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 .
Election/Restrictions
Applicant's election with traverse of Invention I in the reply filed on 6/10/2026 is acknowledged. The traversal is on the ground(s) that the Inventions primarily differ in the preamble with Invention I directed towards a method of assembling an endoscope and Invention II directed towards a method of assembling an endoscope device, wherein a distinction between an endoscope and endoscope device is non-limiting since it's merely recited in the preamble and an endoscope would also read on an endoscope device. The arguments are found persuasive and the restriction requirement is withdrawn between Inventions I and II and Claims 1-20 will be examined.
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 14, 15 and 20 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 14 recites the limitation "arcuate portion" in Line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 15 is also rejected due to it’s dependency on Claim 14.
Claim 20 recites the limitation "the first control wheel" and “the second control wheel in Lines 6, 8 and 10. There is insufficient antecedent basis for this limitation in the claim. The examiner would like to note that Claim 20 appears to have been intended to be dependent on either of Claim 19, which would remove the antecedent basis issues.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 7, 8, 10-13, 16 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Konstorum (US Patent Application Publication No. 2010/0312055).
In regard to claim 1, Konstorum discloses a method of assembling an endoscope (10, Fig. 1), comprising:
inserting a pair of pull wires (26) through an endoscope shaft (Fig. 3, Par. 25);
coupling distal ends of the pair of pull wires to a distal end of an endoscope shaft (Par. 25);
coupling proximal ends of the pair of pull wires to a control wheel assembly (28, Fig. 3, Par. 25);
rotationally securing the control wheel assembly (28) into a handle of the endoscope (Fig. 3); and
coupling a control lever (32) to the control wheel assembly via an opening in the handle (Fig. 3),
wherein manipulation of the control lever causes rotation of the control wheel assembly which then causes deflection of the distal end of the endoscope shaft via the pull wires (Par. 26, Fig. 3), and
wherein the control wheel assembly includes an arcuate member (via o-ring between the shaft of the pulley and the handle, Fig. 3) that covers at least a portion of the control wheel assembly to prevent external contaminants from entering the opening in the handle adjacent the control lever (via providing a seal between the handle and the shaft of the of the pulley).
In regard to claim 7, Konstorum teaches comprising:
inserting a working channel extending through the endoscope shaft (Fig. 3 illustrates a working channel connected to inlet (20)) and coupling the working channel to an access port assembly (20) within the handle for allowing external access to the working channel (Fig. 3, Par. 25).
In regard to claim 8, Konstorum teaches comprising coupling a suction valve assembly to the access port assembly to enable selective application of negative pressure to the endoscope shaft via the working channel (Fig. 3 illustrates the access port assembly (20) having an inlet for surgical tools and an inlet that can be used for irrigation and/or suction capable).
In regard to claim 10, Konstorum discloses a method of assembling an endoscope device (10, Fig. 1) comprising a shaft (12) and a handle (14), the method comprising:
coupling a control wheel assembly (28) to a distal end of the shaft, via at least one pull wire (26, Par. 25, Fig. 3);
rotationally securing the control wheel assembly into the handle (Fig. 3, Par. 25-26); and
coupling a control lever (32) to the control wheel assembly via an opening in the handle (Fig. 3),
wherein manipulation of the control lever causes rotation of the control wheel assembly which then causes deflection of the distal end of the shaft via the at least one pull wire (Par. 25-26, Fig. 3),
wherein the control wheel assembly includes an arcuate member (via o-ring between the shaft of the pulley and the handle, Fig. 3) that covers at least a portion of the control wheel assembly to prevent external contaminants from entering the opening in the handle adjacent the control lever (via providing a seal between the handle and the shaft of the of the pulley).
In regard to claim 11, Konstorum teaches wherein a portion of the handle proximate to the opening has a curved configuration corresponding to a configuration of the control wheel assembly (the interior surface of the opening generally matches a curvature of the O-ring, Fig. 3).
In regard to claim 12, Konstorum teaches wherein the arcuate member is formed on at least a portion of an outer periphery of the control wheel assembly (Fig. 3).
In regard to claim 13, Konstorum teaches comprising:
inserting the at least one pull wire through the shaft; coupling a distal end of the at least one pull wire to the distal end of the shaft; and coupling a proximal end of the at least one pull wire to the control wheel assembly (Fig. 3, Par. 25-26).
