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 .
Response to Arguments
Applicant’s arguments with respect to claims 1, 20-38 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claims 2-19 have been canceled.
Examiner Note
It is noted that non-functional descriptive material does not patentably distinguish over prior art that otherwise renders the claims unpatentable. See for example, MPEP 2111.05, MPEP 2112.01(III). See also In re Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004); Exparte Nehls, 88 USPQ2d 1883, 1887-90 (BPAI 2008) (precedential) (discussing cases pertaining to non-functional descriptive material) see also BPAI’s decision in Appeal 2009-010851 (for Ser. No. 10/622,876) or BPAI’s decision in Appeal 2011-011929 (for Ser. No. 11/709,170), pages 6-7. In this case, a particular type of data or action/performance such as “suction”, “a mucosa”, “arrow”…. could be considered as non-functional descriptive material and are not required to give patentable weight because these particular type of data, particular type of indicator or particular type of action/performance do not functionally change the structure or operation of a system of perform a particular action/performance based of a state of an subject and distance of a subject to a target location/object or indicator for providing direction. The limitation of particular action such as “suction” or target object such as “mucosa”, “arrow”… recited in the claims are only given patentable weight of type of action/performance of type of data. The particular type/name of action/performance such as “suction” or “mucosa” has no moment.
Although non-functional descriptive material are not required to be considered, all claim limitations including non-functional descriptive material are known by prior art as discussed below.
It is also noted that for claims having contingent limitations (e.g., claims 23, 33), according to MPEP 2111.04 II. and See Ex parte Schulhauser, Appeal 2013-007847 (PTAB April 28, 2016), “[i]f the condition for performing a contingent step is not satisfied, the performance recited by the the step need not be carried out in order for the claimed method to be performed….”
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.
Claims 26 and 37 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.
Claims 26, 37, each recites the limitation "the presumption" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1, 20-27, 29-37 are rejected under 35 U.S.C. 103 as being unpatentable over Tojo et al. (US 20190231444) in view of either Tanaka (JP 2010-088572) (citations from the machine language translation provided by the Examiner) or Ahmed et al. (US 20210393907).
Regarding claim 1, Tojo discloses control device (endoscope system 10 – see figure 22, paragraphs 0037, 0127-0128) comprising:
a processor comprising hardware (processor of endoscope system main body 14 comprising hardware/circuits – see figures 1, 22, paragraphs 0042, 0126-0128), wherein the processor is configured to:
acquire an endoscope image captured by an endoscope (receive image captured by endoscope 12 by imaging device 26 – see figures 22-24, paragraphs 0055, 0103, 0133);
determine whether suction is needed, based on the endoscope image (determine, based on the image captured by image captured by the endoscope and output state information for an operation such as recommendation for an air suction operation – see include, but are not limited to, paragraphs 0129, 0159-0160);
when the suction is determined to be needed, implement control to carry out the suction (when the suction is determined to be needed based on the recommended insertion operation information comprises an air suction operation, implement control to carry out the recommended operation includes an air suction operation – see include, but are not limited to, paragraphs 0129-0130, 0148, 0159-0160);
determine a state of a subject based on a change in the endoscope image when the operation is performed; and perform control regarding action based on the state of the subject (determine a state of a subject for attention state such as condition of tube, bending part, bending degree, distance, etc., based on a change in the endoscope image when the operation is performed; and performs control regarding the operation/action based on the state of the subject based on the recommended operation – see include, but are not limited to, figures 2-5, 10-12, 14-18, 22-24, paragraphs 0051-0052, 0057, 0092, 0112, 0129-0130, 0132, 0144, 0146-0148, 0159-0160);
output support information for an operator based on the state of the subject (output support information with attention state information indicator and/or recommended insertion operation information for an operator 70 based on the state of the subject – see include, but are not limited to, figures 4, 10, 12-19, 23-24, paragraphs 0055-0056, 0063-0064, 0071-0072, 0112, 0129-0130, 0143-0144, 0159-0160).
