DETAILED ACTION
This Office Action is in response to the communication dated 15 December 2025 concerning Application No. 17/427,880 filed on 02 August 2021.
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of Claims
Claims 1, 93, 94, 97-100, 102, 103, and 105-111 are pending and currently under consideration for patentability; claims 1, 93, 94, 100, 103, 107, and 109 have been amended; claims 2-92, 95, 96, 101, 104, and 112-114 have been cancelled.
Response to Arguments
Applicant’s arguments dated 15 December 2025 have been fully considered, but they are not persuasive or moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant has amended the claims to recite that the ostium ring exerts a force to disrupt cell-to-cell conduction or compress tissue myocytes, in order to electrically isolate the left atrial appendage from the left atrium. The Examiner has addressed the amended limitations in the updated text of the rejection below.
Claim Objections
Claims 93 and 103 are objected to because of the following informalities.
Claims 93 and 103 contain minor typographical and/or grammatical errors.
Claim 93, lines 1-2: Applicant is advised to change “the self-expanding ostium” to “the self-expanding ostium ring”
Claim 103, line 8: Applicant is advised to change “the tissued myocytes” to “tissue myocytes”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 93, 94, 97, 98, 100, 102, 103, 105, 107-109, and 111 are rejected under 35 U.S.C. 103 as being unpatentable over Asirvatham et al. (US 2017/0281193 A1) in view of Kunis (US 2013/0204311 A1) and Oral et al. (US 2013/0018413 A1).
Regarding claim 1, Asirvatham describes a system for treating a medical condition of a patient ([0023]), comprising an implant configured to be inserted into a left atrial appendage (LAA) of the patient ([0039]), wherein the implant comprises a self-expanding ostium ring with ostial cover ([0036], [0040]) configured to engage the left atrium (LA) ([0040]), wherein the self-expanding ostium ring is configured to exert a force circumferentially about the LAA ostium at a ring contact site (figure 1, [0040]) that results in LAA electrical isolation to electrically isolate the LAA from the LA ([0027], [0032]).
Regarding claim 1, Asirvatham does not explicitly disclose wherein the force exerted by the ostium ring disrupts cell to cell conduction within the ostium tissue, and Asirvatham does not explicitly disclose wherein the implant comprises a fill material configured to engage the LAA.
Regarding the force exerted by the ostium ring disrupting cell to cell conduction within the ostium tissue, Kunis also describes a system for treating a medical condition of a patient ([0006]), including an implant comprising a ring configured to exert a force sufficient to disrupt cell to cell conduction ([0018]). As Kunis is also directed towards treating a medical condition and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate Kunis’s limitation that the force is sufficient to disrupt cell to cell conduction into Asirvatham’s system, as doing so advantageously allows the resulting system to electrically isolate the components on either side of the ring. The Examiner respectfully points out that Asirvatham also describes that “the fully expanded size of occluder device 100 is larger than LAA 10 such that occluder device 100 substantially fills (and may slightly stretch) LAA 100” ([0040]), thereby suggesting a tight fitting of the occluder device within the left atrial appendage.
Regarding the implant including a fill material configured to engage the LAA, Oral also describes a system for treating a medical condition of a patient ([0006]), comprising an implant configured to be inserted into the LAA of the patient ([0006]) to separate the LAA from the LA ([0059]), including fill material configured to engage the LAA ([0006], [0060], figure 3D). As Oral is also directed towards an implant configured to be inserted into a left atrial appendage of a patient and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a fill material similar to that described by Oral when using the system described by Asirvatham, as doing so advantageously allows the resulting device to be better supported within the LAA.
Regarding claim 93, Asirvatham describes wherein the force exerted by the self-expanding ostium ring at the ring contact site is further configured to fluidly isolate the LAA from the LA ([0014]).
Regarding claim 94, Asirvatham describes wherein to fluidly isolate the LAA from the LA prevents clot/thrombus formation inside the LAA from exiting the LAA into the LA ([0044], [0051]).
Regarding claim 97, Asirvatham, Kunis, and Oral do not explicitly disclose wherein the fill material comprises multiple fill portions. However, as Oral describes the use of one fill portion ([0006], [0060]), the Examiner respectfully submits that configuring Oral’s device such that it comprised multiple fill portions would be a matter of duplicating or rearranging the known element of a fill portion without producing a new or unexpected result. One advantage of such a modification is to allow for the implant to be gradually filled, one portion at a time, in order to best conform to the shape of the patient’s ostium.
Regarding claim 98, Oral describes wherein the fill material is configured to anchor the implant ([0067], [0069]).
Regarding claim 100, Asirvatham describes wherein the self-expanding ostium ring is further configured to provide equal pressure around a non-circular shaped LAA ostium ([0039] - [0040]).
Regarding claim 102, Asirvatham describes wherein the implant includes a multi-part implant that enables precise positioning (figure 1).
Regarding claim 103, Asirvatham describes a system for treating a medical condition of a patient ([0023]), comprising an implant configured to be inserted into a left atrial appendage (LAA) of the patient ([0039]), wherein the implant comprises a self-expanding ostium ring with ostial cover ([0036], [0040]) configured to engage the left atrium (LA) ([0040]) and exert a force circumferentially about the LAA ostium (figure 1, [0040]) to electrically isolate the LAA from the LA ([0027], [0032]).
Regarding claim 103, Asirvatham does not explicitly disclose wherein the force exerted by the ostium ring compresses tissue myocytes, and Asirvatham does not explicitly disclose wherein the implant comprises a fill material configured to engage the LAA.
