DETAILED ACTION
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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4-6, 8-9, 12, 15-17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Furnish (U.S. Pat. Pub. No. 2016/0074067 A1).
Regarding claim 1, Furnish discloses an introducer sheath assembly (10) comprising: a tubular frame (reinforcement member 26) having a lumen therein (see Fig. 1-9 and [0028-0030], wherein the frame defines a passageway/lumen for installation of a medical device 12 within the patient), wherein the tubular frame is configured to temporarily expand from a first diameter to a second larger diameter when a portion of a medical device having a diameter greater than the first diameter passes through the tubular frame (see Fig. 2-6 and [0029-0030]); a liner (inner layer 22) adjacent to an interior surface of the tubular frame (see Fig. 4 and [0032]), wherein the liner is formed from expanded polytetrafluoroethylene (ePTFE) ([0032], ln 13-15); and a hub (hemostatic valve assembly 20) coupled to a proximal end of the tubular frame, the hub including a hemostasis valve (see Fig. 1 and [0028]).
Regarding claim 4, Furnish further discloses that an outer liner (here, outer layer 24 and sheath 32 may be interpreted as forming the inner and outer portions respectively of a multilayer outer liner assembly) is formed on an exterior surface of the tubular frame (see Fig. 3-7a and [0033-0034]).
Regarding claim 5, Furnish further discloses that the frame is a laser-cut hypotube (see Fig. 7a-7c and 9-10, [0036], ln 10-16, and [0038], ln 14-17).
Regarding claim 6, Furnish further discloses that the frame is made of Nitinol ([0036], ln 10-16).
Regarding claim 8, Furnish further discloses that the outer liner is made of expanded polytetrafluoroethylene (see Fig. 4 and [0034], wherein the sheath 32, interpreted as the outer part of the multilayer outer liner, is made of expanded polytetrafluoroethylene).
Regarding claim 9, Furnish further discloses that the outer liner is multilayer (see in re claim 4).
Regarding claim 12, Furnish discloses an expandable sheath body (introducer sheath 10) comprising: a tubular frame having a lumen therein (see Fig. 1-9 and [0028-0030], wherein the frame defines a passageway/lumen for installation of a medical device 12 within the patient), the frame having interstices (see Fig. 7a-10, and [0036-0038], wherein in each frame design of Fig. 7a-10, interstices are formed between adjacent ribs 40, within loops 44, or between linkages 48 respectively), wherein the frame is expandable to a larger diameter and contractable to a smaller diameter, and also flexible (see Fig. 2-10, [0029-0030], and [0036-0038]); an inner liner (inner layer 22) formed over a surface of the lumen defined by the tubular frame (see Fig. 4 and [0032]); and an outer liner (here, outer layer 24 and sheath 32 may be interpreted as forming the inner and outer portions respectively of a multilayer outer liner assembly) formed over an exterior surface of the frame (see Fig. 3-7a and [0033-0034]).
Regarding claim 15, Furnish further discloses that the frame is a laser-cut hypotube (see in re claim 5).
Regarding claim 16, Furnish further discloses that the frame is made of Nitinol (see in re claim 6).
Regarding claim 17, Furnish further discloses that the inner liner is made of expanded polytetrafluoroethylene (see in re claim 1).
Regarding claim 19, Furnish further discloses that the outer liner is made of expanded polytetrafluoroethylene (see in re claim 8).
Regarding claim 20, Furnish further discloses that the outer liner is multilayer (see in re claim 9).
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.
Claim(s) 2-3, 7, 10-11, 13, 18, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Furnish in view of Qin (WO 2021/120740 A1).
Regarding claim 2, Furnish discloses the introducer sheath assembly of claim 1, wherein the ePTFE liner (22) is provided on the interior surface of the tubular frame (see Fig. 4 and [0028]). Furnish, however, fails to explicitly teach that the ePTFE liner is attached to the interior surface of the tubular frame.
