DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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 Objections
3. Claim 3 is objected to because of the following informalities: line 3 recites “an rotation”. This should recite “a rotation”. Appropriate correction is required.
4. Claim 15 is objected to because of the following informalities: line 1 recites “an treatment tool”. This should recite “a treatment tool”. Appropriate correction is required.
5. Claim 15 is objected to because of the following informalities: line 8 recites the misspelled word “comprising”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 6 and 9 are 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.
8. Claim 6 recites the limitation "the second deformation part" in lines 3 and 5. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of a second deformation part in Claim 6 or Claim 4, which Claim 6 depends from. This renders the claim indefinite. Proper correction is required. For examination purposes, “a first deformation part” will be interpreted as “a second deformation part”.
9. Claim 9 recites the limitation "the first pressing member" in line 3. There is insufficient antecedent basis for this limitation in the claim. There is no recitation of a first pressing member in Claim 9 or Claim 4, which Claim 6 depends from. This renders the claim indefinite. Proper correction is required. For examination purposes, “the first pressing member” will be interpreted as “the second pressing member”.
Claim Rejections - 35 USC § 103
10. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
11. Claims 1, 2, 7, 10, 11, 12, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over multiple embodiments of Griego U.S. 2002/0095168 (herein referred to as “Griego”).
12. Regarding Claim 1, Griego teaches an endoscopic treatment tool (Fig. 1) comprising:
a. a sheath (Fig. 1, ref num 101) having a lumen (see Fig. 2), and extending in a longitudinal direction (see Fig. 1)
b. a treatment part disposed distally relative to the sheath (Fig. 1, ref num 105);
c. an operation part (Fig. 1, ref num 111) disposed proximally relative to the sheath (see Fig. 1), the sheath being mounted on the operation part (para 0037, “a portion of handle 111 attached to proximal end 103”) so as to be rotatable in a circumferential direction (para 0019, “Reciprocation of the cable causes rotation of at least a distal portion of the catheter to orient the cutting device”; para 0057, “effective rotation of the catheter distal end 104”); and
d. a wire inserted through the lumen (Fig. 9, ref num 901 through lumen, ref num 201), mounted on the treatment part (para 0054, “while distal end 905 of positioning device 900 is located in the distal portion 105 (not shown)…”) and supported by the operation part (para 0055, “Cable assembly 901 is connected at its proximal end (not shown) to the distal end of handle 111”) so as to advance and retract in the longitudinal direction (para 0055, “introduces reciprocal motion in the proximal portion of the cable assembly 901”) and rotatable in the circumferential direction (para 0056, “rotational cable movement in direction 907”).
This embodiment of Griego fails to teach (e) the operation part has a locking mechanism configured to restrict the advancement and retract of the wire in the longitudinal direction.
However, another embodiment of Griego (Fig. 10), teaches the operation part (Fig. 10, ref num 1002, para 0059) has a locking mechanism (Fig. 10, ref num 1008) configured to restrict the advancement and retract of the wire in the longitudinal direction (para 0060, “The stabilizing element 1008 is part of or fixed to the lumen wall and uses this attachment to prevent the needle knife 1002 from being pushed back into the lumen”). Since Griego teaches that the embodiments may be combinable as they produce the same expected result (para 0069), then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first embodiment of Griego with the second in order to have a locking mechanism to restrict the translation of the wire in the longitudinal direction.
13. Regarding Claim 2, Griego teaches the treatment path has a first through hole and a second through hole that communicate with the lumen (Fig. 3, ref num 303 and 304), and the wire is inserted through the first through hole and the second through hole and exposed to an outside of the sheath (Fig. 3, ref num 305; para 0040, “Spaced skived ports 303 and 304 allow active portion 305 of the cutting wire 113 to emerge from catheter 101 through skived aperture 303”).
14. Regarding Claim 7, the first embodiment of Griego fails to teach the locking mechanism comprises a ring member configured to contact with the wire provided on the main body.
