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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/02/2025 has been entered.
Response to Amendment
The amendment filed 05/02/2025 has been entered. Claims 1-2, 4-10, and 12-20 remain pending in the application, claims 3 and 11 are cancelled, and claims 21-22 are added. Applicant’s amendments to the claims have overcome the claim objections and 112(b) rejections, however have not overcome the interpretation of the rejection previously set forth in the Final Office Action mailed 12/03/2024.
Response to Arguments
Applicant's arguments filed 05/02/2025 have been fully considered but they are not persuasive with respect to claims 1, 7, 12, 16, and 18.
Applicant argues on pages 9-12 with respect to section D that Hendriksen and Rafiee, alone or in combination, fail to disclose or suggest the claim limitation of “a mesh structure including a plurality of filaments braided together.” The Office respectfully disagrees. Applicant’s arguments are based on an interpretation that the mesh structure of Hendriksen is element 12 which is formed from a tube (paragraph 22). This is incorrect, as the Office cited to the occluding membrane 40 as the mesh structure, which is disclosed in paragraph 30 to be a PET graft material. Modifying such mesh structure of Hendriksen to be braided as taught by Rafiee’s similar mesh structure would thus be obvious in the formation of a mesh to facilitate coagulation and to reduce or stop leakage from punctures in vessel walls.
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 is 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) within the blood vessel;
an attachment fixture 114 (see Note below) coupled to the mesh structure 100, wherein the attachment 114 20 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 (figure 1B)
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 an apex (peak of 102/112) configured to contact a wall of the blood vessel (figure 1B; 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”),
each of the apices (peak of 102/112) has a thickness along a longitudinal axis of the device 200, 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 1B – 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); Hendriksen’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.
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 1-2, 4-10, and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hendriksen et al. (US PGPub 2011/0301630), hereinafter known as “Hendriksen,” in view of Rafiee.
With regards to claim 1, Hendriksen discloses (Figures 1-3e) a device 10 for embolizing a blood vessel (paragraph 2; figure 3a), comprising:
a mesh structure 40 (paragraphs 29-30) including a plurality of filaments (paragraphs 29-30 - filaments making up the occluding membrane 40) bonded together (paragraph 30), wherein the mesh structure 40 is configured to radially expand from a compressed state (figure 3a; paragraph 38) to an expanded state (figures 3c-3e; paragraph 41) within the blood vessel 60;
an attachment fixture 20 (see Note below) coupled to the mesh structure 40, wherein the attachment fixture 20 is configured to be (a) coupled to a pusher element 76/78 during advancement of the mesh structure 40 through the blood vessel 60 and (b) detached from the pusher element 76/78 when the mesh structure 40 is positioned at a target site for embolization of the blood vessel 60 (paragraphs 37 and 42-43; figures 3d-3e);
wherein, in the compressed state (figure 3a), the mesh structure 40 has a generally cylindrical shape (figure 3a - mesh 40 is attached to the plurality of radially expandable struts 26, therefore the mesh 40 can take on a generally cylindrical shape when further compressed by the plurality of radially expandable struts 26 within a smaller catheter (such as inner sheath 74)); and
wherein, in the expanded state (figures 3c-3e)
the mesh structure 40 includes a plurality of radially extending regions 30/32 (paragraphs 23-24),
individual ones of the radially extending regions 30/32 include an apex (peak of 30/32) configured to contact a wall of the blood vessel 60 (figure 3c; paragraph 41),
each of the apices (peak of 30/32) has a thickness along a longitudinal axis of the device 10, and
the combined thicknesses of the apices is less than about 50% of a total length of the mesh structure 40 along the longitudinal axis (figure 1 – the thickness of the apices is small enough in comparison to the length of the mesh structure 40 such that their combined thickness results in less than about 50% of the total length of the mesh structure 40 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); Hendriksen’s attachment fixture is similarly a rod/collar 20 that is detachable with a pusher member 76 to deploy the device (paragraphs 37 and 43); therefore both attachment fixtures are equivalent in being detachable from a pusher element to deploy the device.
