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 01/30/2026. As directed by the amendment: claims 24, 27-28, 30, and 35 have been amended and claims 1-23, 25-26, 31, and 38 have been cancelled. Thus, claims 24, 27-30, 32-37, and 39-44 are presently pending in this application.
Response to Arguments
Applicant's arguments, see pages 8-9, filed 01/30/2026, with respect to the rejections of claims 24 and 35 under 35 U.S.C. 103 as being unpatentable over Aboytes et al (US 20180036012 A1), herein referenced to as Aboytes, in view of Garza et al (US 20190053811 A1), herein referenced to as “Garza” have been fully considered and are persuasive.
The applicant argues that the combination of Aboytes and Garza fails to teach or render obvious the amended limitations of claim 24 and 35.
The applicant amended claim 24 to recite “an embolic element coupled to the proximal end of the mesh at a joint, wherein the join comprises an elongated, radially compacted portion of the mesh…”.
The applicant amended claim 35 to recite “a guide positioned between and coupled to the proximal end of the mesh and the distal end of the embolic element…”.
The applicant argues that the mesh portion shown in Fig. 12 of Aboytes which his relied upon for the preset curve includes a turn is for the distal end of the mesh, not the proximal end. The examiner agrees that the Aboytes teaches that the preset curve at the distal end of the mesh, not the proximal end.
Therefore, the rejection has been withdrawn.
However, upon further consideration, a new ground(s) of rejection is made in view of Aboytes in view of Garza and DeMeritt (US 20190142435 A1).
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) 24, 26-30, 32-37, and 39-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aboytes et al (US 20180036012 A1), herein referenced to as Aboytes, in view of Garza et al (US 20190053811 A1), herein referenced to as “Garza” and DeMeritt (US 20190142435 A1), herein referenced to as “DeMeritt”.
Claim 24
Aboytes discloses: An occlusive device 100 (see Figs. 1A-1C, [0095]) for treating an aneurysm (see [0097]), wherein a neck of the aneurysm opens to a blood vessel (see Figs. 4A-4E, [0097]), the device 100 comprising: a mesh 101 (see Figs. 1A-1C, [0100]) comprising a plurality of braided filaments (see [0100], the mesh is formed of a tubular braid), the mesh 101 having a low-profile state (see Figs. 1B and 2, [0108]) for intravascular delivery to the aneurysm (see Fig. 2, and 4A) and a deployed state (see Fig. 1A, [0095]), and wherein the mesh 101 comprises a distal end 108 (see Fig. 1B, [0096]), a proximal end 104 (see Fig. 1B, [0096]), and a length the length of 101 between 104 and 108 (see Fig. 1B) extending between the distal 108 and proximal ends 104, and a first side the first side of 101 that is radially inward (see Figs. 1A-1B, [0098], concave shape) and a second side the second side of 101 that is radially outward (see Figs. 1A-1B) opposite the first side the first side of 101 that is radially inward along a thickness the thickness of 101 (see Figs. 1A-1C) of the mesh 101; an embolic element 102 (see Figs. 1A-1B, [0107], 102 is an embolic coil) coupled to the mesh 101 at a joint 109 + 124 (see Fig. 1B, [0097]), and the joint 109 + 124 comprising an elongated radially compacted portion (see Fig. 1B, the mesh is elongated, [0106], radially compacted) of the mesh 101 having a preset curve (see Fig. 1B, the guide is curved to curve 102 as well) configured to orient the mesh 101 relative to the joint such that the first side of the mesh 101 is facing the joint (see Figs. 4A-4C, the concave radial inner side of the mesh faces the joint 109, here shown as 122) and the second side the radial outer side of the mesh of the mesh 101 is facing away from the joint 109, wherein the mesh 101 is configured to be positioned within the aneurysm in the deployed state such that the mesh 101 extends over the neck of the aneurysm (see [0097], a broad portion of 101 is positioned over the neck to allow for complete neck coverage) and the embolic element 102 is positioned between the mesh 101 and a dome of the aneurysm (see Fig. 4E, [0113], as the mesh continues to deploy, the mesh covers the neck, and 102 is positioned between the mesh across the neck and the dome of the aneurysm).
