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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/20/2026 has been entered.
Response to Amendment
As of the reply filed 1/20/2026, claims 70-81, 84-88, 93, and 134-135 are pending. Claims 1-69, 82-83, 89-92, and 94-133 are cancelled. Claims 70 and 75 have been amended. Claims 134-135 are new.
Response to Arguments
Applicant’s argument filed 1/20/2026 regarding the previously filed rejection under 35 U.S.C. 112(b) (see page 7 of reply) has been fully considered but is not persuasive. Claim 75 was amended in the reply filed 1/20/2026, however this reply fails to overcome the previously filed 112(b) rejection as the amended language “one or more mechanisms for locking” is still a means (mechanisms) plus function (locking) phrase. Since the amended language is still being interpreted under 35 U.S.C. 112(f), and since the present disclosure does not recite the corresponding structures for “one or more mechanisms for locking”, the claim is still indefinite.
Applicant’s arguments filed 1/20/2026 regarding the previously filed rejections under 35 U.S.C. 103 (see pages 7-8 of reply) have been considered but are not persuasive. Applicant argues that “Leeflang and Greenhalgh do not teach or suggest an inner layer having a larger diameter relative to a diameter of an outer layer” since “one having skill in the art would further not be motivated to modify the mesh 14 to have a predefined diameter larger [than] another diameter as such a modification would render Greenhalgh’s mesh 14 inoperable for its intended purpose” (see page 7 of reply), but the Examiner respectfully disagrees. The amended limitation only requires wherein the expandable basket comprises an inner layer which “comprises a larger diameter relative to a diameter of the outer layer”, and an outer layer, but does not specifically state the structure or configuration of these layers. The Examiner argues that Leeflang et al. discloses an outer layer (distal end 228 which becomes an outer layer in Fig. 5C when the expandable basket is inverted) and an inner layer (proximal end 226 which becomes an inner layer in Fig. 5C when the expandable basket is inverted) and further discloses wherein the inner layer (226) comprises a larger diameter relative to a diameter of the outer layer (228). Claim 70 does not recite the location of these diameters, therefore the Examiner argues that the inner layer (226 in Figs. 5B-C) comprises a larger diameter (the diameter of proximal end 226 near the center of the device where the diameter is largest, see also 231 in Fig. 5C) relative to a diameter of the outer layer (228, the diameter of 228 near the distal-most tip 224 is less than a diameter of 226 near 216 where the device inverts).
The Applicant further argues, regarding new claims 134-135, that “the art of record does not mention different materials between layers nor conical shaping” (see page 8 of reply).
With respect to the limitation “wherein the inner layer comprises a more resilient material relative to a material of the outer layer” as required by claim 134, Applicant’s argument is moot because the new ground of rejection relies upon the embodiment of Figs. 6A-B of Leeflang et al. instead. This embodiment discloses an outer layer (distal end 328 which becomes an outer layer in Fig. 6B when the expandable basket is inverted) and an inner layer (proximal end 326 which becomes an inner layer in Fig. 6B when the expandable basket is inverted) and further discloses wherein the inner layer (326) comprises a more resilient material relative to a material of the outer layer (328, PP [0076]: “the distal portion 328 has a plurality of openings 319 therein that are substantially smaller than the plurality of openings 317 in the proximal portion 326”). The broadest reasonable interpretation of “resilient” is elastic or flexible (see PP [0063] of present disclosure which states that “the inner layer 105b may be made from a more resilient or elastic material relative to the outer layer 105a”). The larger pores 317 in the inner layer 326 render this layer more resilient because a looser weave pattern imparts flexibility to the inner layer, allowing it to invert and then regain its original shape as the device is actuated.
With respect to the heat-set conical shaping required by claim 135, Leeflang et al. teaches that the tubular mesh may be “heated to a predetermined temperature to program the everted configuration into a shape memory of the tubular mesh. After heating, the second portion may be removed from within the first portion to dispose the tubular mesh in a generally tubular configuration, the tubular mesh maintaining the tubular configuration in a relaxed state” (PP [0020]), where the everted configuration is when the “proximal portion 226 may enter and become disposed within the distal portion 228” (PP [0068]), shown in Fig. 5C. The Examiner argues that this configuration is conical in shape since it has a flat base in profile and a distal tip (see annotation below) and further because it has a rounded cross-section (PP [0065]: “a tubular filter element 216”).
Claim Objections
Claims 134-135 are objected to because of the following informalities:
Claim 134, second to last line: “when the expandable basket is moved to between the collapsed configuration and…” is grammatically incorrect. It is recommended that the extraneous “to” be removed such that the claim limitation recites “when the expandable basket is moved between the collapsed configuration and…” instead.
Claim 135, last two lines: “when the expandable basket is moved to a between the collapsed configuration and…” is grammatically incorrect. It is recommended that the extraneous “to a” be removed such that the claim limitation recites “when the expandable basket is moved between the collapsed configuration and…” instead.
