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 .
Response to Amendment
The Amendment filed February 3rd, 2026 has been entered. Claims 1, 4, 8, 10- 11, 14, 19 and 20 have been amended. Claims 3, 5, 9, and 16-18 have been cancelled. Claims 21-26 have been newly added. Claims 1-2, 4, 6-8, 10-15 and 19-26 are now pending in the application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-16, 19-20 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.
Examiner’s Comments
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4, 6-8, 11-15, 19-26 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Komi (US 5855569 A).
Regarding Claim 1, Komi discloses
A medical device (endoscope, FIG. 2), comprising:
a handle (1, FIG. 2) including a port (instrument entrance 8, FIG. 2);
a shaft (endoscopic insertion rod 2, FIG. 2) extending distally from the handle (depicted in FIG. 2),
wherein the shaft includes a channel (biopsy channel 4, FIG. 6) extending along at least a portion of a length of the shaft (depicted in FIG. 6),
wherein the shaft includes an abutment (rigid end passage ring 5, FIG. 5) outlining a distal opening of the channel (depicted in FIG. 5),
wherein the abutment includes a projection that extends inward along a perimeter of the channel and reduces a perimeter of the distal opening relative to more proximal portions of the channel (depicted in FIG. 5);
wherein the channel includes a longitudinal opening on a radially outer surface of the shaft (Col. 50-51 disclose biopsy channel is opening on distal end and/or lateral side, as depicted in FIG. 5); and
a removable portion (guide tube 21, FIG. 1) extending through the channel (depicted in FIGS. 2,6),
wherein the removable portion includes a first lumen (axial flow passages 31, FIGS. 3-4), and
wherein the removable portion is configured to be separated from the handle and the shaft (FIGS. 1-2, Col. 4, Ln. 60-62 disclose guide tube is detachably inserted into the instrument entrance).
Regarding Claim 2, Komi discloses
The medical device of claim 1, wherein the channel of the shaft is off center from a central longitudinal axis of the shaft (depicted in FIGS. 4-5).
Regarding Claim 4, Komi discloses
The medical device of claim 1, wherein the longitudinal opening of channel includes a notch, a groove, or a slit (flexible passage 6 + connector pipe 7, FIG. 5) extending along an entire length of the shaft (FIG. 5, Col. 50-51 disclose flexible passage extends through entrance of biopsy channel to distal end).
Regarding Claim 6, Komi discloses
The medical device of claim 1, wherein the removable portion includes a second lumen (axial flow passages 31, FIGS. 3-4).
Regarding Claim 7, Komi discloses
The medical device of claim 1, wherein the removable portion consists of the first lumen and a second lumen (axial flow passages 31, FIGS. 3-4).
Regarding Claim 8, Komi discloses
The medical device of claim 1,
wherein the removable portion includes a proximal adapter (connector head member 22, FIG. 2),
wherein the proximal adapter includes a first port (connector pipe member 26 + first chamber 32, FIG. 3) in fluid communication with the first lumen of the removable portion (Col. 5, Ln. 50-51 disclose flow passages in communication with first chamber, i.e. fluid communication; Col. 6, Ln. 7-10 disclose fluid means connected to flow passages via connector pipe member through the first and second chambers).
Regarding Claim 11, Komi discloses
The medical device of claim 8, wherein the proximal adapter is a y-shaped adapter including the first port of the proximal adapter and a second port (check valve member 27 + slit valve portion 27a, FIG. 3) of the proximal adapter (depicted in FIGS. 2-3).
Regarding Claim 12, Komi discloses
The medical device of claim 1, wherein the first lumen includes an elevator (annular flexible bag 36, FIGS. 5-6) configured to adjust an orientation of a tool or instrument inserted within the first lumen (Col. 5 Ln. 63-65 disclose flexible bag connected with flow passages, Col. 6, Ln. 1-5 disclose flexible bag expands to adjust orientation of a tool or instrument, Col. 6, Ln. 7-10 disclose fluid supplier, i.e. tool or instrument, connected to flow passages, i.e. flexible bag capable of adjusting orientation of fluid supplier extending through flow passage).
