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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 28, 2013 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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.
Claims 1-5, 8, and 14-20 are rejected under 35 U.S.C. 102 as being anticipated by Takahashi et al. (US 20210007800 A1)
Regarding Claim 1, Takahashi discloses a medical device [10] comprising: an expansion body [21] that includes a distal end part including a force receiving portion [35], the expansion body configured to be expandable and contractible in a radial direction (see Fig. 1 and compare Figs. 2-3; see also para. 0017, “a medical device is disclosed, which enlarges a biological tissue and includes an elongated shaft portion, and an expansion body disposed in a distal portion of the shaft portion, and configured to expand and contract in a radial direction”); an elongated shaft portion [20] including a distal end part to which a proximal end of the expansion body is fixed (see Fig. 1); a plurality of energy transfer elements [22] disposed along the expansion body (see Fig. 2); a pulling shaft [33] that is disposed inside the shaft portion [31], the pulling shaft configured to be connectable to the force receiving portion [35] of the expansion body by protruding from the distal end part of the shaft portion [31], and to be slidable with respect to the shaft portion [31] (compare Figs. 2-3; see also para. 0057, “The pulling shaft 33 projects from the distal end of the outer shaft 31 to the distal side of the outer shaft 31, and a distal portion of the pulling shaft 33 is fixed to a distal member 35 disposed in the distal portion of the expansion body 21”); and the expansion body [21] including: a first expansion portion including a distal-side expansion portion extending radially outward from the force receiving portion [35] toward a direction of the proximal end and a distal-side top portion disposed on a proximal side of the distal side expansion portion and convexly curved radially outward (see annotated Fig. 2 below); a second expansion portion including a proximal-side expansion portion extending radially outward from the distal end part of the shaft portion toward a direction of the distal end and a proximal-side top portion disposed on a distal side of the proximal-side expansion portion and convexly curved radially outward (see annotated Fig. 2 below); a recess [57] that is recessed radially inward, extends to couple the proximal-side top portion with the distal-side top portion, and configured to define a reception space configured to receive a biological tissue when the expansion body is expanded (see annotated Fig. 2 and Fig. 3; see also para. 0079, “The recessed portion 57 can grip (i.e., pinch) the biological tissue”); the recess includes a bottom portion located on an innermost side in the radial direction, a distal-side upright portion extending radially outward from a distal end of the bottom portion to the distal-side top portion, and a proximal-side upright portion extending radially outward from a proximal end of the bottom portion to the proximal-side top portion (see annotated Fig. 2); one of the distal-side upright portion or the proximal-side upright portion includes a plurality of energy transfer element arrangement portions on which the plurality of individual energy transfer elements [22] is disposed at a substantially regular interval in a circumferential direction of the expansion body (see annotated Fig. 2); another one of the distal-side upright portion or the proximal-side upright portion includes a plurality of facing portions facing the plurality of individual energy transfer elements when the expansion body is expanded (see Fig. 3); the pulling shaft [33] is configured to apply, to the expansion body via the force receiving portion [35], a compressive force configured to compress along an axial center of the shaft portion such that the plurality of energy transfer element arrangement portions and the plurality of facing portions approach each other by sliding in a direction of the proximal end with respect to the shaft portion (compare Figs. 2-3; see also para. 0111, “the pulling shaft 33 is moved to the proximal side so that the distal member 35 moves to the proximal side”); and the expansion body includes a buffer portion [54] that is disposed in the first expansion portion and is configured to relax the compressive force by deforming in a direction different from a direction from the force receiving portion toward the distal- side top portion along the distal-side expansion portion, or a buffer portion [54] that is disposed in the second expansion portion and is configured to relax the compressive force by deforming in a direction different from a direction from the proximal end of the expansion body toward the proximal-side top portion along the proximal-side expansion portion (compare annotated Fig. 2 with Fig. 3, where the angle between the bifurcated struts in the second section tends to increase with the expansion of the expansion body”).
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Regarding Claim 2, Takahashi teaches the first expansion portion includes a plurality of distal-side strut structures extending radially outward from the force receiving portion [35] toward the direction of the proximal end and forming the distal-side expansion portion (see annotated Fig. 2); and each of the plurality of distal-side strut structures includes, as the buffer portion, a bent portion [54] bendable in a direction different from a direction from the force receiving portion toward the distal-side top portion along each of the distal-side strut structures (compare Figs. 2-3).
