DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 7/13/26 have been fully considered but they are not persuasive.
Applicant argues Amplatz fails to disclose the inner braided layer being oval. Applicant argues that the specification paragraph [0185] discloses the criticality of the inner layer being oval. Applicant argues outer braided layer is not in alignment with a superior area of the target site, the radiopaque markers to indicate a direction of alignment.
Examiner notes it appears paragraph [0185] is referring to the shape of the medical device, and thereby the outer layer of the device, such as shown for example in figure 22A and paragraph [0185], as it does not specify that this is referring to criticality of the inner layer being an oval.
Examiner agrees with applicant that the circular shape not being considered similar to an oval shape, as it would require orientation. However, Amplatz et al. discloses wherein a shape of the inner braided layer is different than the shape of the outer braided layer (figure 12f, paragraph 0108). Figure 12f shows the inner layer showing an oval shape which then extends into the disc, but that extending portion is not required. Amplatz et al. discloses any of the characteristics and attachment means as disclosed in figures 12a-12f may be combined for a particular embodiment (paragraphs 0008-0111), such as changing the shape or diameter of the inner and outer braided layers. Additionally, alternative embodiments teach different shapes for the inner and outer layers (for example, figures 14a-c, 15, paragraph 0121-0122) and the shapes may be modified as desired for a particular use (paragraph 0125). Amplatz teaches the inner and outer fabric layers may be heat set into different geometries or different shapes and connections for delivery (paragraph 0055). It would have been an obvious to modify Amplatz et al., to have the inner braided layer is oval-shaped as modified for a particular use. As an example, Amplatz et al. may discloses an oval shape if the shapes may be combined in a particular embodiment, for example, the inner layer shape of figure 12f having the ends of the oval shape being clamped, as shown in figure 12e (see annotated figure 12f below). Applicant argues that an oval shape is not an arbitrary substitute, however, Amplatz discloses an oval as shown in modified figure 12f, the shape of the inner layer oval as claimed is not limited to being oval in a particular direction within the device.
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Further, claim 8 fails to disclose how the outer device must be configured to be in alignment with a superior area of the target site. Examiner notes, the device being placed around the target tissue, will result in and be configured for being in one particular alignment as desired. Radiopaque markers on end clamps of the layer will additionally indicate the placement or orientation (paragraph 0098, 0115).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 8, 10-12, 16-20 and 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amplatz et al. US 2007/0265656 in view of Kariniemi et al. US 2012/0245623.
Regarding claims 1 and 8, Amplatz et al. discloses a medical device for treating a target site, the medical device comprising: a tubular member (tubular fabric layers, paragraph 0054, for example, figures 1, 9, 6, 7, 11a-f, 12a-f, 13b, or 16b) comprising a proximal disc portion at a proximal end and a distal disc portion at a distal end and a waist member extending between the proximal disc portion and the distal disc portion (for example, looking at figures 1, 2, proximal disc portion 14, distal disc portion 12, waist 16; proximal disc portion figures 11 and 12, proximal disc portion 204, distal disc portion 202, waist portion 214 therebetween, paragraph 0100 and 0108), wherein the tubular member has an expanded configuration when deployed at the target site and a reduced configuration for delivery to the target site (paragraph 0061, collapsed configuration for delivery within a catheter),
and wherein the tubular member comprises an inner braided layer and an outer braided layer surrounding the inner braided layer (for example, as shown in figure 4, outer layer 20, inner layers 22 or 24; figures 6-7; outer layer 110, inner layer 112 or 114; figure 12a-12f, outer layer 210, inner layer 212), wherein the inner braided layer comprises a unique layer geometry relative to the outer braided layer (paragraph 0055, inner and outer fabric layers may be different geometries),
wherein the inner braided layer forms an inner proximal disc portion, an inner waist member, and an inner distal disc portion (for example, figures 4, 6, 7, inner and outer layers forming discs and waist as the layers are formed throughout the device, layers 20, 22, 24 or layers 110, 112, 114 generally concentrically oriented; paragraph 0088), the inner proximal disc portion and the inner distal disc portion extending radially outward (for example, figures 6, 7, inner and outer layers forming discs and waist as the layers are formed throughout the device and forming proximal and distal discs and waist between, layers 110, 112, 114 generally concentrically oriented; paragraph 0088),
