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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/19/2026 has been entered.
Response to Arguments
Applicant argues in the response filed 02/19/2026 (the after-final amendment/arguments of which the RCE filed 03/1/2026 submits to enter) that the claim amendments would overcome the 112 rejections. The 112 rejections have been withdrawn.
The applicant argues the claim amendments would overcome the rejections with respect to Chanduszko, Solymbar in view of Widomski, and Linden in view of Widomski. The rejections have been withdrawn.
The applicant argues the amendments would overcome the rejections with respect to Roorda in view of Widomski since the anchors/flanges of Roorda would not read on the “flanges/anchors are collapsed and elongated along an axis”. However, the flanges are collapsed in the delivery configuration and do have an elongated aspect to them which can extend along an axis. Since the flanged are elongated in the insertion configuration, the anchors can be interpreted to be elongated. The rejections are maintained below.
A new rejection with respect to Thommen in view of Widomski and Marchi has been made below.
Claim Objections
Claim 6 is objected to because of the following informalities: Claim 6 states “wherein three lobes extend outwardly…”. Claim 6 is dependent off of claim 1. It is to be noted that claim 5 states the first and second anchors have at least three lobes. For clarity purposes, claim 6 can be amended to be dependent off of claim 5 or state that “the first and second anchors have three lobes” to better clarify the scope of the lobes. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 5, 15-20, 23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2010/0114159 to Roorda in view of U.S. Patent Publication 2005/0288706 to Widomski.
As to claim 1, Roorda discloses a bioabsorbable occlusion system capable for an opening or defect in a wall of a heart (paragraph 11), comprising: an occlusion implant (300) having a first anchor (304), a second anchor (302), and a connector element (308,312) coupled to the first anchor and the second anchor and configured to draw the first and second anchors toward each other (paragraph 26, 33), wherein the second anchor defines a bore (314, paragraph 36, paragraph 1,3) through which the connector element extends, and where an entirety of the occlusion implant is substantially bioabsorbable (paragraph 25, the “closure device” is formed of a bioabsorbable material), wherein the occlusion implant has an insertion configuration (figure 4, paragraph 38), where the first anchor and the second anchor are collapsed and elongated along an axis (figure 4, at least the flange end can be extended along an axis) and have an initial cross-sectional dimension and an expanded configuration (figure 5b), where the first anchor and the second anchor are expanded outwardly and have expanded cross-sectional dimension that is greater than the initial cross-sectional dimension (figure 4a,5a,b) but silent that the first anchor and the second anchor have a plurality of lobes that extend radially outward from the central portion.
Widomski teaches a similar device (occluding device, abstract) having a first and a second anchor each having a central portion and a and a plurality of lobes that extend radially outwardly from the central portion (paragraph 42, the clover shape of an anchor will have a plurality of lobes extending from a central portion) and define a first/second wall-facing surface and a first/second opposing surface spaced apart from the first/second wall-facing surface, wherein the first/second wall-facing surface and the first/second opposing surface extend from the central portion to an outer perimeter of each of the plurality of lobes of the respective first and second anchor such that the first/second wall facing surface and the first/second wall opposing surface cover the opening or defect (figure 3b, 6f) for the purpose of having similar shaped anchors that can help occlude a defect (paragraph 42, 37). Roorda discloses the anchors have the wall facing surface and spaced away opposing surfaces, where the surfaces extend from the central portion to an outer perimeter such that the first/second wall facing surface and the first/second wall opposing surface cover the opening or defect (figure 1, 5b). Further Roorda discloses that the anchors can be any shape, including a disc or other shapes (paragraph 31). Widomski teaches that a clover shape can be similar substitution to a disc shape which can operate to help occlude the defect. Having the anchors of Roorda comprise the lobes will yield the predictable results of being an alternative shape which can help to occlude the defect. It would have been obvious to one of ordinary skill in the art before the effective filing date for the first and second anchors of Roorda comprise the plurality of lobes extending radially outward from the central portion of the anchor, which will then have the wall facing surfaces and spaced away opposing surfaces, where the wall facing surfaces and the opposing surfaces cover the opening or the defect, where the surfaces extend from the central portion to the outer perimeter in order for using an similar shape which can help secure the anchors and occlude the defect.
As to claim 3, with the device of Roorda and Widomski above, Roorda discloses a lock member (310) located on the connector element, wherein the lock member is configured to fix the second anchor in position along the connector element relative to the first anchor, thereby drawing the first anchor and the second anchor toward each other (paragraph 26, 33 35).
