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
The amendment filed 09/15/2025 has been entered. Claims 1-2, 4-10, and 12-22 remain pending in the application, and claims 3 and 11 are cancelled. Applicant’s amendments to the claims have overcome the interpretation of the rejection with respect to Hendriksen previously set forth in the Non-Final Office Action mailed 05/14/2025, however has not overcome the prior art rejection with respect to Rafiee (see rejection below).
Response to Arguments
Applicant's arguments filed 05/02/2025 have been fully considered but they are not persuasive with respect to the rejection under Rafiee.
Applicant argues on pages 10-11 that Rafiee’s radially extending regions 102/112 are not “symmetric about [any] radial axis” and instead, one side of each of the regions is flatter than the other side. The Office respectfully disagrees. As applied in the rejection below, paragraph 68 discloses that figures 2A and 2C are expanded configurations of the mesh structure 100. It can be seen in these figures that the radially extending regions 102/112 are “generally symmetric about a radial axis” as recited in claim 1. Therefore, the rejection in view of Rafiee is maintained.
Claim Interpretation
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. Such claim limitation(s) is/are: “attachment fixture” in claims 1, 7, 12, 16, and 18.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) 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(s) to avoid it/them 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(s) recite(s) 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 § 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.
Claim 1-2, 4, and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rafiee et al. (US PGPub 2017/0014114), hereinafter known as “Rafiee.”
With regards to claim 1, Rafiee discloses (Figures 1A-5C) a device 200 for embolizing a blood vessel (paragraph 108 – occlusion device), comprising:
a mesh structure 100 including a plurality of filaments braided together (paragraph 63), wherein the mesh structure 100 is configured to radially expand from a compressed state (figure 1A; paragraph 108) to an expanded state (figure 1B; paragraph 108);
an attachment fixture 114 (see Note below) coupled to the mesh structure 100, wherein the attachment fixture 114 is configured to be (a) coupled to a pusher element 116 during advancement of the mesh structure 100 through the blood vessel 60 and (b) detached from the pusher element 116 when the mesh structure 100 is positioned at a target site for embolization of the blood vessel (paragraphs 17, 59 and 71 – “removably attached”; figures 1A-1B);
wherein, in the compressed state (figure 1A), the mesh structure 100 has a generally cylindrical shape (figure 1A - mesh 100 has a generally cylindrical shape in the compressed state before axially shortening and radially expanding to the shape in the expanded state of figure 1B); and
wherein, in the expanded state (figures 2A and 2C; paragraph 68)
the mesh structure 100 includes a plurality of radially extending regions 102/112 (paragraph 64),
individual ones of the radially extending regions 102/112 include a proximal side, a distal side, and an apex (peak of 102/112) between the proximal side and the distal side and configured to contact a wall of the blood vessel (figure 2C; paragraph 64 – “disc configured for placement against an inner arterial wall… disc configured for placement, for example, against an inner wall of the inferior vena cava”),
the proximal side and the distal side are (a) generally symmetric about a radial axis extending through the apex orthogonal to a longitudinal axis of the device 200 and (b) angled relative to the radial axis (figure 2C – 100 and 112 are generally symmetric and angled relative to the radial axis)
each of the apices (peak of 102/112) has a thickness along the longitudinal axis, and
the combined thicknesses of the apices is less than about 50% of a total length of the mesh structure 100 along the longitudinal axis (figure 2A – the thickness of the apices is small enough in comparison to the length of the mesh structure 100 such that their combined thickness results in less than about 50% of the total length of the mesh structure 100 along the longitudinal axis).
Note – 112(f) interpretation – Applicant’s attachment fixture is some type of rod that is detachable with a pusher element to deploy the device (spec. [0047] and figures 3-4); Rafiee’s attachment fixture is coupling 114 that is detachable with a pusher member 116 to deploy the device (paragraphs 17, 59 and 71); therefore both attachment fixtures are equivalent in being detachable from a pusher element to deploy the device.
With regards to claim 2, Rafiee discloses wherein the filaments are each formed from a shape-memory material, and wherein the filaments are generally flexible (paragraph 63 – mesh made from NiTi, a shape-memory material with flexible qualities).
With regards to claim 4, Rafiee discloses wherein the radially extending regions 102/112 are porous (figures 1A-1B and 2A-2D – structure of the mesh is porous) and configured to impede blood flow through a vascular lumen of the blood vessel (Abstract).
