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) 1-10 and 13-22 have been considered but are moot because the new ground of rejection over Glithero et al. US 2008/0208324 in view of Michler et al. US 2007/0149988 as discussed below. Claims 23 and 24 are newly added.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 24 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 24, the specification fails to explicitly disclose wherein: a first width of the connection portion is defined between the outer surface and inner surface, a second width of the first and second clamping portions is defined between the inner side and the outer side, and the first width is greater than the second width. Examiner notes the figures disclose a first and second width, but do not disclose explicit dimensions. The figures do not provide sufficient support for those dimensions, for example, the second width between the inner side and the outer side adjacent to the connecting portion appear to be larger in width than at the end of the clamping portions, and are not consistent. Without explicit dimensions, the specification fails to disclose written description for the subject matter as it is unclear as to the exact widths of each portion from the drawings.
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) 1-10 and 13-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glithero et al. US 2008/0208324 in view of Michler et al. US 2007/0149988.
Regarding claims 1, 10, 17, 18, 20 and 22, Glithero et al. discloses a method for occluding a left atrial appendage extending from a lateral wall of a left atrial of a heart, the method comprising: causing an occlusion device to transition from a closed configuration to an open configuration (figures 13, 15, 16, Examiner notes various embodiments may read on the claim language such as clip 900, but will refer to clip 1000 below), wherein the occlusion device for occluding a left atrial appendage extending from a lateral wall of a left atrium of a heart (paragraphs 0002, 0067), the occlusion device comprising: a first clamping portion 1010 extending from a first end of the occlusion device to a second end of the occlusion device (see figure 16 below), the first clamping portion configured for positioning along a first side of the left atrial appendage (left atrial appendage positioned between clamping portions 1010 and 1020); and a second clamping portion 1020 movably connected to the first clamping portion and extending from the first end of the occlusion device to the second end of the occlusion device (see annotated figure 16 below), the second clamping portion configured for positioning along an opposite second side of the left atrial appendage while the first clamping portion is positioned along the first side (left atrial appendage positioned between clamping portions 1010 and 1020); an arcuate connecting portion at the first end of the occlusion device (see annotated figure 16 below), the arcuate connecting portion extending between and connecting proximal ends of the first and second clamping portions (figures 15, 16), and biasing the first and second clamping portions toward a closed configuration (paragraph 0089, upper and lower clamping members are urged together with spring force of arcuate member 1030); wherein the first and second clamping portions are configured to transition between an open configuration (figure 16) and the closed configuration (figure 15), wherein distal ends of the first and second clamping portions are not coupled in either the open or closed configuration (spring force is applied, no latch required to secure tissue between the clamping members); wherein the first clamping portion and the second clamping portion each comprise: an inner side configured to face toward the left atrial appendage when the occlusion device is in a deployed configuration (see annotated figure 16 below, inner side faces the left atrial appendage when placed between the first and second clamping members); an outer side disposed opposite the inner side and configured to face away from the left atrial appendage when the occlusion device is in the deployed configuration (see annotated figure 16 below, outer side faces away from tissue placed within the first and second clamping members); wherein the arcuate connecting portion has an outer surface that continuously connects the proximal end of the outer side of each of the first and second clamping portions to the arcuate connecting portion and an inner surface that continuously connects the proximal end of the inner side of each of the first and second clamping portions to the arcuate connecting portion (outer surface and inner surfaces along the outer side and inner sides extend continuously between the second distal end to the arcuate portion at the first proximal end, figures 15 and 16), positioning the occlusion device relative to the left atrial appendage (paragraph 0002, anatomical structure such as the LAA, paragraph 0089 clamping members placed around anatomical structure) such that the first clamping portion is positioned along a first side of the left atrial appendage and the second clamping portion is positioned along an opposite second side of the left atrial appendage (paragraph 0089 clamping members placed on either side of the LAA); causing the occlusion device to transition from the open configuration (figure 16) to a deployed configuration in which the occlusion device occludes the left atrial appendage (figure 15, paragraph 0089, closed configuration placed around tissue with clamping spring force), wherein, when the occlusion device is in the deployed configuration, the inner sides of the first clamping portion and the second clamping portion each face toward the left atrial appendage (clamping members 1010 and 1020 placed on either side of LAA), the outer sides of the first clamping portion and the second clamping portion each face away from the left atrial appendage (see annotated figure 16 below, outer side faces away from tissue placed within the first and second clamping members).
