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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/06/2026 has been entered.
Response to Amendment
Claims 1-2, 4-7, 9-13, 15-22 are pending. Claims 3, 8, 14, are cancelled.
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 nonobviousness.
Claim(s) 1, 4-7, 9-13, 15-16, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang (US 20180256009) in view of Walen (US 20210068647).
Regarding claim 1, Ouyang discloses an endoscopic device (reusable portion 102. FIGS. 3, 18; FIG. 3 annotated below) comprising:
an elongate member (Single-use portion 104) comprising a proximal end and a distal end, wherein a camera (camera module in tip assembly 110) is located at the distal end of the elongate member, and wherein the elongate member is single-use (Single-use portion 104; para [0081]) and comprises a user interface for controlling an articulation movement of a distal portion of the elongate member (The single-use portion 104 and reusable portion 102 attach mechanically primarily via mating mechanical connectors 320 and 322. Para [0084]), wherein the articulation movement of the distal portion of the elongate member is about a first bending axis (FIG. 1, bending about first bending axis); and
a handle component removably attached to the proximal end of the elongate member via an interface, and wherein the interface provides an electric connection (Electrical connection is made via a mating electrical connector 310 and 312; Combination of mechanical connection and electrical connection may be considered as an interface. FIG. 3; Handle includes electronics for processing data; main board 1500; FIGS. 16-18; para [0101]), wherein the handle component is re-usable (handle 140 and display module 150 are configured to be re-usable and make up reusable portion 102; para [0080]) and comprises electronics for processing data transmitted from the camera (Handle includes electronics for processing data; main board 1500; FIGS. 16-18; para [0101]).
Ouyang does not expressly disclose a first external guiding elements coupled to the elongate member concentrically, wherein the first external guiding element is individually controlled to bend the elongate member about a second bending axis, and wherein the second bending axis relative to the first bending axis is configurable such that when the second bending axis is aligned with the first bending axis, an extent of movement about the first bending axis is increased, and when the second bending axis is not aligned with the first bending axis, an additional degrees of the articulation movement about the second bending axis is provided.
Walen is directed to instrument (abstract) and teaches a first external guiding elements (tube 12; FIG. 1) coupled to the elongate member concentrically ( FIG.1 .), wherein the first external guiding element is individually controlled to bend the elongate member about a second bending axis ( Tube 18 is controlled by actuation assembly 21; The handle 14 is coupled to the proximal end 13 of the outer tube 12; FIG. 1; FIG. 14 and 15 shows a different axis of bending of tube 14; Tube 12 is malleable to provide different bending axis and bendability.), and wherein the second bending axis relative to the first bending axis is configurable such that when the second bending axis is aligned with the first bending axis, an extent of movement about the first bending axis is increased (The bending of tube 18 being controllable by the actuator 21 and tube 12 being malleable, when the axis of tube 12 is aligned with tube 18, this would further add movement with the tubes. FIG. 14), and when the second bending axis is not aligned with the first bending axis, an additional degrees of the articulation movement about the second bending axis is provided (The bending of tube 18 being controllable by the actuator 21 and tube 12 being malleable, when the axis of tube 12 is not aligned, this would add a new degree of freedom of the movement of the tube system.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ouyang to provide an external guiding element in accordance with the teaching of Walen so that articulation could be provided in a more effective way by way of having the external guiding element to provide different movements. For example, in configuration of FIGS. 13-15, annotated below, different movement are possible by way of having external guiding element 12.
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Regarding claim 4, Ouyang discloses wherein the interface (Annotated FIG. 3) between the handle component and the proximal end of the elongate member comprises a locking mechanism (mating mechanical connectors 320 and 322) to secure a mechanical connection between the handle component and the proximal end of the elongate member (Reusable portion 102 attach mechanically primarily via mating mechanical connectors 320 and 322. FIG. 3; Para [0084]).
Regarding claim 5, Ouyang discloses wherein the user interface for controlling the articulation of the distal portion of the elongate member is located at the proximal end of the elongate member (Annotated FIG. 3).
Regarding claim 6, Ouyang discloses wherein the user interface comprises a knob, a lever or a button (Actuation tab 510; FIG. 5A; para [0087]) for controlling the articulation of the distal portion of the elongate member.
Regarding claim 7, Ouyang discloses wherein the user interface further comprises a mechanical structure (fluid line 172; Para [0077]) for flow management (syringe 180; FIG. 3) of the endoscopic device.
Regarding claim 9, Ouyang as modified discloses wherein the first guiding elements are removably assembled with the elongate member concentrically (Walen: FIGS. 13-15).
Regarding claim 13, Ouyang, as modified, teaches wherein a degree of freedom for bending of the distal end of the elongate member is adjusted by adding or moving an external guiding element (Walen: FIGS. 13-15).
Regarding claim 15, Ouyang, as modified, teaches wherein the first external guiding element is pre-bent (Walen: As shown in FIG. 13, the external guiding element 12 is pre-bent.).
Regarding claim 16, Ouyang discloses wherein the elongate member comprises an articulation section formed at least by one or more fluid access holes (fluid port 132; Para [0085]).
Regarding claim 22, Ouyang discloses wherein the elongate member further comprises a working channel for receiving one or more instruments (The cannula 120 includes one or more fluid channels which are fluidly connected to distal fluid port 132 at fluid hub and connection assembly 130. Para [0079]).
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang (US 20180256009) in view of Walen (US 20210068647) and further in view of Al-Jadda (US 20190298460).
Regarding claim 10, Ouyang does not expressly disclose a second external guiding element having a third bending axis.
