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 .
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 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The limitations, under their broadest reasonable interpretation, cover mental process (concept performed in a human mind, including as observation, evaluation, judgment, opinion, organizing human activity and mathematical concepts and calculations). The claim(s) recite(s) a device, a method, and a non-transitory recoding medium for inspection assistance. This judicial exception is not integrated into a practical application because the steps do not add meaningful limitations to be considered specifically applied to a particular technological problem to be solved .The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because [the steps of the claimed invention can be done mentally and no additional features in the claims would preclude them from being performed as such except for the generic computer elements at high level of generality (i.e., processor, memory)].
According to the USPTO guidelines, a claim is directed to non-statutory subject matter if:
STEP 1: the claim does not fall within one of the four statutory categories of invention (process, machine, manufacture or composition of matter), or
STEP 2: the claim recites a judicial exception, e.g. an abstract idea, without reciting additional elements that amount to significantly more than the judicial exception, as determined using the following analysis:
STEP 2A (PRONG 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Using the two-step inquiry, it is clear that claims 1 and 12-13 are directed to an abstract idea as shown below:
STEP 1: Do the claims fall within one of the statutory categories? YES. Claim(s) 1 and 12-13 are directed a device, a method, and a non-transitory recoding medium, respectively.
STEP 2A (PRONG 1): Is the claim directed to a law of nature, a natural phenomenon or an abstract idea? YES, the claims are directed toward a mental process (i.e. abstract idea).
With regard to STEP 2A (PRONG 1), the guidelines provide three groupings of subject matter that are considered abstract ideas:
Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations;
Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and
Mental processes – concepts that are practicably performed in the human mind (including an observation, evaluation, judgment, opinion).
The device in claim 1, the method in claim 12, and the non-transitory recoding medium in claim 13 comprise a mental process that can be practicably performed in the human mind (or generic computers or components configured to perform the method) and, therefore, an abstract idea.
Regarding Claim(s) 1 and 12-13: the device, the method, and the non-transitory recoding medium recite(s) the steps (functions) of:
estimating a tumor cell content rate for each unit region in a region of interest in image data of the pathology specimen (mental process including observation and evaluation, and can be done mentally in the human mind); and
determining a test region in the region of interest based on the tumor cell content rate in the region of interest (mental process including observation and evaluation, and can be done mentally in the human mind).
These limitations, as drafted, is a simple process that, under their broadest reasonable interpretation, covers performance of the limitations in the mind or by a human. The Examiner notes that under MPEP 2106.04(a)(2)(III), the courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’" 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 ("‘[M]ental processes[] and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work’" (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978) (same).
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application? NO, the claims do not recite additional elements that integrate the judicial exception into a practical application.
With regard to STEP 2A (prong 2), whether the claim recites additional elements that integrate the judicial exception into a practical application, the guidelines provide the following exemplary considerations that are indicative that an additional element (or combination of elements) may have integrated the judicial exception into a practical application:
an additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
While the guidelines further state that the exemplary considerations are not an exhaustive list and that there may be other examples of integrating the exception into a practical application, the guidelines also list examples in which a judicial exception has not been integrated into a practical application:
an additional element merely recites the words “apply it” (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea;
an additional element adds insignificant extra-solution activity to the judicial exception; and
an additional element does no more than generally link the use of a judicial exception to a particular technological environment or field of use.
Claim(s) 1 and 12-13 does/do not recite any of the exemplary considerations that are indicative of an abstract idea having been integrated into a practical application. Claim(s) 1 and 12-13 recite(s) the further limitations of:
a memory and a processor configured to (generic computers or components configured to perform the method);
acquiring image data of a pathology specimen (insignificant pre-solution extra activity of generating data); and
outputting information indicating the test region (insignificant post-solution extra activity of generating data).
These limitations are recited at a high level of generality (i.e. as a general action or change being taken based on the results of the acquiring step) and amounts to mere post solution actions, which is a form of insignificant extra-solution activity. Further, the claims are claimed generically and are operating in their ordinary capacity such that they do not use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? NO, the claims do not recite additional elements that amount to significantly more than the judicial exception.
With regard to STEP 2B, whether the claims recite additional elements that provide significantly more than the recited judicial exception, the guidelines specify that the pre-guideline procedure is still in effect. Specifically, that examiners should continue to consider whether an additional element or combination of elements:
adds a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; or
simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Claim(s) 1 and 12-13 does/do not recite any additional elements that are not well-understood, routine or conventional. The use of a computer to ["acquiring, estimating, determining, and outputting”], as claimed in Claim(s) 1 and 12-13 is a routine, well-understood and conventional process that is performed by computers.