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Glithero et al. fails to discloses a first direction parallel to a curved longitudinal axis of the occlusion device, a concave side configured to face away from the lateral wall when the occlusion device is in the deployed configuration; and a convex side disposed opposite the concave side and configured to face toward the lateral wall when the occlusion device is in the deployed configuration, the convex sides having curvatures corresponding to a curvature of the left atrial appendage such that when the occlusion device is in the deployed configuration, the occlusion device is configured to completely occlude the left atrial appendage so as to prevent formation of a residual stump of the atrial appendage, wherein the concave side comprises a concave surface having a concave profile viewed from a lateral side of the occlusion device, concave surface extending along at least a majority of a length of the clamping portion, wherein the convex side comprises a convex surface having a convex profile viewed from a lateral side of the occlusion device the convex surface extending along at least a majority of a length of the clamping portion, wherein the concave sides comprise concave surfaces having concave profiles viewed from a lateral side of the occlusion device, wherein the convex sides comprise convex surfaces having convex profiles viewed from a lateral side of the occlusion device, the concave sides of the first clamping portion and the second clamping portion each face away from the lateral wall, and the convex sides of the first clamping portion and the second clamping portion each face toward the lateral wall; and preventing formation of a residual stump of the left atrial appendage by positioning the occlusion device in contact with the left atrial appendage such that the convex sides contact the curvature of the left atrial appendage, thereby completely occluding the left atrial appendage, wherein preventing formation of a residual stump of the left atrial appendage prevents thrombosis therein.
Michler et al. discloses a first direction parallel to a curved longitudinal axis of the occlusion device, a concave side configured to face away from the lateral wall when the occlusion device is in the deployed configuration (see annotated figure 9 below); and a convex side disposed opposite the concave side and configured to face toward the lateral wall when the occlusion device is in the deployed configuration (see annotated figure 9 below), the convex sides having curvatures corresponding to a curvature of the left atrial appendage such that when the occlusion device is in the deployed configuration, the occlusion device is configured to completely occlude the left atrial appendage so as to prevent formation of a residual stump of the atrial appendage (paragraph 0033, figure 9, arc shape members 32, 34 to allow for closer clamping of the LAA to the heart), wherein the concave side comprises a concave surface having a concave profile viewed from a lateral side of the occlusion device (figure 9), concave surface extending along at least a majority of a length of the clamping portion (figure 9), wherein the convex side comprises a convex surface having a convex profile viewed from a lateral side of the occlusion device (figure 9), the convex surface extending along at least a majority of a length of the clamping portion (figure 9), wherein the concave sides comprise concave surfaces having concave profiles viewed from a lateral side of the occlusion device (figure 9, surface along concave surface), wherein the convex sides comprise convex surfaces having convex profiles viewed from a lateral side of the occlusion device (figure 9, surface along concave side), the concave sides of the first clamping portion and the second clamping portion each face away from the lateral wall (see annotated figure 9 below), and the convex sides of the first clamping portion and the second clamping portion each face toward the lateral wall (see annotated figure 9 below); and preventing formation of a residual stump of the left atrial appendage by positioning the occlusion device in contact with the left atrial appendage such that the convex sides contact the curvature of the left atrial appendage (paragraph 0033, figure 9, arc shape members 32, 34 to allow for closer clamping of the LAA to the heart), thereby completely occluding the left atrial appendage, wherein preventing formation of a residual stump of the left atrial appendage prevents thrombosis therein (paragraph 0014, 0026, 0030, 0033, first and second members close each other to compress the LAA to help prevent thrombi).