With regards to claim 7, Rafiee discloses (Figures 1A-5C) a device 200 for embolizing a blood vessel (paragraph 108 – occlusion device), comprising:
a mesh structure 100 including a plurality of filaments braided together (paragraph 63), wherein the mesh structure 100 is configured to radially expand from a compressed state (figure 1A; paragraph 108) to an expanded state (figure 1B; paragraph 108);
an attachment fixture 114 (see Note below) coupled to the mesh structure 100, wherein the attachment fixture 114 is configured to be (a) coupled to a pusher element 116 during advancement of the mesh structure 100 through the blood vessel 60 and (b) detached from the pusher element 116 when the mesh structure 100 is positioned at a target site for embolization of the blood vessel (paragraphs 17, 59 and 71 – “removably attached”; figures 1A-1B);
wherein, in the compressed state (figure 1A), the mesh structure 100 has a generally cylindrical shape (figure 1A - mesh 100 has a generally cylindrical shape in the compressed state before axially shortening and radially expanding to the shape in the expanded state of figure 1B); and
wherein, in the expanded state (figures 2A and 2C; paragraph 68)
the mesh structure 100 includes a plurality of radially extending regions 102/112 and at least one core portion 110 (paragraph 64),
the at least one core portion 110 is between an adjacent pair of the radially extending regions 102/112 (figures 1A-2D),
the radially extending regions 102/112 and the at least one core portion 110 are flexible to permit the mesh structure 100 to conform to a cross-section of the blood vessel (paragraph 63 – mesh made from NiTi, a shape-memory material with flexible qualities),
individual ones of the radially extending regions 102/112 include a proximal side, a distal side, and an apex (peak of 102/112) between the proximal side and the distal side and configured to contact a wall of the blood vessel (figure 2C; paragraph 64 – “disc configured for placement against an inner arterial wall… disc configured for placement, for example, against an inner wall of the inferior vena cava”),
the proximal side and the distal side are (a) generally symmetric about a radial axis extending through the apex orthogonal to a longitudinal axis of the device and (b) angled relative to the radial axis (figure 2C – 100 and 112 are generally symmetric and angled relative to the radial axis)
each of the apices (peak of 102/112) has a thickness along the longitudinal axis, and
the combined thicknesses of the apices is less than about 50% of a total length of the mesh structure 100 along the longitudinal axis (figure 2A – the thickness of the apices is small enough in comparison to the length of the mesh structure 100 such that their combined thickness results in less than about 50% of the total length of the mesh structure 100 along the longitudinal axis).
Note – 112(f) interpretation – Applicant’s attachment fixture is some type of rod that is detachable with a pusher element to deploy the device (spec. [0047] and figures 3-4); Rafiee’s attachment fixture is coupling 114 that is detachable with a pusher member 116 to deploy the device (paragraphs 17, 59 and 71); therefore both attachment fixtures are equivalent in being detachable from a pusher element to deploy the device.
With regards to claim 8, Rafiee discloses wherein the radially extending regions 102/112 are porous (figures 1A-1B and 2A-2D – structure of the mesh is porous) and configured to impede blood flow through a vascular lumen of the blood vessel (Abstract).
Claim Rejections - 35 USC § 103
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 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.
Claims 5-6, 9-10, and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rafiee.
With regards to claim 5, Rafiee discloses the device as claimed in claim 1.
However, Rafiee does not explicitly disclose wherein, in the expanded state, the thickness of each of the apices is less than about 1 millimeter.
There is no evidence of record that establishes that changing the thickness of the apices (peaks of 102/112 of Rafiee) in the expanded state would result in a difference in function of the Rafiee device. Further, a person having ordinary skill in the art, being faced with modifying the device of Rafiee, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed thickness. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the thickness is “preferably” less than 1 mm, and offering other acceptable ranges (e.g. less than 2 mm, specification at para. [0053]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of the apices of Rafiee to be less than 1 mm as an obvious matter of design choice within the skill of the art.
With regards to claim 6, Rafiee discloses the device as claimed in claim 1.
However, Rafiee does not explicitly disclose wherein, in the expanded state, a distance between adjacent pairs of the apices is between 0.7 millimeter and 4.5 millimeters.
There is no evidence of record that establishes that changing the distance between adjacent pairs of the apices (peaks of 102/112 of Rafiee) in the expanded state would result in a difference in function of the Rafiee device. Further, a person having ordinary skill in the art, being faced with modifying the device of Rafiee, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed distance. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the distance “may” be between 0.7 mm and 4.5 mm, and offering other acceptable ranges (e.g. 0.5 mm to 5 mm, specification at para. [0048]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distance between adjacent pairs of the apices of Rafiee to be between 0.7 mm and 4.5 mm as an obvious matter of design choice within the skill of the art.
With regards to claim 9, Rafiee discloses the device as claimed in claim 7.
However, Rafiee does not explicitly disclose wherein, in the expanded state, the thickness of each of the apices is less than about 1 millimeter.
There is no evidence of record that establishes that changing the thickness of the apices (peaks of 102/112 of Rafiee) in the expanded state would result in a difference in function of the Rafiee device. Further, a person having ordinary skill in the art, being faced with modifying the device of Rafiee, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed thickness. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the thickness is “preferably” less than 1 mm, and offering other acceptable ranges (e.g. less than 2 mm, specification at para. [0053]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of the apices of Rafiee to be less than 1 mm as an obvious matter of design choice within the skill of the art.
With regards to claim 10, Rafiee discloses the device as claimed in claim 7.
However, Rafiee does not explicitly disclose wherein, in the expanded state, a distance between adjacent pairs of the apices is between 0.7 millimeter and 4.5 millimeters.
There is no evidence of record that establishes that changing the distance between adjacent pairs of the apices (peaks of 102/112 of Rafiee) in the expanded state would result in a difference in function of the Rafiee device. Further, a person having ordinary skill in the art, being faced with modifying the device of Rafiee, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed distance. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the distance “may” be between 0.7 mm and 4.5 mm, and offering other acceptable ranges (e.g. 0.5 mm to 5 mm, specification at para. [0048]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distance between adjacent pairs of the apices of Rafiee to be between 0.7 mm and 4.5 mm as an obvious matter of design choice within the skill of the art.
