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 .
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 “retention element” of claim 6 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
(NOTE: a retention element 652 is shown in Fig.6A, which prevents independent movement between the rigid shaft and adapter body (see paragraph [0061] of spec). This is not the same as the “retention element” of claim 6, which prevents movement of the first elongated member relative to the rigid shaft.)
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 Objections
Claim 7 is objected to because of the following informalities: as to claim 7, line 3, term “snuggly” is misspelled (should be “snugly”). Appropriate correction is required.
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) 1-3, 6-7, 13, 16, 17 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Snoke et al. (US 2008/0058595, hereinafter “Snoke”).
As to claim 1, Snoke discloses a scope adapter system for guiding a flexible scope device toward a target area in a living body, comprising:
an adapter body (introducer handle 21, Fig.1) configured to be coupled to a handle of a scope device to be used with the scope adapter system (handle 21 includes a scope connector 28, Fig.1, to securely connect to endoscope handle, [0061]);
a rigid shaft (introducer tube 23, Fig.1, [0058]) extending between a proximal end and a distal end, the rigid shaft including a first shaft lumen (scope lumen 34, Fig.5, [0051]) extending therethrough, the first shaft lumen being sized and shaped to slidably receive a flexible first elongated member of the scope device therein (receives scope shaft 62, Fig.11, [0056]), a distal end of the first shaft lumen being sized so that, when a distal end of the first elongated member is received therein, the distal end of the first elongated member is snugly held so that an aim of the rigid shaft aims the distal end of the first elongated member (implicit: scope shaft 62 will be confined laterally (snugly held) by scope lumen 34 and thus will “aim” in the same direction as the introducer tube); and
a mounting mechanism (manifold 22, Figs.1,4) configured to be removably coupled to the rigid shaft ([0054]), the mounting mechanism being configured to mount the proximal end of the rigid shaft to the adapter body so that, when the adapter body is coupled to the handle of the scope device, the mounting mechanism is mounted on the adapter body and coupled to the rigid shaft (snap fit mechanism 48,49 on manifold mounts introducer tube 23 to handle 21, [0055]) and the first elongated member is inserted into the first shaft lumen so that movement of the handle effects a corresponding movement of the distal end of the first elongated member (when handle is connected to endoscope and endoscope shaft is inserted into the shaft lumen, as shown in Fig.3, movement of handle will cause corresponding movement of endoscope shaft because of the mechanical connection).
As to claim 2, wherein the mounting mechanism includes a first port which, when the mounting mechanism is coupled to the rigid shaft, is aligned with the first shaft lumen (scope lumen 34 in introducer tube extends to a port in the manifold 22, shown as 34 is Fig.4).
As to claim 3, wherein the rigid shaft includes a second shaft lumen (working lumen 35, Fig.5, [0051]) extending therethrough and wherein the mounting mechanism includes a second port aligned with the second shaft lumen (working lumen 35 in introducer tube extends to a port in the manifold 22, shown as 35 in Fig.4), and the second shaft lumen and the second port are configured to receive a second elongated member therethrough (working channel is configured to receive instruments, [0076]).
As to claim 6, Snoke further discloses a retention element (scope connector 28, Fig.1) selectively couplable to the proximal end of the rigid shaft (selectively couplable to shaft 23 via handle 21/mount 22, Fig.1), wherein the retention element is configured so that, when coupled to the proximal end of the rigid shaft, movement of the first elongated member relative to the rigid shaft is prevented (scope connector 28, Fig.1, securely connects to endoscope handle via a lock fitting, [0061]);
As to claim 7, wherein the rigid shaft further comprises a core member received within the rigid shaft (interior material of shaft 23) to define the first shaft lumen (defines scope lumen 34, [0051]), the core member being configured to snuggly receive the first elongated member therethrough (scope shaft 62 will be confined laterally (snugly held) by scope lumen 34).
As to claim 13, wherein the adapter body further comprises a handle (handle 21, Fig.3) configured to snap rigidly onto the scope device to permit a user to manipulate the rigid shaft (handle 21 includes scope connector 28, Fig.1, to lock fit (snap) onto endoscope handle, [0061]);
As to claim 16, Snoke discloses a method for treating tissue within a living body [0039], comprising:
attaching an adapter body to a handle of a flexible scope device (handle 21 attaches to endoscope handle via scope connector 28, Fig.1, [0061]);
attaching the adapter body to a proximal end of a rigid shaft via a mounting mechanism including a first port aligned with a first shaft lumen of the rigid shaft (handle 21 is attached to proximal end of rigid shaft 23 via manifold 22, Figs.1,4; lumen 34 in manifold 22, Fig.5 aligns with lumen 34 in shaft 23, [0051], Fig.4);
inserting a flexible shaft of the flexible scope device into the first shaft lumen (flexible endoscope shaft 62, [0093], is inserted through lumen 34, [0056], Fig.3, and/or flexible hysteroscope shaft into lumen 35), such that a distal end of the flexible shaft is proximal of a distal end of the rigid shaft (Fig.9C, endoscope shaft held proximal to the distal end of the rigid shaft in one position, [0027],[0070]);
guiding the rigid shaft and the flexible shaft toward a target area within the living body (e.g. Fig.10, [0105]); and
manipulating the adapter body to aim the flexible scope device within the living body (Figs.9A-9E,10, [0105].
