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 Objections
Claim 21, 22, and 23 are objected to because of the following informalities: in lines . Claims 24-25 are also objected to for being dependent on objected Claim 23. Appropriate correction is required.
Response to Arguments
Applicant’s arguments, see pages 18-21 (“Rejections under 35 U.S.C. 102”), filed June 25, 2026, with respect to the rejection(s) of claim(s) 1-5, 8, and 14-20 under 25 U.S.C. 102 have been fully considered and are persuasive only in part. Applicant’s arguments, see page 21 (“Rejections under 35 U.S.C. 103”), filed June 25, 2026, with respect to the rejection(s) of claim(s) 6-7 and 9-13 under 25 U.S.C. 103 relies on the same arguments as the above and is likewise fully considered and persuasive only in part.
More specifically, Examiner disagrees that Takahashi does not disclose or suggest each of the plurality of distal-side strut structures includes, as the buffer portion, a bent portion configured to facilitate deformation for relaxing the compressive force. Takahashi does disclose a bent portion [54] that will bend to a more radially outward position after a compressive force (compare Figs. 2-3). In doing so, it must at least somewhat relax the compressive force acting upon it.
However, Examiner agrees that Takahashi does not explicitly disclose the bent portion having a width (or thickness) smaller than a width (or thickness) of other portions of the plurality of distal-side strut structures (Takahashi does disclose that the thickness may be different from other portions, but not specifically smaller; see para. 0117).
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 20150270634 A1 (Buesseler et al.).
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 1, 3-14, 16-17, and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Takahashi et al. (US 20210007800 A1) in view of Buesseler et al. (US 20150270634 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 [57] 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 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”);
wherein 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] configured to facilitate deformation for relaxing the compressive force (the bent portion will relax at least some of the compressive forces by virtue of the compressive force causing it to bend; compare Figs 2-3).
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Takahashi does not explicitly disclose that the bent portion has a width smaller than a width of other portions of the plurality of distal-side strut structures, or a thickness smaller than a thickness of other portions of the plurality of distal-side strut structures so as to bend 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 (Takahashi does disclose that the thickness may be the same or different as other portions, but not specifically smaller; see para. 0117).
Buesseler teaches an expansion body [33] having portions with reduced thickness [e.g., 101a-d, 102a-d] configured to “facilitate predictable bending” (see para. 0042) and “maintain high radial force, yet retain sufficient flexibility” (see Fig. 0046; see also Figs. 3-9). It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Takahashi and Buesseler to provide for a bent portion that has a thickness smaller than a thickness of other portions of the plurality of distal-side strut structures, especially considering Takahashi contemplates the possibility of having a different thickness. Doing so would facilitate the bending towards the distal-side top portion while maintaining sufficient radial force and flexibility, as recognized by Buesseler.
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 6, Takahashi does not explicitly teach the plurality of distal-side strut structures include the first sections and the joint portions [55] twice as many as the plurality of energy transfer elements [22] or that the joint portions [55] alternately 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 [22] 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 [22], 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 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 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. 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 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, Takahashi teaches 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 (e.g., those in the “Third Section”) 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, Takahashi teaches the second expansion portion includes a plurality of secondary struts (e.g., those in the “Fourth Section”) 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).
Regarding Claim 14, Takahashi teaches 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] (see annotated Fig. 2);
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);
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)
wherein 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] configured to facilitate deformation for relaxing the compressive force (the bent portion will relax at least some of the compressive forces by virtue of the compressive force causing it to bend; compare Figs 2-3).
Takahashi does not explicitly disclose that the bent portion has a width smaller than a width of other portions of the plurality of distal-side strut structures, or a thickness smaller than a thickness of other portions of the plurality of distal-side strut structures so as to bend in a direction different from a direction from the force receiving portion [35] toward the distal-side top portion along each of the distal-side strut structures (Takahashi does disclose that the thickness may be the same or different as other portions, but not specifically smaller; see para. 0117).
Buesseler teaches an expansion body [33] having portions with reduced thickness [e.g., 101a-d, 102a-d] configured to “facilitate predictable bending” (see para. 0042) and “maintain high radial force, yet retain sufficient flexibility” (see Fig. 0046; see also Figs. 3-9). It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Takahashi and Buesseler to provide for a bent portion that has a thickness smaller than a thickness of other portions of the plurality of distal-side strut structures, especially considering Takahashi contemplates the possibility of having a different thickness. Doing so would facilitate the bending towards the distal-side top portion while maintaining sufficient radial force and flexibility, as recognized by Buesseler.
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 [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 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 Claims 21-22, Takahashi teaches the bottom portion includes a plurality of bottom connecting struts equal in number to the plurality of energy transfer elements [22] (see annotated Fig. 2),
wherein the proximal-side upright portion includes a plurality of proximal-side upright struts, on which the plurality of energy transfer elements [22] are respectively disposed (see annotated Fig. 2), equal in number to the plurality of bottom connecting struts, each of the plurality of proximal-side upright struts extending from each of the plurality of bottom connecting struts toward the proximal-side top portion substantially along an axial direction of the expansion body (see annotated Fig. 2),
and wherein the distal-side expansion portion includes a buffer portion [54] configured to relax the compressive force by deforming in a direction different from a direction from the force receiving portion [35] toward the distal-side top portion (compare annotated Fig. 2 with Fig. 3), whereby, upon application of the compressive force, deformation of the distal-side expansion portion suppresses excessive radial expansion of the expansion body while the compressive force is transmitted through the proximal-side expansion portion and the proximal-side upright struts (at least some amount of radial expansion must be suppressed by virtue of the bending of the struts) to press the energy transfer elements [22] against the biological tissue (compare annotated Fig. 2 and Fig. 3; see also para. 0079, “The recessed portion 57 can grip (i.e., pinch) the biological tissue”).
