Ll 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 Objections
Claim 8 is objected to because of the following informalities:
“the treatment tool captured in the endoscopic image is other than an energy device and is other than a linear stapler” should read, “the treatment tool captured in the endoscopic image is a tool other than an energy device and is a tool other than a linear stapler”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “specific region”, “specific information” and “specific threshold” in claim 1, 19, and 20 are relative terms which render the claim indefinite. Similarly, relative terminology of “specific treatment tool” in claim 3, “specific position” in claim 4, 7, 11, and 12, “specific time period” in claim 5, and “specific angle” in claim 15 are relative terms which render the claim indefinite.
The term “specific” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example, is a “specific position” a coordinate? Is it a general region? If it is a region, are there limitations of size making it specific?
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-4, 9-11, and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Matsuzaki (US 20240362777 A1) in view of Nichogi (US 20160354164 A1).
Regarding Claim 1, representative of Claims 19 and 20, Matsuzaki teaches an information assistance device comprising:
a processor comprising hardware, the processor being configured to
set a specific region in an endoscopic image captured by an endoscope device as a region of interest ([0085] The surgical instrument tip detector 35 detects the position of the tip portion of the surgical instrument in the image acquired by the image acquisition unit 31, [0089] The image shown in FIG. 4 includes two surgical instruments (first surgical instrument 59 and second surgical instrument 60). The surgical instrument tip detector 35 encloses the first surgical instrument 49 and second surgical instrument 50 in the image acquired by the image acquisition unit 31 in the first bounding box 61 and second bounding box 62),
recognize an attention site captured in the endoscopic image ([0074] The organ area estimation unit 33 inputs the images acquired by the image acquisition unit 31 into the organ area estimation model, which has learned in advance the relationship between the images captured during surgery and the position and range of a certain organ in the images to estimates the position and range of the certain organ in the images acquired by the image acquisition unit 31, [0078] The organ to be estimated by the organ area estimation unit 33 may be correspond to the organ with a high probability of being damaged during the surgery),
recognize a treatment tool captured in the endoscopic image ([0087] The surgical instrument tip detector 35 may use a template corresponding to each surgical instrument and perform pattern matching to detect a surgical instrument based on whether a portion of the image acquired by the image acquisition unit 31 has a predetermined degree of similarity in relation to the template),
calculate a distance between the attention site and the treatment tool ([0092] The organ damage determination unit 36 determines whether the position of the tip portion detected by the surgical instrument tip detector 35 has reached the position and range of a certain organ as estimated by the organ area estimation unit 33), and
transmit a signal to notify specific information when the distance is equal to or less than a specific threshold value ([0093] The organ damage notification unit 37 notifies the surgeon of the possibility of organ damage when the organ damage determination unit 36 determines that the tip portion has reached the position and range)
Matsuzaki does not explicitly teach transmit a signal to notify specific information when the attention site is located outside the region of interest.
Nichogi teaches transmit a signal to notify specific information when the attention site is located outside the region of interest ([0031] Then, whether or not the entire endoscope occupying region is positioned in the non-interference region is monitored by the interference predicting portion 12 (interference predicting step S6), and, when at least a portion of the endoscope occupying region falls outside the non-interference region (“YES” in step S6), the notification signal is output from the interference predicting portion 12 (alerting step S7), [0064] In the first to third embodiments, although the endoscope 1 has mainly been described as the medical device, interference between the treatment tool and the peripheral tissue D may be predicted by using a treatment tool such as forceps or the like instead of the endoscope).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the teachings of Matsuzaki to include the teachings of Nichogi by including a notification of when the treatment tool is approaching the organ area estimated to have a high probability of damage, and thereby a notification when the attention site is located outside the region of interest. Doing so would improve the accuracy of the surgical treatment being performed by alerting an operator, thereby minimizing damage.
