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 .
Applicant’s arguments filed in the reply on March 2, 2026 were received and fully considered. Claims 93-95 were added. Claims 49, 81, 88-89, 91, and 92 were amended. Claims 79-80 and 90 were cancelled. Please see below for more detail.
Claim Objections
The Claims are objected to because of the following informalities:
In Claim 49, the term “wherein the expandable sheath is configured to receive the needle while the tube is in a crimped state, in which the tube has a first inner diameter the tube being expandable from the crimped state to an expanded state, in which the tube has a second inner diameter that is at least double the first inner diameter,” should be replaced with --“wherein the expandable sheath is configured to receive the needle while the tube is in a crimped state, in which the tube has a first inner diameter;
the tube being expandable from the crimped state to an expanded state, in which the tube has a second inner diameter that is at least double the first inner diameter,” -- for claim clarity.
In Claim 91, line 1, the term “the angle” should be replaced with -- the first angle -- for claim clarity.
In Claim 92, line 1, the term “the angle” should be replaced with -- the first angle -- for claim clarity.
Appropriate correction is required and applicant should carefully review the Claims for any other informalities.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 49-52, 77-78, 81-85, 87-89, and 93-95 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti et al (US 2014/0142509) (“Bonutti”) in view of Coyle et al (US 2017/0014157) (“Coyle”) and further in view of Wright, Jr et al (US 2005/0080430) (“Wright”).
Regarding Claim 49, while Bonutti teaches an expandable sheath configured to be inserted into a body of a patient over a needle (Abstract, expandable access system with a wrapped shape over a needle, Fig. 13, [0083], [0090]), comprising:
a tube formed of a single layer that is substantially inelastic (Fig. 13, [0083] “In another embodiment, body 204 may include a sheet that may be rolled, wrapped, or overlapped. (FIG. 13).” Body 204 / tube formed of a single layer, [0090] tube formed of a single inelastic layer by being formed of a polymer, [0071] where the device components may be made of one or more of the listed materials, with substantially inelastic biocompatible polymer examples including polypropylene and polyether ether ketone), the tube being folded around an entirety of an outer circumference of the tube at least once (Figs. 13, 21-22, 27-29, 33-50, [0083]);
wherein the expandable sheath is configured to receive the needle while the tube is in a contracted state, in which the tube has a first inner diameter (Fig. 13, [0089] trocar 112 and introducer 114 configured to be introduced into body 204 while the tube is in an unexpanded state with a first inner diameter, Abstract, trocar can be substituted with a needle as necessary);
the tube being expandable from the contracted state to an expanded state, in which the tube has a second inner diameter that is at least double the first inner diameter ([0103]);
wherein a distal end of the tube is at an angle relative to the longitudinal axis of the expandable sheath to provide a smooth distal taper of the tube in the contracted state (Fig. 33-43, [0104]),
and Bonutti further teaches that a wrapped shape for a sheath can be formed by a trimming action ([0103]),
Bonutti fails to teach the tube having at least one corrugation that is folded around the entirety of an outer circumference of the tube at least once;
The contracted state being a crimped state, and
wherein a distal end of the tube has a first part that is perpendicular to a longitudinal axis of the expandable sheath and a second part extending from the first part, that is at an angle relative to the longitudinal axis of the expandable sheath to provide a smooth distal taper of the tube in the crimped state, a distal end of the two layers of the second portion of the single layer being trimmed at the angle relative to the longitudinal axis of the expandable sheath.
However Coyle teaches an introducer sheath system (Abstract) comprising an inelastic sheath ([0026] introducer sheath 5, [0027] comprising a folded inner layer 55 [0030] this folded inner layer made of inelastic material of HDPE), wherein the expandable sheath has at least one corrugation, and wherein this corrugation is folded around the sheath at least once as part of a contracted, crimped state (Figs. 9 and 10, [0034]-[0036]),
wherein a distal end of the tube has a first part that is perpendicular to a longitudinal axis of the expandable sheath ([0036]-[0037] in the unfolded state shown below, the outer folded layer, opposite the inner folded layer 140, would be a first part that is perpendicular to a longitudinal axis of the expandable sheath), and a second part extending from the first part that is offset relative to the longitudinal axis of the expandable sheath to provide a smooth distal taper of the tube in the crimped state ([0036]-[0037], Fig. 10, the folded section / inner folded layer 140 could be unfolded in a perpendicular orientation relative to the longitudinal axis of the expandable sheath as shown below so as to be offset from the first part to create the step taper in the image below),
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).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the sheath’s contracted state of Bonutti as a single folded corrugation as taught by Coyle as a simple substitution of one form of wrapping a layer to achieve a diminished profile and taper (Bonutti: continuously wrap in a direction of the circumference) for another (Coyle: setting a corrugation fold to continuously wrap in a direction of the circumference. Furthermore, in substituting the expandable sheath, the distal edge of the expandable sheath at a first part will be perpendicular to the longitudinal axis of the expandable sheath and the inner folded layer 140 / second part can be unfolded to extend from the first part with the second part being at a tapered portion. Finally, it would be obvious that Coyle’s wrapping of an entirety of the outer circumference can function with Bonutti as the folding around the entirety of the circumference in Bonutti is applied with the same expansion goal as Coyle and is just dependent on the desired amount of expansion ([0102]-[0103]).
