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 .
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 1/14/26. The claims 1-10, 13-22, 27, 28, 33-41 are pending. The claims 1, 13, 27, and 33 are amended. Claims 11-12, 23-26, 29-32 are cancelled.
Response to Arguments
Applicant’s arguments, filed 1/14/26 with respect to the rejections of claims 1-4, 33-35, and 40 under 35 U.S.C. 102(a)(1) as being anticipated by Bullman (US10912919) have been fully considered and are partially persuasive. The amendment to claim 1 to recite “three thin bands and three thick bands” overcomes the previous rejection. However, a new grounds of rejection has been made in view of Bullman (US10912919). Applicant further argues, Bullman does not disclose “a length of an outer surface of each of said thin bands has a same longitudinal length of an outer surface of each of said thick bands when said expandable sheath is in said second diameter”. Examiner disagrees, since the longitudinal length of the thick bands of Bullman is interpreted as the length of the member 10 that is substantially the same between the two states shown in Fig. 4A, 4B.
Applicant arguments, filed 1/14/26 with respect to the rejection of claims 13, 14, 17, 19-22, and 28 under 102(a)(1) as being anticipated by Passman (US2020/0107931) have been fully considered and the amendment overcomes the previous rejection. However, a new grounds of rejection has been made in view of Passman (US2020/0107931) in view of Liu (US2020/0179657). Applicant argues, the modified invention does not disclose the longitudinal shaping structure being spaced from the frame. Examiner disagrees, where the modified invention discloses the rods 140, 145 of Liu would be spaced from the frame 40 of Passman by being incorporated into the outer layer and therefore spaced radially from the inner layer with the frame of Passman.
Claim Objections
Claims 9 and 13 are objected to because of the following informalities:
Claim 9 recites ““at least three thick bands and at least three thin bands”, and claim 1 from which claim 9 depends also recites “formed of three thin bands and three thick bands”. The limitation from claim 9 appears to be a repeated limitation and should be removed.
Claim 13, line 9 recites “frame includes a plurality of arcuate portions” should be changed to “the frame includes a plurality of arcuate portions”.
Claim 13, line 17 recites “longitudinal shaping structures” should be changed to recite “longitudinal shaping structure”.
Appropriate correction is required.
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.
Claims 33-35 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bullman (US10912919).
Regarding claim 33, Bullman discloses an expandable sheath that provides access to a body passageway for delivering a medical device into the body passageway (see Abstract);
said expandable sheath is expandable from a first diameter to a second diameter (C6:L40-45); said second diameter is greater than said first diameter (see Figs. 4A, 4B);
said expandable sheath includes an internal cavity (lumen, C9:L12-15) that extends a longitudinal length of said expandable sheath (see Fig. 8);
said expandable sheath includes a plurality of thin bands (30) and plurality of thick bands (20) that extend along a longitudinal length of said expandable sheath (see Fig. 8);
each of said thin bands include first and second ends (see annotated Fig. 4B from the rejection of claim 1);
each of said thick bands includes first and second ends (see annotated Fig. 4B from the rejection of claim 1);
each of said first end of said thick bands and thin bands are connected together (see annotated Fig. 4B from the rejection of claim 1);
each of said second end of said thick bands and thin bands are connected together (see annotated Fig. 4B from the rejection of claim 1);
each of said thin bands is configured to increase in longitudinal length when said expandable sheath expands from said first diameter to said second diameter (see Fig. 4A, 4B, the longitudinal length is interpreted as the length of the band 30 that unfolds and increases in Fig. 4B);
each of said thick bands is configured to have substantially a same shape and longitudinal length when said expandable sheath is expanded from said first diameter to said second diameter (the longitudinal length is interpreted as the length of the member 10 that is substantially the same between the two states shown in Fig. 4A, 4B);
each of said thin bands is configured to have a different shape when said expandable sheath is expanded from said first diameter to said second diameter (see Figs. 4A, 4B);
an outer perimeter of each of said thin bands and an outer perimeter of each of said thick bands has a same radius of curvature when said expandable sheath is expanded to said second diameter (see Figs. 4A, 4B);
said thick bands are non-circumferentially continuous about an outer perimeter of said expandable sheath (see Figs. 4A, 4B);
said thin bands are non-circumferentially continuous about an outer perimeter of said expandable sheath (see Figs. 4A, 4B);
one or more of said thin bands has shape memory properties (C9:L43-46);
