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 .
Election/Restrictions
Applicant’s election without traverse of Group I; and species A and species C (Claims 1-5, 8-17 & 21) in the reply filed on October 20th, 2025 is acknowledged.
Claim Objections
Claims 1-5, 8-10, 12, 14-17 & 21 objected to because of the following informalities:
Claim 1, line 12: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 1, line 16: “the shaft portion” should read --the elongated shaft portion--,
Claim 1, lines 18-19: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 1, line 26: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 1, line 26: “the shaft portion” should read --the elongated shaft portion--,
Claim 1, line 29: “the shaft portion” should read --the elongated shaft portion--,
Claim 1, line 38: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 1, line 39: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 1, line 52: “is deformed” should read --is configured to be deformed--,
Claim 1, line 56: “is displaced” should read --is configured to be displaced--,
Claim 2, line 3: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 2, line 5: “changes” should read --is configured to change--,
Claim 2, lines 7-8: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 2, line 9: “is pressed” should read --is configured to be pressed--,
Claim 2, line 10: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 3, line 3: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 3, line 4: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 4, lines 2-3: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 5, lines 2-3: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 8, line 6: “releasable” should read --is configured to be releasable--,
Claim 9, line 4: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 9, line 4: “compresses” should read --is configured to compress--,
Claim 9, line 8: “causes” should read --is configured to cause--
Claim 9, line 8: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 9, lines 12-13: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 9, line 16: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 10, line 6: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 10, line 8: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 12, line 12: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 12, line 14: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 12, line 14: “the shaft portion” should read --the elongated shaft portion--,
Claim 12, line 17: “the shaft portion” should read --the elongated shaft portion--,
Claim 12, line 23: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 12, line 24: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 14, line 3: “is deformed” should read --is configured to be deformed--,
Claim 14, line 7: “is displaced” should read --is configured to be displaced--,
Claim 15, line 3: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 15, line 5: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 15, lines 7-8: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 15, line 9: “is pressed” should read --is configured to be pressed--
Claim 15, line 10: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 16, lines 2-3: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 17, lines 2-3: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 21, line 12: “the displacement shaft” should read --the elongated displacement shaft--,
Claim 21, line 18: “moves” should read --is configured to move--,
Claim 21, line 19: “stops” should read --is configured to stop--.
Appropriate correction is required.
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.
Claims 1-5, 8-17 & 21 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, the claim recites “the shaft portion” in lines 6-7 and it is unclear if this is the same shaft portion as the elongated shaft portion recited in line 4 or is a different shaft portion. For examination purposes, these are the same shaft portions and the limitation will be interpreted as “the elongated shaft portion”. Claim 1 & its dependents contains other recitations of this feature, see Claim Objections section for corrections.
Regarding claim 1, the claim recites “the displacement shaft” in line 10 and it is unclear if this is the same displacement shaft as the elongated displacement shaft recited in line 8 or is a different displacement shaft. For examination purposes, these are the same displacement shafts and the limitation will be interpreted as “the elongated displacement shaft”. Claim 1 & its dependents contains other recitations of this feature, see Claim Objections section for corrections.
Claim 1 recites the limitation “the displacement” in line 33. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “the engagement” in lines 45-46. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-5 & 8-11 are also rejected by virtue of their dependency on claim 1.
Claim 3 recites the limitation “the direction along the axis of the displacement shaft” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation “the direction substantially perpendicular to the axis of the displacement shaft” in lines 12-13. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation “the first convex portion” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation “the distal surface of the first convex portion” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 11, the claim recites “biological tissue” in line 1 and it is unclear if this is the same biological tissue or a different biological tissue from the biological tissue recited in claim 1, from which claim 11 depends. For examination purposes, these are the same biological tissue and the limitation will be interpreted as “the biological tissue”.
Claim 11 recites the limitation “the vicinity” in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation “the size” in line 8. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 12, the claim recites “the shaft portion” in lines 6-7 and it is unclear if this is the same shaft portion as the elongated shaft portion recited in line 4 or is a different shaft portion. For examination purposes, these are the same shaft portions and the limitation will be interpreted as “the elongated shaft portion”. Claim 12 & its dependents contains other recitations of this feature, see Claim Objections section for corrections.
Regarding claim 12, the claim recites “the displacement shaft” in line 10 and it is unclear if this is the same displacement shaft as the elongated displacement shaft recited in line 8 or is a different displacement shaft. For examination purposes, these are the same displacement shafts and the limitation will be interpreted as “the elongated displacement shaft”. Claim 12 & its dependents contains other recitations of this feature, see Claim Objections section for corrections.