As to claim 17, Snoke further discloses advancing the flexible shaft distally beyond a distal end of the rigid shaft (endoscope shaft or hysteroscope shaft is advanced distally so as to extend past distal end, Figs.9A-9E,10, [0070], [0105]); and operating a portion of the flexible shaft extending distally out of the rigid shaft using a steering system of the flexible scope device to access the target area within the living body (Figs.9A-9E, 10, [0079],[0105]).
As to claim 19, wherein the mounting mechanism includes a second port (working lumen 35 in manifold 22, shown as 35 in Fig.4) aligned with a second shaft lumen of the rigid shaft (working lumen 35 in shaft 23, [0051]), further comprising: inserting a second elongated member through the second port and the second shaft lumen (simultaneously using tools, [0101], working channel delivers instruments/tools to interior of body, [0076]), ; moving the second elongated member through the second shaft lumen toward the distal end of the rigid shaft (delivering instruments through working lumen to target site, [0076] constitutes “moving” the instrument through the shaft); advancing the second elongated member distally out of the rigid shaft (delivering instruments through working lumen to target site, [0076], constitutes advancing the instrument beyond the distal end of the rigid shaft (to target site), [0052]), such that a distal end of the second elongated member is distal of the distal end of the rigid shaft (has to be to reach target area inside body); and guiding the second elongated member toward the target area (instrument positioning to a target operative site, [0048]).
Claim(s) 1, 6, 13-14, 16 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin et al. (US 2020/0337548, hereinafter “Lin”).
As to claim 1, Lin discloses a scope adapter system for guiding a flexible scope device toward a target area in a living body, comprising:
an adapter body (fixing support 220, Fig.11) configured to be coupled to a handle of a scope device to be used with the scope adapter system (configured to couple to the handle of flexible endoscope 10, as shown in Fig.2);
a rigid shaft (200/210, Fig.11) extending between a proximal end and a distal end, the rigid shaft including a first shaft lumen (lumen, not numbered, but shown in Figs.12-13) extending therethrough, the first shaft lumen being sized and shaped to slidably receive a flexible first elongated member of the scope device therein (lumen receives flexible shaft 100 of scope 10, Fig.1,2, [0048]), a distal end of the first shaft lumen being sized so that, when a distal end of the first elongated member is received therein, the distal end of the first elongated member is snugly held so that an aim of the rigid shaft aims the distal end of the first elongated member (implicit: scope shaft 100 will be confined laterally (snugly held) by lumen, Fig.2, and thus will “aim” in the same direction as the rigid shaft); and
a mounting mechanism (216,221, Fig.11) configured to be removably coupled to the rigid shaft (221 and 216 are detachably connected, Fig.11, [0049]), the mounting mechanism being configured to mount the proximal end of the rigid shaft to the adapter body so that, when the adapter body is coupled to the handle of the scope device, the mounting mechanism is mounted on the adapter body and coupled to the rigid shaft (couples rigid shaft 210/200 to adapter body 220, [0049])) and the first elongated member is inserted into the first shaft lumen so that movement of the handle effects a corresponding movement of the distal end of the first elongated member (when 220 is connected to the endoscope, Fig.2,.and endoscope shaft is inserted into the lumen, as shown in Fig.2, movement of handle will cause corresponding movement of endoscope shaft because of the mechanical connection, [0049]).
As to claim 6, Lin further discloses a retention element (sheath seal 213, Fig.13) selectively couplable to the proximal end of the rigid shaft (selectively couplable at proximal end of shaft, Figs.12, 13), wherein the retention element is configured so that, when coupled to the proximal end of the rigid shaft, movement of the first elongated member relative to the rigid shaft is prevented (implicit: friction force of seal around endoscope shaft will tend to prevent shafts movement).
As to claim 13, wherein the adapter body further comprises a handle (lock button 222, Fig.11, [0049]) configured to snap rigidly onto the scope device to permit a user to manipulate the rigid shaft ([0049], Figs.2,11).
As to claim 14, wherein the adapter body includes a first body portion (one tine of lock button 222, Fig.11) and a second body portion (second tine of lock button 222, Fig.11) configured to be coupled together around the handle of the scope device to couple the adapter body to the handle of the scope device (snaps around handle, Fig.11, [0049]).