Although Hendriksen discloses a mesh 40 comprising a network of filaments, Hendriksen is silent wherein the plurality of filaments are braided together.
However, in a similar field of endeavor of occlusion devices, Rafiee teaches (Figure 1) wherein a mesh 100 includes a plurality of filaments braided together (paragraph 63).
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 network of filaments of the mesh structure of Hendriksen to be braided together as taught by Rafiee since braiding the filaments would result in the predictable results of forming a mesh to facilitate coagulation and to reduce or stop leakage from punctures in vessel walls.
With regards to claim 2, Hendriksen further discloses wherein the filaments are each formed from a shape-memory material, and wherein the filaments are generally flexible (paragraph 30 – PET is a shape-memory material which has flexible qualities).
With regards to claim 4, Hendriksen further discloses wherein the radially extending regions 30/32 are porous (figures 1-2) and configured to impede blood flow through a vascular lumen of the blood vessel 60 (paragraph 32).
With regards to claim 5, Hendriksen/Rafiee disclose the device as claimed in claim 1.
However, Hendriksen/Rafiee do 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 30/32 of Hendriksen) in the expanded state would result in a difference in function of the Hendriksen/Rafiee device. Further, a person having ordinary skill in the art, being faced with modifying the device of Hendriksen/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 Hendriksen/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, Hendriksen/Rafiee disclose the device as claimed in claim 1.
However, Hendriksen/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 (peaks of 30/32 of Hendriksen) in the expanded state would result in a difference in function of the Hendriksen/Rafiee device. Further, a person having ordinary skill in the art, being faced with modifying the device of Hendriksen/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 Hendriksen/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 7, Hendriksen discloses (Figures 1-3e) a device 10 for embolizing a blood vessel (paragraph 2; figure 3a), comprising:
a mesh structure 40 including a plurality of filaments (paragraphs 29-30 - filaments making up the occluding membrane 40) bonded together (paragraph 30), wherein the mesh structure 40 is configured to radially expand from a compressed state (figure 3a; paragraph 38) to an expanded state (figures 3c-3e; paragraph 41) within the blood vessel 60;
an attachment fixture 20 (see Note below) coupled to the mesh structure 40, wherein the attachment fixture 20 is configured to be (a) coupled to a pusher element 76/78 during advancement of the mesh structure 40 through the blood vessel 60 and (b) detached from the pusher element 76/78 when the mesh structure 40 is positioned at a target site for embolization of the blood vessel 60 (paragraphs 37 and 42-43; figures 3d-3e);
wherein, in the compressed state (figure 3a), the mesh structure 40 has a generally cylindrical shape (figure 3a - mesh 40 is attached to the plurality of radially expandable struts 26, therefore the mesh 40 can take on a generally cylindrical shape when further compressed by the plurality of radially expandable struts 26 within a smaller catheter (such as inner sheath 74)); and
wherein, in the expanded state (figures 3c-3e)
the mesh structure 40 includes a plurality of radially extending regions 30/32 and at least one core portion 22 (paragraphs 23-24),
the at least one core portion 22 is between an adjacent pair of the radially extending regions 30/32 (figure 2);
the radially extending regions 30/32 and the at least one core portion 22 are flexible to permit the mesh structure 40 to conform to a cross-section of the blood vessel (figure 3c; paragraphs 29-30),
individual ones of the radially extending regions 30/32 include an apex (peak of 30/32) configured to contact a wall of the blood vessel 60 (figure 3c; paragraph 41),
each of the apices (peak of 30/32) has a thickness along a longitudinal axis of the device 10, and
the combined thicknesses of the apices is less than about 50% of a total length of the mesh structure 40 along the longitudinal axis (figure 1 – the thickness of the apices is small enough in comparison to the length of the mesh structure 40 such that their combined thickness results in less than about 50% of the total length of the mesh structure 40 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); Hendriksen’s attachment fixture is similarly a rod/collar 20 that is detachable with a pusher member 76 to deploy the device (paragraphs 37 and 43); therefore both attachment fixtures are equivalent in being detachable from a pusher element to deploy the device.