With regards to claim 12, Rafiee discloses (Figures 1A-5C) a device 200 for embolizing a blood vessel (paragraph 108 – occlusion device), comprising:
a mesh structure 100 including a plurality of filaments braided together (paragraph 63), wherein the mesh structure 100 is configured to radially expand from a compressed state (figure 1A; paragraph 108) to an expanded state (figure 1B; paragraph 108);
an attachment fixture 114 (see Note below) coupled to the mesh structure 100, wherein the attachment fixture 114 is configured to be (a) coupled to a pusher element 116 during advancement of the mesh structure 100 through the blood vessel 60 and (b) detached from the pusher element 116 when the mesh structure 100 is positioned at a target site for embolization of the blood vessel (paragraphs 17, 59 and 71 – “removably attached”; figures 1A-1B);
wherein, in the compressed state (figure 1A), the mesh structure 100 has a generally cylindrical shape (figure 1A - mesh 100 has a generally cylindrical shape in the compressed state before axially shortening and radially expanding to the shape in the expanded state of figure 1B); and
wherein, in the expanded state (figures 2A and 2C; paragraph 68)
the mesh structure 100 includes a plurality of radially extending regions 102/112 (paragraph 64),
individual ones of the radially extending regions 102/112 include a proximal side, a distal side, and an apex (peak of 102/112) between the proximal side and the distal side and configured to contact a wall of the blood vessel (figure 2C; paragraph 64 – “disc configured for placement against an inner arterial wall… disc configured for placement, for example, against an inner wall of the inferior vena cava”),
the proximal side and the distal side are (a) generally symmetric about a radial axis extending through the apex orthogonal to a longitudinal axis of the device and (b) angled relative to the radial axis (figure 2C – 100 and 112 are generally symmetric and angled relative to the radial axis).
Note – 112(f) interpretation – Applicant’s attachment fixture is some type of rod that is detachable with a pusher element to deploy the device (spec. [0047] and figures 3-4); Rafiee’s attachment fixture is coupling 114 that is detachable with a pusher member 116 to deploy the device (paragraphs 17, 59 and 71); therefore both attachment fixtures are equivalent in being detachable from a pusher element to deploy the device.
Rafiee does not explicitly disclose wherein, in the expanded state, a distance between adjacent pairs of the apices is between 0.7 millimeter and 4.5 millimeters.
There is no evidence of record that establishes that changing the distance between adjacent pairs of the apices (peaks of 102/112 of Rafiee) in the expanded state would result in a difference in function of the Rafiee device. Further, a person having ordinary skill in the art, being faced with modifying the device of Rafiee, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed distance. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the distance “may” be between 0.7 mm and 4.5 mm, and offering other acceptable ranges (e.g. 0.5 mm to 5 mm, specification at para. [0048]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distance between adjacent pairs of the apices of Rafiee to be between 0.7 mm and 4.5 mm as an obvious matter of design choice within the skill of the art.
With regards to claim 13, Rafiee discloses wherein the filaments are formed from a shape-memory material (paragraph 63 – NiTi is a shape-memory material).
With regards to claim 14, Rafiee discloses where each of the apices (peak of 102/112) has a thickness along the longitudinal axis of the device 200, and wherein the combined thicknesses of the apices is less than about 50% of a total length of the mesh structure 100 along the longitudinal axis (figure 2A – the thickness of the apices is small enough in comparison to the length of the mesh structure 100 such that their combined thickness results in less than about 50% of the total length of the mesh structure 100 along the longitudinal axis).
With regards to claim 15, Rafiee discloses wherein the filaments are flexible (paragraph 63 – NiTi is a flexible material).
With regards to claim 16, Rafiee discloses (Figures 1A-5C) a device 200 for embolizing a blood vessel (paragraph 108 – occlusion device), comprising:
a mesh structure 100 including a plurality of filaments braided together (paragraph 63), wherein the mesh structure 100 is configured to radially expand from a compressed state (figure 1A; paragraph 108) to an expanded state (figure 1B; paragraph 108);
an attachment fixture 114 (see Note below) coupled to the mesh structure 100, wherein the attachment fixture 114 is configured to be (a) coupled to a pusher element 116 during advancement of the mesh structure 100 through the blood vessel 60 and (b) detached from the pusher element 116 when the mesh structure 100 is positioned at a target site for embolization of the blood vessel (paragraphs 17, 59 and 71 – “removably attached”; figures 1A-1B);
wherein, in the compressed state (figure 1A), the mesh structure 100 has a generally cylindrical shape (figure 1A - mesh 100 has a generally cylindrical shape in the compressed state before axially shortening and radially expanding to the shape in the expanded state of figure 1B); and
wherein, in the expanded state (figures 2A and 2C; paragraph 68)
the mesh structure 100 includes a plurality of radially extending regions 102/112 (paragraph 64),
individual ones of the radially extending regions 102/112 include a proximal side, a distal side, and an apex (peak of 102/112) between the proximal side and the distal side and configured to contact a wall of the blood vessel (figure 2C; paragraph 64 – “disc configured for placement against an inner arterial wall… disc configured for placement, for example, against an inner wall of the inferior vena cava”),
the proximal side and the distal side are (a) generally symmetric about a radial axis extending through the apex orthogonal to a longitudinal axis of the device and (b) angled relative to the radial axis (figure 2C – 100 and 112 are generally symmetric and angled relative to the radial axis).
