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
In the present application, claims 1 and 3- 31 are currently pending. Claims 1, 3, 4, 24, and 31 been amended. Claim 2 has been canceled.
Response to Amendment
Applicant’s arguments filed 09/11/2025, with respect to the pending claims have been fully considered. Applicant has amended the independent claim 1 with a newly added limitation stating, “…the lower trigger and the upper trigger being arranged distally of the two limbs.” Applicant has also amended independent claim 31 with the newly added limitations stating, “...each of the two limbs being located at a spaced location from the first trigger and the second trigger.”
Such newly added limitation changes the scope of the claims and renders the previous rejections moot. Therefore, the rejections identified in the non-final office action dated, 06/12/2025, have been withdrawn.
However, upon further consideration, a new ground of rejections are made below. Please see the rejections under 35 U.S.C §102 and 35 U.S.C §103 below.
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, 3, 4, 11 and 31 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Saadat et al. (US2006/0161185) hereinafter Saadat.
Regarding Claim 1, Saadat discloses an endoscopic instrument (Fig. 1 assembly 10) for inserting into a body of a patient ([0078]), wherein the endoscopic instrument comprises:
a handling device (Fig. 1 handle 16 of Fig. 20A handle assembly 550 as the variation within Fig. 20A-B);
a tubular shank (Fig. 1 tubular body 12) which is coupled or can be coupled to the handling device (Fig. 1 handle 16 of Fig. 20A handle assembly 550 as the variation within Fig. 20A-B); and
at least two leads (Figs. 20A-B control wires 592, acquisition member that travels through acquisition member receiving channel 582, needle assembly that travels through channel 574), the at least two leads comprising electrical, mechanical (Figs. 20A-B control wires 592) or optical leads which run through the tubular shank (Fig. 1 tubular body 12),
wherein the handling device comprises (Fig. 1 handle 16 of Fig. 20A handle assembly 550 as the variation within Fig. 20A-B)
a housing (Figs. 20a-b housing of control 522) which at a proximal end has two limbs (Figs. 20a-b near grips 560, 562, see annotated Fig. 20a) which are arranged obliquely to one another and enclose a contact surface (Figs. 19a-20b near opening 558),
wherein at least one of the at least two leads (Figs. 20A-B control wires 592, acquisition member that travels through acquisition member receiving channel 582, needle assembly that travels through channel 574) is led outwards out of the handling device Fig. 1 handle 16 of Fig. 20A handle assembly 550 as the variation within Fig. 20A-B) out of one of the two limbs (Figs. 20a-b near grips 560, 562, see annotated Fig. 20a),
wherein the two limbs (Figs. 20a-b near grips 560, 562, see annotated Fig. 20a) are configured as two rigid grip limbs ([0129] “Another handle variation may be seen in the perspective view of handle assembly 550, as shown in FIG. 19A. This particular variation may have handle enclosure 552 formed in a tapered configuration which allows for the assembly 550 to be generally symmetrically-shaped about a longitudinal axis extending from its distal end 554 to its proximal end 556. The symmetric feature of handle assembly 550 may allow for the handle to be easily manipulated by the user regardless of the orientation of the handle enclosure 552 during a tissue manipulation procedure. An additional feature which may further facilitate the ergonomic usability of handle assembly 550 may further include at least one opening 558 defined through the enclosure 552 to allow the user to more easily grip and control the handle 550. Another feature may include grips 560, 562 which may extend from either side of enclosure 552.”) which distally run together towards the tubular shank in a Y-shape (see annotated Fig. 20A) being symmetric with respect to a longitudinal axis ([0129] “The symmetric feature of handle assembly 550 may allow for the handle to be easily manipulated by the user regardless of the orientation of the handle enclosure 552 during a tissue manipulation procedure.”) of the tubular shank (Fig. 1 tubular body 12), such that the handling device (Fig. 1 handle 16 of Fig. 20A handle assembly 550 as the variation within Fig. 20A-B) is configured to be gripped in a first posture or a second posture ([0129]), wherein, in the first posture, wherein the two limbs (see annotated Fig. 20A) are arranged in the Y-shape (see annotated Fig. 20A), one of the two limbs having a first end (see annotated Fig. 20A), another one of the two limbs (see annotated Fig. 20A) having a second end(see annotated Fig. 20A), the first end (see annotated Fig. 20A) being located at a spaced location from the second end(see annotated Fig. 20A),
wherein the contact surface (Figs. 19a-20b near opening 558) extends between the one of the two limbs (see annotated Fig. 20A) and the another one of the two limbs (see annotated Fig. 20A), the two limbs (see annotated Fig. 20A) being configured to be gripped around as a forceps and an index finger ([0129]) is applied on a lower trigger (controls 588, see annotated Fig. 20A) below the tubular shank (Fig. 1 tubular body 12) for pulling a lower pull cable (control wires 592, [0129-0134]), and
wherein, in a second posture, a ball of a thumb is led between the two limbs and the index finger is applied ([0129]) on an upper trigger (controls 588, see annotated Fig. 20A) above the tubular shank (Fig. 1 tubular body 12) for pulling an upper pull cable and a middle finger ([0129]) is applied on the lower trigger (controls 588, see annotated Fig. 20A) below the tubular shank (Fig. 1 tubular body 12) for pulling a lower pull cable (control wires 592, [0129-0134]),
the lower trigger (controls 588, see annotated Fig. 20A) and the upper trigger (controls 588, see annotated Fig. 20A) being arranged distally of the two limbs (see annotated Fig. 20A).