In regard to claim 16, Konstorum teaches wherein the opening in the handle has a first length and a first width, and wherein the arcuate member has a second length and a second width, wherein the second length of the arcuate member is longer than the first length of the opening and wherein the second width of the arcuate member is wider than the first width of the opening (Fig. 3 illustrates the O-ring configured to engage the walls of the opening, the O-ring would have a diameter slightly larger than a diameter of the opening enabling sealing engagement therebetween).
In regard to claim 17, Konstorum teaches wherein the second length of the arcuate member extends along at least half of the outer periphery of the control wheel assembly (Fig. 3, the o-ring completely surrounds the shaft of the control wheel assembly).
Claims 1-5, 7, 8 and 10-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lund et al. (US Patent Application Publication No. 2020/0229684, hereinafter Lund)
In regard to claim 1, Lund discloses a method of assembling an endoscope (Figs. 1,4), comprising:
inserting a pair of pull wires (17,17’) through an endoscope shaft (2, Fig. 4);
coupling distal ends of the pair of pull wires to a distal end of an endoscope shaft (Par. 30);
coupling proximal ends of the pair of pull wires to a control wheel assembly (7, Fig. 3, Par. 30);
rotationally securing the control wheel assembly (7) into a handle (1) of the endoscope (Fig. 4-6, Par. 37); and
coupling a control lever (6) to the control wheel assembly via an opening (5) in the handle (Fig. 2),
wherein manipulation of the control lever causes rotation of the control wheel assembly which then causes deflection of the distal end of the endoscope shaft via the pull wires (Par. 37), and
wherein the control wheel assembly includes an arcuate member (35) that covers at least a portion of the control wheel assembly to prevent external contaminants from entering the opening in the handle adjacent the control lever (Figs. 2,4-6).
In regard to claim 2, Lund teaches wherein rotationally securing the control wheel assembly into the handle comprises:
rotationally coupling the control wheel assembly to a first shell (4) of the handle (Figs. 3-6);
coupling the pair of pull wires to the control wheel assembly (Figs. 3-6);
tensioning the pair of pull wires (Figs. 3-6, Par. 41);
coupling a second shell (3) of the handle to the first shell of the handle, wherein the coupled first and second shells comprise the opening adjacent the control wheel assembly (via opening (5) within second shell (3) of the combined shells (3,4), Fig. 2); and
coupling the control lever to the control wheel assembly via the opening (Figs. 2-4).
In regard to claim 3, Lund teaches wherein a portion of the handle proximate to the opening has a curved configuration corresponding to the control wheel assembly (Fig. 2), wherein the opening in the handle has a first length and a first width, and wherein the arcuate member has a second length and a second width, wherein the second length of the arcuate member is longer than the first length of the opening and wherein the second width of the arcuate member is wider than the first width of the opening (Fig. 2 illustrates the arcuate member covering the entire opening).
In regard to claim 4, Lund teaches wherein the second length of the arcuate member extends along at least half of the outer periphery of the control wheel assembly (Figs. 5-6 illustrate the arcuate member extending along approximately half of the outer periphery of the control wheel assembly).
In regard to claim 5, Lund teaches wherein the control wheel assembly comprises at least one control wheel that includes an annular groove on a periphery thereof to receive at least one of the pair of pull wires, wherein the method further comprises securing at least one of the pair of pull wires within the annular groove, wherein the arcuate member is further configured to prevent at least one of the pair of pull wires from coming out of the annular groove on the periphery of the at least one control wheel (the arcuate member (35) has a much larger diameter than the annular groove which the pull wires rest within (see Fig. 4) and a flat surface adjacent the annular groove acts as a guide surface for the pull wires aiding in preventing the pull wires from coming out of the annular groove).
In regard to claim 7, Lund teaches comprising:
inserting a working channel (13) extending through the endoscope shaft and coupling the working channel to an access port assembly (11) within the handle for allowing external access to the working channel (Figs. 2-3).
In regard to claim 8, Lund teaches comprising coupling a suction valve assembly (12) to the access port assembly to enable selective application of negative pressure to the endoscope shaft via the working channel (Par. 29, Figs. 2-3).