Tojo discloses endoscope system comprises an air suction machine for sucking the gas in the large intestinal lumen from the distal end of the insertion section 20 (paragraph 0057). The recommended insertion operation information, based on detected state information, includes information on an air suction operation using an air suction mechanism, so that operator can know a specific operation for proceeding with the insertion or an air suction operation or for improving safety (see paragraphs 0129-0132, 0159-0160). However, Tojo does not explicitly disclose determining a state of a subject based on a change in the endoscope image when the suction is performed;
Additionally and/or alternatively, Tanaka discloses a control device comprising:
a processor comprising hardware (control device 19, page 3, first full paragraph), wherein the processor is configured to:
acquire an endoscope image captured by an endoscope (“acquires endoscopic image”, page 4, first full paragraph);
determine whether suction is needed, based on the endoscope image (determines state of the intestinal tract from the image, and decides whether suction is needed based on whether intestinal tract is in an expanded state, crushed state, or red ball state pages 4-7, Figs.6A-6D);
when the suction is determined to be needed, implement control to carry out the suction (performs suction operation when expanded state is detected, page 5, fourth full paragraph);
determine a state of a subject based on a change in the endoscope image when the suction is performed (continues determining state of intestinal tract from image, and when it determines crushed state during suction, controls suction to stop, page 6, paragraph under “Steps S32 and S33”); and
perform control regarding suction based on the state of the subject (controls suction to stop, page 6, paragraph under “Steps S32 and S33”).
Alternatively, Ahmed discloses a control device comprising a processor comprising hardware, wherein the processor is configured to: determine whether suction is needed based on data captured by sensor of suctioning device 100– see include, but are not limited to, figures 3-4, paragraphs 0046-0050);
when the suction is determined to be needed, implement control to carry out the suction (when suction is determined to be needed based on sign of secretion build-up at or around the suction catheter 104 or based on pressure detected by the sensor, automatically initiating/actuating the suction machine 112 into the ON position – see include, but are not limited to, paragraphs 3-4, paragraphs 0046-0050);
determine a state of a subject based on change detected captured by sensor when the suction is performed (determine a state of sensor, secretion build-up, pressure on sensor, balloon, indicator, etc. when the suction is performed – see include, but are not limited to, figures 3-4, paragraphs 0042, 0046-0051);
perform control regarding suction based on the state of the subject (perform control regarding suction based on the state of the sensor, secretion, pressure of sensor, balloon, etc. but are not limited to, figures 3-4, paragraphs 0042, 0046-0051);
output support information for an operator based on the state of the subject (output support information with visual indicators 166, 168, 170 for an operator based on the state of the sensor, speed/force of suction, secretion status, etc. – see figures 3-4, paragraph 0042, 0051).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tojo with the teaching including determining a state of a subject based on a change in endoscope image when the suction is performed as taught by Tanaka or Ahmed (hereinafter referred to as Tanaka/Ahmed) in order to yield predictable result of conveniently keeping a lumen in an appropriate expanded state (see Tanaka: page 2, the tech-solution and advantageous-effects portions) or improving safety, preventing damage (see Ahmed: paragraphs 0048-0049).
Regarding claim 20, limitations of a control method that correspond to limitations of a control device as recited in claim 1 are analyzed as discussed in the rejection of claim 1 are analyzed as discussed in the rejection 1. In particular, Tojo in view of Tanaka/Ahmed discloses a control method, comprising:
acquiring an endoscope image captured by an endoscope;
determining whether suction is needed, based on the endoscope image;
when the suction is determined to be needed, implementing control to carry out the suction;
determining a state of a subject based on a change in the endoscope image when the suction is performed;
performing control regarding suction based on the state of the subject; and
outputting support information for an operator based on the state of the subject. (see similar discussion in the rejection of claim 1, and include, but are not limited to, Tojo: figures 1-2, 22-23, paragraphs 0129-0130, 0142-0146, 0159-0160; Tanaka: figures 6a-6d, page 5, fourth full paragraph).