wherein the outer braided layer forms an outer proximal disc portion, an outer waist member, and an outer distal disc portion, the outer proximal disc portion extending radially outward further than the inner proximal disc portion (for example, figures 4, 6, 7; outer layer radially outward of the inner layers 22, 24 or layers 112, 114) the outer distal disc portion extending radially outward further than the inner distal disc portion (for example, figures 6, 7; outer layer 110 radially outward of the inner layers 112, 114) defining a tissue-contacting peripheral region of the proximal disc portion that is configured to engage proximal tissue at the target site when the medical device is deployed and a tissue contacting peripheral region of the distal disc portion that is configured to engage distal tissue at the target site when the medical device is deployed (discs are configured to engage tissue at a target site when placed in the aorta, for example, similar embodiments shown engaging the tissue in figure 11c, 11f, 16a), each of the tissue contacting peripheral regions being defined by a single braided layer (for example, figure 7, outer layer 110 is larger than the inner layers, the outer layer is configured to engage tissue on the proximal and distal disc ends), wherein the unique layer geometry including the tissue contacting peripheral regions are configured to soften contact between the proximal and distal disc portions and the corresponding tissue without reducing a clamping force provided by the medical device adjacent to the waist member (the outermost edges define only the outer layer 110 and can be considered to soften the edges as it would result in the same structure being less dense and more flexible than the inner braided layers having multiple layer thicknesses, increased layers will increase stiffness of the device, paragraph 0079); further comprises a coating covering at least a portion of the tubular member (paragraphs 0049, 0075, additionally the device wires may be coated with a thrombogenic coating to aid in the occlusion rate or a lubricious coating), wherein the outer braided layer is formed from a greater number of braided wires than the inner braided layer (paragraph 0028, 0029; the inner and outer layers may have the same or different diameter wire with the same or different number of wires in each layer), the outer braided layer is configured to be in alignment with a superior area of the target site (outer braided layer configured to be placed against a vascular defect of a target site, for example, shown within target site, figure 11C)), the medical device including radiopaque markers to indicate a direction of the alignment (end clamps being radiopaque to be visualized or oriented, paragraphs 0098, 0115), the inner braided layer has a minor diameter and a major diameter (see annotated figure 12e below), and the direction of the alignment indicated by the radiopaque markers is a direction of the minor diameter and/or major diameter relative to the superior area of the target site (see annotated figure 12e below, end clamps being radiopaque to be visualized or oriented, paragraphs 0098, 0115, placed on the major diameter ends).
Amplatz et al. fails to explicitly disclose at least one of the inner braided layer and the outer braided layer at the waist member has a different helix length than a corresponding at least one of the inner braided layer and the outer braided layer at least one of the proximal disc portion and the distal disc portion to define a varying helix length of the at least one of the inner braided layer and the outer braided layer, wherein the first portion of the first braided layer has less pics per inch than the second portion of the first braided layer, or wherein the first portion of the first braided layer has more pics per inch than the second portion of the first braided layer, and the unique layer geometry, including the varying helix length and greater number of braided wires forming the outer braided layer are collectively configured to soften contact between the proximal and distal disc portions and the corresponding tissue without reducing a clamping force provided by the medical device adjacent to the waist member (Applicant defines a helix length by the mandrel size and pic rate (braid diameter), the helix lengths refer to the relative axial distance per helical revolution, increasing helix length results in an increased softness or reduced stiffness, paragraphs 0130-0132), wherein, in the expanded configuration of the tubular member, the inner braided layer is explicitly oval-shaped.
Amplatz et al. discloses wherein a shape of the inner braided layer is different than the shape of the outer braided layer (figure 12f, paragraph 0108), but fails to explicitly show wherein, in the expanded configuration of the tubular member, the inner braided layer is explicitly oval-shaped.
