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 12/26/2025 the amendments have support. However it is to be noted “relatively close” was not used in the specification as originally filed as the specific terminology of the spatial placement of the wire legs with respect to tissue. Further, a partially expanded configuration can be seen in figure 5b but the specification is silent about the specific placement of the wire legs in the “partially expanded configuration”. The scope of “relatively close” is unknown since it is unclear what would be relatively close and what would not be close. The examiner argues there is not support for the amendment with respect to “relatively close”.
The applicant argues Garrison as modified by Surti is silent about the collapsed configuration and the partially expanded configuration. It is to be noted claims 1+ and 17+ are device/system claims and therefore cannot positively recite tissue. Figure 11b can be an expanded configuration since the device has an expanded outer diameter. Figure 11a can read on a collapsed configuration since the diameter is collapsed compared to figure 11b. Further there will be a configuration between 11a-b where the ring starts to expand but the posts 321 still are engaged by a delivery device since they are most proximal. Further the posts will be able to be spatially oriented or engage with the upper / lower tissue portions respectively in the claimed configurations. The examiner maintains Surti can teach the hinged limitations. Therefore the examiner maintains the rejection below.
The applicant similarly argues with respect to Gelbart in view of Surti, Garrison and Lichtenstein, using posts of Garrison in place of the barbs 11 of Gelbart would result in similar shortcomings. However the posts of Garrison aren’t necessarily being uses as the barbs of Gelbart. Instead, Garrison does teach leg / barb like elements do cross over in an expanded configuration. Therefore the tines of 11 of Gelbart can cross over which can help to engage tissue. Since the claims are device claims, the “wire legs” and disk can be able to engage and be positioned with respect given first and second sides and upper/lower portions of tissue. The examiner maintains the rejection Gelbart in view of Surti, Garrison and Lichtenstein below.
It is to be noted the examiner does withdraw the 103 rejection with respect to the method claims 18+ based on being able to positively recite the tissue and how the device is spatially oriented and engages with the tissue. However, a 112 rejection with respect to the terms “relatively close” is applicable to method claim 18.
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, 6, 15-18, 21-26, 28, 29 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.
The term “relatively close” in claims 1, 17, and 18 renders the claims indefinite. The term “relatively close” is not defined by the claim and the specification does not provide any support for the degree of the term “relatively close”. It is unclear what would be considered relatively close and what would not be relatively close. Therefore, the limitation, and thus the claims, are considered to be indefinite. The examiner suggests using an alternative term, such as “proximately” or the like, that can seem to be supported by specification and known to one of ordinary skill in the art to ascertain the degree of the spatial arrangement.
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, 6, 15-17, 21, 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2010/0228269 to Garrison in view of U.S. Patent Publication 2010/0331866 to Surti.
As to claim 1, Garrison discloses a medical device (paragraph 66) for treating a target site comprising a device frame (301) comprising a proximal portion (321) and a distal portion (317) and the medical device configured to selectively transition between a collapsed configuration (figure 11a, paragraph 88-90, the device has a smaller diameter to be able to fit into a delivery sheath, see prior art below in at least section 8 below as evidence) and an expanded configuration (figure 11b, the device has an expanded width), wherein the distal portion comprises a collapsible disk (317, paragraph 88) and the proximal portion comprises at least two wire legs (321), each wire leg respectively extending proximally between a distal end hingedly coupled to a peripheral edge (figure 11a,b, paragraph 88-90, where the tines connect to 317) of the disk and a free proximal end (figure 11a,b), each wire leg moving along the respective distal end thereof an into a crossed configuration when the medical device transitions from the collapsed configuration to the expanded configuration (figure 11a,b, paragraph 88-90, the legs move to cross over each other to move into the deployed configuration, the movement starts at the distal end of the leg) and at least one cover (309, paragraph 88-90), wherein the at least one cover is coupled to the distal portion (figure 11c, based on how the posts are folded over the seal member, the seal member is coupled to the distal portion 317), when, in the collapsed configuration of the medical device (figure 11a), the collapsible disk is collapsed, a first wire leg of the two wire legs extends proximally from the collapsed disk, and a second wire leg of the at least two wire legs extends proximally from the collapsed disk, with the first wire leg configured to be positioned relatively close to upper tissue at the target site and with the second wire leg configured to be positioned relatively close to lower tissue at the target site (opposite posts 321 can be positioned near respective tissue which can upper and lower tissue, when the device is in the configuration of figure 11a), wherein the medical device has a partially deployed configuration (a configuration in-between figure 11a and 11b, where the tines 307 start to deploy and the disc can start to expand into the configuration of figure 11b) in which the collapsible disk is expanded while the first wire leg is configured to remain positioned relative close to the upper tissue and the second wire leg configured to remain relative close to the lower tissue, with the collapsible disk configured to be positioned on a first side of the target site (the opposite posts 321 can still be near the upper and lower tissue in a configuration between figures 11a and b where the disk is on a first side), and wherein, in the expanded configuration (figure 11b/c) of the medical device, the collapsible disk is expanded, while the first wire leg is configured to engage the lower tissue on a second side of the target site opposite the first side, and while the second wire leg configured to engage the upper tissue on the second side of the target site (figure 11b/c, the posts cross over each other and do extend out of a plane where the disc is located, therefore the posts can engage tissue on a second side as well as engage the opposite respective lower and upper tissue).
