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 Arguments
Regarding the applicant’s new limitation “the first fluid-impermeable polymer film is thermally bonded to the elongate self-expanding portion”, this is a product-by-process limitation. Per MPEP 2113, "Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." and "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. See MPEP 2113 for more details.
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) 1-9, 11-12, 15, 18, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fitzgerald et al. (Pub. No.: US 2014/0012065 A1): hereinafter referred to as “Fitzgerald”, or in the alternative, over Fitzgerald in view of Verkaik et al. (Pub. No.: US 2012/0143141 A1); hereinafter referred to as “Verkaik”.
Regarding claim 1, Fitzgerald discloses an expandable cannula (e.g. see [0051]-[0053]) for a percutaneous heart pump (e.g. see [0049]-[0050]), the expandable cannula comprising: a substantially open proximal end (e.g. see figures 3 and 4 elements 92, 216A, 216B); a substantially open distal end (e.g. see figures 3 and 4 elements 92, 216A, 216B); an elongate self-expandable central portion (e.g. see figure 4 element 204, [0055]-[0058]) disposed between the substantially open proximal end and the substantially open distal end, the elongate self-expandable central portion having an inner surface and an opposing outer surface; and a first film disposed on at least one of the inner surface and the outer surface (e.g. see [0057], “In the exemplary structure, the polymer material fills the voids in the mesh structure. The polymer material also coats the inner and outer walls such that the mesh structure does not come into contact with blood and tissue”).
Fitzgerald discloses the first fluid impermeable film with a thickness less than 10 µm (e.g. see [0057]) but is silent as to the first fluid impermeable film having a thickness within a range of from 10 µm to 200 µm. It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to use a slightly thicker film thickness (Note: 9.9999 is basically 10), 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 ordinary skill in the art. In re Aller, 105 USPQ 233. Furthermore, MPEP 2144.05 states “ a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.”
Regarding the thermal bonding limitation, this is considered a product by process limitation, Fitzgerald discloses the same device although it teaches the film being applied by a difference process (citation of Par 0057). It is the examiner’s position that such a coating process would implicitly/inherently result in the same structure as a product made with thermal bonding, as both will produce smooth surfaces. The burden has now shifted to applicant to provide evidence showing nonobvious structural difference between the claimed product and that disclosed by Fitzgerald; see MPEP 2113. If applicant disagrees, see alternative 103 rejection below in view of Vervaik.
In the alternative, Fitzgerald discloses the claimed invention but are silent as to the first fluid-impermeable polymer film is thermally bonded to the elongate self-expanding portion. Vervaik teaches it is known to use such a modification as set forth in [0057] (“One example includes thermal bonding fluoropolymer sleeves through the gaps formed by wireforms 65, such that the wires of flange assembly 61 are embedded between two sleeves of a fluoropolymer”) to provide a surface covering all the gaps and crossings of the wireforms making the flow path of blood substantially seamless (e.g. see [0057]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use thermal bonding of the polymer around the metal mesh as taught by Vervaik in the system of Fitzgerald, since said modification would provide the predictable results of a surface covering all the gaps and crossings of the wireforms making the flow path of blood substantially seamless.
Regarding claim 2, Fitzgerald discloses the first fluid impermeable film is disposed on the inner surface, and the expandable cannula further comprises a second fluid impermeable film disposed on the outer surface (e.g. see [0057]).
Regarding claim 3, Fitzgerald discloses the first fluid impermeable film with a thickness less than 10 µm (e.g. see [0057]) but is silent as to the second fluid impermeable film comprises a polymer and has a thickness within a range of from 10 pm to 200 pm. It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to use a slightly thicker film thickness (Note: 9.9999 is basically 10), 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 ordinary skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 4, Fitzgerald discloses the elongate self-expandable central portion comprises a shape memory alloy (e.g. see [0082], “nitinol”, [0055] discloses incorporated reference U.S. application Ser. No. 13/343,617 which includes nitinol in [0125] to [0127]).
Regarding claim 5, Fitzgerald discloses the first fluid impermeable film is a laminate comprising at least two layers (e.g. see [0057]).
Regarding claim 6, Fitzgerald discloses the claimed invention but are silent as to the first fluid impermeable layer is thermally bonded to the elongate self-expandable central portion. Vervaik teaches it is known to use such a modification as set forth in [0057] (“One example includes thermal bonding fluoropolymer sleeves through the gaps formed by wireforms 65, such that the wires of flange assembly 61 are embedded between two sleeves of a fluoropolymer”) to provide a surface covering all the gaps and crossings of the wireforms making the flow path of blood substantially seamless (e.g. see [0057]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use thermal bonding of the polymer around the metal mesh as taught by Vervaik in the system of Fitzgerald, since said modification would provide the predictable results of a surface covering all the gaps and crossings of the wireforms making the flow path of blood substantially seamless.
Regarding claim 7, Fitzgerald discloses the elongate self-expandable central portion comprises a mesh structure (e.g. see [0055]-[0058]).
Regarding claim 8, Fitzgerald discloses the first fluid impermeable film is disposed on the inner surface and a second fluid impermeable film is disposed on the outer surface, and wherein the first fluid impermeable film is bonded to the second fluid impermeable film via bond structures extending through the mesh structure (e.g. see [0057]).
