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 .
Status of Claims
Claims 1-19 are pending and currently under consideration for patentability under 37 CFR 1.104
Foreign Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copies have been received.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/10/2025 and 06/16/2026 have been considered by the examiner.
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 an end of the encapsulating sheath away from the operating handle is partially opened and communicates with an inner cavity of the encapsulating sheath (claim 12) 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.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-5, 10, 11, 13, and 15-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chu et al. (U.S. 2022/0369919).
With respect to claim 1, Chu et al. teaches an apparatus for sheath insertion, characterized in that comprising:
an inner layer member (160), which has an operating handle (162) and an insertion portion (164) connected to the operating handle, and the insertion portion has an imaging portion (para [0084]);
an outer sheath (100), which is provided with a drainage port (116, para [0074]), and has a distal open end (106); the insertion portion is operably inserted into the outer sheath, and at least partially operably extends out of the distal open end (FIG. 8 for example); and the insertion portion and the outer sheath are operably spaced apart to form a first channel that communicates the drainage port and the distal open end (FIG. 12 for example); and a middle layer member (150), which is operably inserted between the outer sheath and the insertion portion and at least partially operably extends out of the distal open end (FIG. 10,11); when the middle layer member is withdrawn from the space between the inner layer member and the outer sheath, the first channel is formed between the inner layer member and the outer sheath (FIG. 12).
With respect to claim 2, Chu et al. teaches the inserting portion is provided with a second passage extending along an extending direction of the inserting portion, and the second passage runs through the inserting portion (para [0096]).
With respect to claim 3, Chu et al. teaches the middle layer member is detachably connected to the inner layer member (via 152, para [0089]).
With respect to claim 4, Chu et al. teaches the middle layer member is a middle layer dilation tube (intended use), and the insertion portion can be operably inserted into or extracted from the middle layer dilation tube (via 152, para [0089]); and the middle layer dilation tube is detachably connected to the insertion portion.
With respect to claim 5, Chu et al. teaches a portion of the middle layer member between the inner layer member and the outer sheath operably fills an area between the inner layer and the distal open end of the outer sheath (FIG. 8 for example).
With respect to claim 10, Chu et al. teaches the outer sheath has a first sheath body (108) and a second sheath body (102) extending from the first sheath body, the drainage port is provided on the first sheath body (FIG. 2), and the distal open end is provided on the second sheath body; wherein the diameter of the cross section of the second sheath body gradually decreases in a direction away from the first sheath body (in the area of the distal tip 106, see FIG. 2).
With respect to claim 11, Chu et al. teaches a drainage tube (112,114) communicating with the first channel protrudingly extends from the side wall of the outer sheath, and the drainage port is provided on the drainage tube (FIG. 2).
With respect to claim 13, Chu et al. teaches when the middle layer member is located between the outer sheath and the inner layer member and reaches the working position, the middle layer member is tightly connected to the outer sheath and the inner layer member (FIG. 8).
With respect to claim 15, Chu et al. teaches the outer sheath has a proximal open end, and the insertion portion is at least partially located outside the proximal open end (FIG. 8).
With respect to claim 16, Chu et al. teaches the apparatus for sheath insertion is a natural orifice apparatus for sheath insertion (intended use).
With respect to claim 17, Chu et al. teaches a method of using an apparatus for sheath insertion, characterized in that using the apparatus for sheath insertion according to claim 1, and comprising the following steps:
inserting the inner layer member into the middle layer member (para [0098]);
inserting the middle layer member inserted with the inner layer member into the outer sheath (para [0091]-[0092]);
inserting the outer sheath, the middle layer member and the inner layer member assembled together into a working area (para [0091]-[0092]);
withdrawing the middle layer member and the inner layer member together from the outer sheath (para [0101]);
separating the inner layer member from the middle layer member (FIG. 12);
inserting the inner layer member into the outer sheath (FIG. 12).
With respect to claim 18, Chu et al. teaches in the step of inserting the middle layer member inserted with the inner layer member into the outer sheath, the middle layer member extends out of the distal open end (FIG. 11 for example).
With respect to claim 19, Chu et al. teaches during the step of inserting the outer sheath, the middle layer member and the inner layer member assembled together into the working area, the imaging portion operates throughout the process (para [0091]\-[0092]).
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. (U.S. 2022/0369919) in view of Harrah et al. (U.S. 2017/0215706).
