DETAILED ACTION
This Office Action is in response to Applicant’s amendment filed 16 January 2026.
Notice of 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.
Response to Arguments
In the response filed 16 January 2026, Applicant argues the amendment to claim 1, which now recites the limitations of dependent claims 2-4, overcome the rejection under Onushko’075. This argument is persuasive. Claims 3-4 were not rejected under Onushko’075 in the last rejection because Onushko’075 does not disclose a plurality of bag filters.
Similarly, claim 12 was amended to recite a plurality of bags elements. This amendment overcomes Onushko’075 because Onushko’075 does not disclose a plurality of bag filters.
However, the amendment to claim 12 raises new issues under 35 USC 112a because the specification does not disclose placing a plurality of “bag elements” around the periphery of the frame. The amendment to dependent claim 13 raises new issues under 35 USC 112a because the specification does not disclose a coagulant associated with any other than the expandable elements. That is to say, the claims are broader than the original disclosure.
Applicant argues the amendment to claim 1 overcomes the rejection under Wang’597 because the expandable elements are “adapted to seal against an ostium of an LAA (left atrial appendage)”. Applicant argues no medical professional would attempt to deploy Wang’s aortic filter in the LAA. This argument is not persuasive because the claims do not recite a step of delivering the device to the LAA. Applicant further argues there is no reasonable belief that deploying Wang’s aortic filter in the LAA would result in the filter sealing “against an ostium of the LAA”. This argument is not persuasive because the specification indicates the opening of an LAA is irregularly shaped. Depending on the shape of the opening, Wang’597’s device is configured to seal against the opening, depending on the shape of the opening. Applicant’s argument that filters allow blood to flow through is not persuasive because the periphery of Wang’597’s device is still configured to form a seal, even if blood can flow through the filtering elements. Filtering and sealing are not mutually exclusive. For example, Applicant’s own invention is adapted to form a seal and allow blood to flow through the filter elements. A seal prevents debris from passing around/outside of the filtering element.
Similar arguments were made with respect to claim 12 and the rejection under Wang’597. Examiner maintains the above arguments for claim 12, as well.
Claim 16 was amended to recite “three or more bag filters”. This amendment overcomes the rejection under Wang’597 and the claim is indicated allowable.
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 12-13 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 12 was amended to recite “a plurality of bag elements secured around the periphery”. The specification does not disclose “bag elements”. Rather, the specification discloses “bag filters”. In order to overcome this rejection, Examiner suggests amending the claims to recite “a plurality of bag filters
Claim 13 was amended to recite the device comprises a coagulant. This is considered new matter because the limitation is broader than the original disclosure. The original application only discloses a coagulant associated with the expandable elements or, more specifically, the bag filters. The specification does not disclose a coagulant associated with any other portion of the device. MPEP 2163 II(3)(a) states: The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 “merely by clearly describing one embodiment of the thing claimed.” LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005).” The claim contains new matter because it is claim is broader than what was disclosed in the original application.
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, 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (US Patent Publication 2014/0100597).
Claim 1: Wang’597 discloses an implantable medical device (Figures 2, 8), comprising:
an expandable frame (240) expandable between a collaps88ed configuration for delivery and an expanded configuration for deployment (Figure 5-8 show expandable frame 240 delivered from catheter 150), the expandable frame including a periphery (outer circumference of 240) defined by the expandable frame;
a covering (paragraph [0057]) spanning at least part of the expandable frame; and
an expandable element (220, 230) secured relative to the periphery (Figure 8), the expandable element adapted to seal against an ostium of a left atrial appendage (paragraph [0032], [0033] describe how the filters cover and overly the ostiums of branch arteries for the purpose of preventing emboli from entering these arteries. In order to function as described, the perimeter of the expandable elements 220, 230 will need to be sealed against the ostiums to aid in preventing emboli from passing outside of the expandable elements 220, 230. Further, paragraph [0058] discloses the size and shape can be modified to be better suited towards deployment in other parts of the body.);
wherein the expandable element comprises a plurality of bag filters (220, 230) that each have an open end (224, 234, respectively) and a closed end (opposite end of 224, 234), and each of the plurality of bag filters are arranged around the periphery with the open end facing one direction and the closed end facing an opposing direction (Figure 2).
Claim 11: This is directed towards the intended use of the device. IN this case, because of its size and shape, Wang’597’s implantable device could be used an as a LAAC device. Wang’597 teaches using the device in other areas of the body (paragraph [0058]).
Claim 12: Wang’597 discloses a LAAC (left atrial appendage closure) device (Figure 2, 8) adapted to fit within an irregular ostium of a patient's LAA (left atrial appendage) (because of its size and shape, Wang’597’s implantable device could be placed in the ostium of a patient’s LAA)., the LAAC device comprising:
an expandable frame (240) expandable between a collapsed configuration for delivery and an expanded configuration for deployment (Figure 5-8 show expandable frame 240 delivered from catheter 150), the expandable frame including a periphery (outer circumference of 240) defined by the expandable frame;
a covering (paragraph [0057]) spanning at least part of the expandable frame; and
a plurality of bag elements (220, 230) adapted to seal against an irregular ostium of the patient's LAA (paragraph [0032], [0033] describe how the filters cover and overly the ostiums of branch arteries).
Allowable Subject Matter
Claims 16, 17 and 20 are allowed.
Claim 7 is 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.
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 extension fee 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 date of this final action.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 17 February 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771