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 Amendment
The amendment filed on 7/8/2026 has been entered. Claims 1, 3, 5-17, and 19 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 4/8/2026. The claim interpretations invoked under 35 USC § 112(f) set forth in the Non-Final Office Action mailed 4/8/2026 have been withdrawn due to Applicant’s amendments.
Response to Arguments
Applicant's arguments, see Pages 11-12, filed on 7/8/2026, with respect to the rejections under 35 U.S.C. § 101 of Claims 1, 15, and 16 have been fully considered but they are not persuasive.
The applicant argues that amended claims 1, 15, and 16 are directed to patent eligible subject matter under 35 USC § 101. The applicant’s argument is on the grounds that the additional limitations of an endoscope configured to capture an image and a processor configured to perform automatic control of the electrical driving of the endoscope to position a distal end section of the endoscope amount to significantly more than the abstract idea. Examiner respectfully disagrees. These additional elements do not amount to significantly more because they represent components and/or activities which would routinely be used in applying the abstract idea, specifically generic tools for performing the abstract idea and insignificant extra-solution activities for performing the abstract idea. In previous arguments, the applicant drew attention to a benefit of the mental process such as avoiding excessive force to organs. Examiner notes that the inclusion of a limitation that specifies the use of the mental process for avoiding exerting excessive force to organs would amount to significantly more than the abstract idea.
Accordingly, the 101 rejections to claims 1, 15, and 16 stand. Please see section 35 USC § 101 below for further explanation.
Applicant’s arguments, see pages 12-18, filed 7/8/2026, with respect to the rejections under 35 USC § 103 of Claims 1 and 15-16 as being obvious over Sokolov in view of Meguro and Gage have been fully considered and are persuasive.
The rejections under 35 USC § 103 of Claims 1 and 15-16 have been withdrawn.
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 1, 3, 5-17, and 19 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 1, 5-6, and 15-16 recite the limitation "the endoscope’s position” in l. 36-37 of claim 1, l. 2-3 of claim 5, l. 2-3 of claim 6, l. 35-36 of claim 15, and l. 37-38 of claim 16. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the endoscope’s position” is being interpreted as “a position of the endoscope.”
Claims 3, 7-14, 17, and 19 are rejected as being dependent upon claims previously rejected under 35 USC § 112(b).
Claim Rejections - 35 USC § 101
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.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements and/or steps are well-understood, routine, and conventional in the art. They represent components and/or activities which would routinely be used in applying the abstract idea. As such, they do not meaningfully limit the claims, taken as a whole, to a particular application of the abstract idea; rather, the claims would tend to monopolize the abstract idea itself in practice.
A review of the instant claim(s) using the Alice two-part analysis is provided herein.
Step 1: The claims are one of the four statutory categories, in this instant, a machine.
Step 2 A:
Prong One: The claims are directed to an abstract idea without significantly more. The claims recite mental processes (MPEP § 2106.04(a)(2)(III)). The mental process is:
In response to recognizing that the predetermined anatomical structure is captured in the image and recognizing that the treatment tool inserted through the endoscope is not captured in the image, determine the endoscope is being positioned
in response to recognizing that the predetermined anatomical structure is captured in the image and recognizing that the treatment tool inserted through the endoscope is captured in the image, determine the treatment tool is being used for a treatment after the endoscope has been positioned
Determine whether a predetermined condition regarding the endoscope’s position is detected
Prong Two: This judicial exception is not integrated into a practical application because the additional elements: (a) merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea; and (b) the additional element does no more than generally link the use of the judicial exception to a particular technological environment or field of use.
Step 2 B: The claims do not contain additional elements which amount to significantly more than the abstract idea. The instant claims recite the additional elements of an endoscope configured to be electrically driven in an instrument motion during a procedure and a processor comprising hardware. The instant claims recite the additional activities of capturing an image, controlling electrical driving of the medical instrument in a full auto mode and a semi auto mode, and performing automatic control to intervene in the manual control.
These additional elements do not amount to significantly more because they represent components and/or activities which would routinely be used in applying the abstract idea, specifically generic tools for performing the abstract idea and insignificant extra-solution activities for performing the abstract idea. As such, they do not meaningfully limit the claims, taken as a whole, to a particular application of the abstract idea; rather, the claims would tend to monopolize the abstract idea itself in practice.