Qin exhibits a process and configuration for making medical tubing (see Fig. 1, [0002], [0005], and [0021-0027]) similar to that of Furnish, wherein the tubing may comprise a reinforcing frame layer (braided layer 4, similar to the embodiment of Fig. 8a-8b of Furnish), an inner liner (PTFE layer 2) formed of PTFE and disposed on an interior surface of the tubular frame (see Fig. 1 and [0021-0027]), and an outer liner (outer layer 5) formed on an exterior surface of the tubular frame (see Fig. 1, [0021], and [0026]). Qin teaches teach that such a medical tubing assembly may be formed via a process in which an adhesion-promoting primer layer (adhesive/bonding layer 3, which may be thermoplastic polyurethane) is applied to the exterior surface of the PTFE liner ([0023]) in order to thereby attach the PTFE liner to the interior surface of the tubular frame, which may be provided or constructed around the PTFE liner ([0024-0025]). Qin teaches that attaching the inner PTFE liner to the interior surface of the tubular frame improves the torsion control performance of the tubing and prevents abnormal delamination between the tubing layers as may occur in use ([0002-0005] and [0015]), thus preventing degradation of the inner liner.
Based on the teachings of Qin, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce the introducer sheath of Furnish via a process like that of Qin, wherein the ePTFE liner is attached to the interior surface of the tubular frame using an adhesion-promoting primer layer (such as a layer of thermoplastic polyurethane, in the manner taught by Qin) formed between the ePTFE liner and an inner surface of the lumen defined by the tubular frame, in order to improve the torsion control performance of the introducer sheath and prevent abnormal delamination between its layers as may otherwise occur during use, as described by Qin ([0002-0005] and [0015]), thus preventing degradation of the inner liner of the introducer sheath.
Regarding claim 3, the proposed combination of Furnish as modified by Qin according to claim 2 exhibits that a primer is formed between the ePTFE liner and an inner surface of the lumen defined by the tubular frame (see above modification in re claim 2).
Regarding claim 7, Furnish discloses the introducer sheath assembly of claim 4 (see in re claim 4). While Furnish teaches that the outer liner may be made of a thermoplastic material, and mentions polyurethane as an acceptable elastomeric material ([0033], ln 6-10), Furnish fails to teach that the outer liner is made of thermoplastic polyurethane.
Qin further teaches that the outer liner (outer layer 5) should be compatible with the adhesion-promoting primer layer (adhesive/bonding layer 3), which may be thermoplastic polyurethane ([0023], ln 5-6), in order to ensure a good bond between the layers ([0026]). Qin thus teaches that the outer liner (outer layer 5) may also be made of thermoplastic polyurethane ([0026]). It would thus have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as a part of the above described modification in re claim 2 and in view of Furnish’s own teachings and suggestions concerning the outer liner material, to form the outer liner as being made of thermoplastic polyurethane, thereby ensuring compatibility with the adhesion-promoting primer layer incorporated from Qin (see in re claim 2).
Regarding claim 10, Furnish further teaches that the outer liner may comprise two layers (here, outer layer 24 and sheath 32 may be interpreted as forming the inner and outer portions respectively of a multilayer outer liner assembly), wherein a first layer (outer layer 24) is formed over the exterior surface of the frame (see Fig. 3-7a and [0033]). While Furnish teaches that the first layer may be made of a thermoplastic material, and mentions polyurethane as an acceptable elastomeric material ([0033], ln 6-10), Furnish fails to explicitly teach that the first layer comprises thermoplastic polyurethane. Furnish, however, it would have been obvious to one of ordinary skill in the art to modify the first layer of Furnish to be made of thermoplastic polyurethane in the same manner and for the same reasons described above in re claim 7.
Regarding claim 11, Furnish further discloses that a second layer (sheath 32) of the two layers of the outer liner is formed over the first layer (see Fig. 2-4 and [0034]), wherein the second layer comprises expanded polytetrafluoroethylene ([0034]).
Regarding claim 13, the proposed combination of Furnish and Qin according to claim 2 exhibits that a primer is formed between the inner liner and the surface of the lumen defined by the tubular frame (see above modification in re claim 2).
Regarding claim 18, the proposed combination of Furnish and Qin according to claim 7 exhibits that the outer liner is made of thermoplastic polyurethane (see in re claim 7).