In regard to claim 10, Lund discloses a method of assembling an endoscope device (Figs. 1,4) comprising a shaft (2) and a handle (1), the method comprising:
coupling a control wheel assembly (7) to a distal end of the shaft, via at least one pull wire (17,17’, Figs. 3-6, Par. 30);
rotationally securing the control wheel assembly into the handle (Figs. 3-6, Par. 37); and
coupling a control lever (6) to the control wheel assembly via an opening (5) in the handle (Figs. 2-3),
wherein manipulation of the control lever causes rotation of the control wheel assembly which then causes deflection of the distal end of the shaft via the at least one pull wire (Par. 37),
wherein the control wheel assembly includes an arcuate member (35) that covers at least a portion of the control wheel assembly to prevent external contaminants from entering the opening in the handle adjacent the control lever (Figs. 2,4-6).
In regard to claim 11, Lund teaches wherein a portion of the handle proximate to the opening has a curved configuration corresponding to a configuration of the control wheel assembly (Fig. 2).
In regard to claim 12, Lund teaches wherein the arcuate member is formed on at least a portion of an outer periphery of the control wheel assembly (4-6).
In regard to claim 13, Lund teaches comprising:
inserting the at least one pull wire through the shaft; coupling a distal end of the at least one pull wire to the distal end of the shaft; and coupling a proximal end of the at least one pull wire to the control wheel assembly (Par. 30).
In regard to claim 14, Lund teaches wherein the handle comprises a first shell (4) and a second shell (3) joined together to form a central cavity therein (Figs. 2-3), and wherein the method further comprises rotationally securing the control wheel assembly within the central cavity such that the arcuate portion is provided adjacent the opening in the handle (Figs. 2-3).
In regard to claim 15, Lund teaches wherein rotationally securing the control wheel assembly into the handle comprises:
rotationally coupling the control wheel assembly to the first shell of the handle (Figs. 3-6, Par. 37);
coupling the at least one pull wire to the control wheel assembly (Figs. 3-6);
tensioning the at least one pull wire (Figs. 3-6, Par. 41);
coupling the second shell of the handle to the first shell of the handle, wherein the coupled first and second shells comprise the opening adjacent the control wheel assembly (via opening (5) within second shell (3) of the combined shells (3,4), Fig. 2); and
coupling the control lever to the control wheel assembly via the opening (Figs. 2-3).
In regard to claim 16, Lund teaches wherein the opening in the handle has a first length and a first width, and wherein the arcuate member has a second length and a second width, wherein the second length of the arcuate member is longer than the first length of the opening and wherein the second width of the arcuate member is wider than the first width of the opening (Fig. 2 illustrates the arcuate member covering the entire opening).
In regard to claim 17, Lund teaches wherein the second length of the arcuate member extends along at least half of the outer periphery of the control wheel assembly (Figs. 5-6 illustrate the arcuate member extending along approximately half of the outer periphery of the control wheel assembly).
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 2-4 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Konstorum (US Patent Application Publication No. 2010/0312055) in view of Currier et al. (US Patent Application Publication No. 2014/0260724, hereinafter Currier).
In regard to claim 2, Konstorum teaches wherein rotationally securing the control wheel assembly into the handle comprises:
rotationally coupling the control wheel assembly to the handle (Fig. 3, Par. 25-26);
coupling the pair of pull wires to the control wheel assembly (Fig. 3, Par. 25-26);
tensioning the pair of pull wires (Fig. 3, Par. 25-26);
wherein the coupled first and second shells comprise the opening adjacent the control wheel assembly (Fig. 3, Par. 25-26); and
coupling the control lever to the control wheel assembly via the opening (Fig. 3, Par. 25-26).
Konstorum does not expressly teach the handle formed of a second shell coupled to a first shell.
Currier teaches an analogous endoscope (1) comprising a handle assembly (2) formed of first and second halves (i.e. first and second shells) joined together by removable fasteners (Par. 26). The handle assembly further comprises a spool (40) rotatably mounted within the handle assembly for actuating pull wires (35, 36) to articulating the distal end of the endoscope shaft (3).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the handle of Konstorum to be formed of first and second shells as taught by Currier as a matter of design choice as an alternative construction of an endoscope handle known in the art. The handle being formed of first and second halves allows for simplified assembly due to the first and second shells being mounted together by removable fasteners such as screws or pins (Par. 26). There being no unexpected results in modifying the handle of Konstorum to be formed of first and second shells as taught by Currier.
