DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application is a continuation of US Application no. 18/593,498, filed 1 March 2024, which is a continuation of US Application no. 17/103,283, now US Patent no. 17/103,283, 24 November 2020, which is a continuation of US Application no. 16/055,471, now US Patent no. 10,881,772, filed 6 August 2018, which is a continuation of US Application no. 15/785,097, now US Patent no. 10,086,122, filed 16 October 2017, which is a continuation of US Application no. 15/221,456, now US Patent no. 9,801,988, filed 27 July 2016, which is a continuation of US Application no. 14/592,630, now US Patent no. 9,433,717, filed 8 January 2015, which is a continuation of US Application no. 14/261,817, now US Patent no. 8,961,388, filed 25 April 2014, which is a continuation of US Application no. 13/926,044, now US Patent no. 9,011,312, filed 25 June 2013, which is a division of US Application no. 13/241,831, now US Patent no. 8,506,471, filed 23 September 2011, which receives the benefit of priority from US Provisional Application no. 61/386,018, filed 24 September 2010.
Information Disclosure Statement
The information disclosure statement filed 5 September 2025 has been considered
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.
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Claims 1, 4, 5, 9, 10, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7, 8, and 11-13 of U.S. Patent No. 10,973,967 in view of LaRose et al. (US Patent no. 7,976,271 – disclosed by Applicant).
In regard to claim 1, The ‘967 patent discloses in claims 1, 3, 7, 8, and 11-13 elements of a ventricular assist device comprising:
a housing defining an inlet opening and an outlet opening, wherein the housing comprises a dividing wall that delineates an inner volume that fluidly connects the inlet opening and the outlet opening (claim 1, at col 11 lines 51-54);
a rotor disposed within the inner volume and comprising one or more permanent magnets (claim 1 in col 12 lines 5-6) and centrifugal impeller blades (claim 3), wherein each of the one or more permanent magnets comprises a permanent north pole and a permanent south pole (the stator magnet is considered necessarily comprise a north and south pole),
wherein the centrifugal impeller blades are configured to pump blood from the inlet opening to the outlet opening during rotation of the rotor within the inner volume, and wherein the rotor and the inner volume are sized for complete magnetic levitation of the rotor within the inner volume so that blood flows (claim 8, stator coils radially levitate rotor) through a secondary blood flow path between the rotor and the dividing wall having a secondary blood flow path gap in a range from 0.2 mm to 2.0 mm (claim 11);
a stator assembly comprising drive coils and levitation coils, wherein the drive coils are arranged radially relative to the rotor, wherein the drive coils are operable to electromagnetically drive rotation of the rotor within the inner volume, wherein the levitation coils are arranged radially relative to the rotor, and wherein the levitation coils are operable to electromagnetically levitate the rotor to control a radial position of the rotor within the inner volume (claim 1 at col 11 line 56 and line 65 – col 12 line 1, and claims 7-8 which describe the coils as a pair);
control electronics disposed withing the housing and configured to control electrical supply to the drive coils and the levitation coils (claim 8).
The above features are considered obvious in view of the ‘967 patent as the combination of previous elements according to known methods to yield predictable results
The ‘967 patent does not teach a percutaneous cable via which the control electronics receive electrical power from an external power supply. LaRose et al. discloses a rotary centrifugal blood pump, similar to the claimed invention. Figure 10 shows a puck shaped pump with a cable 82 for supplying power to the pump motor. Therefore, it is considered to have been obvious to one ordinary skill in the art to modify the ’967 patent pump with a cable since LaRose et al. explicitly show that a percutaneous cable was known for supplying power to an implantable pump.
In regard to present claims 4 and 5, the dimensions of the gap are recited by claim 11 of the ‘967 patent.
In regard to claims 9 and 10, the shape (i.e., puck shape) is described by claim 13 of the ‘967 patent as disk shaped which is considered similar to the claimed puck shape. Claim 13 also discloses a dimension of the thickness as being less than 1 inch, which is considered similar to the 0.5-1.5 range.
In regard to claim 16, the dimension of the flow path described in claim 11 of the ‘967 patent is considered suitable size to achieve the functional limitation as claimed and therefore render the feature obvious.
Allowable Subject Matter
Claims 1, 4, 5, 9, 10, and 16 would be allowed should Applicant’s reply either specifically traverse or comply with the requirements of the double patenting rejection set forth above.
Claims 17-29 are allowed.
Claims 2, 3, 6-8, and 11-15 are objected to as comprising allowable subject matter but depending on a rejected claim.
The following is an examiner’s statement of reasons for allowance: the prior art fails to teach or suggest with sufficient technical specificity for the combination of elements comprising the ventricular device, particularly the feature of the dividing wall, the secondary flow path, nor the control electronics located within the pump housing.
US Patent no. 9,901,271 recites claim limitations the substantially recite the features of the housing comprising the dividing wall, the rotor comprising magnets and centrifugal impeller blades (claim 24), a stator assembly with drive coils and levitation coils (claim 1 in view of claims 5, 11, and 18), control electronics located in the housing and configured to provide power to the drive coils and levitation coils. However, the ‘271 lacks the teachings concerning the gap between the rotor and dividing wall with a range of 0.2 mm to 2.0 mm. Additionally, the ‘271 patent is unavailable as prior art.
LaRose et al. (US Patent no. 7,976,271 – disclosed by Applicant) describes a ventricular assist pump as claimed, however lacks the teaching about the electronics circuit located inside of the housing, nor for the specific dimensions of the gap.
Masuzawa et al. (US Publication no. 2012/0245680 – disclosed by Applicant) describes a centrifugal ventricular assist device and describes an axial clearance gap between the rotor and housing wall as being 0.5 mm +/- 0.5 mm. However, the reference does not teach the housing with the dividing wall, nor electronic circuit located therein.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 21 December 2025