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 12/15/2025 that the claim amendments would overcome the 112 rejections. The previous 112 rejections have been withdrawn, however new 112 rejections have been made below.
The applicant argues with respect to the prior art, a person of ordinary skill in the art would not find it obvious that Ruiz, Chanduszko, Amplatz, King, and Thommen would read on both a waist and a locking mechanism (where the locking mechanism has a radially inwardly extending lip which engages with a protruding edge) based on Ruiz on the disclosure of the link 205 and “in a further alternative, the device may include an internal locking mechanism”. However, paragraph 82 of Ruiz does not state, in alternative of the link, the device can include an internal locking mechanism, just that in another further embodiment, the device can include a locking mechanism. The link seems to provide a load based on having a length. The teaching references can have a locking mechanism as well as having an intermediate member which provides a length which can read help provide the load. Additionally/alternatively, the teaching references can teach an example of a locking mechanism that can be used with a device with the link 205. The locking mechanism can help to “further secure” the device, which has a link / waist member, in the deployed position. A new rejection with respect to Ruiz as modified by Chanduszko, Amplatz, and Huebsch/Thommen as evidenced by Liu has been made below where teaching references Huebsch/Thommen can read on the locking mechanism with a radially inwardly extending lip which engages with a protruding edge as well as Liu/Huebsch can provide evidence that a continuous single braided device with waist member can also include a locking mechanism.
Claim Interpretation
It is to be noted there isn’t specific support for the scope of “an internally threaded proximal screw facing proximally”. Based on the figures, it can be seen that the internally threaded proximal screw has an proximal opening and can be engaged by advancing a complimentary screw from the proximal direction. Therefore the limitation will be interpreted similarly that the internally threaded proximal screw faces proximally by being able to be being open at its proximal end.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 4-9, 12, 20, 21, 25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention:
Claim 1, lines 32-34 state “wherein the medical device is configured to be clamped in place upon deployment to the target site when the medical devices is in the self-expanded configuration and the locking mechanism is in the unlocked state”. The applicant argues there is support for the limitations in paragraphs 3, 4. However, paragraph 3 and 4 provide background to devices made up of Nitinol to treat PFO but does not disclose the unlocked state and how the device can still be clamped in the unlocked state. There is no specific support, for the scope, of how the device can be clamped when the device is self-expanded and the locking mechanism is unlocked. Therefore the limitation is considered to be new matter. The limitation will be interpreted to be if the device is made of a shape memory type material, the device can expand when deploy and be configured to clamp to tissue regardless of further locking elements.
Claim 7, lines 1-3 states that the locking mechanism further comprises “a polymer compressible sleeve configured to couple the distal screw and the proximal screw together”. However claim 7 is ultimately dependent from claim 1 which states that “the proximal locking proton includes a catch element on a distal inner edge… the catch element defining a radially inwardly extending lip… which catches or grasps over a radially protruding edge of a coupling element of the distal locking portion”. This is mechanism is highlighted in the embodiment of figure 2c, paragraph 38 of the published application. The polymer compressible sleeve of claim 7 seems to be supported by figure 2a, paragraph 36 however there is no support for how the compressible sleeve would work, or be combined with, the inwardly extending lip and the radially protruding edge. Therefore the limitation is considered to be new matter.
Claim 8, lines 1-3 states that the locking mechanism further comprises “a metallic split compression ring configured to couple the distal screw and the proximal screw together”. However claim 8 is ultimately dependent from claim 1 which states that “the proximal locking proton includes a catch element on a distal inner edge… the catch element defining a radially inwardly extending lip… which catches or grasps over a radially protruding edge of a coupling element of the distal locking portion”. This is mechanism is highlighted in the embodiment of figure 2c, paragraph 38 of the published application. The metallic split compressing ring of claim 8 seems to be supported by figure 2b, paragraph 37 however there is no support for how the metallic split compressing ring would work, or be combined with, the inwardly extending lip and the radially protruding edge. Therefore the limitation is considered to be new matter.
