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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/01/2026 has been entered.
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 05/21/2026, with respect to the rejection(s) of claim(s) 1, 21, and 22 under 35 USC 103 have been fully considered but they are persuasive. Applicant argues that Cully fails to teach each of the newly recited limitations including “the covering including a substrate having fibrils that are bent and configured to substantially straighten upon application of a force and a reinforcing material imbibed into the substrate between the fibrils” and “the reinforced layer comprising a porous substrate having fibrils that are bent and configured to substantially straighten upon application of a force and a reinforcing material imbibed into the substrate between the fibrils”. It is the examiner’s position that the rejection below addresses each of the newly recited limitations. Specifically, Cully teaches the covering including a reinforcing material imbibed into the substrate between the fibrils because [0040] states the elastomer can fill the pores of the ePFTE membrane, which is interpreted as being imbibed into the substrate between the fibrils.
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.
Claim(s) 1-9, 21-23, and 25-32 are rejected under 35 U.S.C. 103 as being obvious over Nguyen (US 2012/0083877) in view of Culley et al. (US 2018/0177583), further in view of Bales et al. (US 2015/0039078), further in view of Vonesh et al. (US 2001/0053929).
Regarding claim 1 and 29, Nguyen discloses a medical apparatus (expandable sheath 22, FIGs 2A-2C and 5-6, [0076 and 0090-0091]), comprising: a frame (intermediate tubular layer 28, particularly the embodiment shown in FIG 23, [0099-0100]) comprised of a plurality of strut elements (Each of the struts forming the diamonds and connecting struts 64, FIG 23) arranged to form a tubular framework (28 is overall tubular shaped); and a covering (Inner layer 24 and outer layer 26, FIG 2A, [0076]) extending along a portion of the frame such that the frame and the covering define a sheath having a lumen extending therethrough (The combination of layers 24, 26, and 28 form a sheath 22 with lumen 30, [0076, FIG 2A), wherein the strut elements of the frame interact with one another to provide the sheath with axial compressive resistance and hoop strength (The metal wires forming the frame struts are connected to one another such that they increase strength in an axial and radial direction), the lumen having a length (Defined by the length of the sheath) and the sheath being radially expandable such that a diameter of the lumen is operable to be expanded from an initial diameter to an expanded diameter greater than the initial diameter to accommodate the passage of one or more devices therethrough ([0090-0091] wherein 46 is the initial diameter and 48 is the expanded diameter, and localized bulge 44 represents a device being accommodated within the lumen), wherein the sheath is further configured to self-recover the diameter of the lumen along the length of the sheath to a post-delivery diameter that is less than the expanded diameter in response to the one or more devices being removed from the lumen (See axial movement of the bulge in FIGs 5-6; the sheath recovers to the initial diameter 46 after the device has passed through that section of the lumen, [0090] “once the localized bulge associated with the device has passed through a portion of the lumen of the sheath 22, that portion of the sheath 22 can automatically return to its original shape and size, at least in part due to the materials and structure of the sheath 22”), wherein the sheath is configured to exert an inward radial force when a device passes therethrough ([0090] discloses the expansion and contraction of the sheath as it accommodates the device at bulge 44. Because the sheath’s resting state is the diameter at 46, there is a radially inward force being exerted by the material of the sheath when stretched past this initial diameter, as evidenced by the ability of the sheath to return to the initial diameter after the device passes therethrough. The device expands the sheath at bulge 44 by exerting a radially outward force from within the lumen, which is met by an equal and opposite radially inward force exerted by the sheath), wherein the frame and covering of the sheath include an initial diameter (Unexpanded diameter 46, [0091], FIG 5-6).
Nguyen is silent regarding the covering including a substrate having fibrils that are bent and configured to substantially straighten upon application of a force and a reinforcing material imbibed into the substrate between the fibrils.
However, Cully et al. teaches a medical apparatus (Abstract) having a frame (stent body) and a covering (cover, abstract, [0017-0021 and 0039-0044]) wherein the covering includes a substrate (“precursor material/membrane”, [0055-0058]) having fibrils (FIGs 1-2b, abstract, [0002, 0016-0019, 0040, 0053-0058]) that are bent (Serpentine configuration, FIG 1) and configured to substantially straighten upon application of a force ([0054]) and a reinforcing material (elastomeric material, [0058]) imbibed into the substrate between the fibrils ([0040 and 0058]). Cully further discloses that the fibrils are a part of the ePTFE cover ([0040 and 0054-0055]) and are included for the benefit of allowing the covering to exhibit high elongation while substantially retaining the strength properties of the cover material ([0053-0054]). It is noted that Nguyen also discloses its covering being made of PTFE ([0077-0078]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the covering of Nguyen such that it includes a substrate having fibrils that are bent and configured to substantially straighten upon application of a force and a reinforcing material imbibed into the substrate between the fibrils, as taught by Cully, for the purpose of enhancing the covering to have high elongation properties while retaining its strength properties through the inclusion of the serpentine fibrils.