Examiner notes that although figure 12f shows the inner layer extending from an oval shape and further into the disc. However, it is not required to have the extended portion, as any of the characteristics and attachment means as disclosed in figures 12a-12f may be combined for a particular embodiment (paragraphs 0008-0111), such as changing the shape or diameter of the inner and outer braided layers. Additionally, alternative embodiments teach different shapes for the inner and outer layers (for example, figures 14a-c, 15, paragraph 0121-0122) and the shapes may be shapes may be modified as desired for a particular use (paragraph 0125). Amplatz teaches the inner and outer fabric layers may be heat set into different geometries or different shapes and connections for delivery (paragraph 0055), and may discloses an oval shape if the shapes may be combined in a particular embodiment, such as the inner layer shape of figure 12f having the ends of the oval shape being clamped, as shown in figure 12e (see annotated figure 12f below).
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Therefore, it would have been an obvious to modify Amplatz et al., to have the inner braided layer being oval-shaped, as having different shapes or configurations such as an oval shape, as taught by Amplatz et al. and as known in the art or being substituted for a particular procedure location.
Kariniemi et al. discloses an occlusion device having an inner braided layer and an outer braided layer having certain properties of the occluding device such as stiffness, which may be changed or enhanced by modifying one or more braiding parameters such as strand diameter, pitch angle of the braid, pick count, or number of strands (paragraph 0082). The parameters may be changed in one or more layers 150, 155, 180 of the device and/or in one or more portions 105, 110, 115, or another portion of the tubular braided fabric of the device according to the preferences and style of defect to be treated (paragraph 0082), and the unique layer geometry, including the varying helix length and greater number of braided wires forming the outer braided layer are collectively configured to soften contact between the proximal and distal disc portions and the corresponding tissue without reducing a clamping force provided by the medical device adjacent to the waist member (paragraph 0082, occlusion, stiffness, and clamping force may be modified by adjusting the braiding parameters, the device may be configured or adjusted in stiffness, pick count or number of strands to result in softer edges as it would result in the same structure being less dense and more flexible than the inner portions). Additionally, Kariniemi et al. discloses the outer layer comprising a fabric may be softer than inner layer to avoid excessive pressure on the tissue while still providing adequate structural rigidity of the device (paragraph 0065).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Amplatz et al., with at least one of the inner braided layer and the outer braided layer at the waist member has a different helix length than a corresponding at least one of the inner braided layer and the outer braided layer at least one of the proximal disc portion and the distal disc portion to define a varying helix length of the at least one of the inner braided layer and the outer braided layer, the unique layer geometry, including the varying helix length and greater number of braided wires forming the outer braided layer are collectively configured to soften contact between the proximal and distal disc portions and the corresponding tissue without reducing a clamping force provided by the medical device adjacent to the waist member.
Regarding claim 10-12, Amplatz et al. discloses wherein the diameter of the inner waist member is equal to the diameter of the outer waist member (figure 12a, portions 210 and 212 are attached together, for example by sutures figure 12c), wherein the diameter of the inner waist member is less than the diameter of the outer waist member (figure 12f, portion 212 has a circular shape with smaller diameter than the outer waist portion 210), and wherein a shape of the inner braided layer is different than the shape of the outer braided layer (figure 12f, paragraph 0108), but fails to explicitly show the shape of the inner proximal disc portion being different than a shape of the outer proximal disc portion.
Examiner notes that although figure 12f shows the inner layer extending into the disc, it is not required as any of the characteristics and attachment means as disclosed in figures 12a-12f may be combined for a particular embodiment (paragraphs 0008-0111) such as changing the shape or diameter of the inner and outer braided layers. Additionally, alternative embodiments teach different shapes for the inner and outer layers (for example, figures 14a-c, 15, paragraph 0121-0122) and the shapes may be shapes may be modified as desired for a particular use (paragraph 0125). Amplatz teaches the inner and outer fabric layers may be heat set into different geometries or different shapes and connections for delivery (paragraph 0055).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify Amplatz with an inner and outer layer shape and configuration as required for the particular use and placement location.
Regarding claims 16 and 17, Amplatz et al. discloses wherein at least one of the proximal disc portion or the distal disc portion or both of the proximal disc portion or the distal disc portion comprise an edge geometry selected from the group consisting of a tapered shape, a cup shape, and a round shape (edges or the ends of proximal and distal discs are rounded or to a point edge 104, which may also be considered a tapered shape, figures 5, 11f or 12f).
