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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection over Jones et al. US 2017/0245865 in view of Seehusen et al. US 2009/0036768 as discussed below. Applicant’s arguments with respect to claim(s) 19 have been considered but are moot because the new ground of rejection over Jones et al. US 2017/0245865 in view of Seehusen et al. US 2009/0036768 and further in view of Sepetka et al. US 2017/0189033 as discussed below.
Applicant’s arguments, filed 1/20/26, with respect to the rejection(s) of claim(s) 11 under USC 102(a)1(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Jones et al. US 2017/0245865 in view of Seehusen et al. US 2009/0036768 as discussed below.
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 8, 12-14, 16, 17 and 18 are 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.
Claim 8 discloses “the wire extending spirally” in lines 1-2. This language is indefinite, as claim 1 was additionally amended to include a wire that is spirally wound in line 4. It is unclear as to whether this is the same or different spiral configuration.
Claim 12 recites the limitation "the groove" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner notes claim 11 discloses “at least one groove”.
Claim 13 recites the limitation "the groove" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner notes claim 11 discloses “at least one groove”.
Claim 14 recites the limitation "the groove" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner notes claim 11 discloses “at least one groove”.
Claim 16 recites the limitation "the groove" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner notes claim 11 discloses “at least one groove”.
Claim 17 recites the limitation "the grooves" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner notes claim 11 discloses “at least one groove”.
Claim 18 recites the limitation "the groove" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner notes claim 11 discloses “at least one groove”.
Claim 18 discloses the coil body including “a radially inwardly facing inner peripheral surface side” on line 3. This language is indefinite as claim 11 includes the coil body including “an inner surface” on line 3. It is unclear as to whether this is the same or different inner surface.
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(s) 1-9, 11-18 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. US 2017/0245865 in view of Seehusen et al. US 2009/0036768.
Regarding claims 1-9, Jones et al. discloses an embolic coil comprising: a coil body comprised of a coil portion that is helically wound so that the coil body includes axially adjacent helical windings of the coil portion (paragraph 0055, figure 6; initial coil 70 formed from a helically wound biocompatible wire 72), the coil portion that is helically wound being a wire that is spirally wound (paragraph 0045, only coil 70 is formed it may be helically wound to form coil 120, figures 7, 8), and the wire having an axis and a transverse cross-section that is perpendicular to the axis of the wire, the transverse cross-section of the wire being a solid transverse cross-section (paragraph 0039, cross sectional shape of the wire is a circle, therefore a solid transverse cross section 75, figure 3), wherein the coil body includes a radially outwardly facing outer peripheral surface side (exterior of primary coil, for example, figure 8) and a radially inwardly facing inner peripheral surface side (within wound coil, center of 120, for example, facing mandrel 122, figure 7) , wherein the wire extends spirally in an extending direction to form the coil body (figure 8),
Jones et al. fails to disclose wherein a groove is formed on a surface of the wire, with a groove formed on a surface of the wire, wherein the groove is a spiral groove extending spirally along the direction of the wire, wherein the groove is one of a plurality of endless grooves, each of the endless grooves being continuous over a circumferential direction of the wire, and the plurality of endless grooves are spaced apart from one another along the extending direction of the wire, wherein the groove is one of plural end grooves, each end groove extending less than 360 degrees around a circumference of the wire so that the end groove extends between and terminates at two ends, the plural end grooves being disposed at intervals along the extending direction of the wire, or each of the plural end grooves being located on the wire such that the plural end grooves are exposed on the outer peripheral surface side of the coil body, a distal end portion of the coil body including flexible portions at portion of the wire where the grooves are formed, and the flexible portions are disposed at positions facing each other in a coil radial direction of the coil body and at different positions in a coil axis direction of the coil body.
Seehusen et al. teaches forming medical devices such as embolic coils (paragraphs 0003, 0081), the embolic coils comprising at east one groove formed on a surface of the wire (paragraphs 0030, 0075, 0081; grooves can be designed to enhance visualization of select portions of the coil, or control mechanical properties such as enhancing the flexibility of an embolic coil for insertion into a small body lumen).
