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 .
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Prestezog et al. (US2008/0262308) in view of Sekiguchi (US2017/0336621), and Kessler (US2010/0063358).
Regarding claim 1, Prestezog discloses a system for treating a stone in a hollow organ or body passage, comprising:
a scope device (Fig. 1 & 3: endoscope 12 [0033]) including a shaft extending longitudinally from a proximal end to a distal end (Fig. 1: endoscope 12 is a shaft extending from proximal hub 22 to a distal end, opposite the proximal hub 22 [0033]), the shaft configured to be inserted to a target area within a hollow organ or a body passage (endoscope and sheath are introduced to body lumen [0017]) and including a working channel extending therethrough (Fig. 1 & 7: working channel 16 [0033]); and
an outer sheath extending longitudinally from a proximal end to a distal end and configured to be slidable over a length of the shaft (flexible sheath 14 formed of sheath body 30 comprises proximal end 32 and distal end 34 [0034]), the outer sheath configured to deliver a fluid to the target area via a space extending between an interior of the outer sheath and an exterior of the shaft (Fig. 4A: fluid may be present in the central passage 42 of the sheath body 30 [0034]; irrigation fluid is drained through gravity or a vacuum source through central passage 42 [0036], but it also desirable to reverse the flow direction of the working channel of the endoscope and of the sheath flow path [0011]).
Prestezog fails to disclose the details of the distal end of the endoscope, therefore failing to disclose a scope cap, further failing to disclose an adapter mountable over a scope cap at the distal end of the endoscope. In the same field of endeavor, Sekiguchi teaches a distal end hood and an endoscope (hood 50 and endoscope 1 [0021 & 0031]), the endoscope including a scope cap (Fig. 1 & 2: distal end portion 11 [0025]) and a shaft extending longitudinally from a proximal end to a distal end (bending portion 12 and flexible tube portion 13 [0025]), including a working channel extending therethrough (insertion channel 23[0028]), the scope cap coupled to the distal end of the shaft such that an inlet opening of the scope cap is in communication with and in alignment with the working channel (insertion channel 23 opens at the distal end surface 11s [0034]), and wherein the distal end hood is an adapter having a substantially tubular body mountable over the scope cap such that a distal chamber defined via the adapter (Fig. 3: hood 50 is tubular and attached to an outer periphery of the distal end portion 11 [0029]) and the scope cap is open to and in communication with the inlet opening thereof so that, when a negative pressure is applied through the working channel, a suction force is applied through the distal chamber to draw a target stone one of into and against the distal chamber from the target area (if and when a negative pressure is applied to the insertion channel 23, a suction force would draw material toward the interior of hood 50). Since Prestezog fails to provide the details of the distal end of the endoscope, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any known endoscope distal tip, including the one taught by Sekiguchi, to demonstrate that an insertion section of an endoscope commonly is comprised of a shaft and a distal tip/scope cap. Also, in view of Sekiguchi, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the hood of Sekiguchi, to the device of Prestezog, as it is known in the endoscope art that hoods/adapters can help maintain a constant distance from the observation lens and the examination site, preventing direct contact between the two [0005].
While Prestezog suggests the distal end of the outer sheath is forms an elastic annular shape attached to the shaft, Prestezog fails to explicitly disclose an elastic band for attaching the distal end of the outer sheath to the shaft. In the same field of endeavor, Kessler teaches a flexible sleeve placed over a flexible endoscope tube of an endoscope, further teaching wherein a distal end of the flexible sleeve is attached to the flexible endoscope tube via an elastic band (band strip 207 may be formed of a flexible, elastic material [0043]; band strip 207 is wrapped around hollow member 201, thereby forming a seal between the hollow member 201 and endoscope 100 [0042]). In view of Kessler, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the elastic band of Kessler to the sheath of Prestezog, as it is known in the endoscope art to help form a seal between the interior of the sheath and the exterior of the endoscope to prevent fluid from entering undesired areas [0042].