Regarding Claim 2, the Matsuzaki and Nichogi combination teaches the information assistance device according to claim 1. In addition, Matsuzaki teaches wherein the processor is configured to set the region of interest based on the treatment tool captured in the endoscopic image ([0089] The image shown in FIG. 4 includes two surgical instruments (first surgical instrument 59 and second surgical instrument 60). The surgical instrument tip detector 35 encloses the first surgical instrument 49 and second surgical instrument 50 in the image acquired by the image acquisition unit 31 in the first bounding box 61 and second bounding box 62).
Regarding Claim 3, the Matsuzaki and Nichogi combination teaches the information assistance device according to claim 1. In addition, Matsuzaki teaches wherein the processor is configured to recognize a specific treatment tool captured in the endoscopic image among a plurality of treatment tools used during surgery ([0085] The surgical instrument tip detector 35 detects the position of the tip portion of the surgical instrument in the image acquired by the image acquisition unit 31, [0087] The surgical instrument tip detector 35 may use a template corresponding to each surgical instrument and perform pattern matching to detect a surgical instrument, [0089] The image shown in FIG. 4 includes two surgical instruments (first surgical instrument 59 and second surgical instrument 60). The surgical instrument tip detector 35 encloses the first surgical instrument 49 and second surgical instrument 50 in the image acquired by the image acquisition unit 31 in the first bounding box 61 and second bounding box 62).
Regarding Claim 4, the Matsuzaki and Nichogi combination teaches the information assistance device according to claim 2. In addition, Matsuzaki teaches wherein the processor is configured to set a region centered on a specific position of an energy device as the region of interest when the treatment tool captured in the endoscopic image is the energy device ([0089] The image shown in FIG. 4 includes two surgical instruments (first surgical instrument 59 and second surgical instrument 60). The surgical instrument tip detector 35 encloses the first surgical instrument 49 and second surgical instrument 50 in the image acquired by the image acquisition unit 31 in the first bounding box 61 and second bounding box 62). Examiner notes see region 62 centered on the surgical instrument, [0052] Surgical energy devices are directed to surgical instruments that use the force of energy to cutting and excising tissue and stop bleeding).
Regarding Claim 9, the Matsuzaki and Nichogi combination teaches the information assistance device according to claim 2. In addition, Matsuzaki teaches wherein the processor is configured to set a region centered on an image center of the endoscopic image as the region of interest when the treatment tool captured in the endoscopic image is either an energy device or a linear stapler ([0089] The image shown in FIG. 4 includes two surgical instruments (first surgical instrument 59 and second surgical instrument 60). The surgical instrument tip detector 35 encloses the first surgical instrument 49 and second surgical instrument 50 in the image acquired by the image acquisition unit 31 in the first bounding box 61 and second bounding box 62). Examiner notes see region 62 centered in the image due to the surgical instrument being in the center of the image, [0052] Surgical energy devices are directed to surgical instruments that use the force of energy to cutting and excising tissue and stop bleeding).
Regarding Claim 10, the Matsuzaki and Nichogi combination teaches the information assistance device according to claim 1. In addition, Matsuzaki teaches wherein the processor is configured to recognize a surgical scene based on the endoscopic image, and set the region of interest in the endoscopic image based on the surgical scene ([0085] the surgical instrument tip detector 35 detects the position of the tip portion of the surgical instrument in the image acquired by the image acquisition unit 31, [0087] The surgical instrument tip detector 35 may use a template corresponding to each surgical instrument and perform pattern matching to detect a surgical instrument, [0089] The image shown in FIG. 4 includes two surgical instruments (first surgical instrument 59 and second surgical instrument 60). The surgical instrument tip detector 35 encloses the first surgical instrument 49 and second surgical instrument 50 in the image acquired by the image acquisition unit 31 in the first bounding box 61 and second bounding box 62. Examiner interpreting a surgical scene to be the area where a surgical tool is being used).