Although Hendriksen discloses a mesh 40 comprising a network of filaments, Hendriksen is silent wherein the plurality of filaments are braided together.
However, in a similar field of endeavor of occlusion devices, Rafiee teaches (Figure 1) wherein a mesh 100 includes a plurality of filaments braided together (paragraph 63).
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 network of filaments of the mesh structure of Hendriksen to be braided together as taught by Rafiee since braiding the filaments would result in the predictable results of forming a mesh to facilitate coagulation and to reduce or stop leakage from punctures in vessel walls.
Hendriksen is silent to a plurality of core portions, wherein individual ones of the core portions are between an adjacent pair of the radially extending portions.
However, in a similar field of endeavor of occlusions devices, Rafiee teaches (Figures 11A-11B) a plurality of core portions (necks 36), wherein individual ones of the core portions 36 are between an adjacent pair of the radially extending portions (10/12/38/40; figures 11A-11B; paragraph 82).
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 Hendriksen to include the plurality of core portions and multiple (4 or more) radially extending portions, individual core portions 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).
With regards to claim 8, Hendriksen further discloses wherein the radially extending regions 30/32 are porous (figures 1-2) and configured to impede blood flow through a vascular lumen of the blood vessel 60 (paragraph 32).
With regards to claim 9, Hendriksen/Rafiee disclose the device as claimed in claim 7.
However, Hendriksen/Rafiee do 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 30/32 of Hendriksen) in the expanded state would result in a difference in function of the Hendriksen/Rafiee device. Further, a person having ordinary skill in the art, being faced with modifying the device of Hendriksen/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 Hendriksen/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, Hendriksen/Rafiee disclose the device as claimed in claim 7.
However, Hendriksen/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 (peaks of 30/32 of Hendriksen) in the expanded state would result in a difference in function of the Hendriksen/Rafiee device. Further, a person having ordinary skill in the art, being faced with modifying the device of Hendriksen/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 Hendriksen/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, Hendriksen discloses (Figures 1-3e) a device 10 for embolizing a blood vessel (paragraph 2; figure 3a), comprising:
a mesh structure 40 including a plurality of filaments (paragraphs 29-30 - filaments making up the occluding membrane 40) bonded together (paragraph 30), wherein the mesh structure 40 is configured to radially expand from a compressed state (figure 3a; paragraph 38) to an expanded state (figures 3c-3e; paragraph 41) within the blood vessel 60;
an attachment fixture 20 (see Note below) coupled to the mesh structure 40, wherein the attachment fixture 20 is configured to be (a) coupled to a pusher element 76/78 during advancement of the mesh structure 40 through the blood vessel 60 and (b) detached from the pusher element 76/78 when the mesh structure 40 is positioned at a target site for embolization of the blood vessel 60 (paragraphs 37 and 42-43; figures 3d-3e);
wherein, in the compressed state (figure 3a), the mesh structure 40 has a generally cylindrical shape (figure 3a – mesh 40 is attached to the plurality of radially expandable struts 26, therefore the mesh 40 can take on a generally cylindrical shape when further compressed by the plurality of radially expandable struts 26 within a smaller catheter (such as inner sheath 74)); and
wherein, in the expanded state (figures 3c-3e)
the mesh structure 40 includes a plurality of radially extending regions 30/32 (paragraphs 23-24),
individual ones of the radially extending regions 30/32 include an apex (peak of 30/32) configured to contact a wall of the blood vessel 60 (figure 3c; paragraph 41).
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); Hendriksen’s attachment fixture is similarly a rod/collar 20 that is detachable with a pusher member 76 to deploy the device (paragraphs 37 and 43); therefore both attachment fixtures are equivalent in being detachable from a pusher element to deploy the device.
Although Hendriksen discloses a mesh 40 comprising a network of filaments, Hendriksen is silent wherein the plurality of filaments are braided together.
