DETAILED ACTION
Notice of AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
2. Applicant’s remarks received on 01/02/2026 with respect to the amended independent claims have been acknowledged and are moot in view of a new ground of rejection necessitated by the corresponding amendment. Currently claims 1, 3, and 5-13 are rejected; and claims 2 and 4 are cancelled.
Response to Amendment
Claim Rejections - 35 USC § 101
3. 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.
Regarding claims 1, 3, and 5-13, under the broadest reasonable interpretation, the terms of the claims are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skilled in the art. See MPEP 2111.
The claimed invention applies CNN to estimate gastric cancer in endoscope video captured in a magnified manner under narrowband light and display the position of the estimated result.
The claims are directed mental processing and does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
The claims do not have any limitations that are indicative of integration of the judicial exception into a practical application such as improvements to functioning of a computer or a technical field, using any particular machine, effect a transformation of a particular article to a different state or thing, or apply the judicial exception in any meaningful way beyond generally linking the use to a particular technological environment. Therefore, the claims as a whole do not amount to significantly more than the judicial exception.
A patent may be obtained for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof," 35 U.S.C. § 101, but “laws of nature, natural phenomena, and abstract ideas are not patentable.”
Step 1
Claims 1, 3, and 5-13 are directed to one of the four statutory categories of eligible subject matter (process): thus, the claim pass Step 1 of the Subject Matter Eligibility Test.
Step 2A, prong 1 analysis
Claims 1, 3, and 5-13 recite a judicial exception in terms of a mental process. Steps in claims 1, 3, and 5-13 can be performed by a human being observing endoscopic video images for gastric cancer detection. Although the detection is claimed to be accomplished by using a CNN which simply acts as a generic computing tool/device, it does not prevent the process from being performed by a human through mental evaluation or utilizing a CNN to aid the mental process given the broadest and reasonable interpretation.
Specifically, a trained surgeon could perform the claimed gastric cancer estimation by comparing gastric cancer images to non-gastric cancer images. A threshold could be set as a standard to evaluate images so that based on continued presence of images above the threshold within a time limit the surgeon would determine the presence of cancer and estimate the position of it. The surgeon would look at a real-time video to estimate presence of a gastric cancer and its position relative to the organ, assesses a degree of certainty by assigning a probability score. The surgeon would further determine whether the cancer is continuously identified on the video when images were taken from various angles continuously; and based on number of detections to further conclude his analysis.
Notice, a human brain can be trained just like a neural network for configuration/object identification/classification based on feature embedded in images through observation and comparison.
The claimed display or alert acts as an output venue for insignificant extra-solution activity as it merely presents the results of an abstract idea or computer implemented process without contributing to an inventive concept.
Step 2A, prong 2 analysis
The judicial exception is not integrated into a practical application for improving technological field because additional element such as video acquisition and display in claims 1 and 3-9 is only for data collection and presentation which is considered insignificant extra-solution activity to the judicial exception. The claims fail to provide details on how each step is performed other than applying generic and conventional computing devices such as a neural network which is invoked merely as a tool.
Step 2B
Finally, the claims do not include other additional elements that are beyond what is well-understood, routine, conventional activities in the field and sufficient to amount to significantly more than the judicial exception. Nothing in the claims would transform training and utilizing a neural network into something significantly more than the abstract idea of estimating cancer location through the already available application of machine learning.
Conclusion:
The claims do not include additional elements amount to significantly more in terms of improving functionalities of a computer/device itself, improving another technology or technical field, effecting a transformation or reduction of a particular article to a different state or thing, adding unconventional steps that confine claim to a particular useful application or by use of a particular machine that is unconventional. In conclusion, the claims 1 and 3-9 do not comply with the current standards for patent eligible subject matter under 35 USC § 101.
Claim Rejections - 35 USC § 103
4. 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 of this title, 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.
51066.. Claims 1, 3, and 6-13 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al (Convolutional neural network for the diagnosis of early gastric cancer based on magnifying narrow band imaging, 7/22/2019) and in further view of Ishioka et al (Detecting gastric cancer from video images using convolutional neural networks) (Applicant submitted document), Ikuma et al (WO Pub: 2020071086) and Katsuichi et al (WO Pub: 2017081976).
Regarding Claim 1 (Currently amended), Li et al teaches: An image diagnosis apparatus, comprising: an endoscopic video acquisition section configured to acquire an endoscope video captured in a state where a digestive organ of a subject is irradiated with narrowband light and the digestive organ is observed in a magnified manner [page 127: Abstract/Background]; an estimation section configured to estimate the presence of a gastric cancer and a position of the gastric cancer present in the endoscope video acquired, by using a convolutional neural network, and output an estimation result, the convolutional neural network having been subjected to learning with a gastric cancer image and a non-gastric cancer image as training data [page 127: Abstract/Methods and Results; page 129: Statistical analysis].
Li et al estimates presence of a gastric cancer from images obtained from real-time endoscope video and display estimate cancer on the images. In the same field of endeavor, Ishioka et al performs a real-time video based gastric CNN diagnosis [page e34: p01]. Therefore, it would have been obvious for an ordinary skilled in the art before the effective filing date of the claimed invention to combine the teaching of the two to perform gastric cancer real time CNN diagnosis displayed on video image.