Regarding Claim 13, Komi discloses
The medical device of claim 1, wherein the removable portion comprises a substantially teardrop-shaped cross-section (depicted in FIG. 4).
Regarding Claim 14, Komi discloses
The medical device of claim 1,
wherein the removable portion includes a second lumen (axial flow passages 31, FIGS. 3-4), and
wherein only the removable portion is configured to receive fluid via one or more of the first lumen and the second lumen (Col. 6, Ln. 15-17 disclose axial flow passages are fluid supply passages for the guide tube).
Regarding Claim 15, Komi discloses
The medical device of claim 1,
wherein the removable portion is configured to be completely removed from the handle and the shaft by pulling the removable portion proximally from the port of the handle (FIGS. 5-6, Col. 5, Ln. 63-64 disclose flexible bag is attached to guide tube, FIGS. 1-2, Col. 4, Ln. 60-62 disclose guide tube is detachable from the instrument entrance, i.e. guide tube and liner would be detached together).
Regarding Claim 19, Komi discloses
A medical device (endoscope, FIG. 2), comprising:
a handle (1, FIG. 2) including a port (instrument entrance 8, FIG. 2);
a shaft (endoscopic insertion rod 2, FIG. 2) extending distally from the handle (depicted in FIG. 2),
wherein the shaft includes a channel (biopsy channel 4, FIG. 6) extending along at least a portion of a length of the shaft (depicted in FIG. 6); and
a removable portion (guide tube 21, FIG. 1) extending throughout the channel (depicted in FIGS. 2, 6),
wherein the removable portion includes at least one lumen (axial flow passages 31, FIGS. 3-4), and
wherein the removable portion is configured to be removed from the handle and the shaft via the port (FIGS. 1-2, Col. 4, Ln. 60-62 disclose guide tube is detachably inserted into the instrument entrance); and
a liner (annular flexible bag 36, FIG. 5) positioned between the channel and the removable portion (FIGS. 5-6, Col. 5, Ln. 63-64 disclose flexible bag is attached to guide tube, i.e. between guide tube and channel),
wherein the liner spans a portion of an outer surface of the removable portion (depicted in FIGS. 5-6),
wherein the liner is configured to transition between a deflated state and an inflated state (Col. 5 Ln. 65- Col. 6, Ln. 4 disclose flexible bag can transition between deflated and inflated state).
Regarding Claim 20, Komi discloses
The medical device of claim 19,
wherein the liner extends along a majority of the length of the removable portion (Col. 6, Ln. 63-65 disclose the length of the flexible bad can be adjusted based on the required task, i.e. capable of spanning majority of length of guide tube),
wherein the removable portion and the liner are configured to be completely removed from the handle and the shaft by pulling the removable portion proximally from the port of the handle (FIGS. 5-6, Col. 5, Ln. 63-64 disclose flexible bag is attached to guide tube, FIGS. 1-2, Col. 4, Ln. 60-62 disclose guide tube is detachable from the instrument entrance, i.e. guide tube and liner would be detached together).
Regarding Claim 21, Komi discloses
The medical device of claim 19,
wherein the shaft includes a distal end (distal end section 2a, FIG. 5),
wherein the distal end includes an abutment (rigid end passage ring 5, FIG. 5) outlining a distal opening of the channel (depicted in FIG. 5), and
wherein the abutment is configured to inhibit distal translation of the removable portion past the distal end (FIG. 5, Col. 6, Ln. 45-48 disclose guide tube is inhibited from extending past rigid end passage ring and is incapable of being located outward of the end passage).
Regarding Claim 22, Komi discloses
The medical device of claim 1, wherein the projection reduces the perimeter of the distal opening relative to a cross-sectional perimeter of the removable portion (depicted in FIG. 5).
Regarding Claim 23, Komi discloses
The medical device of claim 1, further comprising
a liner (annular flexible bag 36, FIG. 5) positioned between the channel and the removable portion (FIGS. 5-6, Col. 5, Ln. 63-64 disclose flexible bag is attached to guide tube, i.e. between guide tube and channel),
wherein the liner is configured to inflate (Col. 5 Ln. 65- Col. 6, Ln. 4 disclose flexible bag can transition between deflated and inflated state),
thereby increasing pressure between a surface of the channel and the liner (Col. 5 Ln. 65- Col. 6, Ln. 16 disclose expansion of flexible bag, via fluid pressure, anchors it within biopsy channel, i.e. creating pressure between channel and flexible bag; Col. 7, Ln. 23-26 disclose the expanded flexible bag is pressed against an inner surface of biopsy channel).