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Glithero et al. with a first direction parallel to a curved longitudinal axis of the occlusion device, a concave side configured to face away from the lateral wall when the occlusion device is in the deployed configuration; and a convex side disposed opposite the concave side and configured to face toward the lateral wall when the occlusion device is in the deployed configuration, the convex sides having curvatures corresponding to a curvature of the left atrial appendage such that when the occlusion device is in the deployed configuration, the occlusion device is configured to completely occlude the left atrial appendage so as to prevent formation of a residual stump of the atrial appendage, wherein the concave side comprises a concave surface having a concave profile viewed from a lateral side of the occlusion device, concave surface extending along at least a majority of a length of the clamping portion, wherein the convex side comprises a convex surface having a convex profile viewed from a lateral side of the occlusion device the convex surface extending along at least a majority of a length of the clamping portion, wherein the concave sides comprise concave surfaces having concave profiles viewed from a lateral side of the occlusion device, wherein the convex sides comprise convex surfaces having convex profiles viewed from a lateral side of the occlusion device, the concave sides of the first clamping portion and the second clamping portion each face away from the lateral wall, and the convex sides of the first clamping portion and the second clamping portion each face toward the lateral wall; and preventing formation of a residual stump of the left atrial appendage by positioning the occlusion device in contact with the left atrial appendage such that the convex sides contact the curvature of the left atrial appendage, thereby completely occluding the left atrial appendage, wherein preventing formation of a residual stump of the left atrial appendage prevents thrombosis therein, as taught by Michler et al., to allow for closer clamping of the LAA to the heart and prevent formation of a residual stump, and first and second members close each other to compress the LAA to help prevent thrombi.
Regarding claim 2, Glithero et al. in combination with Michler et al. discloses wherein the second clamping portion is movably connected to the first clamping portion via the arcuate connecting portion 1030 (figure 15) wherein the arcuate connecting portion comprises a first flat surface extending between the convex side of each of the first and second clamping portions and configured to face toward the left atrial appendage (paragraph 0089, although shown having a generally curved shape, upper clamping member 1010 and lower clamping member 1020 may be generally straight or have any other suitable configuration, see annotated figure 15 below), and an opposite second flat surface extending between the concave side of the each of the first and second clamping portions and configured to face away from the left atrial appendage (see annotated figure 15 below) wherein the first and second clamping portions each include a first flat surface extending from the convex side toward the distal end of the clamping portion (see annotated figure 15 below), the first flat surface configured to face toward the left atrial appendage and an opposite second flat surface configured to face away from the left atrial appendage (see annotated figure 15 below), wherein the first flat surface of the arcuate connection portion extends in the same plane as the first flat surface of each of the first and second clamping portions (see annotated figure 15 below) Examiner notes the convex and concave sides in the center of the device as modified with Michler et al. will result in the claimed structure.
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Regarding claim 3, Glithero et al. discloses wherein the second clamping portion and the first clamping portion are not connected to one another at the opposite second end of the occlusion device in both the open and closed configuration (figures 15, 16, paragraph 0089, spring closed).
Regarding claim 4, Glithero et al. discloses wherein a spacing between the distal ends of the first and second clamping portions in the closed configuration (figure 15, clamping portions abut or have a minimal space) is less than a spacing between the distal ends of the first and second clamping portions in the open configuration (figure 16, ends spaced apart or open to receive tissue).
Regarding claim 5, Glithero et al. discloses wherein in the closed configuration, the distal ends of the first and second clamping portions do not contact (clamping portions are configured not to contact, but only being spring biased closed when tissue is placed therebetween).
Regarding claim 6, Glithero et al. discloses wherein the arcuate connecting portion comprises a hinge (figure 15, hinge or urging member 1030).
Regarding claim 7, Glithero et al. discloses wherein the second clamping portion and the first clamping portion are configured to pivot relative to one another as the occlusion device is transitioned between the open configuration and the closed configuration (figures 15 and 16, pivot from open to closed configuration with urging member 1030).