Regarding claim 21, Tojo in view of Tanaka/Ahmed discloses the control device as defined in claim 1, wherein the processor performs the control regarding suction and simultaneously outputs the support information (controlling regarding suction and simultaneously outputs the support information such as indicator/state regarding suction – see include, but are not limited to, Tojo, paragraphs 0129-0130, 0159-0140, figures 10, 18, 21-23; Tanaka: figures 6a-6d, pages 3-4; Ahmed: figures 3-4, paragraphs 0042, 0051).
Regarding claim 22, Tojo in view of Tanaka/Ahmed discloses the control device as defined in claim 1, wherein the processor changes the support information based on a change in the state of the subject by the suction (the processor changes the support information with different indication of red, green, stop notification, on, off, or other information for state information based on change of the state of the subject by the suction – see include, but are not limited to, Tojo: figures 2-3, 5, 22-23, paragraphs 051, 0056-0057, 0062, 0129-0130, 0159-0160; Tanaka: page 4, figures 6a-6d; Ahmed: figures 3-4, paragraphs 0042, 0050-0051).
Regarding claim 23, Tojo in view of Tanaka/Ahmed discloses the control device as defined in claim 1, wherein the processor acquires a distance between a mucosa of the subject and a distal end section of the endoscope and, if the distance is a predetermined distance, outputs an operation plan regarding an operation of the endoscope as the support information (e.g., acquire distance/length between a wall of intestine, specific region such as C(Cecum), etc., and predetermined portion of insertion section/object of the endoscope and, if the distance is a predetermined distance/threshold, output an operation of the of the endoscope as the support information regarding changing direction in which the operation bending portion of the insertion section 20 is to be bent, air suction operation, etc. – see include, but are not limited to, Tojo: figures 2-5, 14-17, 23, paragraphs 0051-0053, 0055, 0070, 0076, 0080-0081; or see Tanaka: each of the expanded, crushed, and red ball state is indicative of the distance between the mucosa of the intestinal tract and the endoscope distal end, see Figs.6A-6D) .
Regarding claim 24, Tojo in view of Tanaka/Ahmed discloses the control device as defined in claim 1, wherein the processor acquires a position of the endoscope in a lumen and outputs the support information based on the position (processor acquire a position of endoscope and/insertion section in a lumen as specific area such as arrive the cecum and output the support information based on the information – see for example, Tojo: figure 17, paragraphs 0080-0081).
Regarding claim 25, Tojo in view of Tanaka/Ahmed discloses the control device as defined in claim 1, wherein the processor presents a luminal direction as the support information (processor presents an intestine luminal direction with specific area as the support information – see include, but are not limited to, Tojo: figures 10-17, paragraphs 0076, 0080-0081).
Regarding claim 26, Tojo in view of Tanaka/Ahmed discloses the control device as defined in claim 25, wherein the processor acquires the endoscope image after the control regarding suction (acquire the image after the control regarding suction to determine attention state, secretion/pressure state, or expanded state to stop/off the suction operation – see include, but are not limited to, Tojo, paragraphs 0259-0260; Tanaka: figures 6a-6d, pages 6-7; Ahmed: paragraphs 0010, 0046-0051).
Tojo in view of Tanaka/Ahmed also discloses the sensors can be balloon sensor configured to detect changes in pressure and/or flow from secretions within or around the suction catheter (Ahmed: paragraph 0010) and displaying endoscope images during and after the suction including location of the tip, direction of insertion, and lumen of intestine (see include, but are not limited to, Tojo: figures 2-4, 14-17; Tanaka: figures 6a-6d, pages 6-7; Ahmed: paragraphs 0010, 0046-0051). Thus, it would have been obvious that the processor presumes a flow of fluid due to the suction, and presumes the luminal direction based on a result of the presumption so that the operator can track the attention state for suction and direction of fluid/water and/or location insertion section).