Appropriate correction is required.
Claim Interpretation
Claim 70 requires “wherein the expandable basket comprises an inner layer and an outer layer, wherein the inner layer comprises a larger diameter relative to a diameter of the outer layer when the expandable basket is moved to a partially expanded configuration between the collapsed configuration and expandable configuration”. Since it is not possible for an inner layer to have a larger diameter than an outer layer when these two layers are stacked on top of each other, as an inner layer by virtue of being “inner” must have a smaller diameter, and furthermore since the claim does not recite which configuration the expandable basket is in when this limitation is true, this claim is being interpreted to mean that a portion of the inner layer comprises a larger diameter than a portion of the outer layer.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. The claim limitation is: “one or more mechanisms for locking” in claim 75.
Because this claim limitation being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The present specification mentions the one or more locking mechanisms as follows:
PP [0052]: “The handle 120 may include one or more locking mechanisms 122 configured to lock or secure a location or position of the outer delivery shaft 108 and the inner wire 110 relative to each other (e.g., relative positions of the proximal and distal ends of the expandable basket 102)”
PP [0053]: “the locking mechanism 122 may be configured to secure the outer delivery shaft 108 and the inner wire 110 relative to each other at multiple positions. A shape or size of the proximally oriented cavity 112 may be modified depending on the distance between positions of the outer delivery shaft 108 and inner wire 110”
PP [0067]: “Relative locations or positions of the inner wire 110 and outer delivery shaft 108 may then be secured or locked as described above (e.g., with handle locking mechanisms 122) to maintain the expandable basket 102 in the expanded configuration (e.g., independent of retraction of the basket as described in more detail below)”
See black box view of locking mechanisms 122 in Fig. 2A
If applicant does not intend to have this limitation interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation recite sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 75 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claim limitation “mechanisms for locking” in Claim 75 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. While the present specification references one or more locking mechanisms 122 (see PP [0052-0053]), Figs. 1A and 2A appear to be the only figures where element 122 is shown, and these figures fail to show any structural details of the locking mechanisms. Since the specification also fails to recite any concrete structures of the locking mechanism, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (such as by changing the means plus function name of the locking mechanism to simply recite one or more locks or by cancelling the claim);
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 70-74, 81, 84-88, 93, and 134 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leeflang et al. (PGPub US 2002/0173819 A1).
With respect to claim 70, Leeflang et al. discloses an intravascular device (see Figs. 5A-C) for filtering particulates released during an intravascular procedure performed upon a patient to prevent distal migration of the released particulates (210 is a filter configured to filter particulates during an intravascular procedure, catching/filtering the particulates would prevent distal migration), the intravascular device comprising:
an outer delivery shaft (212); and
an expandable basket (216) movable between a collapsed configuration and an expanded configuration (see Figs. 5A-C), the expandable basket (216) configured to be in the collapsed configuration during delivery into a vasculature of the patient (216 is configured to be in the positions seen in Fig. 5A during delivery) and in the expanded configuration to filter particulates released during the intravascular procedure (216 is configured to filter particulates while in the position of Fig. 5C), the expandable basket (216) including a proximal end (218) and
a distal end (220), the proximal end (218) configured to be centrally and pivotally coupled to the outer delivery shaft (212, PP [0064]: “a tubular filter element 216 having proximal and distal ends 218, 220 attached to respective distal ends 222, 224 of the elongate members 212, 214”), and wherein at least one of the proximal end (218) or the distal end (220) is movable relative to each other such that a proximal portion (226) of the expandable basket (216) is invertible towards a distal portion (228) of the expandable basket (216) to form a proximally oriented cavity (230) configured to filter the released particulates therein (see Fig. 5C for inverted position, PP [0067-0068]),
wherein the expandable basket (216) comprises an inner layer (226 in Fig. 5B which becomes an inner layer when the expandable basket 216 inverts as shown in Fig. 5C, PP [0071]: “the proximal portion 226 is located substantially within the distal portion 228, as shown in FIG. 5C”, emphasis added) and an outer layer (228 in Fig. 5B which becomes an outer layer when the expandable basket 216 inverts as shown in Fig. 5C), wherein the inner layer (226) comprises a larger diameter relative to the outer layer (228, see annotated Figs. 5B-C below, the diameter of the inner layer 226 is taken along a middle of the device when partially expanded in Fig. 5B or a proximal end 231 when inverted in Fig. 5C, this diameter is larger than a distal end 224 of the outer layer 228) when the expandable basket (216) is moved to a partially expanded configuration (see Fig. 5B) between the collapsed configuration (Fig. 5A) and expanded configuration (Fig. 5C), wherein the larger diameter of the inner layer (the diameter of the inner layer 226 is taken along a middle of the device when partially expanded in Fig. 5B or a proximal end 231 when inverted in Fig. 5C) defines the proximally oriented cavity (230) in the expanded configuration (Fig. 5C, 231 of inner layer 226 defines a circumferential edge of the proximally oriented cavity 230).