Regarding claim 21, the proposed combination of Furnish as modified by Qin according to claim 10 exhibits that the outer liner comprises two layers, wherein a first layer is formed over the exterior surface of the frame, wherein the first layer comprises thermoplastic polyurethane (see in re claim 10).
Regarding claim 22, Furnish further discloses that a second layer of the two layers of the outer liner is formed over the first layer, wherein the second layer comprises expanded polytetrafluoroethylene (see in re claim 11).
Claim(s) 7, 10-11, 14, 18, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Furnish in view of Korkuch (U.S. Pat. Pub. No. 2019/0247627 A1).
Regarding claim 7, Furnish discloses the introducer sheath assembly of claim 4 (see in re claim 4). While Furnish teaches that the outer liner may be made of a thermoplastic material, and mentions polyurethane as an acceptable elastomeric material ([0033], ln 6-10), Furnish fails to teach that the outer liner is made of thermoplastic polyurethane, Furnish fails to teach that the outer liner is made of thermoplastic polyurethane.
Korkuch exhibits an expandable introducer sheath assembly (100) very similar to that of Furnish (see Fig. 1-58), wherein the sheath portion (200) may comprise a Nitinol braid ([0151], ln 1-2 and [0152], ln 1-4) or laser cut frame (Fig. 10, [0151], ln 1-3, similar to that of Furnish), upon which an outer liner (polymer coating 1206, applied to the outer diameter of the frame/braid) and inner liner (same material, applied to the inner diameter of the frame/braid) may be provided ([0158-0159]). Korkuch teaches that the outer liner may be made of thermoplastic polyurethane ([0170], ln 3-5) in order to allow for maintaining axial stiffness and elasticity of the sheath ([0170], ln 1-5, and [0171]), while also providing a compatible base layer upon which additional lubricious coatings may be provided ([0170], ln 27-30).
Based on the teachings of Korkuch, and the teachings and suggestions of Furnish, 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 outer liner of Furnish to be made of thermoplastic polyurethane, since this material is known to be suitable for use as an outer liner of an expandable introducer sheath (see example of Korkuch and teachings of Furnish), and since this material choice allows for maintaining axial stiffness and elasticity of the sheath, while also providing a compatible base layer upon which additional lubricious coatings (such as Furnish’s ePTFE sheath layer 32) may be provided, as described by Korkuch ([0170], ln 1-5 and ln 27-30, and [0171]).
Regarding claim 10, Furnish further teaches that the outer liner may comprise two layers (here, outer layer 24 and sheath 32 may be interpreted as forming the inner and outer portions respectively of a multilayer outer liner assembly), wherein a first layer (outer layer 24) is formed over the exterior surface of the frame (see Fig. 3-7a and [0033]). While Furnish teaches that the first layer may be made of a thermoplastic material, and mentions polyurethane as an acceptable elastomeric material ([0033], ln 6-10), Furnish fails to explicitly teach that the first layer comprises thermoplastic polyurethane. Furnish, however, it would have been obvious to one of ordinary skill in the art to modify the first layer of Furnish to be made of thermoplastic polyurethane in the same manner and for the same reasons described above in re claim 7.
Regarding claim 11, Furnish further discloses that a second layer (sheath 32) of the two layers of the outer liner is formed over the first layer (see Fig. 2-4 and [0034]), wherein the second layer comprises expanded polytetrafluoroethylene ([0034]).
Regarding claim 14, Furnish exhibits the expandable sheath body of claim 12 (see in re claim 12). Furnish fails to teach that a primer is formed between the outer liner and the exterior surface of the frame.
Korkuch further teaches the outer liner (polymer layer) may be adhered onto the exterior surface of the frame by use of a primer (a low bodied TPU solvent) which is (at least temporarily) formed between the outer liner and the exterior surface of the frame (see [0173-0178]).
Based on the teachings of Korkuch, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the outer liner of Furnish as being adhered to the exterior surface of the frame according to the method taught by Korkuch, in order to thereby provide the maintained axial stiffness and elasticity of the sheath as described by Korkuch ([0170], ln 1-5, and [0171]), and to prevent delamination between the layers which may degrade the integrity of the introducer sheath.
