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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 7-9, and 14-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation “preferably the support layer forms less than 50% of the inner surface, more preferably less than 25%.” The term of “preferably” renders the scope of the claim indefinite since it is unclear if the limitation following the phrase is part of the claimed invention. For examination purposes, the limitation is being treated as not being required by the claim.
Claims 7 and 14 each recite that the elastomeric outer tube “has a kr value approximately equal to or greater than 1.5 wherein kr is expressed by the formula: kr = ki / k0 = (F * δ0) / ( F * δi), wherein: kr = stiffness ratio of improved elastomeric layer to original k0 = original elastomeric layer longitudinal stiffness (N/mm/m) ki = improved elastomeric layer longitudinal stiffness (N/mm) F = applied longitudinal force (N) δ0 = original elastomeric layer extension, deflection (mm) δi = improved elastomeric layer extension, deflection (mm).” This limitation renders the scope of the claims indefinite since it is unclear what is meant by “improved elastomeric layer”. The term ”Improved” is a subjective term and there is no basis of comparison provided to convey what is considered improved or not. Thus, the terminology “improved elastomeric layer longitudinal stiffness” and “improved elastomeric layer extension, deflection” is considered indefinite. Since the terminology within the formula is indefinite, the formula itself is considered indefinite. The specification does not provide any further clarity as to how to measure or interpret “improved” or how the stiffness ratio is determined.
Claims 8 and 15 each recite “the modulus” in line 4 which renders the scope of the claims indefinite since it is unclear which kind of modulus “the modulus” refers to (e.g., tensile, shear, elastic, etc.). The specification makes reference to different kinds of moduli including tensile, flexural and elastomer (see [0042]), but also does not specify which modulus is of the support element material is at least 50 times the modulus of the continuous elastomeric layer (see [0033] and [0034]). For examination purposes, “the modulus” has been interpreted as the elastic modulus.
Claims 9 and 16 each recite that the circumferentially discontinuous support layer is formed from “a combination of support elements” which renders the scope of the claim indefinite since it is unclear if “a combination of support elements” is further limiting “the one or more support elements” previously recited in claim 1 (i.e., the one or more support elements comprises a combination of support elements) or if the recitation is an introduction of new structure (i.e., there are a combination of support elements in addition to the one or more support elements). For examination purposes, the limitation “a combination of support elements” has been interpreted as further limiting the earlier recited one or more support elements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5, 7, 9-10, 12, 14, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Worthley et al. (WO 2020/056465 A1) and Kirt et al. (US 2020/0078571 A1).
Regarding claims 1, 2, 4, and 10, Worthley discloses a system (see Fig. 4a-5b) for protecting a luminal surface of a blood vessel, the system comprising an introducer sheath being formed from: an annular collar (210) defining an opening extending through the collar (collar 210 is hollow, see [0073]), the annular collar having attached thereto a circumferentially retractable elongated sleeve (sleeve 220 is expandable and retractable, see [0074]) attached at a proximal opening of the elongated sleeve and extending longitudinally to define a luminal channel terminating at a distal opening of the elongated sleeve, the elongated sleeve comprising a circumferentially continuous elastomeric outer tube (410) comprising a continuous elastomeric layer extending longitudinally and spanning the entire length of the sleeve (see [0077]), the elongated sleeve comprising a coiled expandable inner sheet (420) positioned longitudinally within a lumen formed by the circumferentially continuous elastomeric outer tube, positioned substantially in contact with a luminal surface of the circumferentially continuous elastomeric outer tube (coiled sheet 420 is positioned within the lumen of the outer tube 410 such that it is in contact with the luminal surface of the outer tube, see Fig. 4b-4c), and wherein the elastomeric outer tube has a smooth inner surface with a substantially round cross-section (the outer tube 410 has a round cross-section, see Fig. 4b).
Worthley fails to teach the circumferentially continuous elastomeric outer tube further comprising a circumferentially discontinuous support layer formed from one or more support elements.
Kirt, in the same field of art, teaches a related introducer sheath (see Fig. 1-3) comprising a circumferentially continuous outer tube having two layers comprising an elastomeric layer (30) and a circumferentially discontinuous support layer (40), wherein the circumferentially discontinuous support layer is formed from one or more support elements (44) extending longitudinally from the distal opening towards the proximal opening (see Fig. 3) and wherein the inner surface of the elastomeric outer tube is formed by the elastomeric layer and the support layer (see Fig. 2). The circumferentially discontinuous support layer of Kirt provides reinforcement to the introducer sheath (see [0048]) which is understood to impact a number of known desirable properties in introducer sheaths such as radial force, axial stiffness, and kink resistance which all impact navigability.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the circumferentially continuous elastomeric outer tube of Worthley to further include a circumferentially discontinuous support layer, as taught by Kirt, since doing so would provide structural reinforcement to the sheath and other desirable mechanical properties such as radial force, axial stiffness, and kink resistance which impact navigability.