Regarding claim 3, Prestezog, modified by Sekiguchi and Kessler, discloses the system of claim 1. Prestezog further discloses wherein the distal end of the outer sheath is configured to be closed about the shaft (distal end 34 of the sheath body 30 is tapered so that it conforms to the body of the flexible endoscope at the distal tip 70 [0037]) and the outer sheath includes an outlet opening extending through a wall thereof, immediately proximal of the distal end for providing the fluid to the target area (Fig. 1-3: distal drainage ports 74 formed on the tapered region 72 of the sheath body [0034]).
Regarding claim 21, Prestezog, modified by Sekiguchi and Kessler, discloses the system of claim 1. Kessler further teaches wherein the elastic band is mounted over the distal end of the outer sheath (Fig. 2 & 3: band strip 207 formed of flexible or elastic material and formed like a stretchable band which can be wrapped around the hollow member 201, for securing the hollow member 201 onto the distal end 103 of endoscope 100 thereby forming a fluid seal between the hollow member 201 and endoscope 100 [0042-0043]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Prestezog in view of Sekiguchi, Kessler, and Chu et al. (US2020/0352650).
Regarding claim 5, Prestezog, modified by Sekiguchi and Kessler, discloses the system of claim 1. Sekiguchi teaches wherein a proximal portion of the adapter is configured to be mounted over the scope cap ([0029, 0031, 0032]), but does not disclose how the proximal portion of the adapter is to be mounted to the scope cap. In the same field of endeavor, Chu teaches an endoscope and an endoscope adapter (Fig. 2: delivery shaft 20 and adaptor 30 [0029]), wherein the endoscope adapter is configured to be mounted over the endoscope via a friction fit (adaptor 30 may be coupled to delivery shaft 20 via friction fit [0033]). Since Sekiguchi fails to disclose the method of mounting the adapter, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used any of the various known mounting configurations, including a friction fit taught by Chu, to attach an adapter to an endoscope.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Prestezog in view of Sekiguchi, Kessler and Ciulla et al. (US2016/0166320).
Regarding claim 7, Prestezog, modified by Sekiguchi and Kessler, discloses the system of claim 1. Prestezog teaches wherein the endoscope and flexible sheath may be used for kidney [0013] or bladder applications [0045], and discloses instruments or tools introduced within the endoscope working channel [0004], however fails to disclose a laser fiber as an instrument. In the same field of endeavor, Ciulla teaches an endoscope, comprising a working channel wherein the working channel is configured to pass a laser fiber to treat a stone suctioned towards an opening of the working channel (medical device 100 comprising working channel 114, laser 120 and suction may be applied in working channel 114 at the same time [0035]). In view of Ciulla, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a laser fiber as an instrument, as it is known in the endoscope art that laser fibers are common instruments used during kidney and bladder surgeries for breaking stones into smaller pieces [0004].
Claims 6, 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Sekiguchi in view of Kucklick (US2016/0045105).
Regarding claim 6, Segukuchi discloses a system for treating a stone in a hollow organ or body passage, comprising: a scope device (endoscope 1) including a scope cap (Fig. 1 & 2: distal end portion 11 [0025]) and a shaft extending longitudinally from a proximal end to a distal end (bending portion 12 and flexible tube portion 13 form insertion portion 2 [0025]), the shaft configured to be inserted to a target area within a hollow organ or a body passage (insertion portion 2 inserted into a subject or object [0021]) and including a working channel extending therethrough (insertion channel 23 [0028]), the scope cap coupled to the distal end of the shaft such than an inlet opening of the scope cap is in communication with and in alignment with the working channel (insertion channel 23 opens at the distal end surface 11s [0034]);
an adapter having a substantially tubular body mountable over the scope cap such that a distal chamber defined via the adapter (Fig. 3: hood 50 is tubular and attached to an outer periphery of the distal end portion 11 [0029]) and the scope cap is open to and in communication with the inlet opening thereof so that when a negative pressure is applied through the working channel, a suction force applied is applied through the distal chamber to draw a target stone into or against the distal chamber from the target area (if and when a negative pressure is applied to the insertion channel 23, a suction force would draw material toward the interior of hood 50), wherein the distal chamber is open at a distalmost end of the adapter (Fig. 3: interior of hood 50 is open at the distalmost end of the hood 50).
