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 June 30th, 2026 has been entered. Claims 10 and 18 have been amended. Claims 1-9, 14-15, 17 and 23 are cancelled. Claims 10-13, 16, 18-22 and 24-26 are now pending in the application, with claims 16 and 26 withdrawn. The previous drawing objection of claim 7 and the previous 35 U.S.C. 112(b) rejections of claims 15, 18 and 23 are withdrawn in light of Applicant's amendments and cancellations.
Response to Arguments
Applicant's arguments filed 06/30/2026 have been fully considered but they are not persuasive.
In response to arguments that Smith et al. (US 20130172918 A1) does not disclose “the
limitations as amended of claims 10 and 18” the examiner respectfully disagrees. As detailed below, the examiner has updated the rejection to provide more clarity and better reject the claims as amended. Moreover, the examiner recognizes the differences between the prior art and the invention as intended, as pointed out in applicant’s remarks, however, the examiner maintains that Smith anticipates the invention as claimed due to the broadness of the claim language, allowing for room for interpretation. Firstly, the language of “removably connected… in a repeatable position” is simply functional language as distinguished by “configured to be” preceding these limitations, therefore, the prior art invention simply needs to be capable of carrying out these functionalities and the ability of the prior art to detach and attach, as detailed below, is sufficient to be considered capable of carrying out the limited functions. Moreover, any language requiring disposition/ placement of features to be at a “predefined distance” can be interpreted very broadly since any set placement can be considered to be at a predefined distance; the language of “set sheath extension” is also very broad and can be interpreted in many ways. Furthermore, regarding the paragraphs used in the rejection below, par. 0053, 0057 and 0059 are used to describe variable channel placement in order to read on limitations regarding predefined distance since par. 50 discloses section accommodates an outer sheath of a resection device/ loop, and ledge of section stops the sheath from extending distally beyond its distal end, i.e. variable channel placement can vary the distance at which the outer sheath of the resection device is exiting the channel and being stopped by the ledge, therefore, they are directly connected, as better reflected in the updated rejection below.
Therefore, the examiner is maintaining the rejection under 35 U.S.C 102(a)(1) with Smith et al. (US 20130172918 A1).
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”. (See MPEP 2141.02(VI))
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) 10-13, 18-22, 24-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (US 20130172918 A1, hereinafter Smith).
Regarding Claim 10, Smith discloses
A sheath distance setting jig device (EMR cap assembly 100, FIG. 1A-1C) comprising:
a housing (inner cap 102 + outer cap 104, FIG. 1A) configured to be removably connectable to a distal end (distal end 504, FIG. 5) of a scope (elongate tube 502, FIG. 5) in a repeatable position relative to the distal end of the scope (par. 71 discloses elongate tube is an endoscope, par. 37, 82 disclose cap assembly may be detachably connected to distal end of endoscope, i.e. capable of being detached/ attached in a repeatable position/ manner); and
a sheath stop component (section 206, FIG. 2A-2B) configured to limit distal movement of a sheath received within the scope (par. 50 discloses section accommodates an outer sheath of a resection device/ loop, and a ledge of section stops the sheath from extending distally beyond its distal end),
wherein the sheath stop component includes a datum surface (ledge 210, FIG. 2B) disposed at a predefined distance from a working channel exit port of the scope (par. 79 discloses tube may include one or more channels such as a resection loop/ device channel; par. 53 discloses resection loop channel’s, i.e. overall section and ledge structure, placement may vary, par. 57 discloses angular displacement of sections may vary based on application, i.e. under consideration of endoscope channels),
wherein a normal vector of the datum surface is parallel to a longitudinal axis of the working channel exit port (Modified FIG. 5-1 below depicts the axis of the section (206 in FIGS. 2A-2B)/ ledge (210 in FIGS. 2A-2B) at the most tapered portion in blue and the subsequent normal vector in green, Modified FIG. 5-2 below depicts the longitudinal axis of the tube working channel, i.e. longitudinal axis of ramp, in red and the normal vector of the section/ ledge of the cap assembly in green, are parallel), and
wherein the predefined distance corresponds to a set sheath extension beyond the working channel exit port (par. 53 discloses resection loop channel’s, i.e. overall section and ledge structure, placement may vary, par. 57 discloses angular displacement of sections may vary based on application, i.e. capable of corresponding to a component (set sheath extension) provided beyond the channel exit).
PNG
media_image1.png
155
139
media_image1.png
Greyscale
Modified FIG. 5-1 (US 20130172918 A1)
PNG
media_image2.png
155
660
media_image2.png
Greyscale
Modified FIG. 5-2 (US 20130172918 A1)
Regarding Claim 11, Smith discloses
The device of Claim 10, wherein the housing is further configured to be slidably received over a transducer head (distal head of tube 504, FIG. 5) of the distal end of the scope (par. 82 discloses cap assembly may be detachably attached to distal end of tube using any known coupling technique, i.e. slidably fit).
