The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 30, 2026 has been entered.
Response to Arguments
Examiner acknowledges the receipt of the Applicant’s Amendment dated March 30, 2026. Applicant amended claim 1. Applicant canceled claim 7. Applicant added new claim 8. Claims 1, 3-6, and 8 are pending.
Applicant's have been considered. Upon further search and consideration, the claims are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 1023 as discussed below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 8 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stahler et al. (U.S. Publication 2009/0138025, hereinafter “Stahler”).
As to Claim 8, Stahler discloses a robotic “robotically controlled” in [0075] catheter system deployable through an endoscope (3) in [0082] and Figs. 5A and 9A which comprises (41) and “endoscope” in [0076] and [0080] as shown in Fig. 1 working channel comprising:
a flexible catheter body (63) in [0075] and Figs. 1, 2A, and 2B;
a plurality of coaxially arranged steering modules positioned along the catheter body, each steering module including:
a multi-lumen structure (102) in [0075]-[0076] being provided in plurality as shown in Figs. 1 and 14A-14E and forming “platform (P)” in [0076] and [0082] defining a central lumen “central lumen” in [0089] and multiple control lumens (105) in [0089], and tension members “pull wires” in [0089] and Figs. 9A-9E routed through the control lumens;
an articulated surgical instrument including multiple joints (205) in [0075] and Figs. 1, 14A-14E, and 16, wherein each steering module is dedicated to controlling a different joint of the articulated surgical instrument as shown in Figs. 1 and 14A-14E; and
a proximal actuation unit (15) in [0085] and Fig. 5A and “associated motors and mechanical components” in [0086] including a plurality of motors configured to independently actuate the tension members to control spatial orientation of the articulated surgical instrument relative to the distal end of the endoscope.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. The previous rejections are maintained.
Claims 1 and 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Stahler and in further views of Hadani et al. (U.S. Publication 2023/0117416, hereinafter “Hadani”), Tsuji et al. (U.S. Publication 2007/0173694, hereinafter “Tsuji”), and Clerc et al. (U.S. Publication 2007/0225559, hereinafter “Clerc”).
As to Claim 1, Stahler discloses a surgical arrangement, comprising:
an endoscope (3) in [0082] and Figs. 5A and 9A which comprises (41) and “endoscope” in [0076] and [0080] as shown in Fig. 1 defined by having an insertion tube (63) in [0075] and Figs. 1, 2A, and 2B with an imaging system “a fiber optic camera, light source” in [0007];
a catheter subsystem (37) in [0076] and (102) in [0076] as shown in Figs. 1, 2A, 2B, and 5A of a steerable catheter robotic system (1) in [0082] and Fig. 5A that is removably insertable into the instrument channel, the catheter subsystem comprising:
a flexible outer sheath (37) in [0076] and Figs. 1 and 5A and (39) in [0089] as shown in Figs. 9A-9E having a proximal end and a distal end;
at least one flexible robotic steering “robotically controlled” in [0075] multi-lumen assembly (102) in [0075]-[0076] being provided in plurality as shown in Figs. 1 and 14A-14E and forming “platform (P)” in [0076] and [0082] extending through the flexible outer sheath, the flexible robotic steering multi-lumen assembly having a proximal end and a distal end,
wherein the multi-lumen assembly includes
a central instrument lumen “central lumen” in [0089] and shown in Figs. 16 and 17A configured to receive a portion of a robotic surgical instrument, and
a plurality of circumferentially spaced control lumens (277) in [0112] and Fig. 17A surrounding the central lumen; and
a plurality of articulation wires (207) in [0112] and Fig. 16 each extending through the control lumens,
a robotic instrument (3) in [0082] and Fig. 5A for performing a surgical procedure, the robotic instrument being operatively and removably attachable to the distal end of the multi-lumen assembly such that the robotic instrument is teleoperable,
wherein the at least one flexible robotic steering multi-lumen assembly includes a plurality of flexible robotic steering multi-lumen assemblies as shown in Figs. 1 and 14A-14E and the robotic instrument includes a plurality of interconnected articulating segments (205) in [0075] and Figs. 1, 14A-14E, and 16, each of the articulating segments being operatively and removably attachable to a different one of the robotic steering multi-lumen assemblies as shown in Fig. 14E.
each articulating segment being mechanically coupled to a different one of the robotic steering multi-lumen assemblies as shown in Figs. 1, 16, and 17A wherein different robotic steering mutli-lumen assemblies comprise articulating segments such that selective tensioning of articulation wires in the corresponding multi-lumen assembly causes articulation of the associated articulating segment.
