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 Arguments
Applicant's arguments filed 1/6/2026 have been fully considered but they are not persuasive.
Regarding p. 10, para. 2, applicant appears to assert that the obviousness statement to combine Fancher and Lang is inappropriate in that a “shaft” is not present in Lang. Examiner is in accordance that the term “shaft” is not recited regarding the brake bushing system of fig. 6a/b, the term “shaft” is instead referring to the lever 6014, which has properties of a shaft, being a sturdy elongated section. Examiner will revise the term “shaft” in the obviousness statement to refer to the “brake handle” instead for clarity.
Regarding p. 12, para. 2, applicant asserts that the fixed shaft of Kimura would require a reconstruction and redesign of Fancher that would exceed obviousness. Examiner is not in accordance. Regarding fig. 11 of Kimura and para. [0072], a second fixed shaft 102 is disposed within the operation knob that interfaces with a fixed first shaft 101. Fancher in fig. 17 demonstrates a shaft fixed to the knob as well 612 with concentric second shaft 620. Further to that, fig. 20b of Fancher teaches a separate example wherein a separable two shaft assembly receives detachable knobs 514 and 512. Examiner asserts the structure of the shafts of fig. 20b could be modified to support the brake assembly of Kimura in a manner that does not exceed the bounds of obviousness to combine. Regarding the obviousness statement of Kimura, a technical issue resulted in the previously presented obviousness statement drawn to Gruner on 2/27/2025 being attached instead of the proper one.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the device of Lang presents a clear improvement to the standard endoscope operation knob in that the interlocking brake bushing system allows for a means by locking the rotation of the operation knob in an efficient manner (Lang [0009]). Similarly, the system of Kimura presents a modular device that increases the ease of sanitation (Kimura [0008]). These improvements to the system constitute a motivation to apply the teachings to a preexisting device such as the primary reference Lang.
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.
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, 4-16, 18-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fancher in view of Lang (US 20150359415 A1) and Kimura (JP 09084754 A submitted as JP1997084754).
Regarding claim 1, Fancher teaches An endoscope, comprising:
a reusable hand-piece assembly (fig. 3, element 102)
and a single-use shaft assembly (fig. 3, element 104);
the reusable hand-piece assembly selectively attachable to and detachable from the single-use shaft assembly (p. 13, para. 1);
the reusable hand-piece assembly including a housing (fig. 3, element 105), a first articulation control knob (fig. 1, element 108), a second articulation control knob (fig. 1, element 110), a first articulation brake (fig. 10, element 518), and a second articulation brake (fig. 10, element 520); and
the single-use shaft assembly including a housing (fig. 1, element 134) and an endoscope shaft;
Fancher does not explicitly teach wherein the first articulation brake is configurable from a disengaged position that permits rotation of the first articulation control knob relative to the housing of the reusable hand- piece to an engaged position that resists rotation of the first articulation control knob relative to the housing of the reusable hand-piece even when the reusable hand-piece is not attached to the single-use shaft assembly;
wherein the second articulation brake is configurable from a disengaged position that permits rotation of the second articulation control knob relative to the housing of the single-use shaft assembly to an engaged position that resists rotation of the second articulation control knob relative to the housing of the single-use shaft assembly when the reusable hand-piece assembly is attached to the single-use shaft assembly but not when the reusable hand-piece is not attached to the single-use shaft assembly;
wherein the second articulation brake includes a brake articulation shaft extending through the first articulation control knob and engaging the housing of the single-use shaft assembly; and
wherein the brake articulation shaft is rotationally fixed relative to the single-use shaft assembly when the reusable hand-piece assembly is attached to the single-use shaft assembly but not when the reusable hand-piece is not attached to the single-use shaft assembly.
