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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/10/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 06/12/2026. As directed by the amendment: claims 1, 15, and 19 have been amended and claims 3, 6-7, and 13-14 remain withdrawn. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant's arguments, see pages 6-7, filed 06/12/2026 with respect to the rejections of claim 1, 15, and 19 under 35 U.S.C. 103 as being unpatentable over Voss (US 20100198160 A1), herein referenced to as “Voss” in view of Core (US 20040087968 A1), herein referenced to as “Core” have been fully considered but they are not persuasive.
The applicant amended claims 1, 15, and 19 similarly. Claim 1 was amended to recite “wherein the second polymeric material has a thickness that is forty percent or less of a thickness of the side wall”. Claim 15 was amended to recite “wherein the second polymeric material has a thickness that is thirty percent or less of a thickness of the side wall”. Claim 19 was amended to recite “wherein the second polymeric material has a thickness that is twenty percent or less of a thickness of the side wall”.
The applicant asserts that Voss in view of Core does not teach the amended claim limitations.
While the examiner that the combination of Voss and Core does not expressly teach the amended claim limitations, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the combination device of Voss and Core to have wherein the second polymeric material has a thickness that is forty/thirty/twenty percent or less of a thickness of the side wall 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). In the instant case, the device of Voss and Core would not operate differently with the second polymeric material has a thickness that is forty/thirty/twenty percent or less of a thickness of the side wall. Further, the applicant places no criticality on the range claimed, as the applicant discloses that a radial thickness of 70% or less is additionally acceptable, hence values of 41-70% are acceptable alternatives, hence values below 40% are not critical to the invention (see [0083] of patent application publication).
As such the rejection of the claims will be maintained.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-5, 8-12, and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voss (US 20100198160 A1), herein referenced to as “Voss” in view of Core (US 20040087968 A1), herein referenced to as “Core”.
Claim 1
Voss discloses: A delivery system 1100 (see Fig. 11, [0119]) for an occlusive implant, comprising: a delivery sheath 1104 (see Fig. 11, [0120]) having a delivery lumen 1112 (see Fig. 11, [0121]) extending proximally proximal end of 1104 (see Fig. 11, [0121], entry portion) from a distal end distal end of 1104 (see Fig. 11, [0121]) of the delivery sheath 1104, the delivery sheath 1104 being formed from a first polymeric material (see [0048], polymers listed such as polyurethane, PE-EVA, polyethylene, etc.); and a core wire (see [0063], the device has a guide wire, which is a core wire able to slide through the device, see also [0006]) slidably disposed within the delivery lumen 1112; wherein the delivery sheath 1104 includes a circumferential ring (see annotated Fig. 11 below) monolithically formed therewith at the distal end the distal end of 1104 of the delivery sheath 1104 and a plurality of longitudinal slots 1140a/1140b/1140c/1140d/1140f (see Fig. 11, [0122]) disposed proximal the longitudinal slots are proximal of the circumferential ring (see annotated Fig. 11 below) of the circumferential ring (see annotated Fig. 11 below)
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The preamble, "for an occlusive implant," merely recites intended uses of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Voss meets the structural limitations of the claim, and is capable of being used for an occlusive element, as Voss pertains to expandable medical devices (see [0045]) and occlusive implants expand to occlude spaces within the body.
The language, " the core wire being configured to releasably engage the occlusive implant," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Voss meets the structural limitations of the claim, and is capable of a guide wire being able to releasably engage the occlusive implant in conjunction with the delivery sheath, as the guide wire can guide an occlusive implant to a target site by moving an implant over it, and then being released after passing the distal end of the delivery sheath.
Voss does not explicitly teach: and wherein at least some of the plurality of longitudinal slots are filled with a second polymeric material that is different from the first polymeric material, wherein the second polymeric material has a thickness that is forty percent or less of a thickness of the side wall.
However, Core in a similar field of invention teaches a delivery system 60 (see Fig. 6, [0023], sheath) with a delivery sheath 62 + 64 (see Fig. 6) made of a first polymeric material (see [0023], relatively rigid and less elastic section with different material, see also [0010], polymers) with a plurality of longitudinal slots the slots where 66 and 68 are in between 62 and 64 (see Fig. 6). Core further teaches: wherein at least some of the plurality of longitudinal slots the slots where 66 and 68 are in between 62 and 64 are filled with a second polymeric material 64 + 68 (see Fig. 6, [0023], the material that makes up the material disposed in the slots of 62 + 64, 64 + 68, is different than the material that makes up 62 + 64) that is different from the first polymeric material (see [0023], relatively rigid and less elastic section with different material, see also [0010], polymers).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Voss to incorporate the teachings of Core and teach a delivery system with at least some of the plurality of longitudinal slots are filled with a second polymeric material that is different from the first polymeric material. Motivation for such can be found in Core as this allows for a device with a substantially uniform wall thickness (see [0023]) and assist in creating a sheath with a small as a diameter as possible to minimize trauma to vessel that it is inserted into while maintaining a lumen that can still fit an occlusive device (see [0018]-[0019]).