Al-Jadda is directed to instruments with variable bending stiffness profiles (abstract) and teaches second external guiding element having a third bending axis (Second layer for bending; braid jacket 152; endoskeleton 150; Para [0156]; FIGS.16C, 18D).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ouyang to include second external guiding element in accordance with the teaching of Al-Jadda so that additional bending strength or degree of freedom could be achieved.
Regarding claim 11, Ouyang, as modified, teaches first and second external guiding elements comprises an articulation control mechanism for controlling an articulation of the corresponding external guiding element about the first bending axis or the second bending axis (The guiding elements include first bending axis or the second bending axis because of the spacing between them.).
Regarding claim 12, Ouyang, as modified, the first, second and third bending axes are different (When the first, second and third bending axes are used, they would have different axes because they each have different degree of freedom.).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang (US 20180256009) in view of Walen (US 20210068647) and further in view of Berkelaar (US 20110021871).
Regarding claim 2, Ouyang does not expressly disclose wherein the elongate member comprises a stiffening element and wherein a stiffness of the elongate member is adjusted by adjusting a length of the stiffening element inserted into the elongate member.
Berkelaar is directed to an instrument having a flexible and elongated body including at least a lumen and a flex member disposed within the lumen (abstract) and teaches wherein the elongate member comprises a stiffening element (cable 70) and wherein a stiffness of the elongate member is adjusted by adjusting a length of the stiffening element inserted into the elongate member (Note cable 70 attached to the spring 86 causes deflection; FIGS. 14-15; para [0049]; Pull of the cable 70 changes the stiffness.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ouyang to have a cable run through the body of the elongate member (FIGS. 4B, 4C) so that a more controlled bending of the insertion portion could be achieved by way of having cable in accordance with the teaching of Berkelaar.
Claim(s) 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang (US 20180256009) in view of Walen (US 20210068647) and further in view of Anvari (US 20110178367).
Regarding claim 17, Ouyang does not expressly disclose wherein the handle component comprises an electromagnetic (EM) sensor to detect a gravity direction.
Anvari is directed to an end effector mechanism for use in endoscopic surgery (abstract; para [0002]) and teaches wherein the handle component comprises an electromagnetic (EM) sensor to detect a gravity direction (By using an accelerometer, roll angle with respect to gravity may be determined, allowing for the controller 60 to calculate the necessary pixel/frame shift or rotation to display the image being captured by the camera 82 onto the display screen 42 with the image correction such that gravity is always pointing down. Para [0037]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Ouyang to include sensor in accordance with teaching of Anvari so that an image correction could be made by using sensor data to make the image vertical.
Regarding claim 18, Ouyang, as modified, teaches wherein the gravity direction is determined based on sensor data collected from the EM sensor located at the handle component and an EM sensor located at the distal end of the elongate member (Anvari: Sensor such as accelerometer may be housed within the casing 70 or mounted at the end of the manipulator member 74. Para [0037]).
Regarding claim 19, Ouyang as modified teaches wherein the gravity direction is used to correct a view of the image data (Anvari: By using an accelerometer, roll angle with respect to gravity may be determined, allowing for the controller 60 to calculate the necessary pixel/frame shift or rotation to display the image being captured by the camera 82 onto the display screen 42 with the image correct such that gravity is always pointing down. Para [0037]).
Regarding claim 20, Ouyang discloses a fluid shield connected to the proximal end of the elongate member (The plunger of the syringe 180 can be considered as fluid shield. Para [0099]).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang (US 20180256009) in view of Walen (US 20210068647) and further in view of Petruzzi (US 4669172).
Regarding claim 21, Ouyang does not expressly disclose wherein the elongate member comprises an articulation section having a variable wall thickness that affects a direction of the articulation movement of the distal portion of the elongate member.
Petruzzi is directed to fabrication of a flexible shaft (abstract) and teaches wherein the elongate member comprises an articulation section having a variable wall thickness (The degree of flexibility along the segment is in proportion to the relative thickness of the wall with that portion of the segment having the thinner wall being more flexible than that portion of the segment having a comparatively thicker wall. FIG. 2) that affects a direction of the articulation movement of the distal portion of the elongate member.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ouyang’s lumen (such as 430) to include the varying wall thickness in accordance with the teaching of Petruzzi so that flexibility of the elongate member could be achieved by way of varying wall thickness.
Response to Arguments
Applicant' s arguments, filed on 01/06/2026 have been fully considered and persuasive, therefore, the rejection dated 8/14/2025 has been withdrawn. However, upon further consideration a new rejection has been made in view of amendment. See rejections above.
Regarding “configurable relationship between a separate external guide’s bending axis and an inner endoscope’s bending axis” argued by the applicant in lines 12-23 of the remark section dated January 6, 2026, the examiner respectfully notes that when the tube 12 is used with the elongate member of Ouyang, the combination provides configurable relationship between the tube 12 and elongate member because tube 12 can have different configuration as shown in FIGS. 13-15 and this configuration provides configuration of the bending axes. The claim does not recite any structure that bring about second bending axis being configurable relative to the first bending axis other than the elongate member being inserted inside the external guiding element.
Further, as discussed in the rejection above, when Ouyang is combined with Walen, the architectural redesign of both system is not required because claim does not require any structural limitations other than the elongate member being inserted within the external bending tube and the guiding element being concentric with the elongate member.
See rejection set forth above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANKAR R GHIMIRE whose telephone number is (571)272-0515. The examiner can normally be reached 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan 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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/SHANKAR RAJ GHIMIRE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 02/27/2026