DETAILED ACTION
Previous Action Withdrawn
The Office action mailed 07/02/2026 has been vacated/withdrawn.
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 Objections
Claim 29 is objected to because of the following informalities:
In claim 29, “the lumen of the circumferentially retractable elongated sleeve” should read “a lumen of the circumferentially retractable elongated sleeve”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 35 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 35 recites “the inner surface of the elastomeric outer tube is at least partially formed by the one or more support elements” which in combination with the “an elastomeric outer tube having a smooth and continuous inner surface along its length and including one or more longitudinally extending stiffening ridges on its outer surface, wherein each of the stiffening ridges comprises a support element” recited in claim 1 is considered new matter. Specifically, the combination of a stiffening ridge on the outer surface of the outer tube and including a support element which partially forms the inner surface of the outer tube was not described in the specification as originally filed.
The embodiment in which a stiffening ridge or support element is on the outer surface of the tube, does not also have a support element partially forming the inner surface of the outer tube (see Fig. 6b and paragraphs [0076] and [0101] which describe support element 370 as external and affixed to the outer surface of the tube).
The embodiments of the outer tube which have a support element partially forming an inner surface of the outer tube, do not have stiffening ridges on the outer surface of the tube (see Fig. 4a – 6a and 8). Instead, in these embodiments the outer profile of the outer tube protrudes outward to form protuberances (i.e., the outer surface itself forms a ridge of the outer tube) (see Fig. 4a-5a, Fig. 8 and paragraphs [0096] and [0097]) or the support element partially forms the outer surface of the tube (see Fig. 6a and paragraph [0100]).
While Applicant discloses that “features, elements and/or characteristics described with respect to one embodiment of the disclosure may be used with other embodiments of the invention, as desired” (see paragraph [0115]), it is not clear from the disclosure how these features would be combined to meet the limitations of claim 33.
Appropriate action is required.
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 21, 26-27, 32, and 39 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 21 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 following is being treated as not being required by the claim.
Claim 26 recites 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 claim 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 27 and 39 each recite the limitation “the modulus” 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 refers 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.
Claim 32 recites the limitation “the dilator tip” in line 30. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the dilator tip” has been interpreted as “a dilator tip.”
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 20-24, 26, 28, 30 and 32 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 20, 21 and 23, Worthley discloses a system (see Fig. 4a-5b) for protecting a luminal surface of a blood vessel, the system including an introducer sheath comprising: 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) extending longitudinally and spanning the entire length of the sleeve (see [0077]); wherein the circumferentially continuous 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), and 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).
Worthley fails to teach one or more support elements extending longitudinally from the distal opening towards the proximal opening.
Kirt, in the same field of art, teaches a related introducer sheath (see Fig. 1-3) comprising a circumferentially continuous elastomeric outer tube (30) comprising 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 partially formed by the one or more support elements (see Fig. 2 and [0067]). The support elements of Kirt provide reinforcement to the introducer sheath (see [0048]) which is understood to impact several 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 one or more support elements, 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 21, as noted above in the rejection of the claim under 35 U.S.C. 112(b), this limitation has been interpreted as not being required by the claim.
Regarding claim 22, the combination of Worthley and Kirt further teaches the outer surface of the elastomeric outer tube is formed by an elastomeric layer (in the introducer sheath of the combination of Worthley and Kirt, the support elements of Kirt would be radially inward of the outer tube of Worthley, similarly as shown in Fig. 2 of Kirt, and therefore the outer surface of the elastomeric tube would be formed by an elastomeric layer).
Regarding claim 24, 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 circumferentially continuous elastomeric outer tube (Kirt teaches support element formed by spines 44 which are a part of reinforcing member 40 extend longitudinally, see Fig. 3 of Kirt, and the reinforcing member 40 is bonded to the outer sheath 30, see [0067]), wherein the one or more support elements are configured to resist longitudinal compression of the circumferentially continuous elastomeric outer tube along the entire length of the sleeve (the support elements of Kirt in the device of Worthley would be capable of resisting longitudinal compression of the elastomeric outer tube along its entire length because they would provide structural reinforcement and Kirt teaches the support layer extending along the entire length of the outer tube).
Regarding claim 26, 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 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 claim 28, Kirt further teaches the one or more support elements are formed from a combination of 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 30, 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) , and extending longitudinally and spanning the entire length of the sleeve (see [0077]), wherein the circumferentially continuous elastomeric outer tube has a smooth inner surface with a substantially round cross-section, 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 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 elastomeric outer tube (30) comprising 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 partially formed by the one or more support elements (see Fig. 2 and [0067]). The support elements of Kirt provide reinforcement to the introducer sheath (see [0048]) which is understood to impact several 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 elastomeric outer tube of further included one or more support elements, 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 “wherein the one or more support elements are configured to resist longitudinal compression of the circumferentially continuous elastomeric outer tube,” the support elements of Kirt in the device of Worthley would be capable of resisting longitudinal compression of the elastomeric outer tube because they would provide structural reinforcement.
