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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/17/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/18/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Acknowledgment is made to applicant’s response filed on 03/16/2026. Claims 9-14 and 17-22 remain withdrawn and a complete action on the merits of pending claims 1-8 and 15-16 appears below.
Claim Rejections - 35 USC § 103
Claim(s) 1-8 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wallace (US PGPUB No. 20030195553 A1), in view of Wallace2 (US PGPUB No. 20030083676 A1).
Regarding claim 1, Wallace teaches, an implant (Figure 1, vaso-occlusive element (10)) for the treatment of aneurysms (Paragraph [0030]), wherein the implant (vaso-occlusive element (10)) can be brought in a compressed state (Figure 9a; Paragraph [0034]) through a microcatheter (Figure 9a, delivery catheter (450)) to a target site in a blood vessel system of a patient (Paragraph [0049]), with the implant (vaso-occlusive element (10)) being preset to a secondary structure (Paragraphs [0030] and [0034]) causing it to assume an expanded state (Figure 9c) when released from the microcatheter (Paragraph [0052]), wherein the implant (vaso-occlusive element (10)) is separably connected to an insertion aid (Figures 9a-9c, guidewire (465)) at a detachment point (Figures 9a-9c, where joint (455) is located represents a detachment point) (Paragraphs [0049]-[0052]), wherein:
the implant (vaso-occlusive element (10)) in the expanded state (Figures 1 and 9c) has a basic body (Figure 1, central tubular element (15), proximal end (20), and distal end (30); Paragraph [0030]) comprising of a proximal segment (Figure 1, proximal end (20); Paragraph [0030]) and a distal segment (Figure 1, distal end (30); Paragraph [0030]), with the proximal segment (proximal end (20)) and the distal segment (distal end (30)) being of dome-shaped configuration (Paragraph [0030], discloses in part, “proximal (20) and distal (30) ends that are flared open into “umbrella” shapes.” Where the “umbrella” shapes are indeed of dome-shaped configuration), with a convex side of the dome of the proximal segment facing in a proximal direction (As clearly seen in Figure 1, the convex side, which is the side that curves or bulges outward of proximal end (20) is indeed facing a proximal direction) and a convex side of the dome of the distal segment facing in a distal direction (As clearly seen in Figure 1, the convex side, which is the side that curves or bulges outward of distal end (30) is indeed facing a proximal direction), and wherein the proximal segment (proximal end (20)) and the distal segment (distal end (30)) are connected to each other via a plurality of connecting struts (Figure 1, central tubular element (15); Paragraphs [0031]-[0033], describe the manufacture of the overall vaso-occlusive element (10) which includes central tubular element (15) using a relatively dense braid by braiding multiple fine wires (2). As such, central tubular element (15) is indeed a plurality of connecting struts which connects distal end (30) and proximal end (20)).
Wallace fails to teach, the connecting struts do not intersect and are not interwoven with each other so that they can be compressed or stretched independently, wherein the connecting struts are configured in a way that they achieve adaptation to the aneurysm in axial and radial direction.
Wallace2 discloses, an aneurysm treatment device. Wallace2 teaches, the aneurysm treatment device (Figures 7A-7D, collapsible aneurysm obstruction device (64)) including a mesh body (Figures 7A-7C, material base (66)) at a proximal end and a junction element (Figures 7A-7C, radio-opaque band/marker (24)) at a distal end, the mesh and junction being interconnected by a plurality of discrete struts (Figures 7A-7B, plurality of struts (68)) (Paragraph [0065]). Wallace2 explains that struts (68) are “connecting tethers” constructed of shape memory material, utilized instead of instead of a bulk connecting element, and that they are capable of undergoing relatively significant changes in shape during deployment (Paragraph [0065]). Wallace2 further teaches that the use of such struts “eliminate[s] some of the bulk” and provides improved conformance to the aneurysm geometry (Paragraphs [0065]-[0068]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Wallace’s implant by replacing the rigid central tubular element (15) connecting the proximal and distal domes with plurality of discrete struts as taught by Wallace2, as both references and the claimed invention are directed to aneurysm treatment devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wallace’s implant by replacing the rigid central tubular element (15) connecting the proximal and distal domes with plurality of discrete struts as taught by Wallace2, as such a modification would have been predictable, namely, to reduce bulk and allow the connecting elements to undergo significant independent deformation during deployment, thereby enhancing adaptability to the variable axial and radial dimensions of the aneurysm sac. Substituting Wallace’s rigid connector with Wallace2’s flexible struts would have been a predictable design choice yielding the known benefit of improved conformability, as both references are directed to endovascular aneurysm implants (MPEP 2143; KSR v. Teleflex, 550 U.S. 398 (2007)).