Aboytes does not explicitly disclose: the embolic element coupled to the proximal end of the mesh; the preset curve includes a turn between about 150 degrees and 210 degrees; the joint at the proximal end of the mesh.
However, a variant embodiment of Aboytes (see Fig. 12) teaches a preset curve 1206 (see Fig. 12, 1200 is equivalent to the section 124 in Fig. 1B, which is a radially compacted portion of mesh compared to mesh portions 110) of the mesh 1200. The variant embodiment of Aboytes (Fig. 12) further teaches: wherein the preset curve 1206 (see Fig. 12, [0119]) includes a turn 1206 is a turn (see Fig. 12).
The substitution for one known element (the linear directing region as shown in Fig. 1B of Aboytes) for another (the non-linear directing region/curved radially compacted portion of the mesh as shown in Fig. 12 of Aboytes) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of wherein the preset curve includes a turn shown in Fig. 12 of Aboytes would have yielded predictable results, namely, allowing adjustment of angle of the lead-in portion of the device to best fit patient anatomy for proper positioning of the device in the aneurysm (see [0109]). KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Aboytes does not explicitly disclose: the embolic element coupled to the proximal end of the mesh; and the turn being between about 150 degrees and 210 degrees; the joint at the proximal end of the mesh.
However, Garza in a similar field of invention teaches an occlusion device 100 (see Figs. 2-9, [0029]) for treating an aneurysm vascular disorder/aneurysm (see [0011]-[0012]) with an embolic element 104 (see Figs. 2-9, [0032], coil segments, hence an embolic element) the embolic element 104 having a proximal end proximal end of 104 and a distal end distal end of 104 (see Figs. 8B and 9); and a guide 602 (see Fig. 2, [0044], 102 is attached to 104 through 602, hence 602 is between 102 and 104) positioned between the mesh 102 and the embolic element 104, the guide 602 having a preset curve (see Fig. 8B and 9, [0045], 602 can constrain the coil segments 104 and prevent undesirable stretching (or an undesirable amount stretching, hence it has a set curve/length, furthermore, 8B shows the final expanded configuration, in which 602 within 104 has a preset curve in the device’s secondary shape, see [0049]) along its length the length of 602 which extends through 104 (see Fig. 2, 8B, and 9, [0045]), wherein the guide 602 includes a curved portion (see annotated Fig. 8B below) that includes a turn (see annotated Fig. 8 below). Garza further teaches: the embolic element 104 (see Figs. 2-9, [0032], coil segments, hence an embolic element) coupled to the proximal end (see annotated Fig. 2 below) of the mesh 102; the turn (see annotated Fig. 8 below) is between about 150 degrees and 210 degrees (see annotated Fig. 8B below),
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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 Aboytes to incorporate the teachings of Garza and teach an occlusive device with the embolic element coupled to the proximal end of the mesh; and the turn being between about 150 degrees and 210 degrees. Motivation for such can be found in Garza an additional of an additional embolic element on the proximal end of the mesh can increase the overall compliance of the entire device— greater than a braided structure (see [0032]) and the angle of the secondary shape of the turn can encourage the compliance sections/the embolic elements to arrange themselves along an interior wall of the aneurysm cavity which is desirable for treating an aneurysm (see [0049]).
Aboytes and Garza does not explicitly teach: the joint at the proximal end of the mesh.