However, Garrison is silent about the each wire is hingedly coupled at a hinge and folding along the hinge.
Surti teaches a similar device (device with rotatable clamps) having legs (27,28) which are hingedly coupled at a hinge to a peripheral edge of a disk and folds along the hinge (figure 1, 2, paragraph 29, 33) for the purpose of using a known fastening means for a member that rotates about an edge. The members “fold” about the “hinge” as they rotate into the deployed state. Garrison does seem to disclose other embodiments where arms are attached to a ring (see figure 7a,d, 16a-d, 17a-d,) and can fold / bend / move with respect to the ring (see figure 7a,d, 15a-c, 16a-d, 17a-d). Garrison also discloses that different features of different embodiments can be usable together (paragraph 215,216). Surti teaches that similar legs can “permanently attached” to a base or “hingedly coupled”. Therefore Surti does teach that arms attached to a ring can move with the ring or be hingedly coupled with the ring. Based on the teachings of Surti as well as the disclosure of Garrison, the posts of figure 3a-d can be substituted with posts that are hingedly coupled to the ring and fold along the hinge. Substituting a similar fastening mechanism of a hinge in the device of Garrison will yield the predicable result of allowing the legs to move about the disk. By using the hinge of Surti, the legs can fold about the hinge. See prior art below in section 8 as further evidence of a hinge connection. It would have been obvious to one of ordinary skill in the art before the effective filing date to have each wire of Garrison be hingedly coupled at a hinge to the peripheral edge of the disk and each wire leg folding along the hinge as taught by Surti in order for using substituting a known fastening means for a member that conforms to a deployed configuration as desired.
As to claim 6, with the device of Garrison and Surti above, Garrison discloses the at least two wire legs rotate towards the disk during the transition from the collapsed configuration to the expanded configuration (figure 11a,b).
As to claim 15, with the device of Garrison and Surti above, Garrison discloses the device frame is comprises a shape-memory material (paragraph 78).
As to claim 16, with the device of Garrison and Surti above, Garrison discloses the at least one cover is formed from one or more of: a fabric material, a knit material, a polymer material, a bioresorbable material, or a bioabsorbable material (paragraph 87).
