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 .
Priority
This application claims benefit of priority under 35 U.S.C. §119 (e) from Korean application No 10-2022-0013399 filed 01/28/2022 and PCT/KR2023/001351 filed 01/03/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/24/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Office. Please note that the Office has included the application number, filing date, and art unit number on the IDS.
Claim Interpretation
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.
Regarding claim 1, the limitations “Lesion reading unit” and “readout information generating unit” are being interpreted under 35 U.S.C 112(f) because they use a generic placeholder couple with functional language without reciting sufficient structure to achieve the function.
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.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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: Lesion reading unit” and “readout information generating unit” of claim 1.
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.
Lesion reading unit” the lesion readout unit 20.
readout information generating unit” readout information generation unit 30.
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 paragraph.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 1-3,6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beomhee Park et al (2021/0407637) in view of Keum-Yong Oh et al (2014/0191753)
Regarding claim 1 and 6 , Beomhee Park et al. discloses “A lesion reading unit that estimates a presence of lesion from a plurality of medical images by reading medical image information including the plurality of medical images captured of a patient's body, and detects a position and information of the estimated lesion;”
See paragraph [0056] The processor 120 may display one or more lesion information detected from the medical data on a user interface. The lesion information may be displayed in various schemes which are not limited. For example, the lesion information may be expressed as a color based heat map, a shape based heat map, etc. The color based heat map may be a method that distinguishes and displays parts having a high probability of corresponding to the lesion and parts having a low probability of corresponding to the lesion with different colors among regions of the medical data. For example, among the regions included in the medical data, a region having a high probability of belonging to the lesion may be expressed as a red color, a region having a low probability of belonging to the lesion may be expressed as a blue color, and a normal region which does not belong to the lesion may not be expressed as a color. The shape based heat map may be a method that distinguishes and displays parts having a high probability of corresponding to the lesion and parts having a low probability of corresponding to the lesion with different shapes among regions of the medical data. For example the shape based heat map may be displayed by a line, a dotted line, a double line, a dark line, a circular, a rectangle, etc. For example, among the regions included in the medical data, the region having the high probability of belonging to the lesion may be displayed by the circular, and the region having the low probability of belonging to the lesion may be displayed by the rectangle. For example, among the regions included in the medical data, the region having the high probability of belonging to the lesion may be displayed by the double line/dark line, and the region having the low probability of belonging to the lesion may be displayed by a single line/a light line. The detailed description of the display of the lesion information is just an example and the present disclosure is not limited thereto.
Beomhee Park et al fail to disclose “a readout information generation unit that generates readout information displaying markings related to the lesion on a scout image including at least one of the medical images in which the lesion is present and the medical images generated based on the plurality of medical images to represent the lesion;”
“wherein the markings are displayed on the scout image corresponding to the position of the lesion and are displayed in different diagrams according to a type of the lesion, a medical image analysis support system.” As claimed in claim 1 and 6.
However, Keum-Yong Oh et al discloses see paragraph (0059 and 0082-0083] and fig 5. The computer system 1300 receives the image signal from the MRI apparatus 1100, reconstructs the image signal to generate an MR image of a predetermined region of the object 2000, and transmits the MR image to the operating console 1500. 0083] After obtaining the scout image, the scout image is transmitted to the operating console 1500 and displayed on a monitor so that the user can set more accurate start position and end position of a FOV based on locations of a lesion and an internal organ or skeleton obtained from the scout image (operation S260). The FOV refers to an image area or portion to be imaged, and, in particular, a specific region of the object 2000 in an MR image.
[0084] Examination is performed according to the detailed FOV set in operation S260, and an MRI image is acquired (operations S270 and S280). The MRI image may be a 2D image of a slice of the object 2000 that is perpendicular to the axis of motion, or a 3D image containing the axis of motion.
Beomhee Park et al and Keum-Yong Oh et al (2014/0191753) are related to method for display lesion reading results, thus one of ordinary skill in the art, before the effective filing date of the claimed invention, would have recognized the obviousness of modifying the method disclosed by Beomhee with Keum-Yong’s teachings of providing marking of lesion reading result for more accurate and efficient diagnosis.
Regarding claim 2 and 7, Beomhee discloses see fig 2 “wherein a size of the diagram is displayed to correspond to the size of the lesion”. . For example, the shape based heat map may be displayed by a line, a dotted line, a double line, a dark line, a circular, a rectangle, etc. For example, among the regions included in the medical data, the region having the high probability of belonging to the lesion may be displayed by the circular, and the region having the low probability of belonging to the lesion may be displayed by the rectangle. For example, among the regions included in the medical data, the region having the high probability of belonging to the lesion may be displayed by the double line/dark line, and the region having the low probability of belonging to the lesion may be displayed by a single line/a light line. The detailed description of the display of the lesion information is just an example and the present disclosure is not limited thereto.
Regarding claim 3 and 8, Beomhee discloses see paragraph (0054) . “wherein the type of lesion includes a non-solid nodule, a part-solid nodule, and a solid nodule, wherein the diagram is displayed in a dotted line, a solid line, or a double solid line according to the type of lesion.” . For example, among the regions included in the medical data, the region having the high probability of belonging to the lesion may be displayed by the double line/dark line, and the region having the low probability of belonging to the lesion may be displayed by a single line/a light line. The detailed description of the display of the lesion information is just an example and the present disclosure is not limited thereto.