Note – 112(f) interpretation – Applicant’s attachment fixture is some type of rod that is detachable with a pusher element to deploy the device (spec. [0047] and figures 3-4); Rafiee’s attachment fixture is coupling 114 that is detachable with a pusher member 116 to deploy the device (paragraphs 17, 59 and 71); therefore both attachment fixtures are equivalent in being detachable from a pusher element to deploy the device.
Rafiee does not explicitly disclose each of the apices has a thickness along a longitudinal axis of the device of less than about 1 millimeter.
There is no evidence of record that establishes that changing the thickness of the apices (peaks of 102/112 of Rafiee) along a longitudinal axis of the device would result in a difference in function of the Rafiee device. Further, a person having ordinary skill in the art, being faced with modifying the device of Rafiee, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed thickness. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the thickness is “preferably” less than 1 mm, and offering other acceptable ranges (e.g. less than 2 mm, specification at para. [0053]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of the apices of Rafiee to be less than 1 mm as an obvious matter of design choice within the skill of the art.
With regards to claim 17, Rafiee discloses wherein the filaments are formed from a shape-memory material (paragraph 63– NiTi is a shape-memory material), and wherein the combined thicknesses of the apices is less than about 50% of a total length of the mesh structure 100 along the longitudinal axis (figure 2A – the thickness of the apices is small enough in comparison to the length of the mesh structure 100 such that their combined thickness results in less than about 50% of the total length of the mesh structure 100 along the longitudinal axis).
With regards to claim 18, Rafiee discloses (Figures 1A-5C) a device 200 for embolizing a blood vessel (paragraph 108 – occlusion device), comprising:
a mesh structure 100 including a plurality of filaments braided together (paragraph 63), wherein the mesh structure 100 is configured to radially expand from a compressed state (figure 1A; paragraph 108) to an expanded state (figure 1B; paragraph 108);
an attachment fixture 114 (see Note below) coupled to the mesh structure 100, wherein the attachment fixture 114 is configured to be (a) coupled to a pusher element 116 during advancement of the mesh structure 100 through the blood vessel 60 and (b) detached from the pusher element 116 when the mesh structure 100 is positioned at a target site for embolization of the blood vessel (paragraphs 17, 59 and 71 – “removably attached”; figures 1A-1B);
wherein, in the compressed state (figure 1A), the mesh structure 100 has a generally cylindrical shape (figure 1A - mesh 100 has a generally cylindrical shape in the compressed state before axially shortening and radially expanding to the shape in the expanded state of figure 1B); and
wherein, in the expanded state (figures 2A and 2C; paragraph 68)
the mesh structure 100 includes a plurality of radially extending regions 102/112 (paragraph 64),
individual ones of the radially extending regions 102/112 include a proximal side, a distal side, and an apex (peak of 102/112) between the proximal side and the distal side and configured to contact a wall of the blood vessel (figure 2C; paragraph 64 – “disc configured for placement against an inner arterial wall… disc configured for placement, for example, against an inner wall of the inferior vena cava”),
the proximal side and the distal side are (a) generally symmetric about a radial axis extending through the apex orthogonal to a longitudinal axis of the device and (b) angled relative to the radial axis (figure 2C – 100 and 112 are generally symmetric and angled relative to the radial axis).
Note – 112(f) interpretation – Applicant’s attachment fixture is some type of rod that is detachable with a pusher element to deploy the device (spec. [0047] and figures 3-4); Rafiee’s attachment fixture is coupling 114 that is detachable with a pusher member 116 to deploy the device (paragraphs 17, 59 and 71); therefore both attachment fixtures are equivalent in being detachable from a pusher element to deploy the device.
Rafiee does not expressly disclose each of the apices has an edge radius that is between 0.10 millimeter and 0.40 millimeter.
Rafiee discloses (paragraph 64) that the mesh covering preferably defines at least one proximal lobe, or disc 112 and at least one distal lobe, or disc 102 joined by a narrowed neck 110 region that can be adjustable in radial dimension so as to permit a custom fit during implantation to minimize or eliminate leakage from the aorta and IVC. Therefore, it is contemplated that different sizes of the device will be available for selection by the user for a particular presentation of the patient. As seen in figures 2A and 2C and disclosed in paragraph 64, the apices of the radially extending regions 102/112 contact a wall of the blood vessel and as such the edge radius of the apices is disclosed to be a result effective variable in that changing the edge radius of the apices changes the force against the blood vessel. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Rafiee device to have an edge radius between 0.10 mm and 0.40 mm, as it involves only adjusting the dimension of a component disclosed to require adjustment.
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Rafiee by making the edge radius of each of the apices be between 0.10 mm and 0.40 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regards to claim 19, Rafiee discloses wherein the filaments are formed from a shape-memory material (paragraph 63 – NiTi is a shape-memory material).