Thus, since Claim(s) 1 and 12-13 is/are: (a) directed toward an abstract idea, (b) do not recite additional elements that integrate the judicial exception into a practical application, and (c) do not recite additional elements that amount to significantly more than the judicial exception, it is clear that Claim(s) 1 and 12-13 is/are not eligible subject matter under 35 U.S.C 101.
Regarding claim 2: the additional limitations do not integrate the mental process into practical application or add significantly more to the mental process. The limitation(s): determining the test region based on a first condition related to a tumor cell content rate in the test region (mental process including observation and evaluation, and can be done mentally in the human mind).
Regarding claim 3: the additional limitations do not integrate the mental process into practical application or add significantly more to the mental process. The limitation(s): determining the test region in such a way that an average of indices based on a tumor cell content rate in the test region exceeds a first threshold value according to the first condition (mental process including observation and evaluation, and can be done mentally in the human mind).
Regarding claim 4: the additional limitations do not integrate the mental process into practical application or add significantly more to the mental process. The limitation(s): determining the test region based on at least one of a second condition related to a size of an area of the test region and a third condition related to a shape of a contour of the test region in addition to the first condition (mental process including observation and evaluation, and can be done mentally in the human mind).
Regarding claim 5: the additional limitations do not integrate the mental process into practical application or add significantly more to the mental process. The limitation(s): calculating an index based on a tumor cell content rate in the region of interest (mental process including observation and evaluation, and can be done mentally in the human mind).
Regarding claim 6: the additional limitations do not integrate the mental process into practical application or add significantly more to the mental process. The limitation(s): displaying a tumor cell content rate for each unit region in the region of interest on the image (insignificant post-solution extra activity of generating data).
Regarding claim 7: the additional limitations do not integrate the mental process into practical application or add significantly more to the mental process. The limitation(s): acquiring image data of the pathology specimen to which information indicating the region of interest is given (insignificant pre-solution extra activity of generating data), and outputting information indicating the region of interest together with information indicating the test region (insignificant post-solution extra activity of generating data).
Regarding claim 8: the additional limitations do not integrate the mental process into practical application or add significantly more to the mental process. The limitation(s): estimating a tumor cell content rate for each unit region in the region of interest using a neural network (generic computers or components) that was trained on a tumor model (mental process including observation and evaluation, and can be done mentally in the human mind).
Regarding claim 9: the additional limitations do not integrate the mental process into practical application or add significantly more to the mental process. The limitation(s): wherein the information indicating the region of interest is given with an annotation (mental process including observation and evaluation, and can be done mentally in the human mind).
Regarding claim 10: the additional limitations do not integrate the mental process into practical application or add significantly more to the mental process. The limitation(s): wherein the second condition is that an area of the test region exceeds a first lower limit value (mental process including observation and evaluation, and can be done mentally in the human mind).
Regarding claim 11: the additional limitations do not integrate the mental process into practical application or add significantly more to the mental process. The limitation(s): wherein the third condition is that a contour of the test region is a smooth curve (mental process including observation and evaluation, and can be done mentally in the human mind).
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)(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) 1-3, 5-9, and 12-13 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Che et al., US 2024/0312604.
Regarding claim 1, Che discloses an inspection assistance device (fig. 9; para 0099 and 0101; a computer device for performing the tumor cell content evaluation) comprising:
a memory configured to store instructions (fig. 9; para 0101; a memory storing computer-readable instructions); and
at least one processor configured to execute the instructions (fig. 9; para 0101; a processor executes the computer-readable instructions) to perform:
acquiring image data of a pathology specimen (para 0036-0037 and 0101; obtaining a digital pathology slide image);
estimating a tumor cell content rate for each unit region in a region of interest in image data of the pathology specimen (para 0041-0043, 0048-0052, and 0101; determining tumor cell content of the digital pathology slide image based on the tumor cell region according to a preset evaluation rule; The preset evaluation rule refers to a preset evaluation manner or indicator used to evaluate the tumor cell content, for example, evaluation may be performed based on an area of the tumor cell region, a quantity of cells, a tumor proportion, a tumor-stroma ratio, and the like);
determining a test region in the region of interest based on the tumor cell content rate in the region of interest (para 0053-0060 and 0103-0105; after the determining tumor cell content of the digital pathology slide image based on the tumor cell region according to a preset evaluation rule, the method further includes: obtaining a plurality of test diameters corresponding to a plurality of tumor cells, and calculating a mean value of the plurality of test diameters, to obtain an average diameter of a single tumor cell; determining an average area of the single tumor cell based on the average diameter of the single tumor cell; calculating a quantity of tumor cells per unit area based on the average area of the single tumor cell; and calculating a first quantity of tumor cells based on the first area and the quantity of tumor cells per unit area); and
outputting information indicating the test region (para 0058 and 0061; the first quantity of tumor cells in the tumor cell region is calculated, so that the doctor performs disease diagnosis and analysis based on the first quantity; the first quantity is outputted to the doctor); .