As to claim 16, Lin discloses a method for treating tissue within a living body, comprising:
attaching an adapter body to a handle of a flexible scope device (adapter body 220 attached to handle 110 of scope 10, Figs.1,2,11, [0049]);
attaching the adapter body to a proximal end of a rigid shaft via a mounting mechanism (mounting mechanism 216/221 attaches adapter body 220 to proximal end of rigid shaft 200/210, Fig.11, [0049]) including a first port (groove 212, Fig.13) aligned with a first shaft lumen of the rigid shaft (groove 212 is aligned with lumen 211 in the shaft 200/210, Fig.13);
inserting a flexible shaft of the flexible scope device into the first shaft lumen (flexible scope shaft 11, inserted into lumen, [0048], Fig.2), such that a distal end of the flexible shaft is proximal of a distal end of the rigid shaft (inserted until distal end of scope is approximately aligned with distal end of shaft, [0048]);
guiding the rigid shaft and the flexible shaft toward a target area within the living body ([0057]); and
manipulating the adapter body to aim the flexible scope device within the living body (implicit: since the scope and adapter system are fixedly attached, [0049], and inserted together, [0057], they will have the same “aim” direction).
As to claim 17, Lin further discloses advancing the flexible shaft distally beyond a distal end of the rigid shaft (scope adapter system 20, Fig.1, is fixed, the handle of the scope is detached from the adapter body 220, and the scope 10 is pushed forward-distal end of scope will extend beyond distal end of shaft, [0058]); and operating a portion of the flexible shaft extending distally out of the rigid shaft using a steering system of the flexible scope device to access the target area within the living body (scope 10 has a steering part 120, Fig.8, [0051], which is used to aim the distal end at a target area, e.g. renal pelvis, [0051],[0058]).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Snoke et al. (US 2008/0058595, hereinafter “Snoke”) in view of Heimberger (US 2010/0240950).
As to claim 4, Snoke discloses the device as set forth above with respect to claim 3, but fails to disclose a distal tip extending distally from the distal end of the rigid shaft and including a first tip lumen open to the first shaft lumen, the first tip lumen being configured to receive the first elongated member therethrough and a second tip lumen open to the second shaft lumen to receive the second elongated member therethrough. However, Heimberger teaches to provide a distal tip (Fig.2) that extends distally from a rigid shaft ([0004]), such tip including at least two lumens (e.g. channels 10,12, Fig.2) aligned with guide channels in the shaft, and designed with a tapering shape to provide an atraumatic distal tip for reducing trauma and/or perforation upon insertion ([0005]-[0007]). It would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a distal tip at the end of the rigid shaft (23) of Snoke, as taught by Heimberger, to reduce trauma or perforation when inserting the shaft.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Snoke et al. (US 2008/0058595, hereinafter “Snoke”) in view of Pic et al. (US 2022/0355070, hereinafter “Pic”).
As to claim 5, Snoke discloses the device as set forth above with respect to claim 1, but fails to disclose that the first shaft lumen includes a slot extending from the distal end of the first shaft lumen to the proximal end of the first shaft lumen, the slot being sized so that the first elongated member can be removed from the first shaft lumen laterally through the slot. However, Pic teaches in a similar introducer tube for accommodating fluids tubes or instruments tubes (including endoscope instruments) ([0023]), to provide lumens with slots open to the outside of the shaft and extending the length of the lumen in order to facilitate insertion and removal of the tubes into and from the shaft ([0029], Figs.1,2A). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the first shaft lumen with slot as taught by Snoke, to provide the predictable result of facilitating insertion and removal of the scope tube into and from the shaft.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Snoke et al. (US 2008/0058595, hereinafter “Snoke”) in view of Lee-Sepsick et al. (US 2009/0024108, hereinafter “Lee-Sepsick”).
As to claim 8, Snoke discloses the device as set forth above with respect to claim 1, wherein the rigid shaft 23 defines a first working channel configured to receive the flexible first elongated member therethrough (scope lumen 34, Fig.5, [0065]) and a second working channel configured to receive a second elongated member therethrough (working lumen 35, Fig.5, [0065]) but fails to disclose the material of which the shaft is made. Lee-Sepsick teaches that a transcervical introducer shaft can be made of standard medical-grade metal or plastics ([0105]). Since Snoke does not disclose the material used for the shaft, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the shaft from any material known to be suitable material for introducer shafts, including a metal.
Allowable Subject Matter
Claims 9-12, 15 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See references cited on PTO-892. Of particular relevance is Fig.8 of Stem et al. (US 2021/0369095).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN P LEUBECKER whose telephone number is (571)272-4769. The examiner can normally be reached Generally, M-F, 5:30-2:00.
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 T 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.
/JOHN P LEUBECKER/Primary Examiner, Art Unit 3795