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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-11 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 1, claim 1 requires “wherein the hollow portion expands from the bottom side toward the opening.” It is unclear what “the bottom side” is referring to, as this could refer to a bottom portion of the bottomed cylinder, the hollow portion of the cylinder, or the elongated portion. For the purposes of examination this will be interpreted as “Wherein the hollow portion expands from the bottom side”
Claims 2-11 are rejected for their dependence on claim 1.
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.
Claim(s) 1, 4, 5, 7, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jensrud (US 20200323610 A1).
Regarding Claim 1, Jensrud discloses:
A removal tool for removing an adhering substance adhered to an inside of a channel of an endoscopic treatment tool, the removal tool comprising:
a bottomed cylindrical body (100) having an opening at one end (118); and
an elongated part (120) formed in a hollow portion (116) of the bottomed cylindrical body so as to extend from a bottom of the hollow portion toward an opening side of the hollow portion (See Fig. 1A, extends across 114), the elongated part being capable of inserting into the channel (See Para [0023] “The second portion 124 of the elongate member 120 may include a substantially constant outer dimension d.sub.2 (e.g., approximately 0.30 mm) configured to extend into (e.g., be received within) a fluid delivery lumen 418 of the ESD knife 400, including cutting element 416 (FIGS. 6A-6B).”) wherein the hollow portion expands from the bottom side toward the opening (See Annotated Fig. A below).
PNG
media_image1.png
676
876
media_image1.png
Greyscale
Annotated Figure A (Figure 1 of Jensrud)
Regarding Claim 4, Jensrud discloses all the limitations of claim 1 and in addition discloses wherein the hollow portion includes a tapered portion expanding continuously or stepwise from the bottom side toward the opening (See Annotated Figure A).
Regarding Claim 5, Jensrud discloses all the limitations of claim 1 and in addition discloses wherein the bottomed cylindrical body includes a constricted portion (113) formed in a cylindrical shape and having an outer diameter narrower at a central portion than at end portions in an axial direction of the bottomed cylindrical body (See dimples 113 in Fig. 1 which have a smaller outer diameter than the ends of the cylindrical body 110).
Regarding Claim 7, Jensrud discloses all the limitations of claim 1 and in addition discloses wherein an edge portion is formed on a side surface of the elongated part. (See raised portion on 120 in Fig. 4a and further see Para [0028] of Jensrud discussing different features that can be included on elongate member 120 including bumps and burrs).
Regarding Claim 9, Jensrud discloses all the limitations of claim 1 and in addition discloses wherein
the hollow portion has a circular cross section orthogonal to an axial direction of the bottomed cylindrical body (bottomed cylindrical body is cylindrically shaped, resulting in a circular cross section, Additionally, See Fig. 6A and 5A showing an isometric perspective of a similar embodiment), and
the elongated part is disposed in the hollow portion so as to pass through a center of the circular cross section and extend along the axial direction (See Figure 1a showing elongate port 120 extending through the center of the cylindrical body).
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) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Jensrud (US 20200323610 A1) in view of Wu (US 20170347864 A1)
Regarding Claim 2, Jensrud discloses all the limitations of claim 1 but does not explicitly disclose wherein a plurality of slits dividing a side surface of the bottomed cylindrical body into a plurality of portions are formed in a circumferential direction around an axis of the bottomed cylindrical body, and
when the endoscopic treatment tool is inserted into and pressed against the hollow portion, a portion of the bottomed cylindrical body located between the slits is elastically deformed, which causes the hollow portion to expand from the bottom side toward the opening.
However, Wu discloses an auxiliary device for an endoscope which comprises a plurality of slits (1203 1205 1207) dividing a side surface of a cylindrical body (12) into a plurality of portions (space between slits, see Fig. 1) formed in a circumferential direction around an axis of the cylindrical body (See Fig. 1).
It would be obvious to one of ordinary skill in the art before the effective filling date of the invention to modify the bottomed cylinder to have slits as doing will allow for the bottomed cylinder to elastically expand or contrast to accommodate different sized endoscopic tools, as Wu discloses that a device made of elastic material with slits can expand or contrast with external forces. See Para [0030] “In a preferable embodiment, for the damper 12, both the second distance D2 and the third distance D3 are one third of the first distance D1 and the damper 12 is elastic. In this condition, when the endoscopy auxiliary device 1 with the capsule endoscopy 2 passes through the patient's throat P1 and enters the patient's esophagus P3, the capsule endoscopy 2 can be clamped effectively. When the endoscopy auxiliary device 1 is pulled out through the patient's esophagus sphincter P2, the capsule endoscopy 2 can be dropped off and left inside the patient's body.”