However, in another embodiment of Griego (Figs. 10 and 11B), the locking mechanism takes a ring-like shape (see Fig. 11B, ref num 1008) which contacts the wire (para 0060, “stabilizing element 1008 are attached to needle knife wire 100[2]”). The locking mechanism is also provided on the main body (para 0061, “When the sliding mechanism of handle 1004 which is attached to needle knife wire 1003 reciprocates, needle knife wire 1003 also reciprocates. As needle knife wire 1003 reciprocates, threaded needle knife wire 1003 rotates through stabilizing element 1008 and needle knife 1002 advances out of or retracts into lumen 1001. The sliding mechanism of handle 1004 can be locked when needle knife 1002 is deployed to its desired length”). Therefore, the ring member being provided in the main body would only require a rearrangement of parts, which involves only routine skill in the art (In re Japikse, 86 USPQ 70). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified one embodiment of Griego with another in order for the locking mechanism to comprise a ring, since embodiments of Griego are combinable, as well as provide the feature of restricting the translation of the wire in the longitudinal direction.
15. Regarding Claim 10, Griego teaches a marker is provided at a portion of the sheath in the circumferential direction in which the first through hole and the second throughout hole are provided (para 0044, “Fluoroscopy allows the appropriate positioning by utilizing a series of radio-opaque markers 406 at distal portion 105 that may include clamp 302 and reinforcing sleeve 306”; it is understood that the distal portion, ref num 105, has the first and second through holes provided therein).
16. Regarding Claim 11, Griego as modified teaches an endoscopic treatment system (Fig. 1) comprising: the endoscopic treatment tool according to claim 1 (see Claim 1 rejection above); and an endoscope (para 0062, “In operation distal end 104 of device 100 is advanced through the endoscope to the target area”).
17. Regarding Claim 12, Griego teaches the operation part comprising a main body (see Fig. 1, ref num 111) comprises a tapered portion tapered proximally (Fig. 1, ref num 31) and a stopper located proximally relative to the tapered portion (Fig. 1, ref num 115).
18. Regarding Claim 15, Griego teaches a treatment tool (Fig. 1) comprising:
a. a sheath (Fig. 1, ref num 101) having a lumen (see Fig. 2), and extending in a longitudinal direction (see Fig. 1)
b. a treatment part disposed distally relative to the sheath (Fig. 1, ref num 105);
c. a wire inserted through the lumen (Fig. 9, ref num 901 through lumen, ref num 201) and mounted on the treatment part (para 0054, “while distal end 905 of positioning device 900 is located in the distal portion 105 (not shown)…”), the wire being rotatable in a circumferential direction (para 0056, “rotational cable movement in direction 907”); and
d. an operation part (Fig. 1, ref num 111) disposed proximally relative to the sheath (see Fig. 1), the sheath being rotatable in the circumferential direction (para 0019, “Reciprocation of the cable causes rotation of at least a distal portion of the catheter to orient the cutting device”; para 0057, “effective rotation of the catheter distal end 104”); the operation part configured to move the wire in the longitudinal direction (para 0055, “introduces reciprocal motion in the proximal portion of the cable assembly 901”).
This embodiment of Griego fails to teach the operation part comprising a surface configured to restrict the movement of the wire in the longitudinal direction.
However, another embodiment of Griego (Fig. 10), teaches the operation part (Fig. 10, ref num 1002, para 0059) has a surface (Fig. 10, ref num 1008) configured to restrict the advancement and retract of the wire in the longitudinal direction (para 0060, “The stabilizing element 1008 is part of or fixed to the lumen wall and uses this attachment to prevent the needle knife 1002 from being pushed back into the lumen”). Since Griego teaches that the embodiments may be combinable as they produce the same expected result (para 0069), then it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first embodiment of Griego with the second in order to have a surface to restrict the translation of the wire in the longitudinal direction.