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Regarding claim 71, Leeflang et al. further discloses wherein the expandable basket (216 in Fig. 5C) in the expanded configuration further comprises an integral anchor (231) configured to maintain vessel opposition and fixation of the expandable basket (PP [0071]: “An intermediate portion 231 between the first and second portions 226, 228 may expand to substantially engage a wall of the vessel”).
Regarding claim 72, Leeflang et al. further discloses wherein after withdrawal of a delivery catheter through which the intravascular device was advanced (PP [0069]: “The filter element 216 may be directed into a delivery apparatus, e.g., within a distal portion of a catheter or sheath (not shown)”), an aspiration catheter is configured to be navigated toward the anchored expandable basket (PP [0074]: “An aspirating catheter or other device may be advanced from upstream within the vessel, and a distal end of the catheter may be directed into the cavity 230 and a vacuum created to remove the particulate captured within the filter element 216”), wherein the anchored expandable basket (216 in Fig. 5C) provides a substantially fixed pre-positioned guide to the particulates of a thrombus (PP [0071]: “An intermediate portion 231 between the first and second portions 226, 228 may expand to substantially engage a wall of the vessel”, this fixes the expandable basket which enables it to act as a guide).
Regarding claim 73, Leeflang et al. further discloses wherein the proximal end (218 in Figs. 5A-C) of the expandable basket (216) is pivotally coupled to the outer delivery shaft (212) at a distal portion of the outer delivery shaft (222, the basket 216 pivots at 218 when inverting, see Figs. 5A-C).
Regarding claim 74, Leeflang et al. further discloses an inner core wire (214 in Figs. 5A-C) extending coaxially through the outer delivery shaft (212), a distal portion of the inner core wire (214) coupled to the distal end (220) of the expandable basket (216, PP [0064]: “the apparatus 210 includes a pair of substantially flexible guidewires or other elongate members 212, 214, and a tubular filter element 216 having proximal and distal ends 218, 220 attached to respective distal ends 222, 224 of the elongate members 212, 214”).
Regarding claim 81, Leeflang et al. further discloses wherein the proximally oriented cavity (230 in Fig. 5C) is a cup-shaped cavity (230 is cup-shaped since it has a free edge and a rounded curved closed end).
Regarding claim 84, Leeflang et al. further discloses wherein the proximal end (218 in Figs. 5A-C) of the expandable basket (216 in Fig. 5C) is spaced radially inward from a peripheral edge of the distal portion (228) of the expandable basket (216) when the proximal portion (226) is inverted towards the distal portion (228) of the expandable basket (216, see Fig. 5C, the proximal side 218/226 is spaced radially inward relative to an edge of 220/228).
Regarding claim 85, Leeflang et al. further discloses wherein axial positions of the proximal and distal ends (218 and 220 in Figs. 5A-C, respectively) of the expandable basket (216) are securable relative to each other after the proximal portion (226) of the expandable basket (216) is inverted towards the distal portion (228) of the expandable basket (216) to form the proximally oriented cavity (230, PP [0069]: “The catheter may also include an actuator or other locking device for securing the filter element 216 in the everted or other open configuration”).
Regarding claim 86, Leeflang et al. further discloses wherein the proximal and distal ends (218 and 220 in Figs 5A-C, respectively) of the expandable basket (216) are securable relative to each other in a plurality of axial positions such that a shape or size of the proximally oriented cavity (230 in Fig. 5C) is adjustable (PP [0071]: “the filter element 216 is disposed at a desired position (which may be adjusted, if necessary, by pulling the outer guidewire 212 to temporarily compress the filter element 216)”).
Regarding claim 87, Leeflang et al. further discloses wherein the expandable basket (216 in Figs. 5A-C) comprises support ribs (PP [0066]: “the mesh is formed from a plurality of tubular strands that are braided together in a predetermined manner”, the longitudinal mesh strands seen in Figs. 5A-C are support ribs).
Regarding claim 88, Leeflang et al. further discloses wherein a portion of the expandable basket (216 in Figs. 5A-C) comprises multiple layers (see Fig. 5C, when the device is inverted portions 226 and 224 are layered on top of one another and the device comprises multiple layers).
Regarding claim 93, Leeflang et al. further discloses wherein the proximally oriented cavity (230 in Fig. 5C) of the expandable basket (216) is configured to be at least partially positioned over an aspiration catheter during an aspiration procedure, wherein the proximally oriented cavity (230) of the expandable basket (216) is configured to cup a distal portion of the aspiration catheter (PP [0074]: “An aspirating catheter or other device may be advanced from upstream within the vessel, and a distal end of the catheter may be directed into the cavity 230”).