said plurality of thick and thin bands forms a longitudinal cavity in said expandable sheath when said expandable sheath is in said second diameter (lumen of the sheath 1, C9:L13; see Figs. 4A, 4B, 8); a length of an outer surface of each of said thin bands has a same longitudinal length of an outer surface of each of said thick bands when said expandable sheath is in said second diameter (the longitudinal length is interpreted as the length of the member 10 that is substantially the same between the two states shown in Fig. 4A, 4B);
wherein said expandable sheath is configured to expand to said second diameter during movement of the medical device through said internal cavity of said expandable sheath (C4:L15-16, C9:L13-15);
said expandable sheath is configured to at least partially contract from said second diameter to said first diameter after the medical device partially or fully passes through said internal cavity of said expandable sheath (C4:L21-22, C9:L13-15); and
wherein said shape memory properties of said thin bands facilitates in causing said expandable sheath to at least partially contract from said second diameter to said first diameter after the medical device partially or fully passes through said internal cavity of said expandable sheath (C9:L43-46).
Regarding claim 34, Bullman discloses the expandable sheath as defined in claim 33, wherein a thickness of each of said thick bands along a longitudinal length of said thick band is greater than a thickness of a foldable or overlapping portion of each of said thin bands along a longitudinal length of said foldable or overlapping portion of said thin bands (C14:L4-6).
Regarding claim 35, Bullman discloses the expandable sheath as defined in claim 33, wherein a thickness of a foldable or overlapping portion of each said thin bands along a longitudinal length of said foldable or overlapping portion of said thin bands is generally does not change when said expandable sheath is expanded from said first diameter to said second diameter (the thickness of the member 30 generally does not change when expanded as shown in Figs. 4A and 4B).
Regarding claim 40, Bullman discloses the expandable sheath as defined in claim 33, wherein one or more of said thin bands is formed of a different material from one or more of said thick bands (C9:L42-49).
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.
Claims 1-6, 9, 10, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Bullman (US10912919).
Regarding claim 1, Bullman discloses an expandable sheath that provides access to a body passageway for delivering a medical device into the body passageway (see Abstract);
said expandable sheath (1) is expandable from a first diameter to a second diameter (C6:L40-45); said second diameter is greater than said first diameter (see Figs. 4A, 4B);
said expandable sheath including an internal cavity (lumen, C9:L12-15) that extends a longitudinal length of said expandable sheath (see Fig. 8);
said expandable sheath is formed of a number of bands (30) and a number of thick bands (20); each of said thick bands and thin bands extend along a majority or all of a longitudinal length of said expandable sheath (see Fig. 8);
each of said thin bands include first and second ends (see annotated Fig. 4B);
each of said thick bands includes first and second ends (see annotated Fig. 4B);
each of said first end of said thick bands and thin bands are connected together (see annotated Fig. 4B);
each of said second end of said thick bands and thin bands are connected together (see annotated Fig. 4B);
each of said thin bands is configured to increase in longitudinal length when said expandable sheath expands from said first diameter to said second diameter (see Fig. 4A, 4B, the longitudinal length is interpreted as the length of the band 30 that unfolds and increases in Fig. 4B);
each of said thick bands is configured to have substantially a same shape and longitudinal length when said expandable sheath is expanded from said first diameter to said second diameter (the longitudinal length is interpreted as the length of the member 10 that is substantially the same between the two states shown in Fig. 4A, 4B);
each of said thin bands is configured to have a different shape when said expandable sheath is expanded from said first diameter to said second diameter (see Fig. 4A, 4B);
an outer perimeter of at least one of said thin bands and an outer perimeter of at least one of said thick bands has a same radius of curvature when said expandable sheath is expanded to said second diameter (see Fig. 4A, 4B);
said thick bands are non-circumferentially continuous about an outer perimeter of said expandable sheath (see Fig. 4A, 4B);
said thin bands are non- circumferentially continuous about an outer perimeter of said expandable sheath (see Fig. 4A, 4B);
said plurality of thick and thin bands forms a longitudinal cavity in said expandable sheath when said expandable sheath is in said second diameter (lumen of the sheath 1, C9:L13; see Figs. 4A, 4B, 8); and
wherein said expandable sheath is configured to expand to said second diameter during movement of the medical device through said internal cavity of said expandable sheath (C4:L15-16, C9:L13-15); and
wherein said expandable sheath is configured to at least partially contract from said second diameter to said first diameter after the medical device partially or fully passes through said internal cavity of said expandable sheath (C4:L21-22, C9:L13-15).