As to claim 5, with the device of with the device of Roorda and Widomski above, Widomski further teaches the first and second anchors each have at least three lobes (paragraph 42). A clover will have at least 3 lobes.
As to claim 15, with the device of Roorda and Widomski above, Roorda discloses the first anchor and the second anchor each have a cross-sectional dimension that is substantially greater than a cross-sectional dimension of the connector element (figure 1, 5b).
As to claim 16, with the device of Roorda and Widomski above, Roorda discloses the first anchor and the second anchor are formed from a frame of anchor members that are entirely absorbable (paragraph 28, 29). The claim does not state the specific structure for the frame of anchor members. The flanges can be a frame of anchor members for the membrane. Or the membranes can be the frame of anchor members. Both of which are absorbable.
As to claim 17, with the device of Roorda and Widomski above, Roorda discloses further comprising a guide catheter (316) having a channel that extends therethrough and that carries the first anchor and a second anchor in the insertion configuration (figure 4).
As to claim 18, with the device of Roorda and Widomski above, Roorda discloses a delivery device (318/320) movable within and relative to the guide catheter (paragraph 38-40, 44, 45), the delivery device configured to advance the occlusion implant from inside the channel to a location outside the channel (paragraph 38-40, 44, 45) wherein the delivery device is releasably coupled to the occlusion implant (paragraph 38-40, 44, 45).
As to claim 19 with the device of Roorda and Widomski above, Roorda discloses the delivery device is an elongated shaft (figure 4).
As to claim 20, with the device of Roorda and Widomski above, Roorda discloses the delivery device is an elongated tube having a channel for receiving a portion of the connector element therein (figure 4).
As to claim 23, with the device of Roorda and Widomski above, Roorda discloses the connector element includes an elongate shaft (308) with a plurality of engagement members (310) that are configured to releasable couple to a plurality of corresponding engagement members in the bore (306) of the second anchor (paragraph 26, 27, 35).
Claims 1-3, 5, 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2010/0185233 to Thommen in view of U.S. Patent Publication 2005/0288706 to Widomski and U.S. Patent Publication 2014/0142620 to Marchi.
As to claim 1, Thommen discloses a bioabsorbable occlusion system capable for an opening or defect in a wall of a heart (paragraph 8), comprising: an occlusion implant (1) having a first anchor (11), a second anchor (10), and a connector element (30) coupled to the first anchor and the second anchor and configured to draw the first and second anchors toward each other (paragraph 45, 58), wherein the second anchor defines a bore (2/23, paragraph 44, 45, figure 1, 9) through which the connector element extends, wherein the occlusion implant has an insertion configuration (figure 1, 2), where the first anchor and the second anchor are collapsed and elongated along an axis (figure 1, 2) and have an initial cross-sectional dimension and an expanded configuration (figure 9), where the first anchor and the second anchor are expanded outwardly and have expanded cross-sectional dimension that is greater than the initial cross-sectional dimension (figure 1, 2, 9) but is silent that the first anchor and the second anchor have a plurality of lobes that extend radially outward from the central portion and that the entirety of the occlusion implant is substantially bioabsorbable. It is to be noted Thommen does disclose the occluder is at least partly made of biodegradable material.
Marchi teaches a similar device (closure device) where the entirety of the occlusion implant is substantially bioabsorbable (paragraph 17, 18, 20, 33). It would have been obvious to one of ordinary skill in the art before the effective filing date for the entirety of the occlusion implant of Thommen be substantially bioabsorbable since it has been held to be within the general skill of a worker in the art to elect a known material on the basis of its suitability for the intended use.
Widomski teaches a similar device (occluding device, abstract) having a first and a second anchor each having a central portion and a and a plurality of lobes that extend radially outwardly from the central portion (paragraph 42, the clover shape of an anchor will have a plurality of lobes extending from a central portion) and define a first/second wall-facing surface and a first/second opposing surface spaced apart from the first/second wall-facing surface, wherein the first/second wall-facing surface and the first/second opposing surface extend from the central portion to an outer perimeter of each of the plurality of lobes of the respective first and second anchor such that the first/second wall facing surface and the first/second wall opposing surface cover the opening or defect (figure 3b, 6f) for the purpose of having similar shaped anchors that can help occlude a defect (paragraph 42, 37). Thommen discloses the anchors have the wall facing surface and spaced away opposing surfaces, where the surfaces extend from the central portion to an outer perimeter such that the first/second wall facing surface and the first/second wall opposing surface cover the opening or defect (figure 6). Further Thommen discloses that the anchors shape can vary (paragraph 40). Widomski teaches that a clover shape can operate to help occlude the defect. Having the anchors of Thommen comprise the lobes will yield the predictable results of being an alternative shape which can help to occlude the defect. It would have been obvious to one of ordinary skill in the art before the effective filing date for the first and second anchors of Thommen comprise the plurality of lobes extending radially outward from the central portion of the anchor, which will then have the wall facing surfaces and spaced away opposing surfaces, where the wall facing surfaces and the opposing surfaces cover the opening or the defect, where the surfaces extend from the central portion to the outer perimeter in order for using an similar shape which can help secure the anchors and occlude the defect.
