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
The applicant argues the amendments would overcome the 112 rejections. The previous 112 rejections have been withdrawn.
The applicant there is support (figure 72,73) for the amendments with respect to claim 11 with respect to the closed coil comprising winding without gaps between adjacent windings. The examiner disagrees. Figures are not drawn to scale so it is not necessarily known there isn’t any gaps between the windings. Further it would be unclear the scope of a “closed coil” based on the figures 72,73. Further the specification does not state and/or support the specific limitation. Therefore the limitation is considered to be new matter. See the 112 rejections below.
With respect to claim 11, the applicant argues the amendments with respect to the closed coil comprising windings without gaps between adjacent windings would overcome the rejections with respect to Ruiz and Rafiee. The 102 rejections have been withdrawn.
With respect to claim 21, the applicant argues Rafiee is silent about the line extends through a lumen of the hemostatic coil, proximally beyond a proximal end of the hemostatic coil, and into the delivery catheter. The 102 rejection has been withdrawn.
New rejections/interpretations with respect to Campbell, Rafiee in view of Campbell/Wallace, and Rajagopal in view of Tegels have been made below with respect to the independent claims.
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 11-20 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 11 is directed to a hemostatic coil which is a closed coil comprising windings without gaps between adjacent windings. The applicant agues the amendment is supported by figure 72-73. Figures 72-73 does seem to show a tightly coiled device, however it is to be noted that figures are considered not drawn to scale so it would not be known there would be support for the negative limitations of no gaps between adjacent windings. There would need to be specific support in the specification as originally filed for the “closed coil comprising windings without gaps between adjacent windings”. There seems to be support in at least paragraph 203 of the coil with a wide variety for forms (continuous or discontinuous helical or spiral cut…), but there does not seem to be specific support for the closed coil comprising windings without gaps between adjacent wings. Since the support and the scope for the limitation is unknown, the limitations is considered to be new matter.
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 11-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2012/0172927 to Campbell.
As to claim 11, Campbell discloses a method for sealing a puncture channel in a human heart having walls that at least partially define an internal chamber (paragraph 47, 48), the method comprising: positioning a distal end of a delivery catheter (117) adjacent an inner surface of a heart wall at a first location (paragraph 84-86); and delivering a hemostatic plug (100) comprising a hemostatic coil (coil formed from the wires 101 as seen in figure 15b) and at least one layer of a pliable material (109 paragraph 53, 88) extending coaxially around the hemostatic coil (figure 1) through the delivery catheter to the puncture channel such that the hemostatic coil and the at least one layer of a pliable material is positioned within the puncture channel and reduce a flow of blood through the puncture channel (paragraph 82-87, without further limitations with respect to the specific puncture channel, the device is placed within a passage which can read on a puncture channel), wherein the hemostatic coil is a closed coil comprising windings without gaps between adjacent windings (figure 15). Based on the lack of support for the scope of a closed coil comprising adjacent windings without gaps, the coils of figure 15a seems to disclose adjacent windings without gaps and the coil having complete, closed circles. Additionally/Alternatively, the embodiments of figures 20-h, 21a,b, 22, paragraph 74, 75, 81 can read on an embodiment which would have a closed coil (a cover over the spring).
As to claim 12, Campbell discloses the at least one layer of the pliable material forms a skirt (figure 1, the petals of the membrane form the skirt) having a first end (end near hub 110) and a second end (widest part of the petals 112), wherein the first end of the skirt forms an opening that is smaller than an opening formed by the second end (figure 1-3).
As to claim 13, Campbell discloses the skirt is cinched at or near the first end of the skirt (paragraph 145, figure 1, the membrane 109 can be cinched to the hub as seen in figure 1).
As to claim 14, Campbell discloses the first end of the skirt is offset from the distal end of the hemostatic coil (figure 1, the wires 101 extend farther from the first end of the skirt).
As to claim 15, Campbell discloses the skirt comprises a waist configured to enable the skirt to expand laterally when the skirt is compressed in a longitudinal direction extending from the first end to the second end (figure 6, 7, 9, paragraph 53).
