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
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Applicant's arguments filed 1/23/26 have been fully considered but they are not persuasive. Applicant argues that Michler et al. US 2007/0149988 discloses a tapered surface that is not continuous. However, a continuous surface is not required to be unchanged in diameter, but only uninterrupted along the surface. Michler et al. discloses an arcuate connecting portion (hinge 16, figure 8) connected to the first clamping portion 32 and the second clamping portion 34 and positioned at a first end of the occlusion device (figure 8), wherein the arcuate connecting portion has an outer surface that continuously connects a proximal end of the outer side of each of the first and second clamping portions to arcuate connecting portion and a continuous arcuate inner surface that continuously connects a proximal end of the inner side of each of the first and second clamping portions to the arcuate connecting portion (see annotated figure 8 below).
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.
Claims 56 and 57 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 56, the specification fails to explicitly disclose that the continuous arcuate surface is not tapered. The mere absence of a positive recitation is not basis for an exclusion. Any claim containing a negative limitation which does not have basis in the original disclosure should be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. MPEP 2173.05(I).
Regarding claim 57, 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.
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.
Claim(s) 1, 3-10, 12, 14-18, 21, 24, 26 and 56 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Michler et al. US 2007/0149988.
Regarding claim 1, Michler et al. teaches an occlusion device 30 for occluding a left atrial appendage extending from a lateral wall of a left atrium of a heart (paragraph 0011), the occlusion device comprising: a first clamping portion 32 configured for positioning along a first side of the left atrial appendage (figures 8, 9, paragraph 0033); and a second clamping portion 34 movably connected to the first clamping portion and configured for positioning along an opposite second side of the left atrial appendage while the first clamping portion is positioned along the first side (figures 8, 9; paragraph 0033); wherein the first clamping portion 32 and the second clamping portion 34 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 8 below); 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 8 below); 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), an arcuate connecting portion (hinge 16, figure 8) connected to the first clamping portion 32 and the second clamping portion 34 and positioned at a first end of the occlusion device (figure 8), wherein the arcuate connecting portion has an outer surface that continuously connects a proximal end of the outer side of each of the first and second clamping portions to arcuate connecting portion and a continuous arcuate inner surface that continuously connects a proximal end of the inner side of each of the first and second clamping portions to the arcuate connecting portion (see annotated figure 8 below).
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Regarding claim 3, Michler et al. discloses wherein the second clamping portion 34 and the first clamping portion 32 are not connected to one another at an opposite second end of the occlusion device (figure 8, open at side with end latch 14a).
Regarding claim 4, Michler et al. discloses wherein the occlusion device is configured to transition between an open configuration and a closed configuration (open configuration figure 8, closed configuration figure 9, open and closed with hinge 16, paragraph 0028).
Regarding claim 5, Michler et al. discloses wherein the connecting portion is configured to bias the occlusion device toward the closed configuration (may alternatively consider connecting portion on the second end 14a, therefore device is biased closed when the arcuate latch portion is closed).
Regarding claim 6, Michler et al. discloses wherein the connecting portion comprises a hinge (hinge 16, figure 8, paragraph 0028).
Regarding claim 7, Michler 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 (paragraph 0028, pivots with hinge 16).
Regarding claim 8, Michler et al. discloses the arcuate connecting portion defines a first connecting portion 16 connected to the first clamping portion 32 and the second clamping portion 34 (figure 8); and a second connecting portion 14a connected to the first clamping portion and the second clamping portion and positioned at an opposite second end of the occlusion device (figure 8, connected when latch 14a is closed); wherein the second clamping portion is movably connected to the first clamping portion via the first connecting portion and the second connecting portion (pivot from an open to closed position, paragraph 0028).
Regarding claim 9, Michler et al. discloses wherein the first clamping portion 32, the second clamping portion 34, the first connecting portion 16, and the second connecting portion form an enclosed loop defining an opening configured to receive the left atrial appendage therethrough (figure 9, when latch 14a is in the closed position around LAA 2).
Regarding claim 10, Michler et al. discloses wherein the occlusion device is configured to transition between an open configuration and a closed configuration (paragraph 0028, open configuration figure 8, closed configuration figure 9).