Regarding claim 2, modified Wallace teaches, wherein a configuration of the connecting struts (plurality of struts (68) of Wallace2) arranged between proximal and distal segments (proximal end (20) & distal end (30) of Wallace) is curvilinear (Figure 7A of Wallace2, where struts (68) aren’t shown as straight beams; they clearly curve outwardly between radio-opaque band/marker (24) and material base (66); Further, paragraphs [0065]-[0067] of Wallace2 emphasizes that these struts undergo relatively significant changes in shape during deployment and are formed from shape memory material, which strongly indicates and under the broadest reasonable interpretation (BRI) as curvilinear or arcuate paths rather than rigid straight bars).
Regarding claim 3, Wallace further teaches, wherein the proximal segment (proximal end (20)) and the distal segment (distal end (30)) are constructed from frame struts (Figure 2a, fine wires (2); Paragraph [0032]) which are at least partially connected to each other (Paragraphs [0031]-[0033], describe the manufacture of the overall vaso-occlusive element (10) which includes proximal end (20) and distal end (30) using a relatively dense braid by braiding multiple fine wires (2). As such, proximal end (20) and distal end (30) are indeed constructed from struct (wires (2)) that are connected to each other).
Regarding claim 4, Wallace further teaches, wherein in the expanded state (Figures 1 and 9c) the frame struts (fine wires (20)) form a mesh structure in the proximal segment and distal segment (Paragraph [0032]; Further, Paragraph [0040] reinforces this by stating, “The flattened disk (130) has a layer of braided wires on both sides, and thus may advantageously provide two layers of braided wires to cover the entrance zone (150) instead of one layer with the flared open proximal end (20) shown in FIG. 1.” Where the one layer of braided wires with the flared open proximal end further indicates that a mesh structure is present in the proximal end (20) and distal end (30)).
Regarding claim 5, Wallace further teaches, wherein the distal segment (distal end (30)) preferably comprises centrally an area free of frame struts (See annotated Figures 1, 2b, and 9c below, (Area free of frame struts)), said area being expandable and compressible (Paragraph [0030], discloses, “When deployed in its secondary shape, i.e., its deployed shape, the vaso-occlusive element (10) generally includes a central tubular element (15) and proximal (20) and distal (30) ends that are flared open into “umbrella” shapes.” Given this and given Figures 1, 2b, and 9c which all show the expanded state, in comparison to Figure 9a showing the compressed state, the (Area free of frame struts) is indeed expandable and compressible along with distal end (30) of vaso-occlusive element (10)).
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Regarding claim 6, Wallace further teaches, wherein the proximal segment (proximal end (20)) is provided with a membrane which covers the proximal segment at least partially (Paragraph [0032], “Another method involves plating or coating the tubular element (1) with radiopaque material.” Where coating the tubular element (1), which is in essence the vaso-occlusive device (10) which includes central tubular element (15) and proximal (20) and distal (30) ends, provides a membrane that covers proximal end (20)).
Regarding claim 7, Wallace further teaches, wherein the distal segment (distal end (30)) is provided with a membrane which covers the distal segment at least partially (Paragraph [0032], “Another method involves plating or coating the tubular element (1) with radiopaque material.” Where coating the tubular element (1), which is in essence the vaso-occlusive device (10) which includes central tubular element (15) and proximal (20) and distal (30) ends, provides a membrane that covers distal end (30)).
Regarding claim 8, modified Wallace teaches, wherein the connecting struts (plurality of struts (68) of Wallace2) are at least partially covered with a membrane (Paragraph [0065] of Wallace2 discloses, “a portion of each strut (68) is woven into material (66),” where “material (66) (mislabeled in the paragraph as (68) where (68) is plurality of struts) could illustratively be constructed of any of a number of materials suitable to obstruct the neck portion of an aneurysm. In accordance with one embodiment, the material utilized is permeable to blood flow.“ A person of ordinary skill in art would recognize such a material to inherently be a membrane suitable for use with endovascular implants. Because Wallace2 describes the struts (68) as woven into that membrane-like material (66), it teaches that the struts are at least partially covered with a membrane (to obstruct aneurysm inflow, promote thrombosis, and achieve controlled permeability)).