Regarding Claim 3, Takahashi teaches each of the plurality of distal-side strut structures includes a first section that includes a first strut [50] extending from the force receiving portion [35] substantially parallel to the axial center of the expansion body when viewed from a radial outside, and a second section that includes two second struts [54] bifurcated from a proximal end of the first section substantially along the circumferential direction of the expansion body and is coupled to the distal-side top portion (see annotated Fig. 2); and the second section is configured to function as the buffer portion that relaxes the compressive force by bending such that a bifurcation angle formed by the two bifurcated second struts increases (compare annotated Fig. 2 with Fig. 3).
Regarding Claim 4, Takahashi teaches the second section includes, in a vicinity of the distal-side top portion, a plurality of joint portions [55] in which each of the two second struts joins one of the two second struts of another second section adjacent in the circumferential direction (see annotated Fig. 2; see also para. 0082, “from a distal portion 52 toward the center side, the wire portion 50 has the bifurcated portion 53, is bifurcated from the bifurcated portion 53 into the two bifurcated lines 54, and the bifurcated lines 54 merge with each other in the merging portion 55, thereby forming the central wire portion 56 having the recessed portion 57”).
Regarding Claim 5, Takahashi teaches the second section includes an auxiliary curved portion configured to function as the buffer portion between the plurality of joint portions [55] and the distal-side top portion disposed in a same phase as the energy transfer element arrangement portions or the facing portions in the circumferential direction of the expansion body (see annotated Fig. 2).
Regarding Claim 8, Takahashi teaches the recess includes a recessed strut structure that is coupled to the distal-side strut structure via the distal-side top portion and defines the distal-side upright portion, the proximal-side upright portion, and the bottom portion (see annotated Fig. 2); and the recessed strut structure includes, in the bottom portion, a plurality of bottom connecting portions that couples individual pairs of the plurality of energy transfer element [22] arrangement portions and the plurality of facing portions; and the plurality of bottom connecting portions is disposed in a phase different from a phase of the first strut [50] in the circumferential direction of the expansion body (see annotated Fig. 2).
Regarding Claim 14, An expansion body configured to be expandable and contractible in a radial direction (compare Figs. 2-3; see also para. 0017, “a medical device is disclosed, which enlarges a biological tissue and includes an elongated shaft portion, and an expansion body disposed in a distal portion of the shaft portion, and configured to expand and contract in a radial direction”), the expansion body comprising: a distal end part including a force receiving portion [35]; a first expansion portion including a distal-side expansion portion extending radially outward from the force receiving portion [35] toward a direction of the proximal end and a distal-side top portion disposed on a proximal side of the distal-side expansion portion and convexly curved radially outward (see annotated Fig. 2); a second expansion portion including a proximal-side expansion portion extending radially outward from the distal end part of the shaft portion toward a direction of the distal end and a proximal-side top portion disposed on a distal side of the proximal-side expansion portion and convexly curved radially outward (see annotated Fig. 2); a recess [57] that is recessed radially inward, extends to couple the proximal-side top portion with the distal-side top portion, and configured to define a reception space configured to receive a biological tissue when the expansion body is expanded (see annotated Fig. 2 and Fig. 3; see also para. 0079, “The recessed portion 57 can grip (i.e., pinch) the biological tissue”); the recess includes a bottom portion located on an innermost side in the radial direction, a distal-side upright portion extending radially outward from a distal end of the bottom portion to the distal-side top portion, and a proximal-side upright portion extending radially outward from a proximal end of the bottom portion to the proximal- side top portion (see annotated Fig. 2); one of the distal-side upright portion or the proximal-side upright portion includes a plurality of energy transfer element arrangement portions on which the plurality of individual energy transfer elements [22] is disposed at a substantially regular interval in a circumferential direction of the expansion body (see annotated Fig. 2); another one of the distal-side upright portion or the proximal-side upright portion includes a plurality of facing portions facing the plurality of individual energy transfer elements [22] when the expansion body is expanded (see annotated Fig. 2 and Fig. 3); and includes a buffer portion [54] that is disposed in the first expansion portion and is configured to relax a compressive force by deforming in a direction different from a direction from the force receiving portion toward the distal-side top portion along the distal-side expansion portion, or a buffer portion [54] that is disposed in the second expansion portion and is configured to relax the compressive force by deforming in a direction different from a direction from the proximal end of the expansion body toward the proximal-side top portion along the proximal-side expansion portion (compare annotated Fig. 2 with Fig. 3).