Regarding claim 12, Michler et al. discloses wherein the first connecting portion 16 and the second connecting portion 14a each have a curved shape (see annotated figure 8 below).
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Regarding claim 14 and 16, Michler et al. discloses wherein the inner sides and outer sides comprises planar surfaces having linear profiles viewed from a top side or a bottom side of the occlusion device (figure 8).
Regarding claims 15 and 17, Michler 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, wherein the outer sides comprise contoured surfaces having contoured profiles viewed from a top side or a bottom side of the occlusion device (device may additionally comprise a cover 18 formed around the first and second clamping portions, including on the inner surfaces, the cover being a material forming a contoured profile having varying densities to cushion when around tissue when clamped, paragraph 0031).
Regarding claim 18 and 21, Michler et al. discloses wherein the concave sides comprise concave surfaces having concave profiles viewed from a lateral side of the occlusion device (figure 9), and wherein the convex sides comprise convex surfaces having convex profiles viewed from a lateral side of the occlusion device (figure 9).
Regarding claim 24, Michler et al. discloses a fabric covering 18 extending over at least a portion of each of the first clamping portion and the second clamping portion (paragraphs 0013, 0031, flexible cover 18).
Regarding claim 26, Michler et al. discloses a method for occluding a left atrial appendage 2 extending from a lateral wall of a left atrium of a heart 1 (figure 9), the method comprising: causing an occlusion device to transition from a closed configuration (for example, figures 3, 9) to an open configuration (for example, figures 2, 8), wherein the occlusion device comprises: a first clamping portion 32 and a second clamping portion 34 movably connected to the first clamping portion (with hinge 16); wherein the first clamping portion and the second clamping portion each comprise: an inner side (see annotated figure 8 below); an outer side disposed opposite the inner side (see annotated figure 8 below); a concave side (see annotated figure 9 below); and a convex side disposed opposite the concave side (see annotated figure 9 below), wherein an arcuate connecting portion connects the first clamping portion and the second clamping portion and is positioned at a first end of the occlusion device (see annotated figure 8 below), wherein an outer surface of the connecting portion continuously connects a proximal end of the outer side of each of the first and second clamping portions to arcuate connecting portion and an arcuate inner surface of the connecting portion that continuously connects a proximal ends of the inner side of each of the first and second clamping portions to the arcuate connecting portion (see annotated figure 8 below), positioning the occlusion device relative to the left atrial appendage such that the first clamping portion is positioned along a first side of the left atrial appendage (for example, figures 5, 9) and the second clamping portion is positioned along an opposite second side of the left atrial appendage (for example, figures 5, 9); causing the occlusion device to transition from the open configuration (figures 2, 8) to a deployed configuration in which the occlusion device occludes the left atrial appendage (figures 5, 9) 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 (figures 5, 9), the outer sides of the first clamping portion and the second clamping portion each face away from the left atrial appendage (figures 5, 9), the concave sides of the first clamping portion and the second clamping portion each face away from the lateral wall 1 (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 1 (see annotated figure 9 below).
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Regarding claim 56, Michler et al. discloses wherein the continuous arcuate surface is not tapered relative to the inner side of the first and second clamping portions (Examiner notes the continuous arcuate surface may be considered to not be tapered, but instead may be considered a bent or non-linear surface extending to the inner side of the proximal end).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michler et al. US 2007/0149988 in view of Chin US 2008/0039879.
Regarding claim 11, Michler et al. discloses an occlusion device wherein the second connecting portion is configured to bias the occlusion device toward the closed configuration (with latch at second end 14a, figure 8), but fails to disclose wherein the first connecting portion and the connecting portion are configured to bias the occlusion device toward the closed configuration.
Chin et al. discloses an occlusion device (for example, figure 2M) comprising a first clamping portion 12a and a second clamping portion 12b, wherein a first connecting portion and a second connecting portion are configured to bias the occlusion device toward the closed configuration (first and second connecting portions maybe locking mechanisms 16 may be at each end of the device, when latched the device is biased to the closed configuration and locked, paragraphs 0105, 0115, 0116).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Michler et al. with a first and second connecting portion to bias the clamping portions toward a closed configuration, as taught by Chin et al. as is known to provide a first and/or second latch or biasing connecting member at each end of the occlusion device, so close the device around tissue.
