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
In response to the amendment filed on 2/27/2026, no claims have been cancelled and claims 1-15 are pending.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 12 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.
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 1-11 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.
Claim 1 recites the limitation “said robotic system” in line 9. There is insufficient antecedent basis for this limitation in the claim. Examiner best interprets this to be “said robotic instrument”.
Claims 2-11 are rejected on the basis of being dependent on rejected base claim 1.
Claim Objections
Claim 1 is objected to because of the following informalities: “the robotic system” line 11 should be “the system”, and “said robotic system” line 13 should be “said system”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: “the robotic system” line 2 should be “the system”, and “the robotic system” line 4 should be “the system”. Appropriate correction is required.
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.
Claims 1-4, 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over US 20090312775 Gilkey et al. (hereinafter Gilkey) in view of US 20100228249 Mohr et al. (hereinafter Mohr).
Regarding claim 1, Gilkey discloses a system (10, Fig. 1, abstract, paragraph 3, 6) for performing a procedure with respect to a patient, said system comprising:
a instrument (12, Fig. 1-2) having an elongate member configured for insertion through a natural orifice of the patient (Fig. 2-3, paragraph 151, endoscope 12 has an elongate member that ends at a distal end 36 that is inserted into an orifice of a patient as seen in Fig. 24-42, paragraph 159);
a tool module (38, Fig. 3-6, paragraph 151) operably couplable with said elongate member of said instrument (paragraph 151, 153, Fig. 6 tool module 38 is operably coupled to endoscope 12), and configured to perform a procedure on a patient (Fig. 24-42, paragraph 151, 159, tool module 38 performs a suturing operation on a patient); and
a transmission member (32, Fig. 2) having a distal end portion operably associated with said tool module (paragraph 151), and a proximal end portion operably coupled with said instrument (paragraph 151);
wherein: said instrument is operably coupled with the system for control of movement of said instrument and said tool module (Fig. 1, paragraph 7-17, 151-154); and
said transmission member is removable from said system with said tool module (Fig. 6, paragraph 151, 153, tool module 38 is uncoupled from the system along with the transmission member 32 which comprises a push rod 52 and outer sheath 50 which is fixedly secured to the transmission member 32).
Gilkey is silent on the instrument being a robotic instrument.
However, Mohr teaches a robotic surgery system (100a, Fig. 1a) having a robotic instrument (101a/101b, Fig. 1a, 2a) with an elongate member (404, Fig. 2d) configured for insertion through a natural orifice of the patient (paragraph 42-43, 150).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gilkey with the teachings of Mohr to have a robotic instrument in order to be able to control the robotic instrument with more accuracy and precision while performing a surgical operation.
Regarding claim 2, the combination of Gilkey and Mohr teaches the limitations of claim 1, and Gilkey further discloses wherein said tool module is coupled to the distal end of said elongate member via a mechanical connection. (paragraph 153, Fig. 6, the tool module 38 includes an insert guide 70 that fits within the lumen of the instrument 12 at its distal end; paragraph 168, an embodiment of tool module 332 (Fig. 49-50) has an insert guide 334 that has two portions that are biased outwardly to apply an outward force within a lumen of the instrument 12 to aid in the retention of the cap assembly 332 to the distal end of the instrument)
Regarding claim 3, the combination of Gilkey and Mohr teaches the limitations of claim 2, and Gilkey further discloses wherein said mechanical connection comprises interengaging elements on said elongate member and said tool module (paragraph 153, Fig. 3-6, the tool module 38 includes an outer body that slips over the distal end of the elongate member of the instrument 12 and an insert guide 70 that fits within the lumen of the instrument 12 at its distal end; paragraph 168, an embodiment of tool module 332 (Fig. 49-50) has an insert guide 334 that has two portions that are biased outwardly to apply an outward force within a lumen of the instrument 12 to aid in the retention of the cap assembly 332 to the distal end of the instrument).
