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 .
Election/Restrictions
Applicant’s election without traverse of the embodiment of Figs. 37A-40 in the reply filed on 2/3/26 is acknowledged. Claim 10 is withdrawn from consideration by the examiner as being directed to a non-elected invention.
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.
Claim 1-3, 6, 9, 11, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen (US2019/0029823).
Regarding claim 1, Nguyen discloses a sheath (100) for delivering a medical device ([0135]), wherein the sheath has a proximal and a distal end ([0133]) and comprises:
an expandable inner layer (108) having an inner surface and an outer surface (see Fig. 39), wherein the inner surface of the expandable inner layer defines a lumen having a longitudinal axis (see Fig. 39, [0134]) and comprising at least one folded portion (118) having an inner portion and an outer portion (see annotated Fig. 39-2);
an outer layer having an inner surface and an outer surface (see Fig. 39) and extending at least partially around the inner layer such that at least a first portion of the outer surface of the outer layer is positioned adjacent to the inner portion of the at least one folded portion of the inner layer (see annotated Fig. 39-2), while a first portion of the inner surface of the outer layer is positioned adjacent to the outer portion of the at least one folded portion of the inner layer (see annotated Fig. 39-2);
a first polymer (128, where 128 comprises a polyurethane, [0135]) disposed between at least a portion of the inner layer and at least a portion of the outer layer ([0135]), forming an intermediate layer (128),
wherein the first polymer exhibits a melting temperature from about 30 0C to about 450C (the layer 128 is made of tecoflex, [0135], which is capable of having a melting temperature in the range claimed dependent on the formulation).
wherein the at least one folded portion is configured to at least partially unfold during application of a radial outward force by passage of a medical device through the lumen of the inner layer ([0136]).
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Regarding claim 2, Nguyen discloses the sheath of claim 1, wherein the first polymer is disposed between the at least the first portion of the outer surface of the outer layer and the inner portion of the at least one folded portion of the inner layer (see annotated Fig. 39-2, where layer 128 extends over top of fold 118).
Regarding claim 3, Nguyen discloses the sheath of claim 1, wherein the first polymer is disposed between at least the first portion of the inner surface of the outer layer and the outer portion of the at least one folded portion of the inner layer (see annotated Fig. 39, where layer 128 extends over the top of fold 118).
Regarding claim 6, Nguyen discloses the sheath of claim 2, wherein the first polymer disposed between the first portion of the outer surface of the outer layer and the inner portion of the at least one folded portion of the inner layer along a longitudinal axis of the folded portion (where inner portion of the at least one folded of the inner layer includes a portion of the inner layer that includes the fold that is under the adhesive 128, see annotated Fig. 39-2).
Regarding claim 9, Nguyen discloses the sheath of claim 1, wherein the expandable inner layer comprises a fluoropolymer, high density polyethylene (HDPE), or a combination thereof ([0127]).
Regarding claim 11, Nguyen discloses the sheath of claim 1, wherein the inner surface of the outer layer comprises a third portion configured to seal with the outer surface of the inner layer at at least a portion of the distal end of the sheath (third portion is interpreted as a portion of the outer layer 110 that is sealed to the inner layer 108 by the layer 128 that extends along the entire length of the sheath 100, [0135]) and a fourth portion configured to seal with the outer surface of the inner layer at at least a portion of the proximal end of the sheath (fourth portion is interpreted as a portion of the outer layer 110 that is sealed to the inner layer 108 by the layer 128 that extends along the entire length of the sheath 100, [0135]).
Regarding claim 19, Nguyen discloses the sheath of claim 1, wherein the folded portion comprises a first folded edge and a second folded edge and an overlapping portion extending circumferentially between the first and second folded edges, the overlapping portion comprising an overlap in a radial direction of at least two thicknesses of the inner layer (see Fig. 39), and wherein the first folded edge is configured to move closer to the second folded edge to shorten the overlapping portion at a local axial location during application of a radial outward force by passage of the medical device and wherein shortening of the overlapping portion corresponds with a local expansion of the lumen (the fold 118 would shorten when unfolded in the manner as claimed as described in [0136]).
