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 .
Election/Restrictions
Applicant’s election of Invention II claims 11-20 and new claims 21-30 in the reply filed on 12/09/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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 27-30 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 27 is directed to a tissue anchor that includes a suture line attached and extends into the internal chamber. However, claim 27 is ultimately dependent off of claim 21 which also claims “an anchor” with “a line”. The scope of claim 27 is directed to two anchors and two lines. The embodiment of figure 65-82 which is directed to the hemostatic plug with the pliable layer which occludes the puncture channel seems to only include one anchor. However, claim 27 is now claiming 2 anchors. It is noted there are other embodiments (Figure 35) with multiple anchors, but the support for the embodiment of the hemostatic plug with the skirt and multiple anchors and lines is unclear. Therefore the claims are interpreted 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.
Claim 11 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent 5,976,174 to Ruiz.
As to claim 11 Ruiz discloses a method for sealing a puncture channel in a human heart having walls that at least partially define an internal chamber (VSD, figure 3a), the method comprising: positioning a distal end of a delivery catheter (20) adjacent an inner surface of a heart wall at a first location (figure 3a); and delivering a hemostatic plug (10) comprising a hemostatic coil (13, col. 4 ll. 4-15the rings are in coil form, and are hemostatic) and at least one layer of a pliable material (12, col. 3 ll. 50-54) extending coaxially around the hemostatic coil (figure 1a-b, 2) 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 3d).
Claim 11, 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2020/0383668 to Rafiee.
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).
As to claim 21, Rafiee discloses a method for remodeling the shape of human heart that at least defines a heart chamber (paragraph 22-24, the pulling can help to “reshape” the heart), the method comprising positioning a positioning a distal end of a delivery catheter (“main shaft”, figure 12) adjacent an inner surface of a heart wall at a first location (figure 12, the main shaft is adjacent the inner surface of the heart wall that defines the LAA); creating a puncture channel from the heart chamber through the heart wall (paragraph 60, the wall of the heart is punctured to advance the guidewire into the pericardial cavity), inserting an anchor (“collar”, figure 12, paragraph 60) through the puncture channel, wherein a line (“tethers”, which can paragraph 60, figure 12) is connected to the anchor, extending the line from the anchor, through the puncture channel, and into the heart chamber (paragraph 60, figure 12), pulling the line to engage the anchor against a surface of the heart wall (paragraph 59, 60, the distal disc is pulled), delivering a hemostatic plug (the distal mesh anchor disc, figure 8a, 12) comprising a hemostatic coil (“tension spring” paragraph 60) and at least one layer of a pliable material (the “mesh” and/or fabric” of the distal mesh anchor paragraph 55, 60) extending coaxially around the hemostatic coil (figure 8a, paragraph 55, 56, 60) 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, 60). Rafiee discloses the heart wall can be punctured to place the distal mesh disc in figure 12, where the disc has a tether that extends therefrom which can be pulled.
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 12-20, 22-26 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 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 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) attached and 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).
As to claim 22, 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 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 23, 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 24, 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 25, 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 26, 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 5,382,259 to Phelps, U.S. Patent 5,702,421 to Schneidt, U.S. Patent 6,776,754 to Wilk, U.S. Patent Publication 2005/0222489 to Rahdert, U.S. Patent Publication 2006/0264980 to Khairkhahan, U.S. Patent Publication 2012/0016411 to Tuval, U.S. Patent Publication 2012/0071922 to Shanley, U.S. Patent Publication 2012/0283585 to Werneth, and U.S. Patent Publication 2014/0257374 to Heisel all disclose similar method capable of disclosing, rendering obvious, or providing evidence on the claims of record.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771