Regarding Claim 15, Takahashi teaches the first expansion portion includes a plurality of distal-side strut structures extending radially outward from the force receiving portion [35] toward the direction of the proximal end and forming the distal-side expansion portion (see annotated Fig. 2); and each of the plurality of distal-side strut structures includes, as the buffer portion, a bent portion [54] bendable in a direction different from a direction from the force receiving portion toward the distal-side top portion along each of the distal-side strut structures (compare Figs. 2-3).
Regarding Claim 16, Takahashi teaches each of the plurality of distal-side strut structures includes a first section that includes a first strut [50] extending from the force receiving portion substantially parallel to the axial center of the expansion body when viewed from a radial outside, and a second section that includes two second struts bifurcated from a proximal end of the first section substantially along the circumferential direction of the expansion body and is coupled to the distal-side top portion (see annotated Fig. 2); and the second section is configured to function as the buffer portion that relaxes the compressive force by bending such that a bifurcation angle formed by the two bifurcated second struts increases (compare Figs. 2-3).
Regarding Claim 17, Takahashi teaches the second section includes, in a vicinity of the distal-side top portion, a plurality of joint portions [55] in which each of the two second struts joins one of the two second struts of another second section adjacent in the circumferential direction (see Fig. 2; see also para. 0082, “from a distal portion 52 toward the center side, the wire portion 50 has the bifurcated portion 53, is bifurcated from the bifurcated portion 53 into the two bifurcated lines 54, and the bifurcated lines 54 merge with each other in the merging portion 55, thereby forming the central wire portion 56 having the recessed portion 57”).
Regarding Claim 18, Takahashi teaches a method for forming a shunt according to the present disclosure forms, in an oval fossa, a shunt through which a right atrium communicates with a left atrium using a medical device (see para. 0128, “In the forming of the through-hole Hh in the atrial septum HA (S1), the operator causes a puncture device (not illustrated) to penetrate from the right atrium HRa side toward the left atrium HLa side, thereby forming the through-hole Hh”) including an expansion body that includes a distal end part including a force receiving portion [35], the expansion body being expandable and contractible in a radial direction (compare Figs. 2-3; see also para. 0017, “a medical device is disclosed, which enlarges a biological tissue and includes an elongated shaft portion, and an expansion body disposed in a distal portion of the shaft portion, and configured to expand and contract in a radial direction”), an elongated shaft portion [20] including a distal end part to which a proximal end of the expansion body is fixed (see Fig. 1), a plurality of energy transfer elements [22] disposed along the expansion body (see Fig. 2), and a pulling shaft [33] that is disposed inside the shaft portion [31], connectable to the force receiving portion [35] of the expansion body by protruding from the distal end part of the shaft portion and slidable with respect to the shaft portion (see Fig. 2; see also para. 0057, “The pulling shaft 33 projects from the distal end of the outer shaft 31 to the distal side of the outer shaft 31, and a distal portion of the pulling shaft 33 is fixed to a distal member 35 disposed in the distal portion of the expansion body 21”), in which the expansion body includes a first expansion portion including a distal-side expansion portion extending radially outward from the force receiving portion toward a direction of the proximal end and a distal-side top portion disposed on a proximal side of the distal-side expansion portion and convexly curved radially outward (see annotated Fig. 2), a second expansion portion including a proximal-side expansion portion extending radially outward from the distal end part of the shaft portion toward a direction of the distal end and a proximal-side top portion disposed on a distal side of the proximal-side expansion portion and convexly curved radially outward (see annotated Fig. 2), and a recess that is recessed radially inward, extends to couple the proximal-side top portion with the distal-side top portion, and defines a reception space that can receive a biological tissue when the expansion body is expanded (see annotated Fig. 2 and Fig. 3; see also para. 0079, “The recessed portion 57 can grip (i.e., pinch) the biological tissue”), the recess includes a bottom portion located on an innermost side in the radial direction, a distal-side upright portion extending radially outward from a distal end of the bottom portion to the distal-side top portion, and a proximal-side upright portion extending radially outward from a proximal end of the bottom portion to the proximal-side top portion (see annotated Fig. 2), one of the distal-side upright portion or the proximal-side upright portion includes a plurality of energy transfer element arrangement portions on which the plurality of individual