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 Arguments
Applicant's arguments, see pages 7-13, filed 04/02/2026 in regards to the rejection of claim 1 under 35 U.S.C. 103 as being unpatentable over Divino et al (US 20150297240 A1), herein referenced to as “Divino”, in view of Kresslein et al (US 20180161185 A1), herein referenced to as “Kresslein”, and Eskridge et al (US 20070191884 A1), herein referenced to as “Eskridge” have been fully considered but they are not persuasive.
Summary of applicant’s arguments
Divino does not disclose “a device in its unconstrained state, without any type of constraint”
Eskridge does not teach rolling the entire implant about a longitudinal axis in a balled-up configuration
Eskridge is not an intrasaccular device that forms a balled-up configuration
The rolled-up configuration occurs automatically not just forced by the blood vessel or aneurysm
Eskridge cannot be trained to automatically transition toward the predetermined second, short length configuration
The motivation for combining Divino with Eskridge is inapplicable
The examiner respectfully disagrees with the applicant’s arguments.
Argument 1
The applicant argues that Divino does not show a device in its unconstrained state, without any type of constraint in Fig. 2A. They argue that the device of Divino might be released in some other hollow anatomical structure it will be constrained by that anatomical structure. However, the examiner will note that the claimed language reads “unconstrained by the aneurysm” and other hollow anatomical lumens would not be an aneurysm, hence the claim limitations are met. Furthermore, the applicant later argues on pages 12-13 in their argument that the motivation provided by Eskridge would not be compatible with Divino because “Divino does not need to conform to the anatomy of the sac. Divino merely needs to occupy the aneurysm sac and disrupt blood flow in the sac”, which clearly indicates that in applicant’s view, that Divino is not constrained by the aneurysm because it does not need to conform the aneurysm walls. This argument is directly in opposition to argument 1. The examiner does not agree with this assertion; however, this shows that applicant’s arguments are contradictory.
Regardless, Fig. 2A clearly shows Divino’s device when it is not in an aneurysm (as opposed to Figs. 7A-7F. Furthermore, [0040] states “FIG. 2A is a perspective view of an occlusive device that can be released into a target area of a body lumen, according to some embodiments” and [0046] states “ FIGS. 7A-7F illustrate progressive steps in the deployment of a device into an aneurysm, according to some embodiments.” Hence, Fig. 2A shows the device when it is unconstrained by the aneurysm.
Argument 2
The applicant argues that Eskridge does not teach rolling the entire implant about a longitudinal axis in a balled-up configuration. The examiner respectfully disagrees with this assertion.
Eskridge was not relied upon to teach “a balled-up configuration” as the applicant suggests, but that the implant is rolled along its entire length, about a longitudinal axis of the implant.
Argument 2a
The applicant argues that Eskridge discloses a closure device designed to cover the neck of an aneurysm and not an intrasaccular device that forms a balled-up configuration inside the aneurysm sac.
Again, the examiner notes that Eskridge was not relied upon to teach “a balled-up configuration.
Secondly, the examiner respectfully disagrees that Eskridge is “not an intrasaccular device”. As can be clearly seen in Fig. 1E, the device of Eskridge is within the aneurysm sac, hence is an intrasaccular device.
The applicant furthermore asserts that the device of Eskridge does not describe a rolling of an entire implant along a longitudinal axis, as Eskridge describes in [0071] that the anchoring structures may have a generally circular, oblong, or otherwise curvilinear configuration. The examiner respectfully disagrees. As can be seen in Figs. 1A, 1C, and 1E, The anchoring struts 33 and 32, widen and then narrow from proximal to distal end, showcasing a “rolling along the longitudinal axis” along with element 31, and in the same direction as shown in Fig. 1E.
Hence, Eskridge is relied upon to teach rolling of an entire implant along a longitudinal axis.
Argument 2b
The applicant argues that Eskridge does not teach that the device is trained to spontaneously adopt a rolled-up configuration relative to the longitudinal and radial axis automatically.
The examiner respectfully disagrees.