Nguyen is further silent regarding the plurality of strut elements being arranged in a continuous pattern of undulations defining a series of helical turns about the longitudinal axis.
However, Bales et al. teaches a frame (100, FIG 1-3 and 300 of FIG 10) comprised of a plurality of strut elements (28, FIG 1, [0035]) being arranged in a continuous pattern of undulations defining a series of helical turns about the longitudinal axis (FIG 1, [0033-0036] discloses the helical winding 18 formed by the continuous pattern of undulations of struts 28 and apices 30. Stent 300 also forms the same shape wherein the only difference between embodiments is the connecting struts described in [0039]) arranged to form a tubular framework (Tubular shape as described in [0033]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the frame of Nguyen to have the strut pattern taught by Bales et al, including the continuous pattern of undulations defining a series of helical turns about the longitudinal axis, for the purpose of substituting a commonly known frame pattern thereby achieving the predictable result of reliable expanding and contracting with a desired flexibility and strength dependent on the structure and design of the struts and undulations ([0037]).
The device is further silent regarding the frame and covering are in tension with each other when the sheath is in an initial diameter, an expanded diameter, and a post-delivery diameter.
However, Vonesh teaches a medical apparatus (10) having a frame comprised of a plurality of struts (20) and a covering (22) wherein the frame and covering of the sheath include an initial diameter (18, FIG 2, [0055-0057]. The diameter of 18 is the state of the sheath absent a radially compressive or extensive force), and expanded diameter (24, FIG 3, [0058]) and a post-delivery diameter (24, FIG 3, [0058]) and the frame and covering are in tension with each other when the sheath is in the each of the diameters ([0055-0057] disclose that the frame 20 would expand to a larger size than 18 if not for the radially compressive force applied by the covering 22. Therefore, it is understood that in the state of diameter 18, the frame is being radially contracted to a smaller size than its natural state and the covering is being expanded to a size larger than its natural state. This is interpreted as meeting the limitations of being in tension with each other. The diameter of 24 is achieved by radially outward force applied by an element within the lumen, which would thereby force the frame and covering into tension as well).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the frame and covering such that they are in tension with each other in the initial diameter, as taught by Vonesh, for the purpose of forming a self supporting initial diameter such that the sheath will not easily collapse when an external force is applied to it and will elastically recover from most external deformations, thereby providing a stable initial state of the device which does not require a separate structure (such as struts or clamps), anchorage devices (such as sutures, adhesives, or other means), or an increased relative internal pressure differential to maintain the device at the initial diameter (Vonesh [0057]).
Nguyen fails to explicitly state the post-delivery diameter or the initial diameter and therefore fails to teach the post-delivery diameter is greater than the initial diameter.
However, Nguyen does disclose that the diameters are ”substantially” the same ([0090] and that the sheath can “at least partially return to the first diameter” (0010]). The teaches fail to explicitly state equal diameters. One of ordinary skill in the art would understand that a real word material is not perfectly elastic and after expanding, will exhibit at least the slighted degree of plastic deformation/hysteresis. Therefore, one would understand that the post-delivery diameter is at least slightly greater than the initial diameter because no material is perfectly elastic. Alternatively, applicant has not provided evidence of the criticality of the claimed relationship in the instant specification. In paragraph [0157] of the instant invention, Applicant states that the post-delivery and initial diameters can be “the same”, “not more than 1, 2, 3, 4, 5, 6, 7, 8, or 9 percent greater than the initial diameter”, or “between 10 and 15 percent of the initial diameter”. It is the Examiner's position that since there is a lack of criticality/reasoning for the specific relationship of the post-delivery and initial diameters, and the recovery of the sheath diameter after passing of an element therethrough is to achieve the same purpose as Applicant's purpose (to allow for the diameter to return to substantially the same size), it would have been obvious to one of ordinary skill in the art at the time of the invention to cause the post-delivery diameter to be slightly greater than the initial diameter since it has been held that "where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device" Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert denied, 469 U.S. 830, 225 SPQ 232 (1984).