With respect to claim 134, Leeflang et al. discloses an intravascular device (see Figs. 6A-B) for filtering particulates released during an intravascular procedure performed upon a patient to prevent distal migration of the released particulates (310 is a filter configured to filter particulates during an intravascular procedure, catching/filtering the particulates would prevent distal migration), the intravascular device comprising:
an outer delivery shaft (312); and
an expandable basket (316) movable between a collapsed configuration and an expanded configuration (see Figs. 6A-B), the expandable basket (316) configured to be in the collapsed configuration during delivery into a vasculature of the patient (316 is configured to be in the position of Fig. 6A during delivery) and in the expanded configuration to filter particulates released during the intravascular procedure (316 is configured to filter particulates while in the position of Fig. 6B), the expandable basket (316) including a proximal end (318) and
a distal end (320), the proximal end (318) configured to be centrally and pivotally coupled to the outer delivery shaft (312, PP [0064]: “a tubular filter element 216 having proximal and distal ends 218, 220 attached to respective distal ends 222, 224 of the elongate members 212, 214”, this paragraph applies to the embodiment of Figs. 6A-B since the only difference in this embodiment is pore sizes, PP [0076]: “an alternative embodiment of a filter element 316 is shown that includes proximal and distal portions 326, 328 having different pore sizes”), and wherein at least one of the proximal end (318) or the distal end (320) is movable relative to each other such that a proximal portion (326) of the expandable basket (316) is invertible towards a distal portion (328) of the expandable basket (316) to form a proximally oriented cavity (330) configured to filter the released particulates therein (see Fig. 6B for inverted position, PP [0067-0068]),
wherein the expandable basket (316) comprises an inner layer (326 in Fig. 6A which becomes an inner layer when the expandable basket 316 inverts as shown in Fig. 6B, PP [0071]: “the proximal portion 226 is located substantially within the distal portion 228, as shown in FIG. 5C”, emphasis added, this paragraph applies to the embodiment of Figs. 6A-B since the only difference in this embodiment is pore sizes, PP [0076]: “an alternative embodiment of a filter element 316 is shown that includes proximal and distal portions 326, 328 having different pore sizes”) and an outer layer (328 in Fig. 6A which becomes an outer layer when the expandable basket 316 inverts as shown in Fig. 6B), wherein the inner layer (326) comprises a more resilient material relative to a material of the outer layer (328, PP [0076]: “the distal portion 328 has a plurality of openings 319 therein that are substantially smaller than the plurality of openings 317 in the proximal portion 326”, the larger openings 317 in inner layer 326 render this layer more resilient since larger openings render the inner layer 326 more flexible) such that the inner layer (326) defines an opening (see 330 in Fig. 6B with opening defined by inverted edge of 326) for the invertible proximal portion of the basket (316) to invert into (see Fig. 6B) when the expandable basket (316) is moved to between the collapsed configuration and expanded configuration (see Figs. 6A-B).
With respect to claim 135, Leeflang et al. discloses an intravascular device (see Figs. 5A-C) for filtering particulates released during an intravascular procedure performed upon a patient to prevent distal migration of the released particulates (210 is a filter configured to filter particulates during an intravascular procedure, catching/filtering the particulates would prevent distal migration), the intravascular device comprising:
an outer delivery shaft (212); and
an expandable basket (216) movable between a collapsed configuration and an expanded configuration (see Figs. 5A-C), the expandable basket (216) configured to be in the collapsed configuration during delivery into a vasculature of the patient (216 is configured to be in the positions seen in Fig. 5A during delivery) and in the expanded configuration to filter particulates released during the intravascular procedure (216 is configured to filter particulates while in the position of Fig. 5C), the expandable basket (216) including a proximal end (218) and
a distal end (220), the proximal end (218) configured to be centrally and pivotally coupled to the outer delivery shaft (212, PP [0064]: “a tubular filter element 216 having proximal and distal ends 218, 220 attached to respective distal ends 222, 224 of the elongate members 212, 214”), and wherein at least one of the proximal end (218) or the distal end (220) is movable relative to each other such that a proximal portion (226) of the expandable basket (216) is invertible towards a distal portion (228) of the expandable basket (216) to form a proximally oriented cavity (230) configured to filter the released particulates therein (see Fig. 5C for inverted position, PP [0067-0068]),
wherein the expandable basket (216) comprises an inner layer (226 in Fig. 5B which becomes an inner layer when the expandable basket 216 inverts as shown in Fig. 5C, PP [0071]: “the proximal portion 226 is located substantially within the distal portion 228, as shown in FIG. 5C”, emphasis added) and an outer layer (228 in Fig. 5B which becomes an outer layer when the expandable basket 216 inverts as shown in Fig. 5C), wherein the inner layer (226) comprises a heat-set conical shape (PP [0020]: “The tubular mesh may then be heated to a predetermined temperature to program the everted configuration into a shape memory of the tubular mesh”, the shape of 216 including inner layer 226 is conical due to the flat base near 231 and the tip near 220) such that the inner layer (226) defines an opening for the invertible proximal portion of the basket (218 of 216 in Fig. 5B, the opening to 230 is defined by 231 which is an outer circumferential edge of inner layer 226) to invert into when the expandable basket (216) is moved to a between the collapsed configuration (Fig. 5A) and expanded configuration (Fig. 5C).