Regarding claim 27, Tojo in view of Tanaka/Ahmed discloses the control device as defined in claim 25, wherein the processor presents, as a display image, an arrow indicating the luminal direction as the support information (processor presents, as a display image an indicator such as arrow, curve, etc. indicating the luminal direction as the support information - see include, but are not limited to, Tojo: figures 7, 16, 20, 23, paragraphs 0066, 0076, 0080-0081, 0111-0112).
Regarding claim 29, Tojo in view of Tanaka/Ahmed discloses the control device as defined in claim 1, wherein the processor acquires an operation of the operator and outputs the support information based on the operation (processor acquire an operation such as selection of on/off for particular type of attention, output recommendation, changing the direction, suction operation, an insertion operation in a difficult insertion, etc. and outputs the support information based on the operation/selection, – see include, but are not limited to, Tojo: figures 10, 14-15, 17, 21, 23-25, paragraphs 0056-0057, 0060, 0086-0089, 0159-0160; Ahmed: paragraphs 0042, 0046-0051, 0137-0139).
Regarding claim 30, Tojo in view of Tanaka/Ahmed discloses the control device as defined in claim 1, wherein the processor acquires patient information regarding the subject, creates an insertion plan based on the patient information, and performs the suction or an output of the support information based on the insertion plan (processor acquires/collects patient information such as recorded lesion position, cecum arrival time, specific regions/Cecum, regarding the subject of patient 84, creates an insertion plan with projection mapping, specific regions such as C (Cecum), and performs the suction or an output of the support information based on the insertion plan/projection mapping – see include, but are not limited to, figures , paragraphs 0076, 0080-0081, 0085, 0092, 0129-0130, 0137-0140).
Regarding claim 31, Tojo in view of Tanaka/Ahmed discloses the control device as defined in claim 1, wherein the processor acquires luminal internal pressure information regarding the subject and controls the suction based on the luminal internal pressure information (processor acquire internal pressure information regarding the subject/sensor/balloon and controls the suction based on internal pressure information – see include, but are not limited to, Tojo: figures 21, 25, paragraphs 0050, 0163, 0129, 0159-0160; Ahmed: paragraphs 0010-0011,0047-0048, 0050; Tanaka: page 6).
Regarding claim 32, Tojo in view of Tanaka/Ahmed discloses the control device as defined in claim 25, wherein the processor acquires a suction amount due to the suction and controls the suction based on the suction amount (processor acquire suction amount based on recommended insertion operation information, timer or amount to initiate/actuate on/off suction operation, secretion collection canister is full, etc. – see include, but are not limited to, paragraphs 0129, 0159-0160; Tanaka: figures 6a-6d, pages 6-7; Ahmed: paragraphs 0042, 45-48, 050-0051).
Regarding claim 33, Tojo in view of Tanaka/Ahmed discloses the control device as defined in claim 1, wherein the processor acquires a distance between a mucosa of the subject and a distal end section of the endoscope based on the endoscope image (processor acquires/tracks a distance between a wall/surface of the subject and the distal end section of the endoscope/catheter based on the captured image – see include, but are not limited to, Tojo: figures 2-4, 14-17, 20; Tanika: figures 6a-6d, pages 6-7). Tojo in view of Tanaka/Ahmed also discloses based on different distances/threshold between the surface/wall of the subject, select a suitable suction amount/force to prevent damage. For example, control suction unit based with suction force/amount based on expanded state of large intestine 4 determined by the determination unit to keep the expanded state appropriately. For example, if the distance between the surface/target location and the tip is large (e.g., in overexpanded state), control the suction unit with first suction amount/force, based on the expanded state decreases, change the suction amount/force and when the tip is so closer to the wall/surface of the subject (e.g., in the read ball state), stop suction (see include, but are not limited to, Tanaka: figures 6a-6d, paragraphs 3, 6-7. See also Tojo: figures 14-17, paragraphs 0051-0052, 0076, 80-81, 129, 159-160; Ahmed: paragraphs 0042, 0046-0052). Thus, it would have been obvious to one of ordinary skill in the art that if the distance is a first distance, performs suction by a first suction amount, if the distance is a second distance that is shorter than the first distance, performs suction by a second suction amount that is weaker than the first suction amount, and if the distance is a third distance that is shorter than the second distance, stops suction in order to keep the expanded state appropriately as mentioned in Tanaka or to prevent damage to the surface/wall.