Regarding claim 2, Nguyen/Cully/Bales et al./Vonesh discloses the invention substantially as claimed, as set forth above for claim 1. Nguyen further discloses the covering is configured to stretch such that the sheath is radially expandable [0090]), and wherein the covering stores potential energy when the lumen of the sheath is expanded to the expanded diameter ([0090-0091] the material and structure of the sheath provide the characteristic of returning to is original shape after passage of a device through the lumen. Therefore, when a device is causing the lumen to expand to diameter of 48 shown in FIGs 5-6, the material of the covering stores potential energy as it is included towards returning to the unexpanded diameter after the radial form of the device is removed from the lumen), the potential energy of the covering being convertible to kinetic energy to cause the sheath to self-recover the diameter of the lumen to the post-delivery diameter (The elastic nature of the covering returns the diameter to the post-delivery size by transferring the potential energy to connect energy).
Regarding claim 3, Nguyen/Cully/Bales et al./Vonesh discloses the invention substantially as claimed, as set forth above for claim 1. Nguyen further discloses the frame is configured to store potential energy when the sheath is expanded to the expanded diameter ([0090-0091] the material and structure of the sheath provide the characteristic of returning to is original shape after passage of a device through the lumen. Therefore, when a device is causing the lumen to expand to diameter of 48 shown in FIGs 5-6, the material of the frame stores potential energy as it is included towards returning to the unexpanded diameter after the radial form of the device is removed from the lumen. This feature is enhanced by the shape memory properties of the material forming frame 28, [0077, 0092]), the potential energy of the frame being convertible to kinetic energy to cause the sheath to self-recover the diameter of the lumen to the post-delivery diameter (The shape memory nature of the frame returns the diameter to the post-delivery size by transferring the potential energy to connect energy).
Regarding claim 4, Nguyen/Cully/Bales et al./Vonesh discloses the invention substantially as claimed, as set forth above for claim 1. Nguyen further discloses the frame is shape set to an initial configuration where the diameter of the lumen of the sheath is greater than the initial diameter such that the frame stores potential energy when the lumen of the sheath has the initial diameter ([0092] discloses the frame 28 can comprise Nitinol and/or other shape memory alloys, and the intermediate layer 28 can be crimped or radially compressed to a reduced diameter within the outer polymeric tubular layer 26. Therefore, the initial configuration of the frame is different than the initial diameter of the sheath).
Regarding claim 5, Nguyen/Cully/Bales et al./Vonesh discloses the invention substantially as claimed, as set forth above for claim 1. Nguyen further discloses the sheath will “substantially return to its original shape” and “can automatically return to its original shape and size” after delivery of the device ([0090]). Further, [0091] discloses and expanded diameter 48 and unexpanded diameter 46, and based on the direction of travel of the device being delivered in FIGs 5-6, the unexpanded diameter is being used interchangeably to describe the initial diameter and the post-delivery diameter, therefore suggesting they are the same. despite these indications, Nguyen fails to explicitly state that the post- delivery diameter is not more than 115% of the initial diameter.
However, it would have been obvious to one of ordinary skill in the art at the time of filing to select the materials and structure of the sheath such that the post- delivery diameter is not more than 115% of the initial diameter, for the purpose of forming a sheath that is capably of substantially returning to its original shape once the prosthetic device has passed thought he lumen, therefore creating a localized bulge and preventing permanent deformation of the sheath so that multiple device can be passed therethrough while preserving the original shape of the sheath.
Regarding claim 6, Nguyen/Cully/Bales et al./Vonesh discloses the invention substantially as claimed, as set forth above for claim 1. Nguyen further discloses the sheath is configured such that the sheath has a smooth exterior surface when the sheath self- recovers the diameter of the lumen to the post-delivery diameter (lubricious coating on the outer surface 34 in interpreted as a smooth exterior surface, [0081], and would be present after self-recovery of the sheath).
Regarding claim 7, Nguyen/Cully/Bales et al./Vonesh discloses the invention substantially as claimed, as set forth above for claim 1. Nguyen further discloses the covering forms a lubricious impermeable layer of the sheath (Lubricious liner or coating, [0078, 0091]. Further, the material of the covering all together form a structure which is impermeable to blood).
