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 .
Notice of Amendment
The Amendment filed 11/14/2025 has been entered. Claims 24, 27, 28, 34-36 are pending in the application with claims 24, 27, 28, 34 amended, claims 1-23, 25, 26, 30-33 cancelled.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 24 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Birnkrant (US Patent Application Publication No. 2014/0107416) in view of Garcia et al. (US Patent Application Publication No. 2010/0191053, hereinafter Garcia) and Pai (US Patent Application Publication No. 2016/0310701).
In regard to claim 24, Birnkrant discloses a kit (102,104) of components that include a single-use portion (102) and a reusable portion (104) for shipping to a user for assembly by the user into an assembled endoscope for medical procedures in a patient (the kit is capable of being shipped to a user for assembly into an assembled endoscope), wherein:
the single-use portion (102) comprises: (i) a cannula (106) having a bendable distal portion (110) and an imaging module (214) comprising a video camera and one or more LEDs (208) mounted at a distal end of the cannula that is distal from said bendable distal portion (Fig. 3A) and (ii) a fluid hub that has a distal end coupling with a proximal end of said cannula (section including port (226));
a steering hub that has a distal end configured to couple with a proximal end of the fluid hub (114a);
the reusable portion (104) is separate from and unassembled with said single-use portion when said kit is shipped to the user for assembly by the user without tools and to form said assembled endoscope (the reusable portion and single-use portion are capable of being shipped to a user in an unassembled state and then assembled without tools by a user) and comprises an elongated handle that extends down relative to a long axis of the cannula and is configured to be grasped by a user’s hand (Fig. 6) and a display (762) that is mounted to the handle as shipped to the user and extends up from above the long axis of the cannula (Fig. 6); and
wherein said steering hub’s proximal end is configured to couple with a distal end of the reusable portion through respective connectors (via connector (714) as shown in Fig. 6, Par. 66) and the steering hub comprises a single lever (122) that extends radially away from the steering hub in a direction along said elongated handle and is operatively coupled to said bendable portion of the cannula (the lever is couple to the bendable portion via tension wires (220), Fig. 3A) after the user has assembled the single-use and the reusable portions into said endoscope (Fig. 3A), and said endoscope is configured to respond to manual manipulation of the lever to bend said bendable portion of the cannula in at least two differed angular directions and to a selected degree in each of said angular directions (Fig. 2 illustrates the bendable portion is selectively bendable in two angular directions).
Birnkrant is silent with respect to wherein said fluid hub and steering hub are discrete units having respective connectors and are configured to couple with each other through said connectors.
Garcia teaches an analogous endoscope (100, Fig. 9A) comprising a shaft assembly (102a), an operator control section assembly (101) including a steering lever (103) and a display (901) detachable from the operator control section assembly (101). The shaft assembly comprising a flexible insertion shaft (105) and working channel port (104), wherein the shaft assembly is detachable from the operator control section assembly.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the flexible shaft (104) having a working channel (226) and steering lever (122) of Birnkrant into two separate components (101, 102a) as taught by Garcia since Garcia teaches the flexible shaft and working channel can be formed of a first component (102a) that is detachable from a second component (101) which includes the steering lever. Additionally, both Birnkrant and Garcia teaches a component including a visual display can be detachable from the component which includes the steering lever since Fig. 6 of Birnkrant shows a handle (716) including a visual display (762) detachable from the component including the steering lever and Garcia teaches the visual display (901) is detachable from the component including the steering lever in Fig. 9A). Garcia teaches that having detachable components prevents the need to replace the entire endoscope when failure occurs and instead merely replacing the component that failed. There being no unexpected results in modifying the flexible shaft (104) of Birnkrant into two detachable components as taught by Garcia.
Birnkrant is silent with respect to said bendable portion of the cannula is configured to bend relative to a bend point in one angular direction through a maximum that is less than a maximum through which said bendable portion is configured to bend relative to a bend point in another angular direction, wherein both of said angular directions are in the same plane.