In accordance with MPEP § 2106.07(a)(III), Examiner notes that the machine is routine, conventional, and is recited at a high degree of generality. Specifically, Sokolov et al. (US 2025/0064296) and Gage et al. (US 2024/0252775) describe a well-known machine with automatic and semi-automatic motion modes of an endoscope. Accordingly, these additional elements of the instant claims do not amount to significantly more than the abstract idea.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements and/or steps are well-understood, routine, and conventional in the art. They represent components and/or activities which would routinely be used in applying the abstract idea. As such, they do not meaningfully limit the claims, taken as a whole, to a particular application of the abstract idea; rather, the claims would tend to monopolize the abstract idea itself in practice.
A review of the instant claim(s) using the Alice two-part analysis is provided herein.
Step 1: The claims are one of the four statutory categories, in this instant, a process.
Step 2 A:
Prong One: The claims are directed to an abstract idea without significantly more. The claims recite mental processes (MPEP § 2106.04(a)(2)(III)). The mental process is:
In response to recognizing that the predetermined anatomical structure is captured in the image and recognizing that the treatment tool inserted through the endoscope is not captured in the image, determine the endoscope is being positioned
in response to recognizing that the predetermined anatomical structure is captured in the image and recognizing that the treatment tool inserted through the endoscope is captured in the image, determine the treatment tool is being used for a treatment after the endoscope has been positioned
Determine whether a predetermined condition regarding the endoscope’s position is detected
Prong Two: This judicial exception is not integrated into a practical application because the additional elements: (a) merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea; and (b) the additional element does no more than generally link the use of the judicial exception to a particular technological environment or field of use.
Step 2 B: The claims do not contain additional elements which amount to significantly more than the abstract idea. The instant claims recite the additional elements of an endoscope configured to be electrically driven in an instrument motion during a procedure. The instant claims recite the additional activities of capturing an image, controlling electrical driving of the medical instrument in a full auto mode and a semi auto mode, and performing automatic control to intervene in the manual control.
These additional elements do not amount to significantly more because they represent components and/or activities which would routinely be used in applying the abstract idea, specifically extra-solution activities for performing the abstract idea. As such, they do not meaningfully limit the claims, taken as a whole, to a particular application of the abstract idea; rather, the claims would tend to monopolize the abstract idea itself in practice.
In accordance with MPEP § 2106.07(a)(III), Examiner notes that the process is routine, conventional, and is recited at a high degree of generality. Specifically, Sokolov et al. (US 2025/0064296) and Gage et al. (US 2024/0252775) describe a well-known process for using both a full auto mode and semi auto mode for controlling motion of an endoscope. Accordingly, these additional activities of the instant claims do not amount to significantly more than the abstract idea.
Claim 16 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements and/or steps are well-understood, routine, and conventional in the art. They represent components and/or activities which would routinely be used in applying the abstract idea. As such, they do not meaningfully limit the claims, taken as a whole, to a particular application of the abstract idea; rather, the claims would tend to monopolize the abstract idea itself in practice.
A review of the instant claim(s) using the Alice two-part analysis is provided herein.
Step 1: The claims are one of the four statutory categories, in this instant, a machine.
Step 2 A:
Prong One: The claims are directed to an abstract idea without significantly more. The claims recite mental processes (MPEP § 2106.04(a)(2)(III)). The mental process is:
In response to recognizing that the predetermined anatomical structure is captured in the image and recognizing that the treatment tool inserted through the endoscope is not captured in the image, determine the endoscope is being positioned
in response to recognizing that the predetermined anatomical structure is captured in the image and recognizing that the treatment tool inserted through the endoscope is captured in the image, determine the treatment tool is being used for a treatment after the endoscope has been positioned
Determine whether a predetermined condition regarding the endoscope’s position is detected
Prong Two: This judicial exception is not integrated into a practical application because the additional elements: (a) merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea; and (b) the additional element does no more than generally link the use of the judicial exception to a particular technological environment or field of use.
Step 2 B: The claims do not contain additional elements which amount to significantly more than the abstract idea. The instant claims recite the additional elements of an endoscope configured to be electrically driven in an instrument motion during a procedure and a processor comprising hardware. The instant claims recite the additional activities of capturing an image, controlling electrical driving of the medical instrument in a full auto mode and a semi auto mode, and performing automatic control to intervene in the manual control.
These additional elements do not amount to significantly more because they represent components and/or activities which would routinely be used in applying the abstract idea, specifically generic tools for performing the abstract idea and insignificant extra-solution activities. As such, they do not meaningfully limit the claims, taken as a whole, to a particular application of the abstract idea; rather, the claims would tend to monopolize the abstract idea itself in practice.
In accordance with MPEP § 2106.07(a)(III), Examiner notes that the machine is routine, conventional, and is recited at a high degree of generality. Specifically, Sokolov et al. (US 2025/0064296) and Gage et al. (US 2024/0252775) describe a well-known machine with automatic and semi-automatic motion modes of an endoscope. Accordingly, these additional elements of the instant claims do not amount to significantly more than the abstract idea.