As to claim 17, Garrison discloses a delivery system (paragraph 107) for deploying a medical device to a target site, the delivery system comprising the medical device (paragraph 66) which is configured to selectively transition between a preset, expanded configuration (figure 11b, paragraph 80, 88-90, the device can be heat-set into the configuration of 11b, the device has an expanded diameter which can read on the expanded configuration) and a collapsed configuration (figure 11a), and which comprises a device frame (301) comprising a proximal portion (321) and a distal portion (317), wherein the distal portion comprises a collapsible disk (317, paragraph 88) and the proximal portion comprises at least two wire legs (321), each wire leg respectively extending proximally between a distal end hingedly coupled to a peripheral edge (figure 11a,b, paragraph 88-90, where the tines connect to 317) of the disk and a free proximal end (figure 11a,b), each wire leg moving along the respective distal end thereof an into a crossed configuration when the medical device transitions from the collapsed configuration to the expanded configuration (figure 11a,b, paragraph 88-90, the legs move to cross over each other to move into the deployed configuration, the movement starts at the distal end of the leg), and at least one cover (309, paragraph 88-90), wherein the at least one cover is coupled to the distal portion (figure 11c, based on how the posts are folded over the seal member, the seal member is coupled to the distal portion 317), a delivery device comprising a delivery catheter (608) and a delivery cable (606) within the delivery catheter and translatable with respect to the delivery catheter to advance the medical device through the delivery catheter to the target site (paragraph 108, 109), when, in the collapsed configuration of the medical device (figure 11a), the collapsible disk is collapsed within the delivery catheter (figure 21a), a first wire leg of the two wire legs is within the delivery catheter and extends proximally from the collapsed disk, and a second wire leg of the at least two wire legs is within the delivery catheter and extends proximally from the collapsed disk, with the first wire leg configured to be positioned relatively close to upper tissue at the target site and with the second wire leg configured to be positioned relatively close to lower tissue at the target site (opposite posts 321 can be positioned near respective tissue which can upper and lower tissue, when the device is in the configuration of figure 11a), wherein the medical device has a partially deployed configuration (a configuration in-between figure 11a and 11b, where the tines 307 start to deploy and the disc can start to expand into the configuration of figure 11b) in which the collapsible disk is expanded outside of the delivery catheter (the disc will start to transition to the expanded configuration as it exits the catheter), while the first wire leg remains within the delivery configuration and is configured to remain positioned relative close to the upper tissue and the second wire leg remains within the delivery catheter and is configured to remain relative close to the lower tissue, with the collapsible disk configured to be positioned on a first side of the target site (the opposite posts 321 can still be near the upper and lower tissue in a configuration between figures 11a and b where the disk is on a first side), and wherein, in the expanded configuration (figure 11b/c) of the medical device, the collapsible disk is expanded outside of the delivery catheter, while the first wire leg is positioned outside of the delivery catheter and is configured to engage the lower tissue on a second side of the target site opposite the first side, and while the second wire leg is positioned outside of the delivery catheter and is configured to engage the upper tissue on the second side of the target site (figure 11b/c, the posts cross over each other and do extend out of a plane where the disc is located, therefore the posts can engage tissue on a second side as well as engage the opposite respective lower and upper tissue).
However, Garrison is silent about each wire is hingedly coupled at a hinge and folding along the hinge.
Surti teaches a similar device (device with rotatable clamps) having legs (27,28) which are hingedly coupled at a hinge to a peripheral edge of a disk and folds along the hinge (figure 1, 2, paragraph 29, 33) for the purpose of using a known fastening means for a member that rotates about an edge. The members “fold” about the “hinge” as they rotate into the deployed state. Garrison does seem to disclose other embodiments where arms are attached to a ring (see figure 7a,d, 16a-d, 17a-d,) and can fold / bend / move with respect to the ring (see figure 7a,d, 15a-c, 16a-d, 17a-d). Garrison also discloses that different features of different embodiments can be usable together (paragraph 215,216). Surti teaches that similar legs can “permanently attached” to a base or “hingedly coupled”. Therefore Surti does teach that arms attached to a ring can move with the ring or be hingedly coupled with the ring. Based on the teachings of Surti as well as the disclosure of Garrison, the posts of figure 3a-d can be substituted with posts that are hingedly coupled to the ring and fold along the hinge. Substituting a similar fastening mechanism of a hinge in the device of Garrison will yield the predicable result of allowing the legs to move about the disk. By using the hinge of Surti, the legs can fold about the hinge. See prior art below in section 8 as further evidence of a hinge connection. It would have been obvious to one of ordinary skill in the art before the effective filing date to have each wire of Garrison be hingedly coupled at a hinge to the peripheral edge of the disk and each wire leg folding along the hinge as taught by Surti in order for using substituting a known fastening means for a member that conforms to a deployed configuration as desired.
As to claim 21, with the device of Garrison and Surti above, Garrison discloses the proximal portion further comprises a connecting segment extending between respective intermediate portions of the at least two wire legs, the connecting segment oriented parallel to the disk when the at least two wire legs are in the crossed configuration (figure 11b). The prongs can have a middle portion which can be the intermediate portion which will lie parallel to parts of the ring in the crossed configuration.
As to claim 23, with the device of Garrison and Surti above, Garrison discloses in the expanded configuration, respective proximal portions of the at least two wire legs, extending from the connecting segment to the respective free proximal end of the corresponding wire leg, are oriented parallel to the disk (figure 11b).