Alternatively, a second interpretation of Coyle teaches an introducer sheath system (Abstract) comprising an inelastic sheath ([0026] introducer sheath 5, [0027] comprising a folded inner layer 55 [0030] this folded inner layer made of inelastic material of HDPE), wherein the expandable sheath has at least one corrugation, and wherein this corrugation is folded around the sheath at least once (Figs. 9 and 10, [0034]-[0036]).
wherein a distal end of the tube has a first part that is perpendicular to a longitudinal axis of the expandable sheath ([0036]-[0037] in the unfolded state shown below, the outer folded layer, opposite the inner folded layer 140, would be a first part that is perpendicular to a longitudinal axis of the expandable sheath), and a second part extending from the first part that is offset relative to the longitudinal axis of the expandable sheath to provide a smooth distal taper of the tube in the crimped state ([0036]-[0037], Fig. 10, the folded section / inner folded layer 140 could be unfolded in a perpendicular orientation relative to the longitudinal axis of the expandable sheath as shown below so as to be offset from the first part to create the step taper in the image below),
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the sheath’s contracted state of Bonutti with a single folded corrugation as taught by Coyle as a simple substitution of one form of wrapping a layer to achieve a diminished profile and taper (Bonutti: continuously wrap in a direction of the circumference) for another (Coyle: setting a corrugation fold to continuously wrap in a direction of the circumference. Furthermore, in substituting the expandable sheath, the distal edge of the expandable sheath will be perpendicular to the longitudinal axis of the expandable sheath and the inner folded layer / second part can be unfolded to extend from the first part with the second part being at an angle from the longitudinal axis. Finally, it would be obvious that Coyle’s wrapping of an entirety of the outer circumference can function with Bonutti as the folding around the entirety of the circumference in Bonutti is applied with the same expansion goal as Coyle and is just dependent on the desired amount of expansion ([0102]-[0103]).
Yet their combined efforts fail to teach
The tapered offset occurring at a singular angle;
a distal end of the two layers of the second portion of the single layer being trimmed at the angle relative to the longitudinal axis of the expandable sheath.
However Wright teaches an expandable sheath system (Abstract) where a slit may be cut at an angle at a distal end of the sheath, to minimize tearing ([0035]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the tapered offsets in Coyle could be achieved by trimming at an angle as Wright teaches that angular slits minimize tearing of the elastomeric layer. This is likely due to pushing motion forward by the sheath applying less pressure on a rounded surface rather than an exposed corner at the taper. Furthermore, applying this with the trimming teaching in Bonutti renders obvious taking an angular trimming of the sheath to both facilitate the wrapping of the sheath and minimize tearing with a rounded penetration surface.
Regarding Claim 50, Bonutti, Coyle, and Wright teach the expandable sheath of claim 49, and Coyle teaches wherein the tube has a plurality of corrugations ([0032], Fig. 6) and teaches where a corrugation fold around the sheath (See Claims 49, Figs. 9 and 10, [0034]-[0036]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the tube’s crimped state by a folded sheath of Bonutti, Coyle, and Wright as including multiple corrugations as taught by Coyle as the application of known techniques to reduce diameter of a sheath (Coyle: with multiple folds) to the known sheath reducing its diameter (Bonutti: with a single fold) ready for improvement to yield predictable of tight fit of a sheath to Bonutti’s needle.
Regarding Claim 51, Bonutti, Coyle, and Wright teach the expandable sheath of claim 50, wherein the plurality of corrugations includes between two and six corrugations that are folded around the tube ([0032], Fig. 6) and teaches where the corrugation folds around the sheath (See Claims 49 and 50 Rejection).
Regarding Claim 52, Bonutti, Coyle, and Wright teach the expandable sheath of claim 49, and Bonutti teaches a second embodiment of the expandable sheath further comprising: a hub at a proximal end of the tube, opposite the distal end, the hub being configured to overlap with a needle hub (Figs. 8 and 10, [0083] expanded portion of trocar 112 at distal end of system acts as a hub, at a proximal end of the tube 104 shown at opening 102, opposite the distal end, the hub being configured to overlap with a needle hub / proximal end of introducer 114).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the tube and needle distal ends of Bonutti’s first embodiment with the hub teachings shown in Figures 8 and 10 of a second embodiment of Bonutti as a structural relationship based on a desired length of the expandable device.