With regards to claim 20, Rafiee discloses wherein the combined thicknesses of the apices is less than about 50% of a total length of the mesh structure 100 along the longitudinal axis (figure 2A – the thickness of the apices is small enough in comparison to the length of the mesh structure 100 such that their combined thickness results in less than about 50% of the total length of the mesh structure 100 along the longitudinal axis).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Rafiee in view of Amplatz et al. (US PGPub 2008/0200945), hereinafter known as “Amplatz.”
With regards to claims 21-22, Rafiee discloses the device as claimed in claim 1. Although Rafiee does shows some type of hub structure at the proximal and distal ends of the mesh structure 100, Rafiee does not explicitly disclose further comprising: a proximal hub, wherein a proximal portion of each of the filaments is secured to the proximal hub; and a distal hub, wherein a distal portion of each of the filaments is secured to the distal hub (claim 21); and wherein, in the expanded state, the proximal hub and the distal hub are aligned along the longitudinal axis (claim 22).
However, in a similar field of endeavor of occlusion devices, Amplatz teaches (Figures 1-4) a proximal hub 26, wherein a proximal portion of each of the filaments (filaments of disk 12) is secured to the proximal hub 26; and a distal hub 26, wherein a distal portion of each of the filaments (filaments of disk 14) is secured to the distal hub 26 (paragraphs 55-56); and wherein, in the expanded state (figure 1), the proximal hub 26 and the distal hub 26 are aligned along the longitudinal axis (figure 1).
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 device of Rafiee to include a proximal hub and distal hub as taught by Amplatz for the purpose of avoiding fraying of the filaments (paragraph 56 of Amplatz).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4-10 and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 11,304,701 (Lubock) in view of Rafiee.
With regards to claim 1, Lubock claims a device for embolizing a blood vessel, comprising:
a mesh structure, wherein the mesh structure is configured to radially expand from a compressed state to an expanded state (claim 1);
an attachment fixture coupled to the mesh structure, wherein the attachment fixture is configured to be (a) coupled to a pusher element during advancement of the mesh structure through the blood vessel and (b) detached from the pusher element when the mesh structure is positioned at a target site for embolization of the blood vessel (claim 7);
wherein, in the compressed state, the mesh structure has a generally cylindrical shape (claim 1); and
wherein, in the expanded state—
the mesh structure includes a plurality of radially extending regions (claim 1),
individual ones of the radially extending regions include a proximal side, a distal side, and an apex between the proximal side and the distal side and configured to contact a wall of the blood vessel (claim 1),
each of the apices has a thickness along the longitudinal axis (claim 1), and
the combined thicknesses of the apices is less than about 50% of a total length of the mesh structure along the longitudinal axis (claim 1).
Lubock does not claim wherein the mesh structure includes a plurality of filaments braided together; and the proximal side and the distal side are (a) generally symmetric about a radial axis extending through the apex orthogonal to a longitudinal axis of the device and (b) angled relative to the radial axis.
However, Rafiee teaches (Figures 1-5) wherein the mesh structure includes a plurality of filaments braided together (paragraph 63); and the proximal side and the distal side are (a) generally symmetric about a radial axis extending through the apex orthogonal to a longitudinal axis of the device and (b) angled relative to the radial axis (figure 2C – 100 and 112 are generally symmetric and angled relative to the radial axis).
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 device of Lubock have wherein the mesh structure includes a plurality of filaments braided together as taught by Rafiee for the purpose of being able to self-expand when released from a sheath.
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 device of Lubock to have the proximal side and the distal side are (a) generally symmetric about a radial axis extending through the apex orthogonal to a longitudinal axis of the device and (b) angled relative to the radial axis as taught by Rafiee for the purpose of exerting similar force against the blood vessel throughout the mesh structure.
With regards to claim 2, Lubock claims the device of claim 1 (claims 1 and 7). Lubock does not claim wherein the filaments are each formed from a shape-memory material, and wherein the filaments are generally flexible.
However, Rafiee teaches (Figure 1) wherein the filaments are formed from a shape-memory material, and wherein the filaments are generally flexible (paragraph 63 – NiTi alloys are shape-memory and flexible).
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 device of Lubock have wherein the filaments are formed from a shape-memory material, wherein the filaments are generally flexible as taught by Rafiee for the purpose of being able to self-expand when released from a sheath.
With regards to claim 4, Lubock claims wherein the radially extending regions are porous and configured to impede blood flow through a vascular lumen of the blood vessel (claim 1).
With regards to claim 5, Lubock claims the device as claimed in claim 1.
However, Lubock do not explicitly claim wherein, in the expanded state, the thickness of each of the apices is less than about 1 millimeter.
There is no evidence of record that establishes that changing the thickness of the apices in the expanded state would result in a difference in function of the Lubock device. Further, a person having ordinary skill in the art, being faced with modifying the device of Lubock, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed thickness. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the thickness is “preferably” less than 1 mm, and offering other acceptable ranges (e.g. less than 2 mm, specification at para. [0053]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of the apices of Lubock to be less than 1 mm as an obvious matter of design choice within the skill of the art.
