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 Amendment
This office action is responsive to the amendment filed on 08/06/2026. As directed by the amendment: claims 62, 68, 72, and 74-77 have been amended, claims 1-61 have been cancelled and claims 67-68 (see Non-Final Rejection mailed 04/08/2026, Election section, and election section in the office action below as well) and 72-74 remain withdrawn. Thus, claims 62-77 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 11-13, filed 08/06/2026, with respect to the rejection(s) of claim(s) 62 under 35 U.S.C. 102(a)(1) as being anticipated by Slaughter et al (US 20180235640 A1), herein referenced to as “Slaughter” have been fully considered and are persuasive.
The applicant has amended claim 62 to further recite “a longitudinal opening of an insert at a center of the stent umbrella and the insert comprises one or more notches which open in a direction of the first end”.
The examiner agrees that Slaughter does not explicitly teach an insert at a center of the stent umbrella.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Slaughter in view of Wang et al (US 20220022885 A1).
Applicant's arguments, see pages 13-16, filed 08/06/2026, with respect to rejection of claims 75-77 under 35 U.S.C. 103 as being unpatentable over Wang et al (US 20220022885 A1) herein referenced to as “Wang” in view of Slaughter have been fully considered but they are not persuasive.
The applicant amended claim 75 to further recite “a threaded longitudinal opening at a center of an insert of the stent umbrella, and the insert comprises one or more notches which open in a direction of the first end”.
The applicant amended claim 76 to further recite “wherein the implant comprises at least one of a pair of moveable jaws on opposite sides of the anchor, sized to capture tissue of a wall of the LAA and permit the anchor to be secured to the captured tissue, and a longitudinal opening of an insert at a center of the collapsible lattice framework and the insert comprises one or more notches which open in a direction of the collapsible lattice framework”.
The applicant amended claim 77 to further recite “wherein the implant comprises a collapsible stent umbrella at a first end; an anchor at second end; at least one of a pair of moveable jaws on opposite sides of the anchor, sized to capture tissue of a wall of the LAA and permit the anchor to be secured to the captured tissue, and a longitudinal opening of an insert at a center of the stent umbrella and the insert comprises one or more notches which open in a direction of the first end”.
Firstly, the amendments to the claims 76 and 77 now direct the claims to a non-elected species. Specifically, in the response filed by the applicant on 03/10/2026 elected Group 1, Species A (Fig. 4C) which is directed to an anchor is a cork screw with a sharpened leading tip. The limitations in claim 76 and 77, including “at least one of a pair of moveable jaws on opposite sides of the anchor” now direct the claims to Group 1, Species D and away from Group 1, Species A which does not include jaws. Hence claims 76-77 as amended will be considered withdrawn as well.
In regards to claim 75, the applicant asserts that Wang does not teach the amended claim limitation because “Wang’s notch is not opened in the same direction as applicant’s notch, as shown in Applicant Fig. 6A (compared to Wang’s Fig. 3).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., Wang’s notch is not opened in the same direction as the applicant’s notch) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The claimed limitation is “one or more notches which open in a direction of the first end”. Wang meets this claim limitation as the notch 153 is open to both the first end and the second as it is a through hole that extends through the insert 150 (see Fig. 3) and the insert is a threaded longitudinal opening with the external threads 154.
As such the rejection of the claims will be maintained.
Election/Restrictions
Claims 72-74 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/10/2026.
Applicant's election with traverse of Group I drawn to a surgical system for occluding a left atrial appendage, group 1 species A (Fig. 4C) the anchor is a cork screw with a sharpened leading tip, and group 2, species A (Figs. 6A and 12A-12D) the insert is a threaded insert with lateral notches that accept rod prongs in the reply filed on 03/10/2026 is acknowledged.
The traversal is on the ground(s) that Lashinski does not disclose “collapsible”, “umbrella”, or “one or more notches which open in a direction of the first end”. This is not found persuasive because Lashinski does disclose these elements.
