DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant argues in the response filed 10/15/2025 that the claim amendments would overcome the previous claim objections and 112 rejections. The previous objections and 112 rejections have been withdrawn.
The applicant argues the claim amendments would overcome the 102 rejections with respect to Roorda, Solymbar, and Linden. The rejections have been withdrawn.
The applicant argues the claim amendments would overcome the 102 rejections with respect to Chanduszko since “none of the wires, formed into loops, define a wall-facing surface and an opposing surface spaced apart from the wall-facing surface, let alone where the wall-facing surface and opposing surface ‘extend from the central portion to an outer perimeter of each of the plurality of lobes’”. However it is noted the spacing between the surfaces or the specific central portion is not further claimed. The wires of Chanduszko which form the lobes/loops, have a surface which can contact tissue and an opposite surface which does not contact tissue. The surfaces are spaced apart by at least the thickness of the wire. Further the wires do extend from a center section of the anchor, towards an outer perimeter based on the views of the anchors in at least figure 3, 4 since the wire are congregated at the center of each side of the device and then extend out forming the loops/lobes. The view of the figures of Chanduszko can read on the wires forming the lobes by extending from a central portion to a perimeter. Further limitations, at least with respect to the lobes/surfaces, how the surfaces are spaced apart (i.e. via a cavity defined by anchors/lobes) can help to overcome the rejection with respect to Chanduszko. The rejection is maintained below.
Further rejections with respect Roorda in view of Widomski; Solymbar in view of Widomski; and Linden in view of Widomski have been made below.
Claim Rejections - 35 USC § 112
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 1-3, 5-8, 10-23 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 1 recites the limitation "wherein the second wall-facing surface and the second opposing surface extend from the central portion to the outer perimeter of the each of the plurality of lobes" in lines 19-20. Claim 1 has antecedent basis of “an perimeter of each of the plurality of lobes” in lines 14-15. However, the perimeter claimed in claims 14-15 is with respect to the first anchor. Lines 19-20 seem to be directed to the second anchor. It is unclear if the limitation of lines 19-20 is trying to positively recite the previous perimeter or if it should be for the perimeter of the plurality of lobes of the second anchor. For examination purposes, the limitation of line 19-20 will be interpreted to be” wherein the second wall-facing surface and the second opposing surface extend from the central portion to an outer perimeter of the each of the plurality of lobes of the second anchor”. Of note: a similar designation of the “each of the plurality of lobes of the first anchor” in lines 14-15 can be helpful for clarity purposes.
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.
Claims 1, 5-8, 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2004/0073242 to Chanduszko.
As to claim 1, Chanduszko discloses a bioabsorbable occlusion system for an opening or defect in a wall of a heart (paragraph 31), comprising: an occlusion implant (20) having a first anchor (30), a second anchor (40), and a connector element (22) coupled to the first anchor and the second anchor and configured to draw the first and second anchors toward each other (paragraph 48, the joint can be a spring which draws the proximal side closer to the distal side), and an entirety of the occlusion implant is substantially bioabsorbable (paragraph 35, the “occluder” is formed of a bioabsorbable material), wherein the occlusion implant has an insertion configuration (figure 14a,b, 15a-c, 16), where the first anchor and the second anchor are collapsed and have an initial cross-sectional dimension, and an expanded configuration (figure 14e, 15e, paragraph 68, 69), 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 14a,e,15a,e), the first anchor has a central portion (center of 30, figure 4, 5) and a plurality of lobes (32a,b,c, paragraph 36 ) that extend radially outwardly from the central portion and define a first wall-facing surface (figure 14e, the surface of the wire that contacts the tissue, and/or the surface of the wires of the anchor that is in contact with the tissue as seen in figure 3) and a first opposing surface spaced apart from the first wall-facing surface (figure 14e, figure 3, the opposite side of the wire that does not contact the tissue spaced from the first wall-facing surface by at least the thickness of the wire), wherein the first wall-facing surface and the first opposing surface extend from the central portion to an outer perimeter of each of the plurality of lobes (figure 3, 14e, the other edge perimeter of the wire), and the second anchor has a central portion (center of 40, as seen in figure 4, 9) with a plurality of lobes (42a/f, b/c, d/e, figure 9, paragraph 46) that extend radially outwardly from the central portion and define a second wall-facing surface (figure 4, 14e, the surface of the wire that contacts the tissue) and a second opposing surface spaced apart from the first wall-facing surface (figure 4, 14e, the surface of the wire that does not contact the tissue spaced from the first wall-facing surface by at least the thickness of the wire), wherein the second wall-facing surface and the second opposing surface extend from the central portion to an outer perimeter of each of the plurality of lobes (figure 14e, the other edge perimeter of the wire).
As to claim 5, Chanduszko discloses the first and second anchors each have at least three lobes (figure 4, 5, 9, paragraph 36,46).
As to claim 6, Chanduszko discloses three lobes extend outwardly along axes that are between 110 and 130 degrees with respect to each other (paragraph 38) .