Pai teaches an analogous catheter (10) comprising a catheter shaft (14) having a distal deflectable section (20). The distal deflectable section (20) having asymmetric bending in which the distal deflectable section bends to different angles in opposite directions in the same plane as shown in Fig. 1 (Par. 39). Pai teaches the distal deflectable section can bend at the same point along the longitudinal axis in opposite directions or along different points along the longitudinal axis.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the endoscope shaft of Birnkrant to have different bending angles in opposite directions along the same plane as taught by Pai providing additional flexibility to the surgeon to have the bendable portion assume different shape depending the body region being examined.
In regard to claim 34, Birnkrant discloses a kit (102,104) of components for shipping to a user for assembly by the user into an endoscope for medical procedures in a patient (the kit is capable of being shipped to a user for assembly by a user), comprising:
a cannula (104) having a bendable distal portion and an imaging module comprising a video camera (214) and one or more LEDs (208) mounted at a distal end of the cannula that is distal from said bendable portion (Fig. 3A);
a fluid hub that has a distal end from which the cannula extends distally and a proximal end and a port (226) at a location intermediate the hub’s distal and proximal ends (via portion of the section of shaft (104) which includes the port (226));
a steering hub that has a distal end and a proximal end and a bending trigger (via proximal section of the shaft (104) which includes the steering lever (122));
a handle (104) that has a distal and a proximal end and is elongated downardly from a long axis of the cannula (Figs. 2A,6); and
a electronic display (762) integrally mounted on the handle and extending upwardly from the long axis of the cannula (Fig. 6);
wherein:
the distal end of the handle and the proximal end of the steering hub are discrete units configured for releasable connection with each other in assembling said endoscope (114a,114b,Fig. 2A);
the distal end of the fluid hub and the proximal end of the cannula are configured for connection with each other (the fluid hub and cannula are integrally connected to each other, Fig. 2A);
said handle, steering hub, fluid hub and cannula form said endoscope in assembled form when said releasable connections are completed (Fig. 2);
said fluid hub and cannula include an internal channel (224) to which said port is connected and which extends from the port to the distal end of the cannula (Fig. 3A);
said kit is configured to be shipped to the user for releasable assembly into said endoscope by the user without tools (the kit (102,104) is capable of being shipped to a user and assembled into an endoscope by a user); and
said bending trigger of the steering hub extends away from the steering hub and along said elongated handle (Fig. 2A), has a portion configured to be operated with a user’s finger (Fig. 2A), and is operatively coupled to said bendable portion of the cannula when the endoscope is assembled and is configured to respond to manual manipulation to bend said bendable portion (via tension cables (220), Fig. 3A) of the cannula in at least two differed angular direction and to a selected degree in each of said angular directions (Fig. 2 illustrates the bendable portion is selectively bendable in two angular directions).
Birnkrant is silent with respect to the distal end of the steering hub and the proximal end of the fluid hub are discrete units with respective connectors and are configured for releasable connection with each other through said connectors in assembling said endoscope, the fluid hub, the steering hub and the handle are configured for shipping to a user as discrete units for releasable assembly into said endoscope at a user location.
Garcia teaches an analogous endoscope (100, Fig. 9A) comprising a shaft assembly (102a), an operator control section assembly (101) including a steering lever (103) and a display (901) detachable from the operator control section assembly (101). The shaft assembly comprising a flexible insertion shaft (105) and working channel port (104), wherein the shaft assembly is detachable from the operator control section assembly.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the flexible shaft (104) having a working channel (226) and steering lever (122) of Birnkrant into two separate components (101, 102a) as taught by Garcia since Garcia teaches the flexible shaft and working channel can be formed of a first component (102a) that is detachable from a second component (101) which includes the steering lever. Additionally, both Birnkrant and Garcia teaches a component including a visual display can be detachable from the component which includes the steering lever since Fig. 6 of Birnkrant shows a handle (716) including a visual display (762) detachable from the component including the steering lever and Garcia teaches the visual display (901) is detachable from the component including the steering lever in Fig. 9A). Garcia teaches that having detachable components prevents the need to replace the entire endoscope when failure occurs and instead merely replacing the component that failed. There being no unexpected results in modifying the flexible shaft (104) of Birnkrant into two detachable components as taught by Garcia.
