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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-18 rejected on the ground of nonstatutory double patenting as being unpatentable over claims of 1-21 of US 12465748 B2, claims 1-21 of US 12636485 B2, and claims 1-19 of US 12714845 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims read on the application claims with the same expandable conduit, scaffold, and impeller.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 17998624 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application also has a collapsible blood conduit with impellers and support struts.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over McBride (US 9364593 B2) in view of Campbell (US 9138518 B2).
Regarding claim 1, McBride discloses an expandable catheter blood pump (eg. Abstract, Col. 17, Ln. 15-42, claim 1) comprising: a blood conduit supported by a catheter (eg. Col. 7, Ln. 1-5, Col. 24, Ln. 54-60), the blood conduit comprising an expandable scaffold (eg. Col. 19 Ln. 9 – Col. 21, Ln. 11, and an impermeable membrane disposed on a portion of the expandable scaffold (eg. claim 19, Col. 19, Ln. 9 - Col. 20, Ln. 35, elastic coating over at least a portion of the mesh); an impeller assembly rotatably supported within a proximal portion of the blood conduit (eg. Col. 6, Ln. 55 – Col. 7, Ln. 18, Col. 18, Ln. 53-59, Col. 21, Ln. 40-55); but does not explicitly disclose wherein the impeller assembly is the only structure positioned within the blood conduit.
Campbell teaches a percutaneous heart pump that is cantilevered for rotation at one end (eg. Col. 6, Ln. 60 – Col. 7, Ln. 16, Fig. 9 and 13A shaft terminates within the impeller with nothing downstream).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of McBride with a cantilevered impeller as taught by Campbell since the cantilevered impeller is commonly used in the art for reducing hemolysis and minimizing crossing profiles.
Regarding claim 2, the combined invention of McBride and Campbell discloses the impeller assembly includes one or more impeller blades coupled to an impeller shaft (eg. McBride, Claim 26, Col. 3, Ln. 55 – Col. 5, Ln. 25).
Regarding claim 3, the combined invention of McBride and Campbell discloses the impeller shaft passes through an impeller bearing assembly proximal to the one or more impeller blades (eg. Campbell, Col. 8, Ln. 51 – Col. 9, Ln. 10).
Regarding claim 4, the combined invention of McBride and Campbell discloses the impeller bearing assembly is at least partially positioned within a proximal hub of the blood pump (eg. Campbell, Col. 7, Ln. 58 – Col. 8, Ln. 15).
Regarding claim 5, the combined invention of McBride and Campbell discloses a flexible drive cable coupled to a proximal end of the impeller shaft (eg. Campbell, Col. 5, Ln. 3-17, Col. 8, Col. 8, Ln. 35-51, Col. 17, Ln. 22-30).
Regarding claim 6, the combined invention of McBride and Campbell discloses the impeller shaft is stiffer than the flexible drive cable (eg. Campbell, Col. 5, Ln. 3-17, Col. 8, Ln. 35-51, Col. 17, Ln. 22-30, Col. 21, Ln. 23-37, Col. 29, Ln. 10-25, the art indicates that the impeller housing can have varying rigidity, one of ordinary skill would have made the flexible drive cable more flexible than the impeller shaft for the predictable result of being able to navigate through the body more easily and preventing the impeller from folding in on itself).
Regarding claim 7, the combined invention of McBride and Campbell discloses the impeller assembly is cantilevered (eg. Campbell, Col. 6, Ln. 60-67).
Regarding claim 8, the combined invention of McBride and Campbell discloses there are no structures positioned distal to the impeller assembly within the blood conduit (eg. Col. 7, Ln. 3-17, Fig. 9).
Regarding claim 9, the combined invention of McBride and Campbell discloses the blood conduit comprises an open lumen distal to the impeller assembly (Eg. McBride, Claim 34, Col. 19, Ln. 55 – Col. 20, Ln. 3).
Regarding claim 10, the combined invention of McBride and Campbell discloses no bearings are positioned distal of the impeller assembly (eg. Campbell, Fig. 4a-b, Col. 7, Ln. 58 – Col. 8, Ln. 14).
Regarding claim 11, the combined invention of McBride and Campbell discloses the impeller assembly is disposed within an outlet section of the expandable scaffold (eg. McBride, Col. 20, Ln. 35 – Col. 21, Ln. 11, claims 31 and 34).
Regarding claim 12, the combined invention of McBride and Campbell discloses the outlet section includes a plurality of proximal struts that form at least one opening eg. McBride, Col. 20, Ln. 35 – Col. 21, Ln. 11, claims 23, 31 and 34).
Regarding claim 13, the combined invention of McBride and Campbell discloses at least one opening is positioned proximal to a proximal end of the impermeable membrane (eg. McBride, claim 20, 35-36, Col. 19, Ln. 9 – Col. 20, Ln. 3).
Regarding claim 14, the combined invention of McBride and Campbell discloses the impeller assembly is at least partially disposed within the outlet section (eg. McBride, Claim 1 and 31, Col. 20, Ln. 35-60, Fig. 17).
Regarding claim 15, the combined invention of McBride and Campbell discloses the expandable section further comprises a central portion distal to the impeller assembly (eg. McBride, claim 34, Col. 20, Ln. 35-60, Col. 25, Ln. 8-20).
Regarding claim 16, the combined invention of McBride and Campbell discloses the central portion is more flexible than the outlet section (eg. McBride, claim 7, Col. 19, Ln. 9-26, Col. 20, Ln. 10-35, and Campbell, Col. 5, Ln. 3-17, Col. 8, Ln. 35-51, Col. 17, Ln. 22-30, Col. 21, Ln. 23-37, Col. 29, Ln. 10-25, one of ordinary skill would have been able to make the tube more flexible than the outlet to provide the predictable result of not having the outlet buckle/fold on itself).
Regarding claim 17, the combined invention of McBride and Campbell discloses a distal shaft section coupled to the outlet section (eg. McBride, Fig. 20, Col. 24, Ln. 5-20, distal end dilator).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over McBride (US 9364593 B2) in view of Campbell (US 9138518 B2), further in view of Siess (US 6007478).
Regarding claim 18, the combined invention of McBride and Campbell discloses the invention of claim 17, but does not explicitly disclose distal shaft section is more flexible than the outlet section.
Siess teaches a cannula device that has a cannula with a gradually varying degree of resistance to lateral deflection wherein its proximal end is stiffer than its distal end (eg. Abstract, claim 1, Col. 2, Ln. 25-47, Col. 4, Ln. 55 – Col. 5, Ln. 30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of McBride and Campbell with the varying distal stiffness of a cannula as taught by Siess to provide the predictable result of resisting radial collapse/deformation where needed on the cannula (Col. 5, Ln. 28-60, claim 1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LAU whose telephone number is (571)272-2317. The examiner can normally be reached 8-5:30 PM.
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/MICHAEL J LAU/Examiner, Art Unit 3796
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