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 .
Information Disclosure Statement
The information disclosure statement (IDS) filed on October 24, 2023 and February 15, 2024 is being considered by the examiner.
Election/Restrictions
Claims 2 and 8-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 21, 2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the elastic band of claim 4 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: scope cap 948 in paragraph [0122]. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Similar to the claim objection to claim 7 below, paragraph [0012] of the specification reads “the stone suctioned one of in and against the distal chamber”. The examiner believes this is a typo and should read “the stone suctioned in and against the distal chamber”.
Appropriate correction is required.
Claim Objections
Claim 7 is objected to because of the following informalities:
Part of claim 7, lines 3-4 reads “the stone suctioned one of in and against the distal chamber”. This appears grammatically incorrect. The examiner is interpreting the limitation to read “the stone suctioned in and against the distal chamber”.
Appropriate correction is required.
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.
Claims 1, 3, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Prestezog et al. (US2008/0262308) in view of Sekiguchi (US2017/0336621).
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].
Regarding claim 3, Prestezog, modified by Sekiguchi, 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 4, Prestezog, modified by Sekiguchi, discloses the system of claim 1. Prestezog further discloses wherein the distal end of the outer sheath includes an elastic band (although not explicitly stated, the distal end 34 of the sheath body 30 conforms to the body of the flexible endoscope at the distal tip 70 [0037], strongly suggesting that at least the distal end 34 is formed of an elastic, annular material that shapes around the sheath 30; further, sheath 14 is a flexible sheath 14 [0033]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Prestezog et al. (US2008/0262308) in view of Sekiguchi (US2017/0336621) and Chu et al. (US2020/0352650)
Regarding claim 5, Prestezog, modified by Sekiguchi, discloses the system of claim 1. Sekiguchi does not disclose the details of how a proximal portion of the adapter is configured to be mounted over the scope cap, therefore failing to disclose a friction fit. 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 et al. (US2008/0262308) in view of Sekiguchi (US2017/0336621) and Ciulla et al. (US2016/0166320)
Regarding claim 7, Prestezog, modified by Sekiguchi, 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 1, 3, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Kucklick (US2016/0045105) in view of Sekiguchi (US2017/0336621).
Regarding claim 1, Kucklick discloses 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 cannula 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 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 scope cap such that a distal chamber 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 18 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 is applied through the distal chamber to draw a target stone one of into and against the distal chamber from the target area (if a negative pressure were applied through the lumen within rigid cannula 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); 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 (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]; although the art does not explicitly disclose the delivery of a fluid, the structure of inner lumen is capable of delivering a fluid to the target area).
Kucklick fails to disclose the details of the distal end of the arthroscope, therefore failing to disclose a distal end of the rigid cannula to comprise a scope cap. In the same field of endeavor, Sekiguchi teaches 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]). Since Kucklick 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.
Regarding claim 3, Kucklick, modified by Sekiguchi, discloses the system of claim 1. Kucklick further discloses wherein the distal end of the outer sheath is configured to be closed about the shaft (Fig. 12: distal end of sheath 3 is closed, by flange 65, about the cannula 18) 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. 12: hole 33 disposed in sheath 3, capable of fluid communication between a vacuum source and the surgical site 1 [0033]).
Regarding claim 5, Kucklick, modified by Sekiguchi, discloses the system of claim 1. Kucklick further disclose wherein a proximal portion of the adapter is configured to be mounted over the scope cap via a friction fit (cap can be held to arthroscope by friction fit or any suitable method [0026]; contact between flange 65 and the cannula 18 forms a seal [0034], strongly suggesting contact friction between the two surfaces prevents fluid from leaking).
Regarding claim 6, Kucklick, modified by Sekiguchi, discloses the system of claim 1. Kucklick further discloses wherein the adapter and the outer sheath are integrally formed (cap 30 may be integrally formed with sheath 3 [0026]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See references cited in PTO-892.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LI-TING SONG/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
1/12/26