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 .
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
In regard to claim 1, the alternative measurement in inches in parenthesis is not necessary and should be removed as it is not clear if the portion in parenthesis is being recited.
Appropriate correction is required.
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, 3-11, 13-15, 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Center (2015/0005810A1 ).
In regard to claim 1, Center teaches an implantable medical device (see embodiment in Figs, 1-9, device frame, 100, para 0100; also see embodiments in Figs. 7A-B, disc shaped member, 670, para 0128 and Figs. 9A-B, disc-shaped member, 690, para 0136), comprising:
an expandable frame movable (Fig. 1, occlusion frame, 102, para 0100 see also para 0005; see also, Fig. 7A, first frame portion, 670, para 0128 and Fig. 9A, first frame portion, 690, para 0136)
between a collapsed configuration (Fig. 8A, para 0020, see also para 0099 )
for delivery and an expanded configuration (Fig. 8B, para 0021, see also para 0099) for deployment,
the expandable frame comprising:
a first central member (Fig. 2, first hub component, 118, para 0103; see also annotated Fig. 7A and Fig. 9A);
and a first grouping of arcuate articulating members jointed at respective first ends (see below, annotated Fig. 2, AR, para 0100; see also, Fig 7A. and Fig. 9A, where frame members are defined as petal shaped, para 0132 and para 0137; jointed together at the bottom portion of 118 in figure 2) to the first central member (Fig. 2, first hub component, 118, in combination with connecting member, 122, para 0103; see also annotated Fig. 7A and Fig. 9A),
each of the first grouping of arcuate articulating members (see below, annotated Fig. 2, occlusion frame, 102, in combination with AR, para 0103; see also embodiments 7A, Fig. 9A)
extending outwardly from and curving about the first central member (Fig. 2, first hub component, 118 para 0103; see below, annotated Fig. 7A and annotated Fig. 9A, curve somewhat around 118 via the loops); and a covering (para 0100; see also Fig. 7B, covering, 668, para 0132 and Fig. 9A, covering, 698, para 0136)
and a thickness orthogonal to the width ranging from 0.013 to 0.31 millimeters (.0005 to .012 inches) [0120: .009” to .030”] and a covering disposed relative to the first grouping of arcuate articulating members (Fig. 1, occlusion frame, 103, para 0100; ; see also, Fig. 7A, first frame portion, 670, para 0128 and Fig. 9A, first frame portion, 690, para 0136).
However, while Center teaches that the widths of the petal shaped spokes can be selected as desired [0130], Center remains silent to the exact widths.
It has been held that a mere change in size of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed for each of the first grouping of arcuate articulating members to have a width ranging from 3 to 8 millimeters. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04IVA
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In regards to claim 3, Center further teaches wherein the expandable frame is biased into the expanded configuration (para 0099) for deployment, and is moved into the expanded configuration by removing a constraint (para 0096, delivery sheath) that holds the expandable frame (Fig. 1, occlusion frame, 102, para 0100, also see embodiments in Figs. 7A-B, disc shaped member, 670, para 0128 and Figs. 9A-B, disc-shaped member, 690, para 0136) in the collapsed configuration for delivery (para 0096, delivery sheath, can be retracted during deployment).
In regards to claim 4, Center further teaches wherein the covering (Fig. 4A, covering component, 156, para 0110, teaches it attaches to elongate frame members) extends over the first grouping of arcuate articulating members (Fig. 4A, occlusion frame, 152, disclose made of elongate frame members, para 0109-0110).
In regards to claim 5, Center further teaches wherein the first grouping of arcuate articulating members (Fig. 1, occlusion frame, 102, para 0100) is formed of a shape memory material (para 0106, teaches occlusion frame made of nitinol inherently known to have shape memory properties).
In regards to claim 6, Center further teaches wherein the first grouping of arcuate articulating members (Fig. 1, occlusion frame, 102, para 0100) is adapted to have a remembered shape (para 0119) corresponding to the expanded configuration of the expandable frame (Para 0119, teaches elongate members collapse and elongate to pre-formed shape).
In regards to claim 7, Center further teaches wherein the expandable frame (Fig. 7A/B, disc shaped member, 670, para 0128) further comprises:
a second central member (see below, annotated Fig. 7A, 2nd hub, para 0128, see also annotated Fig. 9A, 2nd hub, para 0136) ;
and a second grouping of arcuate articulating members (Fig. 7B, second frame portions, 672, para 0131, see also Fig. 9A, 2nd frame, 694, para 0136 ) joined at respective first ends to the second central member (fig 7A-B), each of the second grouping of arcuate articulating members extending outwardly from and curving about the second central member (see below, annotated Fig. 7A-B, 2nd hub, para 0128).