As to claim 2, with the device of Thommen, Widomski, and Marchi above, Thommen discloses the first anchor includes a coupling element (3) that attached the connector to the first anchor (figure 1).
As to claim 3, with the device Thommen, Widomski, and Marchi above, Thommen discloses a lock member (the “snapping mechanism”, paragraph 58) located on the connector element, wherein the lock member is configured to fix the second anchor in position along the connector element relative to the first anchor, thereby drawing the first anchor and the second anchor toward each other (paragraph 58, paragraph 9).
As to claim 5, with the device of Thommen, Widomski, and Marchi above, Widomski further teaches the first and second anchors each have at least three lobes (paragraph 42). A clover will have at least 3 lobes.
As to claims 11, 12, with the device of Thommen, Widomski, and Marchi above, Thommen discloses an outer edge of the first anchor and second anchor is at least partially inflatable to define a shape of the first and second anchor (paragraph 53, 54,).
As to claim 13, Thommen as modified by Widomski, and Marchi discloses the first anchor, the second anchor, and the connector element are formed from a substantially bioabsorbable membrane such that an entirety of the occlusion implant is inflatable to attain the expanded configuration (paragraph 53, 54). The device can be inflatable and absorbable, as further taught by Marchi as needed
As to claims 14, 15, with the device of Thommen, Widomski, and Marchi above, Thommen discloses the first anchor and the second anchor each have a cross-sectional dimension that is substantially greater than a cross-sectional dimension of the connector element (figure 9).
As to claim 16, with the device of Thommen, Widomski, and Marchi above, Marchi further teaches the first anchor and the second anchor are formed from a frame of anchor members that are entirely absorbable (paragraph 26, 30, 33). The claim does not state the specific structure for the frame of anchor members. Marchi teaches the device can be made bioabsorbable from elements which can read on a frame.
Claim 2 is under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2010/0114159 to Roorda in view of U.S. Patent Publication 2005/0288706 to Widomski as applied to claims 1, 3, 5, 15-20, 23 above, and further in view U.S. Patent Publication 2005/0273135 to Chanduszko (herein Chanduszko ‘135).
As to claim 2, Roorda as modified by Widomski discloses the device about but is silent about the first anchor includes a coupling element that attaches the connector element to the first anchor.
Chanduszko ‘135 teaches a similar device (occluder, abstract) having first anchor includes a coupling element (110) that attaches the connector element to the first anchor for the purpose of fixedly attaching the catch member to the occlusion device. The connector of Roorda can be attached to the first anchor by the coupling element as taught Chanduszko ‘135 which can help at least manufacturing in order to make the distinct parts. Having the connector be connected to the first anchor will yield the predictable result by still allowing the device to approximate the first and second anchors together. It would have been obvious to one ordinary skill in the art before the effective filing date to have the first anchor include a coupling element that attached the connector element to the first anchor in order to allow the connector element to be fixedly attachable to the first anchor.
Claims 6-8 are under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2010/0114159 to Roorda in view of U.S. Patent Publication 2005/0288706 to Widomski as applied to claims 1, 3, 5, 15-20, 23 above, and further in view U.S. Patent Publication 2004/0073242 to Chanduszko (herein Chanduszko ‘242).
As to claims 6-8, Roorda as modified by Widomski discloses the device about but is silent about the three lobes extend outwardly between 110-130 degrees, the first and second anchors have four lobes that extend outwardly along axes that are between 80-100 degrees with respect to each other, or the first and second anchor are arranged in the expanded configuration such that their respective lobes are offset with respect to each other.