Allowable Subject Matter
Claims 1, 15, and 16 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1, U.S. Patent Appl. Publ. No. 2025/0064296 A1 to Sokolov et al. (“Sokolov”) discloses a medical system (an integrated robotic device or system 100; Fig. 1, paragraph 0111) comprising:
an endoscope (endoscope 250; Fig. 2A) configured to:
be electrically driven to engage in an instrument motion during an endoscopic operation (actuating member 240 may be driven in multiple degrees of freedom to result in corresponding motions of the introducer (e.g., endoscope 250)… any suitable actuator 216 for driving actuating member 240 may be included in the device, such as drive electronic, one or more electrical motors; Fig. 2A, paragraph 0145-0146), the instrument motion being at least one of forward and backward movement of an insertion section of the endoscope, bending of a bending section of the insertion section to a bending angle, and rolling rotation of the insertion section (the introducer may have multiple degrees of freedom controlled by driving an actuating member, including longitudinal forward-back movement, axial right-left rotation, and up-down, and right-left articulating motions at its distal tip; Fig. 5, paragraph 0152); and
capture an image (system 200 may include an introducer such as endoscope 250 with image sensor 252 disposed at a distal region of the introducer as shown; Fig. 2A, paragraph 0123); and
a processor comprising hardware (one or more actuators may be under operational control by one or more processors 112 configured to analyze images or image data from one or both of first and second image sensors in the system using suitable AI; Fig. 1, paragraph 0116), the processor being configured to:
receive an operation input from an operator (additionally, or alternatively, actuator(s) 216 may be selectively engaged and/or disengaged in response to a user selection of one or more user interface elements. For example, actuator(s) 216 may be activated by selection of an AI operational button 280 or the like as shown in Fig. 2C and deactivated by selection of a STOP button 284 or the like as shown in Fig. 2C; Fig. 2C, paragraph 0132);
perform image recognition processing of the image acquired by the endoscope to recognize whether a predetermined anatomical structure is captured in the image (actuators 216 may be activated through one or more processors executing image recognition software instructions, in response to the processor(s) recognizing one or more anatomic landmarks through such image recognition techniques; Fig. 1, paragraph 0132) (the method may include automatically guiding the introducer (e.g. endoscope) (730) via an actuating member in the handheld housing based on one or more images from a laryngoscope and/or an endoscope; Fig. 7, paragraph 0172);
control electrical driving of the endoscope in a full auto mode to perform automatic control of the electrical driving of the endoscope to engage in the instrument motion to position a distal end section of the insertion section of the endoscope (in a fully automated mode of exemplary device or assembly 100, the actuator may automatically maneuver the endoscope using AI or other robotic-assisted navigation, and electromechanical control of the actuating member; Fig. 7, #730, paragraph 0116 and 0172); and
control the electrical driving of the endoscope in a semi auto mode (automated-manual assist mode; paragraph 0172) to:
perform operation input-based electrical driving of the endoscope to engage in the instrument motion based on the operation input received (in such an automated-manual assist mode, for example, the actuating member and/or introducer may be controlled manually, such as with the use of a user interface device (e.g., joystick) or through the device display 118; Fig. 8A-10, paragraph 0117 and 0172).
However, Sokolov does not explicitly disclose a processor configured to determine whether a predetermined condition regarding the predetermined medical instrument's position is detected and in response to determining that the predetermined condition is detected, perform the automatic control to intervene in the operation input-based electrical driving of the predetermined medical instrument.
U.S. Patent Appl. Publ. No. 2024/0252775 A1 to Gage et al. (“Gage”) teaches a processor configured to control the electrical driving of the predetermined medical instrument in a semi auto mode to perform operation input-based electrical driving of the predetermined medical instrument to engage in instrument motion based on the operation input received, determine whether a predetermined condition regarding the predetermined medical instrument's position is detected, and in response to determining that the predetermined condition is detected, perform the automatic control to intervene in the operation input-based electrical driving of the predetermined medical instrument (in the case of operating in a manual mode and in an automatic mode simultaneously, the intubation device may be configured to allow the user to operate the intubation device within certain set virtual boundaries, e.g., virtual spatial boundaries, wherein the intubation device may be configured to override the user’s manual operation if the user crosses the virtual boundaries; paragraph 0030-0034). Gage teaches that the use of automatic motion control to override the user’s manual operation may help prevent or at least reduce the risk of injury to the patient caused by human error while allowing the user at least some freedom to operate (paragraph 0030).