Claims 13-17 & 21 are also rejected by virtue of their dependency on claim 12.
Claim 13 recites the limitation “the engagement” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
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 12 is rejected under 35 U.S.C. 103 as being unpatentable over Takahashi et al. (U.S. Pub. No. 20200138445, cited in IDS), herein referred to as “Takahashi” in view of Sheth et al. (U.S. Pub. No. 20210177506), herein referred to as “Sheth”.
Regarding claim 12, Takahashi discloses a medical device (Abstract: A medical device) comprising:
an expandable body (expandable body 100) having a central axis (central axis C1) and configured to be expandable and contractible in a radial direction ([0063]: a state where the expansion body 100 is expanded means that each of the expansion portions 110, 120, 130, and 140 is in an expanded state and a state where the expansion body 100 is contracted means that each of the expansion portions 110, 120, 130, and 140 is in a contracted state. Note that a state at a time when the expansion body 100 is expanded is illustrated in FIGS. 1 to 3);
an elongated shaft portion (outer shaft 153) configured to be connected to the expandable body ([0093]: the base portion 105 of the expansion body 100 is inserted through the lumen of the outer shaft 153);
an energy transmission element (a maintenance treatment element (energy transmission element) 109) provided along the expandable body ([0060]: a maintenance treatment element (energy transmission element) 109 disposed in the expansion body 100 and imparting energy to biological tissue);
a housing (housing 161) configured to be connected to a proximal end portion of the shaft portion ([0093]: The outer shaft 153 is configured such that the distal side of the outer shaft 153 is capable of protruding from the storage sheath 151 and the proximal side of the outer shaft 153 is connected to a hand operation unit 160);
an elongated displacement shaft (pulling shaft 157) configured to compress the expandable body in an axial direction ([0095]: The pulling shaft 157 has a proximal side extending to the proximal side of the hand operation unit 160 (see FIG. 1) and a distal side extending to the distal side of the inner shaft 155. In addition, the distal end of the pulling shaft 157 is connected to the distal portion 106 of the expansion body 100. The pulling shaft 157 is configured such that the pulling shaft 157 can be moved forward and backward along the axial direction by an operation dial 163 (described later));
an operation knob (operation dial 163) configured to operate the displacement shaft that is configured to be movable from a first position to a third position via a second position substantially along an axis of the displacement shaft with respect to the housing ([0095]: The pulling shaft 157 has a proximal side extending to the proximal side of the hand operation unit 160 (see FIG. 1) and a distal side extending to the distal side of the inner shaft 155. In addition, the distal end of the pulling shaft 157 is connected to the distal portion 106 of the expansion body 100. The pulling shaft 157 is configured such that the pulling shaft 157 can be moved forward and backward along the axial direction by an operation dial 163 (described later));
the displacement shaft extends from inside the housing along the shaft portion and is connected to the expandable body, and is configured to compress the expandable body in the axial direction by relatively moving from an initial position to a compression position with respect to the shaft portion along the axial direction of the expandable body according to the movement of the operation knob from the first position to the second position ([0095]: The pulling shaft 157 has a proximal side extending to the proximal side of the hand operation unit 160 (see FIG. 1) and a distal side extending to the distal side of the inner shaft 155. In addition, the distal end of the pulling shaft 157 is connected to the distal portion 106 of the expansion body 100. The pulling shaft 157 is configured such that the pulling shaft 157 can be moved forward and backward along the axial direction by an operation dial 163 (described later)); and
wherein the operation knob (operation dial 163) includes a knob body that protrudes from the housing (see Fig. 1 where the operation dial protrudes from housing 161), and configured move and operate the operation knob from the first position to the third position ([0106]: the operation dial 163 disposed in the housing 161, and a conversion mechanism 164 converting the rotational operation of the operation dial 163 into a forward and backward movement of the pulling shaft 157), an action portion (conversion mechanism 164) configured to be movably disposed in the housing and connected to a proximal end portion of the displacement shaft ([0107]: The pulling shaft 157, which operates the expansion and contraction of the expansion body 100, is connected to the operation dial 163 via the conversion mechanism 164), and configured to cause the displacement shaft to be displaced from the initial position to the compression position according to the movement and the operation of the operation knob ([0108]: The conversion mechanism 164 is capable of including, for example, a rack and pinion mechanism converting the rotation of the operation dial 163 into a forward and backward movement (linear movement) of the pulling shaft 157),
But Takahashi fails to disclose a lock portion configured to lock the operation knob at the second position;
and a first engagement portion configured to move together with the action portion.