However, Lang teaches wherein the first articulation brake is configurable from a disengaged position that permits rotation of the first articulation control knob relative to the housing of the reusable hand- piece to an engaged position that resists rotation of the first articulation control knob relative to the housing of the reusable hand-piece even when the reusable hand-piece is not attached to the single-use shaft assembly (fig. 6a for disengaged, 6b for engaged, [0104-105], rotation of disc 6008 is affected by the position of lever 6014, which will either press protrusions 6009 into indentations 6006 in engaged states or leave a gap to allow for rotation in disengaged states. This coaxial system is disposed solely within the control knob system and is independent of the attachment of disposable portions of the endoscope);
However, Kimura teaches wherein the second articulation brake (fig. 3, element 83, [0045], braking knob 119) is configurable from a disengaged position that permits rotation of the second articulation control knob relative to the housing of the single-use shaft assembly to an engaged position that resists rotation of the second articulation control knob relative to the housing of the single-use shaft assembly when the reusable hand-piece assembly is attached to the single-use shaft assembly but not when the reusable hand-piece is not attached to the single-use shaft assembly ([0057-61], removal of the braking knob 83 from the fixed shaft 11 causes the blocking plate 82 to be unrestricted and prevents locking of the brake knob),
wherein the second articulation brake includes a brake articulation shaft extending through the first articulation control knob and engaging the housing of the single-use shaft assembly (fig. 3, element 11, [0057], fixed shaft 11); and
wherein the brake articulation shaft is rotationally fixed relative to the single-use shaft assembly when the reusable hand-piece assembly is attached to the single-use shaft assembly but not when the reusable hand-piece is not attached to the single-use shaft assembly ([0057-61], removal of the braking knob 83 from the fixed shaft 11 causes the blocking plate 82 to be unrestricted and prevents locking of the brake knob).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the unspecified knob braking mechanism of Fancher to be operated via a brake handle as taught in Lang in order to allow for smooth directional readjustment of the insertion portion while brakes are engaged (Lang [0010]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the unspecified knob braking mechanism of Fancher to be selectively detachable as taught in Kimura in order to assist in cleaning a reusable portion of the endoscope (Kimura [0008]).
Regarding Claim 4, Fancher in view of Lang and Kimura teaches The endoscope of claim 1,
Lang further teaches an endoscope wherein the brake articulation shaft extends through a first articulation control shaft (fig. 4a, element 4020a) associated with the first articulation control knob ([0019]);
and wherein the first articulation control shaft rotates relative to the housing of the reusable hand-piece assembly upon rotation of the first articulation control knob relative to the housing of the reusable hand-piece assembly ([0084-85] discloses the turning of the pin within the control knob shaft).
Regarding Claim 5, Fancher in view of Lang and Kimura teaches The endoscope of claim 4,
Further, Fancher teaches an endoscope wherein a second articulation control shaft (fig. 4, element 4, element 180) associated with the second articulation control knob extends through the first articulation control shaft (fig. 4, element 186);
and wherein the second articulation control shaft rotates relative to the housing of the reusable hand-piece assembly upon rotation of the second articulation control knob relative to the housing of the reusable hand-piece assembly (p. 3, para. 4).
Regarding Claim 6, Fancher in view of Lang and Kimura teaches The endoscope of claim 5,
Further Fancher teaches an endoscope wherein the brake articulation shaft extends through the second articulation control shaft (p. 14, para. 3 discloses concentric drive shafts).
Regarding Claim 7, Fancher in view of Lang and Kimura teaches The endoscope of claim 4,
Lange further discloses an endoscope wherein the first articulation brake includes an outer brake housing (fig. 6a/b, element 6004)
and a caliper (fig. 6a/b, element 6008);
wherein the outer brake housing is associated with the first articulation control knob (fig. 6a/b, element 6014) and first articulation control shaft such that rotation of the first articulation control knob rotates the outer brake housing and the first articulation control shaft ([0105 discloses the rotational relationship between housing and the brake lever]);
wherein the caliper is rotationally fixed relative to the reusable hand-piece ([0105 discloses the rotational relationship between housing and the brake lever]);
and wherein the caliper moves towards the outer brake housing when the first articulation brake is configured from the disengaged configuration to the engaged configuration ([0105] discloses that the protrusions and indentations interact upon rotation to reduce the gap and fix the brake disk).