Regarding claim 15, Wallace further teaches, wherein a detachment element (Figures 9a-9c, joint (455); Paragraphs [0049]-[0052]) is arranged on an outside of the insertion aid (guidewire (465); Paragraph [0049], discloses in part, “At this point, the vaso-occlusive device (10) is in its undeployed shape, and is coupled to an inner guidewire (465) via an electrolytically severable joint (455).” In light of this and Figures 9a-9c, the joint (455) is indeed arranged on the outside of guidewire (465)), said element (joint (455)) being connected to a proximal end of the implant (Figure 9; Paragraph [0049]), wherein by applying an electrical voltage to the detachment element (joint (455)) a liberation of the implant (vaso-occlusive element (10)) is brought about (Paragraph [0052]).
Regarding claim 16, Wallace further teaches, wherein the detachment element (joint (455)) is arranged annularly around the insertion aid (guidewire (465); Paragraph [0049], discloses in part, “At this point, the vaso-occlusive device (10) is in its undeployed shape, and is coupled to an inner guidewire (465) via an electrolytically severable joint (455).” In light of this and Figures 9a-9c, the joint (455) is indeed arranged annularly around guidewire (465)).
Response to Arguments
Applicant's arguments filed on 03/16/2026 have been fully considered but they are not persuasive.
The rejection of Claims 1-8 and 15-16 under 35 U.S.C. 103 as being unpatentable over Wallace (US PGPUB No. 20030195553 A1), in view of Wallace2 (US PGPUB No. 20030083676 A1) is maintained with a detailed rebuttal of Applicant’s arguments below.
With regards to Applicant’s argument, “Fundamental Structural Mismatch Between Wallace2's Device And The Claimed Invention.” Examiner asserts, no fundamental structural mismatch, the proposed modification is a predictable substitution of known connecting structures (MPEP 2143(I)(B) - Simple substitution of one known element for another).
Applicant argues that Wallace2’s struts (68) operate only in a “single-dome” parachute topology (proximal mesh base (66) tethered to a small distal marker (24)) and therefore cannot be transplanted into Wallace’s dual-dome architecture without destroying the claimed structure. This mischaracterizes both the references and the modification actually proposed.
Wallace already discloses the exact dual-dome architecture required by claim 1: proximal and distal umbrella-shaped (dome-shaped) ends (20, 30) whose convex sides face proximally and distally, respectively, connected by a central tubular braided element (15) formed from interwoven fine wires (2) (See Wallace, Figure 1; Paragraphs [0030]-[0033]). The only element modified is the connector between those two domes.
Wallace2 teaches a known alternative connector for NiTi shape-memory aneurysm implants: discrete, non-interwoven struts/tethers (68) that span between two portions of the device and are deliberately configured to undergo relatively significant changes in shape during deployment (See Wallace2, Figures 7A-7C; Paragraph [0065]). One of ordinary skill would immediately recognize that these struts are a flexible, low-bulk substitute for a continuous braided tube. Substituting Wallace’s interwoven central braid (15) with Wallace2’s discrete struts produces a device that still has the two opposing domes required by claim 1; the struts simply become the “plurality of connecting struts” that now bridge the domes. No dome is removed and no topology is altered beyond replacing one known connecting means with another. This is the standard definition of a simple substitution yielding predictable results. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007); MPEP 2143(I)(B).
The fact that Wallace2’s struts happen to be illustrated in a different overall device does not negate the teaching; both references are drawn to the same field (endovascular NiTi braided aneurysm occlusion devices) and solve related problems (delivery profile, conformance, and anchoring). A person of ordinary skill in the art would have been motivated to look to Wallace2’s connector precisely because Wallace’s own central braid is described as part of a “relatively dense braid” that contributes to the device’s compressed bulk (See Wallace, Paragraph [0032]).
With regards to Applicant’s arguments, “The Proposed Modification Of Wallace Is Contrary To The Teachings Of Wallace2,” “The Motivation To Improve Conformance Is Inapplicable,” and “The Proposed Combination Is Not A Predictable Design Choice.” Examiner asserts, the motivation to reduce bulk and improve conformability is directly supported by the combined teachings and is not undermined by retention of the distal dome.
Applicant argues that Wallace2’s struts are intended “to eliminate some of the bulk” only by replacing full material, and that applying them to Wallace while retaining the distal dome achieves no net bulk reduction. This argument is incorrect for two reasons.
First, the bulk-reduction benefit applies to the connector itself. Wallace’s central tubular element (15) is formed from the same dense multi-wire braid used for the domes. Replacing that continuous interwoven tube with Wallace2’s sparse, discrete struts (fewer wires, no interweaving, open spaces between struts) materially reduces the total metal volume and folded profile of the connecting section, precisely the portion that must be compressed inside the microcatheter. Wallace2 expressly teaches this advantage: “…struts (68) are utilized rather than additional material (66) so as to eliminate some of the bulk of the device (64)…” (Paragraph [0065]) and to enable improved conformance to the aneurysm geometry (See Wallace2, Paragraphs [0065]-[0068] and [0049]). The distal dome remains (as required by claim 1), but the overall device is still less bulky than Wallace’s original dense-braid connector. The modification therefore achieves the very benefit Wallace2 identifies.
Second, Wallace himself recognizes that the central connector contributes to stiffness and delivery issues (the flared domes are already intended for conformance, but the rigid braid between them limits adaptability) (See Wallace, Paragraphs [0031]). Wallace2 supplies the missing flexible connector that allows the two domes to move axially and radially relative to each other via independent strut deformation—exactly the “spring effect” and length compensation needed for irregular aneurysm morphology. The combination solves the very problem identified in the present specification (unfavorable stiffness of prior three-dimensional implants and bulkiness for low-caliber catheters) (Paragraph [0006] of the current application’s specification). The motivation is therefore found within the cited prior art references, not in hindsight.
With regards to Applicant’s argument, “Wallace2 Does Not Disclose Connecting Struts That Meet The Limitations Of Claim 1”. Examiner asserts, the “do not intersect, not interwoven, and independently compressed or stretched” limitations are satisfied by the combination.
Applicant contends that Wallace2’s struts are fixed to a common distal marker and therefore cannot be “independently” compressed or stretched. This reads an unclaimed limitation into the claim. Claim 1 requires only that the struts “do not intersect and are not interwoven with each other so that they can be compressed or stretched independently” and thereby “achieve adaptation to the aneurysm in axial and radial direction.” The “so that” clause describes the functional result of the structural feature (non-intersecting, non-interwoven discrete struts).
Wallace2’s struts (68) are explicitly discrete tethers that do not intersect or interweave, they are separate elements arranged circumferentially (See Wallace2, Figure 7A; Paragraph [0065]). When these struts are used to bridge Wallace’s two domes (attached at spaced points around the rim of the proximal dome and corresponding points around the rim of the distal dome), they remain non-intersecting and non-interwoven. Because they are no longer tethered to a single rigid marker but to two separate dome structures, each strut can flex, curve, or straighten independently to a substantial degree, allowing one side of the implant to compress axially while the opposite side stretches, or permitting limited relative rotation of the domes. This is the exact mechanism that produces the axial length compensation and radial flexibility described in the specification (curvilinear struts that exert a spring effect) (Paragraphs [0012]-[0014] and [0078] of the current application’s specification). The combination therefore satisfies the limitation explicitly.
With regards to Applicant’s argument, “The Connecting Struts Of Wallace And Wallace2 Do Not Meet Claim Limitations.” Examiner asserts, axial/radial Adaptation is not hindsight, it is derived directly from the references.
Wallace already teaches that the flared domes improve conformance (See Wallace, Paragraphs [0015] and [0030]-[0031]). Wallace2 teaches that replacing a continuous material connector with discrete struts enables relatively significant changes in shape during deployment and improved conformance to the aneurysm geometry (See Wallace2, Paragraphs [0065]–[0068]). One of ordinary skill would have combined these teachings to obtain a dual-dome device whose connector itself now contributes to, rather than limits axial and radial adaptability. The result is not an impermissible hindsight reconstruction; it is the predictable outcome of applying a known flexible connector to a device that already uses domes for anchoring and neck coverage.
With regards to Applicant’s argument, “The Proposed Modification Is Demonstrably Not Obvious To Artisans.” Examiner asserts that the argument is irrelevant.
That the same inventor, Michael Wallace, filed both references but did not claim the exact combination in the later patent has no bearing on obviousness. MPEP 2141.03; In re Oetiker, 977 F.2d 1443 (Fed. Cir. 1992). Obviousness is judged from the perspective of one of ordinary skill, not the inventor’s subjective choices. Common ownership or successive applications by the same inventive entity do not create a presumption of non-obviousness. See MPEP 2143.
Therefore, the combination of Wallace and Wallace2 renders the claimed subject matter obvious under 35 U.S.C. 103. Applicant’s arguments do not identify any deficiency in the articulated rationale, nor do they demonstrate that the proposed modification would have been beyond the skill of a person of ordinary skill in the art or would have produced unexpected results. Claims 1-8 and 15-16 remain rejected
Conclusion
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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