Firstly, Eskridge is not relied upon to teach that the device is rolled up relative to the radial axis.
Secondly, Eskridge explicitly teaches that its device spontaneously adopts its rolled-up configuration relative to the longitudinal axis in [0032] and [0035] due to shape memory and shape change metallic material.
Argument 3
The applicant argues that the device of Eskridge cannot be trained to automatically transition toward the predetermined second, short length configuration because if the anchors were trained to roll up into a short length configuration they would not engage the walls of the aneurysm.
The examiner respectfully disagrees.
Firstly, the modification provided is a modification of Divino with Eskridge, not Eskridge with Divino.
Secondly, Eskridge specifically teaches in [0037] that devices are placed in a radially compressed state within delivery catheter (hence a long length configuration suitable for placement in a lumen of a microcatheter) and then are released to be radially expanded and in the process rolling as shown in Figs. 1A and 1E.
Argument 4
The applicant argues that the motivation for combining Divino with Eskridge is inapplicable, specifically because Eskridge’s device is to follow the natural curvature of the anatomy and be biased against the neck of the aneurysm from inside the aneurysm and Divino occupies the volume of the aneurysm and is not concerned with following the natural anatomy.
The examiner respectfully disagrees. Divino explicitly teaches that their needs to cover the neck of the aneurysm (see Fig. 8, [0047] and [0123], for substantial coverage of the neck). Hence, a biasing against the neck would be useful to avoid migration away from the neck which would prevent embolization of the aneurysm.
As such, the rejections of the claims are maintained.
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.
Claims 1-3, 6-8, 10-16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Divino et al (US 20150297240 A1), herein referenced to as “Divino”, in view of Kresslein et al (US 20180161185 A1), herein referenced to as “Kresslein”, and Eskridge et al (US 20070191884 A1), herein referenced to as “Eskridge”.
Claim 1
Divino discloses: an implant 100 (see Figs. 2A-2C, [0054]) for the treatment of aneurysms (see [0054], aneurysm), wherein the implant 100 has a proximal end proximal end of 100 (see Fig. 2A) and a distal end distal end of 100 (see Fig. 2A), said implant 100 comprising a plurality of struts struts that form the cells of 100 (see Figs. 2B-2C) forming adjacent cells cells of 100, said implant 100 having a first, long length configuration (collapsed configuration 120, see Fig. 2C, long length configuration with small diameter) suitable for placement in a lumen of the microcatheter (see [0063], when the device is in a catheter), and having a predetermined second, short length configuration (expanded configuration 110, see Fig. 2A, large diameter, short length balled up configuration, see also [0006] heat treated to impart a three-dimensional shape) that the implant 100 assumes upon being released from the microcatheter (see [0062], when unconstrainted may tend to self-adjust or move to the expanded configuration) and in which the implant 100 is rolled up relative to a radial axis (see Fig. 2A, the mesh is rolled and curved to form a balled configuration) to comprise a balled-up configuration (see Fig. 2A) adapted for disposition with a saccular aneurysm (see Fig. 2A); wherein the implant comprises a shape memory material (see [0013], shape memory material, [0085], nitinol), and the implant is trained (see [0006], heat treated to impart a three-dimensional shape and [0062], when unconstrainted may tend to self-adjust or move to the expanded configuration) to spontaneously assume the predetermined second, short length configuration when removed from the microcatheter (see [0062]) and unconstrained by the catheter and the aneurysm (see [0062], upon being released from the delivery catheter, when unconstrained the body 150 self-adjust or move to the expanded configuration in 110, hence the constraint of the aneurysm is not what leads to the balled up configuration shown in Fig. 1A), such that, when released into an aneurysm, the implant automatically transitions toward the predetermined second short length configuration (see [0062]).
Divino does not explicitly disclose: with at least a part of said cells being provided with membranes filling the cells; in which the implant is rolled, along its entire length, about a longitudinal axis of the implant.