Claim 9, lines 1-2 states that the locking mechanism further comprises “a spring loop configured to couple the distal screw and the proximal screw together”. However claim 8 is ultimately dependent from claim 1 which states that “the proximal locking proton includes a catch element on a distal inner edge… the catch element defining a radially inwardly extending lip… which catches or grasps over a radially protruding edge of a coupling element of the distal locking portion”. This is mechanism is highlighted in the embodiment of figure 2c, paragraph 38 of the published application. The spring loop of claim 9 seems to be supported by figure 2b, paragraph 37 however there is no support for how the spring loop would work, or be combined with, the inwardly extending lip and the radially protruding edge. Therefore the limitation is considered to be new matter.
Claim 12, lines 1-4 states that the locking mechanism “is non-reversible such that when the distal locking portion and the proximal locking portion are uncoupled from each other, at least one of the distal locking portion and the proximal locking portion detaches from its respective portion”. However claim 12 is dependent from claim 1 which states that “the proximal locking proton includes a catch element on a distal inner edge… the catch element defining a radially inwardly extending lip… which catches or grasps over a radially protruding edge of a coupling element of the distal locking portion”. This is mechanism is highlighted in the embodiment of figure 2c, paragraph 38 of the published application. The nonreversible locking mechanism with the detaching of the locking portion of claim 12 seems to be supported by paragraph 33, 42, or 55, however there is no support for the inwardly extending lip and the radially protruding edge locking mechanism can be nonreversible and/or detached. Therefore the limitation is considered to be new matter.
Claim 25, lines 1-4 states “the proximal locking member has a textured internal surface defining a sidewall of the distal-facing pocket … the distal locking member has a textured internal surface configured to interface with the textured internal surface …”. However claim 25 is dependent from claim 1 which states that “the proximal locking proton includes a catch element on a distal inner edge… the catch element defining a radially inwardly extending lip… which catches or grasps over a radially protruding edge of a coupling element of the distal locking portion”. This is mechanism is highlighted in the embodiment of figure 2c, paragraph 38 of the published application. The textured surfaces of claim 25 seems to be supported by figure 2d-f, paragraph 39 however there is no support for how textured surfaces would work, or be combined with, the inwardly extending lip and the radially protruding edge. Therefore the limitation is considered to be new matter.
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, 2, 4, 20, 21, are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2011/0082495 to Ruiz in view of U.S. Patent Publication 2005/0273135 to Chanduszko, U.S. Patent Publication 2009/0018562 to Amplatz, U.S. Patent 5,853,422 to Huebsch and/or U.S. Patent Publication 2010/0185233 to Thommen as evidenced by U.S. Patent Publication 2017/0156904 to Liu.
As to claim 1, Ruiz discloses a medical device (paragraph 16) for treating a target site, the medical device comprising: a braided tubular member (paragraph 80, the device is formed from braided wires which can form a tubular member ) comprising a proximal disc portion (200) at a proximal end, a distal disc portion (190) at a distal end, and a waist member (205) extending between the proximal disc portion and the distal disc portion (figure 11a,b, 12, 13), the waist member being expandable (paragraph 80, 82), wherein the tubular member has a self-expanded configuration (figure 13, paragraph 80-82) when unconstrained and a reduced configuration (figure 12, paragraph 83, 84) for delivery to the target site; wherein the tubular member is configured to be constrained in the reduced configuration in response to a first force (figure 12, paragraph 84, the sheath causes the device to transition to a contracted delivery state), and wherein the tubular member is configured to return to the self-expanded configuration from the reduced configuration when the first force is removed upon delivery of the medical device at the target site (paragraph 84), and
a locking mechanism (“internal locking mechanism”, paragraph 82, can be further used with a device having a waist member) having a proximal locking portion (201) attached to the proximal disc portion, the proximal locking portion defining an internally threaded proximal screw facing proximally (paragraph 81, the base has a threaded lumen that accepts a mating threaded component of the delivery system, which can read on a proximally facing screw since it will allow for an proximal engagement), and
the medical device is configured to be clamped in place upon deployment to the target site when the medical device is in the self-expanded configuration and the locking mechanism is in the unlocked state (paragraph 80-82). Ruiz teaches the discloses can be made from nickel-titanium and be self-expandable. Based on the shape memory characteristics, the device will be able to clamp tissue as it self expands, while the locked mechanism is in the unlocked state.