Chanduszko ‘242 teaches a similar device (occluder, abstract) having three lobes extend outwardly along axes that are between 110 and 130 degrees with respect to each other (paragraph 38), first and second anchors have four lobes that extend outwardly along axes that are between 80 and 100 degrees with respect to each other (paragraph 58, figure 10a-d) or first anchor and second anchor are arranged in the expanded configuration such that their respective lobes are offset with respect to each other (figure 5, paragraph and/or paragraph 43) for the purpose of having the anchors comprise a variety shapes that can help secure coverage of the passage (paragraph 59). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the lobes of Roorda and Widomski be three lobes spaced 110-130, four lobes spaced 80-100 degrees, and/or be axially offset lobes in order to obtain a desired shape which can help secure coverage of the passage.
Claims 6-8 are under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2010/0185233 to Thommen in view of U.S. Patent Publication 2005/0288706 to Widomski and U.S. Patent Publication 2014/0142620 to Marchi as applied to claims 1-3, 5, 11-16 above, and further in view U.S. Patent Publication 2004/0073242 to Chanduszko (herein Chanduszko ‘242).
As to claims 6-8, Thommen as modified by Widomski and Marchi discloses the device about but is silent about the three lobes extend outwardly between 110-130 degrees, the first and second anchors have four lobes that extend outwardly along axes that are between 80-100 degrees with respect to each other, or the first and second anchor are arranged in the expanded configuration such that their respective lobes are offset with respect to each other.
Chanduszko ‘242 teaches a similar device (occluder, abstract) having three lobes extend outwardly along axes that are between 110 and 130 degrees with respect to each other (paragraph 38), first and second anchors have four lobes that extend outwardly along axes that are between 80 and 100 degrees with respect to each other (paragraph 58, figure 10a-d) or first anchor and second anchor are arranged in the expanded configuration such that their respective lobes are offset with respect to each other (figure 5, paragraph and/or paragraph 43) for the purpose of having the anchors comprise a variety shapes that can help secure coverage of the passage (paragraph 59). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the lobes of Thommen, Marchi, and Widomski be three lobes spaced 110-130, four lobes spaced 80-100 degrees, and/or be axially offset lobes in order to obtain a desired shape which can help secure coverage of the passage.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2010/0114159 to Roorda in view of U.S. Patent Publication 2005/0288706 to Widomski as applied to claims 1, 3, 5, 15-20, 23 above, and further in view of U.S. Patent Publication 2003/0149463 to Solymar.
As to claim 10, Roorda as modified by Widomski discloses the device above but is silent about the occlusion implant is substantially bioabsorbable between 6-18 months, 9-18 months, or 12-18 months from implantation. However, Roorda does disclose that the device is made from PGA, PLA, or the like (paragraph 28). The application as originally filed does disclose the material of the invention can be made of PGA, PLA or the like as well in paragraph 44 of the published application. Therefore the similar material can have similar rates of substantial bioabsorbability. Solymar teaches a similar device (occlusion device) where a device that is bioabsorbable can a degradation rate within 6-18 months as desired (paragraph 43). It would have been obvious to one of ordinary sill in the art before the effective filing date to have the device of Roorda and Widomski substantially bioabsorbable between 6-18 months, 9-18 months, or 12-18 months from implantation in order for the user to select the material with the preferred degradation rate as desired.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2010/0185233 to Thommen in view of U.S. Patent Publication 2005/0288706 to Widomski and U.S. Patent Publication 2014/0142620 to Marchi as applied to claims 1-3, 5, 11-16 above, and further in view of U.S. Patent Publication 2003/0149463 to Solymar.
As to claim 10, Thommen as modified by Widomski and Marchi discloses the device above but is silent about the occlusion implant is substantially bioabsorbable between 6-18 months, 9-18 months, or 12-18 months from implantation. However, Roorda does disclose that the device is made from PGA, PLA, or the like (paragraph 28). The application as originally filed does disclose the material of the invention can be made of PGA, PLA or the like as well in paragraph 44 of the published application. Therefore the similar material can have similar rates of substantial bioabsorbability. Solymar teaches a similar device (occlusion device) where a device that is bioabsorbable can a degradation rate within 6-18 months as desired (paragraph 43). It would have been obvious to one of ordinary sill in the art before the effective filing date to have the device of Thommen, Marchi, and Widomski substantially bioabsorbable between 6-18 months, 9-18 months, or 12-18 months from implantation in order for the user to select the material with the preferred degradation rate as desired.
Claims 11-14 are under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2010/0114159 to Roorda in view of U.S. Patent Publication 2005/0288706 to Widomski as applied to claims 1, 3, 5, 15-20, 23 above, and further in view U.S. Patent Publication 2009/0209999 to Afremov.