Regarding the limitation “preferably the support layer forms less than 50% of the inner surface, more preferably less than 25%” recited in claim 2, as noted above in the rejection of the claim under 35 U.S.C. 112(b), this limitation as been interpreted as not being required by the claim.
Regarding claim 3, the combination of Worthley and Kirt further teaches wherein the outer surface of the elastomeric outer tube is formed by the elastomeric layer (in the introducer sheath of the combination of Worthley and Kirt the support layer of Kirt would be within the elastomeric layer of Worthley similarly as shown in Fig. 2 of Kirt and therefore the outer surface of the elastomeric tube would be formed by the elastomeric layer).
Regarding claims 5 and 12, the combination of Worthley and Kirt further teaches the one or more support elements extend longitudinally, span the entire length of the sleeve and are bonded to an inner luminal surface of the continuous elastomeric layer (Kirt teaches support element formed by spines 44 extend longitudinally, see Fig. 3 of Kirt, and the reinforcement member 40 is bonded to the outer sheath 30, see [0067]), whereby the circumferentially discontinuous support layer is configured to resist longitudinal compression of the circumferentially continuous elastomeric outer tube along the entire length of the sleeve (the support layer of Kirt in the device of Worthley would be capable of resisting longitudinal compression of the elastomeric outer tube along its entire length because it would provide structural reinforcement and Kirt teaches the support layer extending along the entire length of the outer tube).
Regarding claims 7 and 14, Worthley further teaches the circumferentially continuous elastomeric outer tube is formed of a biocompatible material (see [0049]). Regarding the claimed kr value, as discussed above in the rejection of the claims under 35 U.S.C. 112b, it is unclear to what the stiffness of the outer tube is being compared in order to arrive at the claimed kr value. It is the Examiner’s position that the elastomeric outer tube disclosed by Worthley has a kr value equal to or greater than 1.5, where the kr value is understood to be the stiffness ratio of the tube with respect to some other unspecified element.
Regarding claims 9 and 16, Kirt further teaches the circumferentially discontinuous support layer is formed from a combination of support elements (as discussed above in the rejection of the claims under 35 U.S.C. 112b, for examination purposes, this limitation has been interpreted as the support layer comprises a plurality of support elements) comprising a wire or strip consisting of any one of stainless steel, nitinol, or mixture or composite thereof, and a crescent shaped polymeric material (Kirt teaches a plurality of support elements in the form of longitudinal spines 44 which can be considered strips made of stainless steel, nitinol or combinations thereof, see [0088]).
Regarding claim 17, Worthley discloses a method comprising the steps of: obtaining an introducer sheath (see Fig. 4a-5b) being formed from an annular collar (210)defining an opening extending through the collar (collar 210 is hollow, see [0073]), the annular collar having attached thereto a circumferentially retractable elongated sleeve (sleeve 220 is expandable and retractable, see [0074]) attached at a proximal opening of the elongated sleeve and extending longitudinally to define a luminal channel terminating at a distal opening of the elongated sleeve, the elongated sleeve comprising a circumferentially continuous elastomeric outer tube (410) comprising a continuous elastomeric layer extending longitudinally and spanning the entire length of the sleeve (see [0077]), obtaining an expandable inner sheet (420), positioning the expandable inner sheet longitudinally within a lumen formed by the circumferentially continuous elastomeric outer tube and positioned substantially in contact with a luminal surface of the circumferentially continuous elastomeric outer tube (see Fig. 4b).
Worthley fails to teach the circumferentially continuous elastomeric outer tube further comprising a circumferentially discontinuous support layer formed from one or more support elements.
Kirt, in the same field of art, teaches a related introducer sheath (see Fig. 1-3) comprising a circumferentially continuous outer tube having two layers comprising an elastomeric layer (30) and a circumferentially discontinuous support layer (40), wherein the circumferentially discontinuous support layer is formed from one or more support elements (44) bonded to the elastomeric layer about the distal opening of the sheath and extending longitudinally therefrom towards the proximal opening (the reinforcement member 40 is bonded to the outer sheath 30, see [0067] and Fig. 3), whereby the circumferentially discontinuous support layer is configured to resist longitudinal compression of the circumferentially continuous elastomeric outer tube (the support layer of Kirt is formed by a “reinforcing member” see [0048]). The circumferentially discontinuous support layer of Kirt provides reinforcement to the introducer sheath (see [0048]) which is understood to impact a number of known desirable properties in introducer sheaths such as radial force, axial stiffness, and kink resistance which all impact navigability.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Worthley so that the circumferentially continuous elastomeric outer tube of further included a circumferentially discontinuous support layer, as taught by Kirt, since doing so would provide structural reinforcement to the sheath and other desirable mechanical properties such as radial force, axial stiffness, and kink resistance which impact navigability.