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.
Claims 75-78 are rejected under 35 U.S.C. 103 as being unpatentable over Leeflang et al. (PGPub US 2002/0173819 A1), as applied to claim 70 above, and further in view of Trapp (PGPub US 2015/0127035 A1).
Regarding claim 75, Leeflang et al. further discloses one or more locking mechanisms (PP [0069]: “The catheter may include an actuator or other locking device (not shown) for securing the guidewires 212, 214 relative to one another, i.e., to maintain the tension causing the filter element 216 to assume the compressed configuration. The catheter may also include an actuator or other locking device for securing the filter element 216 in the everted or other open configuration”) configured to secure a position of the outer delivery shaft (212 in Figs. 5A-C) relative to a position of the inner core wire (214).
However, Leeflang et al. fails to specifically discloses a handle coupled to the outer delivery shaft and the inner core wire, the handle including the one or more locking mechanisms.
In the analogous field of vascular filtering devices (abstract), Trapp teaches a filtering device (see Figs. 1 and 18) comprising an outer delivery shaft (2 in Fig. 1), an inner core wire (12), and a handle (20 in Fig. 18) coupled to the outer delivery shaft (2 in Fig. 1) and inner core wire (12, PP [0084]: “To operate the handle 20, safety lock/pin 28 is removed and proximal housing 27 is rotated relative to proximal portion 23 and distal housing 22. Rotation will slowly withdraw core wire 12 and thus cause first expandable portion 4 (and when present, second expandable portion 10) to radially expand”). Trapp further teaches wherein the handle (20 in Fig. 18) includes one or more locking mechanisms (PP [0083]: “handle 20 can include safety lock/pin 28 and end cap 31”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Leeflang et al. device to incorporate the teachings of Trapp and include the handle including the one or more mechanisms for locking as described by the claim. One of ordinary skill in the art would have been motivated to perform this modification because such a modification would have been a combination of prior art elements according to known methods to yield predictable results (the filter of Leeflang et al. with the handle of Trapp). The combination as proposed would not alter the main operating principle of the Leeflang et al. device since the Trapp device is also an expandable device for use within the vasculature configured to operate via the relative translation between an inner core wire (12 in Fig. 1) and an outer delivery shaft (2), but would simply arrange a handle with integrated locking mechanisms on the proximal end of the Leeflang et al. device, which is already contemplated by Leeflang et al. (PP [0069]: “The catheter may include an actuator or other locking device (not shown) for securing the guidewires 212, 214 relative to one another”).
Regarding claim 76, Leeflang et al. fails to disclose a coil extending around a distal tip of the inner core wire.
In the analogous field of vascular filtering devices (abstract), Trapp teaches a filter device (1 in Fig. 1) comprising a coil (5) extending around a distal tip (distal end of 12, PP [0046]: “The core wire 12 distal end extends through and is attached to atraumatic component 5”) of an inner core wire (12).
It would have been obvious for one of ordinary skill in the art before the effective filing date to have further modified the Leeflang et al. and Greenhalgh et al. combination to include the teachings of Trapp by incorporating a coil extending around a distal tip of the inner core wire. One of ordinary skill in the art would have been motivated to perform this modification in order to provide the filter of Leeflang et al. with an atraumatic tip (Trapp PP [0057]: “Further shown is core wire 12, extending from the proximal end of the device, through the lumen, and being attached to atraumatic component 5”) to avoid causing trauma to the patient’s vasculature (as implied in PP [0057]). Extending the inner core wire such that it extends beyond the distal end of the filter would not have changed the main operating principle of the Leeflang et al. device since Leeflang et al. only discloses that “The proximal and distal ends 218, 220 may be substantially closed and/or may be secured around the distal ends 222, 224 of the respective guidewires 212, 214” (PP [0066]) and does not require that inner core wire 214 terminate at distal end 220.
Regarding claim 77, Leeflang et al. as modified by Trapp further fails to disclose wherein the inner core wire comprises a cylindrical portion and a flattened portion, wherein the flattened portion is at a distal end of the inner core wire.