Regarding Claim 8, Fancher in view of Lang and Kimura teaches The endoscope of claim 7,
Further, Lang teaches an endoscope wherein the first articulation brake includes an inner brake housing (fig. 6a/b, element 6002) positioned within the outer brake housing;
and wherein the inner brake housing rotates relative to the caliper so as to translate the caliper towards the outer brake housing when the first articulation brake is configured from the disengaged configuration to the engaged configuration ([0105] discloses the rotational relationship between the housing and the brake disk, aka caliper).
Regarding Claim 9, Fancher in view of Lang and Kimura teaches The endoscope of claim 8,
Further, Lang teaches and endoscope wherein the inner brake housing is rotationally fixed to a brake control lever ([0105]).
Regarding Claim 10, Fancher in view of Lang and Kimura teaches The endoscope of claim 8,
Further, Lang teaches an endoscope wherein the outer brake housing, the inner brake housing, and the caliper are all positioned within the first articulation control knob (fig. 4a shows the arrangement of the brake lever within the articulation knob system).
Regarding Claim 11, Fancher in view of Lang and Kimura teaches The endoscope of claim 5,
Further, Lang teaches an endoscope wherein the second articulation brake includes an outer brake housing (fig. 4a, element 4080a)
and a caliper (fig. 4d, element 4090a is a brake body that is translated along the pin to come into frictional contact with the knob);
wherein the outer brake housing is associated with the second articulation control knob and second articulation control shaft such that rotation of the second articulation control knob rotates the outer brake housing and the second articulation control shaft ([0086]);
wherein the caliper is rotationally fixed relative to the brake articulation shaft ([0085] discloses that the caliper is rotationally fixed);
and wherein the caliper moves towards the outer brake housing when the second articulation brake is configured from the disengaged configuration to the engaged configuration ([0090] discloses the translation of the brake body to come into contact with an inner surface and enable locking).
Regarding Claim 12, Fancher in view of Lang and Kimura teaches The endoscope of claim 11,
Further, Lang teaches an endoscopes wherein the second articulation brake includes an inner brake housing (fig. 4a, element 4112a) positioned within the outer brake housing;
and wherein the inner brake housing rotates relative to the caliper so as to translate the caliper towards the outer brake housing when the second articulation brake is configured from the disengaged configuration to the engaged configuration ([0089] discloses the fitting of elongate members within the shaft opening, and [0090] discloses the translation of the brake body via this action).
Regarding Claim 13, Fancher in view of Lang and Kimura teaches The endoscope of claim 12,
Further, Lang teaches an endoscopes wherein the inner brake housing is rotationally fixed to a brake control knob ([0090]).
Regarding Claim 14, Fancher in view of Lang and Kimura teaches The endoscope of claim 12,
Further, Lang teaches an endoscopes wherein the outer brake housing, the inner brake housing, and the caliper are all positioned within the second articulation control knob (fig. 4b shows the brake components disposed within the operation knob system.).
Regarding claim 15, Fancher in view of Lang and Kimura teaches The endoscope of claim 1,
Further, Fancher teaches an endoscope wherein the first articulation control knob is positioned between the housing of the reusable hand-piece and the second articulation control knob (fig. 4, element 110).
Regarding Claim 16, Fancher teaches An endoscope, comprising:
a hand-piece assembly (fig. 3, element 102) including a housing (fig. 3, element 105) with a first portion (fig. 3, element 102) and a second portion (fig. 3, element 104),
a first articulation control knob (fig. 1, element 108),
a second articulation control knob (fig. 1, element 110),
a first articulation control shaft (fig. 4, element 180),
a second articulation control shaft (fig. 4, element 186),
a first articulation brake (fig. 10, element 520),
and a second articulation brake (fig. 10, element 518);
the first portion of the housing selectively attachable to and detachable to the second portion of the housing (p. 13, para. 1);
the first articulation control shaft associated with the first articulation control knob;
wherein the second articulation control shaft rotates relative to the housing upon rotation of the second articulation control knob relative to the housing (p. 14, para. 3);
wherein the first articulation brake is configurable from a disengaged position that permits rotation of the first articulation control shaft relative to the housing to an engaged position that resists rotation of the first articulation control shaft relative to the housing (p. 17, para. 2 discloses a first clutch for resisting rotation of the first control knob);
Fancher does not explicitly disclose an endoscope
wherein the first articulation control shaft rotates relative to the housing upon rotation of the first articulation control knob relative to the housing even when the first portion of the housing is not attached to the second portion of the housing;
wherein the second articulation brake is configurable from a disengaged position that permits rotation of the second articulation control shaft relative to the housing to an engaged position that resists rotation of the second articulation control shaft relative to the housing but not when the first portion of the housing is not attached to the second portion of the housing;
wherein the second articulation brake includes a brake articulation shaft extending through the second articulation control shaft and rotationally fixed relative to the housing when the first portion of the housing is attached to the second portion but not when the first portion of the housing is not attached to the second portion of the housing.