Regarding claim 8, Nguyen/Cully/Bales et al./Vonesh discloses the invention substantially as claimed, as set forth above for claim 1. Nguyen further discloses a plurality of discrete zones are defined along an axial length of the sheath (A zone could be considered the particular section of the sheath which houses a device at any given time and another zone could be a region which does not have a device within that section of the lumen, such as shown in FIGs 5-6), and wherein the sheath is configured to be progressively expanded and self-recovered such that the diameter of the lumen at a first zone of the plurality of discrete zones is expandable relative to the diameter of the lumen a second zone of the plurality of discrete zones, and such that the diameter of the lumen at the first zone is self-recoverable to the post-delivery diameter (As shown by the movement of the device in FIGS 5-6 where the sheath progressively expands and retracts in diameter, [0090-0091]. Further, in the frame as modified, where the sections 20 are spaced apart from each other along a longitudinal axis parallel to the lumen of the sheath thereby allowing for localized expansion and retraction. Thus, the structure of the intermediate tubular layer 28 can vary from section to section, changing along the length of the sheath).
Regarding claim 9, Nguyen/Cully/Bales et al./Vonesh discloses the invention substantially as claimed, as set forth above for claim 1. Nguyen further discloses the diameter of the lumen is configured to be expandable to the expanded diameter at first cross section along an axial length of the sheath without causing expansion of the diameter of the lumen from the initial diameter at a second cross section along the axial length of the sheath (Shown in FIGS 5-6; the sheath can locally expand such that the expanded diameter 48 is achieve at one cross section and the unexpanded diameter 46 is maintained at an axially different position), and wherein the diameter of the lumen configured to be self-recoverable to the post-delivery diameter at the first cross section without causing a reduction of the diameter of the lumen at the second cross section ([0090-0091]).
Regarding claim 21, Nguyen discloses a medical apparatus (expandable sheath 22, FIGs 2A-2C and 5-6, [0076 and 0090-0091]), comprising: a frame (intermediate tubular layer 28, particularly the embodiment shown in FIG 16, [0037]) comprised of a plurality of strut elements arranged helically (Each of the struts forming the diamonds, FIG 16, [0037] discloses that FIG 16 illustrates “an intermediate tubular layer having a helical or spiral design”) arranged to form a tubular framework (28 is overall tubular shaped); and a covering (Inner layer 24 and outer layer 26, FIG 2A, [0076]) extending along a portion of the frame such that the frame and the covering define a sheath having a lumen extending therethrough (The combination of layers 24, 26, and 28 form a sheath 22 with lumen 30, [0076, FIG 2A), wherein the strut elements of the frame interact with one another to provide the sheath with axial compressive resistance and hoop strength (The metal wires forming the frame struts are connected to one another such that they increase strength in an axial and radial direction), the lumen having a length (Defined by the length of the sheath) and the sheath being radially expandable such that a diameter of the lumen is operable to be expanded from an initial diameter to an expanded diameter greater than the initial diameter to accommodate the passage of one or more devices therethrough ([0090-0091] wherein 46 is the initial diameter and 48 is the expanded diameter, and localized bulge 44 represents a device being accommodated within the lumen), wherein the sheath is further configured to self-recover the diameter of the lumen along the length of the sheath to a post-delivery diameter that is less than the expanded diameter in response to the one or more devices being removed from the lumen (See axial movement of the bulge in FIGs 5-6; the sheath recovers to the initial diameter 46 after the device has passed through that section of the lumen, [0090] “once the localized bulge associated with the device has passed through a portion of the lumen of the sheath 22, that portion of the sheath 22 can automatically return to its original shape and size, at least in part due to the materials and structure of the sheath 22”), wherein the frame and covering have an inward bias when expanded beyond the initial diameter ([0090] discloses the expansion and contraction of the sheath as it accommodates the device at bulge 44. Because the frame and coverings resting state is the diameter at 46, there is an inward bias force being exerted by the material of the sheath when stretched past this initial diameter, as evidenced by the ability of the sheath to return to the initial diameter after the device passes therethrough. The device expands the sheath at bulge 44 by exerting a radially outward force from within the lumen, which is met by an equal and opposite radially inward force exerted by the sheath), wherein the sheath includes an initial diameter (Unexpanded diameter 46, [0091], FIG 5-6).
Nguyen is silent regarding the covering including a substrate having fibrils that are bent and configured to substantially straighten upon application of a force and a reinforcing material imbibed into the substrate between the fibrils.