Birnkrant is silent with respect to said bendable portion of the cannula is configured to bend relative to a bend point in one angular direction through a maximum that is less than a maximum through which said bendable portion is configured to bend relative to a bend point in another angular direction, wherein both of said angular directions are in the same plane.
Pai teaches an analogous catheter (10) comprising a catheter shaft (14) having a distal deflectable section (20). The distal deflectable section (20) having asymmetric bending in which the distal deflectable section bends to different angles in opposite directions in the same plane as shown in Fig. 1 (Par. 39). Pai teaches the distal deflectable section can bend at the same point along the longitudinal axis in opposite directions or along different points along the longitudinal axis.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the endoscope shaft of Birnkrant to have different bending angles in opposite directions along the same plane as taught by Pai providing additional flexibility to the surgeon to have the bendable portion assume different shape depending the body region being examined.
Regarding the limitation ”the fluid hub, the steering hub and the handle are configured for shipping to a user as discrete units for assembly into said endoscope at a user location”, Birnkrant and Garcia teach that the fluid hub, steering hub and handle can each be detachable distinct components and therefore would be capable of shipping to a user as discrete units for assembly into said endoscope at a user location.
Claims 27 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Birnkrant (US Patent Application Publication No. 2014/0107416) in view of Garcia et al. (US Patent Application Publication No. 2010/0191053, hereinafter Garcia) and Pai (US Patent Application Publication No. 2016/0310701), as applied to Claims 24 and 34, and further in view of Schultz et al. (US Patent Application Publication No. 20110009694, hereinafter Schultz).
In regard to claims 27 and 35, Birnkrant is silent with respect to further including a flexible sterile robe enclosing said electronic display as shipped to the user and having a transparent portion covering an image display area of said electronic display.
Schultz teaches an endoscope comprising an electronic display (130) mounted to a hand piece (114). Schultz teaches that a transparent sterile sheath (400, Figs. 4A-4F, Par. 85) surrounds the hand-piece and electronic display maintaining sterility of the hand piece and display.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the handle of Birnkrant with the sterile sheath (400) of Schultz maintaining the handle and display in a sterile state during surgical procedure and transport of the handle.
Claims 28 and 36 is rejected under 35 U.S.C. 103 as being unpatentable over Birnkrant (US Patent Application Publication No. 2014/0107416) in view of Garcia et al. (US Patent Application Publication No. 2010/0191053, hereinafter Garcia) and Pai (US Patent Application Publication No. 2016/0310701), as applied to Claims 24 and 34, and further in view of Wardle (US Patent No. 4,750,477).
In regard to claims 28 and 36, Birnkrant is silent with respect to said steering hub and fluid hub are configured for rotation relative to each other about said long axis of said cannula.
Wardle teaches an analogous endoscope (2, Fig. 1) comprising a control head (4) including an articulating lever (7), an instrument and fluid entry block (24) and a flexible shaft (8). The entry block is rotatably mounted to the control head for selectively rotating the entry port (198) of the entry block to avoid an awkward positioning of the entry port and enabling instruments and fluid to be easily inserted therein (Col. 11, Lines 30-45).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the fluid hub of Birnkrant with the rotatable entry block (24) of Wardle enabling a physician to reposition the fluid and instrument port to avoid awkward positioning port thereby easing the insertion of instruments and fluid therein (Col. 11, Lines 30-45).
Response to Arguments
Applicant’s arguments with respect to claims 24, 27, 28, 34-36 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.
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 RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 December 9, 2025