19. Regarding Claim 19, Griego fails to teach the operation part comprises an o-ring having the surface. However, Griego teaches the surface is a stabilizing element (Fig. 10, ref num 1009; para 0059-0060), and it is well known in the art that an o-ring provides structural and mechanical stabilizing properties. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Griego to have an o-ring in order to provide the same expected result of restricting movement of the wire.
20. Claims 3, 4, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Griego and in view of Hutchins U.S. 2003/0036768 (herein referred to as “Hutchins”).
21. Regarding Claim 3, Griego fails to teach the sheath is configured to rotate in the circumferential direction in response to a rotation of the wire in the circumferential direction.
Hutchins teaches a tool of analogous art (Fig. 1), wherein the sheath is configured to rotate in the circumferential direction in response to a rotation of the wire in the circumferential direction (para 0024, “The rotation of the handle causes the distal portion of the catheter to rotate”). This produces the same expected result of positioning the distal end at the target site by rotating (para 0024, 0100). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Griego to have the sheath rotate to produce the same expected result of rotating the distal end of the device.
22. Regarding Claim 4, Griego teaches the operation part comprising: a main body mounted on a proximal end of the sheath (Fig. 1, ref num 115), a handle connected to the main body (Fig. 1, ref num 111).
Griego fails to teach the handle is rotatable in the circumferential direction and a slider connected to the handle so as to advance and retract in the longitudinal direction, wherein the wire is connected to a connector provided on the slider.
Hutchins teaches an endoscopic treatment tool (Fig. 1) having an operation part (Fig. 9, ref num 111) that comprises a handle being rotatable in the circumferential direction (para 0100, “handle 111 to which cutting wire 113 is attached is freely rotatable relative to catheter 101”). The handle also comprises a connector having a wedge shape (Fig. 9, ref num 901). There is also a slider connected to the handle (Fig. 1, ref num 115) so as to advance and retract in the longitudinal direction (para 0091), wherein the wire is connected to a connector provided on the slider (para 0091, “Central member 115 extends through and slides with respect to body section 117 having opposed finger rings 118. Central member 115 also attaches to catheter 101, at catheter hub assembly 122 and is therefore an extension of catheter 101. Body section 117 additionally includes internal connector 119 for clamping proximal end 114 of cutting wire 113”). The handle being rotatable causes the wire to also rotate (para 0100). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Griego to have the handle rotatable, as this produces the same expected result of rotating and translating the wire as desired.
23. Regarding Claim 13, Griego teaches the operation part comprises a main body mounted on a proximal end of the sheath (see Fig. 1, ref num 111) and a handle connected to the main body (Fig. 1, ref num 111 is a handle)
Griego fails to teach the handle being rotatable in the circumferential direction, the handle comprising a connector having a wedge shape.
Hutchins teaches an endoscopic treatment tool (Fig. 1) having an operation part (Fig. 9, ref num 111) that comprises a handle being rotatable in the circumferential direction (para 0100, “handle 111 to which cutting wire 113 is attached is freely rotatable relative to catheter 101”). The handle also comprises a connector having a wedge shape (Fig. 9, ref num 901). The handle being rotatable causes the wire to also rotate (para 0100). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Griego to have the handle rotatable, as this produces the same expected result of rotating the wire.
24. Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Griego and in view of Ouchi U.S. 6,423,060 (herein referred to as “Ouchi”).
25. Regarding Claim 8, Griego fails to teach the locking mechanism comprises a first pressing member provided on the slider, and the first pressing member is configured to fix a position of the slider with respect to the handle.