Trapp further teaches that the inner core wire (12 in Fig. 1) comprises a cylindrical portion (PP [0077]: “Moreover, the core wire can be a tubular structure of any suitable material”, a tubular structure is cylindrical) and a flattened portion (PP [0077]: “The distal end of the core wire may contain a section which has been rolled to a rectangular profile”) at the distal end of the inner core wire (distal end of 12).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the Leeflang et al. and Trapp combination to further incorporate the teachings of Trapp and include the cylindrical and flattened portions of the inner core wire as claimed. One of ordinary skill in the art would have been motivated to perform this modification to allow for shaping of the atraumatic tip (Trapp PP [0077]), which is beneficial because an atraumatic tip prevents harm to the patient’s vasculature upon insertion (PP [0057] of Trapp). The modification as proposed would not have changed the main operating principle of the Leeflang et al. device since Leeflang et al. does not provide any statements of criticality regarding the cross-sectional shape of the inner core wire, stating only that “The inner guidewire 214 is preferably a single strand of wire, although alternatively, it may include one or more strands wound helically around an axial strand” (PP [0065]). The inner core wire 214 of Leeflang et al. would still be able to translate relative to the outer delivery shaft 212 with the shape change as proposed, and would simply have the predictable result of further shaping the atraumatic characteristics of the inner core wire 214 by enhancing its distal flexibility.
Regarding claim 78, Leeflang et al. as modified by Trapp further discloses wherein the inner core wire (214 in Figs. 5A-C of Leeflang et al., see 12 in Fig. 1 of Trapp) tapers in diameter from a proximal portion to a distal portion of the inner core wire (Trapp PP [0077]: “It can further comprise a tapering outer diameter, resulting in, for example, increasing flexibility of the device distally”).
Claims 79-80 are rejected under 35 U.S.C. 103 as being unpatentable over Leeflang et al. (PGPub US 2002/0173819 A1), as applied to claim 70 above, and further in view of Blagtan et al. (US PGPub 2002/0058888 A1).
Regarding claim 79, Leeflang et al. fails to disclose an extender wire, wherein the inner core wire is configured to be releasably coupled to the extender wire.
In the related field of guidewires (abstract), related in that the reference also concerns itself with the delivery of intraluminal devices within the body (PP [0002]), Blagtan et al. teaches a core wire (80 in Fig. 13) configured for use in vascular procedures (PP [0002]) and an extender wire (83), wherein the core wire (80) is configured to be releasably coupled to the extender wire (83, 80 is releasably coupled via 84).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Leeflang et al. device to incorporate the teachings of Blagtan et al. and include the extender wire as claimed. One of ordinary skill in the art would have been motivated to perform this modification because doing so would have constituted applying a known technique (the use of extender wires and hypotubes to extend the length of a guidewire) to a similar device (the filter of Leeflang et al. which includes a guidewire) in the same way. Furthermore, doing so would have yielded predictable results and would not have changed the main operating principal of the Leeflang et al. device, since Blagtan et al. contemplates the guidewire docking system being used in vascular procedures (PP [0002] of Blagtan et al.) such as that disclosed by the Leeflang et al. disclosure.
Regarding claim 80, Leeflang et al. as modified by Blagtan et al. further discloses one or more extender hypotubes (84 in Fig. 13 of Blagtan et al.), wherein the extender wire (83) is releasably coupled to the inner core wire (214 in Figs. 5A-C of Leeflang et al., see also 80 in Fig. 13 of Blagtan et al.) via the one or more extender hypotubes (84).
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.
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Claims 70-74, 79-81, 84-87, 91, and 93 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,759,221 B2 (hereinafter known as the ‘221 patent) as specified below. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘221 patent anticipate the present claims.
With respect to claim 70, the ‘221 patent discloses an intravascular device for filtering particulates released during an intravascular procedure performed upon a patient to prevent distal migration of the released particulates (claim 1, lines 2-5), the intravascular device comprising:
an outer delivery shaft (claim 1, lines 11-12); and
an expandable basket movable between a collapsed configuration and an expanded configuration, the expandable basket configured to be in the collapsed configuration during delivery into a vasculature of the patient and in the expanded configuration to filter particulates released during the intravascular procedure, the expandable basket including a proximal end and a distal end, the proximal end configured to be centrally and pivotally coupled to the outer delivery shaft (claim 1, lines 13-19), and wherein at least one of the proximal end or the distal end is movable relative to each other such that a proximal portion of the expandable basket is invertible towards a distal portion of the expandable basket to form a proximally oriented cavity configured to filter the released particulates therein (claim 1, lines 20-26),
wherein the expandable basket comprises an inner layer and an outer layer (claim 1, lines 14-15), wherein the inner layer comprises a larger diameter relative to a diameter of the outer layer when the expandable basket is moved to a partially expanded configuration between the collapsed configuration and expanded configuration (claim 1, lines 15-19), wherein the larger diameter of the inner layer defines the proximally oriented cavity in the expanded configuration (claim 1, lines 25-26).
Regarding claim 71, the ‘221 patent further discloses wherein the expandable basket in the expanded configuration further comprises an integral anchor configured to maintain vessel opposition and fixation of the expandable basket (claim 3, which includes the limitations of claim 2 due to its dependency).
Regarding claim 72, the ‘221 patent further discloses wherein after withdrawal of a delivery catheter through which the intravascular device was advanced, an aspiration catheter is configured to be navigated toward the anchored expandable basket, wherein the anchored expandable basket provides a substantially fixed pre-positioned guide to the particulates of a thrombus (claim 6).