However, Kresslein in a similar field of invention teaches an implant for the treatment of aneurysms (Fig. 13A; [0120]) comprising a plurality of struts struts of lattice 101 forming adjacent cells openings between the struts of 101. Kresslein further teaches: with at least a part of said cells openings between the struts of 101 being provided with membranes 102 (see Fig. 13A, [0099], at least two of the interconnected members of the lattice membrane i.e. cells include a polymeric electrospun mesh) filling the cells openings between the struts of 101.
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 Divino to incorporate the teachings of Kresslein and have an implant for the treatment of aneurysms with at least part of the cells of the implant being provided with polymeric membranes filling the cells. Motivation for such can be found in Kresslein as the mesh creates an impedance on the implant resulting in a reduction in blood flow into the aneurysm and biomimicry that may accelerate the rate of cell adhesion and endothelization to close off the aneurysm from the parent artery (see [0109]).
The combination of Divino and Kresslein does not explicitly teach in which the implant is rolled, along its entire length, about a longitudinal axis of the implant.
However, Eskridge in a similar field of invention teaches an implant 30 (see Fig. 1A and 1E) for the treatment of aneurysms A (see Fig. 1E) the implant having a longitudinal axis the longitudinal axis of 31 + 32 + 33 (see Fig. 1A, the length that runs from the end of 33 to 32) with a predetermined second, short length configuration (Fig. 1A and 1E) in which the implant 30 is rolled up relative to a radial axis (see Figs. 1A and 1E, 31 + 32 + 33 are rolled radially inwards to have an overall semi-tubular curvature). Eskridge further teaches: in which the implant 30 is rolled, along its entire length (see Fig. 1A and 1E, the entire length of 30, including 31, 32, and 33 is rolled along a longitudinal axis/length of the implant, [0071], curvilinear configuration), about a longitudinal axis of the implant 30.
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 the implant for treatment of aneurysms of Divino and Kresslein to incorporate the teachings of Eskridge and teach an implant for treatment of aneurysms with the implant is rolled, along its entire length, about a longitudinal axis of the implant. Motivation for such can be found in Eskridge as the curved structure allows the device to follow the natural curvature of the anatomy and be biased against the neck of the aneurysm from inside the aneurysm (see [0074]).
Claim 2
The combination of Divino, Kresslein, and Eskridge teaches: an implant according to claim 1, see 103 rejection above. Kresslein further teaches: wherein: the membranes 102 comprise polymer fibers (see [0099], polymeric electrospun mesh) or polymer films (see [0099], polymeric electrospun mesh).
Claim 3
The combination of Divino, Kresslein, and Eskridge teaches: an implant according to claim 1, see 103 rejection above. Kresslein further teaches: the membranes 102 are produced by an electrospinning process (see [0099], polymeric electrospun mesh).
Claim 6
The combination of Divino, Kresslein, and Eskridge teaches: an implant according to claim 1, see 103 rejection above. Divino (Figs. 2A-2C) does not explicitly disclose: at least some of the cells are provided with center struts each extending from one edge region of a cell to another edge region.
However, a variant embodiment of Divino (Fig. 3C) teaches in the same field of invention an implant 100 with cells the cells of 150 with struts the strands that form the cells of 100. Divino (Fig. 3C) further teaches: at least some of the cells the cells of 150 that have 194 going through them are provided with center struts the parts of 194 that run through the multiple cells of 150 (see Fig. 3C, [0078]-[0079]) each extending from one edge region of a cell to another edge region (see Fig. 3C, 194 runs through the cells, from end to another).
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 Divino and Kresslein to incorporate the teachings of variant embodiment of Divino (Fig. 3C) and have the implant further include some of the cells having a center strut extending from one edge region of the cell to another edge region. Motivation for such can be found in Divino as this member can ensure that the overall end length of the device even when it rolls up stays the same (see [0079]).
Claim 7
The combination of Divino, Kresslein, and Eskridge teaches: an implant according to claim 1, see 103 rejection above. Divino further discloses: the individual cells the cells of 100 are arranged offset from one another (see Fig. 2B, the cells are offset in the direction of 160) in a longitudinal direction the direction of 160.