Takahashi does not explicitly disclose the distal-side upright portion includes a plurality of distal-side upright struts that are twice the number of bottom connecting struts, two circumferentially adjacent distal-side upright struts branching from each of the bottom connecting struts and extending toward the distal-side top portion while spreading such that a circumferential distance between the two circumferentially adjacent distal-side upright struts increases. However, circumferentially adjacent struts branching from other struts are present throughout the expansion body at different locations (see e.g. the “Fourth Section” in annotated Fig. 2). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Takahashi so as to also include distal-side upright strut pairs each branching from the bottom connecting struts in a similar manner to how other struts branch elsewhere in the expansion body (see annotated Fig. 2), since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Such a duplication with the struts branching from the bottom connecting struts towards the top portion would yield the device as claimed.
Regarding Claim 23, A medical device 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] disposed inside the shaft portion [31], the pulling shaft configured to be connectable to the force receiving portion [35] of the expansion body 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”);
wherein the expansion body includes:
a first expansion portion including a distal-side expansion portion extending radially outward from the force receiving portion [35] toward a proximal direction, and a distal-side top portion disposed on a proximal side of the distal side expansion portion (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 distal direction, and a proximal-side top portion disposed on a distal side of the proximal-side expansion portion (see annotated Fig. 2 below);
a recess [57] that is recessed radially inward, extends to couple the distal-side top portion with the proximal-side top portion, and defines 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”);
wherein the recess includes a bottom portion, a distal-side upright portion extending from the bottom portion toward the distal-side top portion, and a proximal-side upright portion extending from the bottom portion toward the proximal-side top portion (see annotated Fig. 2),
wherein the pulling shaft [33] is configured to apply a compressive force to the expansion body such that the distal-side upright portion and the proximal-side upright portion approach each other (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”),
wherein the bottom portion includes a plurality of bottom connecting struts equal in number to the plurality of energy transfer elements [22] (see annotated Fig. 2),
wherein the proximal-side upright portion includes a plurality of proximal-side upright struts, on which the plurality of energy transfer elements [22] are respectively disposed, equal in number to the plurality of bottom connecting struts, each of the plurality of proximal-side upright struts extending from each of the plurality of bottom connecting struts toward the proximal-side top portion substantially along an axial direction of the expansion body (see annotated Fig. 2),
and wherein the distal-side expansion portion includes a buffer portion [54] configured to relax the compressive force by deforming in a direction different from a direction from the force receiving portion [35] toward the distal-side top portion (compare annotated Fig. 2 with Fig. 3), whereby, upon application of the compressive force, deformation of the distal-side expansion portion suppresses excessive radial expansion of the expansion body while the compressive force is transmitted through the proximal-side expansion portion and the proximal-side upright struts (at least some amount of radial expansion must be suppressed by virtue of the bending of the struts) to press the energy transfer elements [22] against the biological tissue (compare annotated Fig. 2 and Fig. 3; see also para. 0079, “The recessed portion 57 can grip (i.e., pinch) the biological tissue”).
Takahashi does not explicitly disclose the distal-side upright portion includes a plurality of distal-side upright struts that are twice the number of bottom connecting struts, two circumferentially adjacent distal-side upright struts branching from each of the bottom connecting struts and extending toward the distal-side top portion while spreading such that a circumferential distance between the two circumferentially adjacent distal-side upright struts increases. However, circumferentially adjacent struts branching from other struts are present throughout the expansion body at different locations (see e.g. the “Fourth Section” in annotated Fig. 2). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Takahashi so as to also include distal-side upright strut pairs each branching from the bottom connecting struts in a similar manner to how other struts branch elsewhere in the expansion body (see annotated Fig. 2), since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Such a duplication with the struts branching from the bottom connecting struts towards the top portion would yield the device as claimed.
Regarding Claim 24, wherein 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] configured to facilitate deformation for relaxing the compressive force (the bent portion will relax at least some of the compressive forces by virtue of the compressive force causing it to bend; compare Figs 2-3).
Takahashi does not explicitly disclose that the bent portion has a width smaller than a width of other portions of the plurality of distal-side strut structures, or a thickness smaller than a thickness of other portions of the plurality of distal-side strut structures so as to bend 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 (Takahashi does disclose that the thickness may be the same or different as other portions, but not specifically smaller; see para. 0117).
Buesseler teaches an expansion body [33] having portions with reduced thickness [e.g., 101a-d, 102a-d] configured to “facilitate predictable bending” (see para. 0042) and “maintain high radial force, yet retain sufficient flexibility” (see Fig. 0046; see also Figs. 3-9). It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Takahashi and Buesseler to provide for a bent portion that has a thickness smaller than a thickness of other portions of the plurality of distal-side strut structures, especially considering Takahashi contemplates the possibility of having a different thickness. Doing so would facilitate the bending towards the distal-side top portion while maintaining sufficient radial force and flexibility, as recognized by Buesseler.
Regarding Claim 25, Takahashi teaches the energy transfer element [22] arrangement portions are disposed on the proximal-side upright portion, but does not explicitly teach the buffer portion is disposed only on the distal-side expansion portion. 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 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).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.S./ Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/ Supervisory Patent Examiner, Art Unit 3794
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