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 .
DETAILED ACTION
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.
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: “robot control system” in claim 1, “imaging system” in claim 1, “mapping system” in claim 5 and “modelling system” in claims 6 and 7.
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.
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
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1, 2, 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2020/0107898) in view of Yamamoto et al. (US 2002/0198542).
Regarding claim 1, Kim et al. disclose a robotic suturing system (Figure 40; ¶[0207]) for use in a gastrointestinal tract of a human patient (¶[0207], Figure 53) the human patient having a natural orifice (mouth) in communication with the gastrointestinal tract, comprising: a flexible, shapeable endoluminal robot (all of Figure 54 and control system; ¶[0207]-[0209], [0224]) adapted to be inserted into the gastrointestinal tract through the natural orifice (Figure 53), the endoluminal robot having a proximal end and a distal end; a suturing tool (300 - Figure 56; ¶[0227]) removably coupled to the distal end of the flexible endoluminal robot (as in prior embodiments - ¶[0147]), a robot control system (Figure 45 - ¶[0224]; interpreted under 35 U.S.C. 112(f) as equivalent to Applicant’s) configured to control movement of the endoluminal robot; an imaging system for capturing real-time images of the gastrointestinal tract; and a display for presenting the real-time images to an operator (endoscope and display - ¶[0215]; interpreted under 35 U.S.C. 112(f) as equivalent to Applicant’s).
Kim et al. fail to disclose that the suturing tool (one of members 300) is adapted to grasp tissue and advance a needle with suture through the grasped tissue. Kim et al. disclose that various surgical tools may be used in place of member 300 including suturing units (¶[0067]).
Yamamoto et al. disclose a suturing tool (236 - Figures 89-91) having an end cap (see cap structure forming slot 404 in Figure 126, disclosed for the above embodiment - ¶[0061]) adapted to grasp tissue and advance a needle with suture through the grasped tissue (evident from Figures 89-91; ¶[0177]-[0184]) which prevents tissue collapse while allowing a deeper penetration of a suture (¶[0184]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the suturing tool of Yamamoto et al. as the suturing tool (300) of Kim et al. (and configuring the robot to control the needle 240 of Yamamoto et al.) in order to prevent tissue collapse while allowing a deeper penetration of a suture.
Regarding claim 2, Kim et al. disclose that the robot control system includes actuators (1114a or 1114b of Kim et al.) to operate the endoluminal robot and the suturing tool, and an operator interface (9; ¶[0224], [0190]; Figure 45) to control the actuators.
Regarding claim 4, the imaging system includes at least one of optical sensors (camera 1012 of Kim et al.), laser scanning sensors, distance sensors, ultrasound sensors, CT scan devices, and LIDAR sensors.
Regarding claim 8, the system further comprises at least one sensor (902) adapted to determine whether the needle is inserted through a full thickness of the tissue (¶[0195]).
Claims 3, 5, 6, 7, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2020/0107898) in view of Yamamoto et al. (US 2002/0198542), as applied to claim 1 above, and further in view of Meglan et al. (WO 2021/158328).
Regarding claims 3 and 5, Kim et al. fail to disclose that the system comprises sensors or a mapping system adapted to map at least a portion of the gastrointestinal tract. Kim et al. intend to suture tissue (¶[0067], [0207])
Meglan et al. disclose a mapping system (interpreted under 35 U.S.C. 112(f) as equivalent to Applicant’s) using sensors for defining a virtual map of a portion of tissue to be sutured (¶[0021], [0036]) in order to help a surgeon determine the appropriate suturing locations and reduce cognitive load (¶[0004], [0005]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the sensors and mapping system of Meglan et al. with the suturing system of Kim et al. (allowing creation of a virtual map of a portion of a gastrointestinal tract) in order to help a surgeon better determine the appropriate suturing locations and reduce cognitive load.
Regarding claim 6, as modified in view of Meglan et al., the system would comprise a modelling system to propose pre-operative planning of a procedure in a gastrointestinal tract (¶[0041], [0049] of Meglan et al.; interpreted under 35 U.S.C. 112(f) as equivalent to Applicant’s).
Regarding claim 7, the modelling system is adapted to project aspects of the preoperative planning over the real-time images (¶[0041], [0049] of Meglan et al.).
Regarding claim 9, as modified in view of Meglan et al., the display would be adapted to present virtual images to guide the operator (graphic reconstruction of tissue site or overlayed markings and trajectories - ¶[0021], [0036], ¶[0041], [0049], [0054] of Meglan et al.).
Regarding claim 10, the virtual images include at least one of: proposed suturing locations (¶[0021], [0036] of Meglen et al.), warning zones for non-suturing, proposed suturing locations, proposed suturing orientations, anatomical landmarks, or fiducials.
Response to Arguments
Applicant's arguments filed March 9th 2026 have been fully considered but they are not persuasive. Applicant has argued that the above terms should not be interpreted under 35 U.S.C. 112(f). In regard to “robot control system”, Applicant has not stated what structure or general types of structure(s) are art-recognized and implied by the term. In regard to the remaining terms, Applicant has argued that they comprise art-recognized computer systems and software. The above terms, without the benefit of Applicant’s specification, could be interpreted as only corresponding to software which is not inherently a structure. Applicant has argued that Kim et al. teach away from providing a detachable suturing tool. Kim et al. specifically state that the end effector (300) can be a suturing tool (¶[0067]) and further state that the end effectors can be detachable (¶[0147]). Regardless, the detachable end cap provided in view of Yamamoto et al. would not require any teaching of detachability by Kim et al. as evident from the above rejection. Applicant has argued that providing the suturing tool of Yamamoto et al. would require an unreasonable amount of reconstruction of the Kim et al. device. The suturing tool of Yamamoto et al. would only require providing the device of Kim et al. with a rotating inner coil (238 of Yamamoto et al.) and an axially movable outer coil tube (244). Such a mechanism would be easily adaptable to Kim et al. by one of ordinary skill in the art. For the above reasons, the previous grounds of rejection are respectfully maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
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