However, Lang discloses an endoscope
wherein the first articulation control shaft rotates relative to the housing upon rotation of the first articulation control knob relative to the housing even when the first portion of the housing is not attached to the second portion of the housing (fig. 6a for disengaged, 6b for engaged, [0104-105], rotation of disc 6008 is affected by the position of lever 6014, which will either press protrusions 6009 into indentations 6006 in engaged states or leave a gap to allow for rotation in disengaged states. Per arguments laid out in Response to Arguments, this coaxial system is disposed solely within the control knob system and is independent of the attachment of disposable portions of the endoscope);
wherein the second articulation brake includes a brake articulation shaft (fig. 4b, element 4110a) extending through the second articulation control shaft ([0088-90]).
However, Kimura teaches wherein the second articulation brake (fig. 3, element 83, [0045], braking knob 119) is configurable from a disengaged position that permits rotation of the second articulation control knob relative to the housing to an engaged position that resists rotation of the second articulation control knob relative to the housing but not when the reusable hand-piece is not attached to the second portion of the housing ([0057-61], removal of the braking knob 83 from the fixed shaft 11 causes the blocking plate 82 to be unrestricted and prevents locking of the brake knob);
wherein the second articulation brake includes a brake articulation shaft (fig. 3, element 11, [0057], fixed shaft 11) extending through the second articulation control shaft and rotationally fixed relative to the housing when the first portion of the housing is attached to the second portion but not when the first portion of the housing is not attached to the second portion of the housing ([0057-61], removal of the braking knob 83 from the fixed shaft 11 causes the blocking plate 82 to be unrestricted and prevents locking of the brake knob).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the unspecified knob braking mechanism of Fancher to be operated via a brake handle as taught in Lang in order to allow for smooth directional readjustment of the insertion portion while brakes are engaged (Lang [0010]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the unspecified knob braking mechanism of Fancher to be selectively detachable as taught in Kimura in order to assist in cleaning a reusable portion of the endoscope (Kimura [0008]).
Regarding Claim 18, Fancher in view of Lang and Kimura teaches The endoscope of claim 16,
Further Fancher teaches an endoscope wherein the second articulation control shaft extends through the first articulation control shaft (p. 14, para. 3 discloses concentric drive shafts).
Regarding Claim 19, Fancher in view of Lang and Kimura teaches The endoscope of claim 16,
Further, Fancher teaches an endoscope wherein the first articulation control shaft extends through a steering knob hub that is rotationally fixed relative to the housing (p. 14, para. 1 discloses the drive shaft engagement with the steering knob hub).
Regarding Claim 20, Fancher in view of Lang and Kimura teaches The endoscope of claim 19,
Further Fancher teaches an endoscope wherein the first articulation control knob is rotationally fixed relative to the steering knob hub when the first articulation brake is configured in the engaged position (p. 17, para. 2 discloses that the first articulation brake fixes the first control knob when engaged.).