Regarding claim 2, the inspection assistance device according to claim 1, Che further discloses wherein the at least one processor is configured to execute the instructions to perform:
determining the test region based on a first condition related to a tumor cell content rate in the test region (para 0053-0060 and 0103-0105).
Regarding claim 3, the inspection assistance device according to claim 2, Che further discloses wherein the at least one processor is configured to execute the instructions to perform:
determining the test region in such a way that an average of indices based on a tumor cell content rate in the test region exceeds a first threshold value according to the first condition (para 0053-0060 and 0104).
Regarding claim 5, the inspection assistance device according to claim 1, Che further discloses wherein the at least one processor is configured to execute the instructions to perform:
calculating an index based on a tumor cell content rate in the region of interest (para 0041-0043, 0048-0052, and 0101).
Regarding claim 6, the inspection assistance device according to claim 1, Che further discloses wherein the at least one processor is configured to execute the instructions to perform:
displaying a tumor cell content rate for each unit region in the region of interest on the image (para 0058 and 0061).
Regarding claim 7, the inspection assistance device according to claim 1, Che further discloses wherein the at least one processor is configured to execute the instructions to perform:
acquiring image data of the pathology specimen to which information indicating the region of interest is given (para 0036-0037 and 0101), and
outputting information indicating the region of interest together with information indicating the test region (para 0036-0037 and 0101).
Regarding claim 8, the inspection assistance device according to claim 1, Che further discloses wherein the at least one processor is configured to execute the instructions to perform:
estimating a tumor cell content rate for each unit region in the region of interest using a neural network that was trained on a tumor model (para 0039).
Regarding claim 9, the inspection assistance device according to claim 7, Che further discloses wherein the information indicating the region of interest is given with an annotation (para 0066).
Regarding claim 12, this claim recites substantially the same limitations that are performed by claim 1 above, and it is rejected for the same reasons.
Regarding claim 13, this claim recites substantially the same limitations that are performed by claim 1 above, and it is rejected for the same reasons.
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.
Claim(s) 4 and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Che et al., US 2024/0312604 in view of Ascierto et al., US 2017/0270346.
Regarding claim 4, the inspection assistance device according to claim 2, Che does not explicitly disclose wherein the at least one processor is configured to execute the instructions to perform: determining the test region based on at least one of a second condition related to a size of an area of the test region and a third condition related to a shape of a contour of the test region in addition to the first condition as claimed.
However, Ascierto discloses the size and shape of inner-tumor regions, peri-tumor regions and/or of different types of metastasis and other forms of tumor cell clusters may depend on the cancer type. For example, the size of the FOVs may be determined in a threshold based manner and have an irregular size. Alternatively, each FOV may have a predefined shape, e.g. a circle or a square that completely covers the pixels belonging to the local intensity maximum (para 0038 and 0046).
Therefore, taking the combined disclosures of Che and Ascierto as a whole, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the size and shape of inner-tumor regions, peri-tumor regions and/or of different types of metastasis and other forms of tumor cell clusters may depend on the cancer type. For example, the size of the FOVs may be determined in a threshold based manner and have an irregular size. Alternatively, each FOV may have a predefined shape, e.g. a circle or a square that completely covers the pixels belonging to the local intensity maximum as taught by Ascierto into the invention of Che for the benefit of providing cancer-type specific rules for identifying the regions in the tumor image, a more accurate immune score may be computed (Ascierto: para 0038).
Regarding claim 10, the inspection assistance device according to claim 4, Ascierto in the combination further disclose wherein the second condition is that an area of the test region exceeds a first lower limit value (para 0046).
Regarding claim 11, the inspection assistance device according to claim 4, Ascierto in the combination further disclose wherein the third condition is that a contour of the test region is a smooth curve (para 0046).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ock et al., US 2023/0237658 discloses a method and system for providing medical information about a pathological image, based on an analysis result on a pathological image.
Van Leeuwen et al., US 2017/0116734 discloses an examining device for processing and analyzing an image of a bio sample.
Ono et al., US 2023/0016320 discloses the usability in annotating an image of a subject derived from a living body is improved.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VAN D HUYNH whose telephone number is (571)270-1937. The examiner can normally be reached 8AM-6PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Stephen R Koziol can be reached at (408) 918-7630. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VAN D HUYNH/Primary Examiner, Art Unit 2665