Regarding claim 18, Amplatz et al. discloses wherein the edge geometry of the proximal disc portion is different from the edge geometry of the distal disc portion (figures 11f, for example, different shape geometry).
Regarding claims 19-20 and 22-24, Amplatz et al. discloses wherein the pattern of the braided layer or the pick of the braided layer may be optimized to produce the desired properties of the medical device, (paragraphs 0049, 0050, for example, the greater the pick and pitch of the fabric, the greater density of the wire strands and the stiffer the device), the pick may be adjusted to the layer comprising less picks per inch or more pics per inch (paragraph 0049, 0050, pick and pitch determined to optimize the desired properties, including higher or lower pick per inch), the braid diameters may be varied in the inner and outer layers to be greater or smaller in each layer (paragraph 0028, 0029, changing the braid diameters may adjust the flexibility or deformability of the device or provide more immediate occlusion), but fails to explicitly disclose the inner waist member has a different braid pattern than at least one of the inner proximal disc portion and the inner distal disc portion, the inner waist member has different pics per inch than the at least one of the inner proximal disc portion and the inner distal disc portion, the outer waist member has a different braid pattern and different pics per inch than at least one of the outer proximal disc portion and the outer distal disc portion, the braid diameter of wires forming the outer layer is smaller than a braid diameter of wires forming the inner layer.
Kariniemi et al. discloses an occlusion device having an inner braided layer and an outer braided layer having certain properties of the occluding device such as stiffness, which may be changed or enhanced by modifying one or more braiding parameters or patterns such as strand diameter, pitch angle of the braid, pick count, or number of strands. The parameters may be changed in one or more layers 150, 155, 180 of the device and/or in one or more portions 105, 110, 115 or another portion of the tubular braided fabric of the device according to the preferences and style of defect to be treated (paragraph 0082, occlusion, stiffness, and clamping force may be modified by adjusting the braiding parameters, the device may be configured or adjusted in stiffness, pick count or number of strands, in different portions such as the waist and disc portions).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Amplatz et al. with the waist member has a different braid pattern than at least one of the proximal disc portion and the distal disc portion, the first portion of the first braided layer has different pics per inch than the at least one of the inner proximal disc portion and the inner distal disc portion, as taught by Kariniemi et al. to provide the desired stiffness or flexibility for various portions of the device, such as the waist and disk portions in the inner and outer layers, as required for a particular location.
Claim(s) 2 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amplatz et al. US 2007/0265656 in view of Kariniemi et al. US 2012/0245623, as discussed above, and further in view of Amplatz US 6123715.
Regarding claims 2 and 5, Amplatz et al. discloses a coating covering at least a portion of the tubular member (paragraphs 0049, 0075, additionally the device wires may be coated with a thrombogenic coating to aid in the occlusion rate or a lubricious coating), but fails to explicitly disclose a fabric coating covering at least one of the proximal disc portions and the distal disc portions, or a polymeric fabric coating located on an outside surface of the outer layer, wherein the polymeric fabric coating is deposited on the outside surface of the outermost layer through an electrospinning process.
However, Amplatz discloses a similar device 60 having a proximal and distal disc portion and a waist portion (figure 5A), comprising a tubular braided layer additionally comprising a coating comprising a fabric coating covering an outside surface of the outer layer at least one of the proximal disc portion and the distal disc portion (column 11, lines 16-19, additionally the device 60 may be coated with a thrombolytic agent or by attaching a silk or wool fabric to the device; Examiner notes the device 60 comprises both a proximal and distal disc that may be covered by the silk or wool fabric to enhance the thrombogenicity as known in the art).
The claimed phrase “deposited on the outside surface of the outermost layer through an electrospinning process” is being treated as a product by process limitation. The resulting product is a device having a polymeric fabric coating. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. “[E]ven though product‑by‑process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product‑by‑process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.2.
Therefore, it would have been obvious to one having ordinary skill in the art to provide a coating comprising a fabric coating covering at least one of the proximal or distal disc portions of the braided layers, as taught by Amplatz, in order to enhance thrombogenicity of the device.