As to claim 24, with the device of Garrison and Surti above, Garrison discloses the first wire leg and the second wire leg have free ends extending radially 180° opposite to one another in the collapsed expanded configuration (figure 11b).
As to claim 25, with the system of Garrison and Surti above, Garrison discloses the delivery system of claim 17, wherein the delivery cable is engaged with a proximal surface of the at least one cover during delivery of the medical device (paragraph 90, the sheath is stretched open to receive the sheath, which can read on engaging the cable, see figure 20a).
As to claim 26, with the system of Garrison and Surti above, Garrison discloses the delivery cable is configured to advance the distal portion of the device frame out of the delivery catheter prior to the proximal portion of the device frame during delivery of the medical device (figure 21b, paragraph 107-109, the tines/ring 317 will be delivered prior to the posts 321).
Claims 1, 3, 6, 15-17, 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2007/0198057 to Gelbart in view of U.S. Patent Publication 2010/0331866 to Surti and U.S. Patent Publication 2010/0228269 to Garrison and/or as evidenced by U.S. Patent Publication 2011/0301618 to Lichtenstein.
As to claim 1, Gelbart discloses a medical device (paragraph 8) for treating a target site comprising a device frame (3, figure 6a,b, 7a,b) comprising a proximal portion (11) and a distal portion (the ring of 3, figure 6a,b,) and the medical device configured to selectively transition between a collapsed configuration (figure 6a/7a, paragraph 29) and an expanded configuration (figure 6b/7b, paragraph 29, when the device as seen in figure 6b/7b engages tissue), wherein the distal portion comprises a collapsible disk (the disk that the ring of 3 forms) and the proximal portion comprises at least two wire legs (11), each wire leg respectively extending proximally between a distal end hingedly coupled to a peripheral edge (figure 6a,b, paragraph 24) of the disk and a free proximal end (figure 6a,b) when, in the collapsed configuration of the medical device (figure 6a,7a), the collapsible disk is collapsed, a first wire leg of the two wire legs extends proximally from the collapsed disk, and a second wire leg of the at least two wire legs extends proximally from the collapsed disk, with the first wire leg configured to be positioned relatively close to upper tissue at the target site and with the second wire leg configured to be positioned relatively close to lower tissue at the target site (opposite barbs 11 can be positioned near respective tissue which can upper and lower tissue, when the device is in the configuration of figure 6a/7a), wherein the medical device has a partially deployed configuration (figure 6b,7b) in which the collapsible disk is expanded while the first wire leg is configured to remain positioned relative close to the upper tissue and the second wire leg configured to remain relative close to the lower tissue, with the collapsible disk configured to be positioned on a first side of the target site (the disk is expanded and the barbs 11 can still remain to be near the upper and lower tissue respectively), and wherein, in the expanded configuration (figure 6b/7b, as the device engages tissue) of the medical device, the collapsible disk is expanded, while the first wire leg is configured to engage the lower tissue on a second side of the target site opposite the first side, and while the second wire leg configured to engage the upper tissue on the second side of the target site (the barbs 11 are capable of engaging tissue on the second side, where the barbs can engage a lower and upper tissue respectively, see interpretations below).
However, Gelbart is silent about each wire leg rotating about the respective distal end thereof an into a crossed configuration when the medical device transitions from the collapsed configuration to the expanded configuration and at least one cover, wherein the at least one cover is coupled to the distal portion and each wire is hingedly coupled at a hinge and folding along the hinge. Gelbart does disclose multiple different barb/leg embodiments can be used.
Garrison teaches a similar device having at least two wire legs (figure 3, 5a,b, ) connected to the peripheral edge of a disk (figure 3, 5a,b) and each wire leg folding along the respective distal end thereof an into a crossed configuration when the device frame transitions from the collapsed configuration to the expanded configuration (figure 3, 5a,b) for the purpose of enhancing flexibility of the clip yet able to increase penetration of the legs to engage tissue (paragraph 73-78). Garrison teaches that having legs move into a cross configuration can help the legs engage tissue to secure the device in place. Garrison further teaches at least one cover (309, figure 9b, 10, 11c; 517, figure 17c,d, 18; 537 20a-c) wherein the at least one cover is coupled to the distal portion for the purpose of aiding in closing the target site (paragraph 84, 94). Lichtenstein can further teach or provide evidence on a cover (72, figure 8e, paragraph 97-99) coupled to a distal portion. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the legs of Garrison in the frame of Gelbart to have the crossed configuration in order for enhancing flexibility of the clip yet able to increase penetration of the legs to engage tissue. It further would have been obvious to one of ordinary skill in the art before the effective filing date to use the cover of Garrison (or/as evidenced by Lichtenstein) in order for aiding in closing the target site.