Chu et al. teaches an apparatus for sheath insertion as set forth above. However, Chu et al. does not teach the middle layer dilation tube has a connecting adapter connected to the tube body.
With respect to claim 6, Harrah et al. teaches an analogous apparatus for sheath insertion wherein the middle layer dilation tube has a tube body (12) and a connecting adapter (10) connected to the tube body (via 14);
the insertion portion has a docking portion connected to the connecting adapter, and the docking portion is close to the operating handle (FIG. 3 for example).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the middle layer of Chu et al. to have a connecting adapter in the manner taught by Harrah et al. in order to allow the middle layer member the flexibility to fit with different model of imaging devices (para [0045] of Harrah et al.).
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. (U.S. 2022/0369919) in view of Singh (U.S. 2004/0254422).
Chu et al. teaches an apparatus for sheath insertion as set forth above. However, Chu et al. does not teach the insertion portion has a encapsulating sheath
With respect to claim 7, Singh teaches the insertion portion has an encapsulating sheath, and an end of the encapsulating sheath away from the operating handle has a first rounded guide surface, and the first rounded guide surface gradually converges toward an axis of the insertion portion in a direction away from the operating handle (FIG. 14).
With respect to claim 8, Singh teaches an end of the middle layer dilation tube away from the operating handle has a second rounded guide surface, and the second rounded guide surface gradually converges toward an axis of the middle layer dilation tube in a direction away from the operating handle (FIG. 14).
With respect to claim 9, Singh teaches the first rounded guide surface and the second rounded guide surface are adjacent to each other and extend into the same plane (FIG. 14).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the insertion portion and middle layer to have rounded guide surfaces in the manner taught by Singh in order to facilitate insertion into the urethra and aid in the negotiation of obstructions if any are encountered (para [0068] of Singh).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. (U.S. 2022/0369919) in view of Matthes (U.S. 2009/0143645).
With respect to claim 12, Chu et al. teaches the operating handle is provided with a liquid inlet extension (168).
However, Chu et al. does not teach an end of the encapsulating sheath away from the operating handle is partially opened and communicates with an inner cavity of the encapsulating sheath, and an end of the light source portion and the imaging portion are located at the end of the encapsulating sheath away from the operating handle.
With respect to claim 12, Matthes teaches an insertion portion has a encapsulating sheath (FIG. 3B), and a light source portion (62) and the imaging portion provided (60) in the encapsulating sheath; a second channel (16) runs through the encapsulating sheath;
an end of the encapsulating sheath away from the operating handle is partially opened and communicates with an inner cavity of the encapsulating sheath, and an end of the light source portion and the imaging portion are located at the end of the encapsulating sheath away from the operating handle (FIG. 3B).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify Chu et al. to include an end of the encapsulating sheath away from the operating handle is partially opened and communicates with an inner cavity of the encapsulating sheath in the manner taught by Matthes et al. in order to provide a means of releasing a tool located in the second channel without the need for withdrawing the endoscope (para [0030] of Matthes et al.).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. (U.S. 2022/0369919) in view of Eisner (U.S. 2017/0303941).
Chu et al. teaches an apparatus for sheath insertion as set forth above. However, Chu et al. does not teach the outer sheath has a hydrophilic coating or the middle layer member is rigid.
With respect to claim 14, Eisner teaches an analogous apparatus for sheath insertion wherein the outer sheath (104, para [0059) has a hydrophilic coating (para [0059]) and is made of a polymer material (para [0056]); the middle layer member is made of a polymer material or a metal material, and the middle layer member is rigid (para [0065]).
While Eisner does not teach the middle layer member is made of a polymer or metal material, it would be obvious to one of ordinary skill in the art that there are a finite number of rigid materials appropriate for surgical application such that one could substitute the material of Eisner and the results of such substitution would be predictable.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the outer sheath of Chu et al. to have a hydrophilic coating in order to assist in positioning the outer sheath (para [0057] of Eisner). It would further be obvious to modify the middle layer member to be rigid in order to provide rigid support for the assembly as it is being positioned in the passageway (para [0067] of Eisner).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexandra Newton Surgan whose telephone number is (571)270-1618. The examiner can normally be reached Monday-Friday 8am-4pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALEXANDRA L. SURGAN
Primary Examiner
Art Unit 3795
/ALEXANDRA L NEWTON/ Primary Examiner, Art Unit 3799