Gage is considered to be analogous to the claimed invention because it is in the same field of endoscopes with automatic and manual motion controls. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Sokolov to incorporate the teachings of Gage by programing the processor to allow automatic control of the endoscope motion to override manual control of the endoscope motion when the endoscope is controlled in the semi auto mode. Doing so would help prevent or at least reduce the risk of injury to the patient caused by human error while allowing the user at least some freedom to operate, as recognized by Gage.
In addition, Sokolov, as previously modified by Gage, does not explicitly disclose the processor being configured to:
perform image recognition processing of the image acquired by the endoscope to recognize whether a treatment tool inserted through the endoscope is captured in the image;
in response to recognizing that the predetermined anatomical structure is captured in the image and recognizing that the treatment tool inserted through the endoscope is not captured in the image, determine that the endoscope being positioned;
in response to recognizing that the predetermined anatomical structure is captured in the image and recognizing that the treatment tool inserted through the endoscope is captured in the image, determine that the treatment tool being used for a treatment after the endoscope has been positioned;
in response to determining that the endoscope is being positioned, control electrical driving of the endoscope in a full auto mode to perform automatic control of the electrical driving of the endoscope to engage in the instrument motion to position a distal end section of the insertion section of the endoscope; and
in response to determining that the treatment tool is being used for the treatment after the endoscope has been positioned, control the electrical driving of the endoscope in a semi auto mode.
U.S. Patent Appl. Publ. No. 2023/0157768 A1 to Meguro (“Meguro”) teaches a processor configured to perform image recognition processing of an image acquired by an endoscope to recognize whether a predetermined anatomical structure is captured in the image and whether the predetermined medical instrument is captured in the image (the image processing unit 204 includes … a region-of-interest recognizing unit 222 (a region-of-interest recognizing unit), a tool information recognizing unit 224 (a tool information recognizing unit); Fig. 3, paragraph 0055 and 0062). Meguro teaches that in response to recognizing that the predetermined anatomical structure is captured in the image and recognizing that the predetermined medical instrument is not captured in the image, the processor determines the predetermined medical instrument is being positioned, and Meguro teaches that in response to recognizing that the predetermined anatomical structure is captured in the image and recognizing that the predetermined medical instrument is captured in the image, the processor determines the predetermined medical instrument is being used for a treatment after being positioned (on the basis of the result, the tool information recognizing unit 224 determines which of a treatment state, a pre-treatment state, and a non-treatment state the state of the endoscope 100 … is; Fig. 6, paragraph 0062 and 0077-0079).
However, neither Sokolov, Meguro, or Gage, teach in response to determining that the endoscope is being positioned, control electrical driving of the endoscope in a full auto mode to perform automatic control of the electrical driving of the endoscope to engage in the instrument motion to position a distal end section of the insertion section of the endoscope and in response to determining that the treatment tool is being used for the treatment after the endoscope has been positioned, control the electrical driving of the endoscope in a semi auto mode.
Additionally, there is no reason, teaching, or suggestion provided with an prior art of record to modify the above medical system to have the above features.
Regarding claims 15, Sokolov, as modified by Gage as shown above, discloses a computer-implemented method of controlling a medical system comprising an endoscope and a processor configured to drive the endoscope in a full auto mode and a semi auto mode. However, neither Sokolov, Meguro, or Gage, teach in response to determining that the endoscope is being positioned, control electrical driving of the endoscope in a full auto mode to perform automatic control of the electrical driving of the endoscope to engage in the instrument motion to position a distal end section of the insertion section of the endoscope and in response to determining that the treatment tool is being used for the treatment after the endoscope has been positioned, control the electrical driving of the endoscope in a semi auto mode.
Additionally, there is no reason, teaching, or suggestion provided with an prior art of record to modify the above medical system to have the above features.
Regarding claims 16, Sokolov, as modified by Gage as shown above, discloses a control apparatus for controlling an endoscope in a full auto mode and a semi auto mode. However, neither Sokolov, Meguro, or Gage, teach in response to determining that the endoscope is being positioned, control electrical driving of the endoscope in a full auto mode to perform automatic control of the electrical driving of the endoscope to engage in the instrument motion to position a distal end section of the insertion section of the endoscope and in response to determining that the treatment tool is being used for the treatment after the endoscope has been positioned, control the electrical driving of the endoscope in a semi auto mode.
Additionally, there is no reason, teaching, or suggestion provided with an prior art of record to modify the above medical system to have the above features.
Conclusion
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 OLIVIA G STARKEY whose telephone number is (571)272-3375. The examiner can normally be reached Monday-Friday 8:00-5:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA GRACE STARKEY/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