Surti teaches a similar device (device with rotatable clamps) having legs (27,28) which are hingedly coupled at a hinge to a peripheral edge of a disk and folds along the hinge (figure 1, 2, paragraph 29, 33) for the purpose of using a known fastening means for a member that rotates about an edge. The members “fold” about the “hinge” as they rotate into the deployed state. Garrison teaches different mechanisms of arms coupled to a ring which seem to fold about a hinge (figure 7a,d, 15a-c, 16a-d, 17a-d). Surti teaches that similar legs can be permanently attached to a base/ring or be hingedly coupled. Gelbart does seem to disclose an embodiment where the barbs/legs seem to move (figure 8a-d) and that different configurations of the barbs/legs can be used. Therefore, the legs of Gelbart, as modified by Garrison/Surti can move into the crossed configuration as taught by Garrison by folding / bending about a hinge in order to use a known mechanism for moving legs into a deployed configuration. Substituting a similar fastening mechanism of a hinge in the device of Gelbart will yield the predicable result of allowing the legs to move into a configuration which can aid in the hemostatic closure. By using the hinge of Surti, the legs can fold about the hinge. See prior art below in section 8 as further evidence of a hinge connection. It would have been obvious to one of ordinary skill in the art before the effective filing date to have each wire of Gelbart as modified by Garrison / Lichtenstein be hingedly coupled at a hinge to the peripheral edge of the disk and each wire leg folding along the hinge as taught by Surti in order for using a known fastening means for a member that moved into a closure configuration.
Of Note: Having the barbs of Gelbart move into the crossed configuration, the legs will further be able to engage the respective lower and upper tissue on a second side of a tissue.
As to claim 3, with the device of Gelbart, Surti, Garrison, and Lichtenstein above, Garrison further teaches the at least one cover is coupled to the peripheral edge of the disk (figure 9b, 10, 11c, 16d, 17c,d, 18, 20c), such that at least one cover expands when the device frame transitions from the collapsed configuration into the expanded configuration. Gelbart does disclose that the ring/disk will “expand” when moved from the collapsed configuration to the expanded configuration as seen in at least figure 6a-b. Therefore, the cover of Gelbart that is attached to the ring/disk will also expand. Additionally/Alternatively, the cover 72 of Lichtenstein also expands when the device frame transitions from the collapsed configuration in to the expanded configuration ( as seen in figure 8a-e). Therefore the cover of the of the modified device of Gelbart, Surti, Garrison, and Lichtenstein can also expand as the device expands into the deployable configuration.
As to claim 6, with the device of Gelbart, Surti, Garrison, and Lichtenstein, Gelbart discloses the at least two wire legs rotate towards the disk during the transition from the collapsed configuration to the expanded configuration (figure 2a-f,). Garrison further teaches the legs will rotate towards the disk in at least figures 2a,b.
As to claim 15, with the device of Gelbart, Surti, Garrison, and Lichtenstein, Gelbart discloses the device frame is comprises a shape-memory material (paragraph 22).
As to claim 16, with the device of Gelbart, Surti, Garrison, and Lichtenstein, Garrison further teaches discloses the at least one cover is formed from one or more of: a fabric material, a knit material, a polymer material, a bioresorbable material, or a bioabsorbable material (paragraph 87, 94).