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Bullman is silent regarding the number of thin bands being three and the number of thick bands being three. Applicant has not disclosed that the sheath having at least three thick bands and at least three thin bands provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [00174] of the specification. One of ordinary skill in the art would have expected the sheath of Bullman and Applicant’s invention to perform equal well with the number of thin and thick bands of Bullman or the claimed at least three thick bands and at least three thin bands because both sheaths would perform the same function of receiving a medical device equally well. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the number of thick and thin bands of the sheath of Bullman to have at least three thick bands and at least three thin bands as an obvious matter of design choice within the level of skill in the art.
Regarding claim 2, Bullman makes obvious the expandable sheath as defined in claim 1, wherein one or more of said thin bands is partially or fully formed of a shape memory material (C9:L43-46).
Regarding claim 3, Bullman makes obvious the expandable sheath as defined in claim 1, wherein one or more of said thin bands is formed of a different material from one or more of said thick bands (C9:L42-49).
Regarding claim 4, Bullman makes obvious the expandable sheath as defined in claim 1, wherein one or more of said thin bands has an S-shaped configuration when said expandable sheath in said first diameter (C2:L67; C3:L1, see Fig. 4A), and wherein one or more of said thin bands is reshaped from said S-shape configuration to an arc-shape when said expandable sheath expands from said first diameter to said second diameter (see Fig. 4B).
Regarding claim 5, Bullman makes obvious the expandable sheath as defined in claim 1; yet, does not explicitly disclose wherein one or more of said thin bands include a tapered transition having a variable thickness; said tapered transition is located at an end portion of one or more of said thin bands and terminates at said first or second end of said thick band. Applicant has not disclosed that the thin bands including a tapered transition having a variable thickness provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0177] of the specification, which states the tapered transition is not a required feature. One of ordinary skill in the art would have expected the sheath of Bullman and Applicant’s invention to perform equal well with shape of the thin bands of Bullman or the claimed thin band with a tapered transition because both thin bands would perform the same function of expanding for receiving a medical device equally well. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thin bands of Bullman to have the thin bands include a tapered transition having a variable thickness as an obvious matter of design choice within the level of skill in the art.
Regarding claim 6, Bullman makes obvious the expandable sheath as defined in claim 1; yet, does not disclose wherein a circumferential length of said one or more of said thin bands is equal to or greater than a circumferential length of said one or more of said thick bands when said expandable sheath is in said second diameter. Applicant has not disclosed that the sheath a circumferential length of the thin bands being equal to or greater than a circumferential length the thick bands when the sheath is in said second diameter provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0058] of the specification. One of ordinary skill in the art would have expected the sheath of Bullman and Applicant’s invention to perform equal well with the circumferential length of the thin bands and the circumferential length of the thick bands in the second diameter of Bullman or the claimed circumferential length of the thin bands being equal to or greater than a circumferential length the thick bands in the second diameter of the sheath because both sheaths would perform the same function of expanding for receiving a medical device equally well. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the circumferential length of the thick and thin bands in the second diameter of Bullman to have the thin bands being equal to or greater than a circumferential length the thick bands in the second diameter of the sheath as an obvious matter of design choice within the level of skill in the art.