Claim(s) 2 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable overAmplatz et al. US 2007/0265656 in view of Kariniemi et al. US 2012/0245623, as discussed above, and further in view of Adams et al. US 2005/0119675.
Regarding claims 2 and 6, Amplatz et al. discloses a coating covering at least a portion of the tubular member (paragraphs 0049, 0075, additionally the device wires may be coated with a thrombogenic coating to aid in the occlusion rate or a lubricious coating), but fails to explicitly disclose the coating comprising a fabric, or a ceramic coating on an outside surface of the outer layer.
Adams et al. teaches a medical device for occluding an opening, the device 700 may be coated with a thin layer of material such as collagen, polyester, ceramic, and the like to provide a tissue ingrowth material, the device may be coated with a fabric comprising the tissue ingrowth material (paragraph 0147), over any portion of the device (paragraph 0147, over the anchor body, elongate body portion or retention element, similar to the proximal disc portion, waist portion and distal disc portion).
Therefore, it would have been obvious to one having ordinary skill to provide a fabric or ceramic coating over the tubular member or device, as taught by Adams et al. to provide the occlusion device with an additional tissue ingrowth material surrounding the outermost layer of the braided layers.
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amplatz et al. US 2007/0265656 in view of Kariniemi et al. US 2012/0245623, as discussed above and further in view of Nita et al. US 2018/0317933.
Regarding claims 3 and 4, Amplatz et al. discloses a coating covering at least a portion of the tubular member (paragraphs 0049, 0075, additionally the device wires may be coated with a thrombogenic coating to aid in the occlusion rate or a lubricious coating), but fails to explicitly disclose the coating comprising a polymer coating encapsulating at least a portion of an outermost layer of the multiple braided layers, the coating comprising a parylene coating covering at least a portion of an outermost layer of the multiple braided layers.
Nita et al. et al. teaches a medical device for occluding having a proximal portion, distal portion and waist portion (figure 4A), the device having a coating encapsulating at least a portion of an outermost layer of the multiple braided layers, the coating comprising a parylene coating covering at least a portion of an outermost layer of the multiple braided layers (paragraph 0136, the surface may be coated with parylene or any other suitable polymer to reduce the friction coefficient between the braid and the catheter wall when the occlusion implant is being deployed out of the delivery catheter or retrieved inside of the delivery catheter (paragraph 0136).
Therefore, it would have bene obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Amplatz et al. with an outer parylene coating covering at least a portion of the outermost layer of the multiple braided layers to reduce the friction coefficient between the braid and the catheter wall when the occlusion implant is being deployed out of the delivery catheter or retrieved inside of the delivery catheter.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amplatz et al. US 2007/0265656 in view of Kariniemi et al. US 2012/0245623, as discussed above, and further in view of Freudenthal US 2006/0224183.
Regarding claims 13-14, Amplatz et al. in combination discloses a medical device essentially as claimed as discussed above, but fails to explicitly disclose wherein the inner braided layer and the outer braided layer comprising at least one braided layer with material removed from a target portion thereof, such the portion has a reduced braid wire thickness, wherein the target portion is located at the proximal disc portion and the distal disc portion, such that the at least one of the inner braided layer and the outer braided layer including the target portion comprises a smaller braid wire diameter at the proximal disc portion and the distal disc portion than at the waist member.
Freudenthal teaches a similar occlusion device having a proximal disc portion 20, a distal disc portion 30, and a waist portion 40 forming a support structure (figure 1a), wherein the concentration of material and/or the material thickness inside the support structure is different from portion to portion or can change across the device (paragraph 0024, 0074), the wire elements may have different material thicknesses or diameters (paragraph 0024) to provide portions which are made particularly stiff or less stiff (paragraph 0024).
The claimed phrase “has material removed from a target portion thereof” is being treated as a product by process limitation; that is from the instant specification the resulting product or structure is a smaller braid wire diameter at the proximal and distal disc portion providing increased compliance on tissue while maintaining centering strength of the device. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. “[E]ven though product‑by‑process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product‑by‑process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.2.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify Amplatz et al. in combination with a wire braid having variable diameter, as taught by Freudenthal, in order to adjust the concentration of material and stiffness along various portions of the device.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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