Specifically,
Lashinski discloses: an occluder 302 (see Figs. 15-16, col. 47, lines 35-55) comprising a collapsible stent umbrella 304 (see Figs. 15-16, col. 47, lines 35-55), an anchor 310 (see Figs. 15-16, col. 47, lines 35-55), and a longitudinal opening 304a (see Figs. 15-16, col. 48, lines 7-25) at a center the center of 304 (see Fig. 16) of the collapsible stent umbrella 304 (see Fig. 16, col. 47-48, lines 63-67 and lines 1-6, the stent umbrella can collapse and expand), and a longitudinal opening 304a (see Fig. 16, col. 48, lines, 7-14) at a center the center of 304 (see Fig. 16) of the stent umbrella 304 and one or more notches 304b (see Fig. 16, col. 48, lines 7-15) which open in a direction the direction towards the end of 304 of the first end the end of 302 towards 304 (see Fig. 16).
The requirement is still deemed proper and is therefore made FINAL.
Furthermore, claims 67-68 are further withdrawn as being directed to a non-elected species, as it includes jaws, which is not part of elected Group 1, species A (Fig. 4C) the anchor is a cork screw with a sharpened leading tip.
Claims 76-77 are further withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, the limitations in claim 76 and 77, including “at least one of a pair of moveable jaws on opposite sides of the anchor” now direct the claims to Group 1, Species D and away from elected Group 1, Species A which does not include jaws. Hence claims 76-77 as amended will be considered withdrawn as well.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 62-63, 65-66, and 69-71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slaughter et al (US 20180235640 A1), herein referenced to as “Slaughter” in view of Wang et al (US 20220022885 A1) herein referenced to as “Wang”.
Claim 62
Slaughter discloses: An occluder 10 (see Figs. 1A-4I, [0045]) for a left atrial appendage (LAA) 5 (see Figs. 4A-4I, [0056]) of a heart 1 (see Figs. 4A-4I, [0055]), comprising: a collapsible stent umbrella 20 (see Figs. 1A-4I, [0045] and [0070], umbrella-like shape) at a first end proximal end of 10 (see Figs. 1A-4I, [0045]); an anchor 40 (see Figs. 1A-4I, [0045]) at second end distal end of 10 (see Figs. 1A-4I, [0045]); and at least one of a pair of moveable jaws (will not be examined here due to being an optional claim limitation) on opposite sides of the anchor, sized to capture tissue of a wall of the LAA and permit the anchor to be secured to the captured tissue (will not be examined here due to being an optional claim limitation), and a longitudinal opening (see annotated Fig. 2A below, the opening that extends from 20 to 40) at a center the center of 20 (see Figs. 1A and 2A) of the stent umbrella 20 and one or more notches the one or more notches defined by the pattern of 20 (see annotated Fig. 2A below, [0048], that open both in a proximal and distal direction) which open in a direction of the first end proximal end of 10.
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Slaughter does not explicitly teach: the longitudinal opening of an insert at the center of the stent umbrella.
However, Wang in a similar field of invention teaches an occluder 10 (see Figs. 1-3, [0084]) comprising a lattice framework 15 (see Figs. 1-3, [0085], is a lattice framework shaped with a cone-like shape), an anchor 11 (see Fig. 3, [0085]), and longitudinal opening 154 (see Fig. 3, [0085]) at a center the center of 15 (see Fig. 3) of the stent umbrella 15, and one or more notches 153 (see Fig. 3, [0085]). Wang further teaches: the longitudinal opening 154 of an insert 150 (see Fig. 3, [0089]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Slaughter to incorporate the teachings of Wang and teach an occluder with the longitudinal opening of an insert at the center of the stent umbrella. Motivation for such can be found in Wang as this provides a proximal end to the stent umbrella (15) that after fastened for occlusion the length of the proximal end/insert (150) can be reduced to reduce the risk of postoperative complications (see [0091]).
Claim 63
The combination of Slaughter and Wang teaches: The occluder of claim 62, see 103 rejection above. Slaughter further discloses: wherein the one or more notches (see annotated Fig. 2A below claim 62) includes at least two notches (see annotated Fig. 2A below claim 62) positioned on opposite sides (see annotated Fig. 2A below claim 62) of the longitudinal opening (see annotated Fig. 2A below claim 62).
Claim 65
The combination of Slaughter and Wang teaches: The occluder of claim 62, see 103 rejection above. Slaughter further discloses: further comprising a longitudinally oriented pass through opening the opening at the end of 40 adjacent to 44 (see Figs. 1A-2B) sized to permit guide wire insertion, tracking, and removal.
The language, " sized to permit guide wire insertion, tracking, and removal," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Slaughter meets the structural limitations of the claim, and is capable of a guide wire being inserted through the device through 40 and permit tracking and removal.