Regarding claim 21, Fancher teaches An endoscope, comprising:
a reusable hand-piece assembly (fig. 3, element 102) and a single-use shaft assembly (fig. 3, element 104);
the reusable hand-piece assembly selectively attachable to and detachable from the single-use shaft assembly (p. 13, para. 1);
the reusable hand-piece assembly including a housing (fig. 3, element 105) defining a recess for receiving the single-use shaft assembly and an articulation knob and brake assembly, wherein the articulation knob and brake assembly includes a first articulation control knob (fig. 1, element 108), a second articulation control knob (fig. 1, element 110), a first articulation brake (fig. 10, element 518), and a second articulation brake (fig. 10, element 520), wherein a portion of the articulation knob and brake assembly extend into the recess defined by the housing of the reusable hand-piece assembly (fig. 3, element 160); and
the single-use shaft assembly including a housing (fig. 1, element 134) and an endoscope shaft;
Fancher does not explicitly teach wherein the first articulation brake is configurable from a disengaged position that permits rotation of the first articulation control knob relative to the housing of the reusable hand- piece to an engaged position that resists rotation of the first articulation control knob relative to the housing of the reusable hand-piece even when the reusable hand-piece is not attached to the single-use shaft assembly;
wherein the second articulation brake is configurable from a disengaged position that permits rotation of the second articulation control knob relative to the housing of the single-use shaft assembly to an engaged position that resists rotation of the second articulation control knob relative to the housing of the single-use shaft assembly when the reusable hand-piece assembly is attached to the single-use shaft assembly but not when the reusable hand-piece is not attached to the single-use shaft assembly;
wherein the second articulation brake includes a brake articulation shaft extending through the first articulation control knob and engaging the housing of the single-use shaft assembly; and
wherein the brake articulation shaft is rotationally fixed relative to the single-use shaft assembly when the reusable hand-piece assembly is attached to the single-use shaft assembly but not when the reusable hand-piece is not attached to the single-use shaft assembly.
However, Lang teaches wherein the first articulation brake is configurable from a disengaged position that permits rotation of the first articulation control knob relative to the housing of the reusable hand- piece to an engaged position that resists rotation of the first articulation control knob relative to the housing of the reusable hand-piece even when the reusable hand-piece is not attached to the single-use shaft assembly (fig. 6a for disengaged, 6b for engaged, [0104-105], rotation of disc 6008 is affected by the position of lever 6014, which will either press protrusions 6009 into indentations 6006 in engaged states or leave a gap to allow for rotation in disengaged states. This coaxial system is disposed solely within the control knob system and is independent of the attachment of disposable portions of the endoscope);
However, Kimura teaches wherein the second articulation brake (fig. 3, element 83, [0045], braking knob 119) is configurable from a disengaged position that permits rotation of the second articulation control knob relative to the housing of the single-use shaft assembly to an engaged position that resists rotation of the second articulation control knob relative to the housing of the single-use shaft assembly when the reusable hand-piece assembly is attached to the single-use shaft assembly but not when the reusable hand-piece is not attached to the single-use shaft assembly ([0057-61], removal of the braking knob 83 from the fixed shaft 11 causes the blocking plate 82 to be unrestricted and prevents locking of the brake knob);
wherein the second articulation brake includes a brake articulation shaft (fig. 3, element 11, [0057], fixed shaft 11) extending through the first articulation control knob and engaging the housing of the single-use shaft assembly; and
wherein the brake articulation shaft is rotationally fixed relative to the single-use shaft assembly when the reusable hand-piece assembly is attached to the single-use shaft assembly but not when the reusable hand-piece is not attached to the single-use shaft assembly ([0057-61], removal of the braking knob 83 from the fixed shaft 11 causes the blocking plate 82 to be unrestricted and prevents locking of the brake knob).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the unspecified knob braking mechanism of Fancher to be operated via an articulation shaft as taught in Lang in order to allow for smooth directional readjustment of the insertion portion while brakes are engaged (Lang [0010]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the unspecified knob braking mechanism of Fancher to be operated by applying a force to the pulley as taught in Kimura in order to assist in cleaning a reusable portion of the endoscope (Kimura [0008]).
Conclusion
THIS ACTION IS MADE FINAL. 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 TIMOTHY TUAN LUU whose telephone number is (703)756-4592. The examiner can normally be reached Monday-Tuesday, Thursday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached on 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY TUAN LUU/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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