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 1-11 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) an apparatus, a method, and a non-transitory computer-readable storage medium for detecting regions of body parts and a lesion from a medical image. 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 10-11 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 10-11 are directed an apparatus, a method, and a non-transitory computer-readable storage 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 apparatus in claim 1, the method in 10, and the non-transitory computer-readable storage medium in claim 11 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 10-11: the apparatus, the method, and the computer-readable storage medium recite(s) the steps (functions) of:
detecting regions of body parts and a lesion from a medical image (mental process including observation and evaluation, and can be done mentally in the human mind);
deriving an evaluation value for each of the regions overlapping the lesion, based on a degree of certainty of each partial image constituting the lesion in the medical image (mental process including observation and evaluation, and can be done mentally in the human mind); and
selecting at least one region detected from the medical image based on the evaluation value (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 10-11 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 10-11 recite(s) the further limitations of:
a processor (generic computers or components configured to perform the method).
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 10-11 does/do not recite any additional elements that are not well-understood, routine or conventional. The use of a computer to [“detects, derives, and selects, as claimed in Claim(s) 1 and 10-11 is a routine, well-understood and conventional process that is performed by computers.
Thus, since Claim(s) 1 and 10-11 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 10-11 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): selects the region of which the evaluation value is equal to or greater than a threshold value from among the detected regions (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): calculates the threshold value by multiplying a reference value of the evaluation value by a sensitivity magnification (mathematical concepts, mathematical relationships, mathematical formulas or equations, mathematical calculations).
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): wherein the reference value of the evaluation value is a maximum value of the evaluation value derived for each of the regions overlapping the detected lesion (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): performs control of displaying a setting screen for a user to set the sensitivity magnification (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): wherein the evaluation value is a value that depends on the degree of certainty and a size of the lesion overlapping the regions (mental process including observation and evaluation, and can be done mentally in the human mind).
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): performs weighting such that a degree to which the evaluation value increases is higher as the degree of certainty is higher (mental process including observation and evaluation, and can be done mentally in the human mind).
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): performs control of displaying a selection result of the region based on the evaluation value (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): performs control of highlighting the region with a higher degree of emphasis as the derived evaluation value is higher (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)(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.
Claim(s) 1-2 and 6-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koizumi et al., US 2021/0321856.
Regarding claim 1, Koizumi discloses an information processing apparatus (fig. 1; para 0051; an electronic endoscope system processes an image of a living tissue in an organ imaged by an electronic endoscope to evaluate the degree of lesion in the organ) comprising:
a processor (fig. 1; element 200; para 0051 and 0067; a processor), wherein the processor
detects regions of body parts and a lesion from a medical image (fig. 6; para 0051, 0054, 0076, and 0138; processes an image of a living tissue in an organ imaged by an electronic endoscope to evaluate the degree of lesion in the organ; The organ to be evaluated include a digestive tract such as pharynx to esophagus, stomach, small intestine, and large intestine; The large intestine includes the rectum, sigmoid colon, descending colon, transverse colon, and ascending colon, in order from the open end (anus). Hereinafter, the rectum is referred to as segment SG5, the sigmoid colon is referred to as segment SG4, the descending colon is referred to as segment SG3, the transverse colon is referred to as segment SG2, and the ascending colon is referred to as segment SG1),
derives an evaluation value for each of the regions overlapping the lesion (para 0053, 0076, 0111, and 0120; In the evaluation of the degree of lesion within an organ, the processor calculates, for example, for each of a plurality of images of the living tissue illuminated by a white light, an image evaluation value indicating the intensity of lesion in each image. This image evaluation value is not particularly limited, but may be an inflammation evaluation value for evaluating the lesion, for example, when the lesion is inflammation, based on the information (for example, redness) of the color component of a lesion portion as the intensity of inflammation of the lesion portion (inflamed portion)), based on a degree of certainty of each partial image constituting the lesion in the medical image (para 0120, 0127-0128, and 0140; In such an evaluation, the extent of lesion can be evaluated assuming that the region where the representative evaluation value exceeds a preset threshold is the lesion portion; In FIG. 7, a plurality of sections are designated as segments SG1 to SG5, and segments having a representative evaluation value equal to or higher than the threshold are illustrated as inflamed lesion portions with a predetermined threshold as a boundary), and
selects at least one region detected from the medical image based on the evaluation value (fig. 7; para 0077, 0113, 0137, and 0140; In FIG. 7, In FIG. 7, a plurality of sections are designated as segments SG1 to SG5, and segments having a representative evaluation value equal to or higher than the threshold are illustrated as inflamed lesion portions with a predetermined threshold as a boundary. The example illustrated in FIG. 7 shows that the entire segment SG5, the entire segment S4, and a part of segment SG3 are inflamed).
