intensity of each pixel in the autofluorescence component correction image( [0057], adding a curved line indicating the autofluorescence adding a curved line indicating the autofluorescence spectrum to the curved line indicating the simple stainning spectrum of the fluorochrome spectrum to the curved line indicating the simple stainning spectrum of the fluorochrome); and a storage unit that stores an imaging condition at a time of acquisition of the fluorescence image by imaging the specimen, and the spectral intensity ratio image, in association with each other( [0087], recording medium).
Regarding claim 11, SAKAI teaches the information processing device according to claim 1, further including a correction unit that corrects the fluorescence component image based on the fluorescence image, the fluorescence component image, and the autofluorescence component correction image, wherein the processing unit processes the corrected fluorescence component image based on the autofluorescence component correction image([0012], , the fluorescence intensity of each of the fluorochromes and the autofluorescence intensity can be computed by approximating a measured spectrum obtained by collecting detection values of the photodetectors with a linear sum of a simple stainning spectrum obtained from the microparticle labeled with one of the fluorochromes and an autofluorescence spectrum obtained from the microparticle that is not labeled with any one of the fluorochromes).
Regarding claim 12, SAKAI teaches the information processing device according to claim 11, wherein the correction unit estimates features of the autofluorescent substance in the fluorescence image from the fluorescence component image and the autofluorescence component correction image, and corrects the fluorescence component image based on the estimated features([12], approximating a measured spectrum).
Regarding claim 15, SAKAI teaches the information processing device according to claim 1, further including an acquisition unit that acquires the fluorescence image by imaging the specimen( [0043], cytometer).
Regarding claim 16, SAKAI teaches the information processing device according to claim 1, wherein the processing unit detects a specific cell included in the fluorescence image based on the processed fluorescence component image([0012], the fluorescence intensity of each of the fluorochromes and the autofluorescence intensity can be computed by approximating a measured spectrum obtained by collecting detection values of the photodetectors) .
Claims 17 -20 recite the method, computer program, microscope system and analysis system for the device in claim 1-4. Since SAKAI teaches method, computer and system ( [0083], a fluorescence intensity computing apparatus), those claims are also rejected.
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.
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over SAKAI in view of Chien ( US 20090305309).
Regarding claim 5, SAKAI teaches the information processing device according to claim 4.
SAKAI does not expressly teach wherein the region information is a binary mask indicating a region labeled with the fluorescent dye.
However, Chien teach the region information is a binary mask indicating a region labeled with the fluorescent dye([0159], to generate a binary mask image with values outside the cell set at zero to select the pixels located within the cell body in the CFP/YFP emission ratio images).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teaching of SAKAI and Chien, by generating binary mask image as taught in Chien for the microscopic images in SAKAI, with motivation “to differentiate the edges of HUVECs from the background in CFP or YFP fluorescence intensity images”( Chien, [0159]).
Regarding claim 6, SAKAI in view of Chien teaches the information processing device according to claim 5, wherein the processing unit generates the binary mask based on a magnitude relationship between a threshold set based on the autofluorescence component correction image and a pixel value of each pixel in the fluorescence image( Chien, [0159], o generate a binary mask image with values outside the cell set at zero to select the pixels located within the cell body in the CFP/YFP emission ratio images).
Regarding claim 7, SAKAI teaches the information processing device according to claim 5, wherein the processing unit sets a threshold for each of the pixels based on a pixel value of each of the pixels in the autofluorescence component correction image, and generates the binary mask based on a magnitude relationship between the threshold for each of the pixels and a pixel value of each of the pixels in the fluorescence image (Chien, [0159], The intensity threshold was used to generate a binary mask image with values outside the cell set at zero to select the pixels located within the cell body in the CFP/YFP emission ratio images).
Conclusion
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 JIANGENG SUN whose telephone number is (571)272-3712. The examiner can normally be reached 8am to 5pm, EST, M-F.
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, Randolph Vincent can be reached at 571 272 8243. 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.
JIANGENG SUN
Examiner
Art Unit 2661
/Jiangeng Sun/Examiner, Art Unit 2671
Prosecution Insights