The combination of Voss and Core does not explicitly teach: wherein the second polymeric material has a thickness that is forty percent or less of a thickness of the side wall.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the combination device of Voss and Core to have wherein the second polymeric material has a thickness that is forty percent or less of a thickness of the side wall 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). In the instant case, the device of Voss and Core would not operate differently with the second polymeric material has a thickness that is forty percent or less of a thickness of the side wall. Further, the applicant places no criticality on the range claimed, as the applicant discloses that a radial thickness of 70% or less is additionally acceptable, hence values of 41-70% are acceptable alternatives, hence values below 40% are not critical to the invention (see [0083] of patent application publication).
Claim 2
The combination of Voss and Core teaches: The delivery system of claim 1, see 103 rejection above. Voss further discloses: wherein the plurality of longitudinal slots 1140a/1140b/1140c/1140d/1140f is disposed adjacent the circumferential ring (see annotated Fig. 11 below claim 1, the longitudinal slots are adjacent to the circumferential ring).
Claim 4
The combination of Voss and Core teaches: The delivery system of claim 1, see 103 rejection above. Voss further discloses: wherein the plurality of longitudinal slots 1140a/1140b/1140c/1140d/1140f extends completely through a side wall 1105 (see Fig. 11, [0122]-[0124], 1140 extends through 1105 to expose 1103, hence extends completely through 1105) of the delivery sheath 1104.
Claim 5
The combination of Voss and Core teaches: The delivery system of claim 1, see 103 rejection above. Core further teaches: wherein all of the plurality of longitudinal slots the slots where 66 and 68 are in between 62 and 64 (see Fig. 6) are filled with the second polymeric material 64 + 68 (see Fig. 6, [0023], the material that makes up the material disposed in the slots of 62 + 64, 64 + 68, is different than the material that makes up 62 + 64).
Claims 8-9 and 12 are rejected over a first interpretation of Voss.
Claim 8
The combination of Voss and Core teaches: The delivery system of claim 1, see 103 rejection above. Voss further discloses: wherein the plurality of longitudinal slots 1140a/1140b/1140c/1140d/1140f comprises a first circumferential row the row with 1140d (see Fig. 11, [0124]) of longitudinal slots and a second circumferential row the row with 1140b (see Fig. 11, [0124], the row of 1140b is proximal to the row with 1140d) of longitudinal slots disposed proximal of the first circumferential row the row with 1140d of longitudinal slots.
Claim 9
The combination of Voss and Core teaches: The delivery system of claim 8, see 103 rejection above. Voss further discloses: wherein adjacent longitudinal slots the slots circumferentially adjacent to 1140b (see Fig. 11, [0124]) of the second circumferential row the row of 1140b of longitudinal slots are spaced apart circumferentially a greater distance (see Fig. 11, the slots of 1140b are spaced circumferentially further apart than 1140d and 1140e) than adjacent longitudinal slots 1140d and 1140e (see Fig. 11, [0124]) of the first circumferential row the row with 1140d of longitudinal slots.
Claim 12
The combination of Voss and Core teaches: The delivery system of claim 8, see 103 rejection above. Voss further discloses: wherein the delivery sheath 1104 further comprises a second circumferential ring (see annotated Fig. 11 below) monolithically formed with the delivery sheath 1104; wherein the second circumferential ring (see annotated Fig. 11 below) is disposed axially between the first circumferential row the row with 1140d of longitudinal slots and the second circumferential row the row with 1140b of longitudinal slots.
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Claims 8 and 10 are rejected over a second interpretation of Voss.
Claim 8
The combination of Voss and Core teaches: The delivery system of claim 1, see 103 rejection above. Voss further discloses: wherein the plurality of longitudinal slots 1140a/1140b/1140c/1140d/1140f comprises a first circumferential row the row with 1140b (see Fig. 11, [0124]) of longitudinal slots and a second circumferential row the row with 1140a (see Fig. 11, [0124], the row of 1140a is proximal to the row with 1140b) of longitudinal slots disposed proximal of the first circumferential row the row with 1140b of longitudinal slots.