However, in a similar field of endeavor of occlusion devices, Rafiee teaches (Figure 1) wherein a mesh 100 includes a plurality of filaments braided together (paragraph 63).
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 network of filaments of the mesh structure of Hendriksen to be braided together as taught by Rafiee since braiding the filaments would result in the predictable results of forming a mesh to facilitate coagulation and to reduce or stop leakage from punctures in vessel walls.
Hendriksen/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 (peaks of 30/32 of Hendriksen) in the expanded state would result in a difference in function of the Hendriksen device. Further, a person having ordinary skill in the art, being faced with modifying the device of Hendriksen, 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 Hendriksen 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, Hendriksen further discloses wherein the filaments are formed from a shape-memory material (paragraph 30 – PET is a shape-memory material).
With regards to claim 14, Hendriksen further discloses wherein each of the apices (peak of 30/32) has a thickness along a longitudinal axis of the device 10, and wherein the combined thicknesses of the apices is less than about 50% of a total length of the mesh structure 40 along the longitudinal axis (figure 1 – the thickness of the apices is small enough in comparison to the length of the mesh structure 40 such that their combined thickness results in less than about 50% of the total length of the mesh structure 40 along the longitudinal axis).
With regards to claim 15, Hendriksen further discloses wherein the filaments are flexible (paragraph 30 – PET is an elastic material).
With regards to claim 16, Hendriksen discloses (Figures 1-3e) a device 10 for embolizing a blood vessel (paragraph 2; figure 3a), comprising:
a mesh structure 40 including a plurality of filaments (paragraphs 29-30 - filaments making up the occluding membrane 40) bonded together (paragraph 30), wherein the mesh structure 40 is configured to radially expand from a compressed state (figure 3a; paragraph 38) to an expanded state (figures 3c-3e; paragraph 41) within the blood vessel 60;
an attachment fixture 20 (see Note below) coupled to the mesh structure 40, wherein the attachment fixture 20 is configured to be (a) coupled to a pusher element 76/78 during advancement of the mesh structure 40 through the blood vessel 60 and (b) detached from the pusher element 76/78 when the mesh structure 40 is positioned at a target site for embolization of the blood vessel 60 (paragraphs 37 and 42-43; figures 3d-3e);
wherein, in the compressed state (figure 3a), the mesh structure 40 has a generally cylindrical shape (figure 3a - mesh 40 is attached to the plurality of radially expandable struts 26, therefore the mesh 40 can take on a generally cylindrical shape when further compressed by the plurality of radially expandable struts 26 within a smaller catheter (such as inner sheath 74)); and
wherein, in the expanded state (figures 3c-3e)
the mesh structure 40 includes a plurality of radially extending regions 30/32 (paragraphs 23-24),
individual ones of the radially extending regions 30/32 include an apex (peak of 30/32) configured to contact a wall of the blood vessel 60 (figure 3c; paragraph 41).
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); Hendriksen’s attachment fixture is similarly a rod/collar 20 that is detachable with a pusher member 76 to deploy the device (paragraphs 37 and 43); therefore both attachment fixtures are equivalent in being detachable from a pusher element to deploy the device.
Although Hendriksen discloses a mesh 40 comprising a network of filaments, Hendriksen is silent wherein the plurality of filaments are braided together.
However, in a similar field of endeavor of occlusion devices, Rafiee teaches (Figure 1) wherein a mesh 100 includes a plurality of filaments braided together (paragraph 63).
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 network of filaments of the mesh structure of Hendriksen to be braided together as taught by Rafiee since braiding the filaments would result in the predictable results of forming a mesh to facilitate coagulation and to reduce or stop leakage from punctures in vessel walls.
Hendriksen/Rafiee do 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 30/32) along a longitudinal axis of the device would result in a difference in function of the Hendriksen device. Further, a person having ordinary skill in the art, being faced with modifying the device of Hendriksen, 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 Hendriksen to be less than 1 mm as an obvious matter of design choice within the skill of the art.