As to claim 17, Gelbart discloses a delivery system (figure 7a) for deploying a medical device to a target site, the delivery system comprising a medical device (paragraph 8) which is configured to selectively transition between a preset expanded configuration (figure the extend the device is expanded is pre-set set based on characteristics of the device and/or the delivery mechanism ) and a collapsed configuration (figure 6a, 7a), which comprises a device frame (3, figure 6a,b, 7a,b) comprising a proximal portion (11) and a distal portion (the ring of 3, figure 6a,b,), wherein the distal portion comprises a collapsible disk (the disk that the ring of 3 forms) and the proximal portion comprises at least two wire legs (11), each wire leg respectively extending proximally between a distal end hingedly coupled to a peripheral edge (figure 6a,b, paragraph 24) of the disk and a free proximal end (figure 6a,b), a delivery device comprising a delivery catheter (1) and a delivery cable (4) within the delivery catheter and translatable with respect to the delivery catheter to advance the medical device through the delivery catheter to the target site (paragraph 29), when, in the collapsed configuration of the medical device (figure 7a), the collapsible disk is collapsed within the delivery catheter (figure 7a), a first wire leg of the two wire legs is within the delivery catheter and extends proximally from the collapsed disk, and a second wire leg of the at least two wire legs is within the delivery catheter and extends proximally from the collapsed disk, with the first wire leg configured to be positioned relatively close to upper tissue at the target site and with the second wire leg configured to be positioned relatively close to lower tissue at the target site (opposite barbs 11 can be positioned near respective tissue which can upper and lower tissue, when the device is in the configuration of figure 7a), wherein the medical device has a partially deployed configuration (figure 7b before the device engages tissue ) in which the collapsible disk is expanded outside of the delivery catheter (figure 7b), while the first wire leg remains within the delivery configuration and is configured to remain positioned relative close to the upper tissue and the second wire leg remains within the delivery catheter and is configured to remain relative close to the lower tissue, with the collapsible disk configured to be positioned on a first side of the target site (the opposite barbs 11 can still be near the upper and lower tissue in figure 7b), and wherein, in the expanded configuration (when the device engages tissue after figure 7b) of the medical device, the collapsible disk is expanded outside of the delivery catheter, while the first wire leg is positioned outside of the delivery catheter and is configured to engage the lower tissue on a second side of the target site opposite the first side, and while the second wire leg is positioned outside of the delivery catheter and is configured to engage the upper tissue on the second side of the target site (figure 7b, the barbs will be capable of engaging lower and upper tissue on a second side, see interpretations below).
However, Garrison is silent about each wire leg rotating about the respective distal end thereof and into a crossed configuration when the device frame transitions from the collapsed configuration to the expanded configuration and at least one cover, wherein the at least one cover is coupled to the distal portion, and each wire is hingedly coupled at a hinge and folding along the hinge. Gelbart does disclose multiple different barb/leg embodiments can be used.
Garrison teaches a similar device (closure device, abstract) having at least two wire legs (figure 3, 5a,b, ) connected to the peripheral edge of a disk (figure 3, 5a,b) and each wire leg folding along the respective distal end thereof an into a crossed configuration when the device frame transitions from the collapsed configuration to the expanded configuration (figure 3, 5a,b) for the purpose of enhancing flexibility of the clip yet able to increase penetration of the legs to engage tissue (paragraph 73-78). Garrison teaches that having legs move into a cross configuration can help the legs engage tissue to secure the device in place. Garrison further teaches at least one cover (309, figure 9b, 10, 11c; 517, figure 17c,d, 18; 537 20a-c) wherein the at least one cover is coupled to the distal portion for the purpose of aiding in closing the target site (paragraph 84, 94). Lichtenstein can further teach or provide evidence on a cover (72, figure 8e, paragraph 97-99) coupled to a distal portion. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the legs of Garrison in the frame of Gelbart to have the crossed configuration in order for enhancing flexibility of the clip yet able to increase penetration of the legs to engage tissue. It further would have been obvious to one of ordinary skill in the art before the effective filing date to use the cover of Garrison (or/as evidenced by Lichtenstein) in order for aiding in closing the target site.
Surti teaches a similar device (device with rotatable clamps) having legs (27,28) which are hingedly coupled at a hinge to a peripheral edge of a disk and folds along the hinge (figure 1, 2, paragraph 29, 33) for the purpose of using a known fastening means for a member that rotates about an edge. The members “fold” about the “hinge” as they rotate into the deployed state. Garrison teaches different mechanisms of arms coupled to ring which seem to fold about a hinge (figure 7a,d, 15a-c, 16a-d, 17a-d). Surti teaches that similar legs can be permanently attached to a base/ring or be hingedly coupled. Gelbart does seem to disclose an embodiment where the barbs/legs seem to move (figure 8a-d) and that different configurations of the barbs/legs can be used. Therefore, the legs of Gelbart, as modified by Garrison/Surti can move into the crossed configuration as taught by Garrison by folding / bending about a hinge in order to use a known mechanism for moving legs into a deployed configuration. Substituting a similar fastening mechanism of a hinge in the device of Gelbart will yield the predicable result of allowing the legs to move into a configuration which can aid in the hemostatic closure. By using the hinge of Surti, the legs can fold about the hinge. See prior art below in section 8 as further evidence of a hinge connection. It would have been obvious to one of ordinary skill in the art before the effective filing date to have each wire of Gelbart as modified by Garrison / Lichtenstein be hingedly coupled at a hinge to the peripheral edge of the disk and each wire leg folding along the hinge as taught by Surti in order for using a known fastening means for a member that moved into a closure configuration.