Regarding Claim 12, Smith discloses
The device of Claim 11, wherein the housing comprises:
a frame (outer cap 104, FIG. 1A) configured to form a hollow passage (lumen 111); and
one or more tabs configured to protrude from the frame into the hollow passage (par. 66 discloses outer cap may include grooves, i.e. tabs, on its inner wall, i.e. protruding into the lumen).
Regarding Claim 13, Smith discloses
The device of Claim 12, wherein at least one of the frames or the one or more tabs are configured to snap fit onto the distal end of the scope (par. 66 discloses snap fitting of outer and inner caps allows for releasable connection to endoscope, par. 82 discloses snap-fitting coupling of cap assembly and distal end of endoscope).
Regarding Claim 18, Smith discloses
A sheath distance setting jig (EMR cap assembly 100, FIG. 1A-1C) for use with an endoscope (elongate tube 502, FIG. 5; par. 71 discloses elongate tube is an endoscope used with cap assembly), comprising:
a housing (inner cap 102 + outer cap 104, FIG. 1A) configured to be removably attachable to a distal end (distal end 504, FIG. 5) of the endoscope in a repeatable position relative to the distal end of the endoscope (par. 37, 82 disclose cap assembly may be detachably connected to distal end of endoscope, i.e. capable of being detached/ attached in a repeatable position/ manner);
a datum surface (section 206 + ledge 210, FIG. 2B) disposed within the housing and positioned to limit distal movement of a sheath advanced through a working channel of the endoscope to a predefined distance of extension of a distal end of the sheath out of a working channel exit port (par. 50 discloses section accommodates an outer sheath of a resection device/ loop, and ledge of section stops the sheath from extending distally beyond its distal end, i.e. distal end of sheath can only extend to a predefined distance; par. 79 discloses tube may include one or more channels such as a resection loop/ device channel; par. 53 discloses resection loop channel’s, i.e. overall section and ledge structure, placement may vary, par. 57 discloses angular displacement of sections may vary based on application, i.e. outer sheath accommodated by sections can be led out of endoscope channels),
wherein a normal vector of the datum surface is parallel to a longitudinal axis of the working channel exit port of the endoscope (Modified FIG. 5-1 below depicts the axis of the section (206 in FIGS. 2A-2B)/ ledge (210 in FIGS. 2A-2B) at the most tapered portion in blue and the subsequent normal vector in green, Modified FIG. 5-2 below depicts the longitudinal axis of the tube working channel, i.e. longitudinal axis of ramp, in red and the normal vector of the section/ ledge of the cap assembly in green, are parallel);
wherein the datum surface is located at a predefined distance from an exit port of the endoscope when the housing is attached to the distal end (par. 79 discloses tube may include one or more channels, i.e. exit port/ opening for each channel; par. 53 discloses resection loop channel’s, i.e. overall section and ledge structure, placement may vary, par. 57 discloses angular displacement of sections may vary based on application, i.e. under consideration of endoscope channels when scope is received),
wherein the predefined distance generates a fixed length of extension of the sheath beyond a distal end of the working channel exit port (par. 50 discloses section accommodates an outer sheath of a resection device/ loop, and ledge of section stops the sheath from extending distally beyond its distal end, i.e. fixed length of extension for the sheath).
PNG
media_image1.png
155
139
media_image1.png
Greyscale
Modified FIG. 5-1 (US 20130172918 A1)
PNG
media_image2.png
155
660
media_image2.png
Greyscale
Modified FIG. 5-2 (US 20130172918 A1)
Regarding Claim 19, Smith discloses
The jig of claim 18, wherein the housing comprises a hollow structure (Lumens 110+111, FIG. 1A) having a proximal opening (working channel 202, FIG. 2B) partially blocked by the datum surface (depicted in FIG. 2B).
Regarding Claim 20, Smith discloses
The jig of claim 18, wherein the housing is configured to mount over a transducer section (distal head of tube 504, FIG. 5) of the distal end of the endoscope (par. 82 discloses cap assembly may be detachably attached to distal end of tube using any known coupling technique).
Regarding Claim 21, Smith discloses
The jig of claim 20, further comprising one or more flexible tabs configured to snap fit onto the distal end of the endoscope to maintain the jig in a predetermined longitudinal position (par. 66 discloses outer cap may include grooves, i.e. tabs, on its inner wall, i.e. protruding into the lumen; par. 66 discloses snap fitting of outer and inner caps allows for releasable connection to endoscope and snap fitting the devices into place, i.e. in longitudinal position of endoscope as depicted in FIG. 5; FIG. 5, par. 82 disclose snap-fitting coupling of cap assembly and distal end of endoscope).
Regarding Claim 22, Smith discloses
The jig of claim 21, wherein the tabs are positioned such that, in a resting configuration, an internal dimension between the tabs is smaller than a cross-sectional width of the transducer section but larger than a cross-sectional dimension of a position proximal to the transducer section (FIG. 5 depicts cap assembly snap fitted onto distal head of endoscope, par. 66 discloses protrusions and grooves of inner and outer caps will snap fit to couple with distal head of endoscope, i.e. cross-section of distal head must be larger than that of the protrusions and grooves to require them to snap fit in order to be secured around the endoscope head; par. 66 further discloses the connection snap fits the endoscope and cap assembly in place, i.e. the cross-section of the protrusions and grooves must be large enough to keep the cap secured to the distal end).
Regarding Claim 24, Smith discloses
The jig of claim 18, wherein the housing is formed from a medical grade material selected from the group consisting of metals and plastics (par. 40 discloses inner and outer caps may be formed of metals, plastics or biocompatible material).
Regarding Claim 25, Smith discloses
The jig of claim 18, further comprising a cross-hatched frame (inner cap 102, FIG. 1A-1C) with a membrane formed over the frame (par. 66 discloses a membrane between the inner cap and outer cap).
Claim(s) 10 and 18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Harada (US 20230355079 A1, using foreign priority date).
Regarding Claim 10, Harada discloses
A sheath distance setting jig device (distal end part 14a, FIGS. 1-2) comprising:
a housing (distal end cap 32, FIG. 2) configured to be removably connectable to a distal end (distal end part main body 31, FIG. 2) of a scope (endoscope 10, FIG. 1) in a repeatable position relative to the distal end of the scope (FIGS. 2-3, par. 43 disclose distal end cap is attachably and detachable fitted onto the distal end part main body, i.e. in a repeatable position/ manner); and
a sheath stop component (elevator 39, FIGS. 2, 13-14) configured to limit distal movement of a sheath (treatment tool 13, FIGS. 13-14) received within the scope (FIGS. 13-14, par. 47 disclose elevator fixes the treatment tool in raised position by sandwiching it with distal end part main body),
wherein the sheath stop component includes a datum surface (treatment tool contact portion 38/ distal end part protrusion 51, FIGS. 13-14) disposed at a predefined distance from a working channel exit port (treatment tool outlet port 35, FIGS. 8A-8B) of the scope (depicted in FIGS. 13-14),
wherein a normal vector of the datum surface is parallel to a longitudinal axis of the working channel exit port (FIGS. 13-14 depict the treatment tool contact portion and distal end part protrusion are raised and lowered with elevator, i.e. normal vector is parallel to long axis at some elevation of at least one), and
wherein the predefined distance corresponds to a set sheath extension beyond the working channel exit port (depicted in FIGS. 13-14).
Regarding Claim 18, Harada discloses
A sheath distance setting jig (distal end part 14a, FIGS. 1-2) for use with an endoscope (endoscope 10, FIG. 1), comprising:
a housing (distal end cap 32, FIG. 2) configured to be removably attachable to a distal end of the endoscope in a repeatable position relative to the distal end of the endoscope (FIGS. 2-3, par. 43 disclose distal end cap is attachably and detachable fitted onto the distal end part main body, i.e. in a repeatable position/ manner);
a datum surface (elevator 39 + treatment tool contact portion 38/ distal end part protrusion 51, FIGS. 13-14) disposed within the housing and positioned to limit distal movement of a sheath (treatment tool 13, FIGS. 13-14) advanced through a working channel (insertion part treatment tool channel 14, FIG. 1) of the endoscope to a predefined distance of extension of a distal end of the sheath out of a working channel exit port (treatment tool outlet port 35, FIGS. 13-14, par. 47 disclose elevator fixes the treatment tool in raised position by sandwiching it with distal end part main body, i.e. fixed at a predefined distance of extension; par. 52 discloses treatment tool channel inside insertion part),
wherein a normal vector of the datum surface is parallel to a longitudinal axis of the working channel exit port of the endoscope (FIGS. 13-14 depict the treatment tool contact portion and distal end part protrusion are raised and lowered with elevator, i.e. normal vector is parallel to long axis at some elevation);
wherein the datum surface is located at a predefined distance from an exit port of the endoscope when the housing is attached to the distal end (depicted in FIGS. 2-3),
wherein the predefined distance generates a fixed length of extension of the sheath beyond a distal end of the working channel exit port (depicted in FIGS. 13-14).
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.
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.
/ABDUL HADI ABBASI/Examiner, Art Unit 3795
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
Prosecution Insights