Regarding claim 9, Bullman makes obvious the expandable sheath as defined in claim 1, wherein a plurality or all of said thin bands have the same shape, size, configuration and/or composition (C8:L64-67); however, doesn’t not explicitly disclose said expandable sheath includes at least three thick bands and at least three thin bands. Applicant has not disclosed that the sheath having at least three thick bands and at least three thin bands provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [00174] of the specification. One of ordinary skill in the art would have expected the sheath of Bullman and Applicant’s invention to perform equal well with the number of thin and thick bands of Bullman or the claimed at least three thick bands and at least three thin bands because both sheaths would perform the same function of receiving a medical device equally well. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the number of thick and thin bands of the sheath of Bullman to have at least three thick bands and at least three thin bands as an obvious matter of design choice within the level of skill in the art.
Regarding claim 10, Bullman makes obvious the expandable sheath as defined in claim 1; yet, does not explicitly disclose wherein a thinnest thickness of one or more said thin bands is 10-80% of a thickness of a maximum thickness of one or more of said thick bands. Bullman teaches thicknesses of the bands are a result effective variable in C8:L45-50. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify thickness of the thin band to be 10-80% of a thickness of the thick band, since these are result effective variables that are dependent on the expansion of the sheath and can be varied prevent tearing during expansion (C8:L45-50). 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.
Regarding claim 41, Bullman discloses the expandable sheath as defined in claim 33 above; yet, does not explicitly disclose wherein one or more of said thin bands includes a tapered transition having a variable thickness located at end portion of one or more of said thin bands and terminates at said first or second end of said thick band. Applicant has not disclosed that the thin bands including a tapered transition having a variable thickness provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0177] of the specification, which states the tapered transition is not a required feature. One of ordinary skill in the art would have expected the sheath of Bullman and Applicant’s invention to perform equal well with shape of the thin bands of Bullman or the claimed thin band with a tapered transition because both thin bands would perform the same function of expanding for receiving a medical device equally well. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thin bands of Bullman to have the thin bands include a tapered transition having a variable thickness as an obvious matter of design choice within the level of skill in the art.
Claims 7, 8, 36, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Bullman in view of Nguyen (US8690936).
Regarding claim 7, Bullman makes obvious the expandable sheath as defined in claim 1; yet, does not disclose wherein said thin bands and/or said thick bands is partially or fully formed of a polymer material. Nguyen teaches an expandable sheath that expands with the passage of a medical device (see Abstract). Where the expandable sheath has an inner tubular layer that comprises a polymer material (C2:L17-20). It would have been obvious to one having ordinary skill in the art to have substituted the polymer material as taught by Nguyen for the material of the thin and thick bands of the annular member 10 (inner member), since the substitution would have yielded the same predictable result of providing an expansive material for passage of a medical device through the sheath.
Regarding claim 8, Bullman makes obvious the expandable sheath as defined in claim 1; yet, does not disclose wherein said thin bands and/or said thick bands is partially or fully formed of a metal material. Nguyen teaches an expandable sheath that expands with the passage of a medical device (see Abstract). Where the expandable sheath has an inner tubular layer that comprises a nitinol (C2:L20). It would have been obvious to one having ordinary skill in the art to have substituted the inner layer that includes nitinol material as taught by Nguyen for the material of the thin and thick bands of the annular member 10 (inner member), since the substitution would have yielded the same predictable result of providing an expansive material for passage of a medical device through the sheath.
Regarding claim 36, Bullman discloses the expandable sheath as defined in claim 33; yet, is silent regarding wherein each of said thin bands includes a shape-memory metal alloy. Nguyen teaches an expandable sheath that expands with the passage of a medical device (see Abstract). Where the expandable sheath has an inner tubular layer that comprises a nitinol (C2:L20). It would have been obvious to one having ordinary skill in the art to have substituted the inner layer that includes nitinol material as taught by Nguyen for the material of the thin and thick bands of the annular member 10 (inner member), since the substitution would have yielded the same predictable result of providing an expansive material for passage of a medical device through the sheath.
Regarding claim 37, Bullman/Nguyen makes obvious the expandable sheath as defined in claim 36, Nguyen further teaches wherein said shape memory material used to at least partially form each of said thin bands includes a nickel-titanium alloy (C2:L20).