Claim 10
The combination of Voss and Core teaches: The delivery system of claim 8, see 103 rejection above. Voss further discloses: wherein the first circumferential row the row with 1140b of longitudinal slots comprises a first quantity 3 slots (see Fig. 11) of longitudinal slots and the second circumferential row the row with 1140a of longitudinal slots comprises a second quantity 2 slots (see Fig. 11) of longitudinal slots less than (see Fig. 11, the row with 1140b has 3 slots while the row with 1140a has 2 slots) the first quantity 3 slots of longitudinal slots.
Claims 8 and 11 are rejected over a third interpretation of Voss.
Claim 8
The combination of Voss and Core teaches: The delivery system of claim 1, see 103 rejection above. Voss further discloses: wherein the plurality of longitudinal slots 1140a/1140b/1140c/1140d/1140f comprises a first circumferential row the row with 1140d (see Fig. 11, [0124]) of longitudinal slots and a second circumferential row the row with 1140c (see Fig. 11, [0124], the row of 1140c is proximal to the row with 1140d) of longitudinal slots disposed proximal of the first circumferential row the row with 1140d of longitudinal slots.
Claim 11
The combination of Voss and Core teaches: The delivery system of claim 8, see 103 rejection above, the third interpretation of Voss. Voss further discloses: wherein a longitudinal slot 1140c (see Fig. 11, [0124]) of the second circumferential row the row with 1140c of longitudinal slots is axially aligned with one longitudinal slot 1140d (see Fig. 11, [0124]) of the first circumferential row the row with 1140d of longitudinal slots.
Voss does not explicitly disclose: each longitudinal slot of the second circumferential row of longitudinal slots is axially aligned with one longitudinal slot.
Since the longitudinal slots/apertures is necessary for expansion of the sheath without creating further apertures in the outer surface of the sheath— as discussed by Voss (see [0127]). Furthermore, variance of the circumferential and axial offsets of the slots is discussed in (see [0124]).
Therefore, it would have been obvious to try, by one of ordinary skill in the art before effective filing date of the invention, to have the delivery system of Voss with each longitudinal slot of the second circumferential row of longitudinal slots is axially aligned with one longitudinal slot since there are a finite number of identified, predictable potential solutions (i.e., the slots of the row of 1140c being circumferentially offset from the row 1140d vs not being circumferentially offset from the row 1140d) to the recognized need of expansion of the sheath without creating further apertures in the outer surface of the sheath and one of ordinary skill in the art would have pursued the known potential solutions with a reasonable expectation of success, as different longitudinal and circumferential offsets are stated to be within the scope of the disclosure of Voss (see [0124]) and 1140c and 1140d are already circumferentially aligned.
Claim 15
Voss discloses: A delivery system 1100 (see Fig. 11, [0119]), comprising: a delivery sheath 1104 (see Fig. 11, [0120]) having a delivery lumen 1112 (see Fig. 11, [0121]) extending proximally proximal end of 1104 (see Fig. 11, [0121], entry portion) from a distal end distal end of 1104 (see Fig. 11, [0121]) of the delivery sheath 1104, the delivery sheath 1104 being formed from a polymeric material (see [0048], polymers listed such as polyurethane, PE-EVA, polyethylene, etc.); and a core wire (see [0063], the device has a guide wire, which is a core wire able to slide through the device, see also [0006]) slidably disposed within the delivery lumen 1112; wherein the delivery sheath 1104 includes a circumferential ring (see annotated Fig. 11 below) monolithically formed therewith at the distal end the distal end of 1104 of the delivery sheath 1104 and a plurality of longitudinal slots 1140a/1140b/1140c/1140d/1140f (see Fig. 11, [0122]) disposed proximal the longitudinal slots are proximal of the circumferential ring (see annotated Fig. 11 below) of the circumferential ring (see annotated Fig. 11 below).
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Voss does not explicitly disclose: An occlusive implant system, comprising: an occlusive implant configured to shift between a delivery configuration and a deployed configuration, the delivery system for the occlusive implant, the core wire being releasably engaged with the occlusive implant at a distal end of the core wire; wherein at least some of the plurality of longitudinal slots are filled with a second polymeric material that is different from the first polymeric material, wherein the second polymeric material has a thickness that is thirty percent or less of a thickness of the side wall; and wherein the occlusive implant is disposed within a distal portion of the delivery lumen in the delivery configuration.
