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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/25/26 has been entered.
Response to Arguments
Applicant's arguments filed 6/29/26 have been fully considered but they are not persuasive.
Applicant argues the prior art fails to disclose wherein the “convex and concave surfaces having complementary curvatures aligned with the curved longitudinal axis of the occlusion device” and correspond to the curvature of the left atrial appendage. Applicant argues Michler presents a device having a uniform profile rather than a series of distinct, interconnected surfaces as claimed. Michler relies on a securing mechanism rather than inherent bias towards a closed position having a smooth, continuous connection between the clamping portions and the connecting portions.
However, Glithero et al. discloses a device comprising a first and second clamping member and an arcuate connecting portion at the first end of the occlusion device (see annotated figure 16 below), 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 distal ends of the first and second clamping portions at the second end of the occlusion device are not coupled in either the open or closed configuration (paragraph 0088, 0089; spring force is applied, no latch required to secure tissue between the clamping members while biased toward each other, figures 15 and 16). Further, Glithero et al. teaches various mechanisms for closing the first and second clamping members, such as by a latch (figure 11) or alternatively biased closed with a spring mechanism (figures 13-16, paragraph 0088, 0089).
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Examiner notes Michler is only being used to modify Glithero et al. with the convex and concave surfaces in order to 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). Michler is not required to additionally comprise a connecting portion as claimed, as it is disclosed in Glithero et al. as discussed above.
Further, Examiner notes continuously and smoothly connects can mean a gradual taper or a smooth connection as they are seamless or not uninterrupted, or free of projections or lumps.
Therefore, in combination, the amendment fails to overcome the prior art of record.
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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 or relationships to one another. The figures, for example, Fig. 4A-4C do not clearly establish the width of the connecting portion is greater than the width of the first or second clamping portion, as the depicted widths are sufficiently similar that the claimed relationship cannot be reliably ascertained from the figures. Further, the specification indicates the relative dimensional relationships may differ from those illustrated in the drawings. Accordingly, there is not sufficient support or explicit relationships for those dimensions or written description for the subject matter.
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 or relationships to one another. The figures, for example, Fig. 4A-4C do not clearly establish the width of the connecting portion is greater than the width of the first or second clamping portion, as the depicted widths are sufficiently similar that the claimed relationship cannot be reliably ascertained from the figures. Further, the specification indicates the relative dimensional relationships may differ from those illustrated in the drawings. Accordingly, there is not sufficient support or explicit relationships for those dimensions or written description for the subject matter.
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 3, 20, 21, 23 and 24 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 3 recites wherein the second clamping portion and the first clamping portion are not connected to one another at the second end of the occlusion device. This language is unclear as Claim 1 discloses “wherein the distal ends of the first and second clamping portions at the second end of the occlusion device are not coupled”. This language appears to be the same second end of the occlusion device which are not coupled and not connected. It is unclear as to how the “not connected” is different than the “not coupled”.
Claim 20 recites the limitation "the connecting portion" in line 24. There is insufficient antecedent basis for this limitation in the claim. Examiner notes the limitation should be changed to “the arcuate connecting portion” to be consistent with the claims.
Claim 21 recites the limitation "the connecting portion" in lines 1 and 5. There is insufficient antecedent basis for this limitation in the claim. Examiner notes the limitation should be changed to “the arcuate connecting portion” to be consistent with the claims.
Claim 23 recites the limitation "the connecting portion" in lines 2 and 5. There is insufficient antecedent basis for this limitation in the claim. Examiner notes the limitation should be changed to “the arcuate connecting portion” to be consistent with the claims.
Claim 24 recites the limitation "the connecting portion" in lines 2 and 6. There is insufficient antecedent basis for this limitation in the claim. Examiner notes the limitation should be changed to “the arcuate connecting portion” to be consistent with the claims.