As to claim 16, Campbell discloses the skirt comprises a plurality of petals joined (112) to a collar (either of the eyelets 113,114 can read on the collar). Wallace also teaches the collar (112) that can be used to help connect the “petals” of Campbell.
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.
Claim 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2020/0383668 to Rafiee in view of U.S. Patent Publication 2012/0172927 to Campbell and/or U.S. Patent Publication 2016/0324668 to Wallace.
As to claim 11, Rafiee discloses a method for sealing a puncture channel in a human heart having walls that at least partially define an internal chamber (paragraph 48, the LAA can read on the puncture channel since it can be punctured, and is a channel with side walls that define the internal chamber), the method comprising: positioning a distal end of a delivery catheter ("main shaft", figure 8a) adjacent an inner surface of a heart wall at a first location (figure 8a, the main shaft is adjacent the inner surface of the heart wall that defines the LAA); and delivering a hemostatic plug (figure 8a, or the plug as seen in figure 12 which is highlighted in figure 8a) comprising a hemostatic coil ("spring") and at least one layer of a pliable material (the "mesh" and/or fabric" paragraph 55, 60) extending coaxially around the hemostatic coil (figure 8a, paragraph 55,56, the proximal portion is coaxial with the distal portion, which can be coaxial with the spring) through the delivery catheter to the puncture channel such that the hemostatic coil and the at least one layer of a pliable material is positioned within the puncture channel and reduce a flow of blood through the puncture channel (paragraph 55) but is silent about the hemostatic coil is a closed coil comprising windings without gaps between adjacent windings.
Campbell teaches a similar device in a method (occlusion device/method) comprising a hemostatic coil (the spring coil formed from the wires 101) which is a closed coil comprising windings without gaps between adjacent windings (figure 15) for the purpose of obtaining a device with the desired pushability and flexibility (paragraph 56, 72, 81, 82). Based on the lack of support for the scope of a closed coil comprising adjacent windings without gaps, the coils of figure 15a seems to disclose adjacent windings without gaps and the coil having complete, closed circles. Additionally/Alternatively, the embodiments of figures 20-h, 21a,b, 22, paragraph 74, 75, 81 can read on an embodiment which would have a closed coil (a cover over the spring). Wallace also teaches a similar device in a method (occlusion device/method, abstract) having a hemostatic coil (106) which is a closed coil comprising windings without gaps between adjacent windings (figure 1, paragraph 29,30, 31) for the purpose of being able to position an occlusion device as desired. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to use a closed coil hemostatic coil comprising windings without gaps between the adjacent windings as the spring in the device of Rafiee in order to obtaining a device with the desired pushability and flexibility properties.
As to claim 12, Rafiee discloses the method above but is silent about the at least one layer of the pliable material forms a skirt. Rafiee does disclose anchors can be multiple of different structures (paragraph 55,56).
Campbell further teaches a similar device in a method (occlusion device/method) having least one layer of the pliable material forms a skirt (figure 1, the petals of the membrane form the skirt) having a first end (end near hub 110) and a second end (widest part of the petals 112), wherein the first end of the skirt forms an opening that is smaller than an opening formed by the second end (figure 1-3) for the purpose of improving sealing qualities (paragraph 53, 62). Wallace teaches a similar device in a method (occlusion device/method, abstract) having least one layer of the pliable material forms a skirt (108) having a first end (“proximal end”, paragraph 29) and a second end (opposite free end, figure 1), wherein the first end of the skirt forms an opening that is smaller than an opening formed by the second end (figure 1) for the purpose of aiding in delivering the device through a catheter and being able to transition to the desired delivered configuration (paragraph 29, 30). Campbell teaches a “skirt” shape of a pliable material can aid in sealing qualities while Wallace teaches the “skirt” shape can help to deliver the device without damaging it. The pliable material of Rafiee can take the form of the skirt shape as taught by Campbell/Wallace which will yield the predictable result of being to seal the channel as desired. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the at least one layer of pliable material of Rafiee form a skirt having a first end with an opening smaller than an opening of a second end in order to aid in delivering the device and improving sealing qualities.