Regarding claim 32, Worthley further teaches the step of: passing a dilator tip and the introducer sheath through a blood vessel wall (see [0057]).
Claims 25 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Worthley and Kirt, as applied to claims 20 above, and further in view of Korkuch et al. (US 2019/0351194).
Regarding claim 25, the combination of Worthley and Kurt teaches the system according to claim 20. 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 claim 27, the combination of Worthley and Kurt teaches the system according to claim 20. 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 outer tube. 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 outer tube, as taught by Korkuch, since doing so would improve the kink resistance of the sheath.
Claims 29 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Worthley and Kirt, as applied to claims 20 and 30 above, and further in view of Horzewski et al. (US 5,318,588 A).
Regarding claim 29, the combination of Worthley and Kirt teaches the system according to claim 20. 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 31, the combination of Worthley and Kirt teaches the method according to claim 30. 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.
Claims 33-34 and 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over Worthley in view of Zhou et al. (US 10,327,896 B2) and further in view of Horzewski.
Regarding claim 33, Worthley discloses a system (see Fig. 4a-5b) for protecting a luminal surface of a blood vessel, the system including: an introducer sheath (200) comprising: an elastomeric outer tube (410) having a smooth and continuous inner surface along its length, and a coiled expandable inner sheet (420) positioned within a lumen of the elastomeric outer tube; and a dilator (510) having a dilator tip (520), wherein the dilator tip is configured to pass through a lumen of the coiled expandable inner sheet (see Fig. 5a-5b).
Worthley fails to teach the elastomeric outer tube further comprising one or more longitudinally extending stiffening ridges on its outer surface, wherein each of the stiffening ridges comprises a support element and the dilator tip being of greater diameter than a distal opening of the elastomeric outer tube.
Zhou, in the same field of art, teaches multiple embodiments of an introducer sheath (3, see Fig. 1-3) comprising an elastomeric outer tube (54, see Fig. 15 and col. 14, lines 29-36) and including one or more longitudinally extending stiffening ridges on its outer surface, wherein each of the stiffening ridges comprises a support element (stiff wall portions 52 form ridges on the outer surface of stiff wall portion 54). The combination of elastic and stiff wall portions “allow for torque and push strength to advance the expandable sheath while at the same time accommodating temporary expansion” (see Abstract).
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 elastomeric outer tube of Worthley to further include stiffening ridges, as taught by Zhou, since doing so would provide the sheath with structural reinforcement and desirable mechanical properties which impact navigability.
The combination of Worthley and Zhou fails to teach the dilator tip being of greater diameter than a distal opening of the elastomeric outer tube.
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 Zhou so that the dilator has a dilator tip of greater diameter than the distal opening of the elastomeric outer tube, as taught by Horzewski, since doing so would allow for the introduction of larger diameter devices through the introducer sheath.
Regarding claim 34, Worthley further discloses the introducer sheath further comprises an annular collar (210, see Fig. 4a) formed of a rigid material (the collar is rigid, see [0073]) and having attached thereto a proximal opening of the elastomeric outer tube , the annular collar being configured to allow a user to introduce materials into the lumen of the elastomeric outer tube (the annular collar allows a user to introduce material into the lumen of the outer tube as shown in Fig. 5a-5b).
Regarding claim 36, Zhou further teaches the one or more stiffening ridges comprises a longitudinally extending radial protrusion of the elastomeric outer tube (see Fig. 15).
Regarding claim 37, Worthley further discloses the introducer sheath is a flexible structure tapering, at least in part, between the proximal end and the distal end (sleeve 220 tapers from its proximal end 230 to the distal end 240, see Fig. 4a and [0074]).
Regarding claim 38, Zhou further teaches a section of the support element is thicker in the middle than at its ends (the middle section of each stiff wall portion 52 is thicker than the portion at the ends, see Fig. 15).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Worthley, Zhou, and Horzewski, as applied to claim 33 above, and further in view of Korkuch.
Regarding claim 39, the combination of Worthley, Zhou, and Horzewski teaches the system according to claim 33, but fails to teach the one or more support elements comprises a material having at least 50 times the modulus of the elastomeric outer tube.
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, Zhou, and Horzewski by selecting the material of the support elements such that the material has 50 times the elastic modulus of the elastomeric outer tube, as taught by Korkuch, since doing so would improve the kink resistance of the sheath.
Conclusion
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