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Examiner’s Note: Examiner would like to point out that the limitation “the two limbs being configured to be gripped around as a forceps and an index finger is applied on a lower trigger below the tubular shank for pulling a lower pull cable, and wherein, in a second posture, a ball of a thumb is led between the two limbs and the index finger is applied on an upper trigger above the tubular shank for pulling an upper pull cable and a middle finger is applied on a lower trigger below the tubular shank for pulling a lower pull cable” is function language. Specifically, the functional language describing how the two limbs are configured to be gripped.
MPEP 2114 (II) addresses functional language and states, “A recitation with respect to the manner in which a claimed apparatus is intended to be used does distinguish the claims apparatus from the prior art – if the prior art apparatus teaches all the structural limitations of the claim.”
Here Saadat meets the structural limitation of the claim, as required by MPEP 2114, because Saadat discloses such structure that allows for such gripping of the two limbs as defined above and explicitly states, “..the handle [can] be easily manipulated by the user regardless of the orientation of the handle…” [0129].
Regarding Claim 3, Saadat discloses the endoscopic instrument according to claim 1, further comprising: a distally running pull wire (control wires 592, [0129-0134]), the each of the upper trigger (controls 588, see annotated Fig. 20A) and the lower trigger (controls 588, see annotated Fig. 20A) comprising an operating lever (distal ends of controls 588, Figs. 20a-b) actuatable by two fingers of a hand ([0129]) of a user by way of proximal pulling, wherein each of the lower trigger (controls 588, see annotated Fig. 20A) and the upper trigger (controls 588, see annotated Fig. 20A) is located at a spaced location from each of the two limbs (see annotated Fig. 20A).
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Regarding Claim 4, Saadat discloses the endoscopic instrument according to claim 3, further comprising a guide roller or cam disc (disc near reference numeral 590 of Fig. 20a) arranged between the operating lever (distal ends of controls 588, Figs. 20a-b) of the upper trigger (controls 588, see annotated Fig. 20A) and the operating lever (distal ends of controls 588, Figs. 20a-b) of the lower trigger (controls 588, see annotated Fig. 20A), about which the guide roller or cam disc (disc near reference numeral 590 of Fig. 20a) and the distally running pull wire (control wires 592, [0129-0134]) are each lead as a section of the distally running pull wire (control wires 592, [0129-0134]) as a common pull wire (control wires 592, [0129-0134])which is led around the guide roller or cam disc (disc near reference numeral 590 of Fig. 20a), wherein the guide roller or cam disc (disc near reference numeral 590 of Fig. 20a)is rotatable in two directions in an angular range about a rotation axis in a housing of the handling device (Fig. 1 handle 16 of Fig. 20A handle assembly 550 as the variation within Fig. 20A-B), wherein the rotation axis (Fig. 20a pivot 590) runs perpendicularly to a plane which is spanned by the two limbs (see annotated Fig. 20a).
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Regarding Claim 11, Saadat discloses endoscopic instrument according to claim 1, wherein the handling device (Fig. 1 handle 16 of Fig. 20A handle assembly 550 as the variation within Fig. 20A-B) is fixedly connected (Fig. 1 illustrates handle 16 is connected to body 12) or is releasably connectable to a proximal end of the tubular shank (Fig. 1 proximal end of tubular body 12).
