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
The RCE filed 2/4/2026 has been entered. Claims 1, 3-5, 13, 15-17, 24-29 are pending in the application with claims 1, 24 amended, claims 2, 6-12, 14, 18-23, 30-44 cancelled.
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.
Claims 1, 3-5, 13, 15-17 and 24-29 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (US Patent Application Publication No. 2018/0206708) in view of Maseda et al. (US Patent Application Publication No. 2007/0225554, hereinafter Maseda).
In regard to claim 1, Miller discloses a device (10) for use with an endoscope (40), the device comprising:
a main body (12) comprising a visualization section (24) for allowing viewing of tissue by the endoscope and a proximal end configured for attachment to a distal end portion of the endoscope (Fig. 1);
a working channel extension (34) within the main body, the working channel extension having an open distal end and a proximal end that is configured for attachment to the working channel of the endoscope (Fig. 4), when the proximal end of the main body is attached to the distal end portion of the endoscope (the proximal end (34a) of the instrument channel (34) sealable connects to the working channel (42) of the endoscope, Fig. 4, Par. 49); and
wherein the device is configured to constrain an instrument passing through the instrument channel (an instrument is constrained by the tubular walls which define the instrument channel).
Miller does not expressly teach wherein the open distal end comprises a substantially V-shaped groove for receiving the instrument.
Maseda teaches an analogous endoscope (Fig. 1) comprising a plurality of working channel configurations. The working channel can have a non-circular cross-section, such as a pentagon (50) or hexagonal shape (52) illustrated in Fig. 2. The first working channel (50), the instrument (14) inserted within the channel can have a complementary shape to the working channel (50) thereby forming a lock and key relationship in order to maintain a desired orientation of the instrument and prevent rotation of the instrument within the channel (Par. 27). The second working channel (52) has a hexagonal shape for receiving a circular instrument (62) such that fluid can pass through gaps between the circular instrument and the hexagonal shape of the working channel (Par. 23).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the cross-sectional shape of the working channel and working channel extension of Miller to be a pentagon or hexagonal shape as taught by Maseda thereby enabling instruments having complimentary shapes to the pentagon or hexagonal shaped working channel to form a lock and key configuration enabling a surgeon to maintain an orientation of the instruments. Additionally, circular instruments can be inserted through the pentagon or hexagonal shaped working channel thereby forming gaps between the instrument and the working channel allowing fluids to pass therethrough. There being no unexpected results modifying the circular cross-sectional shape of the working channel and working channel extension of Miller for the pentagon or hexagonal working channel shapes as taught by Miller.
In regard to claim 3, Miller teaches wherein the device is configured to compress a portion of the working channel extension against the instrument to secure the instrument in place within the working channel extension (Par. 61).
In regard to claim 4, Miller teaches wherein the open distal end is oriented at an angle relative to a longitudinal axis of the endoscope working channel, the device being configured to secure the instrument in position at said angle (Fig. 4).
In regard to claim 5, Miller teaches wherein the device is configured to allow movement of the instrument while the instrument is secured at said angle (Fig. 4).
In regard to claim 13, Miller and Maseda teaches further comprising one or more protrusions (Maseda teaches a sleeve (66) can be mounted to the instrument to mate with the hexagonal shape of the working channel) extending into the instrument channel and an actuator (50, Miller) for compressing the instrument channel to secure the instrument within the groove (via engagement of the elevator (50) with the working channel).
In regard to claim 15, Miller teaches wherein the protrusions are removably coupled to the instrument channel (via removably inserting the instrument and sleeve therein).
In regard to claim 16, Miller teaches further comprising a mechanism (50) for articulating an instrument passing through the endoscope (Figs. 5-7).
In regard to claim 17, Miller teaches wherein the working channel extension is flexible and capable of angular adjustment by actuation of the endoscope (Figs. 5-7).
In regard to claim 24, Miller discloses a kit (10, 40) for use in a procedure on a patient, the kit comprising:
an endoscope (40) having an optical element and a working channel for receiving an instrument (Par. 47, Fig. 1); and
a main body (12) comprising a visualization section (24) for allowing viewing of tissue by the endoscope and a proximal end configured for attachment to a distal end portion of the endoscope (Fig. 1);
a passageway (34) within the main body having an open distal end and a proximal end in operational proximity to the working channel of the endoscope when the proximal end of the coupler device is attached to the distal end portion of the endoscope (the proximal end (34a) of the instrument channel (34) sealable connects to the working channel (42) of the endoscope, Fig. 4, Par. 49); and
and
wherein the coupler device is configured to constrain an instrument passing through the passageway (an instrument is constrained by the tubular walls which define the instrument channel).
Miller does not expressly teach wherein the open distal end comprises a substantially V-shaped groove for receiving the instrument.
Maseda teaches an analogous endoscope (Fig. 1) comprising a plurality of working channel configurations. The working channel can have a non-circular cross-section, such as a pentagon (50) or hexagonal shape (52) illustrated in Fig. 2. The first working channel (50), the instrument (14) inserted within the channel can have a complementary shape to the working channel (50) thereby forming a lock and key relationship in order to maintain a desired orientation of the instrument and prevent rotation of the instrument within the channel (Par. 27). The second working channel (52) has a hexagonal shape for receiving a circular instrument (62) such that fluid can pass through gaps between the circular instrument and the hexagonal shape of the working channel (Par. 23).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the cross-sectional shape of the working channel and working channel extension of Miller to be a pentagon or hexagonal shape as taught by Maseda thereby enabling instruments having complimentary shapes to the pentagon or hexagonal shaped working channel to form a lock and key configuration enabling a surgeon to maintain an orientation of the instruments. Additionally, circular instruments can be inserted through the pentagon or hexagonal shaped working channel thereby forming gaps between the instrument and the working channel allowing fluids to pass therethrough. There being no unexpected results modifying the circular cross-sectional shape of the working channel and working channel extension of Miller for the pentagon or hexagonal working channel shapes as taught by Miller.
In regard to claim 25, Miller teaches further comprising the instrument (100).
In regard to claim 26, Miller teaches wherein the instrument comprises a guidewire (Par. 13).
In regard to claim 27, Miller teaches wherein the coupler device is configured to secure the instrument in place (Par. 61).
In regard to claim 28, Miller teaches wherein the open distal end is oriented at an angle relative to the endoscope working channel, the coupler device being configured to secure the instrument into position at said angle (Par. 61).
In regard to claim 29, Miller teaches wherein the coupler device is configured to allow translational movement of the instrument while the instrument is secured at said angle (Figs. 5-7).
Response to Arguments
Applicant’s arguments with respect to claims 1, 3-5, 13, 15-17, 24-29 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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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.
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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 June 13, 2026
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