Li et al in view of Ishioka et al does not disclose probability threshold or continuous monitoring across frames.
In the same field of endeavor, Ikuma et al teaches: wherein the estimate section is configured to estimate the presence of the gastric cancer and the position of the gastric cancer present in the endoscope video by [page 4: p06]: estimating a degree of certainty of the position of the gastric cancer present in the endoscope video as a probability score [page 4: p05; page 10: p04, page 12: p04, p05]; identifying endoscopic images in the endoscope video in which the degree of certainty is equal to or greater than a predetermined value [page 4: p05; page 10: p04],
determining whether a predetermined number of the identified endoscopic images are continuously present within a predetermined time, and responsive to the predetermined number of the identified endoscopic images being continuously present within the predetermined time, determining that the gastric cancer is present in the endoscope video [page 11: p01-p04]; and a display control section configured to display the position of the estimated gastric cancer on the endoscope video in a superimposed manner [page 4: p06, page 5: p03].
Ikuma et al continuously monitors cancer presence in the endoscope video with predefined number of frames which inherently defines a predetermined time. In the same field of endeavor, Katsuichi teaches continuous monitoring in a predetermined time: determining whether a predetermined number of the identified endoscopic images are continuously present within a predetermined time, and responsive to the predetermined number of the identified endoscopic images being continuously present within the predetermined time, determining that the gastric cancer is present in the endoscope video [page 8: p02-p03; page 10: p03, p07]; and a display control section configured to display the position of the estimated gastric cancer on the endoscope video in a superimposed manner [page 8: p04-p05].
Therefore, given Ikuma et al’s teaching on probability score for determining degree of certainty of gastric cancer and Ikuma et al in view of Katsuichi’s disclosure on continued detection of lesion within a predetermined frames/time, it would have been obvious for an ordinary skilled in the art before the effective filing date of the claimed invention to combine the teaching of all to confirm gastric cancer diagnosis certainty based on continued detection within a predetermined time for improved accuracy.
Regarding claim 3 (currently amended), the rationale applied to the rejection of claim 1 has been incorporated herein. Ikuma et al in view of Katsuichi et al further teaches: The image diagnosis apparatus according to claim 1, wherein when the degree of certainty estimated is equal to or greater than the predetermined value, the display control section displays the position of the gastric cancer on the endoscope video in a superimposed manner [Ikuma: page 4: p06, page 5: p03; Katsuichi: page 8: p04-p05].
Regarding claim 6 (currently amended), the rationale applied to the rejection of claim 1 has been incorporated herein. Katsuichi et al further teaches: The image diagnosis apparatus according to claim 1, further comprising an alert output control section configured to output an alert when it is estimated that the gastric cancer is present in the endoscope video [page 11: p09].
Claims 7-9 (currently amended) have been analyzed and rejected with regard to claim 1 and in accordance with Ikuma et al’s further teaching on a non-transitory computer readable medium [page 7: p09].
Regarding claim 10 (New), the rationale applied to the rejection of claim 1 has been incorporated herein. Li et al further teaches: The image diagnosis apparatus according to claim 1, wherein the digestive organ is a stomach [page 127: p02].
Regarding claim 11 (New), the rationale applied to the rejection of claim 7 has been incorporated herein. Li et al further teaches: The image diagnosis method according to claim 7, wherein the digestive organ is a stomach [page 127: p02].
Regarding claim 12 (New), the rationale applied to the rejection of claim 8 has been incorporated herein. Li et al further teaches: The non-transitory computer readable medium according to claim 8, wherein the digestive organ is a stomach [page 127: p02].
Regarding claim 13 (New), the rationale applied to the rejection of claim 9 has been incorporated herein. Li et al further teaches: The computer-implemented learned model according to claim 9, wherein the digestive organ is a stomach [page 127: p02].
61066.. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Li et al (Convolutional neural network for the diagnosis of early gastric cancer based on magnifying narrow band imaging, 7/22/2019), Ishioka et al (Detecting gastric cancer from video images using convolutional neural networks) (Applicant submitted document), Ikuma et al (WO Pub: 2020071086), and Katsuichi et al (WO Pub: 2017081976); and in further view of Wang et al (CN Pub: 108154509).
Regarding claim 5 (currently amended), the rationale applied to the rejection of claim 1 has been incorporated herein. Ikuma et al in view of Katsuichi has made it obvious for continuous detection of a cancer area for confirmation. In the same field of endeavor, Wang et al further teaches: The image diagnosis apparatus according to claim 1, wherein the predetermined number becomes greater as the predetermined value becomes smaller [page 15: p02]. Adding additional sample image for detection verification has been well practiced in the art as prescribed by Wang et al. Therefore, it would have been obvious for an ordinary skilled in the art before the effective filing date of the claimed invention to combine the teaching of the all to increase number of images for lower verification pass rate for cancer detection confirmation purpose.
Conclusion
7. There is a new ground of rejection necessitated by the corresponding amendment 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 extension fee 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.
Contact
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FAN ZHANG whose telephone number is (571)270-3751. The examiner can normally be reached on Mon-Fri 9:00-5:00.
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/Fan Zhang/
Patent Examiner, Art Unit 2682