Regarding Claim 31, Saadat discloses an endoscopic instrument (Fig. 1 assembly 10) for inserting into a body of a patient ([0078]), wherein the endoscopic instrument comprises:
a handling device (Fig. 1 handle 16 of Fig. 20A handle assembly 550 as the variation within Fig. 20A-B);
a tubular shank (Fig. 1 tubular body 12) which is coupled or can be coupled to the handling device (Fig. 1 handle 16 of Fig. 20A handle assembly 550 as the variation within Fig. 20A-B), the tubular shank (Fig. 1 tubular body 12) comprising a longitudinal axis (Fig. 1 longitudinal axis of tubular body 12); and
at least two leads (Figs. 20A-B control wires 592, acquisition member that travels through acquisition member receiving channel 582, needle assembly that travels through channel 574) comprising electrical, mechanical (Figs. 20A-B control wires 592) or optical leads which run through the tubular shank (Fig. 1 tubular body 12), wherein the handling device (Fig. 1 handle 16 of Fig. 20A handle assembly 550 as the variation within Fig. 20A-B) comprises a housing (Fig. 1 housing of handle 16 of Fig. 20A housing of handle assembly 550 as the variation within Fig. 20A-B) which at a proximal end (Fig. 20a near reference numeral 560) has two limbs (Figs. 20a-b near grips 560, 562, see annotated Fig. 20a) which are arranged obliquely to one another in a Y-shape (see annotated Fig. 20A) and enclose a contact surface (Figs. 19a-20b near opening 558), wherein at least one of the at least two leads (Figs. 20A-B control wires 592, acquisition member that travels through acquisition member receiving channel 582, needle assembly that travels through channel 574) is led outwards out of the handling device (Fig. 1 handle 16 of Fig. 20A handle assembly 550 as the variation within Fig. 20A-B) out of one of the two limbs (Figs. 20a-b near grips 560, 562, see annotated Fig. 20a), wherein the two limbs (Figs. 20a-b near grips 560, 562, see annotated Fig. 20a) are configured as two grip limbs ([0129] “Another handle variation may be seen in the perspective view of handle assembly 550, as shown in FIG. 19A. This particular variation may have handle enclosure 552 formed in a tapered configuration which allows for the assembly 550 to be generally symmetrically-shaped about a longitudinal axis extending from its distal end 554 to its proximal end 556. The symmetric feature of handle assembly 550 may allow for the handle to be easily manipulated by the user regardless of the orientation of the handle enclosure 552 during a tissue manipulation procedure. An additional feature which may further facilitate the ergonomic usability of handle assembly 550 may further include at least one opening 558 defined through the enclosure 552 to allow the user to more easily grip and control the handle 550. Another feature may include grips 560, 562 which may extend from either side of enclosure 552.”) distally extending together towards the tubular shank (Fig. 1 tubular body 12), wherein a distance between one end of one of the two grip limbs (see annotated Fig. 20a, [0129]) and one end of another one of the two grip limbs (see annotated Fig. 20a, [0129]) increases in a direction away from the tubular shank (Fig. 1 tubular body 12), the one end of the one of the two grip limbs(see annotated Fig. 20a, [0129]) being located at a spaced location (Fig. 20a shows annotated limbs within annotated Fig. 20a are spaced apart one either side of opening 558.) from the one end of the another one of the two grip limbs (see annotated Fig. 20a, [0129]), the two grip limbs (see annotated Fig. 20a, [0129]) being symmetric ([0129] “This particular variation may have handle enclosure 552 formed in a tapered configuration which allows for the assembly 550 to be generally symmetrically-shaped about a longitudinal axis extending from its distal end 554 to its proximal end 556. “) with respect to the longitudinal axis (Fig. 1 longitudinal axis of tubular body 12) of the tubular shank (Fig. 1 tubular body 12), the contact surface defining an outer periphery portion of the housing, the contact surface (Figs. 19a-20b near opening 558) facing in the direction away from the tubular shank (Fig. 1 tubular body 12), the contact surface (Figs. 19a-20b near opening 558) extending between the one of the two grip limbs(see annotated Fig. 20a, [0129]) and the another one of the two grip limbs (see annotated Fig. 20a, [0129]);
a first trigger (see annotated Fig. 20a) provided on one side of the housing, the first trigger (see annotated Fig. 20a) being configured to pull a lower cable (control wires 592, [0129-0134]);
a second trigger (see annotated Fig. 20a) provided on another side of the housing, the one side being opposite the another side with respect to the longitudinal axis, each of the two limbs (see annotated Fig. 20a, [0129]) being located at a spaced location from the first trigger (see annotated Fig. 20a) and the second trigger (see annotated Fig. 20a).
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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.
Claims 1, 3, 4, 7-19, 21-26, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang et al. (US11013396) hereinafter Ouyang in view of Saadat.