However, DeMeritt in a similar field of invention teaches an occlusive device 20 (see Figs. 1A-1B and 20A-20B) for treating an aneurysm 82 (see Figs. 20A-20B) with a mesh 22 + 23 (see Figs. 1A-1B) with a first side (see annotated Fig. 1A below), a second side (see annotated Fig. 1A below) opposite the second side, with a proximal end the proximal end of 22 (see Figs. 1A-1B) with a joint the joint at 25 (see Figs. 1A-1B) that comprises an elongated radially compacted portion (see annotated Fig. 1A below) of the mesh 22 + 23 having a preset curve 92 (see Figs. 1A-1B, [0069], curve/spiraling) that is configured to orient the mesh 22 + 23 relative to the joint the joint at 25 such that the first side (see annotated Fig. 1A below) of the mesh is facing the joint the joint at 25 and the second side (see annotated Fig. 1A below) of the mesh is facing away from the joint the joint at 25. DeMeritt further teaches: the joint the joint at 25 (see annotated Fig. 1A below) at the proximal end the proximal end of 22 of the mesh 22.
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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 Aboytes and Garza to incorporate the teachings of DeMeritt and teach an occlusive device for treating an aneurysm with the joint at the proximal end of the mesh. Motivation for such can be found in DeMeritt as this generates a small-diameter curve for the rest of the device to create outward radial force for device anchoring (see [0069]).
Claim 27
The combination of Aboytes, Garza, and DeMeritt teaches: The device of Claim 24, see 103 rejection above. Aboytes further discloses: wherein an average cross-sectional dimension the cross-sectional dimension of 124 of the joint 109 + 124 in a delivery configuration (see Fig. 1B, in a constrained lengthened configuration, the dimension of 124 is the same as in the deployed configuration as shown in Fig. 1A) is substantially the same as an average cross- sectional dimension the cross-sectional dimension of 124 of the guide 124 in a deployed configuration.
Claim 28
The combination of Aboytes, Garza, and DeMeritt teaches: The device of Claim 24, see 103 rejection above. Aboytes further discloses: wherein a greatest cross-sectional dimension the cross-sectional dimension of 124 of the joint 109 + 124 in a deployed configuration (see Fig. 1A) is less than a greatest cross-sectional dimension the cross-sectional dimension of a broad portion of 101 (see Fig. 1A, 124’s cross-sectional dimension is less than that of 101) of the mesh 101 in the deployed state (see Fig. 1A).
Claim 29
The combination of Aboytes, Garza, and DeMeritt teaches: The device of Claim 24, see 103 rejection above. Aboytes further discloses: wherein the first side the first side of 101 that is radially inward (see Figs. 1A-1B, [0098], concave shape) of the mesh 101 is concave (see [0098], concave).
Claim 30
The combination of Aboytes, Garza, and DeMeritt teaches: The device of Claim 24, see 103 rejection above. Garza further teaches: wherein the preset curve of the joint 604 includes a turn of about 180 degrees (see annotated Fig. 8B below claim 24 above).
Claim 32
The combination of Aboytes, Garza, and DeMeritt teaches: The device of Claim 24, see 103 rejection above. Aboytes further discloses: wherein the mesh 101 includes a first layer 111a (see Fig. 1C, [0100]) and a second layer 111b (see Fig. 1C, [0100]), and wherein, in an expanded, unconstrained state, the first layer 111a generally conforms to the second layer 111b such that the mesh 101 does not include an interior volume (see Figs. 1A and 1C, [0100], there is no interior volume between 111a and 111b).
Claim 33
The combination of Aboytes, Garza, and DeMeritt teaches: The device of Claim 24, see 103 rejection above. Aboytes further discloses: wherein the mesh 101 includes a first layer 111a (see Fig. 1C, [0100]) and a second layer 111b (see Fig. 1C, [0100]), and wherein, in an expanded, unconstrained state (see Fig. 1A), the thickness of the mesh 101 is generally equivalent to a combined thickness (see Figs. 1A and 1C, [0100]) of the individual first 111a and second layers 111b.
Claim 34
The combination of Aboytes, Garza, and DeMeritt teaches: The device of Claim 24, see 103 rejection above. Aboytes further discloses: wherein the embolic element 102 is a coil 102 (see Figs. 1A-1B, [0107], 102 is an embolic coil).