Seehusen et al. teaches a variety of grooves wherein the groove extends in a direction intersecting an extending direction of the wire (for example, figure 4, grooves 18), wherein the groove is a spiral groove extending spirally along the direction of the wire (for example, figure 9, helical grooves 18 along the axis), wherein the groove is one of a plurality of endless grooves (circumferential grooves, for example, figures 1A, 5, 7), each of the endless grooves being continuous over a circumferential direction of the wire (paragraph 0041, 0051, 0072; grooves extend around the circumference of body), and the plurality of endless grooves are spaced apart from one another along the extending direction of the wire (paragraph 0051, grooves 18 are spaced), wherein the groove is one of plural end grooves, each end groove extending less than 360 degrees around a circumference of the wire so that the end groove extends between and terminates at two ends (paragraph 0072, grooves 18 can extend only a part of a circumference), the plural end grooves being disposed at intervals along the extending direction of the wire (for example, figure 4, paragraph 0072), the groove including axially adjacent groove portions positioned at substantially equal intervals along the direction of the wire and over an entire region of the wire in the extending direction of the wire (for example, figures 1A, 4), each of the plural end grooves being located on the wire such that the plural end grooves are exposed on the outer peripheral surface side of the coil body (In combination, Seehusen et al. discloses grooves that were formed around all sides of the wire, for example, figure 1A, 4, 6, and would be configured to result in a configuration wherein the grooves are at least partially formed on the outer side when formed into the coil structure of Jones et al.), the groove including axially adjacent groove portions positioned at substantially equal intervals (for example, figures 1A, 4), a distal end portion of the coil body including flexible portions at portion of the wire where the grooves are formed, and the flexible portions are disposed at positions facing each other in a coil radial direction of the coil body and at different positions in a coil axis direction of the coil body (Examiner further notes that any configuration of grooves may be realized or adjusted to provide or control the desired visualization and flexibility as necessary along the embolic coil, paragraphs 0030, 0074-0076 and 0081).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify Jones et al. with a groove formed on a surface of the wire, wherein the groove is a spiral groove extending spirally along the direction of the wire, wherein the groove is one of a plurality of endless grooves, each of the endless grooves being continuous over a circumferential direction of the wire, and the plurality of endless grooves are spaced apart from one another along the extending direction of the wire, wherein the groove is one of plural end grooves, each end groove extending less than 360 degrees around a circumference of the wire so that the end groove extends between and terminates at two ends, the plural end grooves being disposed at intervals along the extending direction of the wire, as taught by Seehusen et al. to enhance visualization and/or modify the flexibility of an embolic coil for insertion into a small body lumen.
Regarding claims 11-18 and 22, Jones et al. discloses an embolic coil comprising: a coil body comprised of a coil portion that is helically coiled so that the coil body that has an inner surface surrounding an interior of the helical coil body (figure 6, wire 72 helically coiled to form coil 70); the elongated coil portion being constituted by an elongated wire that is spirally wound around a coil axis in an extending portion from the coil portion (figures 7, 8); the elongated wire possessing an outer surface having a 360 degree circumferential extend and extending along a longitudinal extend of the elongated wire (wire 72 has a circumference of 360 as it is a circular cross section, paragraph 0008), and the wire having an axis and a transverse cross-section that is perpendicular to the axis of the wire, the transverse cross-section of the wire being a solid transverse cross-section (paragraph 0039, cross sectional shape of the wire is a circle, therefore a solid transverse cross section 75, figure 3).
Jones et al. fails to disclose wherein at least one groove is formed on a surface of the wire, the at least one groove extending around at least a portion of the 360 degrees circumferential extend of the outer surface of the elongated wire, wherein the groove extends in a direction intersecting an extending direction of the wire wherein the groove is a spiral groove extending spirally along the direction of the wire so that the groove extends more than 360 degrees around the outer surface, wherein the groove is one of a plurality of endless grooves that are separate from one another and axially spaced apart from one another along at least a portion of the longitudinal extend of the elongated wire, wherein at least one groove extends along at least a portion of the longitudinal extend of the elongated wire, the portion of the longitudinal extent of the elongated wire being a distal portion of the elongated wire, the at least one groove being a plural grooves that are spaced apart from one another along the extending direction of the wire, wherein each of the grooves extends around the circumferential extend of the wire less than 360 degrees, each of the grooves terminating at opposite ends that are spaced apart from one another, wherein the groove is one of plural grooves, the coil body including a radially outward facing outer peripheral surface side and a radially inwardly facing inner peripheral surface side, each of the plural grooves being located on the wire such that the plural grooves are on the outer peripheral surface side of the coil body.
Seehusen et al. teaches forming medical devices such as embolic coils (paragraphs 0003, 0081), the embolic coils comprising a groove formed on a surface of the wire (paragraphs 0030, 0075, 0081; grooves can be designed to enhance visualization of select portions of the coil, or control mechanical properties such as enhancing the flexibility of an embolic coil for insertion into a small body lumen).
