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 § 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) 1-7 and 9-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Protsenko et al. (US 2023/0043645 A1, Feb. 9, 2023) (hereinafter “Protsenko”).
Regarding claim 1: Protsenko discloses a medical support device comprising a processor, the processor being configured to: acquire a size of an observation target region appearing in a medical image obtained by imaging an imaging target region including the observation target region with a modality ([0049], [0071], [0093], [0101], [0104]; fig. 2); and output auxiliary information for assisting in clinical decision making in cases in which the size falls within a size range determined with respect to a reference value for the decision making ([0106], [0114]-[0115]; fig. 2).
Regarding claim 2: Protsenko discloses the medical support device according to claim 1, wherein the size is measured based on the medical image ([0073], [0095]).
Regarding claim 3: Protsenko discloses The medical support device according to claim 1, wherein the auxiliary information includes: the size of the observation target region in at least one direction; position information enabling identification of a position of the observation target region in the medical image; shape information enabling identification of a shape of the observation target region; measurement direction information enabling identification of a measurement direction used to measure the size; a degree of certainty obtained from Al in cases in which the size is measured using the AI; size variation range information enabling identification of a range of variation in the size identified in cases in which the size is measured based on a plurality of the medical images; an image indicating the observation target region; and/or a statistical measure based on previously measured size ([0114]-[0119]).
Regarding claim 4: Protsenko discloses the medical support device according to claim 1, wherein the reference value and/or the size range is determined based on medical knowledge ([0051]-[0055], [0058], [0109]).
Regarding claim 5: Protsenko discloses the medical support device according to claim 1, wherein the reference value and/or the size range is determined based on a characteristic of the observation target region ([0107] – [0111]).
Regarding claim 6: Protsenko discloses the medical support device according to claim 1, wherein the reference value and/or the size range is determined in accordance with a given instruction ([0111]).
Regarding claim 7: Protsenko discloses the medical support device according to claim 1, wherein the auxiliary information is output by displaying the auxiliary information on a screen ([0076], [0130]).
Regarding claim 9: Protsenko discloses the medical support device according to claim 1, wherein the decision making is decision making as to whether to excise the observation target region from the imaging target region ([0128]-[0129], [0131]-[0132]).
Regarding claim 10: Protsenko discloses the medical support device according to claim 1, wherein the modality is an endoscope system ([0038], [0071], [0100]).
Regarding claim 11: Protsenko discloses the medical support device according to claim 1, wherein the medical image is an endoscopic image obtained by imaging the imaging target region with an endoscope ([0038], [0071], [0100]).
Regarding claim 12: Protsenko discloses the medical support device according to claim 1, wherein the observation target region is a lesion ([0002] - a polyp is a type of lesion, [0048]-[0049]).
Regarding claim 13: Protsenko discloses an endoscope system comprising: the medical support device according to claim 1; and an endoscope that performs imaging of the imaging target region ([0048]-[0049], [0100], claim 31).
Regarding claim 14: Protsenko discloses a medical support method comprising: acquiring a size of an observation target region appearing in a medical image obtained by imaging an imaging target region including the observation target region with a modality ([0049], [0071], [0093], [0101], [0104]; fig. 2); and outputting auxiliary information for assisting in clinical decision making in cases in which the size falls within a size range determined with respect to a reference value for the decision making ([0106], [0114]-[0115]; fig. 2).
Regarding claim 15: Protsenko discloses the medical support method according to claim 14, wherein the modality includes an endoscope, and the medical support method comprises using the endoscope ([0038], [0071], [0100], claim 31).
Regarding claim 16: Protsenko discloses a non-transitory computer-readable storage medium storing a program executable by a computer to execute a medical support process, the medical support process comprising: acquiring a size of an observation target region appearing in a medical image obtained by imaging an imaging target region including the observation target region with a modality ([0049], [0071], [0093], [0101], [0104]; fig. 2); and outputting auxiliary information for assisting in clinical decision making in cases in which the size falls within a size range determined with respect to a reference value for the decision making ([0106], [0114]-[0115]; fig. 2).
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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Protsenko in view of Kimura et al. (US 2025/0089984 A1, Mar. 20, 2025) (hereinafter “Kimura”).
Regarding claim 8: Protsenko discloses displaying the endoscopic image and the auxiliary information ([0024], [0076], [0130]) but is silent on displaying the auxiliary information on a first screen, the medical image is displayed on a second screen different from the first screen, and the first screen and the second screen are arranged in a manner that enables comparison with each other.
Kimura, in the same field of endeavor, discloses displaying an acquired endoscopic image and auxiliary information about the image on two separate screens, where the screens are arranged in a manner that enables comparison with each other (fig. 5, [0058]-[0062]). Kimura further discloses that the display mode may be set by each individual doctor to provide an easy-to-see display for each doctor ([0073]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Protsenko by including the dual-screen display of Kimura in order to provide the user with additional information that would support diagnosis and decision making on a single easy-to-see display.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Marugame (US 2025/0078255, Mar. 6, 2025) – discloses every limitation of at least claim 1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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, Chris Koharski can be reached at (571) 272-7230. 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.
/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799