energy transfer elements [22] is disposed at a substantially regular interval in a circumferential direction of the expansion body (see annotated Fig. 2), the other one of the distal-side upright portion or the proximal-side upright portion includes a plurality of facing portions facing the plurality of individual energy transfer elements when the expansion body is expanded (see annotated Fig. 2 and Fig. 3), the pulling shaft is configured to apply, to the expansion body via the force receiving portion [35], a compressive force that makes compression along an axial center of the shaft portion such that the plurality of energy transfer element arrangement portions and the plurality of facing portions approach each other by sliding in a direction of the proximal end with respect to the shaft portion (compare annotated Fig. 2 with Fig. 3; see also para. 0111, “the pulling shaft 33 is moved to the proximal side so that the distal member 35 moves to the proximal side”), and the expansion body includes a buffer portion [54] that is disposed in the first expansion portion and is configured to relax the compressive force by deforming in a direction different from a direction from the force receiving portion toward the distal-side top portion along the distal-side expansion portion, or a buffer portion [54] that is disposed in the second expansion portion and is configured to relax the compressive force by deforming in a direction different from a direction from the proximal end of the expansion body toward the proximal-side top portion along the proximal-side expansion portion (see annotated Fig. 2), the method including: inserting the medical device from an inferior vena cava into the right atrium (see Figs. 5-6); inserting the expansion body in a contracted state into a hole formed in the oval fossa (see Figs. 5-6); expanding the expansion body in the hole to dispose the biological tissue surrounding the hole in the reception space defined by the recess (see Figs. 5-6); sliding the pulling shaft in the direction of the proximal end with respect to the shaft portion to compress the expansion body such that the distal-side upright portion and the proximal-side upright portion of the recess approach each other (see Figs. 5-6, see also para. 0141-0142, “In the enlarging of the diameter of the through-hole Hh by using the expansion body 21 (S3), the operator operates the operation unit 23 in a state where the atrial septum HA is gripped by the recessed portion 57. In this manner, the pulling shaft 33 is moved to the proximal side. In this manner, the expansion body 21 further expands in the radial direction to widen the gripped through-hole Hh in the radial direction.”); bringing the energy transfer elements [22] disposed to face the recess [57] along the distal-side upright portion or the proximal-side upright portion of the recess into contact with the biological tissue while relaxing the compressive force by deforming the buffer portion [54] in a direction different from the direction from the force receiving portion [35] toward the distal-side top portion along the distal-side expansion portion or relaxing the compressive force by deforming the buffer portion [54] disposed in the second expansion portion in a direction different from the direction from the proximal end of the expansion body toward the proximal-side top portion along the proximal- side expansion portion (see annotated Fig. 2, Fig. 3, and Figs. 5-6); and cauterizing the biological tissue disposed in the reception space using the energy transfer elements in contact with the biological tissue to inhibit occlusion due to natural healing of the hole (see para. 0149, “When the biological tissue in the vicinity of the edge portion of the through-hole Hh is cauterized through the maintenance treatment element 22, a degenerated portion having the degenerated biological tissue is formed in the vicinity of the edge portion”).
Regarding Claim 19, Takahashi teaches the first expansion portion includes a plurality of distal-side strut structures extending radially outward from the force receiving portion [35] toward the direction of the proximal end and forming the distal-side expansion portion (see annotated Fig. 2); and each of the plurality of distal-side strut structures includes, as the buffer portion [54], a bent portion bendable in a direction different from a direction from the force receiving portion toward the distal-side top portion along each of the distal-side strut structures (compare annotated Fig. 2 with Fig. 3).
Regarding Claim 20, Takahashi teaches each of the plurality of distal-side strut structures includes a first section that includes a first strut extending from the force receiving portion [35] substantially parallel to the axial center of the expansion body when viewed from a radial outside, and a second section that includes two second struts bifurcated from a proximal end of the first section substantially along the circumferential direction of the expansion body and is coupled to the distal-side top portion (see annotated Fig. 2); and the second section functions as the buffer portion that relaxes the compressive force by bending such that a bifurcation angle formed by the two bifurcated second struts increases (compare annotated Fig. 2 with Fig. 3).