Claim 35
Aboytes discloses: An occlusive device 100 (see Figs. 1A-1C, [0095]) for treating an aneurysm (see [0097]), wherein a neck of the aneurysm opens to a blood vessel (see Figs. 4A-4E, [0097]), the device 100 comprising: a mesh 101 (see Figs. 1A-1C, [0100]) comprising a plurality of braided filaments (see [0100], the mesh is formed of a tubular braid), the mesh 101 having a low-profile state (see Figs. 1B and 2, [0108]) for intravascular delivery to the aneurysm (see Fig. 2, and 4A) and a deployed state (see Fig. 1A, [0095]), and wherein the mesh 101 comprises a distal end 108 (see Fig. 1B, [0096]), a proximal end 104 (see Fig. 1B, [0096]), and a length the length of 101 between 104 and 108 (see Fig. 1B) extending between the distal 108 and proximal ends 104, and a first side the first side of 101 that is radially inward (see Figs. 1A-1B, [0098], concave shape) and a second side the second side of 101 that is radially outward (see Figs. 1A-1B) opposite the first side the first side of 101 that is radially inward along a thickness the thickness of 101 (see Figs. 1A-1C) of the mesh 101; an embolic element 102 (see Figs. 1A-1B, [0107], 102 is an embolic coil) coupled to the mesh 101 at a joint 109 (see Fig. 1B, [0097]), the embolic element 102 having a proximal end 122b (see Fig. 1B, [0106]) and a distal end 116 (see Fig. 1B, [0106]); and a guide 124 (see Fig. 1B, [0106]) positioned between the mesh 101 and the embolic element 102, the guide 124 comprising a radially compacted portion (see [0106], radially compacted) of the mesh 101 and having a preset curve (see Fig. 1B, the guide is curved to curve 102 as well) along its length the length of 124, wherein, when the occlusive device 100 is positioned within a delivery catheter 200/300 (see Figs. 2-4E, [0108]) and a portion the portion of 100 outside of 200 of the occlusive device 100 extending between a proximal terminus 122a (see Figs. 2-4E, [0106]) of the guide 122 and a distal terminus 106 (see Fig. 2, [0106]) of the mesh 101 have been pushed from the delivery catheter 200 into an open space outside of a body of the patient (see Figs. 1A and 2-3B) such that the mesh 101 and guide 124 are in respective expanded, unconstrained configurations, the preset curve the curve of the guide 124 is configured to orient the mesh 101 relative to the delivery catheter 200 such that a concave surface concave inner surface of 101 (see Fig. 3A) of the mesh is facing the same direction as a convex portion convex portion of 124 (see Fig. 3A0 of the preset curve (see Fig. 3A, both are facing towards the catheter 300), wherein the mesh 101 is configured to be positioned within the aneurysm in the deployed state such that the mesh 101 extends over the neck of the aneurysm (see [0097], a broad portion of 101 is positioned over the neck to allow for complete neck coverage) and the embolic element 102 is positioned between the mesh 101 and a dome of the aneurysm (see Fig. 4E, [0113], as the mesh continues to deploy, the mesh covers the neck, and 102 is positioned between the mesh across the neck and the dome of the aneurysm).
Aboytes does not explicitly disclose: the guide positioned between and coupled to the proximal end of the mesh and the distal end of the embolic element; wherein the radially compacted portion of the mesh includes a curved portion that includes a turn between about 150 degrees and 210 degrees.
However, a variant embodiment of Aboytes (see Fig. 12) teaches a radially compacted portion 1210 (see Fig. 12, 1200 is equivalent to the section 124 in Fig. 1B, which is a radially compacted portion of mesh compared to mesh portions 110) of the mesh 1200. The variant embodiment of Aboytes (Fig. 12) further teaches: wherein the radially compacted portion 1210 of the mesh 1200 includes a curved portion 1206 (see Fig. 12, [0119]) that includes a turn 1206 is a turn (see Fig. 12).