Regarding Claim 24, Komi discloses
A medical device (endoscope, FIG. 2), comprising:
a handle (1, FIG. 2);
a shaft (endoscopic insertion rod 2, FIG. 2) extending distally from the handle (depicted in FIG. 2),
wherein the shaft includes a channel (biopsy channel 4, FIG. 6) extending along at least a portion of a length of the shaft (depicted in FIG. 6),
wherein the channel includes a longitudinal opening on an outer surface of the shaft (Col. 50-51 disclose biopsy channel is opening on distal end and/or lateral side, as depicted in FIG. 5),
wherein the shaft includes a projection (rigid end passage ring 5, FIG. 5) extending inward along a perimeter of a distal end of the channel relative to more proximal portions of the channel (depicted in FIG. 5);
an elongated portion (guide tube 21, FIG. 1) extending through the channel (depicted in FIGS. 2,6),
wherein the projection inhibits distal translation of the elongated portion past a distal end (distal end section 2a, FIG. 5) of the shaft (FIG. 5, Col. 6, Ln. 45-48 disclose guide tube is inhibited from extending past rigid end passage ring and is incapable of being located outward of the end passage); and
a liner (annular flexible bag 36, FIG. 5) positioned between the channel and the elongated portion (FIGS. 5-6, Col. 5, Ln. 63-64 disclose flexible bag is attached to guide tube, i.e. between guide tube and channel),
wherein the liner is configured to transition between a deflated state and an inflated state (Col. 5 Ln. 65- Col. 6, Ln. 4 disclose flexible bag can transition between deflated and inflated state).
Regarding Claim 25, Komi discloses
The medical device of claim 24, wherein the liner spans a portion of a perimeter of the elongated portion (depicted in FIGS. 5-6).
Regarding Claim 26, Komi discloses
The medical device of claim 24, wherein the projection reduces the perimeter of the distal opening relative to a cross-sectional perimeter of the elongated portion (depicted in FIG. 5).
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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Komi (US 5855569 A) as applied to claim 8 above, and further in view of Motai et al. (US 20080214890 A1, hereinafter Motai).
Regarding Claim 10, Komi discloses all of the elements of the current invention disclosed in claim 8, however, Komi does not disclose wherein the proximal adapter includes an actuator configured to release the proximal adapter from the port of the handle.
Motai teaches an analogous medical device (therapeutic system 1; FIG. 1) equipped with an overtube (11, i.e. handle) which includes a port (catheter-inserting port 52) where a catheter (12, i.e. removable portion) can be inserted through [FIG. 1, 0044]. The catheter (12) has a flexible tubular portion (12C, i.e. proximal adaptor) which interacts with the port (52) upon insertion, specifically with the base end portion (52B), where the adaptor (12C) initiates a locking mechanism between its protrusion (76, i.e. actuator) and with a groove (54A) in the base end portion (52B).
It would have been obvious to one of ordinary skill in the art at the effective filing date of
the invention to provide the proximal adaptor of Komi with the locking mechanism of Motai in order to provide a connection between the proximal adaptor of the removable portion and the port of the handle where upon rotation of the proximal adaptor, the removable portion can be locked and unlocked [0079] which can enable the removable portion to be locked in a given attitude which holds a predetermined relative positional relationship with the medical device (i.e. shaft of Komi) [0101].
Additionally, the invention of Komi would be capable of utilizing this feature by including a groove in the mount frame (8a) of the instrument entrance and a protrusion in the first tubular section (23, FIG. 3) of the connector head (Komi - Col. 5, Ln. 1-3 disclose mount frame detachably fitted onto first tubular section).
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 ABDUL HADI ABBASI whose telephone number is (571)272-4076. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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.
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/ABDUL HADI ABBASI/Examiner, Art Unit 3795
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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