In regard to claim 3, Konstorum teaches wherein a portion of the handle proximate to the opening has a curved configuration corresponding to the control wheel assembly (the interior surface of the opening generally matches a curvature of the O-ring, Fig. 3), wherein the opening in the handle has a first length and a first width, and wherein the arcuate member has a second length and a second width, wherein the second length of the arcuate member is longer than the first length of the opening and wherein the second width of the arcuate member is wider than the first width of the opening (Fig. 3 illustrates the O-ring configured to engage the walls of the opening, the O-ring would have a diameter slightly larger than a diameter of the opening enabling sealing engagement therebetween).
In regard to claim 4, Konstorum teaches wherein the second length of the arcuate member extends along at least half of the outer periphery of the control wheel assembly (Fig. 3, the o-ring completely surrounds the shaft of the control wheel assembly).
In regard to claim 14, Konstorum teaches wherein the method further comprises rotationally securing the control wheel assembly within a central cavity of the handle such that the arcuate portion is provided adjacent the opening in the handle.
Konstorum does not expressly teach wherein the handle comprises a first shell and a second shell joined together to form a central cavity therein.
Currier teaches an analogous endoscope (1) comprising a handle assembly (2) formed of first and second halves (i.e. first and second shells) joined together by removable fasteners (Par. 26). The handle assembly further comprises a spool (40) rotatably mounted within the handle assembly for actuating pull wires (35, 36) to articulating the distal end of the endoscope shaft (3).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the handle of Konstorum to be formed of first and second shells as taught by Currier as a matter of design choice as an alternative construction of an endoscope handle known in the art. The handle being formed of first and second halves allows for simplified assembly due to the first and second shells being mounted together by removable fasteners such as screws or pins (Par. 26). There being no unexpected results in modifying the handle of Konstorum to be formed of first and second shells as taught by Currier.
In regard to claim 15, Konstorum and Currier teaches wherein rotationally securing the control wheel assembly into the handle comprises:
rotationally coupling the control wheel assembly to the first shell of the handle (Konstorum and Currier teach of rotationally securing the control wheel assembly within the handle, with Currier teaches of the handle formed of first and second shells, Par. 25-26);
coupling the at least one pull wire to the control wheel assembly (Konstorum, Fig. 3, Par. 25-26);
tensioning the at least one pull wire (Konstorum, Fig. 3, Par. 25-26);
coupling the second shell of the handle to the first shell of the handle (Currier, Par. 26), wherein the coupled first and second shells comprise the opening adjacent the control wheel assembly (the opening would be disposed within the first or second shell, i.e. left half or right half); and
coupling the control lever to the control wheel assembly via the opening (Konstorum, Fig. 3, Par. 25-26).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Konstorum (US Patent Application Publication No. 2010/0312055) in view of Kaneko (US Patent Application Publication No. 2016/0073861)
In regard to claim 9, Konstorum does not expressly teach wherein the handle comprises a tube engagement device provided adjacent a proximal end of the endoscope shaft for retaining a device tube over the endoscope shaft prior to use, and wherein the tube engagement device is configured to frictionally engage an outside diameter of the device tube.
Kaneko teaches an analogous endoscope system (1) comprising an endoscope (10) and sheath (2). The endoscope is provided with a shaft portion (19a) adjacent a proximal end of the shaft and the sheath is provided with a groove (4m) at a proximal end thereof, wherein the shaft portion (19a) and groove (4m) are configured to interlock with each other to retain the sheath on the shaft of the endoscope. During engagement of the shaft portion (19a) within the groove (4m), the shaft portion (19a) would contact both the inner and outer diameters of the sheath. A sheath body (3) of the sheath (2) can be selectively advanced/retracted with respect to the endoscope to prevent or allow bending of the bending portion (16) of the shaft of the endoscope.
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the device of Konstorum with the shaft portion (19a) and sheath (2) of Kaneko enabling the shaft to be selectively rigid and/or bendable by adjusting the position of the sheath body with respect to the shaft thereby aiding in insertion of the shaft within a body cavity.
Allowable Subject Matter
Claims 6 and 18-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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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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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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 June 26, 2026
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