The substitution for one known element (the linear directing region as shown in Fig. 1B of Aboytes) for another (the non-linear directing region/curved radially compacted portion of the mesh as shown in Fig. 12 of Aboytes) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of wherein the radially compacted portion of the mesh includes a curved portion that includes a turn shown in Fig. 12 of Aboytes would have yielded predictable results, namely, allowing adjustment of angle of the lead-in portion of the device to best fit patient anatomy for proper positioning of the device in the aneurysm (see [0109]). KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Aboytes does not explicitly disclose: the guide positioned between and coupled to the proximal end of the mesh and the distal end of the embolic element; and the turn being between about 150 degrees and 210 degrees.
However, Garza in a similar field of invention teaches an occlusion device 100 (see Figs. 2-9, [0029]) for treating an aneurysm vascular disorder/aneurysm (see [0011]-[0012]) with an embolic element 104 (see Figs. 2-9, [0032], coil segments, hence an embolic element) the embolic element 104 having a proximal end proximal end of 104 and a distal end distal end of 104 (see Figs. 8B and 9); and a guide 602 (see Fig. 2, [0044], 102 is attached to 104 through 602, hence 602 is between 102 and 104) positioned between the mesh 102 and the embolic element 104, the guide 602 having a preset curve (see Fig. 8B and 9, [0045], 602 can constrain the coil segments 104 and prevent undesirable stretching (or an undesirable amount stretching, hence it has a set curve/length, furthermore, 8B shows the final expanded configuration, in which 602 within 104 has a preset curve in the device’s secondary shape, see [0049]) along its length the length of 602 which extends through 104 (see Fig. 2, 8B, and 9, [0045]), wherein the guide 602 includes a curved portion (see annotated Fig. 8B below) that includes a turn (see annotated Fig. 8 below). Garza further teaches: the guide joint (see annotated Fig. 8B below) coupled to the distal end of the embolic element 104 (see Figs. 2-9, [0032], coil segments, hence an embolic element); the turn (see annotated Fig. 8 below) is between about 150 degrees and 210 degrees (see annotated Fig. 8B below),
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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 Aboytes to incorporate the teachings of Garza and teach an occlusive device with the embolic element coupled to the proximal end of the mesh; and the turn being between about 150 degrees and 210 degrees. Motivation for such can be found in Garza an additional of an additional embolic element on the proximal end of the mesh can increase the overall compliance of the entire device— greater than a braided structure (see [0032]) and the angle of the secondary shape of the turn can encourage the compliance sections/the embolic elements to arrange themselves along an interior wall of the aneurysm cavity which is desirable for treating an aneurysm (see [0049]).
The combination of Aboytes and Garza does not explicitly teach: the guide coupled to the proximal end of the mesh.
However, DeMeritt in a similar field of invention teaches an occlusive device 20 (see Figs. 1A-1B and 20A-20B) for treating an aneurysm 82 (see Figs. 20A-20B) with a mesh 22 + 23 (see Figs. 1A-1B) with a first side (see annotated Fig. 1A below), a second side (see annotated Fig. 1A below) opposite the second side, with a proximal end the proximal end of 22 (see Figs. 1A-1B) with a guide the joint at 25 (see Figs. 1A-1B) that comprises an elongated radially compacted portion (see annotated Fig. 1A below) of the mesh 22 + 23 having a preset curve 92 (see Figs. 1A-1B, [0069], curve/spiraling). DeMeritt further teaches: the guide the joint at 25 (see annotated Fig. 1A below) coupled to the proximal end the proximal end of 22 of the mesh 22.
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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 Aboytes and Garza to incorporate the teachings of DeMeritt and teach an occlusive device for treating an aneurysm with the guide coupled to the proximal end of the mesh. Motivation for such can be found in DeMeritt as this generates a small-diameter curve for the rest of the device to create outward radial force for device anchoring (see [0069]).