Regarding claim 18, the proposed combination of Furnish as modified by Korkuch according to claim 7 exhibits that the outer liner may be made of thermoplastic polyurethane (see in re claim 7).
Regarding claim 21, the proposed combination of Furnish as modified by Korkuch according to claim 10 exhibits that the outer liner comprises two layers, wherein a first layer is formed over the exterior surface of the frame, wherein the first layer comprises thermoplastic polyurethane (see in re claim 10).
Regarding claim 22, Furnish further discloses that a second layer of the two layers of the outer liner is formed over the first layer, wherein the second layer comprises expanded polytetrafluoroethylene (see in re claim 11).
Claim(s) 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Furnish in view of Aizenberg (U.S. Pat. Pub. No. 2014/0187666 A1).
Regarding claim 23, Furnish discloses the expandable sheath of claim 17. Furnish fails to teach that the expanded polytetrafluoroethylene is infused with silicone oil.
Aizenberg exhibits a self-lubricating surface configuration (a SLIPS surface – see Fig. 1-35 and [0013-0018], and [0107-0110]) that may be applied as a coating/liner for medical tubing (see Fig. 7C-9B and 35, [0109], ln 17-20, [0116], and [0147]), such as the introducer sheath of Furnish. Aizenberg teaches that such a liner/coating may comprise a porous substrate of expanded polytetrafluoroethylene ([0117], ln 14-15, [0122], [0127], ln 8-11), which may be infused with a lubricating liquid (Liquid B) of silicone oil (see Fig. 7D-9B, [0017-0018], [0152], ln 8-10, [0187], ln 1-11, and [0188], wherein polydimethylsiloxane is silicone oil, and may be applied to a ePTFE membrane substrate as a lubricating liquid – Liquid B) in order to thereby provide a coating that is highly effective at preventing adhesion of proteins, microbes, blood, issue, and the like ([0187], ln 13-15, [0188], and [0246]). Aizenberg further teaches that such a coating may be formed on the interior of medical tubing by providing the tubing with an inner liner of roughened expanded polytetrafluoroethylene (see Fig. 7D-9B, [0144], ln 5-6, and [0163], wherein the substrate may be expanded polytetrafluoroethylene, as described above) and by exposing the roughened surface of the expanded polytetrafluoroethylene to silicone oil, whereupon the expanded polytetrafluoroethylene may be infused with the silicone oil by wicking of the silicone oil from the liquid surface against which the layer of expanded polytetrafluoroethylene is exposed (see Fig. 7D-9B, [0119-0127], wherein substrates, including porous expanded polytetrafluoroethylene, may be formed and roughened in a manner that promotes wicking, and see [0159-0160] and [0162-0163], wherein lubricating liquid, which may be silicone oil as described above, may be applied as liquid surfaces which infiltrate the roughened surface of the substrate, which may be porous expanded polytetrafluoroethylene, by capillary action – i.e. wicking). Aizenberg teaches that such a lubricant-infused inner coating is desirable in order to prevent or reduce adhesion of proteins, microbes, blood, issue, and the like ([0246]) and to allow the coatings to be self-healing, thereby maintaining lubricity even if scraped/damaged ([0109], ln 13 - [0110], ln 5, and [0169]).
Based on the teachings of Aizenberg, 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 expanded polytetrafluoroethylene inner liner of Furnish to be formed as a SLIPS surface infused with silicone oil in the manner described by Aizenberg, since such a configuration improves upon the lubricity of the inner liner by preventing or reducing adhesion of proteins, microbes, blood, issue, and other such accumulations to the inner liner, as described by Aizenberg ([0246]), each of which may inhibit delivery of the medical device, and in order to allow the coatings to be self-healing, thereby maintaining lubricity even if scraped/damaged during use ([0109], ln 13 - [0110], ln 5).