Seehusen et al. teaches a variety of grooves wherein the groove extends in a direction intersecting an extending direction of the wire (for example, figure 4, grooves 18), , the at least one groove extending around at least a portion of the 360 degrees circumferential extend of the outer surface of the elongated wire (for example, figures 1A, 4, 5, 7), wherein the groove is a spiral groove extending spirally along the direction of the wire so that the groove extends more than 360 degrees around the outer surface (for example, figure 9, helical grooves 18 along the axis), wherein the groove is one of a plurality of endless grooves that are separate from one another and axially spaced from one another along at least a portion of the longitudinal extend or extending direction of the elongated wire, (circumferential grooves, for example, figures 1A, 5, 7, spaced along the axis of wire), , the portion of the longitudinal extent of the elongated wire being a distal portion of the elongated wire (grooves may be formed on any portion along the wire as desired for flexibility or visualization, paragraphs 0030, 0075, 0081) each of the endless grooves being continuous over a circumferential direction of the wire (paragraph 0041, 0051, 0072; grooves extend around the circumference of body), and the plurality of endless grooves are spaced apart from one another along the extending direction of the wire (paragraph 0051, grooves 18 are spaced), wherein the groove is one of plural end grooves, each end groove extending less than 360 degrees around a circumference of the wire so that the end groove extends between and terminates at two ends (paragraph 0072, grooves 18 can extend only a part of a circumference), the plural end grooves being disposed at intervals along the extending direction of the wire (for example, figure 4, paragraph 0072), the groove including axially adjacent groove portions positioned at substantially equal intervals along the direction of the wire and over an entire region of the wire in the extending direction of the wire (for example, figures 1A, 4), each of the plural end grooves being located on the wire such that the plural end grooves are exposed on the outer peripheral surface side of the coil body (In combination, Seehusen et al. discloses grooves that were formed around all sides of the wire, for example, figure 1A, 4, 6, and would be configured to result in a configuration wherein the grooves are at least partially formed on the outer side when formed into the coil structure of Jones et al.), the groove including axially adjacent groove portions positioned at substantially equal intervals (for example, figures 1A, 4), a distal end portion of the coil body including flexible portions at portion of the wire where the grooves are formed, and the flexible portions are disposed at positions facing each other in a coil radial direction of the coil body and at different positions in a coil axis direction of the coil body (Examiner further notes that any configuration of grooves may be realized or adjusted to provide or control the desired visualization and flexibility as necessary along the embolic coil, paragraphs 0030, 0074-0076 and 0081).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify Jones et al. with at least one groove formed on a surface of the wire, wherein the groove is a spiral groove extending spirally along the direction of the wire, wherein the groove is one of a plurality of endless grooves, each of the endless grooves being continuous over a circumferential direction of the wire, and the plurality of endless grooves are spaced apart from one another along the extending direction of the wire, wherein the groove is one of plural end grooves, each end groove extending less than 360 degrees around a circumference of the wire so that the end groove extends between and terminates at two ends, the plural end grooves being disposed at intervals along the extending direction of the wire or the flexible portion or groves being at a distal end, as taught by Seehusen et al. to enhance visualization and/or modify the flexibility of an embolic coil for insertion into a small body lumen as desired.
Claim(s) 10, 19, 20 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. US 2017/0245865 in view of Seehusen et al. US 2009/0036768 and further in view of Sepetka et al. US 2017/0189033.
Regarding claim 10, Jones et al. in combination discloses the embolic coil essentially as claimed as discussed above, but fails to disclose a swellable body configured to swell by coming into contact with a body fluid, wherein the swellable body is: i) a tubular swellable body having an interior in which is positioned the coil body so that the tubular swellable body covers an outside of the coil body in the coil radial direction and an inner surface of the tubular swellable body faces toward an outer surface of the coil body: or ii) is a linear swellable body accommodated inside the coil body in the coil radial direction so that an inner surface of the coil body faces toward an outer surface of the linear swellable body.
Sepetka et al. teaches an occlusive embolic coil 36 further comprising a swellable body 34, the swellable body configured to swell by coming into contact with a body fluid (paragraph 0056, expands when exposed to blood) being a linear swellable body accommodated inside the coil body in the coil radial direction so that an inner surface of the coil body faces toward an outer surface of the linear swellable body (figures 11, 12; paragraph 0055, swellable body or hydrogel 34 is a string shaped to fit within the interior space of coil 36) or may also be placed on or around the hydrogel (paragraphs 0055, 0057 such as a tubular structure surrounding the coil).
Therefore, it would have been obvious to one having ordinary skill in the art to provide a disclose a swellable body configured to swell by coming into contact with a body fluid, wherein the swellable body is: i) a tubular swellable body having an interior in which is positioned the coil body so that the tubular swellable body covers an outside of the coil body in the coil radial direction and an inner surface of the tubular swellable body faces toward an outer surface of the coil body: or ii) is a linear swellable body accommodated inside the coil body in the coil radial direction so that an inner surface of the coil body faces toward an outer surface of the linear swellable body, as taught by Sepetka et al., to provide a body that will expand and fill the space surrounding the embolic coil.