Regarding Claim 1, Ouyang discloses an endoscopic instrument (abstract) for inserting into a body of a patient (abstract), wherein the endoscopic instrument (abstract) comprises:
a handling device (Fig. 1A- 6H hub 170);
a tubular shank (Fig. 1A-6H cannula 120) which is coupled or can be coupled to the handling device (Fig. 1A- 6H hub 170); and
at least two leads (Fig. 4B lower cable 430 and upper cable 432), the at least two leads comprising electrical, mechanical (Fig. 4B lower cable 430 and upper cable 432) or optical leads which run through the tubular shank (Fig. 1A-6H cannula 120),
wherein the handling device (Fig. 1A- 6H hub 170) comprises a housing (Fig. 1A- 6H housing of hub 170) which at a proximal end has two limbs (Figs. 4A-b proximal ends of actuation hub 170 near connectors 160/162 and distal portion of handle portion 140 that mates with connectors 160/162) which are arranged obliquely to one another and enclose a contact surface (Figs. 1A-5 contact surface of hub 170),
wherein at least one of the at least two leads (Fig. 4B lower cable 430 and upper cable 432) is led outwards out of the handling device (Fig. 1A- 6H hub 170) out of one of the two limbs (Figs. 1A-5 lower lever 220 and upper lever 230),
wherein the two limbs (Figs. 4A-b proximal ends of actuation hub 170 near connectors 160/162 and distal portion of handle portion 140 that mates with connectors 160/162)
Ouyang is silent as to explicitly disclose wherein the two limbs are configured as two rigid grip limbs which distally run together towards the tubular shank in a Y-shape being symmetric with respect to a longitudinal axis of the tubular shank, such that the handling device is configured to be gripped in a first posture or a second posture, wherein, in the first posture, wherein the two limbs are arranged in the Y-shape, one of the two limbs having a first end, another one of the two limbs having a second end, the first end being located at a spaced location from the second end, wherein the contact surface extends between the one of the two limbs and the another one of the two limbs, the two limbs being configured to be gripped around as a forceps and an index finger is applied on a lower trigger below the tubular shank for pulling a lower pull cable, and wherein, in a second posture, a ball of a thumb is led between the two limbs and the index finger is applied on an upper trigger above the tubular shank for pulling an upper pull cable and a middle finger is applied on the lower trigger below the tubular shank for pulling a lower pull cable, the lower trigger and the upper trigger being arranged distally of the two limbs.
However Saadat, in the same field of endeavor, teaches wherein the two limbs (Figs. 20a-b near grips 560, 562, see annotated Fig. 20a) are configured as two rigid grip limbs ([0129] “Another handle variation may be seen in the perspective view of handle assembly 550, as shown in FIG. 19A. This particular variation may have handle enclosure 552 formed in a tapered configuration which allows for the assembly 550 to be generally symmetrically-shaped about a longitudinal axis extending from its distal end 554 to its proximal end 556. The symmetric feature of handle assembly 550 may allow for the handle to be easily manipulated by the user regardless of the orientation of the handle enclosure 552 during a tissue manipulation procedure. An additional feature which may further facilitate the ergonomic usability of handle assembly 550 may further include at least one opening 558 defined through the enclosure 552 to allow the user to more easily grip and control the handle 550. Another feature may include grips 560, 562 which may extend from either side of enclosure 552.”) which distally run together towards the tubular shank in a Y-shape (see annotated Fig. 20A) being symmetric with respect to a longitudinal axis ([0129] “The symmetric feature of handle assembly 550 may allow for the handle to be easily manipulated by the user regardless of the orientation of the handle enclosure 552 during a tissue manipulation procedure.”) of the tubular shank (Fig. 1 tubular body 12), such that the handling device (Fig. 1 handle 16 of Fig. 20A handle assembly 550 as the variation within Fig. 20A-B) is configured to be gripped in a first posture or a second posture ([0129]), wherein, in the first posture, wherein the two limbs (see annotated Fig. 20A) are arranged in the Y-shape (see annotated Fig. 20A), one of the two limbs having a first end (see annotated Fig. 20A), another one of the two limbs (see annotated Fig. 20A) having a second end(see annotated Fig. 20A), the first end (see annotated Fig. 20A) being located at a spaced location from the second end(see annotated Fig. 20A),
wherein the contact surface (Figs. 19a-20b near opening 558) extends between the one of the two limbs (see annotated Fig. 20A) and the another one of the two limbs (see annotated Fig. 20A), the two limbs (see annotated Fig. 20A) being configured to be gripped around as a forceps and an index finger ([0129]) is applied on a lower trigger (controls 588, see annotated Fig. 20A) below the tubular shank (Fig. 1 tubular body 12) for pulling a lower pull cable (control wires 592, [0129-0134]), and
wherein, in a second posture, a ball of a thumb is led between the two limbs and the index finger is applied ([0129]) on an upper trigger (controls 588, see annotated Fig. 20A) above the tubular shank (Fig. 1 tubular body 12) for pulling an upper pull cable and a middle finger ([0129]) is applied on the lower trigger (controls 588, see annotated Fig. 20A) below the tubular shank (Fig. 1 tubular body 12) for pulling a lower pull cable (control wires 592, [0129-0134]),
the lower trigger (controls 588, see annotated Fig. 20A) and the upper trigger (controls 588, see annotated Fig. 20A) being arranged distally of the two limbs (see annotated Fig. 20A).