However, Cully et al. teaches a medical apparatus (Abstract) having a frame (stent body) and a covering (cover, abstract, [0017-0021 and 0039-0044]) wherein the covering includes a substrate (“precursor material/membrane”, [0055-0058]) having fibrils (FIGs 1-2b, abstract, [0002, 0016-0019, 0040, 0053-0058]) that are bent (Serpentine configuration, FIG 1) and configured to substantially straighten upon application of a force ([0054]) and a reinforcing material (elastomeric material, [0058]) imbibed into the substrate between the fibrils ([0040 and 0058]). Cully further discloses that the fibrils are a part of the ePTFE cover ([0040 and 0054-0055]) and are included for the benefit of allowing the covering to exhibit high elongation while substantially retaining the strength properties of the cover material ([0053-0054]). It is noted that Nguyen also discloses its covering being made of PTFE ([0077-0078]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the covering of Nguyen such that it includes a substrate having fibrils that are bent and configured to substantially straighten upon application of a force and a reinforcing material imbibed into the substrate between the fibrils, as taught by Cully, for the purpose of enhancing the covering to have high elongation properties while retaining its strength properties through the inclusion of the serpentine fibrils.
Nguyen is further silent regarding the plurality of strut elements being arranged in a continuous pattern of undulations defining a series of helical turns about the longitudinal axis.
However, Bales et al. teaches a frame (100, FIG 1-3 and 300 of FIG 10) comprised of a plurality of strut elements (28, FIG 1, [0035]) being arranged in a continuous pattern of undulations defining a series of helical turns about the longitudinal axis (FIG 1, [0033-0036] discloses the helical winding 18 formed by the continuous pattern of undulations of struts 28 and apices 30. Stent 300 also forms the same shape wherein the only difference between embodiments is the connecting struts described in [0039]) arranged to form a tubular framework (Tubular shape as described in [0033]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the frame of Nguyen to have the strut pattern taught by Bales et al, including the continuous pattern of undulations defining a series of helical turns about the longitudinal axis, for the purpose of substituting a commonly known frame pattern thereby achieving the predictable result of reliable expanding and contracting with a desired flexibility and strength dependent on the structure and design of the struts and undulations ([0037]).
The device is further silent regarding the frame being elastically radially contracted when the sheath is in the initial diameter and the covering is elastically radially expanded when the sheath is in the initial diameter.
However, Vonesh teaches a medical apparatus (10) having a frame comprised of a plurality of struts (20) and a covering (22), wherein the frame and covering of the sheath include an initial diameter (18, FIG 2, [0055-0057]. The diameter of 18 is the state of the sheath absent a radially compressive or extensive force) and the frame is elastically radially contracted when the sheath is in the initial diameter and the covering is elastically radially expanded when the sheath is in the initial diameter ([0055-0057] disclose that the frame 20 would expand to a larger size than 18 if not for the radially compressive force applied by the covering 22. Therefore, it is understood that in the state of diameter 18, the frame is being radially contracted to a smaller size than its natural state and the covering is being radially expanded to a size larger than its natural state, while in the initial diameter of 18. The contraction and expansion is elastic because [0057] discloses the device is self supporting and “will elastically recover from most external deformations and it will readily return to the second dimension once the external force is removed”).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the frame and covering such that the frame is elastically radially contracted when the sheath is in the initial diameter and the covering is elastically radially expanded when the sheath is in the initial diameter, as taught by Vonesh, for the purpose of forming a self supporting initial diameter such that the sheath will not easily collapse when an external force is applied to it and will elastically recover from most external deformations, thereby providing a stable initial state of the device which does not require a separate structure (such as struts or clamps), anchorage devices (such as sutures, adhesives, or other means), or an increased relative internal pressure differential to maintain the device at the initial diameter (Vonesh [0057]).
Nguyen fails to explicitly state the post-delivery diameter or the initial diameter and therefore fails to teach the post-delivery diameter is greater than the initial diameter.
However, Nguyen does disclose that the diameters are ”substantially” the same ([0090] and that the sheath can “at least partially return to the first diameter” (0010]). The teaches fail to explicitly state equal diameters. One of ordinary skill in the art would understand that a real word material is not perfectly elastic and after expanding, will exhibit at least the slighted degree of plastic deformation/hysteresis. Therefore, one would understand that the post-delivery diameter is at least slightly greater than the initial diameter because no material is perfectly elastic. Alternatively, applicant has not provided evidence of the criticality of the claimed relationship in the instant specification. In paragraph [0157] of the instant invention, Applicant states that the post-delivery and initial diameters can be “the same”, “not more than 1, 2, 3, 4, 5, 6, 7, 8, or 9 percent greater than the initial diameter”, or “between 10 and 15 percent of the initial diameter”. It is the Examiner's position that since there is a lack of criticality/reasoning for the specific relationship of the post-delivery and initial diameters, and the recovery of the sheath diameter after passing of an element therethrough is to achieve the same purpose as Applicant's purpose (to allow for the diameter to return to substantially the same size), it would have been obvious to one of ordinary skill in the art at the time of the invention to cause the post-delivery diameter to be slightly greater than the initial diameter since it has been held that "where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device" Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert denied, 469 U.S. 830, 225 SPQ 232 (1984).