With regards to claim 6, Lubock claims the device as claimed in claim 1.
However, Lubock does not explicitly disclose wherein, in the expanded state, a distance between adjacent pairs of the apices is between 0.7 millimeter and 4.5 millimeters.
There is no evidence of record that establishes that changing the distance between adjacent pairs of the apices in the expanded state would result in a difference in function of the Lubock device. Further, a person having ordinary skill in the art, being faced with modifying the device of Lubock, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed distance. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the distance “may” be between 0.7 mm and 4.5 mm, and offering other acceptable ranges (e.g. 0.5 mm to 5 mm, specification at para. [0048]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distance between adjacent pairs of the apices of Lubock to be between 0.7 mm and 4.5 mm as an obvious matter of design choice within the skill of the art.
With regards to claim 7, Lubock claims a device for embolizing a blood vessel (claim 1), comprising:
a mesh structure configured to radially expand from a compressed state to an expanded state (claim 1);
an attachment fixture coupled to the mesh structure, wherein the attachment fixture is configured to be (a) coupled to a pusher element during advancement of the mesh structure through the blood vessel and (b) detached from the pusher element when the mesh structure is positioned at a target site for embolization of the blood vessel (claim 7);
wherein, in the compressed state, the mesh structure has a generally cylindrical shape (claim 1); and
wherein, in the expanded state—
the mesh structure includes a plurality of radially extending regions (claim 1),
individual ones of the radially extending regions include a proximal side, a distal side, and an apex between the proximal side and the distal side and configured to contact a wall of the blood vessel (claim 1),
each of the apices has a thickness along the longitudinal axis (claim 1), and
the combined thicknesses of the apices is less than about 50% of a total length of the mesh structure along the longitudinal axis (claim 1).
Lubock does not claim wherein the mesh structure includes a plurality of filaments braided together; wherein the radially extending regions are flexible to permit the mesh structure to conform to a cross-section of the blood vessel; at least one core portion, wherein the at least one the core portion is between an adjacent pair of the radially extending portions; and the proximal side and the distal side are (a) generally symmetric about a radial axis extending through the apex orthogonal to a longitudinal axis of the device and (b) angled relative to the radial axis.
However, Rafiee teaches (Figures 1-5) wherein the mesh structure includes a plurality of filaments braided together (paragraph 63); the radially extending regions 102/112 and the at least one core portion 110 are flexible to permit the mesh structure 100 to conform to a cross-section of the blood vessel (paragraphs 63-64 – mesh made from NiTi, a shape-memory material with flexible qualities); and a plurality of core portions (necks 36), wherein at least one core portion 110 is between an adjacent pair of the radially extending portions (102/112; figures 1A-2D; paragraph 64); and wherein the mesh structure includes a plurality of filaments braided together (paragraph 63); and the proximal side and the distal side are (a) generally symmetric about a radial axis extending through the apex orthogonal to a longitudinal axis of the device and (b) angled relative to the radial axis (figure 2C – 100 and 112 are generally symmetric and angled relative to the radial axis).
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 device of Lubock have wherein the mesh structure includes a plurality of filaments braided together as taught by Rafiee for the purpose of being able to self-expand when released from a sheath.
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 device of Lubock to include wherein the radially extending regions are flexible to permit the mesh structure to conform to a cross-section of the blood vessel as taught by Rafiee for the purpose of being the same size of the blood vessel in order to occlude blood flow.
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 device of Lubock to include at least one core portion and a plurality of radially extending portions, the at least one core portion between adjacent pairs of radially extending portions as taught by Rafiee for the purpose of further reducing leaks in body lumens (paragraphs 23-24 of Rafiee).
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 device of Lubock to have the proximal side and the distal side are (a) generally symmetric about a radial axis extending through the apex orthogonal to a longitudinal axis of the device and (b) angled relative to the radial axis as taught by Rafiee for the purpose of exerting similar force against the blood vessel throughout the mesh structure.
With regards to claim 8, Lubock further claims wherein the radially extending regions are porous and configured to impede blood flow through a vascular lumen of the blood vessel (claim 1).
With regards to claim 9, Lubock/Rafiee claim the device as claimed in claim 7.
However, Lubock/Rafiee do not explicitly claim wherein, in the expanded state, the thickness of each of the apices is less than about 1 millimeter.
There is no evidence of record that establishes that changing the thickness of the apices in the expanded state would result in a difference in function of the Lubock/Rafiee device. Further, a person having ordinary skill in the art, being faced with modifying the device of Lubock/Rafiee, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed thickness. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the thickness is “preferably” less than 1 mm, and offering other acceptable ranges (e.g. less than 2 mm, specification at para. [0053]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of the apices of Lubock/Rafiee to be less than 1 mm as an obvious matter of design choice within the skill of the art.
With regards to claim 10, Lubock/Rafiee claim the device as claimed in claim 7.
However, Lubock/Rafiee do not explicitly disclose wherein, in the expanded state, a distance between adjacent pairs of the apices is between 0.7 millimeter and 4.5 millimeters.