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It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Ouyang with the teachings of Saadat to include such configuration of the two limb grips as discloses above for the benefit of creating a handle that “…can allow for the handle to be easily manipulated…[and]…facilitate the ergonomic usability of the handle assembly…” ([Saadat – [0129]).
Examiner’s Note: Examiner would like to point out that the limitation “the two limbs being configured to be gripped around as a forceps and an index finger is applied on a lower trigger below the tubular shank for pulling a lower pull cable, and wherein, in a second posture, a ball of a thumb is led between the two limbs and the index finger is applied on an upper trigger above the tubular shank for pulling an upper pull cable and a middle finger is applied on a lower trigger below the tubular shank for pulling a lower pull cable” is function language. Specifically, the functional language describing how the two limbs are configured to be gripped.
MPEP 2114 (II) addresses functional language and states, “A recitation with respect to the manner in which a claimed apparatus is intended to be used does distinguish the claims apparatus from the prior art – if the prior art apparatus teaches all the structural limitations of the claim.”
Here Saadat meets the structural limitation of the claim, as required by MPEP 2114, because Saadat discloses such structure that allows for such gripping of the two limbs as defined above and explicitly states, “..the handle [can] be easily manipulated by the user regardless of the orientation of the handle…” [0129].
Regarding Claim 3, Ouyang in view of Saadat teach the endoscopic instrument according to claim 1, further comprising: a distally running pull wire (Ouyang – Fig. 1A – 6h cable 430, 432), the each of the upper trigger and the lower trigger (Ouyang – Figs. 1A-5 lower lever 220 and upper lever 230) comprising an operating lever (Ouyang – Figs. 1A-5 lower lever 220 and upper lever 230) actuatable by two fingers of a hand of a user by way of proximal pulling (Ouyang – [col. 7 lines 9-61]).
Regarding Claim 4, Ouyang in view of Saadat teach the endoscopic instrument according to claim 3, further comprising a guide roller or cam disc (Ouyang – Fig. 4B wheel 410) arranged between the operating the upper trigger and the operating lever of the lower trigger (Ouyang – Figs. 1A-5 lower lever 220 and upper lever 230), about which the guide roller or cam disc (Ouyang – Fig. 4B wheel 410) the distally running pull [[wires]] wire (Ouyang – Fig. 1A – 6h cable 430, 432) are each lead as a section of the pull wire (Ouyang – Fig. 1A – 6h cable 430, 432) as a common pull wire (Ouyang – Fig. 1A – 6h cable 430, 432) which is led around the guide roller or cam disc (Ouyang – Fig. 4B wheel 410), wherein the guide roller or cam disc (Ouyang – Fig. 4B wheel 410) is rotatable in two directions in an angular range about a rotation axis (Ouyang – Fig. 4B central axis 408) in a housing (Ouyang – Fig. 1A- 6H housing of hub 170) of the handling device (Ouyang – Fig. 1A- 6H hub 170), wherein the rotation axis (Ouyang – Fig. 4B central axis 408) runs essentially perpendicularly to a plane which is spanned by the two limbs (Ouyang – Figs. 1A-5 lower lever 220 and upper lever 230).
Regarding Claim 7, Ouyang in view of Saadat teach the endoscopic instrument according to claim 1, further comprising a fluid channel (Ouyang – [col. 6 lines 1-11] “The cannula 120 includes one or more fluid channels which are fluidly connected to fluid port 132 at fluid hub and connection assembly 130. Port 132 includes a Luer fitting to facilitate leak-free connection of port 132 with various medical fluid components. The fluid channels or lumens in cannula 120 are also connected to a distal facing fluid ports of tip assembly 110.”) which individually directly surrounds the at least two leads (Ouyang – Fig. 4B lower cable 430 and upper cable 432) which run through the tubular shank (Ouyang – Figs. 1A-6H cannula 120) is formed in the tubular shank (Ouyang – Figs. 1A-6H cannula 120), wherein a portion of the contact surface (Ouyang – fig. 1A- 4B surface of hub 170) is located on one side of the longitudinal axis (Ouyang – see annotated Fig. 4B) and another portion of the contact surface (Ouyang – fig. 1A- 4B surface of hub 170) is located on another side of the longitudinal axis (Ouyang – see annotated Fig. 4B).
