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 inner balloon film and an outer balloon film are at least partially thermally fused to one another and to the plurality of struts positioned therebetween”, 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.
Regarding the applicant’s new limitation “an inner balloon film and an outer balloon film”, [0057] of Fitzgerald discloses “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”. Thus, the examiner is interpreting polymer on the inner wall as the inner balloon film and the polymer on the outer wall as the outer balloon film.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 21-25 and 28-38 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”, in view of Scheckel et al. (Pub. No.: US 2016/0279310 A1); hereinafter referred to as “Scheckel”, or in the alternative, over Fitzgerald and Scheckel, in view of Verkaik et al. (Pub. No.: US 2012/0143141 A1); hereinafter referred to as “Verkaik”.
Regarding claim 21, Fitzgerald discloses a mechanical circulatory support device for treating a heart condition, the mechanical circulatory support device comprising: a self-expanding cannula (e.g. see [0051]-[0053], [0058]) that is insertable into a vasculature of a patient for advancement through the vasculature to a desired location for treating the heart condition (e.g. see figure 3, [0051]), the self-expanding cannula including an elongate central portion defining a lumen (e.g. see [0052], “blood flow lumen”) extending between opposing substantially open ends; and an expandable impeller (e.g. see [0052]-[0053]) received in the elongate central portion, the impeller generating a blood flow through the lumen when rotated at a predetermined speed to provide the circulatory support to treat the heart condition (e.g. see [0052]-[0053]); wherein the self-expanding cannula has an integrated composite structure (e.g. see [0056]-[0057], “cannula mesh structure 204”) including a plurality of struts comprised of 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]) and a fluid impermeable membrane comprising an inner balloon film and an outer balloon film applied to the elongate central portion (e.g. see [0056]-[0057], “a cannula is formed by enclosing the circumferential members 224 with a polymer material, e.g., a film, to create a flow channel open on the ends but otherwise sealed to maximize axial flow through the cannula and the pump” and “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 middle shape memory alloy layer (e.g. see [0082], “nitinol”, [0055] discloses incorporated reference U.S. application Ser. No. 13/343,617 which includes nitinol in [0125] to [0127]) but silent as to the shape memory alloy has an austenite finish temperature Af that is about 37°C or less. Scheckel teaches that it is known to use such a modification as set forth in [0016]-[0017] to provide improved stability and the longevity of the housing (e.g. see [0017]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a shape memory alloy (nitinol) at an austenite finish temperature Af that is about 37°C or less as taught by Scheckel in the system of Fitzgerald, since said modification would provide the predictable results of improved stability and the longevity of the housing (e.g. see [0017]).
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 and Scheckel disclose the claimed invention but are silent as to the inner balloon film and an outer balloon film are at least partially thermally fused to one another and to the plurality of struts positioned therebetween. 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 and Scheckel, 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 claims 22-24, Fitzgerald discloses the claimed invention but silent as to the Af is between 5°C and 30°C, Af is between 100C to 25°C, and the Af is between 100C to 20°C. Scheckel teaches that it is known to use such a modification as set forth in [0017] to provide improved stability and the longevity of the housing (e.g. see [0017]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use such a modification as taught by Scheckel in the system of Fitzgerald, since said modification would provide the predictable results of improved stability and the longevity of the housing (e.g. see [0017]).
Regarding claim 25, Fitzgerald discloses the shape memory alloy is selected from the group consisting of nickel-titanium (nitinol), copper-zinc, copper-zinc-aluminum, copper-aluminum-nickel, and gold-cadmium (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 claims 28 and 29, Fitzgerald discloses the shape memory alloy has a cage or mesh structure and the cage or mesh structure is at least one of a braided mesh, a woven mesh, or a laser-cut interconnected maze-like pattern (e.g. see [0053]-[0058]).
Regarding claim 30, Fitzgerald discloses the fluid impermeable membrane encapsulates the cage or mesh structure in the elongate central portion, the encapsulating defining substantially smooth inner and outer surfaces in the self- expandable elongate central portion (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”).
Regarding claim 31, Fitzgerald discloses the fluid impermeable membrane is applied to the cage or mesh structure in multiple material layers (e.g. see [0057], “In various embodiments, the polymer coating is formed of a plurality of layers”).
Regarding claim 32, Fitzgerald discloses the multiple material layers are 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 (e.g. see [0057]).
Regarding claim 33, Fitzgerald discloses the multiple material layers are adhered to one another (e.g. see [0057]).
Regarding claims 34 and 35, Fitzgerald and Scheckel disclose the claimed invention but are silent as to the multiple material layers are thermally bonded to one another and the multiple material layers are fused together. 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 and Scheckel, 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 36, Fitzgerald discloses the multiple material layers includes at least one layer applied from an inside of the cage or mesh structure and at least one layer applied from an outside of the cage or mesh structure (e.g. see [0057]).
Regarding claim 37, Fitzgerald discloses the substantially open proximal portion and the substantially open distal portion each comprise a plurality of struts (e.g. see [0053]-[0058]).
Regarding claim 38, Fitzgerald discloses the plurality of struts are fabricated from 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]).
Claim(s) 26 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fitzgerald and Scheckel in view of Campbell et al. (Pub. No.: US 2012/0172655 A1); hereinafter referred to as “Campbell”.
Regarding claims 26 and 27, Fitzgerald and Scheckel disclose the claimed invention but are silent as to the self-expanding cannula has an outer diameter of approximately 3.5 mm when being advanced through the vasculature of the patient and the self-expanding cannula has an outer diameter of approximately 7 mm when the impeller is being rotated. Campbell teaches that it is known to use such a modification as set forth in [0072] to provide a first configuration for insertion and a larger size facilitates greater flow rates by the impeller assembly (e.g. see [0072]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use such the cannula sizes as taught by Campbell in the system of Fitzgerald and Scheckel, since said modification would provide the predictable results of a first configuration for insertion and a larger size facilitates greater flow rates by the impeller assembly.
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 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