Regarding claim 4, the combination of Gilkey and Mohr teaches the limitations of claim 3, and Gilkey further discloses wherein said mechanical connection is selected from the group consisting of: a bayonet lock; a threaded connection; a collet on one of said elongate member and said tool module and a compressible portion on the other of said elongate member and said tool module, the collet adapted to compress the compressible portion; a set screw configured to secure said tool module relative to said elongate member; a split ring; at least one resilient retainer (paragraph 168, an embodiment of tool module 332 (Fig. 49-50) has an insert guide 334 that has a split portion (the end of the insert guide 334 is a ring shape that is split in half), the two portions are biased outwardly to apply an outward force within a lumen of the instrument 12 (the two portions of the split are resiliently biased outward to apply an outward force on the lumen)); at least one hook and at least one resilient retention arm; at least one clip; a banded element; at least deformable tab and at least one ridge against which the at least one deformable tab interferes; a pin insertable into a hole extending through the distal end and the tool module; or a key and a keyway.
Regarding claim 10, the combination of Gilkey and Mohr teaches the limitations of claim 1, and the combination further discloses further comprising a mechanized system operably associated with said elongate member and the system for input therefrom to control movement of said elongate member and/or said tool module based on input from the system (Gilkey: paragraph 12, 151, handle 22 receives input to control movement of the tool module; Mohr: paragraph 44, 88, 96-97, a master control console 150 (Fig. 3a) receives input from an operator to control the movements of robotic instruments 101a/101b).
Regarding claim 11, the combination of Gilkey and Mohr teaches the limitations of claim 10, and Mohr further discloses further including sensors (viewing sensor 320, Fig. 3a, roll sensor 370, Fig. 3c, remote sensor assembly 386, Fig. 3c) operably associated with said robotic instrument and said mechanized system and usable to control operation of said robotic instrument (paragraph 94, 102-107).
Regarding claim 12, Gilkey discloses a system (10, Fig. 1, abstract, paragraph 3, 6) for performing a procedure with respect to a patient, said system comprising:
an instrument (12, Fig. 1-2) comprising an elongate member having a distal end and a proximal end (Fig. 2-3, paragraph 151, endoscope 12 has an elongate member with a proximal end and a distal end 36 that is inserted into an orifice of a patient as seen in Fig. 24-42, paragraph 159);
a tool module (38, Fig. 3-6, paragraph 151) configured to perform a procedure with respect to a patient (Fig. 24-42, paragraph 151, 159, tool module 38 performs a suturing operation on a patient);
a transmission member (32, Fig. 2) having a distal end portion operably associated with said tool module (paragraph 151), and a proximal end portion operably coupled with said instrument (paragraph 151);
and a mounting system comprising at least one of a mechanical connection, a magnetic and/or electromagnetic connection, a friction fit connection, an adhesive connection, or a separate element provided over a portion of said distal end of said elongate member and a portion of said tool module to retain said tool module operably coupled with respect to said elongate member and configured to transmit movements from said instrument to said tool module to operate said tool module to perform the procedure with respect to the patient (paragraph 151, 153, Fig. 6 tool module 38 is operably coupled to endoscope 12, paragraph 168, an embodiment of tool module 332 (Fig. 49-50) has an insert guide 334 that has a split portion (the end of the insert guide 334 is a ring shape that is split in half), the two portions are biased outwardly to apply an outward force within a lumen of the instrument 12 to aid in the retention of the cap assembly 332 to the distal end of the instrument); wherein:
said transmission member is removable from said instrument with said tool module (Fig. 6, paragraph 151, 153, tool module 38 is uncoupled from the system along with the transmission member 32 which comprises a push rod 52 and outer sheath 50 which is fixedly secured to the transmission member 32).
Gilkey is silent on said proximal end of said elongate member is operably coupled with a mechanized system to control automated movement of said elongate member.
However, Mohr teaches a robotic surgery system (100a, Fig. 1a) having a robotic instrument (101a/101b, Fig. 1a, 2a) with an elongate member (404, Fig. 2d) and a proximal end operably coupled with a mechanized system (paragraph 63-65, as seen in Fig. 2a-b, proximal end of elongate member 404 is operably coupled to a robotic arm 153 of the robotic surgery system 100a) to control automated movement of said elongate member (paragraph 44, 88, 96-97, a master control console 150 (Fig. 3a) receives input from an operator to control the movements of robotic instruments 101a/101b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Gilkey with the teachings of Mohr in order to control the elongate member of the instrument with more accuracy and precision while performing a surgical operation.