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, 3-10, 13, 15, 17-23 and 25 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, 22 and 25, Glithero et al. discloses a method for occluding a left atrial appendage extending from a lateral wall of a left atrial of a heart (paragraph 0002), 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) along a first direction parallel to a curved longitudinal axis of the occlusion device (figure 16, curved longitudinal axis along the curved clamping portions), 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);
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) along the first direction parallel to a curved longitudinal axis of the occlusion device (figure 16, curved longitudinal axis along the curved clamping portions), 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 at the second end of the occlusion device are not coupled in either the open or closed configuration (paragraph 0088, 0089; spring force is applied, no latch required to secure tissue between the clamping members while biased toward each other, figures 15 and 16);
wherein the first clamping portion and the second clamping portion each comprise:
an inner surface configured to face toward the left atrial appendage when the occlusion device is in a deployed configuration (see annotated figure 16 below, inner surface faces the left atrial appendage when placed between the first and second clamping members);
an outer surface disposed opposite the inner surface 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 surface faces away from tissue placed within the first and second clamping members);
wherein the arcuate connecting portion has an outer surface that continuously and smoothly connects (Examiner notes continuously and smoothly connects can mean a gradual taper or a smooth connection as they are seamless or not uninterrupted, or free of projections or lumps, figures 15, 16) the proximal end of the outer surface 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 surface 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 surfaces 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 surfaces 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 disclose a concave surface of the first clamping portion and the second clamping portion each are configured to face away from the lateral wall when the occlusion device is in the deployed configuration; said concave surface extending between the inner surface and the outer surface; and
a convex surface disposed opposite the concave surface, extending between the inner surface and the outer surface, and configured to face toward the lateral wall when the occlusion device is in the deployed configuration, the convex and concave surfaces having complementary curvatures aligned with the curved longitudinal axis of the occlusion device and 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 surface has 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 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, the concave surfaces of the first clamping portion and the second clamping portion each face away from the lateral wall, and the convex surfaces of the first clamping portion and the second clamping portion each face toward the lateral wall; wherein the concave surface and the convex surfaces are each smooth, continuous surfaces having concave and convex profiles, respectively viewed from a lateral side of the occlusion device; 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 surfaces 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); said concave surface extending between the inner and outer surface (see annotated figures 8, 9 below); and a convex surface disposed opposite the concave surface, extending between the inner surface and the outer surface (see annotated figures 8, 9 below), and configured to face toward the lateral wall when the occlusion device is in the deployed configuration (see annotated figure 9 below), the convex and concave surfaces have complementary curvatures corresponding aligned with the curved longitudinal axis of the occlusion device and 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 surface has 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 surface has 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), 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); wherein the concave surface and the convex surfaces are each smooth, continuous surfaces (Examiner notes the continuously and smoothly does not mean there are not tapered portion, but can mean a gradual taper or a smooth connection as they are seamless or not uninterrupted) having concave and convex profiles, respectively (figure 9) viewed from a lateral side of the occlusion device (figure 9); 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 surface configured to face away from the lateral wall when the occlusion device is in the deployed configuration; and a convex surface disposed opposite the concave surface and configured to face toward the lateral wall when the occlusion device is in the deployed configuration, the convex surfaces 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 surface has a concave profile viewed from a lateral side of the occlusion device, the concave surface extending along at least a majority of a length of the clamping portion, wherein the convex surface has 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 convex surface has convex profiles viewed from a lateral side of the occlusion device, the concave surfaces of the first clamping portion and the second clamping portion each face away from the lateral wall, and the convex surfaces 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 surface 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 3, Glithero et al. discloses wherein the second clamping portion and the first clamping portion are not connected to one another at the 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, figure 15).
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 surface, the outer surface, the concave surface, and the convex surface configured to receive the left atrial appendage therethrough (paragraph 0066, positioned on the inner surface 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 surfaces are planar and have 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 15, Glithero et al. disclose wherein the outer surfaces 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 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).
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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 surfaces 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).
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 width of the connection portion is defined between the outer surface and inner surface, a width of the first or second clamping portions is defined between the inner surface and the outer surface, and the width of the connecting portion is greater than the width of the first or second clamping portions.
However, Chin et al. discloses a similar ligation device comprising a first and second clamping portions (figure 13B, arms 170), wherein: a width of the connection portion is defined between the outer surface and inner surface, a width of the first and second clamping portions is defined between the inner surface and the outer surface, and the width of the connecting portion is greater than the width of the first or second clamping portions (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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