Regarding claim 22, Nguyen discloses a medical apparatus (expandable sheath 22, FIGs 2A-2C and 5-6, [0076 and 0090-0091]), comprising: a frame (intermediate tubular layer 28, particularly the embodiment shown in FIG 23, [0099-0100]) comprised of a plurality of strut elements (Each of the struts forming the diamonds and connecting struts 64, FIG 23) arranged to form a tubular framework (28 is overall tubular shaped); and a covering (Inner layer 24 and outer layer 26, FIG 2A, [0076]) extending along a portion of the frame such that the frame and the covering define a sheath having a lumen extending therethrough (The combination of layers 24, 26, and 28 form a sheath 22 with lumen 30, [0076, FIG 2A), wherein the cover includes a plurality of layers (layers 24 and 26) including at least one reinforced layer (Inner layer 24 is interpreted as the reinforced layer because it can be provided with a lubricious liner on its inner surface, [0078]. The addition of this liner reinforces the layer 24. This interpretation is consistent with the disclosure of the present invention which states in [0146] that the reinforcing material may be coated on the membrane material of the layer and configured such that the covering forms a lubricious layer of the introducer sheath) and at least one layer without reinforcement (outer layer 26 is interpreted as the layer without reinforcement because it does not comprise the lubricious liner), wherein the strut elements of the frame interact with one another to provide the sheath with axial compressive resistance and hoop strength (The metal wires forming the frame struts are connected to one another such that they increase strength in an axial and radial direction), the lumen having a length (Defined by the length of the sheath) and the sheath being radially expandable such that a diameter of the lumen is operable to be expanded from an initial diameter to an expanded diameter greater than the initial diameter to accommodate the passage of one or more devices therethrough ([0090-0091] wherein 46 is the initial diameter and 48 is the expanded diameter, and localized bulge 44 represents a device being accommodated within the lumen), wherein the sheath is further configured to self-recover the diameter of the lumen along the length of the sheath to a post-delivery diameter that is less than the expanded diameter in response to the one or more devices being removed from the lumen (See axial movement of the bulge in FIGs 5-6; the sheath recovers to the initial diameter 46 after the device has passed through that section of the lumen, [0090] “once the localized bulge associated with the device has passed through a portion of the lumen of the sheath 22, that portion of the sheath 22 can automatically return to its original shape and size, at least in part due to the materials and structure of the sheath 22”), wherein the sheath is configured to exert an inward radial force when a device passes therethrough ([0090] discloses the expansion and contraction of the sheath as it accommodates the device at bulge 44. Because the sheath’s resting state is the diameter at 46, there is a radially inward force being exerted by the material of the sheath when stretched past this initial diameter, as evidenced by the ability of the sheath to return to the initial diameter after the device passes therethrough. The device expands the sheath at bulge 44 by exerting a radially outward force from within the lumen, which is met by an equal and opposite radially inward force exerted by the sheath), wherein the medical apparatus has an initial diameter (Unexpanded diameter 46, [0091], FIG 5-6).
Nguyen is silent regarding the reinforced layer comprising a porous substrate having fibrils that are bent and configured to substantially straighten upon application of a force and a reinforcing material imbibed into the substrate between the fibrils.
However, Cully et al. teaches a medical apparatus (Abstract) having a frame (stent body) and reinforced layer (cover, abstract, [0017-0021 and 0039-0044]) comprising a porous substrate (“precursor material/membrane”, [0055-0058]; wherein ePTFE membrane comprises pores, [0040]) having fibrils (FIGs 1-2b, abstract, [0002, 0016-0019, 0040, 0053-0058]) that are bent (Serpentine configuration, FIG 1) and configured to substantially straighten upon application of a force ([0054]) and a reinforcing material (elastomeric material, [0058]) imbibed into the substrate between the fibrils ([0040 and 0058]). Cully further discloses that the fibrils are a part of the ePTFE cover ([0040 and 0054-0055]) and are included for the benefit of allowing the covering to exhibit high elongation while substantially retaining the strength properties of the cover material ([0053-0054]). It is noted that Nguyen also discloses its covering being made of PTFE ([0077-0078]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the reinforced layer of Nguyen such that it includes a porous substrate having fibrils that are bent and configured to substantially straighten upon application of a force and a reinforcing material imbibed into the substrate between the fibrils, as taught by Cully, for the purpose of enhancing the covering to have high elongation properties while retaining its strength properties through the inclusion of the serpentine fibrils.