Regarding claim 13, the combination of Gilkey and Mohr teaches the limitations of claim 12, and Gilkey further discloses wherein said tool module comprises a suturing tool (20, Fig. 3, paragraph 151, 159-160).
Regarding claim 14, the combination of Gilkey and Mohr teaches the limitations of claim 13, and Gilkey further discloses wherein said suturing tool comprises a fastener holder arm (48, Fig. 3-6) adapted to rotate a releasable tissue fastener (44, 46, Fig. 3-4) through a path (paragraph 151, 159-160, Fig. 24-38).
Regarding claim 15, the combination of Gilkey and Mohr teaches the limitations of claim 14, and Gilkey further discloses wherein said releasable tissue fastener is a suture needle (44, Fig. 3-4, 24-38) coupled with a length of suture (46, Fig. 3-5, 24-38) (paragraph 151).
Claims 5-6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Gilkey in view of Mohr as applied to claim 1 above, and further in view of US 20180042603 Mitelberg et al. (hereinafter Mitelberg).
Regarding claim 5, the combination of Gilkey and Mohr teaches the limitations of claim 1.
The combination is silent on wherein said tool module is coupled to said elongate member by a separate structure positioned over said tool module and said elongate member to retain said tool module with respect to said elongate member.
However, Mitelberg teaches an endoscopic suturing system having a tool module (50, Fig. 3-4) coupled to an elongate member (12, Fig. 1, 4) by a separate structure (98, Fig. 7) positioned over said tool module and said elongate member to retain said tool module with respect to said elongate member (paragraph 57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Gilkey with Mohr with the teachings of Mitelberg to have wherein said tool module is coupled to said elongate member by a separate structure positioned over said tool module and said elongate member to retain said tool module with respect to said elongate member in order to additionally secure the tool module to the elongate member during use as disclosed by Mitelberg (paragraph 57).
Regarding claim 6, the combination of Gilkey, Mohr and Mitelberg teaches the limitations of claim 5, and Mitelberg further discloses wherein said separate structure is selected from the group consisting of: a crimpable collar; an elastic retaining strap; a heat shrinkable element; at least one o-ring; a resilient diametrically reducible member; or an unrollable sock (paragraph 57, the separate structure is a cohesive band 98).
Regarding claim 9, the combination of Gilkey and Mohr teaches the limitations of claim 1.
The combination is silent on wherein said tool module is coupled to said elongate member via an adhesive coupling.
However, Mitelberg teaches an endoscopic suturing system having a tool module (50, Fig. 3-4) coupled to an elongate member (12, Fig. 1, 4) via an adhesive coupling (paragraph 58, adhesive 104).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Gilkey with Mohr with the teachings of Mitelberg to have wherein said tool module is coupled to said elongate member via an adhesive coupling in order to enhance the grip to the elongate member as disclosed by Mitelberg (paragraph 58).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Gilkey in view of Mohr as applied to claim 1 above, and further in view of US 20080243106 Coe et al. (hereinafter Coe).
Regarding claim 7 and claim 8, the combination of Gilkey and Mohr teaches the limitations of claim 1.
The combination is silent on wherein said tool module is coupled to said elongate member via a magnetic coupling (claim 7), and wherein said tool module is coupled to said elongate member via an electromagnetic coupling (claim 8).
However, Coe teaches devices for performing various surgical procedures that use interchangeable end effectors (abstract, paragraph 5) and wherein the end effector is coupled to an elongate shaft using electromagnetic coupling (paragraph 8, 86, Fig. 8, electromagnetic coupling being a form of magnetic coupling).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Gilkey with Mohr with the teachings of Coe to have wherein said tool module is coupled to said elongate member via an electromagnetic coupling in order to facilitate the attachment and detachment of interchangeable end effectors to a shaft to allow the surgeon to perform various procedures without the need to remove the shaft from the patient’s body as disclosed by Coe (paragraph 5).
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 KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
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