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 07/09/2026. As directed by the amendment: claims 1 have been amended, claims 6-7 have been cancelled and claims 10-22 have been added. Thus, claims 1-5 and 8-22 are presently pending in this application.
Response to Arguments
Applicant's arguments, see pages 7-8, filed 07/09/2026, with respect to the rejections of claim 7, now incorporated into claim 1 under 35 U.S.C. 103 as being unpatentable over Xu et al (US 20200069313 A1), herein referenced to as “Xu” have been fully considered but they are not persuasive.
The applicant amended claim 1 to incorporate the limitations of claim 7, further reciting “wherein the second diameter is between about 25% and about 75% of the first diameter”.
Summary of arguments
The applicant argues that one of ordinary skill in the art would not be motivated to modify Xu to have the second expanded shape having a second diameter between 25% and 75% of the first diameter
Applicant cites [0044], [0139], and [0140] of Xu to support their assertation— alleging that a function described in Xu would no longer be possible with the proposed modification
“[0044] In some embodiments, the dual layer is configured to increase metal coverage at or adjacent thereby promoting aneurysm embolization and flow diversion effect.”
“[0139] After being inverted into itself, portion 113 is movable between positions at or adjacent neck N by proximally moving braid 110 before detaching from delivery system 140. In some embodiments, portion 113 is configured to form a dual layer bowl when inverted into itself, as in FIG. 11B. Portion 113 can be in turn made of a single heat shaped layer that is invertible into itself to form the dual layered bowl sealable at the neck N. The dual layer configuration of portion 113 can be capable of increasing metal coverage at or adjacent the neck N thereby promoting aneurysm embolization and flow diversion effect. In some examples, a porosity of portion 113 can be less than a porosity of the distal expandable portion 112.”
The applicant asserts that modification of Xu with the range above, would prevent the functionality of “the dual layer is configured to increase metal coverage at or adjacent thereby promoting aneurysm embolization and flow diversion effect”. The examiner respectfully disagrees.
The dual layer that Xu is referring to and the function associated with, as clearly described in [0139] is the proximal portion 113 “In some embodiments, portion 113 is configured to form a dual layer bowl when inverted into itself, as in FIG. 11B. Portion 113 can be in turn made of a single heat shaped layer that is invertible into itself to form the dual layered bowl sealable at the neck N. The dual layer configuration of portion 113 can be capable of increasing metal coverage at or adjacent the neck N thereby promoting aneurysm embolization and flow diversion effect”.
The element of Xu that was relied upon teach the first and second diameter belong to the element 112, see non-final office action, mailed 03/09/2026, pages 2-3, and annotated Fig. 12A, reproduced below.
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The applicant erroneously applies the functionality described in Xu to a separate element the proximal cover portion 113, instead of the occlusion element 112 with its outer layer forming the first expanded shape and the inner layer forming a second expanded shape (see annotated Fig. 12A above).
As such the rejection of claims will be 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.
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) 1-4, 8-10, 12-14, and 17-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al (US 20200069313 A1), herein referenced to as “Xu”.
Claim 1
Xu discloses: An apparatus (see Figs. 12A-12B, [0140]) for treating an aneurysm A (see Figs. 12A-12B, [0140]) in a blood vessel (see [0059], vessel associated with the aneurysm) comprising: an occlusion element 110 + 112 (see Figs. 12A-12B, [0140]) configured to be releasably coupled to an elongate delivery shaft 20 (see Figs. 12A-12B, [0140]) and configured to be delivered in a collapsed configuration (see Fig. 2A, the device is collapsed) through an inner lumen the lumen of 20 (see Fig. 2A) of a delivery catheter 20 (see Fig. 2A), the occlusion element 112 including an inverted mesh tube (see Fig. 12A, [0140], inverted dual layer configuration) having an outer layer (see annotated Fig. 12A below) and an inner layer (see annotated Fig. 12A below), the outer layer (see annotated Fig. 12A below) transitioning to the inner layer (see annotated Fig. 12A below) at an inversion fold (see annotated Fig. 12A below), wherein at least the outer layer (see annotated Fig. 12A below) is formed into a first expanded shape (see annotated Fig. 12A below) having a first diameter (see annotated Fig. 12A below), wherein the inner layer (see annotated Fig. 12A below) is formed into a second expanded shape (see annotated Fig. 12A below) contained within the first expanded shape (see annotated Fig. 12A below), the second expanded shape (see annotated Fig. 12A below) having a second diameter (see annotated Fig. 12A below).
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Xu does not explicitly disclose: wherein the second diameter is between about 25% and about 75% of the first diameter.