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In regards to claim 8, Center further teaches wherein the second central member (see above, annotated Fig. 7A, 2nd hub, para 0128) is coaxial (see above, 1st hub in combination with 2nd hub, para 0128) with the first central member (see above, annotated Fig. 7A, 1st hub, para 0128).
In regards to claim 9, Center further teaches, wherein the first grouping of arcuate articulating members curve in a first direction (Fig. 7B, first frame portions, 674, para 0131, where first direction is interpreted as clockwise) and the second grouping of arcuate articulating members curve (Fig. 7B, second frame portions, 672, para 0131, where second direction is interpreted as counterclockwise) in a second direction that is opposite the first direction (Fig. 7A/B, discloses that first frame portion, 674, is the mirror image of second frame portion, 672, para 0131).
In regards to claim 10, Center further teaches wherein the first grouping of arcuate articulating members (Fig. 7B, first frame portion, 6674, para 0131) and the second grouping of arcuate articulating (Fig. 7B, second frame portions, 672, para 0131) members curve in the same direction (Fig. 9A/B, second frame portion, 694, in combination with first frame portion, 692, para 0137, teaches no such mirror offset exists so spokes with same direction are used).
In regards to claim 11, Center further teaches wherein the first grouping of arcuate articulating members (Fig. 7B, first frame portion, 6674, para 0131) and the second grouping of arcuate articulating (Fig. 7B, second frame portions, 672, para 0131) members curve in the same direction (Fig. 9A/B, second frame portion, 694, in combination with first frame portion, 692, para 0137, teaches no such mirror offset exists so spokes with same direction are used) but are circumferentially offset from one another (para 0101, teaches referenced embodiments can be eccentric about the longitudinal axis; as shown in figures 7A-B, the second group of arcuate articulating members are not directly above one another and are therefore circumferentially offset from one another).
In regards to claim 13, Center further teaches comprising a plurality of anchor members (Fig. 2, anchor members, 114, para 0100) secured relative to at least some of the first grouping of arcuate articulating members (see below, annotated Fig. 2, AR, para 0100) .
In regards to claim 14, Center further teaches comprising an LAAC (left atrial appendage closure) device (Fig. 22A/B, device, 400, para 0165).
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In regards to claim 15, Center teaches a left atrial appendage closure (LAAC) device (Fig. 25, device, 600, para 0169, stated to be the same as occlusion frame, 102; and therefore includes the embodiments in Figs. 1-7 also), comprising:
an expandable frame (Fig. 35A/B-36A/B, occlusion frame, 760, para 0191) movable between a collapsed configuration (Fig. 8A, para 0020) for delivery and an expanded configuration (Fig. 8B, para 0021) for deployment, the expandable frame comprising:
a central member (Fig. 22A, first hub component, 410, in combination with flexible linkage, 406, para 0167);
and a grouping of arcuate articulating members (see below, annotated Fig. 7A, para 0165) joined at respective first ends to the central member (fig 7A), each of the grouping of arcuate articulating members extending outwardly from and curving about the central member (see below, annotated Fig. 22A) each of the grouping of arcuate articulating members having a width that is greater than a thickness thereof;
and a covering (para 0100, discloses covering component over occlusion frame) disposed relative to the grouping of arcuate articulating members.
While Center teaches the widths can be selected as desired [0130], Center does not teach each of the arcuate articulating members having a width that is greater than a thickness thereof.
It has been held that a mere change in size or proportions of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have each of the arcuate articulating members having a width that is greater than a thickness thereof. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04IVA
In regards to claim 17, Center further teaches wherein the expandable frame (Fig. 25, device, 600, para 0169) is biased into the expanded configuration for deployment, and is moved into the expanded configuration (Fig. 8B, para 0021) by removing a constraint (para 0096, delivery sheath) that holds the expandable frame in the collapsed configuration for delivery (para 0096, delivery sheath, can be retracted during deployment).