Claim(s) 4-5 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beomhee Park et al (2021/0407637) in view of Keum-Yong Oh et al (2014/0191753) and further in view of (KR10-0996050)
Regarding claim 4 and 9, Beomhee Park et al and Keum-Yong Oh et al teach claim 1 and 6 see above rejection. Furthermore Beomhee Park teaches, see paragraph (0051] Throughout the detailed description and claims of the present disclosure, a Picture Archiving and Communication System (PACS)′ is a term that refers to a system for performing storing, processing, and transmitting according to the DICOM standard, and medical images such as X-ray, CT, and MM, which are acquired by using digital medical image equipment may be stored in a DICOM format and transmitted to terminals inside or outside a hospital through a network, and additionally include a reading result and a medical chart.
but fail to teach “wherein the medical image information and the readout information include data in DICOM (Digital Imaging and Communications in Medicine) format, wherein the readout information generation unit determines a coordinate information of the image position patient in the DICOM header information of the readout information based on a coordinate information of the image position patient in the DICOM header information of the medical images in which the lesion is present and a position information of the lesion in the medical images in which the lesion is present.
However, (KR10-0996050) teaches, A capsule endoscope receiving unit for receiving a signal from the capsule endoscope in real time through a communication method using electromagnetic waves or human body impedance, or a human body wireless communication method, and decoding the received signal and converting the received signal into a capsule endoscope image; and
After receiving the capsule endoscope image from the capsule endoscope receiver in real time and compressing the provided capsule endoscope image to JPEG or a compression standard equivalent thereto, the acquisition time of the capsule endoscope image, the location information of the human body, the capsule unique number, the capsule endoscope receiving unit number, and the inspection After adding the header including information such as unique number, patient number, patient name, sex, and test location, convert it to DICOM, which is an international medical imaging standard, or a standard format, and transmit the converted capsule endoscope image to the lesion detection server. Automatic lesion detection system based on U-Health using the capsule endoscope image, characterized in that it comprises an image transmitter.
Beomhee Park et al; Keum-Yong Oh et al and (KR -10-0996050) are related to method for display lesion reading results, thus one of ordinary skill in the art, before the effective filing date of the claimed invention, would have recognized the obviousness of modifying the method disclosed by Beomhee; Keum-Yong with (KR10-0996050) teachings of providing a lesion reading result information and location for more accurate and efficient diagnosis.
Regarding claims 5 and 10 “wherein the readout information generation unit determines the position information of the lesion based on a pixel spacing information in the DICOM header information of the medical images in which the lesion is present, and a number of pixels between a reference point corresponding to a coordinate information of the image position patient and the lesion.”
(KR10-0996050) teaches, That is, the lesion detector 24 calculates the brightness at the pixel coordinates of the capsule endoscope image using Equation 1 to remove the capsule endoscope image irregularly photographed according to the amount of illumination, and then the calculated brightness is the first reference brightness. If the value is less than (i.e., dark) or exceeds the second reference brightness (i.e., bright), the image of the corresponding pixel is removed. The image transmitter 14 receives the capsule endoscope image from the capsule endoscope receiver 12 in real time and compresses the capsule endoscope image provided to a Joint Photographic Coding Experts Group (JPEG) or a compression standard equivalent thereto, and then acquires the capsule endoscope image. DICOM (Digital Imaging and Communications in International Medical Imaging Standard) is added by adding headers including information on the location of the human body, capsule unique number, capsule endoscope receiver number, test unique number, patient number, patient name, gender, and test location. Medicine) or a standard format equivalent thereto and then transmit the converted capsule endoscope image to the lesion detection server 20.
After receiving the capsule endoscope image from the capsule endoscope receiver in real time and compressing the provided capsule endoscope image to JPEG or a compression standard equivalent thereto, the acquisition time of the capsule endoscope image, the location information of the human body, the capsule unique number, the capsule endoscope receiving unit number, and the inspection After adding the header including information such as unique number, patient number, patient name, sex, and test location, convert it to DICOM, which is an international medical imaging standard, or a standard format, and transmit the converted capsule endoscope image to the lesion detection server. Automatic lesion detection system based on U-Health using the capsule endoscope image, characterized in that it comprises an image transmitter.
Beomhee Park et al; Keum-Yong Oh et al and (KR -10-0996050) are related to method for display lesion reading results, thus one of ordinary skill in the art, before the effective filing date of the claimed invention, would have recognized the obviousness of modifying the method disclosed by Beomhee; Keum-Yong with (KR10-0996050) teachings of providing a lesion reading result information and location for more accurate and efficient diagnosis.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TEMESGHEN GHEBRETINSAE whose telephone number is (571)272-3017. The examiner can normally be reached Monday-Friday 7:30-4.00 p.m..
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, TEMESGHEN GHEBRETINSAE can be reached at 571-272-3017. 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.
/TEMESGHEN GHEBRETINSAE/Supervisory Patent Examiner, Art Unit 2626