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 Xu to have wherein the second diameter is between about 25% and about 75% of the first diameter 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 Xu would not operate differently with wherein the second diameter is between about 25% and about 75% of the first diameter. Further, applicant places no criticality on the range claimed, as alternative ranges of 15% to 95% and 33% and 67% are listed, hence the percentages outside of the claimed range of 25% to 75%, (15-24% and 75-95%) are acceptable alternatives.
Claim 2
Xu teaches: The apparatus of claim 1, see 103 rejection above. Xu further discloses: further comprising: a proximal cover portion 113 (see Figs. 12A-12B, [0140]) having a cover diameter (see annotated Fig. 12B below).
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Claim 3
Xu teaches: The apparatus of claim 2, see 103 rejection above. Xu further discloses: wherein the cover 113 comprises a convex proximal face (see annotated Fig. 12B below) and a concave distal face (see annotated Fig. 12B below).
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Claim 4
Xu teaches: The apparatus of claim 3, see 103 rejection above. Xu further discloses: wherein the concave distal face (see annotated Fig. 12B below claim 3) is configured to substantially surround (see annotated Fig. 12B below claim 3, the concave distal face surrounds a proximal portion of 112 such that it is not exposed to the blood vessel or the neck of the aneurysm, see also [0140], 113 is inverted into 112, hence surrounding it) a proximal portion the proximal portion of 112 of the outer layer outer layer of 112 (see annotated Fig. 12A below claim 1 and annotated Fig. 12B below claim 3) of the inverted mesh tube.
Claim 8
Xu teaches: The apparatus of claim 1, see 103 rejection above. Xu does not explicitly teach: wherein the second diameter is between about 33% and about 67% of the first diameter.
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 Xu to have wherein the second diameter is between about 33% and about 67% of the first diameter 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 Xu would not operate differently with wherein the second diameter is between about 33% and about 67% of the first diameter. Further, applicant places no criticality on the range claimed, as alternative ranges of 15% to 95% and 25% and 75% are listed, hence the percentages outside of the claimed range of 33% to 67%, (15-34% and 68-95%) are acceptable alternatives.
Claim 9
Xu teaches: The apparatus of claim 1, see 103 rejection above. Xu further discloses: wherein the first expanded shape (see annotated Fig. 12A below claim 1) and the second expanded shape (see annotated Fig. 12A below claim 1) are heat set (see [0057], [0139], and [0149], heat set).
Claim 10
Xu teaches: The apparatus of claim 1, see 103 rejection above. Xu further discloses: wherein the second expanded shape (see annotated Fig. 12A below claim 1) provides an axial support configured to resist a distal end of the occlusion device from being compacted toward a proximal end proximal end of the occlusion device, which is the proximal end of 113 (see Fig. 12A) of the occlusion device.
The language, "wherein the second expanded shape provides an axial support configured to resist a distal end of the occlusion device from being compacted toward a proximal end of occlusion device," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Xu meets the structural limitations of the claim, and is capable of resisting a compressive force from the distal end towards the proximal end, as 112 which includes the second expanded shape support the aneurysm against compaction and compression (see [0138]), additionally the shape of the second expanded shape is formed such that a compressive force over the distal end of the device translates into a radially expansive force due to the curvature of the second expanded shape within the first expanded shape, as this force is translated into the second expanded shape towards the first expanded shape, thus preventing the collapse of the aneurysm inwards.
Furthermore, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 I.
Claim 12
Xu teaches: The apparatus of claim 1, see 103 rejection above. Xu further discloses: further comprising an elongate pusher 30 (see Figs. 9-12B, [0135]), coupled to the occlusion device 110 by a detachable joint 116 (see Figs. 9-12B, [0134]-[0135], clean separation).
Claim 13
Xu teaches: The apparatus of claim 1, see 103 rejection above. Xu further discloses: further comprising a first internal volume (see annotated Fig. 12A below) between the first expanded shape (see annotated Fig. 12A below) and the second expanded shape (see annotated Fig. 12A below).
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Claim 14
Xu teaches: The apparatus of claim 13, see 103 rejection above. Xu further discloses: further comprising a second internal volume (see annotated Fig. 12A below claim 13) within the second expanded shape (see annotated Fig. 12A below claim 13).
Claim 17
Xu teaches: The apparatus of claim 3, see 103 rejection above. Xu further discloses: wherein the convex proximal face (see annotated Fig. 12B below) is adjacent to a proximal concavity (see annotated Fig. 12B below).
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Claim 18
Xu teaches: The apparatus of claim 3, see 103 rejection above. Xu further discloses: wherein the convex proximal face (see annotated Fig 12b below claim 3) is configured to seal against the aneurysm.