Claim 36
The combination of Aboytes, Garza, and DeMeritt teaches: The device of Claim 35, see 103 rejection above. Aboytes further discloses: when the occlusive device 100 is positioned within the delivery catheter 200/300 and the portion of the occlusive device 100 extending between the proximal terminus 122a of the guide 124 and the distal terminus 106 of the mesh 101 have been pushed from the delivery catheter 200/300 into the open space outside of the body of the patient such that the mesh 101 and guide 124 are in respective expanded, unconstrained configurations (see Fig. 3A), the preset curve the curve of 124 is configured to orient the mesh 101 relative to the delivery catheter 200/300 such that a lateral edge lateral edge of 101/120 (see Fig. 3A) of the mesh 101 is adjacent (see Fig. 3A, a lateral edge of 101 is adjacent to 300) the delivery catheter 300.
Claim 37
The combination of Aboytes, Garza, and DeMeritt teaches: The device of Claim 35, see 103 rejection above. Aboytes further discloses: wherein, when the occlusive device 100 is positioned within the delivery catheter 200/300 and the portion of the occlusive device 100 extending between the proximal terminus 122a of the guide 124 and the distal terminus 106 of the mesh 101 have been pushed from the delivery catheter 200/300 into the open space outside of the body of the patient such that the mesh 101 and guide 124 are in respective expanded, unconstrained configurations (see Fig. 3B), the preset curve the curve of 124 is configured to orient the mesh 101 relative to the delivery catheter 300 such that the concave surface concave surface of 101 of the mesh 101 and a concave portion concave surface of 120 facing towards 122/124 (see Fig. 3B) of the preset curve of the guide 124 are facing towards one another (see Fig. 3B).
Claim 39
The combination of Aboytes, Garza, and DeMeritt teaches: The device of Claim 35, see 103 rejection above. Aboytes further discloses: wherein an average cross-sectional dimension the cross-sectional dimension of 124 of the guide 124 in a delivery configuration (see Fig. 1B, in a constrained lengthened configuration, the dimension of 124 is the same as in the deployed configuration as shown in Fig. 1A) is substantially the same as an average cross- sectional dimension the cross-sectional dimension of 124 of the guide 124 in a deployed configuration.
Claim 40
The combination of Aboytes, Garza, and DeMeritt teaches: The device of Claim 35, see 103 rejection above. Aboytes further discloses: wherein a greatest cross-sectional dimension the cross-sectional dimension of 124 of the guide 124 in a deployed configuration (see Fig. 1A) is less than a greatest cross-sectional dimension the cross-sectional dimension of a broad portion of 101 (see Fig. 1A, 124’s cross-sectional dimension is less than that of 101) of the mesh 101 in the deployed state (see Fig. 1A).
Claim 41
The combination of Aboytes, Garza, and DeMeritt teaches: The device of Claim 35, see 103 rejection above. Aboytes further discloses: wherein the first side the first side of 101 that is radially inward (see Figs. 1A-1B, [0098], concave shape) of the mesh 101 is concave (see [0098], concave).
Claim 42
The combination of Aboytes, Garza, and DeMeritt teaches: The device of Claim 35, see 103 rejection above. Garza further teaches: wherein the curved portion of the guide 604 includes a turn of about 180 degrees (see annotated Fig. 8B below claim 24 above).
Claim 43
The combination of Aboytes, Garza, and DeMeritt teaches: The device of Claim 35, see 103 rejection above. Aboytes further discloses: wherein the mesh 101 includes a first layer 111a (see Fig. 1C, [0100]) and a second layer 111b (see Fig. 1C, [0100]), and wherein, in an expanded, unconstrained state, the first layer 111a generally conforms to the second layer 111b such that the mesh 101 does not include an interior volume (see Figs. 1A and 1C, [0100], there is no interior volume between 111a and 111b).
Claim 44
The combination of Aboytes, Garza, and DeMeritt teaches: The device of Claim 35, see 103 rejection above. Aboytes further discloses: wherein the mesh 101 includes a first layer 111a (see Fig. 1C, [0100]) and a second layer 111b (see Fig. 1C, [0100]), and wherein, in an expanded, unconstrained state (see Fig. 1A), the thickness of the mesh 101 is generally equivalent to a combined thickness (see Figs. 1A and 1C, [0100]) of the individual first 111a and second layers 111b.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. US 11678887 B2 in view of Garza et al (US 20190053811 A1).