With regards to claim 17, Hendriksen further discloses wherein the filaments are formed from a shape-memory material (paragraphs 30 – PET 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 40 along the longitudinal axis (figure 1 – the thickness of the apices is small enough in comparison to the length of the mesh structure 40 such that their combined thickness results in less than about 50% of the total length of the mesh structure 40 along the longitudinal axis).
With regards to claim 18, Hendriksen discloses (Figures 1-3e) a device 10 for embolizing a blood vessel (paragraph 2; figure 3a), comprising:
a mesh structure 40 including a plurality of filaments (paragraphs 29-30 - filaments making up the occluding membrane 40) bonded together (paragraph 30), wherein the mesh structure 40 is configured to radially expand from a compressed state (figure 3a; paragraph 38) to an expanded state (figures 3c-3e; paragraph 41) within the blood vessel 60;
an attachment fixture 20 (see Note below) coupled to the mesh structure 40, wherein the attachment fixture 20 is configured to be (a) coupled to a pusher element 76/78 during advancement of the mesh structure 40 through the blood vessel 60 and (b) detached from the pusher element 76/78 when the mesh structure 40 is positioned at a target site for embolization of the blood vessel 60 (paragraphs 37 and 42-43; figures 3d-3e);
wherein, in the compressed state (figure 3a), the mesh structure 40 has a generally cylindrical shape (figure 3a - mesh 40 is attached to the plurality of radially expandable struts 26, therefore the mesh 40 can take on a generally cylindrical shape when further compressed by the plurality of radially expandable struts 26 within a smaller catheter (such as inner sheath 74)); and
wherein, in the expanded state (figures 3c-3e)
the mesh structure 40 includes a plurality of radially extending regions 30/32 (paragraphs 23-24),
individual ones of the radially extending regions 30/32 include an apex (peak of 30/32) configured to contact a wall of the blood vessel 60 (figure 3c; paragraph 41).
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); Hendriksen’s attachment fixture is similarly a rod/collar 20 that is detachable with a pusher member 76 to deploy the device (paragraphs 37 and 43); therefore both attachment fixtures are equivalent in being detachable from a pusher element to deploy the device.
Although Hendriksen discloses a mesh 40 comprising a network of filaments, Hendriksen is silent wherein the plurality of filaments are braided together.
However, in a similar field of endeavor of occlusion devices, Rafiee teaches (Figure 1) wherein a mesh 100 includes a plurality of filaments braided together (paragraph 63).
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 network of filaments of the mesh structure of Hendriksen to be braided together as taught by Rafiee since braiding the filaments would result in the predictable results of forming a mesh to facilitate coagulation and to reduce or stop leakage from punctures in vessel walls.
Hendriksen/Rafiee do not expressly disclose each of the apices has an edge radius that is between 0.10 millimeter and 0.40 millimeter.
Hendriksen discloses (paragraphs 33-35) that the degree of the oversize of the diameter of the radially extending regions 30/32 will generally be less than about 50%, or more preferably about 25% or less, and that the degree of oversize desired depends on many factors, such as in which blood vessel the device is to be located (for example, artery or vein), the rate of blood flow at the desired location, and even on the medical condition of the patient. 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 figure 3c, the apices of the radially extending regions 30/32 contact a wall of the blood vessel 60 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 Hendriksen 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 Hendriksen 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, Hendriksen further discloses wherein the filaments are formed from a shape-memory material (paragraph 30 – PET is a shape-memory material).
With regards to claim 20, Hendriksen further discloses wherein the combined thicknesses of the apices is less than about 50% of a total length of the mesh structure 40 along the longitudinal axis (figure 1 – the thickness of the apices is small enough in comparison to the length of the mesh structure 40 such that their combined thickness results in less than about 50% of the total length of the mesh structure 40 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, 4-6, 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 within the blood vessel (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 an apex configured to contact a wall of the blood vessel (claim 1),
each of the apices has a thickness along a 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).
Lubock does not claim wherein the mesh structure includes a plurality of filaments braided together.
However, Rafiee teaches (Figure 1) wherein the mesh structure includes a plurality of filaments braided together (paragraph 63).
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.
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 betwe