However, Sheth discloses a lock portion (locking feature 322, Fig. 8A) configured to lock the operation knob at the second position ([0072]: rack (306) is prevented from moving further distally by locking assembly (316). Locking assembly (316) includes locking features (320, 322, 324));
and a first engagement portion (one of locking features 322 or 324) configured to move together with the action portion ([0072]: rack (306) includes locking features (322, 324) that are spaced from one another along longitudinal axis (L-L)).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the medical device of Takahashi to include a lock portion and an engagement portion, as taught by Sheth, for the purpose of providing a coupling that is strong enough to resist unintended longitudinal movement of the rack (e.g., in response to lateral forces exerted against the end effector by patient anatomy, etc.) when locking assembly is in the state; yet weak enough to enable the operator to intentionally transition the assembly between the without needing to apply undue torqueing on rocker arm (Sheth: [0074]).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Takahashi in view of Sheth as applied to claim 12 above, and further in view of Chu et al. (U.S. Pat. No. 10849638), herein referred to as “Chu”.
Regarding claim 16, Takahashi in view of Sheth fail to disclose a biasing portion that is elastically deformable along the axis of the displacement shaft so as to bias the first engagement portion of the operation knob located at the second position toward the second engagement portion.
However, Chu discloses a biasing portion (biasing member 176) that is elastically deformable along the axis of the displacement shaft so as to bias the first engagement portion of the operation knob located at the second position toward the second engagement portion (Col. 12, lines 23-28: Biasing member 176 may exert a force biasing actuation member 146 distally relative to handle body 158 and handle cover 160. Biasing member 176 may tend to force actuation member 146 distally relative to handle body 158 and handle cover 160 until stops 170 and 172 are forced against ends of stroke limiter 168). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the medical device of Takahashi in view of Sheth to include a biasing portion, as taught by Chu, for the purpose of preventing inadvertent extension and expansion of end effector (Chu: Col. 12, lines 31-32).
Regarding claim 17, Takahashi in view of Sheth and Chu disclose wherein the action portion (Chu: sleeve 180) of the operation knob is connected to a proximal end portion of the displacement shaft (drive member 104) via the biasing portion (Col. 12, lines 18-22: proximal end of biasing member 176 may engage a distal end of handle body 158, a distal end of a sleeve 180 around drive member 104 that is received in passage 162 of handle body 158, and/or a portion of handle cover 160).
Allowable Subject Matter
Claims 1-5 & 8-11 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 13-15 & 21 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.
The following is an examiner’s statement of reasons for allowance:
Claim 1:
The current prior art of record, neither alone nor in combination, fail to disclose " a lock portion configured to lock the operation knob at the second position; … and a first engagement portion configured to move together with the action portion; … the lock portion including a second engagement portion that is disposed in the housing and configured to be displaceable between an engagement position at which the second engagement portion is engaged with the first engagement portion of the operation knob located at the second position, and a release position at which the engagement with the first engagement portion is released, a release button that is exposed from the housing and configured to cause the second engagement portion to be displaced from the engagement position to the release position, and a flexible deformable portion that connects the release button and the second engagement portion to each other; and when the release button is pressed in a state in which the operation knob is located at the second position, the flexible deformable portion is configured to be deformed to prevent displacement of the second engagement portion engaged with the first engagement portion from the engagement position to the release position, and when the release button is pressed in a state in which the operation knob is located at the third position, the second engagement portion is configured to be displaced from the engagement position to the release position and an engagement state between the first engagement portion and the second engagement portion is releasable" in combination with the other claim limitations.