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Regarding Claim 8, Ouyang in view of Saadat teach the endoscopic instrument according to claim 7, wherein the fluid channel (Ouyang – [col. 6 lines 1-11]) is configured as a channel (Ouyang – [col. 6 lines 1-11]), wherein the channel (Ouyang – [col. 6 lines 1-11]) comprises a feed channel (Ouyang – Fig. 3B port 132, 332) , a discharge channel or a feed and discharge channel.
Regarding Claim 9, Ouyang in view of Saadat teach the endoscopic instrument according to claim 7, wherein the fluid channel (Ouyang – [col. 6 lines 1-11]) comprises a distal fluid channel opening (Ouyang – [col. 6 lines 1-11], near tip piece 110) and a proximal fluid channel opening (Ouyang – [col. 6 lines 1-11] near port 132 or 332), wherein the proximal fluid channel opening (Ouyang – [col. 6 lines 1-11] near port 132 or 332) is arranged laterally on the tubular shank (Ouyang – Figs. 1A-6H cannula 120) and can be subjected to fluid pressure or a fluid vacuum (Ouyang – [col. 6 lines 1-11]).
Regarding Claim 10. Ouyang in view of Saadat teach the endoscopic instrument according to claim 1, further comprising a sealing means which forms a proximal end of the fluid channel and comprises feed-throughs for the at least two leads (Ouyang – Fig. 4B lower cable 430 and upper cable 432) [col. 5 lines 18-45] “…Note that electrical connector 164 and mechanical connector 160 are both separated from the fluid hub 130, and are separated from each other by a distance of several cm, e.g., 5 cm or more. This separation allows for easy and effective, yet simple and inexpensive, fluid sealing to prevent fluid from hub 130, and any fluid from steering actuation hub 170 from penetrating internally towards connectors 160 and 164 and also allows some protection against any exterior fluid, for example from fluid port 132 from reaching and possibly compromising electrical connectors 164 and 166. The physical separation of the fluid hub 130 and the mechanical and electrical connectors 160 and 164 also provide additional assurance against accidental contamination from fluid hub 130 to the re-usable portion 102. For further details regarding the physical separation and associated benefits, see said U.S. Pat. No. 9,895,048.”).
Regarding Claim 11, Ouyang in view of Saadat teach the endoscopic instrument according to claim 1, wherein the handling device (Ouyang – Fig. 5 hub 170) is fixedly connected or is releasably connectable to a proximal end of the tubular shank (Ouyang – Fig. 5 cannula 120).
Regarding Claim 12, Ouyang in view of Saadat the endoscopic instrument according to claim 1, wherein the tubular shank (Ouyang – Figs. 1A -6H cannula 120) , at least in a shank section (Ouyang – Fig. 2 distal section of cannula 120), is jointlessly elastically bendable by more than 270
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( Ouyang – Examiner’s note: Fig. 2 illustrates the cannula can defect upwards at 210 degrees and then downward at 130 degrees. Therefore, that is a total of at least 340 degrees of movement in the embodiment shown in Fig. 2.)
Regarding Claim 13, Ouyang in view of Saadat teach the endoscopic instrument according to claim 1, wherein the endoscopic instrument or at least the tubular shank is configured as a disposable article for disposal after a single use (Ouyang – abstract).
Regarding Claim 14, Ouyang in view of Saadat teach the endoscopic instrument according to claim 1, wherein a cross-sectional area of a fluid channel (Ouyang – [col. 6 lines 1-11]) corresponds to a cross-sectional area of a shank interior (Ouyang – Figs. 1A-6H interior of cannula 120) which is formed by the tubular shank (Ouyang – Figs. 1A-6H cannula 120), minus a sum of the cross-sectional areas of [[all]]the at least two leads (Ouyang – Fig. 4B lower cable 430 and upper cable 432) which run through the shank interior (Ouyang – Figs. 1A-6H interior of cannula 120).
Regarding Claim 15, Ouyang in view of Saadat teach the endoscopic instrument according to claim 1, wherein the tubular shank (Ouyang – Figs. 1A-6H cannula 120), in a distal shank section, comprises a plurality of slots (Ouyang – Fig. 6H slots holding leds 650 and 652).
Regarding Claim 16, Ouyang in view of Saadat teach the endoscopic instrument according to claim 15, wherein the plurality of slots (Ouyang – Fig. 6H slots holding leds 650 and 652) only extend over a part of a shank periphery in a circumferential direction (Ouyang – Fig. 6H).