Regarding claim 73, the ‘221 patent further discloses wherein the proximal end of the expandable basket is pivotally coupled to the outer delivery shaft at a distal portion of the outer delivery shaft (claim 12).
Regarding claim 74, the ‘221 patent further discloses an inner core wire extending coaxially through the outer delivery shaft, a distal portion of the inner core wire coupled to the distal end of the expandable basket (claim 13).
Regarding claim 79, the ‘221 patent further discloses an extender wire, wherein the inner core wire is configured to be releasably coupled to the extender wire (claim 15).
Regarding claim 80, the ‘221 patent further discloses one or more extender hypotubes, wherein the extender wire is releasably coupled to the inner core wire via the one or more extender hypotubes (claim 16, which encompasses claim 15 and therefore matches the dependency set forth in the present claims).
Regarding claim 81, the ‘221 patent further discloses wherein the proximally oriented cavity is a cup-shaped cavity (claim 1, the proximally oriented cavity as claimed would have to be cup-shaped because it is a concave hollow portion).
Regarding claim 84, the ‘221 patent further discloses wherein the proximal end of the expandable basket is spaced radially inward from a peripheral edge of the distal portion of the expandable basket when the proximal portion is inverted towards the distal portion of the expandable basket (claim 1, “to invert a proximal portion of the expandable basket towards a distal portion of the expandable basket to form a proximally oriented cavity” would yield a device where the proximal end of the expandable basket is spaced more radially inward).
Regarding claim 85, the ‘221 patent further discloses wherein axial positions of the proximal and distal ends of the expandable basket are securable relative to each other after the proximal portion of the expandable basket is inverted towards the distal portion of the expandable basket to form the proximally oriented cavity (claim 2, when the device is anchored the proximal and distal ends are secured).
Regarding claim 86, the ‘221 patent further discloses wherein the proximal and distal ends of the expandable basket are securable relative to each other in a plurality of axial positions such that a shape or size of the proximally oriented cavity is adjustable (claim 4, which contains the limitations of claim 2 and matches the dependency set forth).
Regarding claim 87, the ‘221 patent further discloses wherein the expandable basket comprises support ribs (claim 21).
Regarding claim 91, the ‘221 patent further discloses wherein a distal portion of the expandable basket comprises a pre-set conical configuration (claim 22).
Regarding claim 93, the ‘221 patent further discloses wherein the proximally oriented cavity of the expandable basket is configured to be at least partially positioned over an aspiration catheter during an aspiration procedure, wherein the proximally oriented cavity of the expandable basket is configured to cup a distal portion of the aspiration catheter (claim 10).
Claims 134-135 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,759,221 B2 (hereinafter known as the ‘221 patent) in view of Leeflang et al. (US PGPub 2002/0173819 A1).
Regarding claim 134, the ‘221 patent discloses an intravascular device for filtering particulates released during an intravascular procedure performed upon a patient to prevent distal migration of the released particulates (claim 1, lines 2-5), the intravascular device comprising:
an outer delivery shaft (claim 1, lines 11-12); and
an expandable basket movable between a collapsed configuration and an expanded configuration, the expandable basket configured to be in the collapsed configuration during delivery into a vasculature of the patient and in the expanded configuration to filter particulates released during the intravascular procedure, the expandable basket including a proximal end and a distal end, the proximal end configured to be centrally and pivotally coupled to the outer delivery shaft (claim 1, lines 13-19), and wherein at least one of the proximal end or the distal end is movable relative to each other such that a proximal portion of the expandable basket is invertible towards a distal portion of the expandable basket to form a proximally oriented cavity configured to filter the released particulates therein (claim 1, lines 20-26),
wherein the expandable basket comprises an inner layer and an outer layer (claim 1, lines 14-15).
However, the ‘221 patent fails to disclose wherein the inner layer comprises a more resilient material relative to a material of the outer layer such that the inner layer defines an opening for the invertible proximal portion of the basket to invert into when the expandable basket is moved to between the collapsed configuration and expanded configuration.