Examiner notes that Jensrud as modified would additionally disclose when the endoscopic treatment tool is inserted into and pressed against the hollow portion, a portion of the bottomed cylindrical body located between the slits is elastically deformed, which causes the hollow portion to expand from the bottom side toward the opening (Jensrud as modified by Wu would be capable of being elastically deformed to allow the expansion or contraction of the hallow portion from the bottom side toward the opening).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Jensrud (US 20200323610 A1) in view of Garvey (US 20160278876 A1)
Regarding Claim 6, Jensrud discloses all the limitations of claim 1 but does not explicitly disclose wherein the bottomed cylindrical body is formed of a material through which light having at least a part of visible wavelength is capable of passing.
However, Garvey discloses a similar cleaning device for medical instruments which made of transparent materials (See Para [0023] “The upper and lower body portions 118, 120 can be made from opaque materials or transparent materials to enable viewing of internal aspects of the cleaning device 110 in use.”)
It would be obvious to one of ordinary skill in the art before the effective filling date of the invention to modify Jensrud as modified to be made of a material through which light having at least a part of visible wavelength is capable of passing as doing so would allow for a user to see the interior of the device while in use as advantageously suggested in Para [0023] of Garvey as cited above.
Claim(s) 8 are rejected under 35 U.S.C. 103 as being unpatentable over Jensrud (US 20200323610 A1) in view of Boyle (WO 2004098654 A2).
Regarding Claim 8, Jensrud discloses all the limitations of claim 1 but does not explicitly disclose wherein a distal end portion of the elongated part has a tapered shape.
However, Boyle discloses a similar cleaning device with an elongated member (26) with a distal end portion (46) with a tapered shape (see Fig. 6B).
It would be obvious to one of ordinary skill in the art before the effective filling date of the invention to modify the distal end portion of the elongated part as Boyle that a tapered shape is an enhanced surface for dislodging foreign material within a body (See Page 14 Lines 23-26 of Boyle “Figure 6B is a side view of a cleaning member 24a in accordance with an embodiment of the invention. The cleaning member 24a comprises a cleaning member distal end 26 comprising a cleaning member distal tip 46 adapted to provide an enhanced surface, such as, but not limited to, an abrasive or sharp surface, so as to assist in dislodging foreign material 19 within the body tube lumen 15.”).
Claim(s) 10, 12, 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Jensrud (US 20200323610 A1) in view of Bagwell (US 20170106128 A1).
Regarding Claim 10, Jensrud discloses all the limitations of claim 1 and in addition discloses
wherein the hollow portion has a circular cross section orthogonal to an axial direction of the bottomed cylindrical body (bottomed cylindrical body is cylindrically shaped, resulting in a circular cross section, Additionally, See Fig. 6A and 5A showing an isometric perspective of a similar embodiment), and
the elongated part is disposed in the hollow portion (See Figure 1a showing elongate port 120 extending through the center of the cylindrical body) but does not disclose the elongated part is disposed in the hollow portion so as to pass through a position deviated from a center of the circular cross section and extend along the axial direction. However, Bagwell discloses a similar device for removing debris from a tubular member, including, including an elongated part (126, See Fig. 3b), disposed in a hollow portion of a cylindrical body (120) so as to pass through a position deviated from a center of the circular cross section of the cylindrical body (See Fig. 3b) and extend along the axial direction (See Fig. 3b).
It would be obvious to one of ordinary skill in the art before the effective filling date of the invention to modify the Jensrud such that the elongated part is disposed in the hollow portion so as to pass through a position deviated from a center of the circular cross section and extend along the axial direction, as doing so would allow for a reciprocating motion to be applied to the elongated portion by the user rotating the bottomed cylinder in order to contact debris adhering to the tube to cleaned as advantageously described in Para [0048] of Bagwell “As depicted in FIGS. 2-4B, the clearing stem 120 also includes an irrigation conduit 125 having an irrigation lumen 126 therein. The irrigation conduit 125 is at least partially disposed within the aspiration lumen 122 of the clearing stem 120, and provides irrigant 127 to the distal end of the clearing stem 120.” And additionally, as Jensrud discloses in Para [0028] “By way of non-limiting example, a helical groove may extend along all or a portion of the elongate member (FIG. 4A). In addition, or alternatively, all or a portion of the elongate member may include a helical twist, e.g., with a solid flattened profile. In various additional embodiments, the elongate member may include a variety of additional surface features (e.g., bumps, burrs, filaments, brushes, recessed portions, etc.) to break-up and/or remove debris from within the fluid delivery lumen of an ESD knife. In various additional embodiments, a channel or lumen (not shown) may extend through all or a portion of the elongate member 120, 320.” Elements that would be eccentric to center as they would extend off of the elongate member perpendicular to the extension direction of the elongate member, and such elements would assist in the cleaning process.