As to claim 13, with the method of Rafiee and Campbell/Wallace, Campbell further teaches discloses skirt is cinched at or near the first end of the skirt (paragraph 145, figure 1, the membrane 109 can be cinched to the hub as seen in figure 1). Wallace teaches the skirt is cinched, and how it can be cinched, at or near the first end (paragraph 30,31).
As to claim 14, the method of Rafiee as modified by Campbell/Wallace discloses the first end of the skirt is offset from the distal end of the hemostatic coil (Rafiee discloses the pliable material of the distal mesh anchor will be offset from distal end of the hemostatic coil, so using the skirt Campbell/Wallace will have the first end of the skirt be offset from the coil, figure 8a, 12, figure 8a, 12). Campbell further teaches the first end of the skirt is offset from the distal end of the hemostatic coil (figure 1, the wires 101 extend farther from the first end of the skirt). Wallace also teaches the first end of the skirt is offset from the distal end of the hemostatic coil (figure 1, a coil will extend further than the distal end of the skirt). The distal end of the coil of Rafiee will be offset from the pliable material as modified to be the skirt.
As to claim 15, with the method of Rafiee and Campbell/Wallace, Campbell further teaches the skirt comprises a waist configured to enable the skirt to expand laterally when the skirt is compressed in a longitudinal direction extending from the first end to the second end (figure 6, 7, 9, paragraph 53). The petals/skirt expands when the device is deployed, which compressed in a longitudinal direction. Wallace also teaches the skirt comprises a waist (110) configured to enable the skirt to expand laterally when the skirt is compressed in a longitudinal direction extending from the first end to the second end.
As to claim 16, with the method of Rafiee and Campbell/Wallace, Campbell further teaches the skirt comprises a plurality of petals joined (112) to a collar (either of the eyelets 113,114 can read on the collar). Wallace also teaches the collar (112) that can be used to help connect the “petals” of Campbell.
As to claim 17, with the method of Rafiee and Campbell/Wallace, Rafiee discloses delivering a tissue anchor (“distal mesh anchor disc”) through the delivery catheter to the heart wall such that the tissue anchor anchors to the heart wall (figure 8a), wherein the tissue anchor includes a first suture line (“length limiting tether, figure 8b, 12 paragraph 55, 60) that extends into the internal chamber. The “hemostatic plug” can be used with a tissue anchor having tethers/suture lines extending therefrom into the internal chamber which connects to the hemostatic plug.
As to claim 18, with the method of Rafiee and Campbell/Wallace, Rafiee discloses the step of delivering the tissue anchor is performed prior to the step of delivering the hemostatic plug (paragraph 59, 60). The proximal portion can be adjusted, after the distal anchor is deployed. Additionally/alternatively, the distal anchor can be used as a docking collar to help deliver proximal portion after the distal anchor is delivered. Therefore the tissue anchor is delivered prior to completing the delivery of the hemostatic plug.
As to claim 19, with the method of Rafiee and Campbell/Wallace, Rafiee discloses the step of delivering the tissue anchor is performed simultaneously with the step of the hemostatic plug (paragraph 58). If the device is a single piece, the delivery can be simultaneously.
As to claim 20, with the method of Rafiee and Campbell/Wallace, Rafiee discloses the hemostatic plug is coupled to the tissue anchor through the first suture line (figure 8b, paragraph 55).
Claims 21, 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2021/0220130 to Rajagopal in view of U.S. Patent 9,839,415 to Tegels.
