DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed 1/21/2026 have been fully considered and are persuasive. The pre-appeal conference decision is to re-open prosecution. The examiner is reopening prosecution with a new non-final rejection. Pfeffer is now the primary reference as it addresses the damping component more adequately. It also addresses a majority of the dependent claims.
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 21-22, 24-25, and 28-31 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 the parent application fully encompasses the subject matter of the current pending application as the parent has the same features of a percutaneous heart pump comprising a distal impeller, a proximal motor, and a damping component.
The specific claim correspondences are as follows:
Instant application 18/154,417 -> U.S. Patent No. 11,925,796 B2
Claim 21 -> Claims 1, 11
Claim 22 -> Claims 1, 11
Claim 24 -> Claims 2, 12
Claim 25 -> Claims 3, 4, 13, 14
Claim 28 -> Claims 3, 4, 13, 14
Claim 29 -> Claims 9, 19
Claim 30 -> Claims 8, 18
Claim 31 -> Claims 7, 17
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 21-30 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 mechanical circulatory support device (e.g. see [0181]-[0183]) for stabilizing a patient after cardiogenic shock (e.g. see [0181]-[0183]. Note: This is an intended use limitation of a system claim), the mechanical circulatory support device comprising: a catheter pump (e.g. see figure 1 element 3, [0055]-[0057]) including flexible drive shaft (e.g. see figure 24 elements 4 and 8, [0056]) for rotating, the catheter pump being insertable through a cardiovascular system of the patient to locate the impeller at the patient's heart (e.g. see [0181]-[0183]); a motor assembly (e.g. see figure 1 element 7, [0056]) producing a torque for rotating the catheter pump (e.g. see [0015]) at a predetermined speed (e.g. see [0171]) via the flexible drive shaft to increase the flow of blood out of the patient's heart and through the patient's vascular system (e.g. see [0181]-[0183]); and at least one damping component (e.g. see figure 15 element 20.3, [0138], “the magnet ring bearing acts as a vibration damper”, Note: The applicant claims in 24 the damping component is an O-ring) configured to reduce a vibration of the motor assembly while operating to produce the torque.
Pfeffer discloses the invention uses a rotor (e.g. see figure 2 element 3.2, [0056]) but does not explicitly disclose the rotor is an impeller (Note: An impeller is a type of rotor). Campbell teaches it is known to use such a modification as set forth in [0059]-[0061] to provide an improved impeller design that allows for a reduced diameter (e.g. see [0140]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use an impeller rotor as taught by Campbell in the system of Pfeffer, since said modification would provide the predictable results of an improved impeller design that allows for a reduced diameter.
Regarding claim 22, Pfeffer discloses the at least one damping component is further configured to reduce noise of the motor assembly while operating to produce the torque (e.g. see figure 15 element 20.3, [0138], Note: The examiner’s understanding is that less vibration will produce less noise).
Regarding claim 23, Pfeffer discloses the vibration damping component is provided between the motor assembly and the catheter pump (e.g. see figure 15 element 20.3, [0138]. Note: Element 20.3 in figure 15 is distal to the motor and proximal to the pump).
Regarding claim 24, Pfeffer discloses the vibration damping component comprises a stabilizing O-ring (e.g. see figure 15 element 20.3, [0138]).
Regarding claim 25, Pfeffer discloses the motor assembly includes a plurality of motor windings (e.g. see [0086]), an output shaft (e.g. see figure 1 element 4), and a rotatable drive magnet (e.g. see figures 14-15, elements 23.1, 23.2, [0114]-[0115]) coupled to the output shaft.
Regarding claim 26, Pfeffer discloses the at least one damping component is disposed radially around the output shaft (e.g. see figure 15 element 20.3, [0138]).
Regarding claim 27, Pfeffer discloses the at least one damping component (e.g. see figure 15 element 20.3, [0138]) is provided between separable housings (e.g. see figure 2 element 3.1, [0057] for the pump housing and the exterior surface of element 7 for the motor housing) of the motor assembly and the catheter pump (e.g. see figure 15 element 20.3, [0138]. Note: Element 20.3 in figure 15 is distal to the motor and proximal to the pump).
Regarding claim 28, Pfeffer discloses the motor assembly includes a plurality of motor windings (e.g. see [0086]); wherein the catheter pump includes a driven magnet (e.g. see figures 14-15, elements 23.1, 23.2, [0114]-[0115]) coupled to the flexible drive shaft (e.g. see figure 1 element 4); and wherein a rotation of the driven magnet is induced by magnetic fields generated the plurality of motor windings when the plurality of motor windings are energized (e.g. see [0086], [0114]-[0115]).
Regarding claims 29 and 30, Pfeffer teaches the vibration damping component (e.g. see figure 15 element 20.3) is provided between the motor assembly and the catheter pump (e.g. see figure 15 element 20.3, [0138], Note: Element 20.3 in figure 15 is distal to the motor and proximal to the pump). However, Pfeffer does not explicitly teach the motor assembly includes a motor and a motor housing, the at least one damping component applied between the motor and the motor housing or the motor assembly includes a motor and a motor mount, the at least one damping component applied between the motor and the motor mount. The specification does not provide any criticality with the specific location of the damping component (see [0072] of the USPGPub. version of the specification). It would have been obvious to one of ordinary skill in the art at the time the invention was made to use the damping component in a different place relative to the motor, since it has been held that rearranging parts of a prior art structure involves only routing skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Claim 31 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 31, Pfeffer and Campbell disclose the claimed invention except for the at least one damping component includes a damping material of a visco-elastic or elastic polymer. Yusuf teaches that it is known to use such a modification as set forth in [0007] to provide a physically soft damping element (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 a physically soft damping element.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached on 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.C.E/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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