Claims 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. US 11678887 B2 in view of Aboytes et al (US 20180036012 A1).
See the bolded language in the table below.
Current application 18343282
U.S. Patent No. US 11678887 B2
24. An occlusive device for treating an aneurysm, wherein a neck of the aneurysm opens to a blood vessel, the device comprising: a mesh comprising a plurality of braided filaments, the mesh having a low-profile state for intravascular delivery to the aneurysm and a deployed state, the mesh comprising a distal end, a proximal end, and a length extending between the distal and proximal ends, and a first side and a second side opposite the first side along a thickness of the mesh; an embolic element coupled to the proximal end of the mesh at a joint, wherein the joint comprises an elongated radially compacted portion of the mesh and having a preset curve that is configured to orient the mesh relative to the joint such that the first side of the mesh is facing the joint and the second side of the mesh is facing away from the joint, wherein the preset curve includes a turn between about 150 degrees and 210 degrees, wherein the mesh is configured to be positioned within the aneurysm in the deployed state such that the mesh extends over the neck of the aneurysm and the embolic element is positioned between the mesh and a dome of the aneurysm.
1. An occlusive device for treating an aneurysm, wherein a neck of the aneurysm opens to a blood vessel, the device comprising: a mesh having a low-profile state for intravascular delivery to the aneurysm and a deployed state, the mesh comprising— a distal end, a proximal end, and a length extending between the distal and proximal ends, a first lateral edge, a second lateral edge, and a width extending between the first and second lateral edges, and a first side and a second side opposite the first side along a thickness of the mesh, wherein the second side of the mesh is convex, wherein the mesh is curved along its length and its width; an embolic element coupled to the proximal end of the mesh at a joint, the embolic element having a proximal end and a distal end; and a guide positioned between the mesh and the embolic element, the guide having a preset curve along its length configured to orient the mesh relative to the joint such that the first side of the mesh is facing the joint and the second side of the mesh is facing away from the joint, wherein the guide includes a curved portion that includes a turn between about 150 degrees and 210 degrees, wherein the mesh is configured to be positioned within the aneurysm in the deployed state such that the mesh extends over the neck of the aneurysm and the embolic element is positioned between the mesh and a dome of the aneurysm.
8. The device of claim 1, wherein the mesh is formed of a plurality of braided filaments.
35. An occlusive device for treating an aneurysm of a patient, wherein a neck of the aneurysm opens to a blood vessel, the device comprising: a mesh comprising a plurality of braided filaments, the mesh having a low-profile state for intravascular delivery to the aneurysm and a deployed state, the mesh comprising a distal end, a proximal end, and a length extending between the distal and proximal ends, and a first side and a second side opposite the first side along a thickness of the mesh; an embolic element having a proximal end and a distal end; and a guide positioned between and coupled to the proximal end of the mesh and the distal end of the embolic element, the guide comprising a radially compacted portion of the mesh and having a preset curve along its length, wherein the radially compacted portion of the mesh includes a curved portion that includes a turn between about 150 degrees and 210 degrees, wherein, when the occlusive device is positioned within a delivery catheter and a portion of the occlusive device extending between a proximal terminus of the guide and a distal terminus of the mesh have been pushed from the delivery catheter into an open space outside of a body of the patient such that the mesh and guide are in respective expanded, unconstrained configurations, the preset curve is configured to orient the mesh relative to the delivery catheter such that a concave surface of the mesh is facing the same direction as a convex portion of the preset curve, wherein the mesh is configured to be positioned within the aneurysm in the deployed state such that the mesh extends over the neck of the aneurysm and the embolic element is positioned between the mesh and a dome of the aneurysm.