Regarding claim 24, Furnish fails to teach that the expanded polytetrafluoroethylene may be infused with silicone oil by wicking the silicone oil from a surface against which a layer of expanded polytetrafluoroethylene is placed, however, Aizenberg further teaches that the expanded polytetrafluoroethylene may be infused with silicone oil by wicking the silicone oil from a surface (the liquid surface of the liquid silicone oil applied to the roughened expanded polytetrafluoroethylene liner) against which a layer of expanded polytetrafluoroethylene is exposed during manufacturing (see in re claim 23). As such, it would further have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to implement the modification described above in re claim 23 according to the method taught by Aizenberg, such that the expanded polytetrafluoroethylene may be infused with silicone oil by wicking the silicone oil from a surface (the liquid surface of the liquid silicone oil applied to the roughened expanded polytetrafluoroethylene liner) against which a layer of expanded polytetrafluoroethylene is exposed during manufacturing.
Claim(s) 25 is rejected under 35 U.S.C. 103 as being unpatentable over Furnish as modified by Aizenberg according to claim 23, and in further view of Aizenberg, Harding (U.S. Pat. Pub. No. 2008/0161763 A1) and Bandyopadhyay (WO 2022/212785 A1).
Regarding claim 25, Furnish as modified by Aizenberg according to claim 23 exhibits the expandable sheath of claim 23. Furnish fails to teach that the expanded polytetrafluoroethylene has a density of about 0.4 g/cc and the silicone oil has a viscosity of about 350 cP, however, it is clear from the teachings of Aizenberg that the porosity of the expanded polytetrafluoroethylene liner (and thereby the density, which is inversely related to porosity for a given composition) plays a role in the liner’s ability to be infused with and retain lubricating liquid, which may be silicone oil (see above discussion in re Aizenberg, and associated citations). Aizenberg further teaches that, alongside porosity and roughness, the viscosity of the lubricating liquid, which may be silicone oil, directly determines the amount of time that the SLIPS surface needs to self-heal ([0169], ln 1-12). While both Aizenberg and Furnish fail to teach that the expanded polytetrafluoroethylene may have a density of about 0.4 g/cc and the silicone oil has a viscosity of about 350 cP (neither references give any explicit indication of the density of the expanded polytetrafluoroethylene or viscosity of the silicone oil), such values are known within the art to be suitable for use in similar medical devices.
For example, Harding exhibits a vascular access device (Fig. 1), wherein a portion (slit 24 of septum 22) of the device comprises a lubricious and antimicrobial inner lining of PTFE ([0049]), and wherein a lubricating coating of silicone oil may be applied onto the PTFE lining ([0050-0051]). Harding teaches that a suitable viscosity for silicone oil in such an application may be greater than or equal to 300 cP. Such a range encompasses “about 350 cP” as being known within the art to be suitable in medical lubrication applications, such as that of Furnish as modified by Aizenberg.
Bandyopadhyay exhibits a catheter (1) (see Fig. 1-2 and [00010]), wherein the catheter tubing may be formed of porous ePTFE ([00023]). Bandyopadhyay teaches that the known range of suitable densities for such porous ePTFE tubing layers is between 0.3 g/cc and 1.9 g/cc ([00025]). Such a range encompasses “about 0.4 g/cc” as being known within the art to be suitable in medical lubrication applications, such as that of Furnish as modified by Aizenberg.
Based on the teachings of Aizenberg, wherein density of the porous ePTFE and viscosity of the silicone oil may be recognized as result effective variables governing the lubricity and self-healing capabilities of the SLIPS surface, and based upon the examples of Harding and Bandyopadhyay, which establish that a density of porous ePTFE (like that of Furnish as modified by Aizenberg) of about 0.4 g/cc and a viscosity of silicone oil of about 350 cP are known within the art to be suitable in similar applications, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to embody the porous ePTFE and silicone oil as comprising these values of density and viscosity, respectively, as a matter of routine design optimization, whereupon values of each of these variables would be routinely selected from within ranges known to be suitable within the art in order to achieve a desired set of performance characteristics (lubricity, lubricant retention, strength, self-healing response time, etc.) in a known manner. See MPEP 2144.05(II).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric A Lange whose telephone number is (571)272-9202. The examiner can normally be reached on M-F 8:30am-noon and 1pm-5:30pm.
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/ERIC A LANGE/Examiner, Art Unit 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783