Ouchi teaches an endoscopic tool of analogous art (Fig. 1), wherein the tool comprising a locking mechanism (Fig. 1, ref num 22) comprising a first pressing member on a slider (Fig. 1, ref num 14 = slider, ref num 22 = pressing member), such that the first pressing member is configured to fix a position of the slider with respect to the handle (Fig. 1, ref num 13 = handle; Col. 3, lines 66-67 – Coo. 4, lines 1-16, “lock/unlock button 22 is used to lock and unlock the stopper 7a of the rod 7 with respect to the slider 14. The lock/unlock button 22 has a slide plate 23 connected to the axial center of the lock/unlock button 22. The slide plate 23 has a slit 24 barely wide enough for the stopper 7a of the rod 7 to pass. The lock/unlock button 22 is urged outward by a compression coil spring 25. Pressing in the lock/unlock button 22 against the urging force of the compression coil spring 25 causes the slide plate 23 to be set in a position where the stopper 7a can pass through the slit 24. Thus, the proximal end of the rod 7 can be engaged with or disengaged from the slider 14. On release of the lock/unlock button 22, the rod 7 is set in a narrow portion 24a of the slit 24, where the stopper 7a cannot pass through the slit 24, by the urging force of the compression coil spring 25. Thus, the proximal end of the rod 7 is locked to the slider 14”). This controls whether the wire is translated longitudinally (Col. 5, lines 1-16). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Griego to have a first pressing member configured to fix a position of the slider with respect to the handle, as this produces the same expected result of controlling the movement of the wire.
26. Regarding Claim 9, Griego fails to teach the locking mechanism comprises a second pressing member provided on the slider, and the first pressing member is configured to fix a position of the slider with respect to the handle.
Ouchi teaches an endoscopic tool of analogous art (Fig. 1), wherein the tool comprising a locking mechanism (Fig. 1, ref num 22) comprising a pressing member on a slider (Fig. 1, ref num 14 = slider, ref num 22 = pressing member), such that the first pressing member is configured to fix a position of the slider with respect to the handle (Fig. 1, ref num 13 = handle; Col. 3, lines 66-67 – Coo. 4, lines 1-16, “lock/unlock button 22 is used to lock and unlock the stopper 7a of the rod 7 with respect to the slider 14. The lock/unlock button 22 has a slide plate 23 connected to the axial center of the lock/unlock button 22. The slide plate 23 has a slit 24 barely wide enough for the stopper 7a of the rod 7 to pass. The lock/unlock button 22 is urged outward by a compression coil spring 25. Pressing in the lock/unlock button 22 against the urging force of the compression coil spring 25 causes the slide plate 23 to be set in a position where the stopper 7a can pass through the slit 24. Thus, the proximal end of the rod 7 can be engaged with or disengaged from the slider 14. On release of the lock/unlock button 22, the rod 7 is set in a narrow portion 24a of the slit 24, where the stopper 7a cannot pass through the slit 24, by the urging force of the compression coil spring 25. Thus, the proximal end of the rod 7 is locked to the slider 14”). This controls whether the wire is translated longitudinally (Col. 5, lines 1-16). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Griego to have a first pressing member configured to fix a position of the slider with respect to the handle, as this produces the same expected result of controlling the movement of the wire.
27. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Griego and in view of Yanuma U.S. 2015/0342633 (herein referred to as “Yanuma”).
28. Regarding Claim 20, Griego fails to teach the operation part comprises a lever having the surface configured to press the wire.
Yanuma teaches a tool of analogous art (Fig. 1), wherein the tool has an operation part (Fig. 1, ref num 70) comprising a lever having a surface configured to press the wire (Fig. 1, ref num 72; para 0073). This controls whether the wire is advanced or retracted (para 0073). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Griego to have a lever comprising the surface in order to control the translation of the wire.
Allowable Subject Matter
29. Claims 5, 6, 14, and 16-18 contain allowable subject matter. The following is a statement of reasons for the indication of allowable subject matter: the prior art of record fails to specifically teach the locking mechanism comprising a deformation part provided on the main body that is configured to be deformed inward in a radial direction when the main body and the handle move closer to each other and the deformation part is configured to contact the wire to restrict the advancement and retract of the wire. The prior art also fails to provide sufficient motivation to make such specific modifications and would require improper use of hindsight to arrive at the claimed invention when considered along or in any proper combination.
30. Claims 5, 6, 14, and 16-18 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
31. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
Prosecution Insights