Regarding Claim 77, while Bonutti, Coyle, and Wright teach the expandable sheath of claim 49, where an angle for a smooth distal taper by the expandable sheath is variable between 1-100% ([0102] in an unfolded configuration off of the longitudinal axis, an overlap of 100% would have the expandable sheath extend from the longitudinal axis in a perpendicular fashion, and an overlap of 1% would have the expandable sheath extend from the longitudinal axis at an angle closer to 0 degrees relative to the longitudinal axis of the expandable sheath) and an exemplary aggressive angle of taper is 45 degrees ([0104]), their combined efforts fail to explicitly teach wherein the angle is between 5 degrees and 30 degrees relative to the longitudinal axis of the expandable sheath.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that teaching variable measures of overlap of Bonutti with an extreme resultant end angle being 45 degrees, will lead to an understanding of a range of resultant end angles for the distal taper with 45 degrees being an upper threshold. In view of these teachings, it would be obvious that the ideal overlap can be caused by the second part being at an angle of 5 to 30 degrees, relative to the longitudinal axis, as an optimization of ranges for desired overlap ("[W]here 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)].
Regarding Claim 78, Bonutti, Coyle, and Wright teach the expandable sheath of claim 49, and Bonutti teaches wherein the first part of the distal end of the tube is folded over the second part of the distal end of the tube (See Claim 49 Rejection, [0102] wrapping direction is flexible and would be performed in the direction that would achieve the desired wrapping taper).
Regarding Claim 81, Bonutti, Coyle, and Wright teach the expandable sheath of claim 49, wherein a gap is formed between distal ends of the two layers of the second portion that forms the smooth distal taper of the second part of the distal end of the tube (See Claim 49 Rejection, where the unfolded distal end of the two layers of the second portion shows a gap between the two layers, as highlighted by the image below).
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Examiner will note that if the gap at the below circled area is definitively claimed as the gap, specifying the gap as a vertical offset at one side of the distal end of the second portion, the claim language would likely overcome the prior art.
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Regarding Claim 82, Bonutti, Coyle, and Wright teach the expandable sheath of claim 49, and Bonutti teaches wherein, with the tube in the crimped state, the tube is further configured to receive an object that expands the tube from the crimped state to the expanded state ([0097]).
Regarding Claim 83, Bonutti, Coyle, and Wright teach the expandable sheath of claim 82, and Bonutti teaches wherein the object is a central catheter or a balloon catheter ([0096]-[0097] received object uses balloon to control expansion, [0107] expandable sheath may be used with any elongate structure accessing a body portion as shown in Figs. 52-57, which includes catheters).
Regarding Claim 84, Bonutti, Coyle, and Wright teach the expandable sheath of claim 49, and Bonutti teaches wherein the first inner diameter is between 0.3 millimeters (mm) and 3.0 mm ([0103]).
Regarding Claim 85, Bonutti, Coyle, and Wright teach the expandable sheath of claim 84, and Bonutti teaches wherein the second inner diameter is between 1.0 mm and 7.0 mm ([0103]).
Regarding Claim 87, Bonutti, Coyle, and Wright teach the expandable sheath of claim 49, wherein the single layer comprises polytetrafluoroethylene (PTFE), polyether block amid (PEBAX), polyether ether ketone (PEEK), or polypropylene (See Claim 49 Rejection).
Regarding Claim 88, Bonutti, Coyle, and Wright teach the expandable sheath of claim 49, wherein Coyle teaches the fold of the second portion of the single layer that forms the two layers extends parallel to the longitudinal axis of the expandable sheath (See Claim 80 Rejection, Coyle Fig. 10 when the fold is unfolded, the fold of the second portion will extended parallel to the longitudinal axis of the expandable sheath).
Regarding Claim 89, Bonutti, Coyle, and Wright teach the expandable sheath of claim 49, and Bonutti teaches wherein, with the second portion of the single layer unfolded around the first portion of the single layer, the two layers of the second portion of the single layer has a length extending radially from the longitudinal axis of the expandable sheath that is at least double a diameter of the inner portion of the tube formed by the first portion of the single layer ([0103] a possible upper limit of circumferential overlaps is 7. A circumference of the circle is the diameter multiple by pi. Thus, at an upper limit, the sheet overlapping the circumference 7 times is equivalent to a length off ~22 times the diameter. With this upper threshold, a length of the corrugation, the component performing the overlap, is envisioned to include at least double a diameter of the inner portion of the tube formed by the first portion of the single layer).