There is no evidence of record that establishes that changing the distance between adjacent pairs of the apices in the expanded state would result in a difference in function of the Lubock/Rafiee device. Further, a person having ordinary skill in the art, being faced with modifying the device of Lubock/Rafiee, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed distance. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the distance “may” be between 0.7 mm and 4.5 mm, and offering other acceptable ranges (e.g. 0.5 mm to 5 mm, specification at para. [0048]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distance between adjacent pairs of the apices of Lubock/Rafiee to be between 0.7 mm and 4.5 mm as an obvious matter of design choice within the skill of the art.
With regards to claim 12, Lubock claims a device for embolizing a blood vessel (claim 1), comprising:
a mesh structure configured to radially expand from a compressed state to an expanded state (claim 1);
an attachment fixture coupled to the mesh structure, wherein the attachment fixture is configured to be (a) coupled to a pusher element during advancement of the mesh structure through the blood vessel and (b) detached from the pusher element when the mesh structure is positioned at a target site for embolization of the blood vessel (claim 7);
wherein, in the compressed state, the mesh structure has a generally cylindrical shape (claim 1); and
wherein, in the expanded state—
the mesh structure includes a plurality of radially extending regions (claim 1),
individual ones of the radially extending regions include a proximal side, a distal side, and an apex between the proximal side and the distal side and configured to contact a wall of the blood vessel (claim 1).
Lubock does not claim wherein the mesh structure includes a plurality of filaments braided together; and the proximal side and the distal side are (a) generally symmetric about a radial axis extending through the apex orthogonal to a longitudinal axis of the device and (b) angled relative to the radial axis.
However, Rafiee teaches (Figures 1-5) wherein the mesh structure includes a plurality of filaments braided together (paragraph 63); and the proximal side and the distal side are (a) generally symmetric about a radial axis extending through the apex orthogonal to a longitudinal axis of the device and (b) angled relative to the radial axis (figure 2C – 100 and 112 are generally symmetric and angled relative to the radial axis).
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 device of Lubock have wherein the mesh structure includes a plurality of filaments braided together as taught by Rafiee for the purpose of being able to self-expand when released from a sheath.
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 device of Lubock to have the proximal side and the distal side are (a) generally symmetric about a radial axis extending through the apex orthogonal to a longitudinal axis of the device and (b) angled relative to the radial axis as taught by Rafiee for the purpose of exerting similar force against the blood vessel throughout the mesh structure.
Lubock does not explicitly claim wherein, in the expanded state, a distance between adjacent pairs of the apices is between 0.7 millimeter and 4.5 millimeters.
There is no evidence of record that establishes that changing the distance between adjacent pairs of the apices in the expanded state would result in a difference in function of the Lubock device. Further, a person having ordinary skill in the art, being faced with modifying the device of Lubock, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed distance. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the distance “may” be between 0.7 mm and 4.5 mm, and offering other acceptable ranges (e.g. 0.5 mm to 5 mm, specification at para. [0048]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distance between adjacent pairs of the apices of Lubock to be between 0.7 mm and 4.5 mm as an obvious matter of design choice within the skill of the art.
With regards to claim 13, Lubock claims the device as claimed in claim 12.
Lubock does not claim wherein the filaments are formed from a shape-memory material.
However, Rafiee teaches (Figure 1) wherein the filaments are formed from a shape-memory material (paragraph 63 – NiTi alloys).
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 device of Lubock have wherein the filaments are formed from a shape-memory material as taught by Rafiee for the purpose of being able to self-expand when released from a sheath.
With regards to claim 14, Lubock further claims wherein each of the apices has a thickness along the longitudinal axis of the device (claim 1), and the combined thicknesses of the apices is less than about 50% of a total length of the mesh structure along the longitudinal axis (claim 1).
With regards to claim 15, Lubock/Rafiee claim the device of claim 13. Lubock/Rafiee do not claim wherein the filaments are flexible.
However, Rafiee further teaches wherein the filaments are flexible (paragraph 63 – NiTi alloys are elastic 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 the device of Lubock to include wherein the filaments are generally flexible as taught by Rafiee for the purpose of being able to self-expand when released from a sheath.
With regards to claim 16, Lubock claims a device for embolizing a blood vessel (claim 1), comprising:
a mesh structure configured to radially expand from a compressed state to an expanded state (claim 1);
an attachment fixture coupled to the mesh structure, wherein the attachment fixture is configured to be (a) coupled to a pusher element during advancement of the mesh structure through the blood vessel and (b) detached from the pusher element when the mesh structure is positioned at a target site for embolization of the blood vessel (claim 7);
wherein, in the compressed state, the mesh structure has a generally cylindrical shape (claim 1); and
wherein, in the expanded state—
the mesh structure includes a plurality of radially extending regions (claim 1),
individual ones of the radially extending regions include a proximal side, a distal side, and an apex between the proximal side and the distal side and configured to contact a wall of the blood vessel (claim 1).
Lubock does not claim wherein the mesh structure includes a plurality of filaments braided together; and the proximal side and the distal side are (a) generally symmetric about a radial axis extending through the apex orthogonal to a longitudinal axis of the device and (b) angled relative to the radial axis.