Regarding claim 2, the information processing apparatus according to claim 1, Koizumi discloses wherein the processor selects the region of which the evaluation value is equal to or greater than a threshold value from among the detected regions (para 0140 and 0142).
Regarding claim 6, the information processing apparatus according to claim 1, Koizumi discloses wherein the evaluation value is a value that depends on the degree of certainty and a size of the lesion overlapping the regions (para 0107, 0120 and 0127-0130).
Regarding claim 7, the information processing apparatus according to claim 1, Koizumi discloses wherein, in a case of deriving the evaluation value, the processor performs weighting such that a degree to which the evaluation value increases is higher as the degree of certainty is higher (figs. 7-9; para 0091-0093 and 0140-0142).
Regarding claim 8, the information processing apparatus according to claim 1, Koizumi discloses wherein the processor performs control of displaying a selection result of the region based on the evaluation value (figs. 10; para 0077, 0137, 0140 and 0143.
Regarding claim 9, the information processing apparatus according to claim 1, Koizumi discloses wherein the processor performs control of highlighting the region with a higher degree of emphasis as the derived evaluation value is higher (fig. 10; para 0091-0093, 0113-0114, and 0140).
Regarding claim 10, this claim recites substantially the same limitations that are performed by claim 1 above, and it is rejected for the same reasons.
Regarding claim 11, 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) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koizumi et al., US 2021/0321856 in view of Kimura, US 2010/0091106.
Regarding claim 3, the information processing apparatus according to claim 2, Koizumi does not explicitly disclose wherein the processor calculates the threshold value by multiplying a reference value of the evaluation value by a sensitivity magnification as claimed.
However, Kimura discloses the threshold setting means is configured to set the edge threshold at a value which is calculated by multiplying the standard deviation by a magnification larger than 1 which is previously set (para 0018).
Therefore, taking the combined disclosures of Koizumi and Kimura 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 threshold setting means is configured to set the edge threshold at a value which is calculated by multiplying the standard deviation by a magnification larger than 1 which is previously set as taught by Kimura into the invention of Koizumi for the benefit of an object on an acquired image can be more properly recognized (Kimura: para 0018).
Regarding claim 4, the information processing apparatus according to claim 3, Koizumi in the combination disclose wherein the reference value of the evaluation value is a maximum value of the evaluation value derived for each of the regions overlapping the detected lesion (fig. 5; para 0136).
Regarding claim 5, the information processing apparatus according to claim 3, Koizumi and Kimura in the combination disclose wherein the processor performs control of displaying a setting screen for a user to set (Koizumi: fig. 1, element 300; para 0067) the sensitivity magnification (Kimura: para 0018).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Makino, US 2021/0259515 discloses an electronic endoscope system that evaluates the degree of lesion in an organ by imaging a living tissue in the organ.
Kubota et al., US 2021/0012886 discloses the processor detects a lesion candidate in the image, discriminates the lesion candidate detected and outputs discrimination information.
Kono et al., US 2019/0089895 discloses image processing devices which extract an intraluminal image that is optimal for diagnosis from an intraluminal image group that is captured by an endoscope.
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
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