Regarding claim 20, Nguyen discloses the sheath of claim 2, wherein the folded portion comprises a first folded edge and a second folded edge and an overlapping portion extending circumferentially between the first and second folded edges (see Fig. 39), the overlapping portion comprising an overlap in a radial direction of at least two thicknesses of the inner layer (see Fig. 39),
wherein the first folded edge is configured to move closer to the second folded edge to shorten the overlapping portion at a local axial location during application of a radial outward force by passage of the medical device and wherein shortening of the overlapping portion corresponds with a local expansion of the lumen, the overlapping portion (the fold 118 would shorten when unfolded in the manner as claimed as described in [0136]),
wherein the outer layer includes a first longitudinally extending edge and a second longitudinally extending edge configured to separate as the sheath expands, the first longitudinal extending edge and an overlapping portion of the outer layer extending over the second longitudinal extending edge when the sheath is not expanded (see annotated Fig. 39-3), and
wherein the first polymer is provided between the at least the first portion of the outer surface of the outer layer proximate to the second longitudinally extending edge and the inner surface of the overlapping portion of the folded portion (overlapping portion is interpreted as including the inner layer 108 that forms the inner lumen, where the adhesive 128 would extend between the extended portion of the overlapping portion and the outer surface of the outer layer, see annotated Fig. 39-3).
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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 of this title, 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 4, 5, 7, 8, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US2019/0029823).
Regarding claim 4, Nguyen discloses the sheath of claim 1; yet, does not explicitly disclose wherein the sheath further comprises an outer jacket comprising an inner surface and outer surface extending at least partially around the outer layer such that the inner surface of the outer jacket overlies the outer surface of the outer layer. Nguyen according to the embodiment of sheath 22 teaches an additional outer covering 50 (outer jacket) that covers the outer layer 26 of the sheath ([0092]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have modified the sheath to include an outer jacket that covers the outer layer in order to protect the sheath prior to insertion of the sheath into the patient’s body ([0092]).
Regarding claim 5, Nguyen makes obvious the sheath of claim 4, wherein the first polymer is disposed between at least a portion of the inner surface of the outer jacket and at least a portion of the outer surface of the outer layer (where the modified invention would have the outer jacket over the outer layer, and a portion of the outer surface of the outer layer would be the underlying portion 122, where the layer 128 would be between the outer jacket and portion 122, see Fig. 39).
Regarding claim 12, Nguyen makes obvious the sheath of claim 4, the modified invention discloses wherein the outer surface of the outer layer comprises a second portion configured to seal with at least a first portion of the inner surface of the outer jacket at least a portion of the distal end of the sheath (the modified outer cover would extend along the distal end of the sheath 100 until removed, [0092]; where the second portion of the outer layer 110 is a portion that is covered by the outer cover and where the seal is formed by the covering of the outer cover over the outer layer 110).
Regarding claim 7, Nguyen makes obvious the sheath of claim 1; yet, is silent regarding wherein the sheath further comprises a tie layer disposed between at least a second portion of the inner surface of the outer layer and at least a portion of the outer surface of the inner layer, such that it is configured to seal the at least a second portion of the inner surface of the outer layer with the at least a portion of the outer surface of the inner layer. Nguyen according to the embodiment of sheath 22 teaches an additional outer covering 50 (tie layer) that covers the outer layer 26 of the sheath ([0092]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have modified the sheath to include an outer jacket that covers the outer layer in order to protect the sheath prior to insertion of the sheath into the patient’s body ([0092]). Where the outer covering 50 (tie layer) would be between at least a second portion of the inner surface of the outer layer and at least a portion of the outer surface of the inner layer by extending radially between the portions. Furthermore, the outer covering 50 (tie layer) could act as a seal by covering the portions.
Regarding claim 8, Nguyen makes obvious the sheath of claim 7, wherein the tie layer is disposed between the inner surface of the outer layer and the outer surface of the inner layer along a circumference of the inner layer along its longitudinal axis (the outer covering 50 or tie layer as taught by Nguyen would extending circumferentially between the two portions in the same manner as claimed).