However, Rafiee teaches (Figures 1-5) wherein the mesh structure includes a plurality of filaments braided together (paragraph 63); and the proximal side and the distal side are (a) generally symmetric about a radial axis extending through the apex orthogonal to a longitudinal axis of the device and (b) angled relative to the radial axis (figure 2C – 100 and 112 are generally symmetric and angled relative to the radial axis).
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 device of Lubock have wherein the mesh structure includes a plurality of filaments braided together as taught by Rafiee for the purpose of being able to self-expand when released from a sheath.
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 device of Lubock to have the proximal side and the distal side are (a) generally symmetric about a radial axis extending through the apex orthogonal to a longitudinal axis of the device and (b) angled relative to the radial axis as taught by Rafiee for the purpose of exerting similar force against the blood vessel throughout the mesh structure.
Lubock does not explicitly claim each of the apices has a thickness along a longitudinal axis of the device of less than about 1 millimeter.
There is no evidence of record that establishes that changing the thickness of the apices along a longitudinal axis of the device would result in a difference in function of the Lubock device. Further, a person having ordinary skill in the art, being faced with modifying the device of Lubock, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed thickness. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the thickness is “preferably” less than 1 mm, and offering other acceptable ranges (e.g. less than 2 mm, specification at para. [0053]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of the apices of Lubock to be less than 1 mm as an obvious matter of design choice within the skill of the art.
With regards to claim 17, Lubock further claims wherein the combined thicknesses of the apices is less than about 50% of a total length of the mesh structure along the longitudinal axis (claim 1).
With regards to claim 18, Lubock claims a device for embolizing a blood vessel (claim 1), comprising:
a mesh structure configured to radially expand from a compressed state to an expanded state (claim 1);
an attachment fixture coupled to the mesh structure, wherein the attachment fixture is configured to be (a) coupled to a pusher element during advancement of the mesh structure through the blood vessel and (b) detached from the pusher element when the mesh structure is positioned at a target site for embolization of the blood vessel (claim 7);
wherein, in the compressed state, the mesh structure has a generally cylindrical shape (claim 1); and
wherein, in the expanded state—
the mesh structure includes a plurality of radially extending regions (claim 1),
individual ones of the radially extending regions include a proximal side, a distal side, and an apex between the proximal side and the distal side and configured to contact a wall of the blood vessel (claim 1), and
each of the apices has an edge radius that is between 0.10 millimeter and 0.40 millimeter (claim 1).
Lubock does not claim wherein the mesh structure includes a plurality of filaments braided together; and the proximal side and the distal side are (a) generally symmetric about a radial axis extending through the apex orthogonal to a longitudinal axis of the device and (b) angled relative to the radial axis.
However, Rafiee teaches (Figures 1-5) wherein the mesh structure includes a plurality of filaments braided together (paragraph 63); and the proximal side and the distal side are (a) generally symmetric about a radial axis extending through the apex orthogonal to a longitudinal axis of the device and (b) angled relative to the radial axis (figure 2C – 100 and 112 are generally symmetric and angled relative to the radial axis).
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 device of Lubock have wherein the mesh structure includes a plurality of filaments braided together as taught by Rafiee for the purpose of being able to self-expand when released from a sheath.
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 device of Lubock to have the proximal side and the distal side are (a) generally symmetric about a radial axis extending through the apex orthogonal to a longitudinal axis of the device and (b) angled relative to the radial axis as taught by Rafiee for the purpose of exerting similar force against the blood vessel throughout the mesh structure.
With regards to claim 19, Lubock claims the device as claimed in claim 18.
Lubock does not claim wherein the filaments are formed from a shape-memory material.
However, Rafiee teaches (Figure 1) wherein the filaments are formed from a shape-memory material (paragraph 63 – NiTi alloys).
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 device of Lubock have wherein the filaments are formed from a shape-memory material as taught by Rafiee for the purpose of being able to self-expand when released from a sheath.
With regards to claim 20, Lubock claims wherein the combined thicknesses of the apices is less than about 50% of a total length of the mesh structure along the longitudinal axis (claim 1).
Claims 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 11,304,701 (Lubock) in view of Rafiee, and further in view of Amplatz.
With regards to claims 21-22, Lubock/Rafiee claim the device as claimed in claim 1. Although Rafiee does shows some type of hub structure at the proximal and distal ends of the mesh structure 100, the combination does not explicitly claim further comprising: a proximal hub, wherein a proximal portion of each of the filaments is secured to the proximal hub; and a distal hub, wherein a distal portion of each of the filaments is secured to the distal hub (claim 21); and wherein, in the expanded state, the proximal hub and the distal hub are aligned along the longitudinal axis (claim 22).
However, in a similar field of endeavor of occlusion devices, Amplatz teaches (Figures 1-4) a proximal hub 26, wherein a proximal portion of each of the filaments (filaments of disk 12) is secured to the proximal hub 26; and a distal hub 26, wherein a distal portion of each of the filaments (filaments of disk 14) is secured to the distal hub 26 (paragraphs 55-56); and wherein, in the expanded state (figure 1), the proximal hub 26 and the distal hub 26 are aligned along the longitudinal axis (figure 1).
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 device of Lubock/Rafiee to include a proximal hub and distal hub as taught by Amplatz for the purpose of avoiding fraying of the filaments (paragraph 56 of Amplatz).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 12/18/2025
/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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