However, Core in a similar field of invention teaches a delivery system 60 (see Fig. 6, [0023], sheath) with a delivery sheath 60 + 62 + 64 (see Fig. 6) made of a first polymeric material (see [0023], relatively rigid and less elastic section with different material, see also [0010], polymers) with a plurality of longitudinal slots the slots where 66 and 68 are in between 62 and 64 (see Fig. 6) and a core wire guide wire (see Fig. 7, the wire pushing the occluder, [0018], guide wire). Core further teaches: an occlusive implant system (see Figs. 6-7, [0019] and [0023]), comprising: an occlusive implant occluder (see Fig 7, [0019]) configured to shift between a delivery configuration (see Fig. 7-1, [0019], delivery) and a deployed configuration (see Fig. 7-3, deployed configuration), the delivery system 60 for the occlusive implant (see [0018], sheaths are conduit for occluders), the core wire guide wire (see Fig. 7, [0019]) being releasably engaged (see [0019], delivery of the occluder, which during implantation will be disconnected to be deployed in the body) with the occlusive implant occluder at a distal end distal end of the guide wire that connects to the occluder (see Fig. 7-3) of the core wire guide wire; wherein at least some of the plurality of longitudinal slots the slots where 66 and 68 are in between 62 and 64 are filled with a second polymeric material 64 + 68 (see Fig. 6, [0023], the material that makes up the material disposed in the slots of 62 + 64, 64 + 68, is different than the material that makes up 62 + 64) that is different from the first polymeric material (see [0023], relatively rigid and less elastic section with different material, see also [0010], polymers); and wherein the occlusive implant occluder is disposed within a distal portion distal portion of the delivery lumen (see Fig. 7-1) of the delivery lumen (see Fig. 7-1) in the delivery configuration (see Fig. 7-1).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Voss to incorporate the teachings of Core and teach a delivery system to be used with an occlusive implant system, comprising: an occlusive implant configured to shift between a delivery configuration and a deployed configuration, the delivery system for the occlusive implant, the core wire being releasably engaged with the occlusive implant at a distal end of the core wire; wherein the occlusive implant is disposed within a distal portion of the delivery lumen in the delivery configuration. Motivation for such can be found in Core as this system that can expand can be useful for delivery and retrieval of an occluder or a patent foramen ovale closure device (see [0019]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Voss to incorporate the teachings of Core and teach a delivery system with at least some of the plurality of longitudinal slots are filled with a second polymeric material that is different from the first polymeric material. Motivation for such can be found in Core as this allows for a device with a substantially uniform wall thickness (see [0023]) and assist in creating a sheath with a small as a diameter as possible to minimize trauma to vessel that it is inserted into while maintaining a lumen that can still fit an occlusive device (see [0018]-[0019]).
The combination of Voss and Core does not explicitly teach: wherein the second polymeric material has a thickness that is thirty percent or less of a thickness of the side wall.
it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the combination device of Voss and Core to have wherein the second polymeric material has a thickness that is thirty percent or less of a thickness of the side wall 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). In the instant case, the device of Voss and Core would not operate differently with the second polymeric material has a thickness that is thirty percent or less of a thickness of the side wall. Further, the applicant places no criticality on the range claimed, as the applicant discloses that a radial thickness of 70% or less is additionally acceptable, hence values of 41-70% are acceptable alternatives, hence values below 40% are not critical to the invention (see [0083] of patent application publication).
Claim 16
The combination of Voss and Core teaches: The occlusive implant system of claim 15, see 103 rejection above. Core further teaches: wherein the occlusive implant occluder (see Fig. 7) comprises an expandable framework umbrella/radial spokes (see [0019]) and an occlusive element fabric supported on radial spokes (see [0019]) secured to the expandable framework umbrella/radial spokes.
Claim 17
The combination of Voss and Core teaches: The occlusive implant system of claim 15, see 103 rejection above. Core further teaches: wherein the distal end distal end of the sheath 60 (see Fig. 7) of the delivery sheath 60 is configured to expand radially outward during recapture of the occlusive implant occluder (see [0019], the distal end of the sheath expands during retrieval of occluder).
Claim 18
The combination of Voss and Core teaches: The occlusive implant system of claim 15, see 103 rejection above. Voss further discloses: wherein the circumferential ring (see annotated Fig. 11 below claim 15) extends uninterruptedly (see annotated Fig. 11 below claim 15, the circumferential ring is uninterrupted) around the delivery lumen 1112.