Regarding Claim 12, Jensrud discloses:
A removal tool for removing an adhering substance adhered to an inside of a channel of an endoscopic treatment tool, the removal tool comprising:
a bottomed cylindrical body (100) having an opening at one end (118); and
an elongated part (120) formed in a hollow portion (116) of the bottomed cylindrical body (See Fig. 1a) so as to extend from a bottom of the hollow portion toward an opening side of the hollow portion (See Fig. 1a), the elongated part being capable of inserting into the channel (See Para [0023] “The second portion 124 of the elongate member 120 may include a substantially constant outer dimension d.sub.2 (e.g., approximately 0.30 mm) configured to extend into (e.g., be received within) a fluid delivery lumen 418 of the ESD knife 400, including cutting element 416 (FIGS. 6A-6B).”), wherein
wherein the hollow portion has a circular cross section orthogonal to an axial direction of the bottomed cylindrical body (bottomed cylindrical body is cylindrically shaped, resulting in a circular cross section, Additionally, See Fig. 6A and 5A showing an isometric perspective of a similar embodiment), and
the elongated part is disposed in the hollow portion (See Figure 1a showing elongate port 120 extending through the center of the cylindrical body) but does not disclose the elongated part is disposed in the hollow portion so as to pass through a position deviated from a center of the circular cross section and extend along the axial direction.
However, Bagwell discloses a similar device for removing debris from a tubular member, including, including an elongated part (126, See Fig. 3b), disposed in a hollow portion of a cylindrical body (120) so as to pass through a position deviated from a center of the circular cross section of the cylindrical body (See Fig. 3b) and extend along the axial direction (See Fig. 3b).
It would be obvious to one of ordinary skill in the art before the effective filling date of the invention to modify the Jensrud such that the elongated part is disposed in the hollow portion so as to pass through a position deviated from a center of the circular cross section and extend along the axial direction, as doing so would allow for a reciprocating motion to be applied to the elongated portion by the user rotating the bottomed cylinder in order to contact debris adhering to the tube to cleaned as advantageously described in Para [0048] of Bagwell “As depicted in FIGS. 2-4B, the clearing stem 120 also includes an irrigation conduit 125 having an irrigation lumen 126 therein. The irrigation conduit 125 is at least partially disposed within the aspiration lumen 122 of the clearing stem 120, and provides irrigant 127 to the distal end of the clearing stem 120.” And additionally, as Jensrud discloses in Para [0028] “By way of non-limiting example, a helical groove may extend along all or a portion of the elongate member (FIG. 4A). In addition, or alternatively, all or a portion of the elongate member may include a helical twist, e.g., with a solid flattened profile. In various additional embodiments, the elongate member may include a variety of additional surface features (e.g., bumps, burrs, filaments, brushes, recessed portions, etc.) to break-up and/or remove debris from within the fluid delivery lumen of an ESD knife. In various additional embodiments, a channel or lumen (not shown) may extend through all or a portion of the elongate member 120, 320.” Elements that would be eccentric to center as they would extend off of the elongate member perpendicular to the extension direction of the elongate member, and such elements would assist in the cleaning process.
Regarding Claim 13, Jensrud as modified discloses all the limitations of claim 12 and in addition discloses wherein the bottomed cylindrical body (100) includes a constricted portion (113) formed in a cylindrical shape (See Fig. 1) and having an outer diameter narrower at a central portion than at end portions in an axial direction of the bottomed cylindrical body (recessed portions 113 has a smaller outer diameter than the end portions of cylindrical body 100).
Regarding Claim 15, Jensrud as modified discloses all the limitations of claim 12 and in addition discloses wherein an edge portion is formed on a side surface of the elongated part (See raised portion on 120 in Fig. 4a and further see Para [0028] of Jensrud discussing different features that can be included on elongate member 120 including bumps and burrs).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Jensrud (US 20200323610 A1) in view of Frey (US 20200375692 A1).
Regarding Claim 11, Jensrud discloses
A removal system comprising:
The removal tool according to claim 1 (See Rejection of claim 1 above)
An endoscopic treatment tool (ESD knife 400) to be inserted into the removal tool, wherein
But does not explicitly disclose An indicator indicating an amount of the endoscopic treatment tool to be inserted into the removal tool is marked on the endoscopic treatment tool.
However, Jensrud does disclose a length (L3) that the endoscopic tool is to be inserted into the removal tool.
Frey discloses a tool for cleaning surgical devices that has a physical protrusion (106) to provide a tactile indication for the for the depth the tool is meant to be inserted (See Para [0116] “The purpose of the physical obstruction 106 is to provide a tactile indication to the user that the instrument has been inserted to the maximum allowable depth in the housing. In other words, as the instrument is inserted, eventually the distal end of the instrument will impinge against the physical obstruction 106, thus preventing further insertion of the instrument”).
It would be obvious to one of ordinary skill in the art before the effective filling date of the invention to mark the endoscopic treatment to indicate the maximum degree the tool can be inserted to prevent the user from damaging the treatment tool or removal tool.
Claim(s) 14 are rejected under 35 U.S.C. 103 as being unpatentable over Jensrud (US 20200323610 A1) in view of Harr (US 20170203338 A1) as modified in claim 12 and in further view of Garvey (US 20160278876 A1).
Regarding Claim 14, Jensrud as modified discloses all the limitations of claim 12 and in addition discloses wherein the bottomed cylindrical body is formed of a material through which light having at least a part of visible wavelength is capable of passing.
However, Garvey discloses a similar cleaning device for medical instruments which made of transparent materials (See Para [0023] “The upper and lower body portions 118, 120 can be made from opaque materials or transparent materials to enable viewing of internal aspects of the cleaning device 110 in use.”)
It would be obvious to one of ordinary skill in the art before the effective filling date of the invention to modify Jensrud as modified to be made of a material through which light having at least a part of visible wavelength is capable of passing as doing so would allow for a user to see the interior of the device while in use as advantageously suggested in Para [0023] of Garvey as cited above.
Claim(s) 16 are rejected under 35 U.S.C. 103 as being unpatentable over Jensrud (US 20200323610 A1) in view of Harr (US 20170203338 A1) as modified in claim 12 and in further view of Boyle (WO 2004098654 A2).
Regarding Claim 16, Jensrud as modified discloses all the limitations of claim 12 but does not explicitly disclose wherein a distal end portion of the elongated part has a tapered shape.
However, Boyle discloses a similar cleaning device with an elongated member (26) with a distal end portion (46) with a tapered shape (see Fig. 6B).
It would be obvious to one of ordinary skill in the art before the effective filling date of the invention to modify the distal end portion of the elongated part as Boyle that a tapered shape is an enhanced surface for dislodging foreign material within a body (See Page 14 Lines 23-26 of Boyle “Figure 6B is a side view of a cleaning member 24a in accordance with an embodiment of the invention. The cleaning member 24a comprises a cleaning member distal end 26 comprising a cleaning member distal tip 46 adapted to provide an enhanced surface, such as, but not hmited to, an abrasive or sharp surface, so as to assist in dislodging foreign material 19 within the body tube lumen 15.”).
Allowable Subject Matter
Claim 3 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.
Jensrud as modified discloses all the limitations of claim 2 but does not explicitly disclose further comprising an exterior part holding the bottomed cylindrical body, wherein
The bottomed cylindrical body has higher pliability than the exterior part.
The claim is neither anticipated nor rendered obvious by the prior art, as it is not disclosed, nor suggested in the prior art. It would not be obvious to one of ordinary skill in the art to modify Jensrud to include an exterior holding part holding the bottomed cylindrical body, as doing so would disrupt the construction of the holding portions (113) of the outer cylindrical body of 110.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tyler James McFarland whose telephone number is (571)272-7270. The examiner can normally be reached M-F 7:30AM-5PM (E.S.T), Flex First Friday.
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, David Posigian can be reached at (313) 446-6546. 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.
/T.J.M./Examiner, Art Unit 3723
/DAVID S POSIGIAN/Supervisory Patent Examiner, Art Unit 3723
Prosecution Insights