Regarding Claim 91, while Bonutti, Coyle, and Wright teach the expandable sheath of claim 49, where an angle for a smooth distal taper by the expandable sheath is variable between 1-100% ([0102] in an unfolded configuration off of the longitudinal axis, an overlap of 100% would have the expandable sheath extend from the longitudinal axis in a perpendicular fashion, and an overlap of 1% would have the expandable sheath extend from the longitudinal axis at an angle closer to 0 degrees relative to the longitudinal axis of the expandable sheath) and an exemplary aggressive angle of taper is 45 degrees ([0104]), their combined efforts fail to explicitly teach wherein the angle is between 5 degrees and 45 degrees relative to the longitudinal axis of the expandable sheath.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that teaching variable measures of overlap of Bonutti with an extreme resultant end angle being 45 degrees, will lead to an understanding of a range of resultant end angles for the distal taper with 45 degrees being an upper threshold. In view of these teachings, it would be obvious that the ideal overlap can be caused by the second part being at an angle of 5 to 45 degrees, relative to the longitudinal axis, as an optimization of ranges for desired overlap ("[W]here 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)].
Regarding Claim 92, while Bonutti, Coyle, and Wright teach the expandable sheath of claim 49, where an angle for a smooth distal taper by the expandable sheath is variable between 1-100% ([0102] in an unfolded configuration off of the longitudinal axis, an overlap of 100% would have the expandable sheath extend from the longitudinal axis in a perpendicular fashion, and an overlap of 1% would have the expandable sheath extend from the longitudinal axis at an angle closer to 0 degrees relative to the longitudinal axis of the expandable sheath) and an exemplary aggressive angle of taper is 45 degrees ([0104]), their combined efforts fail to explicitly teach wherein the angle is between 10 degrees and 30 degrees relative to the longitudinal axis of the expandable sheath.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that teaching variable measures of overlap of Bonutti with an extreme resultant end angle being 45 degrees, will lead to an understanding of a range of resultant end angles for the distal taper with 45 degrees being an upper threshold. In view of these teachings, it would be obvious that the ideal overlap can be caused by the second part being at an angle of 10 to 30 degrees, relative to the longitudinal axis, as an optimization of ranges for desired overlap ("[W]here 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)].
Regarding Claim 93, Bonutti, Coyle, and Wright teach the expandable sheath of claim 49, wherein the distal end of the two layers of the second portion of the single layer is further trimmed such that a gap is formed between distal ends of the two layers (See Claim 49 Rejection, where the unfolded distal end of the two layers of the second portion shows a gap between the two layers, as highlighted by the image below. This gap is formed between the two layers in the perpendicular direction).
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Examiner will note that if the gap at the below circled area is definitively claimed as the gap, specifying the gap as a vertical offset at one side of the distal end of the second portion, the claim language would likely overcome the prior art.
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Regarding Claim 94, Bonutti, Coyle, and Wright teach the expandable sheath of claim 49, wherein the distal end of the two layers of the second portion of the single layer is further trimmed such that a distal end of an inner layer of the two layers is shorter than a distal end of an outer layer of the two layers (See Claim 49 Rejection, should we consider the left side of the unfolded structure as the inner layer, than the below image shows the distal end of the inner layer being shorter than the outer layer on the right side).
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Regarding Claim 95, Bonutti, Coyle, and Wright teach the expandable sheath of claim 94, wherein the outer layer is folded over the inner layer (See Claim 94 Rejection, the corrugation folding around an entirety of the circumference of the tube at least once means that at least in some area, the outer layer is folded over the inner layer).
Claim(s) 86 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti in view of Coyle and further in view of Wright and further in view of Zhou et al (US 2016/0296730) (“Zhou”).
Regarding Claim 86, while Bonutti, Coyle, and Wright teach the expandable sheath of claim 49, their combined efforts fail to teach wherein the single layer has a wall thickness that is between 0.01 millimeters (mm) and 0.3 mm.
However Zhou teaches an expandable sheath (Abstract, Figs. 7-9, [0073]) where an expanding single layer has a wall thickness that is between 0.01 mm and 0.3 mm ([0073] at the thickest portion, the wall thickness is envisioned as 0.012 inches, which is about 0.3 mm, and at the thinnest portion, the wall thickness is envisioned as 0.0055 inches, which is about 0.14 mm).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the wall thickness of Bonutti can be configured as between 0.01 mm and 0.3 mm as taught by Zhou as a standardization teaching that ensures that application of Bonutti’s system will give consistent results.
Response to Arguments
Applicant’s amendments and arguments filed 3/02/2026 with respect to the 35 USC 103 rejections have been fully considered. Despite Examiner’s previous statement that the subject matter of Claim 90 was allowable, upon further search and consideration of the claim language, a new ground(s) of rejection is made in view of Bonutti, Coyle, and Wright.
The rejection stands.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights