DETAILED ACTION
Claims 1, 5, 7, 11, and 14-16 are amended. A complete action on the merits of pending claims 1-2, 4-12, and 14-20 appears below.
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.
Response to Amendment
Acknowledgment is made to Applicant’s amendments filed on 07/02/2026 which are entered. With regards to the 35 USC 112(b) rejections documented in the Non-Final Office Action sent on 04/03/2026, they’re overcome through Applicant’s amendments filed on 07/02/2026 and are withdrawn.
Claim Objections
Claims 4 and 6 are objected to because of the following informalities:
Claim 1 should be amended to the following, “A method for treating an aneurysm, the method comprising:
positioning a distal end of a first elongate shaft in an aneurysm cavity, wherein a proximal portion of an occlusive member is detachably coupled, via a connector, to a distal portion of a second elongate shaft positioned within a lumen of the first elongate shaft, the second elongate shaft defining a lumen therethrough;
releasing the occlusive member from the first elongate shaft into the aneurysm cavity, the occlusive member comprising a mesh structure, wherein releasing the occlusive member allows the occlusive member to self-expand into an expanded state in which the mesh structure defines an internal cavity, and wherein the occlusive device is configured such that, when the occlusive device is positioned in the aneurysm cavity, a height of the occlusive device is no more than half of a height of the aneurysm such that a space exists between a distal surface of the occlusive member and an inner surface of a dome of the aneurysm; and
delivering a coil into the internal cavity of the mesh structure and not into the space between the occlusive member and the dome of the aneurysm.”
Claim 4 should be amended to the following, “The method of Claim 1, wherein the coil is detachably coupled to an elongate member, and wherein the coil and elongate member are configured to be advanced through the lumen of the first elongate shaft.” Given independent claim 1 which claim 4 depends upon was amended by Applicant to recite/introduce the limitation of a “lumen of the elongate shaft” as such there is no need to reintroduce it and create confusion as to whether it refers to the same limitation recited/introduced in claim 1 or it’s a different limitation. Further, Applicant amended claim 1 to recite/introduce the “elongate shaft” as a “first elongate shaft” as such the claim terminology should be consistent.
Claim 6 should be amended to the following, “The method of Claim 5, wherein the coil is detachably coupled to an elongate member configured to be advanced through the lumen of the second elongate shaft.” Given independent claim 1 which claim 5 depends upon (and claim 6 depends upon claim 5) was amended by Applicant to recite/introduce the limitation of a “lumen of the second elongate shaft” as such there is no need to reintroduce it and create confusion as to whether it refers to the same limitation recited/introduced in claim 1 or it’s a different limitation.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
Claim(s) 1-2, 4-12, and 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Connor (US 2020/0054344 A1), in view of Porter (US 2004/0044391 A1).
Regarding claim 1, Connor discloses, an intrasaccular aneurysm occlusion device. Connor teaches, a method for treating an aneurysm (Paragraph [0225], discloses, “An aneurysm occlusion device can comprise … which is inserted into an aneurysm sac … and wherein the distal mesh and/or proximal mesh are filled with embolic material (such as … coils).”), the method comprising:
positioning a distal end of a first elongate shaft in an aneurysm cavity (Paragraph [0206], discloses, “…an expandable net or mesh which is delivered to an aneurysm sac through the catheter and inserted into the aneurysm sac…” – i.e., the device is advanced through a catheter into the aneurysm; Paragraph [0149], discloses delivery via a micro-catheter) wherein a proximal portion of an occlusive member is detachably coupled, via a connector, to a distal portion of a second elongate shaft positioned within a lumen of the first elongate shaft, the second elongate shaft defining a lumen therethrough (Paragraph [0206], net/mesh delivered through the catheter; Paragraph [0149], micro-catheter would indeed be advanced within a lumen of the catheter for delivery of members into the net/mesh; Paragraph [0142], proximal opening of the net or mesh in open communication with a catheter/delivery tube and embolic members via the same or a second catheter/delivery tube; Paragraph [0160], net/mesh delivered via a catheter/delivery tube and embolic members via the same or a second catheter/delivery tube; Paragraph [0167], dispensing/detachment mechanisms including pusher rod/plunger for members into the net/mesh. The open communication and dual-catheter delivery arrangements provide the detachable coupling of the distal end of the second (micro) catheter shaft that is positioned within the first catheter shaft and defines a lumen for subsequent delivery);
releasing the occlusive member from the first elongate shaft into the aneurysm cavity (Paragraph [0142], discloses in part, “…a net or mesh can have a proximal opening that is in open communication with a catheter. …embolic members can be introduced into the net or mesh through this proximal opening.” Describing delivery from catheter and release), the occlusive member comprising a mesh structure (Paragraph [0227], discloses, “An aneurysm occlusion device can comprise: a generally-spherical distal mesh … and a bowl shaped proximal mesh … wherein the distal mesh and/or proximal mesh are filled with embolic material (such as … coils).”), wherein releasing the occlusive member allows the occlusive member to self-expand into an expanded state in which the mesh structure defines an internal cavity (Paragraph [0140], discloses, “…an aneurysm occlusion device can have a first, compressed configuration as it travels through a catheter to an aneurysm. … an aneurysm occlusion device can transition from the first, compressed configuration to a second, expanded, generally spherical configuration within the aneurysm sac.”); and
delivering a coil into the internal cavity of the mesh structure (Paragraph [0050], discloses in part, “…three-dimensional embolic members which are inserted into and retained within the expandable net or mesh after the net or mesh has been inserted into the aneurysm sac…” and Paragraph [0225], discloses in part, “… wherein the distal mesh and/or proximal mesh are filled with embolic material (such as … coils).”).
Connor does not expressly disclose that the occlusive device is configured such that its expanded height is no more than half the height of the aneurysm, with a resulting space between the distal surface of the occlusive member and the inner surface of the dome.
Porter discloses, a vaso-occlusive device which is adapted to be inserted into a portion of a vasculature for treatment of a body vessel such as an aneurysm, and to methods of using the device. Porter teaches, an intrasaccular occlusive member (Figures 1 and 5-7, occlusive member (20); Paragraph [0035]) that is deployed across the neck of the aneurysm in an expanded configuration. Porter expressly states that the occlusive member “may be in the form of a disc, parabola, sphere, or the like” and is sized and shaped to block or bridge the neck while being pulled back to seat against the support structure (e.g., stent) at the neck (Figures 5-7; Paragraph [0042]). A spherical or globular expanded form, when seated at the neck in the manner shown, necessarily occupies only the lower/proximal portion of the aneurysm sac, leaving an unfilled space between its distal surface and the dome. Porter further teaches that the device is deliberately not required to fill the entire sac; its primary function is neck occlusion with anchoring on the opposite side of the stent struts, allowing the remainder of the sac to thrombose naturally (Figures 6-7; Paragraphs [0005], [0042]-[0045], and [0078]-[0082]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Connor’s self-expanding mesh and coil method by sizing and shaping the occlusive mesh member in the manner taught by Porter (i.e., deploying it as a disc-, parabolic-, or spherical-shaped member seated at the neck such that its expanded height is no more than half the aneurysm height, thereby leaving an intentional space between the distal surface and the dome), as both references and the claimed invention are directed to the treatment of aneurysms with self-expanding mesh devices and embolic materials. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Connor’s self-expanding mesh and coil method by sizing and shaping the occlusive mesh member in the manner taught by Porter (i.e., deploying it as a disc-, parabolic-, or spherical-shaped member seated at the neck such that its expanded height is no more than half the aneurysm height, thereby leaving an intentional space between the distal surface and the dome), as such a modification would have been predictable, namely, Connor already teaches a partial-fill intrasaccular mesh that covers the neck, contacts the side walls, and receives coils in its interior while leaving portions of the sac unfilled for faster healing. Porter supplies a known, compatible neck-bridging occlusive member geometry (explicitly including spherical forms) that achieves the same neck occlusion with minimal sac fill and explicit anchoring. A person of ordinary skill in the art would have been motivated to combine them because both references address the same problem (reliable neck occlusion of an aneurysm with reduced fill volume) and Porter’s short-height, neck-seated geometry predictably improves Connor’s system by further reducing the material burden and healing surface area. The combination yields only predictable results with a reasonable expectation of success (KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007)).
Moreover, even if the precise “no more than half” numerical limitation were viewed as a refinement, it would have been obvious as routine optimization of a result-effective variable. Once the general conditions of a short-height, neck-bridging intrasaccular occlusive member are shown in the combined references (partial-fill mesh in Connor an neck-seated disc/parabola/sphere in Porter), discovering the optimum workable range for device height (here, ≤1/2 aneurysm height to ensure the claimed dome space) is a matter of ordinary skill and routine experimentation. No unexpected results are alleged. In re Aller, 220 F.2d 454 (CCPA 1955); MPEP 2144.05.
Regarding claim 2, Connor teaches, releasing a self-expanding mesh structure into the aneurysm and delivering a coil into the internal cavity of the mesh. Connor further teaches that the combined mesh and coil construct is a partial-fill device that occupies only a portion of the aneurysm volume. Specifically, Connor states that the coils fill a high percentage of the mesh interior while the overall device and embolics are configured so that the distal portion of the mesh conforms to “the remaining portion of the aneurysm sac which is not filled by the proximal portion,” resulting in less total volume and surface area requiring healing compared to conventional devices that fill the majority or all the aneurysm (Paragraphs [0046]-[0049], [0051]-[0052], [0138], [0140], and throughout [0160s]-[0200s [0200-0210]]).
Connor does not expressly teach, wherein a combined volume of the mesh structure and the coil comprise no more than half of a volume of the aneurysm.
Porter teaches, the intrasaccular occlusive member (occlusive member (20); Paragraph [0035]) that is deployed across the neck of the aneurysm in an expanded configuration (disc, parabola, sphere, or the like) and is explicitly designed not to fill the entire aneurysm (Figures 6-7). The occlusive member blocks the neck while the remainder of the sac is left to thrombose naturally, with the device anchored on the opposite side of the stent struts. Porter emphasizes that the device is seated at the neck and does not require complete sac filling (Figures 5-7, 10, and 16; Paragraphs [0005], [0042]-[0046], and [0078]-[0082]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Connor’s self-expanding mesh and coil method so that the combined volume of the mesh structure and the delivered coil(s) is no more than half the aneurysm volume as taught by Porter, as both references and the claimed invention are directed to the treatment of aneurysms with self-expanding mesh devices and embolic materials. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Connor’s self-expanding mesh and coil method so that the combined volume of the mesh structure and the delivered coil(s) is no more than half the aneurysm volume as taught by Porter, as such a modification would have been predictable, namely, Connor already desires a partial filling for faster healing and reduced surface area. Porter supplied a known neck-bridging occlusive geometry that deliberately avoids full-sac fill, leaving the majority of the aneurysm volume unfilled while still achieving effective neck occlusion. A person of ordinary skill in the art would combine the references with a reasonable expectation of success because both references solve the same problem (reliable neck occlusion with minimal implant burden) and Porter’s partial-fill approach predictably enhances Connor’s system by further reducing the volume that must endothelialize. The result is predictable and yields the same clinical benefits already recognized in Connor (KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007)).
Furthermore, the exact “no more than half” volume limitation is a routine optimization of a result-effective variable (total implant volume controls healing time, recanalization risk, and mechanical stress on the aneurysm wall). Once the general condition of partial-fill neck occlusion is shown in the combined references, selecting the optimum workable range (≤1/2 aneurysm volume) is a matter of ordinary skill and routine experimentation. No unexpected results are alleged. In re Aller, 220 F.2d 454 (CCPA 1955); MPEP 2144.05.
Regarding claim 4, Connor further teaches, wherein the coil is detachably coupled to an elongate member, and wherein the coil and elongate member are configured to be advanced through the lumen of the first elongate shaft (Paragraph [0206], discloses, “…an expandable net or mesh which is delivered to an aneurysm sac through the catheter and inserted into the aneurysm sac…” – i.e., the device is advanced through a catheter into the aneurysm. Further, Paragraph [0167], discloses, the dispensing/detachment of embolic members (such as coils) into the net or mesh in situ by a mechanism such as, “…pushing embolic members into a net or mesh using the force of a … pusher rod and/or plunger …” Thus, the embolic member is indeed detachably coupled to an elongate member (pusher rod), where the coil (embolic member such as coils) and elongate member (pusher rod) are configured to be advanced through a lumen of the elongate shaft (catheter)).
Regarding claim 5, Connor further teaches, wherein the second elongate shaft (micro-catheter) is configured to be advanced within the lumen of the first elongate shaft (Paragraph [0206], discloses, “…an expandable net or mesh which is delivered to an aneurysm sac through the catheter and inserted into the aneurysm sac…”; Paragraph [0149], discloses, “…embolic members … being delivered to an aneurysm sac via a micro-catheter …”; Paragraph [0160] further reinforces the disclosure of nested/dual catheters; As such the micro-catheter will indeed be advanced within a lumen of the catheter).
Regarding claim 6, Connor further teaches, wherein the coil is detachably coupled to an elongate member configured to be advanced through the lumen of the second elongate shaft (Paragraph [0167], discloses, the dispensing/detachment of embolic members (such as coils) into the net or mesh in situ by a mechanism such as, “…pushing embolic members into a net or mesh using the force of a … pusher rod and/or plunger …” Thus, the embolic member is indeed detachably coupled to an elongate member (pusher rod), advanced through the lumen of the “micro-catheter” disclosed in Paragraph [0149]).
Regarding claim 7, Connor further teaches, wherein the mesh structure comprises a wall (Figure 3) having a proximal portion (Figure 3, proximal portion (301)), a distal portion (Figure 3, distal portion (302)), and a side portion extending therebetween (Figure 3; Portion of expandable net or mesh between proximal portion (301) and distal portion (302)), and wherein the mesh structure is positioned in the aneurysm such that the proximal portion of the wall of the mesh structure is positioned over a neck of the aneurysm (Figure 3; Paragraph [0049]).
Regarding claim 8, Connor further teaches, wherein the mesh structure comprises a wall (Figure 3) having a proximal portion (proximal portion (301)), a distal portion (distal portion (302)), and a side portion extending therebetween (Figure 3; Portion of expandable net or mesh between proximal portion (301) and distal portion (302)), and wherein the mesh structure is positioned in the aneurysm such that the side portion of the wall of the mesh structure is in contact with an inner surface of a wall of the aneurysm (Paragraph [0137], discloses, that upon deployment, the mesh self-expands to conform to the inner surface of the aneurysm sac. This inherently results in side portions contacting the aneurysm wall).
Regarding claim 9, modified Connor teaches, wherein the mesh structure comprises a wall (Figure 3) having a proximal portion (proximal portion (301)), a distal portion (distal portion (302)), and a side portion extending therebetween (Figure 3; Portion of expandable net or mesh between proximal portion (301) and distal portion (302)), and wherein the mesh structure is positioned in the aneurysm such that the distal portion of the wall of the mesh structure is between the proximal portion of the wall of the mesh structure and a dome of the aneurysm (Figure 3 of Connor; Paragraph [0049] of Connor), and wherein the distal portion of the wall of the mesh structure is spaced apart from the dome of the aneurysm (Figures 6-7 and Paragraph [0042] of Porter which states, the occlusive member “may be in the form of a disc, parabola, sphere, or the like”).
Regarding claim 10, Connor further teaches, wherein the coil is a first coil and the method further comprises delivering a second coil to the internal cavity of the mesh structure (Paragraph [0049], discloses in part, “… a plurality of three-dimensional embolic members (including 303) which are inserted into and retained within the expandable net or mesh after the net or mesh has been inserted into the aneurysm sac … .” Further, paragraph [0223], discloses, “In an example, a distal mesh and/or a proximal mesh can be filled with embolic material (such as microsponges, hydrogels, or coils).” Where delivery of “a plurality of three-dimensional embolic members” such as “coils” (plural) into the internal cavity of the mesh structure as seen in Figure 3, indicates multiple coils are delivered to sufficiently fill the sac).
Regarding claim 11, Connor teaches, a method for treating an aneurysm (Paragraph [0225], discloses, “An aneurysm occlusion device can comprise … which is inserted into an aneurysm sac … and wherein the distal mesh and/or proximal mesh are filled with embolic material (such as … coils).”), the method comprising:
positioning a mesh structure in an expanded state within an aneurysm cavity (Paragraph [0140], “An aneurysm occlusion device can have a first, compressed configuration as it travels through a catheter … and transition … to a second, expanded, generally spherical configuration within the aneurysm sac.”) such that a proximal portion of the mesh structure is positioned over a neck of the aneurysm (Figure 3, proximal portion (301); Paragraph [0049], proximal portion (301) is positioned at the aneurysm neck), a distal portion (Figure 3, distal portion (302)) of the mesh structure is between the proximal portion and a dome of the aneurysm (Figure 3; Paragraph [0049]), and a side portion of the mesh structure, defined as a region of the mesh structure between the proximal and distal portions (Figure 3; Portion of expandable net or mesh between proximal portion (301) and distal portion (302)), is in contact with an inner surface of the aneurysm wall (Paragraph [0137], discloses, “… upon deployment, the mesh self-expands to conform to the inner surface of the aneurysm sac.”), wherein the proximal portion of the mesh structure is detachably coupled via a connector, to a distal portion of a second elongate shaft positioned within a lumen of a first elongate shaft the second elongate shaft defining a lumen therethrough (Paragraph [0206], net/mesh delivered through the catheter; Paragraph [0149], micro-catheter advanced within a lumen of the catheter; Paragraph [0142], proximal opening of the net or mesh in open communication with a catheter; Paragraph [0160], dual catheter/delivery tube arrangements; Paragraph [0167], pusher/detachment mechanisms; the arrangements provide the detachable coupling via a connector of the proximal portion of the mesh to the distal end of the second shaft (micro-catheter) that is within the first shaft and defines a lumen), wherein the mesh structure defines an internal cavity in the expanded state (Figure 3); and
delivering a coil into the internal cavity of the mesh structure (Paragraph [0050], discloses, “… three-dimensional embolic members which are inserted into and retained within the expandable net or mesh after the net or mesh has been inserted into the aneurysm sac …” and Paragraph [0225], discloses in part, “… wherein the distal mesh and/or proximal mesh are filled with embolic material (such as … coils).”).
Connor does not expressly teach, “… distal portion … spaced apart from the dome of the aneurysm.” Connor describes conforming to sac shape, but not an intentional dome gap. Furthermore, Connor does not expressly teach, wherein the mesh structure is configured such that, when the mesh structure is positioned in the aneurysm cavity, a height of the mesh structure is no more than half of a height of the aneurysm.
Porter teaches, an intrasaccular occlusive member (Figures 1 and 5-7, occlusive member (20); Paragraph [0035]) that is deployed across the neck of the aneurysm in an expanded configuration. Porter expressly states that the occlusive member “may be in the form of a disc, parabola, sphere, or the like” and is sized and shaped to block or bridge the neck while being pulled back to seat against the support structure (e.g., stent) at the neck (Figures 5-7; Paragraph [0042]). A spherical or globular expanded form, when seated at the neck in the manner shown, necessarily occupies only the lower/proximal portion of the aneurysm sac, leaving an unfilled space between its distal surface and the dome. Porter further teaches that the device is deliberately not required to fill the entire sac; its primary function is neck occlusion with anchoring on the opposite side of the stent struts, allowing the remainder of the sac to thrombose naturally (Figures 6-7; Paragraphs [0005], [0042]-[0045], and [0078]-[0082]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Connor’s self-expanding mesh and coil method by sizing and shaping the occlusive mesh member in the manner taught by Porter (i.e., deploying it as a disc-, parabolic-, or spherical-shaped member seated at the neck such that its expanded height is no more than half the aneurysm height, thereby leaving an intentional space between the distal surface and the dome), as both references and the claimed invention are directed to the treatment of aneurysms with self-expanding mesh devices and embolic materials. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Connor’s self-expanding mesh and coil method by sizing and shaping the occlusive mesh member in the manner taught by Porter (i.e., deploying it as a disc-, parabolic-, or spherical-shaped member seated at the neck such that its expanded height is no more than half the aneurysm height, thereby leaving an intentional space between the distal surface and the dome), as such a modification would have been predictable, namely, Connor already teaches a partial-fill intrasaccular mesh that covers the neck, contacts the side walls, and receives coils in its interior while leaving portions of the sac unfilled for faster healing. Porter supplies a known, compatible neck-bridging occlusive member geometry (explicitly including spherical forms) that achieves the same neck occlusion with minimal sac fill and explicit anchoring. A person of ordinary skill in the art would have been motivated to combine them because both references address the same problem (reliable neck occlusion of an aneurysm with reduced fill volume) and Porter’s short-height, neck-seated geometry predictably improves Connor’s system by further reducing the material burden and healing surface area. The combination yields only predictable results with a reasonable expectation of success (KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007)).
Moreover, even if the precise “no more than half” numerical limitation were viewed as a refinement, it would have been obvious as routine optimization of a result-effective variable. Once the general conditions of a short-height, neck-bridging intrasaccular occlusive member are shown in the combined references (partial-fill mesh in Connor an neck-seated disc/parabola/sphere in Porter), discovering the optimum workable range for device height (here, ≤1/2 aneurysm height to ensure the claimed dome space) is a matter of ordinary skill and routine experimentation. No unexpected results are alleged. In re Aller, 220 F.2d 454 (CCPA 1955); MPEP 2144.05.
Regarding claim 12, Connor teaches, releasing a self-expanding mesh structure into the aneurysm and delivering a coil into the internal cavity of the mesh. Connor further teaches that the combined mesh and coil construct is a partial-fill device that occupies only a portion of the aneurysm volume. Specifically, Connor states that the coils fill a high percentage of the mesh interior while the overall device and embolics are configured so that the distal portion of the mesh conforms to “the remaining portion of the aneurysm sac which is not filled by the proximal portion,” resulting in less total volume and surface area requiring healing compared to conventional devices that fill the majority or all the aneurysm (Paragraphs [0046]-[0049], [0051]-[0052], [0138], [0140], and throughout [0160s]-[0200s [0200-0210]]).
Connor does not expressly teach, wherein a combined volume of the mesh structure and the coil comprise no more than half of a volume of the aneurysm.
Porter teaches, the intrasaccular occlusive member (occlusive member (20); Paragraph [0035]) that is deployed across the neck of the aneurysm in an expanded configuration (disc, parabola, sphere, or the like) and is explicitly designed not to fill the entire aneurysm (Figures 6-7). The occlusive member blocks the neck while the remainder of the sac is left to thrombose naturally, with the device anchored on the opposite side of the stent struts. Porter emphasizes that the device is seated at the neck and does not require complete sac filling (Figures 5-7, 10, and 16; Paragraphs [0005], [0042]-[0046], and [0078]-[0082]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Connor’s self-expanding mesh and coil method so that the combined volume of the mesh structure and the delivered coil(s) is no more than half the aneurysm volume as taught by Porter, as both references and the claimed invention are directed to the treatment of aneurysms with self-expanding mesh devices and embolic materials. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Connor’s self-expanding mesh and coil method so that the combined volume of the mesh structure and the delivered coil(s) is no more than half the aneurysm volume as taught by Porter, as such a modification would have been predictable, namely, Connor already desires a partial filling for faster healing and reduced surface area. Porter supplied a known neck-bridging occlusive geometry that deliberately avoids full-sac fill, leaving the majority of the aneurysm volume unfilled while still achieving effective neck occlusion. A person of ordinary skill in the art would combine the references with a reasonable expectation of success because both references solve the same problem (reliable neck occlusion with minimal implant burden) and Porter’s partial-fill approach predictably enhances Connor’s system by further reducing the volume that must endothelialize. The result is predictable and yields the same clinical benefits already recognized in Connor (KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007)).
Furthermore, the exact “no more than half” volume limitation is a routine optimization of a result-effective variable (total implant volume controls healing time, recanalization risk, and mechanical stress on the aneurysm wall). Once the general condition of partial-fill neck occlusion is shown in the combined references, selecting the optimum workable range (≤1/2 aneurysm volume) is a matter of ordinary skill and routine experimentation. No unexpected results are alleged. In re Aller, 220 F.2d 454 (CCPA 1955); MPEP 2144.05.
Regarding claim 14, Connor further teaches, further comprising advancing the mesh structure in a low-profile, constrained configuration through the lumen of the first elongate shaft (catheter) (Paragraph [0140], discloses, “an aneurysm occlusion device can have a first, compressed configuration as it travels through a catheter …”).
Regarding claim 15, Connor further teaches, wherein the coil is detachably coupled to an elongate member, and wherein the coil and elongate member are configured to be advanced through the lumen of the first elongate shaft (catheter) (Paragraph [0167], discloses, coils detachably coupled to a pusher rod that will be advanced through a catheter lumen).
Regarding claim 16, Connor further teaches, wherein the elongate member and coil are configured to be advanced through the lumen of the second elongate shaft (micro-catheter) (Paragraph [0149], discloses, delivery of embolic members through a microcatheter (second elongate shaft) which will be positioned within the catheter/guiding catheter (first elongate shaft) disclosed in paragraph [0140]. Further, the pusher rod of paragraph [0167] (elongate member), will be advanced through a lumen of the micro-catheter).
Regarding claim 17, Connor further teaches, further comprising: detaching the coil from the elongate member to leave the coil within the internal cavity of the mesh structure, removing the elongate member from the lumen of the second elongate shaft, detaching the mesh structure from the second elongate shaft, and removing the first and second elongate shafts from the vasculature (Paragraph [0167], describes detachment of coils from a pusher rod. Paragraph [0149], describes a microcatheter used in the delivery of embolic members. Paragraph [0140], describes the use of a catheter/guiding catheter in the process of device deployment. Thus, it is inherent that the pusher rod, microcatheter, and catheter/guiding catheter must be removed after deployment of the device).
Regarding claim 18, Connor further teaches, wherein the coil is a first coil and the method further comprises delivering a second coil to the internal cavity of the mesh structure (Paragraph [0049], discloses, “… a plurality of three-dimensional embolic members … inserted into and retained within the expandable net or mesh …” and Paragraph [0223] discloses, “… distal mesh and/or proximal mesh can be filled with embolic material (such as … coils).”).
Regarding claim 19, Connor further teaches, wherein the mesh structure is globular in the expanded state (Figure 3; Paragraph [0140], discloses, “… can transition … to a second, expanded, generally spherical configuration within the aneurysm sac.”).
Regarding claim 20, Connor further teaches, wherein the distal portion of the mesh structure comprises a substantially flat distal portion in the expanded state (Paragraph [0072], describe the intrasaccular aneurysm occlusion device of varying shapes/geometries, thus, the distal mesh/portion can assume flat or rounded shapes depending on configuration).
Response to Arguments
Applicant's arguments filed on 07/02/2026 have been fully considered but they are not persuasive.
Applicant asserts that amended independent claims 1 and 11 are patentable over Connor and Porter because neither reference discloses or suggests the newly added limitations requiring that a proximal portion of the occlusive member/mesh structure is detachably coupled, via a connector, to a distal portion of a second elongate shaft positioned within a lumen of a first elongate shaft, the second elongate shaft defining a lumen therethrough.
This argument is not persuasive. As set forth in the updated rejection above, Connor expressly teaches delivery of an expandable net or mesh to an aneurysm sac through a catheter (first elongate shaft) (Paragraph [0206]) together with delivery of embolic members (including coils) via a micro-catheter (second elongate shaft) that is advanced within a lumen of the catheter (Paragraphs [0149] and [0160]). Connor further teaches that the net or mesh may have a proximal opening in open communication with a catheter so that embolic members are introduced therethrough (Paragraph [0142]) and contemplates delivery of the net/mesh and the embolic members via the same catheter/delivery tube or via a second catheter/delivery tube (Paragraph [0160]). Detachment of the embolic members is accomplished by known mechanisms such as a pusher rod or plunger (Paragraph [0167]). These disclosures collectively teach explicitly and/or inherently the claimed dual-shaft arrangement in which the proximal portion of the mesh is detachably coupled (via the open-communication proximal opening and associated delivery/detachment structures functioning as a connector) to the distal portion of the second (micro) catheter shaft that is positioned within the lumen of the first shaft/catheter and itself defines a lumen for advancing the coil.
It is further noted that Porter supplies known severable-junction technology for detachable coupling of occlusive members to delivery shafts (Paragraphs [0036] and [0040]-[0041]).
Thus, the combination of Connor’s dual-catheter delivery system with Porter’s partial-fill, neck-seated geometry therefore continues to render the amended claims obvious under 35 U.S.C. 103. The newly recited features do not patentably distinguish the claims from the prior-art combination; they represent known, predictable delivery-system elements that a person of ordinary skill in the art would have combined with the primary teachings to achieve sequential, controlled deployment of a partial-height mesh followed by coil delivery into its interior cavity. The dependent claims stand rejected for the same reasons and for the additional reasons set forth in the rejection.
See updated rejections above.
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 OSAMA NEMER whose telephone number is (571)272-6365. The examiner can normally be reached Monday-Friday 7:30-5:00.
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, Jackie Ho can be reached at (571)272-4696. 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 (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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