Claims 6, 8, 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Worthley and Kirt, as applied to claims 1 and 10 above, and further in view of Korkuch et al. (US 2019/0351194).
Regarding claims 6 and 13, the combination of Worthley and Kurt teaches the introducer sheath according to claim 1 and the system according to claim 10. Kirth further teaches the one or more support elements is formed of a biocompatible material (see [0088] and [0094] of Kirt). Kirt fails to expressly teach the material has a k value approximately equal to or greater than 0.1, wherein k is expressed by the formula: k = F / δ/l, wherein: k = longitudinal stiffness in Newtons per millimetre per metre (N/mm/m) F = applied longitudinal force in Newtons (N) δ = extension, deflection in millimetres (mm) l = length of support element in metres (m).
However, the k value as claimed is understood to be affected by the geometry (i.e., length, size, shape, thickness, etc.) of the support elements.
Korkuch, in the same field of art, teaches a related introducer sheath including a support layer, where the stiffness of the support layer needs to optimized in order to provide the desired mechanical properties to the sheath (see [0015]).
While Korkuch does not expressly teach the support layer having a k value equal to or greater than 0.1, Korkuch discloses the stiffness of the support layer as a result effective variable in that changing the geometry and material of the support layer affects the stiffness and thereby the kink resistance and navigability of the overall structure of the sheath (see [0015]). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Worthley and Kirt by making the one or more support elements have a k value equal to or greater than 0.1, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 8 and 15, the combination of Worthley and Kurt teaches the introducer sheath according to claim 1 and the system according to claim 10. Kirt further teaches the one or more support elements comprises a material selected from the group consisting of fibrous materials, textiles, metals, metal alloys, polymers, mixtures or composites thereof (see [0088] and [0094] of Kirt).
The combination of Worthley and Kirt fails to teach the selected material having at least 50 times the modulus of the continuous elastomeric layer. As noted above, in the rejection of the claims under 35 U.S.C. 112b, “the modulus” has been interpreted as the elastic modulus for examination purposes.
Korkuch, in the same field of art, teaches a related introducer sheath where the support layer is formed from a material having an elastic modulus over 50 times the modulus of an inner and/or outer layer of the sheath to improve the kink resistance of the sheath(see [0015]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the modify the introducer sheath of Worthley and Kirt by selecting the material of the support elements such that the material has 50 times the elastic modulus of the elastomeric layer, as taught by Korkuch, since doing so would improve the kink resistance of the sheath.
Claims 11 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Worthley and Kirt, as applied to claims 10 and 17 above, and further in view of Horzewski et al. (US 5,318,588 A).
Regarding claim 11, the combination of Worthley and Kirt teaches the system according to claim 10. Worthley further teaches a dilator (510, see Fig. 5a) having a dilator tip (520), wherein the dilator tip is configured to pass through a lumen formed by the expandable inner sheet along the length of the circumferentially retractable elongated sleeve (see Fig. 5a-5b).
Worthley fails to expressly teach the dilator tip having a greater diameter than the distal opening of the elongated sleeve.
Horzewski, in the same field of art, teaches providing an introducer sheath (see Fig. 5A) comprising an elongated sleeve (90) with a dilator (150) having a dilator tip of greater diameter than the distal opening of the elongated sleeve (see Fig. 5A) which allows for the introduction of larger devices through the lumen of the sheath (see col. 12, line 63 – col. 13, line 21).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Worthley and Kirt so that the dilator has a dilator tip of greater diameter than the distal opening of the elongated sleeve, as taught by Horzewski, since doing so would allow for the introduction of larger diameter devices through the introducer sheath.
Regarding claim 18, the combination of Worthley and Kirt teaches the method according to claim 17. Worthley further teaches the step of: obtaining a dilator (510, see Fig. 5a) having a dilator tip (520), passing the dilator tip through a lumen formed by the expandable inner sheet and along the length of the circumferentially retractable elongated sleeve (see Fig. 5a-5c).
Worthley fails to expressly teach the dilator tip having a greater diameter than the distal opening of the elongated sleeve.
Horzewski, in the same field of art, teaches providing an introducer sheath (see Fig. 5A) comprising an elongated sleeve (90) with a dilator (150) having a dilator tip of greater diameter than the distal opening of the elongated sleeve (see Fig. 5A) which allows for the introduction of larger devices through the lumen of the sheath (see col. 12, line 63 – col. 13, line 21).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Worthley and Kirt so that the dilator has a dilator tip of greater diameter than the distal opening of the elongated sleeve, as taught by Horzewski, since doing so would allow for the introduction of larger diameter devices through the introducer sheath.
Regarding claim 19, Worthley further teaches the step of: passing the dilator tip and introducer sheath through a blood vessel wall (see [0057]).
Conclusion
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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