The language, "wherein the convex proximal face is configured to seal against the aneurysm," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Xu meets the structural limitations of the claim, and the convex proximal face, which continues along the radial sides of 113 until it becomes concave on the distal side of 113 seals against the aneurysm as shown in Fig. 12b, and is further supported in ([0138]-[0139]) as 112 secures 113 against the aneurysm wall to seal it.
Claim 19
Xu teaches: The apparatus of claim 1, see 103 rejection above. Xu does not explicitly disclose: wherein the occlusion device has an outer diameter of 3 mm to 15 mm.
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 Xu to have wherein the occlusion device has an outer diameter of 3 mm to 15 mm 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 Xu would not operate differently with wherein the occlusion device has an outer diameter of 3 mm to 15 mm. Further, applicant places no criticality on the range claimed, as alternative ranges of 3 mm and 7 mm are acceptable alternatives (see [0066] of applicant’s specification) hence the diameters outside of alternative ranges (8-15 mm) are not critical as a range of 3 mm to 7 mm is an acceptable alternative. Claim 20
Xu teaches: The apparatus of claim 1, see 103 rejection above. Xu further discloses: wherein the inversion fold (see annotated Fig. 12A below claim 1) defines a distal orifice 114 (see [0140], open distal end).
Claim 21
Xu teaches: The apparatus of claim 1, see 103 rejection above. Xu further discloses: wherein the mesh tube (see Fig. 12A, [0140], inverted dual layer configuration) comprises nickel- titanium filaments (see [0115], the braids in Xu are made of nickel-titanium alloy wires).
Claim 22
Xu teaches: The apparatus of claim 1, see 103 rejection above. Xu further discloses: wherein the mesh tube (see Fig. 12A, [0140], inverted dual layer configuration) comprises drawn filled tubes (see [0115], the braids in Xu are Drawn Filled Tube (DFT) nitinol).
Claim(s) 5, 11, and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xu in view of Lorenzo (US 20180242979 A1), herein referenced to as “Lorenzo”.
Claim 5
Xu teaches: The apparatus of claim 1, see 103 rejection above. Xu does not explicitly teach: wherein the second expanded shape comprises a ball shape.
However, Lorenzo in a similar field of invention teaches an apparatus for treating an aneurysm (see Figs. 12A-12F) with an occlusive element 10 + 12 + 15(see Figs. 12A-12F) comprising an inverted mesh tube (see Fig. 12B, [0034], inverting the braid) with a first expanded shape 12 (see Figs. 12A-12F) and a second expanded shape 15 (see Figs. 12E-12F). Lorenzo further teaches: wherein the second expanded shape 15 comprises a ball shape 15 (see Figs. 12E-12F, [0108], spherical shape).
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 Xu to incorporate the teachings of Lorenzo and teach an apparatus for treating an aneurysm with the second expanded shape comprises a ball shape. Motivation for such can be found in Lorenzo as this can better shape the first expanded shape to better match the aneurysm morphology (see [0107]) and allows for a filling approach similar to a coil approach except retraction is possible if the operator desires to re-position the implant with the aneurysm (see [0106]).
Claim 11
The combination of Xu and Lorenzo teaches: The apparatus of claim 5, see 103 rejection above. Xu further discloses: wherein the second expanded shape (see annotated Fig. 12A below claim 1) provides an axial support configured to resist a distal end of the occlusion device from being compacted toward a proximal end proximal end of the occlusion device, which is the proximal end of 113 (see Fig. 12A) of the occlusion device.
The language, "wherein the second expanded shape provides an axial support configured to resist a distal end of the occlusion device from being compacted toward a proximal end of occlusion device," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Xu meets the structural limitations of the claim, and is capable of resisting a compressive force from the distal end towards the proximal end, as 112 which includes the second expanded shape support the aneurysm against compaction and compression (see [0138]), additionally the shape of the second expanded shape is formed such that a compressive force over the distal end of the device translates into a radially expansive force due to the curvature of the second expanded shape within the first expanded shape, as this force is translated into the second expanded shape towards the first expanded shape, thus preventing the collapse of the aneurysm inwards.
Claim 15
The combination of Xu and Lorenzo teaches: The apparatus of claim 5, see 103 rejection above. Xu further discloses: further comprising a first internal volume (see annotated Fig. 12A below) between the first expanded shape (see annotated Fig. 12A below) and the second expanded shape (see annotated Fig. 12A below).
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Claim 16
The combination of Xu and Lorenzo teaches: The apparatus of claim 15, see 103 rejection above. Xu further discloses: further comprising a second internal volume (see annotated Fig. 12A below claim 15) within the second expanded shape (see annotated Fig. 12A below claim 15).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pedroso et al (US 20200367900 A1), which teaches an apparatus for occluding an aneurysm with an inverted mesh tube with several internal shapes (see Fig. 16A), including a spherical shape
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 8:00 AM - 5:00 PM.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
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