Furthermore, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 I.
Claim 66
The combination of Slaughter and Wang teaches: The occluder of claim 62, see 103 rejection above. Slaughter further discloses: wherein the anchor 40 is in a form of a helical coil 40 (see Figs. 1A-4I, [0045], corkscrew, hence a helical coil), or in a form of a hook (will not be examined here due to being an optional claim limitation).
Claim 69
The combination of Slaughter and Wang teaches: The occluder of claim 62, see 103 rejection above. Slaughter further discloses: wherein the collapsible stent umbrella 20 comprises a lattice framework 20 (see Figs. 1A-4I, 20 is a lattice framework) formed from a super-elastic or shape memory metal or metal alloy (see [0051], 20 is made from nitinol, which is a shape memory metal alloy that is super elastic) that has a heat set deployed shape (see [0053], heat shape, deployed position), wherein the lattice framework 20 is deformable and returnable to the deployed shape (see [0053], deployed position) via material super-elasticity (see [0053]), or wherein at body temperature the lattice framework assumes the heat set deployed shape in an absence of restricting external forces via material shape memory (see [0053], this happens in the body, see Figs. 3 and 4H-4I), and wherein the lattice framework 20 is sized to extend over an LAA ostium of a heart (see Fig. 4I, 20 covering the ostium 6, [0055]); and a fabric covering 50 (see Fig. 1B, [0062]) affixed to the lattice framework 20; and wherein the anchor 40 is a coil anchor (see Figs. 1A-4I, 40 is a coil anchor) secured to (will not be examined here due to being an optional claim limitation) or integrally formed (see [0051], 20 a+ 40 are cut from a single nitinol tube, hence integrally formed) with the lattice framework 20, wherein the coil anchor 40 is a helical coil 40 (see Figs. 1A-4I, 40 is a helical coil/corkscrew) with a sharpened end 44 (see Figs. 1A-4E, [0050], improved penetration) opposite the lattice framework 20.
The language, " wherein at freezing or near freezing temperatures the lattice framework is collapsible to a tubular shape," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Slaughter meets the structural limitations of the claim, and is capable of the lattice framework, as it is a nitinol structure to be collapsible to a tubular shape to fit within a catheter such as seen in Fig. 3, and capable of doing so at freezing or near freezing temperatures as it made of nitinol which his capable of shape-memory memory properties.
Slaughter does not explicitly disclose: which is annealed and quenched so as to set the lattice framework in a heat set deployed shape.
Slaughter teaches that the lattice framework comprises a nitinol material (see [0051]), but is silent as to the method of heat setting the lattice framework. The claimed phrase “which is annealed and quenched so as to set the lattice framework in a heat set deployed shape” is being treated as a product by process limitation; that is, that the lattice framework is made by annealing and quenching to form the heat set deployed shape. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Thus, even though Slaughter is silent as to the process used to heat set the lattice framework, it appears that the product in Slaughter would be the same or similar as that claimed; especially since both applicant’s product and the prior art product is made of a nitinol material (see applicant’s patent application publication [0085], nitinol alloys).
Claim 70
The combination of Slaughter and Wang teaches: The occluder of claim 69, see 103 rejection above. Slaughter further discloses: wherein the fabric covering 50 is or has at least one of: is a woven polyethylene terephthalate which is structured to facilitate tissue in-growth and encapsulation (the alternatives to “medical fabric material” will not be examined here due to being optional claim limitations); has attachment holes on lattice members at a circumferential periphery of the stent umbrella, and wherein the fabric covering is secured to the attachment holes; is an expanded polytetrafluoroethylene (ePTFE) or other medical fabric material 50 (see [0062], biocompatible material, polyethylene terephthalate) which is structured to facilitate tissue in-growth and encapsulation (see [0062], promote epithelialization); has attachment holes on lattice members at a circumferential periphery of the lattice framework, and wherein the fabric covering is secured to the attachment holes; has rounded stent tips on lattice members at a circumferential periphery of the lattice framework; and is attached directly (see Fig. 1B, [0063] 50 is directly attached to 20) to struts of the lattice framework 20.
Claim 71
The combination of Slaughter and Wang teaches: The occluder of claim 69, see 103 rejection above. Slaughter further discloses: wherein the coil anchor 40 and the lattice framework 20 are integrally formed from a single piece of super-elastic or shape memory material (see [0051], 20 a+ 40 are cut from a single nitinol tube, hence integrally formed), or integrally formed from multiple pieces (will not be examined due to being an optional claim limitation) of super-elastic or shape memory material.