See Sakamoto et al. (US 20200398265) also the concept of performing suction by different suction amount based on different distance between tip of the suction device and the surface of subject/cell.
Regarding claim 34, Tojo in view of Tanaka/Ahmed further discloses wherein the processor weakens a suction amount as the distance between the mucosa and the distal end section becomes closer (weaker a suction amount/stop suction as the distance between the surface/wall of the intestine is distal end section become closer for example, in red ball state – see include, but are not limited to, Tanaka: figure 6d, pages 6-7).
Regarding claims 35-37, the additional limitations of the method that correspond to the additional limitations of control device recited in claims 21, 25-26 are analyzed as discussed in the rejection of claims 21, 25-26.
Claims 28 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Tojo et al. (US 20190231444) in view of either Tanaka (JP 2010-088572) (citations from the machine language translation provided by the Examiner) or Ahmed et al. (US 20210393907) as applied to claim 25 or 36 above and further in view of Sakaguchi et al. (US 20230020596).
Regarding claim 28, Tojo in view of Tanaka/Ahmed discloses the control device as defined in claim 25. Tojo in view of Tanaka/Ahmed also discloses processor input the endoscope image and recording the images and the attention state information of the lumen, lumen, direction for improving the next endoscope examination based on the analysis result leads to an improvement of the medical quality. In the image analysis, pattern and color matching, machine learning, etc. are used (see include, but are not limited to, Tojo: paragraphs 0133, 0137-0139).
However, Tojo in view of Tanaka/Ahmed does not explicitly disclose
The processor inputs image to a training model.
Sakaguchi discloses processor inputs endoscope image to a trained model and presumes the luminal direction based on a presumption result of the trained model (generating training data in which data indicating a lumen across section is attached with a plurality of medical images with direction of lumen comprising main trunk, a side branch across section, etc. and input into learning/training model and presuming a direction of lumen with portion of main trunk, side branch, etc. based on a presumption result/recognition of the trained/learned model – see include, but are not limited to, figures 2-3, 10-11b, 14, paragraphs 0011, 0050, 0097-0098).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tojo in view of Tanaka/Ahmed with the teaching including processor inputs endoscope/captured image to a trained model and presume the luminal direction based on a presumption result of the trained model as taught by Sakaguchi in order to yield predictable result of assisting a doctor to efficiently recognize a main trunk and a side branch of a blood cell – see paragraphs 0006-0008, 0012).
Regarding claim 38, the additional limitations of the method that correspond to the additional limitations of control device recited in claim 28 are analyzed as discussed in the rejection of claim 28.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sakamoto et al. (US 20200398265) discloses device for picking up biological subject and perform different sucking mount/force based on different distance, shape or material of the subject (see figures 2a-2c, 3a, 5a-5b, 7a-9).
Guan (US 20180126106) discloses endotracheal tube comprising pharyngeal suction catheter.
Oh et al. (US 20190261846) discloses treating prostate disorders with suction of amount (see also paragraph 0070).
Kawano et al. (US 20170150874) discloses capsule endoscope system and magnetic field generating device and detecting distance between the endoscope and lumen wall surface/mucosa for performing operation (see figures 4-8, 13-15g).
Hyde et al. (US 20170119278) discloses lumen traveling device (see also figures 2a-3b).
Kawano et al. (US 20070221233) discloses body insertable device system and in-vivo observation method.
Applicant's amendment necessitated the new ground(s) of rejection 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AN SON P HUYNH whose telephone number is (571)272-7295. The examiner can normally be reached 9:00 am-6:00 pm.
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, ANH TUAN T. NGUYEN can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AN SON P HUYNH/Primary Examiner, Art Unit 3795
September 25, 2026
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