Regarding claim 9, Fitzgerald discloses the claimed invention but are silent as to the first fluid impermeable film and the second impermeable film are thermally bonded to one another. Vervaik teaches it is known to use such a modification as set forth in [0057] (“One example includes thermal bonding fluoropolymer sleeves through the gaps formed by wireforms 65, such that the wires of flange assembly 61 are embedded between two sleeves of a fluoropolymer”) to provide a surface covering all the gaps and crossings of the wireforms making the flow path of blood substantially seamless (e.g. see [0057]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use thermal bonding of the polymer around the metal mesh as taught by Vervaik in the system of Fitzgerald, since said modification would provide the predictable results of a surface covering all the gaps and crossings of the wireforms making the flow path of blood substantially seamless.
Regarding claim 11, Fitzgerald discloses each of the first fluid impermeable film and the second fluid impermeable film comprise a plurality of layers (e.g. see [0057]).
Regarding claim 12, Fitzgerald discloses at least one of the first fluid impermeable film and the second fluid impermeable film comprises a biocompatible polymer (e.g. see [0057]).
Regarding claim 15, Fitzgerald discloses the elongate self-expandable central portion comprises a nickel-titanium alloy (e.g. see [0082], “nitinol”, [0055] discloses incorporated reference U.S. application Ser. No. 13/343,617 which includes nitinol in [0125] to [0127]).
Regarding claim 18, Fitzgerald discloses the first fluid impermeable film is disposed on the inner surface and a second fluid impermeable film is disposed on the outer surface and wherein the first fluid impermeable film, the second fluid impermeable film, and the elongate self-expandable central portion are a fused integrated structure having a substantially smooth, continuous inner surface and a substantially smooth, continuous outer surface (e.g. see [0057]).
Regarding claim 21, Fitzgerald discloses the first fluid impermeable film comprises at least three layers, and wherein an intermediate layer of the plurality of layers comprises a polymer that is adhesive (e.g. see [0057]).
Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over Fitzgerald and Verkaik, in view of Mori et al. (Pub. No.: 2007/0005010 A1); hereinafter referred to as “Mori”.
Regarding claim 10, Fitzgerald and Verkaik disclose the claimed invention except for the a total wall thickness of the first fluid impermeable film, the elongate self-expandable central portion and the second fluid impermeable film together is from 70m to 550m. Mori teaches that it is known to use such a modification as set forth in [0053], [0056], [0080], [0084], [0089] to provide a catheter size that can fit through blood vessels. It would have been obvious to one having ordinary skill in the art at the time the invention was made to the catheter wall thickness as taught by Mori in the system of Fitzgerald and Verkaik, since said modification would provide the predictable results of a catheter size that can fit through blood vessels.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Fitzgerald and Verkaik, in view of Haselby et al. (Pub. No.: US 2011/0106115 A1); hereinafter referred to as “Haselby’.
Regarding claims 13-14, Fitzgerald and Verkaik disclose the claimed invention but is silent as to the thermal transition temperature of the polymer is from 500C to 2500C and the thermal transition temperature is from 1000C to 2500C. Haselby teaches that it is known to use such a modification as set forth in [0068]-[0070] to provide self-expanding device capable of being percutaneously inserted and deployed within a body cavity. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Fitzgerald and Verkaik, with such a modification as taught by Haselby, since such a modification would provide the predictable results of self- expanding device capable of being percutaneously inserted and deployed within a body cavity.
Claims 16-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fitzgerald and Verkaik, in view of Sakai et al. (Pub. No.: US 2006/0195005 A1).
Regarding claims 16 and 17, Fitzgerald and Verkaik disclose the invention but is silent as to the polymer is a thermoplastic elastomer and the thermoplastic elastomer is selected from the group consisting of a thermoplastic, segmented polyurethane block copolymer, a poly(ether-b-amide) copolymer, poly(ether ester) block copolymer, a functionalized olefinic thermoplastic elastomer having polar functional groups, a styrenic thermoplastic elastomer functionalized by polar functional groups, and combinations thereof, wherein the polar functional groups are selected from the group consisting of maleic anhydride, acrylate, epoxy, amine, and combinations thereof. Sakai teaches that it is known to use such a modification as set forth in [0015] to provide a polymer more compatible to blood (e.g. see [0015]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a thermoplastic as taught by Sakai in the system of Fitzgerald and Verkaik, since said modification would provide the predictable results of a a polymer more compatible to blood.
Regarding claims 19 and 20, Fitzgerald and Verkaik disclose the invention but is silent as to a surface layer of the first fluid impermeable film comprises a first biocompatible thermoplastic elastomer, and a surface layer of the second fluid impermeable film comprises a second biocompatible thermoplastic elastomer, wherein the first biocompatible thermoplastic elastomer and the second biocompatible thermoplastic elastomer, are independently selected from the group consisting of a thermoplastic polyurethane block copolymers comprising hard blocks and soft blocks of different types, and wherein the hard blocks and the soft blocks of different types are selected from the group consisting of poly(ether urethane), poly(carbonate urethane), poly(ester urethane), silicone- poly(ether urethane), silicone-poly(carbonate urethane), and a blend or admixture of a combination thereof. Sakai teaches that it is known to use such a modification as set forth in [0015] to provide a polymer more compatible to blood (e.g. see [0015]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a thermoplastic as taught by Sakai in the system of Fitzgerald and Verkaik, since said modification would provide the predictable results of a a polymer more compatible to blood.
Conclusion
THIS ACTION IS MADE FINAL. 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 PHILIP C EDWARDS whose telephone number is (571)270-1804. The examiner can normally be reached Mon-Fri, 9:00-5:00 EST.
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/PHILIP C EDWARDS/Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796