DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 21-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,925,796 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed towards a percutaneous heart pump with the same structural components of a catheter pump, motor assembly, and a damping component.
Claims 21-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-31 of copending Application No. 18/154,417 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of copending Application anticipate instant claims since the claims of copending Application are directed towards a percutaneous heart pump with the same structural components of a catheter pump, motor assembly, and a damping component.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21-27 and 29-38 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pfeffer et al. (Pub. No.: US 2009/0093764 A1); hereinafter referred to as “Pfeffer”, in view of Campbell et al. (Pub. No.: US 2011/0004046 A1); hereinafter referred to as “Campbell”.
Regarding claim 21, Pfeffer discloses a heart pump (e.g. see figure 1 element 1, [0055]-[0057]) for a medical patient, the heart pump comprising: a catheter body (e.g. see figure 1 element 8, [0056], “catheter body”); a motor (e.g. see figure 1 element 7, [0056], “motor”), wherein the motor includes a damping component (e.g. see [0137]-[0138], [0180], figure 15 element 20.3) configured to reduce vibration associated with operation of the motor as it rotates to pump blood and therefore assists a blood pumping function of the heart (e.g. see abstract, [0015]).
Pfeffer discloses a pump head (e.g. see figures 1 and 8 element 3, [0056]) and a drive shaft (e.g. see figure 1 element 4, [0056]-[0057]) but is silent as to a percutaneously insertable impeller disposed at a distal portion of the catheter body and positionable through a vasculature of the medical patient to a desired location and the drive shaft is a flexible drive shaft. Campbell teaches it is known to use such a modification as set forth in (e.g. see figure 2A element 20, [0059]-[0061], especially [0059]) to provide more flexibility which promotes ease of the delivery of the pump into a patient's anatomy (e.g. see [0059]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a distal impeller connected to a flexible drive shaft as taught by Campbell in the system of Pfeffer, since said modification would provide the predictable results of more flexibility which promotes ease of the delivery of the pump into a patient's anatomy.
Regarding claim 22, Pfeffer discloses the motor comprises a plurality of windings operable to rotate the flexible drive shaft (e.g. see [0086]).
Regarding claim 23, Pfeffer discloses the damping component comprises a stabilizing O-ring (e.g. see [0137]-[0138], [0180], figure 15 element 20.3).
Regarding claim 24, Pfeffer discloses the motor further includes a drive magnet (e.g. see [0114]-[0115], figures 14 and 15 element 23.2).
Regarding claim 25, Pfeffer discloses a driven magnet attached to the flexible drive cable (e.g. see [0114]-[0115], figures 14 and 15 element 23.1).
Regarding claim 26, Pfeffer discloses the motor includes a motor housing and a motor mount (e.g. see [0153]-[0164], figures 14 and 22, element 7.1).
Regarding claim 27, Pfeffer discloses the damping component comprises a damping material applied proximate the motor mount or the motor housing (e.g. see figures 14 and 15, elements 20.3 and 7.1).
Regarding claim 29, Pfeffer discloses the damping material comprises a rib formed in the motor housing (e.g. see [0153]-[0164], figures 14 and 22, element 7.1).
Regarding claim 30, Pfeffer discloses the motor includes an output shaft (e.g. see [0137], drive shaft 4), and wherein the damping component is disposed radially around the output shaft (e.g. see [0137], “The magnet ring bearing 20.3 centres the drive shaft 4 axially and radially”).
Regarding claim 31, Pfeffer discloses the damping component is provided between separable housings (e.g. see [0137]-[0138], [0180], figure 15 element 20.3).
Regarding claim 32, Pfeffer discloses an infusion system (e.g. see [0177], figure 16 element 19.15).
Regarding claims 33 and 34, Pfeffer discloses the claimed invention except for the heart pump is configured as a ventricular assist device and the heart pump is configured as a left ventricular assist device. Campbell teaches that it is known to use such a modification as set forth in [0003] and [0058] to provide reduced load on the heart muscle for a period of time, which may be as long as a week, allowing the affected heart muscle to recover while healing in a substantially unloaded state (e.g. see [0006]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use ventricular assistance as taught by Campbell in the system of Pfeffer, since said modification would provide the predictable results of reduced load on the heart muscle for a period of time, which may be as long as a week, allowing the affected heart muscle to recover while healing in a substantially unloaded state.
Regarding claims 35 and 36, Pfeffer discloses the claimed invention except for the percutaneously insertable impeller is expandable and the motor is disposed outside of the vasculature of the medical patient. Campbell teaches that it is known to use such a modification as set forth in [0059]-[0061] to provide more flexibility which promotes ease of the delivery of the pump into a patient's anatomy (e.g. see [0059]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use an expandable impeller and external motor as taught by Campbell in the system of Pfeffer, since said modification would provide the predictable results of more flexibility which promotes ease of the delivery of the pump into a patient's anatomy.
Regarding claim 37, Pfeffer discloses the motor is decouplable from the catheter body (e.g. see [0056]. “Decoupable” is a functional use limitation of a system claim that the prior art is capable of and/or configured to meet. More specifically, anything is “decoupable” in terms of claim language).
Regarding claim 38, Pfeffer discloses the motor is permanently secured to the catheter body (e.g. see [0056]).
Claim 28 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pfeffer and Campbell in view of Yusuf et al. (Pub. No.: US 2012/0323318 A1); hereinafter referred to as “Yusuf”.
Regarding claim 28, Pfeffer and Campbell disclose the claimed invention except for the damping material comprises a elastic polymer. Yusuf teaches that it is known to use such a modification as set forth in [0007] to provide vibration dampening devices employing elastomers capable of deformation (e.g. see [0007]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a vibration damping elastomer as taught by Yusuf in the system of Pfeffer and Campbell, since said modification would provide the predictable results of vibration dampening devices employing elastomers capable of deformation.
Conclusion
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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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