Claim 19
Voss discloses: A delivery system 1100 (see Fig. 11, [0119]) for an occlusive implant, comprising: a delivery sheath 1104 (see Fig. 11, [0120]) having a delivery lumen 1112 (see Fig. 11, [0121]) extending proximally proximal end of 1104 (see Fig. 11, [0121], entry portion) from a distal end distal end of 1104 (see Fig. 11, [0121]) of the delivery sheath 1104, the delivery sheath 1104 being formed from a first polymeric material (see [0048], polymers listed such as polyurethane, PE-EVA, polyethylene, etc.); and a core wire (see [0063], the device has a guide wire, which is a core wire able to slide through the device, see also [0006]) slidably disposed within the delivery lumen 1112; wherein the delivery sheath 1104 includes a circumferential ring (see annotated Fig. 11 below) monolithically formed therewith at the distal end the distal end of 1104 of the delivery sheath 1104, and a plurality of longitudinal slots 1140a/1140b/1140c/1140d/1140f (see Fig. 11, [0122]); wherein the plurality of longitudinal slots 1140a/1140b/1140c/1140d/1140f (see Fig. 11, [0122]) are embedded within a side wall 1105 (see Fig. 11, [0124]) of the delivery sheath 1104 proximal of the circumferential ring (see annotated Fig. 11 below).
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Voss does not explicitly disclose: for an occlusive implant, the core wire being configured to releasably engage the occlusive implant; a plurality of longitudinal strips in the plurality of slots formed from a second polymeric material different from the polymeric material; wherein the second polymeric material has a thickness that is twenty percent or less of a thickness of the side wall.
However, Core in a similar field of invention teaches a delivery system 60 (see Fig. 6, [0023], sheath) with a delivery sheath 60 + 62 + 64 (see Fig. 6) made of a polymeric material (see [0023], relatively rigid and less elastic section with different material, see also [0010], polymers) with a plurality of longitudinal slots the slots where 66 and 68 are in between 62 and 64 (see Fig. 6) and a core wire guide wire (see Fig. 7, the wire pushing the occluder, [0018], guide wire). Core further teaches: for an occlusive implant occluder (see Fig 7, [0019]), the core wire guide wire (see Fig. 7, [0019]) being configured to releasably engage (see [0019], delivery of the occluder, which during implantation will be disconnected to be deployed in the body) the occlusive implant occluder; a plurality of longitudinal strips 66 + 68 (see Fig. 6, [0023]) in the plurality of slots the slots where 66 and 68 are in between 62 and 64 (see Fig. 6) formed from a second polymeric material (see Fig. 6, [0023], the material that makes up the material disposed in the slots of 62 + 64, 64 + 68, is different than the material that makes up 62 + 64) different from the first polymeric material (see [0023], relatively rigid and less elastic section with different material, see also [0010], polymers).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Voss to incorporate the teachings of Core and teach a delivery system with an occlusive implant, the core wire being configured to releasably engage the occlusive implant; a plurality of longitudinal strips in the plurality of slots formed from a second polymeric material different from the polymeric material. Motivation for such can be found in Core as this system that can expand can be useful for delivery and retrieval of an occluder or a patent foramen ovale closure device (see [0019]) and the longitudinal strips allow for a device with a substantially uniform wall thickness (see [0023]) and assist in creating a sheath with a small as a diameter as possible to minimize trauma to vessel that it is inserted into while maintaining a lumen that can still fit an occlusive device (see [0018]-[0019]).
The combination of Voss and Core does not explicitly teach: wherein the second polymeric material has a thickness that is twenty percent or less of a thickness of the side wall.
it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the combination device of Voss and Core to have wherein the second polymeric material has a thickness that is twenty percent or less of a thickness of the side wall 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). In the instant case, the device of Voss and Core would not operate differently with the second polymeric material has a thickness that is twenty percent or less of a thickness of the side wall. Further, the applicant places no criticality on the range claimed, as the applicant discloses that a radial thickness of 70% or less is additionally acceptable, hence values of 41-70% are acceptable alternatives, hence values below 40% are not critical to the invention (see [0083] of patent application publication).
Claim 20
The combination of Voss and Core teaches: The delivery system of claim 19, see 103 rejection above. Core further teaches: wherein the second polymeric material (see [0023], the material of 66 + 68 is more flexible and has a lower durometer and [0009, a lower durometer material is more elastic) has a lower durometer than the first polymeric material (see [0023], more rigid material).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ciulla et al (US 20170209133 A1) teaches an expandable delivery sheath with longitudinal slots and a thinner, lower durometer material filling those slots (see Fig. 11)
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
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