Takahashi (US 20200138445, cited in IDS ) discloses a medical device (Abstract: A medical device) comprising: an expandable body (expandable body 100) having a central axis and configured to be expandable and contractible in a radial direction ([0063]: a state where the expansion body 100 is expanded means that each of the expansion portions 110, 120, 130, and 140 is in an expanded state and a state where the expansion body 100 is contracted means that each of the expansion portions 110, 120, 130, and 140 is in a contracted state. Note that a state at a time when the expansion body 100 is expanded is illustrated in FIGS. 1 to 3); an elongated shaft portion (outer shaft 153) configured to be connected to the expandable body ([0093]: the base portion 105 of the expansion body 100 is inserted through the lumen of the outer shaft 153); an energy transmission element (a maintenance treatment element (energy transmission element) 109) provided along the expandable body ([0060]: a maintenance treatment element (energy transmission element) 109 disposed in the expansion body 100 and imparting energy to biological tissue); a housing (housing 161) configured to be connected to a proximal end portion of the shaft portion ([0093]: The outer shaft 153 is configured such that the distal side of the outer shaft 153 is capable of protruding from the storage sheath 151 and the proximal side of the outer shaft 153 is connected to a hand operation unit 160); an elongated displacement shaft (pulling shaft 157) configured to compress the expandable body in an axial direction ([0095]: The pulling shaft 157 has a proximal side extending to the proximal side of the hand operation unit 160 (see FIG. 1) and a distal side extending to the distal side of the inner shaft 155. In addition, the distal end of the pulling shaft 157 is connected to the distal portion 106 of the expansion body 100. The pulling shaft 157 is configured such that the pulling shaft 157 can be moved forward and backward along the axial direction by an operation dial 163 (described later)); an operation knob (operation dial 163) configured to operate the displacement shaft that is configured to be movable from a first position to a third position via a second position substantially along an axis of the displacement shaft with respect to the housing ([0095]: The pulling shaft 157 has a proximal side extending to the proximal side of the hand operation unit 160 (see FIG. 1) and a distal side extending to the distal side of the inner shaft 155. In addition, the distal end of the pulling shaft 157 is connected to the distal portion 106 of the expansion body 100. The pulling shaft 157 is configured such that the pulling shaft 157 can be moved forward and backward along the axial direction by an operation dial 163 (described later)); the expandable body including a concave portion (concave portion 115) recessed inward in the radial direction at an intermediate portion in the axial direction ([0065]: concave portion 115 has a shape recessed in a concave shape in a direction intersecting with the axial direction of the shaft portion 150 (in the up-down direction illustrated in FIG. 2)), a first connection portion (proximal ends of expansion portions 110, 120, 130 & 140) connected to the shaft portion (see Fig. 3), and a second connection portion (distal ends of expansion portions 110, 120, 130 & 140) facing the first connection portion with the concave portion interposed between the second connection portion and the first connection portion in the axial direction and connected to the displacement shaft (see Fig. 3, [0067]: The concave portion 115 is formed in each of the plurality of expansion portions 110, 120, 130, and 140 included in the expansion body 100); the concave portion including, in order to define a receiving space configured to receive a biological tissue ([0066]: the size of the concave portion 115 (amount by which the concave portion 115 is recessed with respect to the axial direction) with respect to the degree of expansion (expansion amount) of the expansion body 100 is not particularly limited insofar as the concave portion 115 can be disposed with respect to a treatment target site (such as the edge portion Hhe of the through-hole Hh formed in the atrial septum HA) during treatment by means of the maintenance treatment element 109), a distal erected section (portion of expansion body distally adjacent to maintenance treatment element 109 is located), a proximal erected section (portion of expansion body proximally adjacent to maintenance treatment element 109 is located), and a bottom section (portion of expansion body 100 where maintenance treatment element 109 is located) located on an innermost side in the radial direction and disposed between the distal erected section and the proximal erected section (see Fig. 3); the energy transmission element is disposed along one of the distal erected section and the proximal erected section in a manner of facing the receiving space ([0079]: The maintenance treatment element 109 can be formed in, for example, the entire concave portion 115 (entire region including the bottom portion 115a, the distal side standing portion 115b, and the proximal side standing portion 115c)); the displacement shaft extends from inside the housing along the shaft portion and is connected to the second connection portion, and is configured to compress the expandable body in the axial direction by relatively moving from an initial position to a compression position with respect to the shaft portion along the axial direction of the expandable body according to the movement of the operation knob from the first position to the second position ([0095]: The pulling shaft 157 has a proximal side extending to the proximal side of the hand operation unit 160 (see FIG. 1) and a distal side extending to the distal side of the inner shaft 155. In addition, the distal end of the pulling shaft 157 is connected to the distal portion 106 of the expansion body 100. The pulling shaft 157 is configured such that the pulling shaft 157 can be moved forward and backward along the axial direction by an operation dial 163 (described later)); the distal erected section and the proximal erected section configured to grip the biological tissue by the displacement of the displacement shaft from the initial position to the compression position ([0095]: The pulling shaft 157 has a proximal side extending to the proximal side of the hand operation unit 160 (see FIG. 1) and a distal side extending to the distal side of the inner shaft 155. In addition, the distal end of the pulling shaft 157 is connected to the distal portion 106 of the expansion body 100. The pulling shaft 157 is configured such that the pulling shaft 157 can be moved forward and backward along the axial direction