As to claim 21, Rajagopal discloses a method for remodeling the shape of human heart that at least defines a heart chamber (paragraph 3, 28), the method comprising positioning a positioning a distal end of a delivery catheter (132, figure 39-41) adjacent an inner surface of a heart wall at a first location (figure 7, the catheter can be positioned adjacent the inner surface of the heart wall to deploy the devices as seen in figure 7); creating a puncture channel from the heart chamber through the heart wall (figure 41-45, a similar method creating the puncture channel of can be used to create the puncture channel of figure 7), inserting an anchor (41, figure 27,28, at least paragraph 191, 204, alternatively the anchor 434 in figure 79) through the puncture channel, wherein a line (46 or the line 438 that is used to deliver the anchor 434) is connected to the anchor, extending the line from the anchor, through the puncture channel, and into the heart chamber (figure 28), pulling the line to engage the anchor against a surface of the heart wall (paragraph 231, figure 119,120), delivering a hemostatic coil (either the coil 21, paragraph 191, which can be similar to the coil seen in figure between 210,41 or the coil 204) and at least one layer of a pliable material (210/201, figure 28, paragraph 200, the membrane of paragraph 200 which covers the flange can also read on the pliable material) extending coaxially around the hemostatic coil (figure 28) through the delivery catheter to the puncture channel such that the hemostatic coil and the at least one layer of a pliable material is positioned within the puncture channel and reduce a flow of blood through the puncture channel (figure 7) wherein the line extends through a lumen of the hemostatic coil, proximally beyond a proximal end of the hemostatic coil, and into the delivery catheter (figure 28). Rajagopal discloses different embodiments of where the device punctures the heart and different structures of the anchoring system. The anchor of either figure 27 or figure 79/119-12041 can be used in the embodiment of figure 7 where the puncture of figure 7 is also similarly created as shown in at least figures 42-46. Paragraph 248 also discloses that modifications of the embodiments. It would have been obvious to one of ordinary skill in the art before the effective filing date to combine embodiments to read on the claims of record in order for remodeling the heart as desired.
If it would not be known that the hemostatic coil and pliable material would be placed within the puncture channel and reduce flow of blood through the puncture, Tegels teaches a similar device in a method where a general coil (400) and pliable material (350, col. 9 ll. 45-50) is placed within a puncture channel over a line attached to an anchor to reduce blood flow therethrough (col. 9 ll. 51-col. 10 ll. 23) for the purpose of sealing the puncture wound. It would seem that the coil/pliable material of figure 7 would be placed within the puncture channel and can be able to reduce blood flow as taught by Tegels. Tegels also further teaches or provides evidence of pulling on the line to position to the anchor and system with respect to the puncture channel (col. 9 ll. 51-col. 10 ll. 23). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the hemostatic coil and pliable material of Rajagopal be placed within the puncture channel and reduce flow of blood through the puncture in order to seal the puncture wound.
As to claim 27, with the method of Rajagopal and Tegels above, Rajagopal discloses inserting the anchor through the puncture channel comprises deploying the anchor from the delivery catheter and through the puncture channel (figure 7, 27, 28, 47-48), and wherein pulling the line to engage the anchor against a surface of the heart wall is effective to move the line through the lumen of the hemostatic coil. The anchor is in deployed from the catheter, and the line is pulled to position to position the anchor with respect to the channel, which will move the line through the coil.
As to claim 28, with the method of Rajagopal and Tegels above, Rajagopal discloses the step of deploying the anchor is performed prior to the step of delivering the hemostatic coil (figure 48-54, 99-102). The anchor is deployed first, then the coil/compliable material follows.
As to claim 29, with the method of Rajagopal and Tegels above, Rajagopal discloses the step of deploying the anchor is performed simultaneously with the step of delivering the hemostatic coil (figure 54c,d). The anchor is deployed with the coil. Tegels can also teach the coil and deployed with the anchor (figure 11).
As to claim 30, with the method of Rajagopal and Tegels above, Rajagopal discloses the hemostatic col is coupled to the tissue anchor through the line (figure 28). Tegels can also teach the limitation (figure 11).
Claims 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2021/0220130 to Rajagopal in view of U.S. Patent 9,839,415 to Tegels as applied to claims 21, 27-30 above, and further in view of U.S. Patent Publication 2012/0172927 to Campbell and/or U.S. Patent Publication 2016/0324668 to Wallace.
