DETAILED ACTION
The following Office Action is in response to the Amendment filed on June 9, 2026. Claims 1-20 are currently pending.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
Concerning the “Claim Objections” section on page 6 of the Applicant’s Response filed on June 29, 2026, the amendments to claims 3, 9, and 17 to address the informalities have obviated the necessity of the objections to the claims. Therefore, the objections to the claims are withdrawn.
Concerning the “Claim Rejections - 35 U.S.C. § 101” section on page 6 of the Applicant’s Response filed on June 29, 2026, the amendments to claims 1, 12, and 19 to address the limitations encompassing a human organism have obviated the necessity of the rejections of the claims under 35 U.S.C. §101. Therefore, the rejections of the claims under 35 U.S.C. §101 are withdrawn.
Concerning the “Claim Rejections under 35 U.S.C. § 112” section on pages 6-7 of the Applicant’s Response filed on June 29, 2026, the amendments to claims 1, 6, 12, and 19 to address the issues of indefiniteness have obviated the necessity of the rejections of the claims under 35 U.S.C. §112(b). Therefore, the rejections of the claims under 35 U.S.C. §112(b) are withdrawn.
Response to Arguments
Concerning the “Claim Rejections under 35 U.S.C. § 102” section on pages 7-8 of the Applicant’s Response filed on June 29, 2026, the applicant’s arguments have been fully considered, but they are not persuasive. The applicant argues that the Van Tassel reference does not teach the added limitations of a first anchor adapted to engage the atrial tissue around the proximal side of the ostium, a second anchor adapted to engage the left atrial appendage tissue around the distal side of the ostium, and a ratcheting element coupled to the first and second anchors, the ratcheting element configured to securely clamp tissue on the proximal and distal sides of the ostium between the first and second anchors, arguing that the Van Tassel reference instead teaches one anchor positioned outside the distal wall of the left atrial appendage. However, the examiner asserts that the newly added limitation is an intended use limitation, wherein a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instance case, the left atrial appendage occlusion implant of the Van Tassel reference has the same exact recited structure of the claimed invention and is completely capable of being deployed in the same manner as that of the claimed invention even if it is disclosed to be deployed in a different way. Thus, the Van Tassel reference still anticipates the claim given there is no structural difference. Therefore, the rejections of the claims under 35 U.S.C. §102(a)(1) are withdrawn.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-20 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by VanTassel et al. (US 2003/0120337, hereinafter VanTassel).
Concerning claim 1, the VanTassel et al. prior art reference teaches a left atrial appendage occlusion implant (Figures 14-24), comprising: a first anchor configured to be positioned on a proximal side of an ostium in a left atrium having one or more barrier elements (Figure 15; 40) adapted to engage the atrial tissue around the proximal side of the ostium (Figure 16; 13); a second anchor configured to be positioned on the distal side of the ostium in the left atrial appendage (Figure 15; 130) and capable of engaging the left atrial appendage around the distal side of the ostium (if deployed in such a way by a user), and a ratcheting element coupled to the first and second anchors (Figure 15; 90), the ratcheting element capable of securely clamping tissue on the proximal and distal sides of the ostium between the first and second anchors and seal the ostium with the one or more barrier elements of the first anchor (Figure 17; 13).
Concerning claim 2, the VanTassel reference teaches the device of claim 1, wherein the one or more barrier elements include a barrier element configured to prevent flow of blood into the LAA ([¶ 0067]).
Concerning claim 3, the VanTassel reference teaches the device of claim 1, wherein the first anchor may include an uncovered portion for use in cardiac monitoring and/or pacing (Figure 5; 300 | [¶ 0072]).
Concerning claim 4, the VanTassel reference teaches the device of claim 1, wherein the ratcheting element is configured to adjust a distance between the first and second anchors to securely clamp tissue on opposite sides of the ostium (Figure 17).
Concerning claim 5, the VanTassel reference teaches the device of claim 1, wherein the distance between first and second anchors can be adjusted by actuation of a delivery device releasably coupled to the ratcheting element (Figures 20-22; 170).
Concerning claim 6, the VanTassel reference teaches the device of claim 5, wherein once the tissue at the ostium is sufficiently clamped between the anchors, the delivery device can be released from the ratcheting element (Figure 21-22; 170).
Concerning claim 7, the VanTassel reference teaches the device of claim 1, wherein the ratcheting element includes a shaft with teeth slidably coupled to the first anchor and fixedly coupled to the second anchor ([¶ 0089]), the ratcheting element being configured to retract proximally causing the teeth on the ratcheting element to ratchet with respect to the first anchor while moving the first anchor toward the second anchor the clamp the tissue (Figures 12-21 | [¶ 0089]).