As to claims 11, 12, Roorda as modified by Widomski discloses the device about but is silent about the outer edge of the first and second anchor is at least partially inflatable to define a shape of the first and second anchor.
Afremov teaches a similar device (occluder, abstract) having an outer edge of a first and second anchor is at least partially inflatable to define a shape of the first and second anchor (paragraph 39, 40, 41, 77, 75) for the purpose of obtaining the desired shape of the anchor that can exert radial force against the walls of the tissue and to resist compression. Afremov teaches the material used (paragraph 45, 47) will be similar to those disclosed of Roorda (paragraph 28). Roorda also discloses a flexible membrane can be used for the first and second anchors. The anchors of Roorda can be inflatable as taught by Afremov which can help the anchors obtain the desired shape to help conform the tissue to obtain the desired closure. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for an outer surface of the first and second anchor of Roorda as modified by Widomski be inflatable to define a shape of the anchors in order for obtaining the desired shape of the anchor that can exert radial force against the walls of the tissue and to resist compression.
As to claim 13, with the device of Roorda and Widomski above, Linden discloses the first anchor, the second anchor, and the connector element are formed from a substantially bioabsorbable membrane such that an entirety of the occlusion implant is inflatable to attain the expanded configuration (paragraph 28, 29). Roorda does disclose a bioabsorbable membrane can be used, where the membrane is flexible. The membrane can be capable of being inflatable. If it would not be known that the membrane can be inflatable, Afremov teaches a similar device (occluder, abstract) having a first anchor, a second anchor, and the connector element are formed from a substantially bioabsorbable membrane such that an entirety of the occlusion implant is inflatable to attain the expanded configuration (paragraph 39, 40, 41, 77, 75) for the purpose of obtaining the desired shape of the anchor that can exert radial force against the walls of the tissue and to resist compression. Afremov teaches the material used (paragraph 45, 47) will be similar to those disclosed of Roorda (paragraph 28). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the first anchor, the second anchor, and the connector element of Roorda and Widomski be formed from a substantially bioabsorbable membrane such that an entirety of the occlusion implant is inflatable to attain the expanded configuration in order for obtaining the desired shape of the anchor that can exert radial force against the walls of the tissue and to resist compression.
As to claim 14, with the device of Roorda, Widomski, Afremov and above, Roorda discloses the first anchor and the second anchor each have a cross-sectional dimension that is substantially greater than a cross-sectional dimension of the connector element (figure 1). Afremov can also teach the claim limitation (figure 4).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2010/0114159 to Roorda in view of U.S. Patent Publication 2005/0288706 to Widomski as applied to claims 1-3, 5, 15, 17-20, 23 above, and further in view of U.S. Patent Publication 2013/0138144 to Yribarren.
As to claim 21 Roorda as modified by Widomski discloses the device above but silent about the an access sheath having a proximal end, a distal end, and an access sheath channel that extends from the proximal end to the distal end, wherein the guide catheter is insertable into the access sheath channel.
Yribarren teaches a similar device (tissue closure device) having an access sheath (paragraph 6, 52) having a proximal end, a distal end, and an access sheath channel that extends from the proximal end to the distal end, wherein the guide catheter is insertable into the access sheath channel for the purpose of guiding the device into position for the medical procedure. It would have been obvious to one of ordinary skill in the art before the effective filing date to use an access sheath having a proximal end, a distal end, and an access sheath channel that extends from the proximal end to the distal end, wherein the guide catheter is insertable into the access sheath channel in the system of Roorda and Widomski in order for helping to guide the device into position for the medical procedure.
Claim 22 is under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2010/0114159 to Roorda in view of U.S. Patent Publication 2005/0288706 to Widomski as applied to claims 1, 3, 5, 15-20, 23 above, and further in view U.S. Patent Publication 2005/0273135 to Chanduszko (herein Chanduszko ‘135) or U.S. Patent Publication 2017/0360419 to Phillips.
As to claim 22, Roorda as modified by Widomski discloses the device about but is silent about the connector element includes a plurality of teeth that are configured to engage a plurality of teeth located in a bore of the first anchor and the second anchor.