As to claim 7, Chanduszko discloses the 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). The four loops equally spaced and centered will be 90 degrees with respect to each other.
As to claim 8, Chanduszko discloses the first anchor and the 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).
As to claim 15, Chanduszko 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 6, 7).
As to claim 16, Chanduszko discloses the first anchor and the second anchor are formed from a frame (the wires 25, paragraph 35) of anchor members that are entirely absorbable.
As to claim 17, Chanduszko discloses further comprising a guide catheter (140/150) having a channel that extends therethrough and that carries the first anchor and the second anchor in the insertion configuration (paragraph 18-70, figure 14a-e, 15a-e).
As to claim 18, Chanduszko discloses a delivery device (161) movable within and relative to the guide catheter, the delivery device configured to advance the occlusion implant from inside the channel to a location outside the channel, wherein the delivery device is releasably coupled to the occlusion implant (paragraph 70).
As to claim 19 Chanduszko discloses the delivery device (161) is an elongated shaft (figure 16).
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, 17-20, 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 (302), a second anchor (304), 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), and 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 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 (figure 3b) 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 (figure 1). 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 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 Roorda and Widomski above, Roorda discloses the first anchor includes a coupling element (308) that attached the connector element to the first anchor, and wherein the second anchor includes at least one opening (306, figure 3) through which the connector element extends.
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 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 a bore (306) of the first anchor or the second anchor (paragraph 26, 27, 35).
Claims 1-3, 5, 10-12, 14, 15, 17-20, 23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2003/0149463 to Solymar in view of U.S. Patent Publication 2005/0288706 to Widomski.
As to claim 1, Solymar discloses a bioabsorbable occlusion system for an opening or defect in a wall of a heart (paragraph 30), comprising: an occlusion implant (2) having a first anchor (6a), a second anchor (6b), and a connector element (14, paragraph 33, 35-37) coupled to the first anchor and the second anchor and configured to draw the first and second anchors toward each other (paragraph 35-37, figure 3-5), and an entirety of the occlusion implant is substantially bioabsorbable (paragraph 9), wherein the occlusion implant has an insertion configuration (pre expansion, paragraph 32,34), where the first anchor and the second anchor are collapsed and have an initial cross-sectional dimension, and an expanded configuration (figure 4/5), 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 (after expansion paragraph 32,34) 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 (figure 3b) for the purpose of having similar shaped anchors that can help occlude a defect (paragraph 42, 37). Solymar 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 (figure 4). Widomski teaches that a clover shape can be similar substitution to a disc shape, similar to the shape of the anchors of Solymar (figure 4/5), which can operate to help occlude the defect. Having the anchors of Solymar 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 Solymar 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 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 Solymar and Widomski above, Solymar discloses the first anchor includes a coupling element (14a, paragraph 35) that attached the connector element to the first anchor, and wherein the second anchor includes at least one opening (14b, paragraph 35, figure 3,4) through which the connector element extends.
As to claim 3, with the device of Solymar and Widomski above, Solymar discloses a lock member (14a,b) 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 3, 37).
As to claim 5, with the device of with the device of Solymar 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 10, with the device of Solymar and Widomski above, Solymar occlusion implant is substantially bioabsorbable between 6-18 months, 9-18 months, or 12-18 months from implantation (paragraph 43).
As to claim 11, with the device of Solymar and Widomski above, Solymar discloses an outer edge of the first anchor is at least partially inflatable to define a shape of the first anchor (paragraph 33, the first anchor 6a is inflatable).
As to claim 12, with the device of Solymar and Widomski above, Solymar discloses an outer edge of the second anchor is at least partially inflatable to define a shape of the second anchor (paragraph 33, the first anchor 6b is inflatable).
As to claim 14, with the device of Solymar and Widomski above, Solymar 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 3-5).
As to claim 15, with the device of Solymar and Widomski above, Solymar 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 3-5).
As to claim 17, with the device of Solymar and Widomski above, Solymar discloses further comprising a guide catheter (24) having a channel that extends therethrough and that carries the first anchor and a second anchor in the insertion configuration (paragraph 37).
As to claim 18, with the device of Solymar and Widomski above, Solymar discloses a delivery device (20/15) movable within and relative to the guide catheter (paragraph 37), the delivery device configured to advance the occlusion implant from inside the channel to a location outside the channel (paragraph 37) wherein the delivery device is releasably coupled to the occlusion implant (37).
As to claim 19, with the device of Solymar and Widomski above, Solymar discloses the delivery device is an elongated shaft (figure 3).
As to claim 20, with the device of Solymar and Widomski above, Solymar discloses the delivery device is an elongated tube having a channel for receiving a portion of the connector element therein (figure 3).
As to claim 23, Solymar discloses the connector element includes an elongate shaft with a plurality of engagement members (paragraph 35, “snap together members”) that are configured to releasable couple to a plurality of corresponding engagement members in a bore (paragraph 35) of the first anchor or the second anchor.