Claim(s) 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michler et al. US 2007/0149988 in view of Thomas et al. US 2021/0378674.
Regarding claim 57, Michler 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.
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However, Thomas et al. discloses a similar ligation device comprising a first and second clamping portions (figure 8, 504, 506), 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 8 below, as the distal end of the clamping portion is tapered forming a second width that is less than the first width).
It would have been an obvious matter of design choice to modify the Michler 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, the distal end of the clamping portion is tapered forming a second width that is less than the first 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 designs.
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).
Claim(s) 11, 58 and 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michler et al. US 2007/0149988 in view of Glithero et al. US 2008/0208324.
Regarding claim 11, Michler et al. discloses an occlusion device wherein the second connecting portion is configured to bias the occlusion device toward the closed configuration (with latch at second end 14a, figure 8), but fails to disclose wherein the first connecting portion and the connecting portion are configured to bias the occlusion device toward the closed configuration.
Glithero et al. discloses an occlusion device (for example, figure 15) comprising a first clamping portion 1010 and a second clamping portion 1020, wherein a first connecting portion and a second connecting portion are configured to bias the occlusion device toward the closed configuration (paragraph 0089, hinge 1030 urges occlusion device toward the closed configuration with a spring force). Glithero et al. further teaches a latch at a distal end (for example, figure 17A) as known substitute for clamping tissue.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Michler et al. wherein the first connecting portion and the connecting portion are configured to bias the occlusion device toward the closed configuration, as taught by Glithero et al., and known in the art as a known substitute to provide spring loaded clamping portions biased to the closed configuration instead of a latch to clamp and secure tissue between the clamping portions.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Michler et al. with a first and second connecting portion to bias the clamping portions toward a closed configuration, as taught by Chin et al. as is known to provide a first and/or second latch or biasing connecting member at each end of the occlusion device, so close the device around tissue.
Regarding claim 58, Michler et al. discloses a device essentially as claimed as discussed above, but fails to disclose wherein: the first and second clamping portions are configured to transition between an open configuration and a closed configuration, and distal ends of the first and second clamping portions are not coupled in either the open or closed configuration.
Glithero et al. teaches an occluding device having a first and second clamping portions (clamping portions 1010, 1020) which are connected by an arcuate portion 1030 (figure 15), the first and second clamping portions are configured to transition between an open configuration and a closed configuration (figure 15 closed position, figure 16 open position), and distal ends of the first and second clamping portions are not coupled in either the open or closed configuration (figures 15, 16, clamp portions are only coupled on one end with connecting portion 1030 as they are spring biased to clamp tissue, paragraph 0089) Examiner notes Glithero et al. further teaches a latch at a distal end (for example, figure 17A) as known substitute for clamping tissue.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Michler et al. wherein: distal ends of the first and second clamping portions are not coupled in either the open or closed configuration, as taught by Glithero et al., and known in the art as a known substitute to provide spring loaded clamping portions instead of a latch to clamp and secure tissue between the clamping portions.
Regarding claim 59, Michler et al. discloses a device essentially as claimed as discussed above, but fails to disclose wherein a width of the outer surface of the connecting portion and a width of the first and second clamping portions in a 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 close configuration.
Glithero et al. teaches an occluding device having a first and second clamping portions (clamping portions 1010, 1020) which are connected by an arcuate portion 1030 (figure 15), the first and second clamping portions are configured to transition between an open configuration and a closed configuration (figure 15 closed position, figure 16 open position), wherein a width of the outer surface of the connecting portion and a width of the first and second clamping portions in a 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 close configuration (see annotated figure 15 below, Examiner notes the thickness of the arcuate portions and the distal ends of the clamping portions are the same width between the inner and outer surfaces, shown in figure 16, in the closed position the distal ends of the clamping portions are abutting each other while the arcuate portion 1030 has an open space, thereby provide a greater width).
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It would have been an obvious matter of design choice to modify the Michler et al., wherein a width of the outer surface of the connecting portion and a width of the first and second clamping portions in a 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 close configuration, 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 designs.
Furthermore, absent a teaching as to criticality that wherein a width of the outer surface of the connecting portion and a width of the first and second clamping portions in a 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 close configuration, 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