Chanduszko ‘135 teaches a similar device (occluder, abstract) having a connector element includes a plurality of teeth that are configured to engage a plurality of teeth located in a bore of the first anchor and the second anchor (figure 27-29; 45-49; 69,70; paragraph 69, 70, 72, 87, 90, 112) for the purpose of using different catching mechanisms which can allow the device to obtain and lock the occluding configuration. Chanduszko ‘135 teaches multiple of connector elements which can engage both first and second anchor within the anchors, where engagement elements can have a teeth configuration. Having the teeth can allow the device to securely lock the occlusion configuration. Phillips also teaches a similar device (sealing device, abstract) having a connector element includes a plurality of teeth that are configured to engage a plurality of teeth located in a bore of the first anchor and the second anchor (904,906, figure 11, paragraph 61-66); and other embodiments as seen in figure 6, 13) for the purpose of facilitating locking the device in the expanded configuration. Phillips also teaches the use of a connector that engages the bore of both anchors. Further embodiments of Phillips teach that the engagement structure are a plurality of teeth. The use of a plurality of teeth on the connector element which engages with a plurality of teeth in a bore of the first and second anchors can help to lock the device in the expanded desired configuration. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the connector element of Roorda and Widomski include a plurality of teeth that are configured to engage a plurality of teeth located in a bore of the first anchor and the second anchor in order for help to lock the device in the expanded desired configuration.
Claims 22, 23 are under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2010/0185233 to Thommen in view of U.S. Patent Publication 2005/0288706 to Widomski and U.S. Patent Publication 2014/0142620 to Marchi as applied to claims 1-3, 5, 11-16 above, and further in view U.S. Patent Publication 2005/0273135 to Chanduszko (herein Chanduszko ‘135) or U.S. Patent Publication 2017/0360419 to Phillips.
As to claim 22, Thommen as modified by Widomski and Marchi discloses the device about but is silent about the connector element includes a plurality of teeth that are configured to engage a plurality of teeth located in a bore of the first anchor and the second anchor. Thommen does disclose that the connector member will engage with a structure in the bore of the first and second anchors (figure 9).
Chanduszko ‘135 teaches a similar device (occluder, abstract) having a connector element includes a plurality of teeth that are configured to engage a plurality of teeth located in a bore of the first anchor and the second anchor (figure 27-29; 45-49; 69,70; paragraph 69, 70, 72, 87, 90, 112) for the purpose of using different catching mechanisms which can allow the device to obtain and lock the occluding configuration. Chanduszko ‘135 teaches multiple of connector elements which can engage both first and second anchor within the anchors, where engagement elements can have a teeth configuration. Having the teeth can allow the device to securely lock the occlusion configuration. Phillips also teaches a similar device (sealing device, abstract) having a connector element includes a plurality of teeth that are configured to engage a plurality of teeth located in a bore of the first anchor and the second anchor (904,906, figure 11, paragraph 61-66); and other embodiments as seen in figure 6, 13) for the purpose of facilitating locking the device in the expanded configuration. Phillips also teaches the use of a connector that engages the bore of both anchors. Further embodiments of Phillips teach that the engagement structure are a plurality of teeth. The use of a plurality of teeth on the connector element which engages with a plurality of teeth in a bore of the first and second anchors can help to lock the device in the expanded desired configuration. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the connector element of Thommen, Marchi, and Widomski include a plurality of teeth that are configured to engage a plurality of teeth located in a bore of the first anchor and the second anchor in order for help to lock the device in the expanded desired configuration.
As to claim 23, Thommen as modified by Widomski and Marchi discloses the device about but is silent about the connector element includes an elongate shaft with a plurality of engagement members that are configured to releasable couple to a plurality of engagement members in the bore of the second anchor. Thommen does disclose that the connector member will engage with a structure in the bore of the first and second anchors (figure 9).
Chanduszko ‘135 teaches a similar device (occluder, abstract) the connector element includes an elongate shaft with a plurality of engagement members that are configured to releasable couple to a plurality of engagement members in the bore of the second anchor (figure 27-29; 45-49; 69,70; paragraph 69, 70, 72, 87, 90, 112) for the purpose of using different catching mechanisms which can allow the device to obtain and lock the occluding configuration. Phillips also teaches a similar device (sealing device, abstract) that has a connector element with a shaft with a plurality of engagement members that can help engage with the bore of the anchor (904,906, figure 11, paragraph 61-66); and other embodiments as seen in figure 6, 13) for the purpose of facilitating locking the device in the expanded configuration. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the connector element of Thommen, Marchi, and Widomski includes an elongate shaft with a plurality of engagement members that are configured to releasable couple to a plurality of engagement members in the bore of the second anchor in order for help to lock the device in the expanded desired configuration.
Conclusion
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