Regarding Claim 11, the Matsuzaki and Nichogi combination teaches the information assistance device according to claim 10. In addition, Matsuzaki teaches wherein the processor is configured to set a region centered on a specific position of an energy device that is the treatment tool as the region of interest when the surgical scene is a surgical scene in which a tissue is detached or dissected ([0085] the surgical instrument tip detector 35 detects the position of the tip portion of the surgical instrument in the image acquired by the image acquisition unit 31, [0089] The image shown in FIG. 4 includes two surgical instruments (first surgical instrument 59 and second surgical instrument 60). The surgical instrument tip detector 35 encloses the first surgical instrument 49 and second surgical instrument 50 in the image acquired by the image acquisition unit 31 in the first bounding box 61 and second bounding box 62. Examiner interpreting a surgical scene to be the area where a surgical is tool being used, [0052] Surgical energy devices are directed to surgical instruments that use the force of energy to cutting and excising tissue and stop bleeding).
Regarding Claim 14, the Matsuzaki and Nichogi combination teaches the information assistance device according to claim 10. In addition, Matsuzaki teaches wherein the processor is configured to set a region centered on an image center of the endoscopic image as the region of interest when the surgical scene is a surgical scene in which a tissue is detached or dissected or a surgical scene in which an intestinal tract is resected ([0085] the surgical instrument tip detector 35 detects the position of the tip portion of the surgical instrument in the image acquired by the image acquisition unit 31, [0087] The surgical instrument tip detector 35 may use a template corresponding to each surgical instrument and perform pattern matching to detect a surgical instrument, [0089] The image shown in FIG. 4 includes two surgical instruments (first surgical instrument 59 and second surgical instrument 60). The surgical instrument tip detector 35 encloses the first surgical instrument 49 and second surgical instrument 50 in the image acquired by the image acquisition unit 31 in the first bounding box 61 and second bounding box 62. Examiner notes see region 62 centered in the image due to the tool being in the center of the image. Examiner interpreting a surgical scene to be area where a surgical tool is being used, [0052] Surgical energy devices are directed to surgical instruments that use the force of energy to cutting and excising tissue and stop bleeding).
Regarding Claim 15, the Matsuzaki and Nichogi combination teaches the information assistance device according to claim 1. In addition, Matsuzaki teaches wherein the region of interest has a shape that is rotationally symmetric at a specific angle with a center of the region of interest as a central axis ([0089] The image shown in FIG. 4 includes two surgical instruments (first surgical instrument 59 and second surgical instrument 60). The surgical instrument tip detector 35 encloses the first surgical instrument 49 and second surgical instrument 50 in the image acquired by the image acquisition unit 31 in the first bounding box 61 and second bounding box).
Regarding Claim 16, the Matsuzaki and Nichogi combination teaches the information assistance device according to claim 1. In addition, Matsuzaki teaches wherein the processor is configured to transmit a signal to notify the specific information by at least one of an image, light, sound, and vibration ([0017]: notification unit that notifies the surgeon of the possibility of the organ damage when the organ damage determination unit determines that the position of the tip portion has reached the estimated position and range, [0093]: The method of notification by the organ damage notification unit 37 may include the display of a predetermined notification screen on the monitor 12 and smart glasses 13, and the sounding of a predetermined alarm tone ).
Regarding Claim 17, the Matsuzaki and Nichogi combination teaches an endoscope system comprising: the information assistance device according to claim 1. In addition, Matsuzaki teaches an endoscope device configured to capture an image of an inside of a subject ([0111] FIG. 8 is a diagram illustrating an example of the image captured by the endoscope for the surgery assisting system 10).
Regarding Claim 18, the Matsuzaki and Nichogi combination teaches the endoscope system according to claim 17. In addition, Matsuzaki teaches further comprising: a first display configured to display the endoscopic image ([0004]: images captured by the laparoscope are displayed on a monitor to perform operations); and a second display configured to display the image processed by the information assistance device ([0126]: highlighting the portion of one organ that is close to the other organ can alert the surgeon to the portion of one organ that is most likely to be damaged, [0111]: FIG. 9 is a diagram illustrating an example of a display of the image captured by the endoscope on which highlighted position and range of organs with a high probability of being damaged).