Concerning claim 8, the VanTassel reference teaches the device of claim 7, wherein the teeth of the ratcheting element are configured to lock the first anchor on the shaft (Figure 21 | [¶ 0089]).
Concerning claim 9, the VanTassel reference teaches the device of claim 1, wherein the first and second anchors are generally annular shaped (Figure 15; 40, 130).
Concerning claim 10, the VanTassel reference teaches the device of claim 1, wherein the first and second anchors are self-expanding ([¶ 0084]).
Concerning claim 11, the VanTassel reference teaches the device of claim 10, wherein the self-expanding first and second anchors are configured to collapse or compress into a delivery configuration for delivery of the implant to the LAA (Figure 14), and then self-expand after delivery (Figure 15).
Concerning claim 12, the VanTassel et al. prior art reference teaches a left atrial appendage occlusion implant (Figures 14-24), comprising: a first anchor configured to be positioned on a proximal side of an ostium in a left atrium having one or more barrier elements (Figure 15; 40) adapted to engage the atrial tissue around the proximal side of the ostium (Figure 16; 13) and prevent blood flow into the LAA ([¶ 0067]); a second anchor configured to be positioned on the distal side of the ostium in the left atrial appendage (Figure 15; 130) and capable of engaging the left atrial appendage tissue around the distal side of the ostium (if deployed in such a way by a user), and a ratcheting element coupled to the first and second anchors ([¶ 0085]), the ratcheting element configured to adjust a distance between the first and second anchors to securely clamp tissue on opposite sides of the ostium and seal the ostium with the first anchor (Figure 17).
Concerning claim 13, the VanTassel reference teaches the device of claim 12, wherein the ratcheting element includes a shaft with teeth slidably coupled to the first anchor and fixedly coupled to the second anchor ([¶ 0089]), the ratcheting element being configured to retract proximally causing the teeth on the ratcheting element to ratchet with respect to the first anchor while moving the first anchor toward the second anchor the clamp the tissue (Figures 12-21 | [¶ 0089]).
Concerning claim 14, the VanTassel reference teaches the device of claim 13, wherein the teeth of the ratcheting element are configured to lock the first anchor on the shaft (Figure 21 | [¶ 0089]).
Concerning claim 15, the VanTassel reference teaches the device of claim 12, wherein the first and second anchors are self-expanding ([¶ 0084]).
Concerning claim 16, the VanTassel reference teaches the device of claim 15, wherein the self-expanding first and second anchors are configured to collapse or compress into a delivery configuration for delivery of the implant to the LAA (Figure 14), and then self-expand after delivery (Figure 15).
Concerning claim 17, the VanTassel reference teaches the device of claim 12, further comprising a cardiac monitoring element and/or treatment element secured to at least the first or second anchor ([¶ 0072]).
Concerning claim 18, the VanTassel reference teaches the device of claim 12, wherein the first anchor includes sensing and/or stimulating electrodes in contact with the LAA tissue (Figure 5; 300 | [¶ 0072]).
Concerning claim 19, the VanTassel et al. prior art reference teaches a left atrial appendage occlusion implant (Figures 14-24), comprising: a first self-expanding anchor configured to be positioned on a proximal side of an ostium in a left atrium having one or more barrier elements (Figure 15; 40) adapted to engage the atrial tissue around the ostium (Figure 16; 13) and prevent blood flow into the LAA ([¶ 0067]); a second self-expanding anchor configured to be positioned on the distal side of the ostium in the left atrial appendage (Figure 15; 130) and capable of engaging the left atrial appendage tissue around the distal side of the ostium (if deployed in such a way by a user), and a ratcheting element coupled to the first and second anchors ([¶ 0085]), the ratcheting element configured to adjust a distance between the first and second anchors to securely clamp tissue on opposite sides of the ostium and seal the ostium with the first anchor (Figure 17), wherein the self-expanding first and second anchors are configured to collapse or compress into a delivery configuration for delivery of the implant to the LAA (Figure 14), and then self-expand after delivery (Figure 15).
Concerning claim 20, the VanTassel reference teaches the device of claim 19, wherein the ratcheting element includes a shaft with teeth slidably coupled to the first anchor and fixedly coupled to the second anchor ([¶ 0089]), the ratcheting element being configured to retract proximally causing the teeth on the ratcheting element to ratchet with respect to the first anchor while moving the first anchor toward the second anchor the clamp the tissue (Figures 12-21 | [¶ 0089]).
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 MARTIN TRUYEN TON whose telephone number is (571)270-5122. The examiner can normally be reached Monday - Friday; EST 10:00 AM - 6:30 PM.
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/MARTIN T TON/Examiner, Art Unit 3771 9/23/2026