Regarding Claim 17, Ouyang in view of Saadat teach the endoscopic instrument according to claim 15, wherein the plurality of slots (Ouyang – Fig. 6H slots holding leds 650 and 652) are arranged axially to one another such that the plurality of slots (Ouyang – Fig. 6H slots holding leds 650 and 652) alternately lie on a first lateral side of the tubular shank (Ouyang – Figs. 1A-6H cannula 120) and a second lateral side of the tubular shank (Ouyang – Figs. 1A-6H cannula 120) which lies diametrically opposite the first lateral side of the tubular shank (Figs. 1A-6H cannula 120).
Regarding Claim 18, Ouyang in view of Saadat teach the endoscopic instrument according to claim 15, wherein the plurality of slots are configured as a distal fluid channel opening for a fluid channel and to locally increase a flexibility of the tubular shank for a jointless bending of a distal shank end (Ouyang – [col. 6 lines 1-11] “According to some embodiments, the cannula 120 includes one or more fluid channels which are fluidly connected to fluid port 132 at fluid hub and connection assembly 130. Port 132 includes a Luer fitting to facilitate leak-free connection of port 132 with various medical fluid components. The fluid channels or lumens in cannula 120 are also connected to a distal facing fluid ports of tip assembly 110.”)
Regarding Claim 19, Ouyang in view of Saadat teach the endoscopic instrument according to claim 1, further comprising at least one working channel (Ouyang – Fig. 6H working channel 630) which runs through the tubular shank (Ouyang – Figs. 1A-6H cannula 120) and which is directly surrounded by [[the]] a fluid channel ([col. 6 lines 1-11]).
Regarding Claim 21, Ouyang in view of Saadat teach the endoscopic instrument according to claim 19, wherein the working channel (Ouyang – Fig. 6H working channel 630) serves as a channel (Ouyang – Fig. 6H working channel 630), wherein the channel (Ouyang – Fig. 6H working channel 630) comprises a feed channel discharge channel, or a feed and and/or discharge channel with a flow direction which runs opposite with respect to [[the]] a fluid channel (Ouyang – [col. 8 lines 41-64] “…the working channel 630 can be used for fluid infusion…”).
Regarding Claim 22, Ouyang in view of Saadat teach the endoscopic instrument according to claim 19, wherein the at least one working channel (Ouyang – Fig. 6H working channel 630) runs axially through a sealed proximal end of a fluid channel (Ouyang – [col. 8 lines 41-64] “…the working channel 630 can be used for fluid infusion…”).
Regarding Claim 23, Ouyang in view of Saadat teach the endoscopic instrument according to claim 19, wherein the at least one working channel (Ouyang – Fig. 6H working channel 630) comprises a distal working channel opening (Ouyang – Fig. 6H opening of working channel 630 as illustrated in Fig. 6H in distal tip 110) and a proximal working channel opening (Ouyang – Fig. 3B device port 332).
Regarding Claim 24, Ouyang in view of Saadat teach the endoscopic instrument according to claim 23, wherein [[the]] a proximal working channel opening (Ouyang – Fig. 3B device port 332) is arranged proximally of the proximal end of [[the]] a fluid channel (Ouyang – [col. 8 lines 41-64] “…the working channel 630 can be used for fluid infusion…”).
Regarding Claim 25, Ouyang in view of Saadat teach the endoscopic instrument according to claim 23, wherein the distal working channel opening (Ouyang – Fig. 6H opening of working channel 630 as illustrated in Fig. 6H in distal tip 110) is arranged distally of a distal fluid channel opening of[[the]] a fluid channel (Ouyang – [col. 8 lines 41-64] “…the working channel 630 can be used for fluid infusion…”).
Regarding Claim 26, Ouyang in view of Saadat teach the endoscopic instrument according to claim 23, wherein the handling device (Ouyang – Fig. 1A- 6H hub 170) is fixedly connected or releasably connectable (Fig. 5) to a proximal end of the tubular shank (Ouyang – Figs. 1A-6H cannula 120), wherein the proximal working channel opening (Ouyang – Fig. 3B device port 332) is formed by the handling device (Ouyang – Fig. 1A- 6H hub 170).
Regarding Claim 30 , Ouyang in view of Saadat teach the endoscopic instrument according to claim 1, wherein a distal shank end is controllably jointlessly bendable (Ouyang – [col. 8 lines 1-16] “…the cannula 120 is made of a steel tube 520 which has a series of notches cut in the flexible portion 320 that allow tube 520, and cannula 120 to bend upwards and downwards.”).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Saadat in view of Justin Reed (US2013/0324973) hereinafter Reed.
Regarding Claim 5, Saadat discloses the endoscopic instrument according to claim 4, but is silent whether further comprising an arresting device, wherein the guide roller or cam disc is fixable in a momentary position via the arresting device.