Nguyen is further silent regarding the plurality of strut elements being arranged in a continuous pattern of undulations defining a series of helical turns about the longitudinal axis.
However, Bales et al. teaches a frame (100, FIG 1-3 and 300 of FIG 10) comprised of a plurality of strut elements (28, FIG 1, [0035]) being arranged in a continuous pattern of undulations defining a series of helical turns about the longitudinal axis (FIG 1, [0033-0036] discloses the helical winding 18 formed by the continuous pattern of undulations of struts 28 and apices 30. Stent 300 also forms the same shape wherein the only difference between embodiments is the connecting struts described in [0039]) arranged to form a tubular framework (Tubular shape as described in [0033]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the frame of Nguyen to have the strut pattern taught by Bales et al, including the continuous pattern of undulations defining a series of helical turns about the longitudinal axis, for the purpose of substituting a commonly known frame pattern thereby achieving the predictable result of reliable expanding and contracting with a desired flexibility and strength dependent on the structure and design of the struts and undulations ([0037]).
The device is further silent regarding the frame having a radially outwardly directed bias and the covering having a radially inwardly directed bias, wherein the sheath and the cover are at equilibrium when the sheath is at the initial diameter.
However, Vonesh teaches a medical apparatus (10) having a frame comprised of a plurality of struts (20) and a covering (22), wherein the frame and covering of the sheath include an initial diameter (18, FIG 2, [0055-0057]. The diameter of 18 is the state of the sheath absent a radially compressive or extensive force) and the frame has a radially outwardly directed bias and the covering has a radially inwardly directed bias, wherein the sheath and the cover are at equilibrium when the sheath is at the initial diameter ([0055-0057] disclose that the frame 20 would expand to a larger size than 18 if not for the radially compressive force applied by the covering 22. Therefore, it is understood that in the state of diameter 18, the frame is being radially contracted to a smaller size than its natural state therefore possesing a radially outward bias and the covering is being radially expanded to a size larger than its natural state therefore possessing a radially inward bias, while in the initial diameter of 18. The sheath and cover are at equilibrium in this state because [0057] discloses the device is self supporting and will not easily collapse when an external force is applied to it ).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the frame and covering such that the frame has a radially outwardly directed bias and the covering has a radially inwardly directed bias, wherein the sheath and the cover are at equilibrium when the sheath is at the initial diameter, as taught by Vonesh, for the purpose of forming a self supporting initial diameter such that the sheath will not easily collapse when an external force is applied to it and will elastically recover from most external deformations, thereby providing a stable initial state of the device which does not require a separate structure (such as struts or clamps), anchorage devices (such as sutures, adhesives, or other means), or an increased relative internal pressure differential to maintain the device at the initial diameter (Vonesh [0057]).
Nguyen fails to explicitly state the post-delivery diameter or the initial diameter and therefore fails to teach the post-delivery diameter is greater than the initial diameter.
However, Nguyen does disclose that the diameters are ”substantially” the same ([0090] and that the sheath can “at least partially return to the first diameter” (0010]). The teaches fail to explicitly state equal diameters. One of ordinary skill in the art would understand that a real word material is not perfectly elastic and after expanding, will exhibit at least the slighted degree of plastic deformation/hysteresis. Therefore, one would understand that the post-delivery diameter is at least slightly greater than the initial diameter because no material is perfectly elastic. Alternatively, applicant has not provided evidence of the criticality of the claimed relationship in the instant specification. In paragraph [0157] of the instant invention, Applicant states that the post-delivery and initial diameters can be “the same”, “not more than 1, 2, 3, 4, 5, 6, 7, 8, or 9 percent greater than the initial diameter”, or “between 10 and 15 percent of the initial diameter”. It is the Examiner's position that since there is a lack of criticality/reasoning for the specific relationship of the post-delivery and initial diameters, and the recovery of the sheath diameter after passing of an element therethrough is to achieve the same purpose as Applicant's purpose (to allow for the diameter to return to substantially the same size), it would have been obvious to one of ordinary skill in the art at the time of the invention to cause the post-delivery diameter to be slightly greater than the initial diameter since it has been held that "where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device" Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert denied, 469 U.S. 830, 225 SPQ 232 (1984).