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Matsuzaki (US 20240362777 A1) and Nichogi (US 20160354164 A1) in view of Shelton (US 20210196423 A1).
Regarding Claim 7, the Matsuzaki and Nichogi combination teaches the information assistance device according to claim 2. In addition, Matsuzaki teaches wherein the processor is configured to set a region centered on a specific position of a linear stapler as the region of interest when the treatment tool captured in the endoscopic image is the linear stapler ([0089] The image shown in FIG. 4 includes two surgical instruments (first surgical instrument 59 and second surgical instrument 60). The surgical instrument tip detector 35 encloses the first surgical instrument 49 and second surgical instrument 50 in the image acquired by the image acquisition unit 31 in the first bounding box 61 and second bounding box 62). Examiner notes see region 62 centered in the image due to the tool being in the center of the image).
Although Matsuzaki teaches a surgical instrument, neither Matsuzaki nor Nichogi explicitly teach a linear stapler.
However, a linear stapler is a common surgical treatment tool known in the art as taught by Shelton ([0129]: surgical device 102 can be any suitable surgical device such as, for example, a dissector, a stapler, a grasper, a clip applier, and/or an energy device, [0114]: by identifying the critical structure 101, a clinician can avoid maneuvering a surgical device around the critical structure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the teachings of the Matsuzaki and Nichogi combination to include the teachings of Shelton, by substituting the generic surgical instrument for a linear stapler. Doing so would provide the predictable result of a commonly used surgical tool, and organ damage prediction when using the tool.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Matsuzaki (US 20240362777 A1) and Nichogi (US 20160354164 A1) in view of Qin (Qin, H. Q., Liao, J. K., Wang, W. T., Meng, L. H., Huang, Z. G., & Mo, X. W. (2022). Feasibility and advantages analyses of wedge resection without mesentery detached approach applied to closure of loop ileostomy. BMC surgery, 22(1), 211. https://doi.org/10.1186/s12893-022-01661-5).
Regarding Claim 12, the Matsuzaki and Nichogi combination teaches the information assistance device according to claim 10. In addition, the Matsuzaki and Nichogi combination teaches wherein the processor is configured to set a region centered on a specific position of ([0085] the surgical instrument tip detector 35 detects the position of the tip portion of the surgical instrument in the image acquired by the image acquisition unit 31, [0089] The image shown in FIG. 4 includes two surgical instruments (first surgical instrument 59 and second surgical instrument 60). The surgical instrument tip detector 35 encloses the first surgical instrument 49 and second surgical instrument 50 in the image acquired by the image acquisition unit 31 in the first bounding box 61 and second bounding box 62. Examiner interpreting a surgical scene to be the area where a surgical is tool being used, [0052] Surgical energy devices are directed to surgical instruments that use the force of energy to cutting and excising tissue and stop bleeding)
Although Matsuzaki teaches a surgical instrument and use of an energy device to cut and excise tissue, neither Matsuzaki nor Nichogi explicitly teach using a linear stapler and a surgical scene in which an intestinal tract is resected.
However, a linear stapler is a common surgical treatment tool known in the art to be applicable in intestinal tract resection as taught by Qin ([introduction, paragraph 1]: the commonly used surgical approaches for ileostomy closure surgery included the hand suture approach (end-to-end anastomosis) and the stapler approach).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to have modified the teachings of the Matsuzaki and Nichogi combination to include the teachings of Shelton, by substituting the generic surgical instrument for a linear stapler used for an intestinal tract resection. Doing so would provide the predictable result of a commonly used surgical tool, and organ damage prediction when using the tool for intestinal tract resection.
Allowable Subject Matter
Claims 5-6, 8, and 13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANICE VAZ whose telephone number is (703)756-4685. The examiner can normally be reached Monday-Friday 9:00-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Matthew Bella can be reached at (571) 272-7778. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANICE E. VAZ/Examiner, Art Unit 2667
/MATTHEW C BELLA/Supervisory Patent Examiner, Art Unit 2667
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