In the same field of vascular filter devices (abstract), Leeflang et al. teaches an expandable basket (316 in Figs. 6A-B) comprising an inner layer (326 in Fig. 6A which becomes an inner layer when the expandable basket 316 inverts as shown in Fig. 6B, PP [0071]: “the proximal portion 226 is located substantially within the distal portion 228, as shown in FIG. 5C”, emphasis added, this paragraph applies to the embodiment of Figs. 6A-B since the only difference in this embodiment is pore sizes, PP [0076]: “an alternative embodiment of a filter element 316 is shown that includes proximal and distal portions 326, 328 having different pore sizes”) and an outer layer (328 in Fig. 6A which becomes an outer layer when the expandable basket 316 inverts as shown in Fig. 6B), wherein the inner layer (326) comprises a more resilient material relative to a material of the outer layer (328, PP [0076]: “the distal portion 328 has a plurality of openings 319 therein that are substantially smaller than the plurality of openings 317 in the proximal portion 326”, the larger openings 317 in inner layer 326 render this layer more resilient since larger openings render the inner layer 326 more flexible) such that the inner layer (326) defines an opening (see 330 in Fig. 6B with opening defined by inverted edge of 326) for the invertible proximal portion of the basket (316) to invert into (see Fig. 6B) when the expandable basket (316) is moved to between the collapsed configuration and expanded configuration (see Figs. 6A-B).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the ‘221 patent claims according to the teachings of Leeflang et al. to arrive at the device as claimed. One of ordinary skill in the art would have been motivated to perform this modification because doing so constitutes the use of a known technique to improve a similar device ready for improvement to yield predictable results, since the Leeflang et al. reference teaches a substantially similar inverting filter device. Modifying the ‘221 patent claims according to the teachings of Leeflang et al. would not have changed the main operating principle of the device of the ‘221 patent since both devices are intended to invert and filter out particulates in the same manner, but would have simply yielded an intravascular filter with a more resilient and flexible inner layer portion more readily able to invert and filter out thrombi.
With respect to claim 135, the ‘221 patent discloses an intravascular device for filtering particulates released during an intravascular procedure performed upon a patient to prevent distal migration of the released particulates (claim 1, lines 2-5), the intravascular device comprising:
an outer delivery shaft (claim 1, lines 11-12); and
an expandable basket movable between a collapsed configuration and an expanded configuration, the expandable basket configured to be in the collapsed configuration during delivery into a vasculature of the patient and in the expanded configuration to filter particulates released during the intravascular procedure, the expandable basket including a proximal end and a distal end, the proximal end configured to be centrally and pivotally coupled to the outer delivery shaft (claim 1, lines 13-19), and wherein at least one of the proximal end or the distal end is movable relative to each other such that a proximal portion of the expandable basket is invertible towards a distal portion of the expandable basket to form a proximally oriented cavity configured to filter the released particulates therein (claim 1, lines 20-26),
wherein the expandable basket comprises an inner layer and an outer layer (claim 1, lines 14-15).
However, the ‘221 patent fails to disclose wherein the inner layer comprises a heat-set conical shape such that the inner layer defines an opening for the invertible proximal portion of the basket to invert into when the expandable basket is moved to a between the collapsed configuration and expanded configuration.
In the same field of vascular filter devices (abstract), Leeflang et al. teaches an expandable basket (316 in Figs. 6A-B) comprising an inner layer (226 in Fig. 5B which becomes an inner layer when the expandable basket 216 inverts as shown in Fig. 5C, PP [0071]: “the proximal portion 226 is located substantially within the distal portion 228, as shown in FIG. 5C”, emphasis added) and an outer layer (228 in Fig. 5B which becomes an outer layer when the expandable basket 216 inverts as shown in Fig. 5C), wherein the inner layer (226) comprises a heat-set conical shape (PP [0020]: “The tubular mesh may then be heated to a predetermined temperature to program the everted configuration into a shape memory of the tubular mesh”, the shape of 216 including inner layer 226 is conical due to the flat base near 231 and the tip near 220) such that the inner layer (226) defines an opening for the invertible proximal portion of the basket (218 of 216 in Fig. 5B, the opening to 230 is defined by 231 which is an outer circumferential edge of inner layer 226) to invert into when the expandable basket (216) is moved to a between the collapsed configuration (Fig. 5A) and expanded configuration (Fig. 5C).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the ‘221 patent claims according to the teachings of Leeflang et al. to arrive at the device as claimed. One of ordinary skill in the art would have been motivated to perform this modification because doing so constitutes the use of a known technique to improve a similar device ready for improvement to yield predictable results, since the Leeflang et al. reference teaches a substantially similar inverting filter device. Modifying the ‘221 patent claims according to the teachings of Leeflang et al. would not have changed the main operating principle of the device of the ‘221 patent since both devices are intended to invert and filter out particulates in the same manner, but would have simply yielded an intravascular filter with a pre-set conical shape via heat-setting that is more readily able to invert and filter out thrombi.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lorenzo et al. (US Patent No. 10,716,574 B2) teaches an expandable occlusion device (see Figs. 4A-B) comprising a distal end (14) and a proximal end (11), wherein the proximal end is configured to invert within the distal end (see Fig. 4B where 11 inverts within 14), and further teaches wherein the proximal end is more pliable than the distal end to facilitate inversion (col. 7, lines 28-32: “Portions of braid 10 on or proximate end 16 may be more pliable that portions of braid 10 on or proximate end 14 in order to induce self-expansion during delivery and inversion as braid 10 forms its predetermined, sack-like shape within aneurysm A”). This piece of prior art is particularly relevant to claim 134.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771