Claims 1, 2, 4, 9, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US2019/0029823) in view of Wada (US2019/0192826).
Regarding claim 1, Nguyen under a different interpretation discloses a sheath (100) for delivering a medical device ([0135]), wherein the sheath has a proximal and a distal end ([0133]) and comprises:
an expandable inner layer (108) having an inner surface and an outer surface (see Fig. 39), wherein the inner surface of the expandable inner layer defines a lumen having a longitudinal axis (see Fig. 39, [0134]) and comprising at least one folded portion (118) having an inner portion and an outer portion (see annotated Fig. 39-2);
an outer layer having an inner surface and an outer surface (see Fig. 39) and extending at least partially around the inner layer such that at least a first portion of the outer surface of the outer layer is positioned adjacent to the inner portion of the at least one folded portion of the inner layer (see annotated Fig. 39-2), while a first portion of the inner surface of the outer layer is positioned adjacent to the outer portion of the at least one folded portion of the inner layer (see annotated Fig. 39);
wherein the at least one folded portion is configured to at least partially unfold during application of a radial outward force by passage of a medical device through the lumen of the inner layer ([0136]).
Nguyen does not explicitly disclose a first polymer disposed between at least a portion of the inner layer and at least a portion of the outer layer, forming an intermediate layer, wherein the first polymer exhibits a melting temperature from about 30 0C to about 450C. Wada teaches catheter 110 that includes a lubricating layer 170 on the outer surface that can be made of polyethylene glycol (PEG) material ([0043]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have modified the outer layer of the outer surface to include a lubricant layer made of PEG as taught by Wada in order to provide for surface lubricity when making contact with the body or another component ([0042]).
Nguyen/Wada teaches the first polymer exhibits a melting temperature from about 30 0C to about 450C, since the sheath would have the same composition of the claimed invention and is capable of exhibiting the same characteristics as the claimed invention.
Regarding claim 2, Nguyen/Wada makes obvious the sheath of claim 1, wherein the first polymer is disposed between the at least the first portion of the outer surface of the outer layer and the inner portion of the at least one folded portion of the inner layer (the intermediate layer as added by Wada, would be on the outer surface of outer layer around the entire circumference and therefore in the folded portion the intermediate layer would be between the outer surface of the outer layer and inner portion of the at least one folded portion such as in Fig. 39 of Nguyen).
Regarding claim 4, Nguyen/Wada makes obvious the sheath of claim 1; yet, does not explicitly disclose wherein the sheath further comprises an outer jacket comprising an inner surface and outer surface extending at least partially around the outer layer such that the inner surface of the outer jacket overlies the outer surface of the outer layer. Nguyen according to the embodiment of sheath 22 teaches an additional outer covering 50 (outer jacket) that covers the outer layer 26 of the sheath ([0092]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have modified the sheath to include an outer jacket that covers the outer layer in order to protect the sheath prior to insertion of the sheath into the patient’s body ([0092]).
Regarding claim 9, Nguyen/Wada makes obvious the sheath of claim 1, wherein the expandable inner layer comprises a fluoropolymer, high density polyethylene (HDPE), or a combination thereof ([0127]).
Regarding claim 12, Nguyen/Wada makes obvious the sheath of claim 4, the modified invention discloses wherein the outer surface of the outer layer comprises a second portion configured to seal with at least a first portion of the inner surface of the outer jacket at at least a portion of the distal end of the sheath (the modified outer cover would extend along the distal end of the sheath 100 until removed, [0092]; where the second portion of the outer layer 110 is a portion that is covered by the outer cover and where the seal is formed by the covering of the outer cover over the outer layer 110).
Regarding claim 15, Nguyen/Wada makes obvious sheath of claim 1, wherein the sheath exhibits at least about 5% reduction in insertion force when inserted into a body having a temperature of 37 °C when compared to a substantially identical reference sheath without the first polymer (the sheath would exhibit this reduction in insertion force when compared to a sheath of a different material, since it is the same material construction of the claimed invention).