Ruiz discloses in paragraph 82 the device can include an internal locking mechanism as described in U.S. Patent Publication 2005/0273135 to Chanduszko, the entirety of which are incorporated by reference. The locking mechanism can help to further secure the device of figure 11a in the locked configuration, in a further embodiment. Chanduszko teaches a tubular device (figure 2f, paragraph 38) comprising a distal disc portion (figure 2f, the right disc), a proximal disc portion (figure 2f the left disc), a locking mechanism having a distal locking portion (100a) attached to, and positioned within the distal disc portion (figure 2f, paragraph 49), a proximal locking portion (106) attached to the proximal disc portion, the locking mechanism having both an unlocked sate (figure 2f) and a locked state (figure 2g) when the tubular member is in the expanded configuration at the deliver site, wherein the distal locking portion and the proximal locking portion are configured to be coupled together when the tubular member has returned to the expanded configuration (figure 2f,g, paragraph 49-50), such that when the tubular member is in the expanded configuration and the locking mechanism is in the locked state, at least one of the distal disc portion and the proximal disc portion exhibits reduced bulging than when the tubular member is in the expanded configuration and the locking mechanism is in the unlocked state (paragraph 49). Ruiz does disclose the self expanded state and that a locking mechanism can be used, such as Chanduszko. Therefore the locking mechanism, as taught by Chanduszko can obtain the locked and unlocked states of the device of Ruiz when the tubular member is in the self-expanded configuration. Further, the application as originally filed supports the reduced bulging occurs when the discs are pulled together and held together via a locking mechanism (paragraph 5, 23). Since the locking mechanism of Chanduszko does pull the discs together and holds the discs the together, bulging can be minimized. Chanduszko does disclose the locking mechanism aids is securing the occluder in an expanded, deployed configuration. Prior art Liu provides evidence that a locking mechanism, similar to Chanduszko, can be used in a braided continuous two disc device (paragraph 44, 45) with a middle section (similar to 205 of Ruiz). If it would not be known that Ruiz, which incorporates by reference the locking mechanism of Chanduszko, would be able to disclose the locking mechanism with the locked and unlocked states as claimed it would have been obvious in order for securing the occluder in an expanded, deployed configuration.
However, the locking mechanism of Chanduszko (and thus Ruiz), is silent the proximal disc portion is attached to and positioned within the proximal disc portion, the proximal locking portion defining a distal-facing pocket extending distally away from the internally threaded proximal screw, wherein the disclose locking member is secured within the distal-facing pocket to transition the locking mechanism from the unlocked state to the locked state, the proximal portion includes a catch element on a distal inner edge of the proximal locking portion, the catch element defining a radially inwardly extending lip, such that in the locked state of the locking mechanism, the lip catches or grasps over a radially protruding edge of a coupling element of the distal locking portion to maintain the proximal disc portion and the distal disc portion in a pulled-together configuration.
If, however, it would not be known that the device of Ruiz would be able to read on a tubular member where the waist member is expandable, Amplatz teaches a similar device (occlusion device, abstract) having a braided tubular member (abstract, paragraph 30, 33, 46) with an self-expandable waist member (306, paragraph 54, 61, 68, 69) for the purpose of allowing the device to conform to the tissue, align the proximal and distal portions of the device, and/or to efficiently optimize occlusion. Liu provides evidence that a device with a waist member can be used in a device with a locking mechanism. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the device of Ruiz be tubular and have a waist member be expandable in order to conform to the tissue, align the proximal and distal portions of the device, and/or to efficiently optimize occlusion.
Huebsch teaches a similar device (occluding device, abstract) having a proximal locking portion (122) attached to, and positioned within a proximal disc portion (figure 6, 9), where the proximal locking portion defining a distal facing pocket (124) extending distally away from a proximal end (figure 6, 9), wherein a distal locking member (122), attached to and positioned within a distal disc portion (figure 6, 9) is secured within the distal-facing pocket to transition the locking mechanism from the unlocked state to the locked state (col. 5 ll. 22-38), where the proximal portion includes a catch element (figure 6, 9, the indentation within 124) on a distal inner edge of the proximal locking portion, the catch element defining a radially inwardly extending lip (figure 6,9), such that in the locked state of the locking mechanism, the lip catches or grasps over a radially protruding edge (the tip of 122) of a coupling element of the distal locking portion to maintain the proximal disc portion and the distal disc portion in a pulled-together configuration (col. 5 ll. 22-38). Huebsch teaches each of the proximal locking portion and distal locking portion has internal structure (130,132) which engages with a delivery device. These structures can be the internal screws. Huebsch can also further teach or provide evidence that a locking mechanism can be used in a continuous braided device with a waist (col. 3 ll. 64-col. 4 ll. 2).