Claim 8
The combination of Divino, Kresslein, and Eskridge teaches: an implant according to claim 1, see 103 rejection above. Divino (Figs. 2A-2C) does not explicitly disclose: the size of the cells varies.
However, a variant embodiment of Divino (see Fig. 3H) in the same field of invention teaches implant 100 with cells the cells of 100. Divino (Fig. 3H) further teaches: the size of the cells varies 240 (see Fig. 3H, [0096]-[0097]).
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 Divino and Kresslein to incorporate the teachings of variant embodiment of Divino (Fig. 3H) and have the implant have the size of the cells vary. Motivation for such can be found in Divino as a lower density can permit injection of embolic materials or coils while higher density can reduce or blow flow (see [0097]).
Claim 10
The combination of Divino, Kresslein, and Eskridge teaches: an implant according to claim 1, see 103 rejection above. Divino further discloses: wherein the implant 100 is characterized, in the predetermined second, short length configuration, by a curvature the curvature of 100 about the radial axis, and the curvature about the radial axis of the implant 100, when in the predetermined second, short length configuration increases from the proximal end proximal end of 100 of the implant to the distal end distal end of 100 (see annotated Fig. 2A below, from proximal end to distal end of 100, the curvature increases to maintain the spherical shape).
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Claim 11
The combination of Divino, Kresslein, and Eskridge teaches: an implant according to claim 1, see 103 rejection above. Divino further discloses: when in the predetermined second, short length configuration (see Fig. 2A) the individual cells the cells of 100 in the implant overlap (see Fig. 2A, the cells of 100 overlap due to the balled-configuration).
Claim 12
The combination of Divino, Kresslein, and Eskridge teaches: an implant according to claim 1, see 103 rejection above. Kresslein further teaches: at least a part of the cells, which are located in an interior of the implant after its formation (as cells are between interconnected member of lattice framework 101), are not or only partially provided with the membrane (as at least two of the interconnected members include the mesh 102; thus, not all the cells require the mesh).
Claim 13
The combination of Divino, Kresslein, and Eskridge teaches: an implant according to claim 1, see 103 rejection above. The combination of Divino and Kresslein does not explicitly teach: wherein: the implant has a diameter ranging between 4 and 25 mm when the implant has been fully released.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Divino, Kresslein, and Eskridge to have the implant have a diameter ranging between 4 and 25 mm when the implant has been fully released since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Divino, Kresslein, and Eskridge would not operate differently with the implant having a diameter ranging between 4 and 25 mm when the implant has been fully released or expanded as the implant is intended to reside in an aneurysm sac. Further, applicant places no criticality on the range claimed, (see applicant’s PGPUB US 20220330947 A1, [0033], the structure typically has a diameter in 4 to 25 mm range, and is specifically stated this diameter may vary, hence there is no criticality on the range as claimed).
Claim 14
The combination of Divino, Kresslein, and Eskridge teaches: an implant according to claim 1, see 103 rejection above. Divino further discloses: further comprising radiopaque markers (see [0007], radiopaque filaments can be added to enhance visibility).
Claim 15
The combination of Divino, Kresslein, and Eskridge teaches: an implant according to claim 1, see 103 rejection above. Divino further discloses: a method for manufacturing (see [0006]) is created from the plurality of struts (see Figs. 2A-2C, the struts of 100) and the implant is transformed into a balled-up configuration adapted for disposition within a saccular aneurysm (see [0006], heat treated to impart a three dimensional shape), subjected to heat treatment (see [0006]). Kresslein further teaches the membranes 102 (see Fig. 13A) provided in the cells of the implant.
Claim 16
The combination of Divino, Kresslein, and Eskridge teaches: an implant according to claim 1, see 103 rejection above. Divino does not explicitly disclose: the implant is configured for detachable connection to a delivery wire.