Regarding claims 19, 20, and 23, Jones et al. discloses a method comprising moving a catheter toward an indwelling position in an inner cavity of a patient’s living body while an embolic coil is positioned inside the catheter (paragraph 0008, coil is delivered through a catheter to a target site), the embolic coil comprising a coil body in which a wire 72 extends spirally to include adjacent windings (figure 6), the wire possessing an outer surface (outer surface of wire 72), moving the embolic coil from inside the catheter to a position outside the catheter to deliver the embolic coil to the indwelling position in the inner cavity being a blood vessel or aneurysm (embolic coil implant for delivery into a vessel, aneurysm, or other location through a catheter, paragraph 0008), the moving of the embolic coil from inside the catheter to the position outside the catheter causing the coil body to form loops in the inner cavity (delivered within catheter in a linear configuration, once outside the catheter the coil body forms loops in the inner cavity, for example, shown deployed in similar embodiment figures 19, 20), and the wire having an axis and a transverse cross-section that is perpendicular to the axis of the wire, the transverse cross-section of the wire being a solid transverse cross-section (paragraph 0039, cross sectional shape of the wire is a circle, therefore a solid transverse cross section 75, figure 3).
Jones et al. fails to disclose the outer surface of the wire being provided with at least one groove or a swellable body configured to swell by coming into contact with a body fluid, wherein the swellable body is: i) a tubular swellable body having an interior in which is positioned the coil body so that the tubular swellable body covers an outside of the coil body in the coil radial direction and an inner surface of the tubular swellable body faces toward an outer surface of the coil body: or ii) is a linear swellable body accommodated inside the coil body in the coil radial direction so that an inner surface of the coil body faces toward an outer surface of the linear swellable body.
Seehusen et al. teaches forming medical devices such as embolic coils (paragraphs 0003, 0081), the embolic coils comprising a groove formed on a surface of the wire (paragraphs 0030, 0075, 0081; grooves can be designed to enhance visualization of select portions of the coil, or control mechanical properties such as enhancing the flexibility of an embolic coil for insertion into a small body lumen).
Sepetka et al. teaches an occlusive embolic coil 36 further comprising a swellable body 34, the swellable body configured to swell by coming into contact with a body fluid (paragraph 0056, expands when exposed to blood) being a linear swellable body accommodated inside the coil body in the coil radial direction so that an inner surface of the coil body faces toward an outer surface of the linear swellable body (figures 11, 12; paragraph 0055, swellable body or hydrogel 34 is a string shaped to fit within the interior space of coil 36) or may also be placed on or around the hydrogel (paragraphs 0055, 0057 such as a tubular structure surrounding the coil).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify Jones et al. with a groove formed on a surface of the wire, as taught by Seehusen et al. to enhance visualization and/or modify the flexibility of an embolic coil for insertion into a small body lumen, and with a swellable body configured to swell by coming into contact with a body fluid, wherein the swellable body is: i) a tubular swellable body having an interior in which is positioned the coil body so that the tubular swellable body covers an outside of the coil body in the coil radial direction and an inner surface of the tubular swellable body faces toward an outer surface of the coil body: or ii) is a linear swellable body accommodated inside the coil body in the coil radial direction so that an inner surface of the coil body faces toward an outer surface of the linear swellable body, as taught by Sepetka et al., to provide a body that will expand and fill the space surrounding the embolic coil.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones et al. US 2017/0245865 in view of Seehusen et al. US 2009/0036768 and further in view of Divino et al. US 9011480.
Regarding claim 21, Jones et al. further discloses a resin or metal wire member or a tubular member positioned inside the coil body and fixed relative to the coil body to constitute an elongation resistor that prevents excessive elongation of the coil body (paragraph 0008, stretch resistant members fixed to the coil to limit undesirable elongation).
Jones et al. fails to explicitly disclose the elongation resistor being a resin or metal wire member or a tubular member.
Divino et al. teaches an embolic coil further comprising an elongation resistor 1808 (figure 18) the elongation resistor being made of any suitable material including but not limited to polymers, metals, wires, tubes, filaments, braided filaments, coated filaments, combinations thereof, or the like (column 37, line 62- column 38, line 4).
Therefore, it would have been obvious to one having ordinary skill in the art to modify Jones et al. to provide the elongation resistor to be a metal wire or tubular member, as taught by Divino et al. as known in the art and an obvious substitute for providing a resistor that is able to restrict elongation of an embolic coil.
Conclusion
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/CHRISTINA C LAUER/ Examiner, Art Unit 3771
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