Regarding the force exerted by the ostium ring compressing tissue myocytes, Kunis also describes a system for treating a medical condition of a patient ([0006]), including an implant comprising a ring configured to exert a force sufficient to compress tissue myocytes ([0008], [0018]). As Kunis is also directed towards treating a medical condition and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate Kunis’s limitation that the force is sufficient to compress tissue myocytes into Asirvatham’s system, as doing so advantageously allows the resulting system to electrically isolate the components on either side of the ring. The Examiner respectfully points out that Asirvatham also describes that “the fully expanded size of occluder device 100 is larger than LAA 10 such that occluder device 100 substantially fills (and may slightly stretch) LAA 100” ([0040]), thereby suggesting a tight fitting of the occluder device within the left atrial appendage.
Regarding the implant including a fill material configured to engage the LAA, Oral also describes a system for treating a medical condition of a patient ([0006]), comprising an implant configured to be inserted into the LAA of the patient ([0006]) to separate the LAA from the LA ([0059]), including fill material configured to engage the LAA ([0006], [0060], figure 3D). As Oral is also directed towards an implant configured to be inserted into a left atrial appendage of a patient and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a fill material similar to that described by Oral when using the system described by Asirvatham, as doing so advantageously allows the resulting device to be better supported within the LAA.
Regarding claim 105, Oral describes wherein the fill material is configured to anchor the implant ([0067], [0069]).
Regarding claim 107, Asirvatham describes wherein the force exerted by the self-expanding ostium ring around the LAA ostium is further configured to fluidly isolate the LAA from the LA ([0014]).
Regarding claim 108, Asirvatham describes wherein the implant includes a multi-part implant that enables precise positioning (figure 1).
Regarding claim 109, Asirvatham describes a system for treating a medical condition of a patient ([0023]), comprising an implant configured to be inserted into a left atrial appendage (LAA) of the patient ([0039]), wherein the implant comprises a self-expanding ostium ring with ostial cover ([0036], [0040]) configured to engage the left atrium (LA) ([0040]), wherein the self-expanding ostium ring is configured to exert a force circumferentially about the LAA ostium at a ring contact site (figure 1, [0040]) that results in LAA electrical isolation to electrically isolate the LAA from the LA ([0027], [0032]).
Regarding claim 109, Asirvatham does not explicitly disclose wherein the force exerted by the ostium ring disrupts cell to cell conduction within the ostium tissue and wherein the ostium ring compresses tissue myocytes, and Asirvatham does not explicitly disclose wherein the implant comprises a multi-part fill material configured to engage the LAA and anchor the implant.
Regarding the force exerted by the ostium ring disrupting cell to cell conduction within the ostium tissue and compressing tissue myocytes, Kunis also describes a system for treating a medical condition of a patient ([0006]), including an implant comprising a ring configured to exert a force sufficient to disrupt cell to cell conduction ([0018]) and compress tissue myocytes ([0008], [0018]). As Kunis is also directed towards treating a medical condition and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate Kunis’s limitation that the force is sufficient to disrupt cell to cell conduction into Asirvatham’s system, as doing so advantageously allows the resulting system to electrically isolate the components on either side of the ring. The Examiner respectfully points out that Asirvatham also describes that “the fully expanded size of occluder device 100 is larger than LAA 10 such that occluder device 100 substantially fills (and may slightly stretch) LAA 100” ([0040]), thereby suggesting a tight fitting of the occluder device within the left atrial appendage.
Regarding the implant including a multi-part fill material configured to engage the LAA and anchor the implant, Oral also describes a system for treating a medical condition of a patient ([0006]), comprising an implant configured to be inserted into the LAA of the patient ([0006]) to separate the LAA from the LA ([0059]), including fill material configured to engage the LAA ([0006], [0060], figure 3D) and anchor the implant ([0067], [0069]). As Oral is also directed towards an implant configured to be inserted into a left atrial appendage of a patient and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a fill material similar to that described by Oral when using the system described by Asirvatham, as doing so advantageously allows the resulting device to be better supported within the LAA. As Oral describes the use of one fill portion ([0006], [0060]), the Examiner respectfully submits that configuring Oral’s device such that it comprised a multi-part fill material would be a matter of duplicating or rearranging the known element of a fill portion without producing a new or unexpected result. One advantage of such a modification is to allow for the implant to be gradually filled, one portion at a time, in order to best conform to the shape of the patient’s ostium.
Regarding claim 111, Oral describes wherein the implant includes a multi-part fill material that enables precise positioning ([0010]).
Claims 99, 106, and 110 are rejected under 35 U.S.C. 103 as being unpatentable over Asirvatham in view of Kunis and Oral, further in view of Osypka (US 2017/0340336 A1).
Regarding claims 99, 106, and 110, Asirvatham in view of Kunis and Oral suggests the system according to claims 1, 103, and 109. Although Asirvatham describes using shape memory materials for the occluder skirt ([0037]), Asirvatham, Kunis, and Oral do not explicitly disclose wherein the fill material comprises shape memory material. However, Osypka also describes a system for treating a medical condition of a patient, comprising an implant configured to be inserted into a left atrial appendage of the patient (Abstract), including the use of fill material comprised of shape memory material ([0132], [0142], [0150]). As Osypka is also directed towards an implant configured to be inserted into a left atrial appendage of a patient and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate shape memory fill materials, similar to those described by Osypka, when using the system described by Asirvatham, Kunis, and Oral, as doing so advantageously allows the resulting fill material to better conform to the shape of the LAA.
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
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 Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. 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, Carl Layno, can be reached by telephone at 571-272-4949. 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 at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3792