Claims 38 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Bullman in view of Allen (US2016/0067444).
Regarding claim 38, Bullman discloses the expandable sheath as defined in claim 33; yet, does not disclose further including a hydrophilic coating to facilitate in the insertion of said expandable sheath into and/or out of a body passageway. Allen teaches a sheath for passage of a medical device, that includes a coating on the inner surface ([0136]). Where the coating may be hydrophilic ([0136]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner cavity of the sheath of Bullman to include a hydrophilic coating as taught by in order to prevent adhesion between components ([0136]).
Regarding claim 39, Bullman discloses the expandable sheath as defined in claim 33; yet, does not disclose further including a lubricating coating to facilitate movement of the medical device through said internal cavity of said expandable sheath. Allen teaches a sheath for passage of a medical device, that includes a coating on the inner surface ([0136]). Where the coating may be lubricating ([0136]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner cavity of the sheath of Bullman to include a lubricating coating as taught by in order to prevent adhesion between components ([0136]).
Claims 13-22, 27, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over by Passman (US2020/0107931) in view of Liu (US2020/0179657).
Regarding claim 13, Passman discloses a sheath adapted for use in the delivery of a medical device into a body passageway (see Abstract); said sheath is expandable and contractable between an expanded and an unexpanded position ([0029]); said sheath comprising:
an outer layer portion (42);
an inner layer portion (36);
a frame (40);
said frame is at least partially positioned between said inner and outer layer portions (see Fig. 2A);
said frame extends along a majority of said longitudinal length of said sheath (see Figs. 2A, 4A-4B, [0035]);
the frame includes a plurality of arcuate portions ([0036], see Figs. 4A-4B);
a plurality of said arcuate portions overlap one another along a longitudinal axis of said frame when said sheath is in said unexpanded position (the arcuate portions overlap from the view shown in Fig. 4A, and would also overlap when looking down the longitudinal axis);
said outer layer portion is a continuous layer about a complete circumference of said sheath along at least a portion of a longitudinal length of said sheath (jacket encloses the entire sheath exterior, [0029], see Fig. 2A);
and wherein said sheath is configured to expand from a first outer diameter of said unexpanded position ([0030]) to a second outer diameter of said expanded position ([0030]) as the medical device is moved through said sheath ([0031]), and thereafter said sheath partially or fully returns to said first outer diameter of said unexpanded position once the medical device has passed partially or fully through an internal cavity or passageway of said sheath ([0033]).
Passman does not disclose including a longitudinal shaping structure; said longitudinal shaping structure is at least partially positioned in said outer layer position; said longitudinal shaping structure is spaced from said frame; said longitudinal shaping structure is configured to inhibit kinking of said sheath; said longitudinal shaping structure extend a majority of said longitudinal length of said sheath, said longitudinal shaping structure includes two shaping wires that are spaced from one another. Liu teaches a sheath that comprises an inner layer and an outer layer that form the sheath body (see Abstract). Where the outer layer may comprise a polymeric material and the support layer may comprise rods 140, 145 (longitudinal shaping structure) ([0048]-[0049]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the outer layer and support layer having rods as taught by Liu for the outer layer of Passman, since the substitution would have yielded predictable results of a sheath for passage of a medical device and provided the additional benefit of kink resistance ([0060]).
Liu further teaches wherein said longitudinal shaping structure is at least partially located in said outer layer portion (where the outer layer and the support layer with rods 140, 145 of Liu as in paragraph [0049] are interpreted as the claimed outer layer portion).
The modified invention discloses wherein said outer layer portion is a continuous layer about a complete circumference of said sheath along at least a portion of a longitudinal length of said sheath (Liu teaches the outer layer 120 is continuous layer by surrounding the entirety of the other layers, and a portion of the thickness of the outer layer portion is continuous by being a single material, [0048] of Liu).
Where the modified invention discloses wherein said longitudinal shaping structure is positioned along a majority of said longitudinal length of said sheath; said longitudinal shaping structure is spaced from said frame (rods extend linearly along sheath body, [0060] of Liu; where the rods 140, 145 of Liu would be spaced from the frame of Passman by being incorporated into the outer layer and therefore spaced radially from the inner layer with the frame of Passman).