However Reed, in the same field of endeavor, teaches comprising an arresting device (Reed – tension knob 116 [0072]), wherein the guide roller or cam disc (Reed – Fig. 2 actuator body 48) is fixable in a momentary position via the arresting device (Reed – tension knob 116 [0072]).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify Saadat with the teaching of Reed and have further comprise an arresting device, wherein the guide roller or cam disc is fixable in a momentary position via the arresting device for the benefit to “increase or decrease the ability to rotate the actuator body.. [while having the]… advantage of such functionality is that once a physician has deflected the shaft … a desired amount, the physician may maintain the deflection by adjusting the tension knob … to limit the ability to rotate the actuator body … in either direction” (Reed – [0072]).
Regarding Claim 6, Saadat in view of Reed teach endoscopic instrument according to claim 5, wherein the arresting device (Reed - tension knob 116 [0072]) comprises a knurled screw (Reed - Fig. 2 screw 118 [0072-0073]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Ouyang in view of Saadat in view of Bonnet et al. (US4486680) hereinafter Bonnet.
Regarding claim 20, Ouyang in view of Saadat teach the endoscopic instrument according to claim 19, but is silent as to further disclose wherein the working channel is configured to lead through a laser fiber optic, a capture basket or a Dormia loop.
However Bonnet, in the same field of endeavor, teaches wherein the working channel (Bonnet - Fig. 1 sheath 2) is configured to lead through a laser fiber optic, a capture basket or a Dormia loop (Bonnet - Fig. 1 strands 3a, [col. 2 lines 16-30] and [col. 1 lines 17-33] “ It is known moreover that a wire may be connected at the distal end projecting out of the sheath to a basket-like loop structure (Dormia loop structure), which serves the purpose of receiving a stone which is to be removed.)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Ouyang in view of Saadat with the teachings of Bonnet to include wherein the working channel is configured to lead through a laser fibre optic, a capture basket or a Dormia loop for the benefit of “receiving a stone which is to be removed” [col. 1 lines 17-33]).
Claim 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Ouyang in view of Saadat in view of St. Onge et al. (US2011/0124960) hereinafter St. Onge.
Regarding Claim 27, Ouyang in view of Saadat teach the endoscopic instrument according to claim 23, but is silent whether wherein a cross section of the distal working channel opening is smaller than a cross section of the working channel.
However St. Onge, in the same field of endeavor teaches ramp 34 to be in the cross section of the distal working channel opening (St. Onge - Figs. 7A-B near reference numeral 22b) is smaller than a cross section of the working channel (St. Onge - Figs. 7A-B near reference numeral 31).
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Ouyang in view of Saadat teach with the teachings of St. Onge to include wherein a cross section of the distal working channel opening is smaller than a cross section of the working channel for the benefit of directing an instrument to specific side of the a distal opening ( St. Onge –[0067]).
Regarding Claim 28, Ouyang in view of Saadat teach in view of St. Onge teaches the endoscopic instrument according to claim 27, wherein the cross section of the at least one working channel tapers towards the distal working channel opening (St. Onge - Figs. 7A-B near reference numeral 22b).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Ouyang in view of Saadat in view of Goddard et al. (US2016/0120557) hereinafter Goddard.
Regarding Claim 29, Ouyang in view of Saadat teach the endoscopic instrument according to claim 1, but is silent to further disclose wherein at least one of a through-flow direction and/or and a through-flow rate through [[the]] a fluid channel is selectable or can be set.
However Goddard, in the same field of endeavor, teaches wherein at least one of a through-flow direction and/or and a through-flow rate through [[the]] a fluid channel is selectable or can be set ([0041-0045] “The operator may connect lumen 112 to the fluid supply assembly 140. The fluid supply assembly 140 provides fluid, through lumen 112, to the distal end 104 of tube 108 and into kidney 408. The fluid supply assembly 140 may be any device and/or devices that can supply fluid to lumen 112. The fluid supply assembly 140 may include, but is not limited to, a fluid source, a pump, a control system, a heat exchanger, a filter, a temperature sensor, a pressure sensor, a supply line, and/or various user input devices. In some embodiments, the fluid supplied is a saline solution, for example, 0.9% saline.”)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the teachings of Ouyang in view of Saadat teach with the teachings of Goddard for the benefit of having control of the flow rate into a pulsed flow because “…pulsed flow may dislodge stone fragments/dust adhering to various surfaces within the patient's body. The pulsed flow may create turbulence. The turbulence to stir up any stone fragments/dust which may be located in an area where the stone fragments/dust may be less likely to flow out naturally (e.g. the lower pole of the kidney). The turbulence may aid in keeping stone fragments/dust 480 in suspension so that they may be more effectively suctioned out through lumen 114 “ ( Goddard – [0043]).
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.
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/MEGAN ELIZABETH MONAHAN/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795