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In regards to claim 18, A left atrial appendage closure (LAAC) device (Fig. 25, device, 600, para 0169, which is the same as embodiments in Figs. 1-7, 8 and 9A-B, and therefore includes all the features of embodiments in Figs. 1-9), comprising:
an expandable frame (Fig. 1, occlusion frame, 102, para 0100 see also para 0005) movable between a collapsed configuration (Fig. 8A, para 0020) for delivery and an expanded configuration (Fig. 8B, para 0021) for deployment, the expandable frame comprising:
a first central member (see above, annotated Fig. 7A, 1st hub, para 0128);
a first grouping of arcuate articulating members (Fig. 7B, first frame portions, 672, para 0131) joined at respective first ends (fig 7A-B; joined at the central member by first ends), each of the first grouping of arcuate articulating members extending outwardly from and curving about the first central member (see above, annotated Fig. 7A);
a second central member (see above, annotated Fig. 7A, 2nd hub, para 0128);
a second grouping of arcuate articulating members (Fig. 7B, second frame portions, 674, para 0131) joined at respective second ends to the second central member (fig 7A-B), each of the second grouping of arcuate articulating members extending outwardly from and curving about the second central member (see above, annotated Fig. 7B, 2nd hub in combination with second frame portions, 674, para 0131);
and a covering disposed relative to the first grouping and second grouping of arcuate articulating members (Fig. 7B, covering, 668, para 0132). Disposed relative to does not appear to be a particular arrangement.
While Center teaches the widths can be selected as desired [0130], Center does not teach each of the second grouping of arcuate articulating members having a width that is greater than a thickness thereof.
It has been held that a mere change in size or proportions of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have each of the second grouping of arcuate articulating members having a width that is greater than a thickness thereof. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04IVA
In regards to claim 19, Center further teaches wherein the first grouping of arcuate articulating members curve in a first direction (Fig. 7B, first frame portions, 672, para 0131, where first direction is interpreted as clockwise) and the second grouping of arcuate articulating members curve in a second direction (Fig. 7B, second frame portions, 674, para 0131, where second direction is interpreted as counterclockwise) that is opposite the first direction.
In regards to claim 20, Center further teaches wherein the first grouping of arcuate articulating members (Fig. 9A/B, first frame portion, 692, para 0137) and the second grouping of arcuate articulating members (Fig. 9A/B, second frame portion, para 0137) curve in the same direction (para 0137, teaches no such mirror offset exists so spokes with same direction are used.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0005810 A1 (hereinafter, "Center") as applied to claims 1-11 above, and further in view of US 2009/0099647 A1 (hereinafter, “Glimsdale”).
In regards to claim 12, Center teaches the implantable medical device (Fig, 1, device frame, 100, para 0100) of claim 7, wherein the expandable frame (Fig. 7A/B, disc shaped member, 670, para 0128) further comprises:
a grouping of arcuate articulating members (Fig. 7A/B, second frame portion, 672, para 0131) joined at one end to the second central member (see above, annotated Fig. 7A, 2nd hub, para 0128) , each of the plurality of arcuate articulating members extending outwardly from the central member (see above, annotated Fig. 7A, 2nd hub in combination with second frame portion, para 0128).
However, Center does not explicitly teach the third group of articulating members.
Glimsdale teaches an intravascular device (para 0004) that further comprises a third central member (Fig. 14A, outer cylindrical section, 136, para 0082)
and a third grouping of articulating members (Fig. 14A, flange, 130, para 0082) joined at respective first ends to the second central member (Fig. 14A, internal section, 134, in combination with flange, 130, para 0082), each of the third grouping of arcuate articulating members extending outwardly (Fig. 14A, flange, 130, para 0082) and curving about the third central member (Fig. 14A, outer cylindrical section, 136, para 0082).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the expandable frame with articulating members of Center, to include three groups as taught but Glimsdale to allow for each component to be fabricated differently, or have a variety of anchoring properties (para 0026).
Allowable Subject Matter
Claim(s) 2, 16 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regard to claim 2, Center (2015/0005810A1) meets all of the claimed limitations except “the expandable frame is moved into the expanded configuration for deployment by rotating the first central member to move the circumferentially adjacent arcuate articulating members away from one another” in combination with the other claimed limitations.
In regard to claim 16, Center (2015/0005810A1) meets all of the claimed limitations except “is biased into the collapsed configuration for delivery to move the circumferentially adjacent arcuate articulating members circumferentially away from one another” in combination with the other claimed limitations.
Tsugita (5910154A) teaches adjacent arcuate members moving circumferentially to move a device into a delivery configuration (fig 5A-B) but does not teach “a central member, a grouping of articulating members jointed at respective first ends to the central member, curving about the central member”.
Response to Arguments
In regard to the 102(a)(1) rejection of claims 1-11 and 13-20 as anticipated by Center (2015/005810A1), the applicant’s arguments have been fully considered but are directed towards newly amended claim limitations which have been addressed above.
In regard to the 103(a) rejection of claim 12 over Center in view of Glimsdale (2009/0099647A1), no further arguments have been submitted.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