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.
Claims 6-7 and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Takahashi et al. (US 20210007800 A1).
Regarding Claim 6, Takahashi does not explicitly teach the plurality of distal-side strut structures to include the first sections and the joint portions [55] twice as many as the plurality of energy transfer elements; and the joint portions [55] alternately to include, in the circumferential direction of the expansion body, a first joint portion disposed in a same phase as the plurality of energy transfer element arrangement portions and the plurality of facing portions in the circumferential direction of the expansion body, and a second joint portion disposed in a phase different from the phase of the plurality of energy transfer element arrangement portions and the plurality of facing portions. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to omit the facing portions and energy transfer element arrangement portions including the energy transfer elements in half of the struts of the device of Takahashi so as to have twice as many of the first sections and joint portions [55] as the plurality of energy transfer elements, since it has been held that omission of an element and its function in a combination where the remaining elements perform the same functions as before involves only routine skill in the art (see In re Karlson, 136 USPQ 184). Incorporating such an omission to an alternating half of the struts would result in the joint portions [55] to alternatively include a first joint portion disposed in a same phase as the plurality of energy transfer element arrangement portions and the plurality of facing portions in the circumferential direction of the expansion body, and a second joint portion disposed in a phase different from the phase of the plurality of energy transfer element arrangement portions and the plurality of facing portions.
Regarding Claim 7, Takahashi teaches the medical device further comprises an auxiliary curved portion configured to function as the buffer portion between the first joint portion and the distal-side top portion (see annotated Fig. 2).
Regarding Claim 9, Takahashi teaches the energy transfer element [22] arrangement portions disposed on the proximal-side upright portion, but does not explicitly teach the buffer portion disposed only on the distal-side expansion portion. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to omit the buffer portion on the proximal-side expansion portion so as to only have the buffer portion disposed on the distal-side expansion portion, since it has been held that omission of an element and its function in a combination where the remaining elements perform the same functions as before involves only routine skill in the art (see In re Karlson, 136 USPQ 184).
Regarding Claim 10, the second expansion portion includes a plurality of proximal-side strut structures that extends radially outward from the distal end part of the shaft portion toward the direction of the distal end and forms the proximal-side expansion portion (see annotated Fig. 2); and each of the plurality of proximal-side strut structures includes a third strut that is disposed in a same phase as the plurality of energy transfer element arrangement portions in the circumferential direction of the expansion body and extends from the distal end part of the shaft portion to the proximal-side top portion substantially parallel to the axial center of the expansion body when viewed from a radial outside (see annotated Fig. 2).
Regarding Claim 11, the second expansion portion includes a plurality of secondary struts that couples the third struts adjacent in the circumferential direction in the plurality of proximal-side strut structures (see annotated Fig. 2); each of the plurality of secondary struts includes at least one support strut including two junctions joined to respective two third struts adjacent in the circumferential direction among a plurality of the third struts (see annotated Fig. 2); and each of a plurality of the support struts is formed to be longer than a linear distance between the two junctions (see annotated Fig. 2).
Regarding Claim 12, the second expansion portion includes a plurality of proximal-side strut structures that extends radially outward from the distal end part of the shaft portion toward the direction of the distal end and forms the proximal-side expansion portion (see annotated Fig. 2); each of the plurality of proximal-side strut structures includes a third section that includes a third strut extending from the distal end part of the shaft portion substantially parallel to the axial center of the expansion body when viewed from a radial outside, and a fourth section that includes two fourth struts bifurcated from a distal end of the third section substantially along the circumferential direction of the expansion body and is coupled to the proximal-side top portion (see annotated Fig. 2); and the fourth section is configured to function as the buffer portion that relaxes the compressive force by bending such that a bifurcation angle formed by the two bifurcated fourth struts increases (compare annotated Fig. 2 with Fig. 3).
Regarding Claim 13, Takahashi teaches the fourth section includes, in a vicinity of the proximal-side top portion, a plurality of third joint portions [55] in which each of the two fourth struts joins one of the two fourth struts of another fourth section adjacent in the circumferential direction (see annotated Fig. 2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Auerbach et al. (US 20180085064 A1) teaches wave-shaped strain-relief elements for use in a basket catheter.
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/C.S./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794