As to claim 22, with the method of Rajagopal and Tegels above, Rajagopal discloses the at least one layer of the pliable material forms a skirt (figure 28). Rajagopal does disclose the flange can form a skirt like element and the membrane is attached to the flange.
If it would not be known that Rajagopal would be able to read on the skirt, Campbell teaches a similar device in a method (occlusion device/method) having least one layer of the pliable material forms a skirt (figure 1, the petals of the membrane form the skirt) having a first end (end near hub 110) and a second end (widest part of the petals 112), wherein the first end of the skirt forms an opening that is smaller than an opening formed by the second end (figure 1-3) for the purpose of improving sealing qualities (paragraph 53, 62). Wallace teaches a similar device in a method (occlusion device/method, abstract) having least one layer of the pliable material forms a skirt (108) having a first end (“proximal end”, paragraph 29) and a second end (opposite free end, figure 1), wherein the first end of the skirt forms an opening that is smaller than an opening formed by the second end (figure 1) for the purpose of aiding in delivering the device through a catheter and being able to transition to the desired delivered configuration (paragraph 29, 30). Campbell teaches a “skirt” shape of a pliable material can aid in sealing qualities while Wallace teaches the “skirt” shape can help to deliver the device without damaging it. The pliable material of Rajagopal can take the form of the skirt shape as taught by Campbell/Wallace which will yield the predictable result of being to seal the channel as desired. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the at least one layer of pliable material of Rajagopal form a skirt having a first end with an opening smaller than an opening of a second end in order to aid in delivering the device and improving sealing qualities.
As to claim 23, with the method of Rajagopal, Tegels, and Campbell/Wallace above, Campbell further teaches discloses skirt is cinched at or near the first end of the skirt (paragraph 145, figure 1, the membrane 109 can be cinched to the hub as seen in figure 1). Wallace teaches the skirt is cinched, and how it can be cinched, at or near the first end (paragraph 30,31).
As to claim 24, with the method of Rajagopal, Tegels, and Campbell/Wallace above, Rajagopal discloses the first end of the skirt is offset from the distal end of the hemostatic coil (Rajagopal discloses the pliable material will be offset from distal end of the hemostatic coil, so using the skirt Campbell/Wallace will have the first end of the skirt be offset from the coil, figure 27). Campbell further teaches the first end of the skirt is offset from the distal end of the hemostatic coil (figure 1, the wires 101 extend farther from the first end of the skirt). Wallace also teaches the first end of the skirt is offset from the distal end of the hemostatic coil (figure 1, a coil will extend further than the distal end of the skirt). The distal end of the coil of Rafiee will be offset from the pliable material as modified to be the skirt.
As to claim 25, with the method of Rajagopal, Tegels, and Campbell/Wallace above, Rajagopal discloses teaches the skirt comprises a waist configured to enable the skirt to expand laterally when the skirt is compressed in a longitudinal direction extending from the first end to the second end (figure 26,28). Campbell further teaches the skirt comprises a waist configured to enable the skirt to expand laterally when the skirt is compressed in a longitudinal direction extending from the first end to the second end (figure 6, 7, 9, paragraph 53). The petals/skirt expands when the device is deployed, which compressed in a longitudinal direction. Wallace also teaches the skirt comprises a waist (110) configured to enable the skirt to expand laterally when the skirt is compressed in a longitudinal direction extending from the first end to the second end.
As to claim 26, with the method of Rajagopal, Tegels, and Campbell/Wallace above, Campbell further teaches the skirt comprises a plurality of petals joined (112) to a collar (either of the eyelets 113,114 can read on the collar). Wallace also teaches the collar (112) that can be used to help connect the “petals” of Campbell.
Allowable Subject Matter
Claims 31-33 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Of note: A call was made to the applicant about an Examiner’s Amendment to place the application in condition for allowance, but an agreement was not reached in the allotted time.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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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.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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