However Stahler does not specifically disclose further details of the endoscope wherein the imaging system is integrated directly within the insertion tube of the endoscope and the insertion tube further includes at least one instrument channel extending therethrough. Hadani teaches in the analogous field of endoscopy wherein an endoscope (200) in [0043] and [0057] as shown in Fig. 2 is defined by an insertion tube (223) in [0057] with an imaging system (221, 222, 224) in [0057] integrated directly within the insertion tube, the imaging system having a sensor “optic imager” and “video imager” in [0057] wherein (204) in [0057] can also be an imager as described in [0004] disposed in and secured to the distal end of the insertion tube, the insertion tube further including at least one instrument channel (202) in [0058] and (302) in [0063] as shown in Fig. 2 as well as the channel surrounding (102) in [0043] and [0061] as shown in Figs. 1 and 2 extending therethrough. Hadani also teaches that catheters, endoscopic tubes, endoscopes, and bronchoscopes, and any other device that introduces an endoscopic tool are known equivalents in the art in [0043] wherein tools and image capturing device equivalents in the art are further described in [0003]-[0004]. In order to expedite prosecution, Tsuji is also applied as a secondary teaching to evidence the level of ordinary skill in the art at the time of invention. Tsuji teaches in the analogous field of endeavor of endoscopy an endoscope (1) in [0044] and Figs. 1 and 2 having an insertion tube (11) in [0046] with an imaging system (31) in [0054] integrated directly within the insertion tube, the imaging system having a sensor (33) in [0054] that is a CCD disposed in and secured to the distal end of the insertion tube, the insertion tube further including at least one instrument channel (38) in [0059] extending therethrough. It would have been obvious to one of ordinary skill in the art at the time of invention to provide the endoscope of Stahler with a CCD or equivalent at the distal end directly within the insertion tube of the endoscope and the insertion tube further includes at least one instrument channel extending therethrough as taught by Hadani and Tsuji in order to for the endoscope to fulfill the same function of optical imaging and treatment means using known configurations in the art.
In order to expedite prosecution as to the degree in which the catheter subsystem is removably insertable into the instrument channel, Clerc is applied as a secondary teaching to evidence the level of ordinary skill in the art at the time of invention. Clerc teaches in the analogous field of endeavor of endoscopy, an endoscope (50) in [0029] and Fig. 2A with an imaging system (90) in [0023] and Fig. 2B disposed on its distal end and at least one instrument channel (58) in [0029] extending therethrough, and that a catheter subsystem (10) in [0029] can be removably insertable into the instrument channel as additionally shown via (320) in Fig. 6. It would have been obvious to one of ordinary skill in the art at the time of invention to that the catheter subsystem insertable into the instrument channel of the endoscope of Stahler to be appropriate sized to accommodate strict definition of catheters within endoscopes as taught by Clerc as known configurations in the art.
As to Claim 4, Stahler in views of Hadani, Tsuji, and Clerc discloses the surgical arrangement of claim 1 wherein Stahler further teaches that the flexible outer sheath, the flexible robotic steering multi- lumen assembly and robotic instrument are formed from polymer materials “polymer” in [0274].
As to Claim 5, Stahler in views of Hadani, Tsuji, and Clerc discloses the surgical arrangement of claim 1 wherein Stahler further teaches that the at least one robotic steering multi-lumen assembly includes at least one actuating arrangement (15) in [0085] and Fig. 5A and “associated motors and mechanical components” in [0086] for steering the instrument attached thereto.
As to Claim 6, Stahler in views of Hadani, Tsuji, and Clerc discloses the surgical arrangement of claim 5 Stahler further teaches that a control assembly (27) in [0084] and Fig. 5B operatively coupled to the proximal end of the at least one robotic steering multi-lumen assembly for providing rotational movement (input that is “multi-degree-of-freedom” in [0084]) that imparts translational movement to the actuating arrangement (input translated into “appropriate mechanical response” in [0086]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Stahler in views of Hadani, Tsuji, and Clerc and in further view of Taylor et al. (U.S. Publication 2014/0094968, hereinafter “Taylor”).
As to Claim 3, Stahler in views of Hadani, Tsuji, and Clerc discloses the surgical arrangement of claim 2 wherein Stahler further teaches that the robotic instrument is configured to have multiple degrees of freedom “multi-degree-of-freedom” in [0084] in conjunction with Fig. 11B and a tip itself having three degrees in [0095]. However, Stahler does not specifically disclose seven degrees of freedom. Taylor teaches in the analogous field of endeavor of teleoperative robotics for invasive procedures in [0008] wherein seven degrees of freedom are utilized for control “7-DoF serial robot” in [0086]. It would have been obvious to one of ordinary skill in the art to have provided the surgical arrangement of Stahler in views of Hadani, Tsuji, and Clerc having multiple varying degrees of freedom to be specifically seven degrees of freedom as taught by Taylor in order to fulfill the same function of performing endoscopic imaging within a patient and instrument delivery with predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM B CHOU whose telephone number is (571) 270-3367. The examiner can normally be reached on M-F 9 am - 6 pm.
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/WILLIAM CHOU/
Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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