Thommen teaches a similar device (occluding device, abstract) having a proximal locking portion (2) attached to and positioned within a proximal disc portion (1, figure 1, 9 at least 22,23 of locking portion “2” is positioned within the proximal disc portion, and/or at least in the expanded configuration of figure 9), where the proximal locking portion defining a distal facing pocket (proximal region of passage 23 starting at the tapering and extending distal) extending distally away from a screw (figure 1), wherein a distal locking member is secured within the distal-facing pocket to transition the locking mechanism from the unlocked state to the locked state (paragraph 58), where the proximal portion includes a catch element (22, figure 1) on a distal inner edge of the proximal locking portion, the catch element defining a radially inwardly extending lip (figure 1), such that in the locked state of the locking mechanism, the lip catches or grasps over a radially protruding edge (the ridge of 36, paragraph 58) of a coupling element of the distal locking portion to maintain the proximal disc portion and the distal disc portion in a pulled-together configuration (figure 9). Thommen teaches a similar locking engagement mechanism that has a distal locking portion, attached to and positioned within a disc (figure 1, 9) having a protruding edge configured to engage a radially extending lip of a distal-facing pocket of a proximal locking portion to transition the device from a locked state to an unlocked state. Further the pocket is distal to a screw which is used to attach to a delivery component. This screw can be the positioned similarly with respect to the “internally threaded screw” of Ruiz.
Both Huebsch and Thommen teaches equivalent locking mechanisms that have proximal and distal locking portions attached to and positioned within proximal and distal disc portions respectively having a lip and protruding edge coupling mechanism. Further the proximal locking portion has a distal facing pocket configured to engage with the distal locking portion to transition the locking mechanism from the unlocked state to the locked state. The proximal locking portions both of Huebsch and Thommen can further allow for the internal thread of Ruiz. Ruiz does disclose a similar lip and edge engagement in a locking mechanism of another embodiment (figure 3, 4a-c). Using the locking mechanisms of either Huebsch or Thommen in the device of Ruiz as the locking mechanism between proximal and distal portions will yield the predictable result of being able to lock the device in the expanded state. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the proximal locking portion of Ruiz, Chanduszko, and Amplatz attach to the interior surface of proximal disc portion and have the distal facing pocket to engage with the distal locking portion to transition the locking mechanism from the unlocked state to the locked state as taught by Huebsch/Thommen in order for using an alternative mechanism that can ensure stability of the shape of the device.
In summary, Ruiz discloses the braided tubular comprising a proximal disc portion, a distal disc portion, a waist member, a locking mechanism which has a proximal portion with an internally threaded proximal screw facing proximally to engage with a delivery device. The continuous single braided device of Ruiz, with the waist, can also include a locking mechanism, as evidenced by Liu/Huebsch. The locking mechanism of Ruiz can incorporate by reference the locking mechanism of Chanduszko. The locking mechanism of Chanduszko can disclose/teach that the locking mechanism can have the locked/unlocked states by engaging a distal locking portion with the proximal locking portion. The engagement can help reduce bulging in the locked state. Both Huebsch and Thommen teaches similar locking mechanism that have a proximal locking portion having distally facing pocket with a radially inwardly extending lip which can engage with a protruding edge of a distal locking portion. Both of the proximal locking portions of Huebsch and Thommen can further allow for the proximal threaded portion and the locked/unlocked states.
As to claim 2, with the device of Ruiz, Chanduszko, Amplatz, and Huebsch/Thommen above, Chanduszko further teaches the locking mechanism is an active locking mechanism that required manually coupling the distal locking portion to the proximal locking portion when in the expanded configuration (paragraph 49, the pulling of the catch mechanism will read on the active locking mechanism). Huebsch also teaches the locking mechanism is an active locking mechanism that required manually coupling the distal locking portion to the proximal locking portion when in the expanded configuration (col. 5 ll. 22-37). Thommen also teaches the locking mechanism is an active locking mechanism that required manually coupling the distal locking portion to the proximal locking portion when in the expanded configuration (paragraph 58).