12. An occlusive device for treating an aneurysm of a patient, wherein a neck of the aneurysm opens to a blood vessel, the device comprising: a mesh having a low-profile state for intravascular delivery to the aneurysm and a deployed state, the mesh comprising— a distal end, a proximal end, and a length extending between the distal and proximal ends, a first lateral edge, a second lateral edge, and a width extending between the first and second lateral edges, and a first side and a second side opposite the first side along a thickness of the mesh, wherein the second side of the mesh is convex, wherein the mesh is curved along the length and the width; an embolic element coupled to the proximal end of the mesh at a joint, the embolic element having a proximal end and a distal end; and a guide positioned between the mesh and the embolic element, the guide having a preset curve along its length, wherein the guide includes a curved portion that includes a turn between about 150 degrees and 210 degrees, wherein, when the occlusive device is positioned within a delivery catheter and a portion of the occlusive device extending between a proximal terminus of the guide and a distal terminus of the mesh have been pushed from the delivery catheter into an open space outside of a body of the patient such that the mesh and guide are in respective expanded, unconstrained configurations, the preset curve is configured to orient the mesh relative to the delivery catheter such that a concave surface of the mesh is facing the same direction as a convex portion of the preset curve, wherein the mesh is configured to be positioned within the aneurysm in the deployed state such that the mesh extends over the neck of the aneurysm and the embolic element is positioned between the mesh and a dome of the aneurysm.
15. The device of claim 12, wherein the guide comprises a radially-compacted portion of the mesh.
For claim 24, U.S. Patent No. US 11678887 B2 does not explicitly disclose: the guide comprising a radially compacted portion of the mesh.
However, Garza in a similar field of invention teaches an occlusion device 100 (see Figs. 2-9, [0029]) for treating an aneurysm vascular disorder/aneurysm (see [0011]-[0012]) with an embolic element 104 (see Figs. 2-9, [0032], coil segments, hence an embolic element) the embolic element 104 having a proximal end proximal end of 104 and a distal end distal end of 104 (see Figs. 8B and 9); and a guide 602 (see Fig. 2, [0044], 102 is attached to 104 through 602, hence 602 is between 102 and 104) positioned between the mesh 102 and the embolic element 104, the guide 602 having a preset curve (see Fig. 8B and 9, [0045], 602 can constrain the coil segments 104 and prevent undesirable stretching (or an undesirable amount stretching, hence it has a set curve/length, furthermore, 8B shows the final expanded configuration, in which 602 within 104 has a preset curve in the device’s secondary shape, see [0049]) along its length the length of 602 which extends through 104 (see Fig. 2, 8B, and 9, [0045]), wherein the guide 602 includes a curved portion (see annotated Fig. 8B below) that includes a turn (see annotated Fig. 8 below). Garza further teaches: wherein the guide 602 comprises a radially compacted portion (see [0044]-[0045], 602 is described as mesh-screen extension, while 102 is described a mesh-screen segment, hence 602 is an extension of 102, as it extends into 104, it is compacted in comparison to the mesh 102) of the mesh 102.
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 U.S. Patent No. US 11678887 B2 to incorporate the teachings of Garza and teach an occlusive device with the guide comprising a radially compacted portion of the mesh. Motivation for such can be found in Garza as the extension of the mesh can prevent undesirable stretching of the compliant portions (the coil segments) of the occlusion device (see [0045]).
For claim 35, U.S. Patent No. US 11678887 B2 does not explicitly disclose: the mesh comprising a plurality of braided filaments.
However, Aboytes in a similar field of invention teaches an occlusive device 100 (see Figs. 1A-1C, [0095]) for treating an aneurysm (see [0097]), wherein a neck of the aneurysm opens to a blood vessel (see Figs. 4A-4E, [0097]), the device 100 comprising: a mesh 101 (see Figs. 1A-1C, [0100]). Aboytes further teaches: the mesh comprising a plurality of braided filaments (see [0100], the mesh is formed of a tubular braid).
It would have been obvious to one of ordinary skill in the art before effective filing date of the invention to include the mesh comprising a plurality of braided filaments as taught by Aboytes in the mesh of U.S. Patent No. US 11678887 B2, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
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).
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/ Examiner, Art Unit 3771
/DARWIN P EREZO/ Supervisory Patent Examiner, Art Unit 3771