Regarding claim 23, Nguyen/Cully/Bales et al./Vonesh discloses the invention substantially as claimed, as set forth above for claim 1. Nguyen further discloses the covering is positioned on an interior side of the frame and an exterior side of the frame (Inner layer 24 is positioned on the interior side of the frame and outer layer 26 is positioned on the exterior side of the frame).
Regarding claim 25, Nguyen/Cully/Bales et al./Vonesh discloses the invention substantially as claimed, as set forth above for claim 1. The device as modified by Bales et al. further discloses the undulations define a plurality of first facing apices (Apices which face towards end 12 as viewed in FIG 1 or 10) and a plurality of second facing apices (Opposed apices which face end 10 as viewed in FIG 1 or 10), wherein the plurality of first facing apices are circumferentially aligned with each other (See the dashed lines in FIG 1 which follow the first facing apices and create the helical path), the plurality of second facing apices are circumferentially aligned with each other (See the dashed lines in FIG 1 which follow the second facing apices and create the helical path), and the first and second facing apices are circumferentially misaligned with each other (The misalignment distance is defined by the length of the strut in between opposed apices, FIG 1).
Regarding claim 26, Nguyen/Cully/Bales et al./Vonesh discloses the invention substantially as claimed, as set forth above for claim 25. The device as modified by Bales et al. further discloses the plurality of struts includes connecting struts (44, FIG 10) that extend between adjacent apices of at least some of the first facing apices ([0039], FIG 10 shows strut 44 connects between adjacent apices of the first facing apices).
Regarding claim 27, Nguyen/Cully/Bales et al./Vonesh discloses the invention substantially as claimed, as set forth above for claim 1. Nguyen further discloses the covering is coupled to the frame by one of at least fiber, adhesive, or bonding ([0098] discloses the inner and outer polymeric layers can be coupled to the frame via bonding; “the layers can then be thermally fused or melted into one another by placing the assembly in an oven or otherwise heating it”.
Regarding claim 28, Nguyen/Cully/Bales et al./Vonesh discloses the invention substantially as claimed, as set forth above for claim 1. Nguyen further discloses the covering is positioned in on an interior surface of the frame (At least inner polymeric layer 24 is positioned on an interior surface of the frame, FIG 2A and process described in [0098]).
Regarding claim 30, Nguyen/Cully/Bales et al./Vonesh discloses the invention substantially as claimed, as set forth above for claim 1. Nguyen further discloses the lumen is operable to be expanded radially uniformly from the initial diameter to the expanded diameter (As shown in the expansion of FIG 5-6, the lumen is at least configured such that it can expand uniformly upon application of a uniform radially outward force).
Regarding claim 31, Nguyen/Cully/Bales et al./Vonesh discloses the invention substantially as claimed, as set forth above for claim 30. Nguyen further discloses the lumen is operable to maintain an exterior surface of the sheath that is wrinkle-free when the lumen is in the initial diameter, the expanded diameter, and the post-delivery diameter (FIGs 5-6 show an outer surface which is smooth and wrinkle-free).
Regarding claim 32, Nguyen/Cully/Bales et al./Vonesh discloses the invention substantially as claimed, as set forth above for claim 1. The device as modified by Cully further discloses the reinforcing material is an elastomeric material ([0040 and 0058]).
Claim(s) 24 is rejected under 35 U.S.C. 103 as being obvious over Nguyen (US 2012/0083877) in view of Culley et al. (US 2018/0177583), further in view of Bales et al. (US 2015/0039078), further in view of Vonesh et al. (US 2001/0053929), further in view of Parker (US 2012/0004610).
Regarding claim 24, Nguyen/Cully/Bales et al./Vonesh discloses the invention substantially as claimed, as set forth above for claim 22.
Nguyen is silent regarding the covering being partially everted over the frame such that a first side of the covering is facing both an interior side of the frame and an exterior side of the frame.
However, Parker teaches a medical apparatus (Sheath 35, FIG 1, 8A, and 8B) wherein a frame (50, FIG 8A, [0019-0021]) is covered on both its interior side (51, [0020], FIG 8A) and exterior side (52, [0020], FIG 8A) by the same side of a covering (40) which is everted over the frame ([0021]).
Therefore, I would have been obvious to one of ordinary skill in the art at the time of filing to modify the covering of the device of Nguyen/Culley such that it consists of a layer being partially everted over the frame such that a first side of the covering is facing both the interior side of the frame and the exterior side of the frame, as taught by Parker, for the purpose of achieving the predictable result of covering an interior and an exterior side of the frame using an alternative means that that of Nguyen (everting one layer over the distal end of the frame versus applying an inner and outer layer to the frame).
Conclusion
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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