Sekiguchi fails to disclose the system comprising an outer sheath, however in the same field of endeavor, Kucklick teaches a system for treating a stone in a hollow organ or body passage, comprising: a scope device including a shaft extending longitudinally from a proximal end to a distal end (Fig. 1: rigid canula 18 extends from a proximal end to a distal end), the shaft configured to be inserted to a target area within a hollow organ or a body passage (rigid cannula Is intended to be placed within an operating field inside or near a joint [0004]) and including a working channel extending therethrough (lumen within rigid cannula 18 [0034]);
an adapter having a substantially tubular body mountable over the shaft such that a distal chamber is defined via the adapter (Fig. 12: protective cap 30 is tubular and mounted over sheath 3 [0033] and mounted over cannula 18 where flange 65 contacts rigid cannula to form a seal [0034], forming the oval chamber between the distal end of cannula 18 and the concave lens 55), and when a negative pressure is applied through the working channel, a suction force applied is applied through the distal chamber to draw a target stone into or against the distal chamber from the target area (if a negative pressure were applied through lumen within rigid channel 18 [0034], a suction force would be applied within the distal chamber proximal the concave lens 55 that could draw material into the immediate area). Kucklick further teaches the system comprising an outer sheath extending longitudinally from a proximal end to a distal end and configured to be slidable over a length of the shaft (cap and sheath 3 slides over the arthroscope including the rigid cannula 18 [0022]), the outer sheath configured to deliver a fluid to the target area via a space extending between an interior of the outer sheath and an exterior of the shaft (Fig. 12: inner lumen 63, between the inner surface of sheath 3 and the exterior surface of cannula 18, comprises a hole 33 that allows fluid communication from a vacuum source to the surgical site [0033]; holes 33 may be used for suction, irrigation or injection of therapeutic agents [0023]), wherein the adapter and the outer sheath are integrally formed (cap 30 may be integrally formed with sheath 3, attached to sheath 3 or fit over sheath 3 [0026]). In view of Kucklick, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the sheath of Kucklick to the system of Sekiguchi, further including wherein the adapter is integrally formed with the sheath, as sheath are known in the art to facilitate an atraumatic entry into the body passage and provide another inflow/outflow fluid lumen [0020-0021] and Kucklick teaches wherein the adapter and sheath may alternatively and equivalently formed integrally or separately [0026].
Regarding claim 22, Segukuchi, modified by Kucklick, discloses the system of claim 6. Kucklick further teaches wherein the outer sheath includes an outlet opening proximal to the distal end of the outer sheath (Fig. 2-3: similar holes 33 placed on the sheath for suction, irrigation or the injection of therapeutic agents [0023]).
Regarding claim 23, Segukuchi, modified by Kucklick, discloses the system of claim 6. Kucklick further teaches wherein the distal end of the outer sheath is fitted about the shaft (distal end of sheath 3 is fitted about or around the shaft of arthroscope 2, sheath is a tube of polymeric material sized and dimensioned to slip fit over the outer surface of a cannula or endoscope [0022]).
Response to Arguments
Applicant’s arguments filed April 9, 2026, with respect to the rejection(s) of claim(s) 1 under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Kessler.
Claim 6 has been amended to include the limitation wherein the adapter and the outer sheath are integrally formed and wherein the distal chamber is open at a distalmost end of the adapter. The examiner has reinterpreted the prior art references Segukuchi and Kucklick, which teaches these limitations of claim 6. Segukuchi teaches wherein the distal chamber is open at a distalmost end of the adapter of an endoscopic device and Kucklick teaches an adapter and an outer sheath of an endoscopic device, wherein the adapter and the outer sheath may be integrally or separately formed.
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 LI-TING SONG whose telephone number is (571)272-5771. The examiner can normally be reached 8-5.
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/LI-TING SONG/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 8/3/26
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