Claims 1, 5, 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 5,634,936 to Linden in view of U.S. Patent Publication 2005/0288706 to Widomski.
As to claim 1, Linden discloses a bioabsorbable occlusion system for an opening or defect in a wall of a heart (col. 2 ll. 19-38), comprising: an occlusion implant (206, figure 9-11) having a first anchor (the right/distal side of the 206 as seen in figure 9-11), a second anchor (the left/proximal side of the 206 as seen in figure 9-11), and a connector element (middle portion of the device, figure 9-11) coupled to the first anchor and the second anchor and configured to draw the first and second anchors toward each other (figure 9-11, col. 8 ll. 46-65, the proximal and distal sides are drawn toward together, without limitations with the mechanism, the characteristics of the material that is in the connector element can help to draw the anchors together), and an entirety of the occlusion implant is substantially bioabsorbable (col. 8 ll. 51-54), wherein the occlusion implant has an insertion configuration (figure 9), where the first anchor and the second anchor are collapsed 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 11) 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 (figure 3b) for the purpose of having similar shaped anchors that can help occlude a defect (paragraph 42, 37). Linden 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 (figure 11). Widomski teaches that a clover shape can be similar substitution to a disc shape, similar to the shape of the anchors of Linden (figure 4/5), which can operate to help occlude the defect. Having the anchors of Solymar 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 Solymar 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 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 5, with the device of with the device of Solymar 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 11, with the device of Linden and Widomski above, Linden discloses an outer edge of the first anchor is at least partially inflatable to define a shape of the first anchor (col 8 ll. 66-col 9 ll. 4 ).
As to claim 12, with the device of Linden and Widomski above, Linden discloses an outer edge of the second anchor is at least partially inflatable to define a shape of the second anchor (col 8 ll. 66-col 9 ll. 4).
As to claim 13, with the device of Linden 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 (col 8 ll. 46-col. 9 ll. 4, figure 9-11).
As to claim 14, with the device of Linden and Widomski above, Linden 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 9-11).
As to claim 15, with the device of Linden and Widomski above, Linden 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 9-11).
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, 17-20, 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 2004/0073242 to Chanduszko in view of U.S. Patent Publication 2003/0149463 to Solymar.
As to claim 10, Chanduszko 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, Chanduszko does disclose that the device can be made from a bioabsorbable polymer. 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 Chanduszko 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 U.S. Patent 5,634,936 to Linden in view of U.S. Patent Publication 2005/0288706 to Widomski as applied to claims 1, 5, 11-15 above, and further in view of U.S. Patent Publication 2003/0149463 to Solymar.
As to claim 10, Linden 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, Linden does disclose that the device is made from lactides, or the like (col. 7 ll. 55-65). The application as originally filed does disclose the material of the invention can be made of lactides 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 Linden 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 21 is under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2003/0149463 to Solymar in view of U.S. Patent Publication 2005/0288706 to Widomski as applied to claims 1-3, 5, 10-12, 14, 15, 17-20, 23 above, and further in view of U.S. Patent Publication 2006/0252984 to Rahdert.
As to claim 21, Solymar as modified by Widomski discloses an access sheath (“catheter” initially placed in the left upper pleural vein, paragraph h37) 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 (paragraph 37). If however, it would not be known that Solymar would be able to read on the access sheath, Rahdert teaches a similar device (heart implants, abstract) using discloses an access sheath (paragraph 183) 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 using a known mechanism that can provide access to and into the vascular system. 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 Solymar and Widomski in order for using a known mechanism that can provide access to and into the vascular system.
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 21 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2004/0073242 to Chanduszko in view of U.S. Patent Publication 2013/0138144 to Yribarren.
As to claim 21 Chanduszko 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 Chanduszko in order for helping to guide the device into position for the medical procedure.
Claim 22 is rejected under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2003/0149463 to Solymar in view of U.S. Patent Publication 2005/0288706 to Widomski as applied to claims 1-3, 5, 10-12, 14, 15, 17- 20, 23 above, and further in view of U.S. Patent Publication 2021/0236102 to Perszyk.
As to claim 22, Solymar as modified by Widomski discloses 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 (paragraph 35, 57). Solymar discloses the connector element has locking members 14a,b, which will be in the a bore of the first and second anchors. These locking members have snap together members. Without further limitations on the teeth, the snap tighter members can read on the teeth. Additionally/alternatively, Solymar teaches another embodiment with locking mechanisms including teeth. The teeth mechanism can be used in the embodiment of figure 3-5 to help lock the device. Perszyk teaches a similar device (locking mechanism of expanded devices, abstract) having a locking mechanism with teeth (figure 2F, paragraph 39) for the purpose of using known textured elements that can engage with other to create a locking mechanism. If it would not be known, it would have been obvious for Solymar to read on 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 in order for using a known type of locking mechanism that can keep the device in the configurations as desired.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Publication 2022/0395266 to Eidenschink discloses a similar device capable of disclosing, rendering obvious, or providing evidence on the claims of record.
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 ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
Prosecution Insights