Of Note: Having the barbs of Gelbart move into the crossed configuration, the legs will further be able to engage the respective lower and upper tissue on a second side of a tissue.
As to claim 21, with the device of Gelbart, Surti, Garrison, and Lichtenstein above, Garrison further teaches the proximal portion further comprises a connecting segment extending between respective intermediate portions of the at least two wire legs, the connecting segment oriented parallel to the disk when the at least two wire legs are in the crossed configuration (figure 2a,3,11b). The prongs can have a middle portion which can be the intermediate portion which will lie parallel to parts of the ring in the crossed configuration.
As to claim 22, with the device of Gelbart, Surti, Garrison, and Lichtenstein above, Gelbart discloses in the expanded configuration, the respective free proximal ends of the at least two wire legs are oriented radially outwardly (figure 2c, 7b,). Without limitation of what the outward orientation is respective to, Gelbart does have the legs in an expanded configuration that can have the free ends be oriented radially outwards. Further, Garrison teaches in embodiment figures 5b, 10c that the free ends can be oriented outwardly.
As to claim 23, with the device of Gelbart, Surti, Garrison, and Lichtenstein above, Garrison further teaches in the expanded configuration, respective proximal portions of the at least two wire legs, extending from the connecting segment to the respective free proximal end of the corresponding wire leg, are oriented parallel to the disk (figure 2a,3,11b).
As to claim 24, with the device of Gelbart, Surti, Garrison, and Lichtenstein above, Garrison further teaches wherein the at least two wire legs comprise two wire legs having free ends thereof extending radially 180° opposite to one another in the collapsed expanded configuration (figure 2a,3,11b).
As to claim 25, with the device of Gelbart, Surti, Garrison, and Lichtenstein above, Garrison further teaches the delivery system of claim 17, wherein the delivery cable is engaged with a proximal surface of the at least one cover during delivery of the medical device (paragraph 90, the sheath is stretched open to receive the sheath, which can read on engaging the cable, see figure 20a).
As to claim 26, with the device of Gelbart, Surti, Garrison, and Lichtenstein above, Gelbart discloses the delivery cable is configured to advance the distal portion of the device frame out of the delivery catheter prior to the proximal portion of the device frame during delivery of the medical device (figure 7a,b).
Allowable Subject Matter
It is noted that correcting “relatively close” terminology (for example using “proximately” instead of “relatively close” in method claim 18 as well as cancelling device claims 1+ and 17+ can place the application in condition for allowance. A call as made to the applicant but an agreement was not reached.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Publication 2012/0172927 to Campbell (as cited as reference B in the 892 filed 02/08/2024), U.S. Patent 6,726,704 to Loshakove (as cited as reference D in the 892 filed 11/12/2024 ), U.S. Patent Publication 2006/0276839 to McGuckin (as cited as reference E in the 892 filed 11/12/2024), U.S. Patent Publication 2007/0249985 to Brenneman (as cited as reference B in the 892 filed 03/28/2025), U.S. Patent Publication 2007/0282352 to Carley (as cited as reference F in the 892 filed 11/12/2024), U.S. Patent Publication 2008/0312686 to Ellingwood (as cited as reference G in the 892 filed 11/12/2024), U.S. Patent 7,930,016 to Saadat (as cited as reference H in the 892 filed 11/12/2024), U.S. Patent Publication 2012/0209318 to Qadeer (as cited as reference I in the 892 filed 11/12/2024), U.S. Patent Publication 2015/0080945 to Michalak (as cited as reference C in the 892 filed 03/28/2025), and U.S. Patent Publication 2019/0167242 to Rowe (as cited as reference J in the 892 filed 11/12/2024) all disclose similar device capable of disclosing, rendering obvious and/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.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771