Claim(s) 64 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slaughter in view of Wang as applied to claim 62 above, and further in view of O’Brien et al (US 20100043802 A1), herein referenced as “O’Brien”.
Claim 64
The combination of Slaughter and Wang teaches: The occluder of claim 62, see 103 rejection above. The combination of Slaughter and Wang does not explicitly teach: wherein the anchor has a diameter of 1-3 mm.
However, O’Brien in a similar field of invention teaches an occluder 202 with a stent 206 (see Fig. 2A) and an anchor 204 that is a coil (see Fig. 2A, 204 is a coil). O’Brien further teaches: wherein the anchor 204 has a diameter of 1-3 mm (see [0061], 3 mm).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Slaughter to incorporate the teachings of O’Brien and teach an occluder with the anchor has a diameter of 1-3 mm. Motivation for such can be found in O’Brien as this allows the device to expand from a narrow catheter to flex to fit local tissue variation at the time of implantation (see [0062]).
Claim(s) 75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Slaughter.
Claim 75
Wang discloses: A control handle 20 + 60 (see Fig. 1, [0084]) for a catheter delivery tool 23 + 42 + 46 (see Fig. 1, [0084]) for installing an occluder 10 (see Figs. 1-3, [0084]) in a left atrial appendage (LAA) (see [0002], left atrial appendage) of a heart (see [0002], the LAA is in the heart), wherein the occluder 10 comprises a stent umbrella 15 (see Figs. 1-3, [0085], is a mesh stent that is umbrella shaped with a cone-like shape) at a first end proximal end of 10 (see Fig. 3), an anchor 11 (see Fig. 3, [0085]) at a second end distal end of 10 (see Fig. 3), a threaded longitudinal opening 154 (see Figs. 2-3, [0085], extend threads with a proximal opening, wherein 153 is a notch in 150) at a center the center of 15 (see Fig. 3) an insert 150 (see Figs. 2-3, [0085]) of the stent umbrella 15, and the insert 150 comprises one or more notches 153 (see Fig. 3, [0085], wherein 153 is a notch in 150, which meets the limitation) which open in a direction (see Fig. 3, opens proximally) of the first end the proximal end of 10; the control handle 20 + 60 comprising: a primary handle 60 (see Fig. 1, [0084]); a steerable catheter handle 20 (see Fig. 1, [0084]) connected to the primary handle 60; and one or more actuators 25 + 67 + 65 + 66 (see Fig. 1, [0084]) for steering a catheter 23 (see Fig. 1, [0084], 25 controls bending of 23) which delivers the occluder 10 to the LAA, anchoring (see [0084] and [0158]-[0161], 68 controls anchoring on a rupture, [0088]) the anchor 11 to an inner wall of the LAA, deploying the stent umbrella 15 to a deployed position in a left atrium of the heart and covering an opening to the LAA (see [0088]), and releasing the catheter delivery tool (see Fig. 58, the catheter detaching from 10) from the occluder 10 once the occluder is installed at the LAA (see [0158]-[0161]).
Wang does not explicitly disclose: the stent umbrella is collapsible.
However, Slaughter in a similar field of invention teaches an occluder 10 (see Figs. 1A-4I) for a left atrial appendage (LAA) 5 (see Figs. 4A-4I, [0056]) of a heart 1 (see Figs. 4A-4I, [0055]) with a stent umbrella 20 (see Figs. 1A-4I ) at a first end proximal end of 10 (see Figs. 1A-4I) and an anchor 40 (see Figs. 1A-4I) at second end distal end of 10 (see Figs. 1A-4I). Slaughter further teaches: the stent umbrella 20 is collapsible (see Figs. 1A-4I, [0012], collapsible frame).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Wang to incorporate the teachings of Slaughter and teach an occluder with the stent umbrella is collapsible. Motivation for such can be found in Slaughter as the collapsibility of the frame allows the stent umbrella to accommodate anatomical variability between subjects and allow the device to effectively seal off a left atrial appendage upon implantation (see [0013]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dasnurkar et al (US 20180338767 A1) teaches an implant with a threaded insert at the proximal end with two notches that mate with the tabs of a delivery device (see Figs. 37-38)
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 RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
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