by an operation dial 163 (described later); [0126]: By the expansion and contraction of the expansion body 100 being repeated, the biological tissue of the atrial septum HA around the edge portion Hhe of the through-hole Hh is loosened and becomes likely to be elastically deformed); the operation knob (operation dial 163) includes a knob body that protrudes from the housing (see Fig. 1 where the operation dial protrudes from housing 161), and configured move and operate the operation knob from the first position to the third position ([0106]: the operation dial 163 disposed in the housing 161, and a conversion mechanism 164 converting the rotational operation of the operation dial 163 into a forward and backward movement of the pulling shaft 157), an action portion (conversion mechanism 164) configured to be movably disposed in the housing and connected to a proximal end portion of the displacement shaft ([0107]: The pulling shaft 157, which operates the expansion and contraction of the expansion body 100, is connected to the operation dial 163 via the conversion mechanism 164), and configured to cause the displacement shaft to be displaced from the initial position to the compression position according to the movement and the operation of the operation knob ([0108]: The conversion mechanism 164 is capable of including, for example, a rack and pinion mechanism converting the rotation of the operation dial 163 into a forward and backward movement (linear movement) of the pulling shaft 157), but Takashi fails to disclose "a lock portion configured to lock the operation knob at the second position; … and a first engagement portion configured to move together with the action portion; … the lock portion including a second engagement portion that is disposed in the housing and configured to be displaceable between an engagement position at which the second engagement portion is engaged with the first engagement portion of the operation knob located at the second position, and a release position at which the engagement with the first engagement portion is released, a release button that is exposed from the housing and configured to cause the second engagement portion to be displaced from the engagement position to the release position, and a flexible deformable portion that connects the release button and the second engagement portion to each other; and when the release button is pressed in a state in which the operation knob is located at the second position, the flexible deformable portion is configured to be deformed to prevent displacement of the second engagement portion engaged with the first engagement portion from the engagement position to the release position, and when the release button is pressed in a state in which the operation knob is located at the third position, the second engagement portion is configured to be displaced from the engagement position to the release position and an engagement state between the first engagement portion and the second engagement portion is releasable".
Claim 13
The current prior art of record, neither alone nor in combination, fail to disclose "wherein the lock portion includes a second engagement portion that is disposed in the housing and configured to be displaceable between an engagement position at which the second engagement portion is engaged with the first engagement portion of the operation knob located at the second position, and a release position at which an engagement with the first engagement portion is released, a release button that is exposed from the housing and configured to cause the second engagement portion to be displaced from the engagement position to the release position, and a flexible deformable portion that connects the release button and the second engagement portion to each other" in combination with the other claim limitations.
Claim 14 is also objected to by virtue of its dependency on claim 13.
Claim 15
The current prior art of record, neither alone nor in combination, fail to disclose "wherein the flexible deformable portion has an elongated shape projected on a plane including the axis of the elongated displacement shaft, and is pivotally disposed in the housing such that an inclination amount of the flexible deformable portion with respect to the axis of the elongated displacement shaft changes; the release button and the second engagement portion are disposed at both ends of the flexible deformable portion in a direction along the axis of the elongated displacement shaft; and the release button is configured to be pressed, so that an inclination of the flexible deformable portion with respect to the axis of the elongated displacement shaft is increased, and the second engagement portion is displaced from the engagement position to the release position" in combination with the other claim limitations
Claim 21
The current prior art of record, neither alone nor in combination, fail to disclose "wherein the lock portion comprises: a second engagement portion that is disposed in the housing and configured to be displaceable between an engagement position at which the second engagement portion is engaged with the first engagement portion of the operation knob located at the second position, and a release position at which the engagement with the first engagement portion is released; and a release button that is exposed from the housing and configured to cause the second engagement portion to be displaced from the engagement position to the release position, wherein the medical device further comprises a biasing portion elastically deformable along an axis of the elongated displacement shaft and configured to bias the first engagement portion of the operation knob located at the second position toward the second engagement portion such that a frictional force is generated between the first engagement portion and the second engagement portion, wherein, when the first engagement portion of the operation knob is disposed on a proximal side of the second engagement portion of the lock portion, the operation knob is configured to move toward a distal side by a reaction force received from the biasing portion and is configured to stop at the second position by engagement of the first engagement portion with the second engagement portion, and wherein, by displacing the operation knob from the second position to the third position, the first engagement portion is separated from the second engagement portion such that the frictional force no longer acts" in combination with the other claim limitations
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Schultz (US 20190111238): deformable section, Figs. 5-7; Ianchulev (US 20160074220): slider along a helical cam, Figs. 16-18; Yoon (US 5645076): Fig. 57.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794