Regarding claim 14, Passman/Liu makes obvious the sheath as defined in claim 13, wherein said outer layer portion includes a polymer material ([0029]).
Regarding claim 15, Passman/Liu makes obvious the sheath as defined in claim 14; yet, does not disclose wherein said outer layer portion includes first and second polymer layers. Liu teaches a sheath that comprises an inner layer and an outer layer that form the sheath body (see Abstract). Where the outer layer may comprise a polymeric material and the support layer may comprise a second polymeric material and the layers bonded together ([0048]). Where the two layers are interpreted as the claimed outer layer. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the outer layer comprising two layers of different polymer materials as taught by Liu for the material of the outer layer of Passman, since the substitution would have yielded predictable results of a sheath for passage of a medical device.
Regarding claim 16, Passman/Liu makes obvious the sheath as defined in claim 13; yet, is silent regarding wherein a thickness of said outer layer portion is greater than a thickness of said inner layer portion. Applicant has not disclosed having the thickness of the outer layer portion be greater than a thickness of the inner layer portion provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0027] of the specification, which states a large range of thicknesses for the coextrusion. One of ordinary skill in the art would have expected the sheath of Passman and Applicant’s invention to perform equal well with the thicknesses of the inner and outer layers of Passman or the claimed thickness of the outer layer being greater than a thickness of the inner layer because both sheath designs would perform the same function of expanding and collapsing after a medical device is passed through the sheath equally well. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sheath of Passman to have the thickness of the outer layer portion be greater than a thickness of the inner layer portion as an obvious matter of design choice within the level of skill in the art.
Regarding claim 17, Passman/Liu makes obvious the sheath as defined in claim 13, wherein said inner layer portion includes a polymer material ([0029])
Regarding claim 18, Passman/Liu makes obvious the sheath as defined in claim 17; yet, does not disclose wherein said inner layer portion includes a first and second polymer layer. Liu teaches a sheath that comprises an inner layer and an outer layer that form the sheath body (see Abstract). Where the inner layer may comprise a first polymeric material and the support layer may comprise a second polymeric material and the layers bonded together ([0048]). Where the two layers are interpreted as the claimed inner layer. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the inner layer comprising two layers of different polymer materials as taught by Liu for the material of the inner layer of Passman, since the substitution would have yielded predictable results of a sheath for passage of a medical device.
Regarding claim 19, Passman/Liu makes obvious the sheath as defined in claim 13, wherein said frame includes a shape memory material ([0034]).
Regarding claim 20, Passman/Liu makes obvious the sheath as defined in claim 19, wherein said shape memory material includes a nickel-titanium alloy ([0034]).
Regarding claim 21, Passman/Liu makes obvious the sheath as defined in claim 13, wherein said frame is substantially fully positioned between said inner and outer layer portions (see Fig. 2A, [0029]).
Regarding claim 22, Passman/Liu makes obvious the sheath as defined in claim 13, wherein said first and second frame wires have substantially a same shape (circumferential and longitudinal links appear to have the same shape as shown in Fig. 4A); said first and second frame wires are spaced from one another along a full longitudinal length of said sheath (see Fig. 4A).
Regarding claim 27, Passman/Liu makes obvious the sheath as defined in claim 13, Liu further teaches wherein said longitudinal shaping structure include a shape memory material (support layer rods can be made of PEEK, which is a shape memory material, [0025]).
Regarding claim 28, Passman/Liu makes obvious the sheath as defined in claim 13, wherein a second end of said sheath is subjected to a reflow process to connect together said inner and outer layer portions (the second end of the sheath is capable of being subjected to the reflow process); a majority of said longitudinal length of said sheath is not subjected to said reflow process. The limitations that "subjected to a reflow process” are product-by-process limitations. The patentability of a claim reciting product by process limitations does not depend on the method by which the final product is produced. The structure provided by Passman meets therefore meets the claim because it provides a sheath that is connected together.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached on (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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