Claims 17 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US2019/0029823) in view of Wada (US2019/0192826) as applied to claim 1, and further in view of Cruise (WO2020/159881).
Regarding claim 17, Nguyen/Wada makes obvious the sheath of claim 1; yet, does not explicitly disclose wherein the first polymer comprises polyethylene glycol (PEG) having a molecular weight from about 500 to about 1,500 g/mol. Cruise sets forth that the molecular weight is a result effective variable, dependent on the desired amount of lubricity ([0006]) and can range from 500 g/mol and higher ([0043]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have the molecular weight be from about 500 to about 1500 g/mol, for the purpose of providing lubricity to the sheath, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 13, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US2019/0029823) in view of Wada (US2019/0192826) as applied to claims 2 and 1, respectively and further in view of Accisano (US2017/0340867).
Regarding claim 13, Nguyen/Wada makes obvious the sheath of claim 2, wherein the first polymer adheres the first portion of the outer surface of the outer layer to the inner portion of the at least one folded portion of the inner layer (see annotated Fig. 39-2 from the rejection of claim 1, where the first portion of the outer surface of the outer layer and the inner portion of the at least one folded portion of the inner layer are adhered at least indirectly by the polymer 128 that extends in between the inner and outer layer 108, 110 along the circumference of the sheath). Nguyen does not explicitly disclose the first polymer is solid at a temperature below 30°C. Accisano teaches an introducer that is stiff or solid at room temperature and softens as the material warms to body temperature ([0052]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have modified the polymer of Nguyen/Wada to be solid at a temperature below 30°C as taught Accisano in order to allow the lubricant of Nguyen/Wada to transition to a softer form when making contact with other components or the tissues of the body.
Regarding claim 14, Nguyen/Wada makes obvious the sheath of claim 1, Wada further teaches wherein the intermediate layer is a lubricant ([0043]); yet, does not explicitly disclose the intermediate layer is a viscoelastic fluid at a temperature from 30°C to about 45°C. Accisano teaches an introducer that is stiff or solid at room temperature and softens as the material warms to body temperature ([0052]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have modified the polymer of Nguyen/Wada to be a viscoelastic fluid at a temperature from 30°C to about 45°C as taught Accisano in order to allow the lubricant of Nguyen/Wada to transition to a softer form when inside the body when making contact with other components or the body. The modified invention teaches the intermediate layer transitions to a viscoelastic temperature; since, the material as taught by Wada is the same composition of the claimed invention and is capable of exhibiting the same characteristics as the claimed invention and Accisano teaches it is desirable to have the transition occur at body temperature.
Regarding claim 16, Nguyen/Wada/Accisano makes obvious the sheath of claim 12, further comprising a second polymer (tecoflex layer 128) exhibiting a melting temperature above about 45°C (layer 128 is capable of having a melting temperature above 45°C, where the layers are intended to be melted and fused together, [0098]) that is disposed between the second portion of the outer surface of the outer layer at least a portion of the distal end of the sheath and the at least a first portion of the inner surface of the outer jacket (where the second portion of the outer layer 110 is a portion that is covered by the added outer cover, second portion is interpreted as having some portion over the folded portion and that would have the layer 128 between the outer layer and outer cover, see Fig. 29).
Claims 18 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US2019/0029823) in view of Wada (US2019/0192826) and Accisano (US2017/0340867) as applied to claim 16, and further in view of Cruise (WO2020/159881).
Regarding claim 18, Nguyen/Wada/Accisano makes obvious the sheath of claim 16; yet, does not explicitly disclose wherein the second polymer and/or third polymer comprises polyethylene glycol (PEG) having a molecular weight from about 1,500 to about 3,500 g/mol. Cruise sets forth that the molecular weight is a result effective variable, dependent on the desired amount of lubricity ([0006]) and can range from 500 g/mol and higher ([0043]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have the molecular weight be from about 500 to about 1500 g/mol, for the purpose of providing lubricity to the sheath, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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