As to claim 4, with the device of Ruiz, Chanduszko, Amplatz, and Huebsch/Thommen above, Chanduszko further teaches the distal locking portion is located in a center of the distal disc portion and wherein the proximal portion is located in a center of the proximal disc portion (figure 2f,g, as seen by the centered hubs of Ruiz figure 11a,b). Huebsch also teaches distal locking portion is located in a center of the distal disc portion and wherein the proximal portion is located in a center of the proximal disc portion (figure 6). Thommen also teaches distal locking portion is located in a center of the distal disc portion and wherein the proximal portion is located in a center of the proximal disc portion (figure 9, paragraph 54).
As to claim 20, Ruiz as modified by Chanduszko, Amplatz, and Huebsch/Thommen discloses a method of eliminating or reducing erosion of cardiac tissue, the method comprising: providing a medical device according to claim 1 (the device of Ruiz as modified by Chanduszko, Amplatz, and Huebsch/Thommen above); constraining the medical device in the reduced configuration (figure 12, via the sheath, paragraph 83); delivering the medical device (paragraph 86); deploying the medical device from the reduced configuration to self-expanded configuration (paragraph 87); after said deploying, activating the locking mechanism by pulling the proximal locking portion toward the distal locking portion (paragraph 49 of Chanduszko teaches pulling), and coupling together the distal locking portion and the proximal locking portion to reduce bulging of the distal disc portion (paragraph 49 of Chanduszko teaches the coupling and locking which can reduce bulging); and increasing the medical device compliance on cardiac tissue (paragraph 49, figure 2g of Chanduszko teaches the expansion which can increase the compliance).
As to claim 21, with the device of Ruiz, Chanduszko, Amplatz, and Huebsch/Thommen above, Chanduszko further teaches when the tubular member is in the self-expanded configuration and the locking mechanism is in the locked state, both of the distal disc portion and the proximal portion exhibit reduced bulging than when the tubular member is in the self-expanded configuration and the locking mechanism is in the unlocked state (paragraph 49). The application as originally filed supports the reduced bulging occurs when the discs are pulled together and held together via a locking mechanism (paragraph 5, 23). Since locking mechanism does pull the both discs together and holds the discs the together, bulging can be minimized in both discs.
Claims 5, 6 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2011/0082495 to Ruiz in view of U.S. Patent Publication 2005/0273135 to Chanduszko, U.S. Patent Publication 2009/0018562 to Amplatz, U.S. Patent 5,853,422 to Huebsch and/or U.S. Patent Publication 2010/0185233 to Thommen as applied to claims 1, 2, 4, 20, 21, above, and further in view of U.S. Patent Publication 2008/0086168 to Cahill.
As to claims 5, 6, Ruiz as modified by Chanduszko, Amplatz, and Huebsch/Thommen discloses the device above but is silent about the proximal screw is larger than a internally threaded distal screw of the distal locking portion.
Cahill teaches a similar device (occlusion device, abstract) having a locking mechanism (650, 660, 654, 670, 658, 628, figure 34a) with a distal locking portion (650) comprising an internally threaded distal screw (660), where a proximal screw (672, figure 34a) is larger than the distal screw (figure 34a) for the purpose of allowing the delivery device to securely move the distal locking portion (paragraph 133). Ruiz does disclose internally threaded proximal screw (paragraph 83,84) and Huebsch does teach a structure to engage a delivery member in both the proximal and distal locking member. Cahill teaches the locking mechanism with the teaches a proximal screw is larger than the distal screw (figure 34a) where the proximal screw is used to help attach to the delivery catheter (paragraph 133) similar to Ruiz. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the internally threaded distal screw and the sizes comparisons of the threaded engagements of Cahill in the locking mechanism of Ruiz as modified by Chanduszko, Amplatz, and Huebsch/Thommen in order for helping to attach the device to the delivery system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 5,171,259 to Inoue discloses a similar device capable of rendering obvious or providing evidence on the locking mechanism with the lip and protruding edge of the proximal and distal locking portion (figure 13-15).
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