However, a variant embodiment of Divino (Fig. 3C) teaches in the same field of invention an implant 100 with cells the cells of 150. Divino (Fig. 3C) further teaches: the implant 100 is configured for detachable connection (releasably engaged, see [0083]) to a delivery wire core wire (see [0083]).
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 Divino and Kresslein to incorporate the teachings of a variant embodiment of Divino (Fig. 3C) and have the implant to be configured to have a detachable connection to a delivery wire. Motivation for such can be found in Divino as this allows for also for controlled delivery of the implant to a target area (see [0083]).
Claim 20
The combination of Divino, Kresslein, and Eskridge teaches: an implant according to claim 1, see 103 rejection above. Divino further discloses: in the predetermined second, short length configuration (see Fig. 2A), the proximal end of the implant has a first radius of curvature about the radial axis and the distal end of the implant has a second radius of curvature about the radial axis which is smaller than the first radius of curvature (see annotated Fig. 2A below)
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Claims 4-5, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Divino in view of Kresslein and Eskridge as applied to claim 1 above, and further in view of Monstadt et al (US 20180353187 A1), herein referenced to as “Monstadt”.
Claim 4
The combination of Divino, Kresslein, and Eskridge teaches: an implant according to claim 1, see 103 rejection above. The combination of Divino, Kresslein, and Eskridge does not explicitly teach: wherein the membranes are composed of an electrospun polycarbonate urethane.
However, Monstadt in a similar field of invention teaches an implant 13 (see Figs. 2-3) to fill a saclike dilation or aneurysm (abstract) with a plurality of cells within struts 17 having membranes 6 (see Figs. 2-3), a distal end 4, and a proximal end 3. Monstadt further teaches: wherein the membranes are composed of an electrospun polycarbonate urethane (see [0025], PCU, which is produced by electrospinning).
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 Divino, Kresslein, and Eskridge to incorporate the teachings of Monstadt and have an implant membrane made of electrospun polycarbonate urethane. This is due to electrospun polycarbonate urethane being common in the art and suitable for the intended purpose of filling aneurysms, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Claim 5
The combination of Divino, Kresslein, and Eskridge teaches: an implant according to claim 1, see 103 rejection above. The combination of Divino, Kresslein, and Eskridge does not explicitly teach: the membranes comprise substance promoting endothelial formation and/or thrombogenesis.
However, Monstadt in a similar field of invention teaches an implant 13 (see Figs. 2-3) with a plurality of struts 17 having membranes 6 (see Figs. 2-3), a distal end 4, and a proximal end 3. Monstadt further teaches: the membranes 6 comprise substance promoting endothelial formation (will not be examined here due to being an optional claim limitation) and/or thrombogenesis (see [0026], thrombogenic materials).
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 Divino, Kresslein, and Eskridge to incorporate the teachings of Monstadt and have the membranes of the implant be coated with a substance that promotes thrombogenesis. Motivation for such can be found in Monstadt this thrombogenic substance will improve the implant’s ability to seal off the aneurysm (see [0026] and [0047]).
Claim 9
The combination of Divino, Kresslein, and Eskridge teaches: an implant according to claim 1, see 103 rejection above. The combination of Divino, Kresslein, and Eskridge teaches the size of the cells can vary (see rejection of claim 8 above), but does not explicitly teach: the size of the cells increases from the distal end to proximal end of the implant.
However, Monstadt in a similar field of invention teaches an implant 13 (see Figs. 2-3) with a plurality of struts 17 having membranes 6 (see Figs. 2-3), a distal end 4, and a proximal end 3. Monstadt further teaches: the size of the cells increases (see [0040]) from the distal end 4 to proximal end 3 of the implant 73 (increase in size from one end of the implant to the other).
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 Divino, Kresslein, and Eskridge to incorporate the teachings of Monstadt and have the size of the cells of the implant increase from the distal end to the proximal end of the implant. Motivation for such can be found in Monstadt as a change in size is a change in shape and this can prove beneficial for expansion, catheter navigation and guidance or the fabrication of the implant (see [0039]- [0040]).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
Prosecution Insights