Regarding claims 8, 9, and 19, Glithero et al. discloses a fabric covering over at least a portion of each of the first clamping portion and the second clamping portion (paragraph 0066, occlusion device may include a sock configured to cover the occlusion device, the sock being a knit, braided or fabric material), wherein the fabric covering extends over at least a portion of each of the inner side, the outer side, the concave side, and the convex side configured to receive the left atrial appendage therethrough (paragraph 0066, positioned on the inner side to facilitate scar tissue and secure in place, shown in similar embodiment with sock 1150 extending around the first and second clamping portions and connecting portion, figures 18B).
Regarding claim 13, Glithero et al. disclose wherein the inner sides comprise planar surfaces having linear profiles viewed from a top side or a bottom side of the occlusion device (paragraphs 0087, 0089, although shown having a generally curved shape, upper clamping member and lower clamping member may be generally straight or have any other suitable configuration). Examiner notes first and second clamping portion having a straight configuration will result in a linear profile.
Regarding claim 14, Glithero et al. discloses wherein the inner sides comprise contoured surfaces having contoured profiles viewed from a top side or a bottom side of the occlusion device (paragraph 0066, components of an occlusion device may be provided with a textured surface, or some other device or configuration may be used to provide results similar to those provided by a sock).
Regarding claim 15, Glithero et al. disclose wherein the outer sides comprise planar surfaces having linear profiles viewed from a top side or a bottom side of the occlusion device (paragraphs 0087, 0089, although shown having a generally curved shape, upper clamping member and lower clamping member may be generally straight or have any other suitable configuration). Examiner notes first and second clamping portion having a straight configuration will result in a linear profile.
Regarding claim 16, Glithero et al. discloses wherein the outer sides comprise contoured surfaces having contoured profiles viewed from a top side or a bottom side of the occlusion device (paragraph 0066, components of an occlusion device may be provided with a textured surface, or some other device or configuration may be used to provide results similar to those provided by a sock).
Regarding claim 21, Glithero et al. discloses wherein the connecting portion is configured to bias the occlusion device toward the closed configuration (paragraph 0089, connecting portion 1030 is configured such that a spring force is applied to upper clamping member and lower clamping member urging occlusion device toward a closed configuration), wherein causing the occlusion device to transition from the closed configuration to the open configuration comprises applying an external force to the occlusion device to overcome a biasing force provided by the connecting portion (paragraph 0089, spring biased closed, thereby will require an external force to open).
Regarding claim 23, Glithero et al. discloses wherein a width of the outer surface of the connecting portion and a width of the first and second clamping portions in the closed configuration is measured when viewed from a top side or a bottom side of the occlusion device, and the width of the outer surface of the connecting portion is greater than a width of the device between the outer sides of the first and second clamping portions in the closed configuration (see annotated figure 15 below, width of the individual for and second clamping portion and the connecting portion is generally equal, therefore, when closed the distal end of the clamping portions abut or are close to one another, while the connecting portion has a space therebetween, resulting in a larger width of profile, see annotated figure 15 below).
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Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glithero et al. US 2008/0208324 in view of Michler et al. US 2007/0149988 and further in view of Chin et al. US 2008/0039879.
Regarding claim 24, Glithero et al. discloses a device essentially as claimed as discussed above, but fails to disclose wherein: a first width of the connection portion is defined between the outer surface and inner surface, a second width of the first and second clamping portions is defined between the inner side and the outer side, and the first width is greater than the second width.
However, Chin et al. discloses a similar ligation device comprising a first and second clamping portions (figure 13B, arms 170), wherein: a first width of the connection portion is defined between the outer surface and inner surface, a second width of the first and second clamping portions is defined between the inner side and the outer side, and the first width is greater than the second width (see annotated figure 13B below).
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It would have been an obvious matter of design choice to modify the Glithero et al., to have a first width of the connection portion is defined between the outer surface and inner surface, a second width of the first and second clamping portions is defined between the inner side and the outer side, and the first width is greater than the second width, since applicant has not disclosed that having those particular dimensions solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design.
Furthermore, absent a teaching as to criticality that the first width of the connection portion is defined between the outer surface and inner surface, a second width of the first and second clamping portions is defined between the inner side and the outer side, and the first width is greater than the second width, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
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.C.L/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771