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 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12263331. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and the US Patent claim a system for assisting a circulation of blood inside a body of a patient, the system comprising: a pump including: a housing having an upstream portion and a downstream portion; an inducer positioned in the upstream portion of the housing, the inducer including one or more helically-wound inducer blades to rotate around a longitudinal axis of the pump; an impeller positioned downstream of the inducer in the housing, the impeller including one or more impeller blades to rotate around the longitudinal axis of the pump; a diffuser positioned in the downstream portion of the housing, to direct blood through at least one aperture in a circumference of the housing; and a stator to rotate the inducer and the impeller relative to the housing and the diffuser.
Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11793992. Although the claims at issue are not identical, they are not patentably distinct from each other because both the current application and the US Patent claim a system for assisting a circulation of blood inside a body of a patient, the system comprising: a pump including: a housing having an upstream portion and a downstream portion; an inducer positioned in the upstream portion of the housing, the inducer including one or more helically-wound inducer blades to rotate around a longitudinal axis of the pump; an impeller positioned downstream of the inducer in the housing, the impeller including one or more impeller blades to rotate around the longitudinal axis of the pump; a diffuser positioned in the downstream portion of the housing, to direct blood through at least one aperture in a circumference of the housing; and a stator to rotate the inducer and the impeller relative to the housing and the diffuser.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 10-11, 15-17, 20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Benkowski et al. (US 5947892).
Regarding claim 1, Benkowski discloses a system for assisting a circulation of blood (Fig. 1, abstract), the system comprising:
a pump 10 including: a housing 12 having an upstream portion and a downstream portion (Fig. 1), an impeller 54 positioned in the upstream portion of the housing 12 (Fig. 1, Column 8 lines 37-53), the impeller 54 including one or more impeller blades 68, 70 to rotate around a longitudinal axis of the pump (Column 8 lines 37-53), and a diffuser 20 positioned in the downstream portion of the housing (Fig. 1), to direct blood through at least one aperture 36, 40, 378 in the housing (Fig. 1, 11A-D, column 15 lines 12-16, 23-26), wherein the at least one aperture 36, 40, 378 is positioned radially outward of the diffuser with reference to the longitudinal axis of the pump (Fig. 1, 11A-D); and
a stator 80 to rotate the impeller relative to the housing and the diffuser 20 (Fig. 1, column 8, lines 37-53).
Regarding claim 2, Benkowski discloses the system of claim 1, wherein
the at least one aperture 36, 40 includes at least two apertures 36, 40 defined by cylindrical portions of the housing at downstream and upstream portions of the at least two apertures and strut-like portions of the housing at sides of the at least two apertures (Fig. 1, column 3 lines 27-29).
Regarding claim 3, Benkowski discloses the system of claim 1, wherein:
the one or more impeller blades 68, 70 are configured to rotate to increase a rotational velocity of the blood, and the diffuser includes two or more curved fins to convert the rotational velocity of the blood imparted by the impeller into an axial velocity through the at least one aperture (Fig. 1, column 6 lines 33-42).
Regarding claim 10, Benkowski discloses a system for assisting a circulation of blood (Fig. 1, abstract), the system comprising:
a pump 10 including: a housing 12, an impeller 54 positioned in the housing (Fig. 1), the impeller 54 including one or more impeller blades 68, 70 to rotate around a longitudinal axis of the pump (Fig. 1, column 6 lines 33-42), and a diffuser 20 positioned in the housing, to direct blood from the impeller through at least one aperture in the housing, wherein the at least one aperture 36, 40, 378 is positioned radially outward of the diffuser with reference to the longitudinal axis of the pump (Figs. 1, 11A-D, column 15 lines 12-16, 23-26).
Regarding claim 11, Benkowski discloses the system of claim 10, wherein
the at least one aperture 36, 40 in the housing is configured to direct flow 13 to a particular vessel with an appropriate radiologic marking in order to aid in proper positioning and fixation (Fig. 1, column 5 lines 22-28).
Regarding claim 15, Benkowski discloses a system for assisting a circulation of blood (Fig. 1, abstract), the system comprising:
a pump 10 including: a housing 12 including a downstream end, an upstream end (Fig. 1), and at least one aperture 36, 40 between the downstream end and the upstream end (Fig. 1, column 3 lines 27-29), an impeller 55 positioned in the housing upstream of the at least one aperture (Fig. 1), the impeller 55 including one or more impeller blades 68, 70 to rotate around a longitudinal axis of the pump (Fig. 1, column 6 lines 33-42), and a diffuser 20 positioned in the housing radially inward of the at least one aperture, to direct blood from the impeller through the at least one aperture (Figs. 1, 11A-D, column 15 lines 12-16, 23-26).
Regarding claim 16, Benkowski discloses The system of claim 15, wherein
the impeller 55 is rotatable relative to the diffuser 20 and the housing (Fig. 1, column 6 lines 12-32).
Regarding claim 17, Benkowski discloses The system of claim 15, wherein
a circumference of a surface of the diffuser 20 increases in a downstream direction of the longitudinal axis of the pump (Fig. 1).
Regarding claim 20, Benkowski discloses The system of claim 15, wherein
an upstream end of the at least one aperture 36, 40 (Fig. 1) is downstream of a downstream end 44 of the impeller 55 (Fig. 1, column 6 lines 25-33).
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) 4-9, 12-14, 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Benkowski et al. (US 5947892) in view of Corbett et al. (US 20180055979).
Regarding claim 4, Benkowski discloses The system of claim 1, however
does not disclose the at least one aperture includes three apertures.
Corbett discloses the at least one aperture 216 includes three apertures 218, 220, 230 (Fig. 2, section 0053). This allow for the pump to have reduced the risk of occlusion of the apertures, thereby allowing the heart pump assembly to provide more assistance to the heart. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Benkowski by adding at least one aperture includes three apertures as taught by Corbett in order to facilitate pump to have reduced the risk of occlusion of the apertures, thereby allowing the heart pump assembly to provide more assistance to the heart.
Regarding claim 5, Benkowski in view of Corbett, specfically Corbett discloses The system of claim 4, wherein
the three apertures 218, 220, 230 (Fig. 2) are circumferentially spaced with centers of the three apertures being approximately degrees apart around the longitudinal axis of the pump (Fig. 2, 5). This allow for the pump to have reduced the risk of occlusion of the apertures, thereby allowing the heart pump assembly to provide more assistance to the heart.
Regarding claim 6, Benkowski in view of Corbett, specfically Corbett discloses The system of claim 4, wherein
the three apertures are divided by three strut-like portions 517a-c of the housing (Fig 5).
Regarding claim 7, Benkowski in view of Corbett, specfically Corbett discloses The system of claim 6, wherein
the three strut-like portions 517 are circumferentially spaced approximately 120 degrees apart around the longitudinal axis of the pump (Fig. 2, 5).
Regarding claim 8, Benkowski in view of Corbett, specfically Corbett discloses The system of claim 4, wherein
the three strut-like portions 517 are unequally spaced around the longitudinal axis of the pump (Fig. 5-8).
Regarding claim 9, Benkowski in view of Corbett, specfically Corbett discloses The system of claim 6, wherein
the three strut-like portions 517a-c are integrally molded with cylindrical portions of the housing (Fig. 5).
Regarding claim 12, Benkowski in view of Corbett, specfically Corbett discloses The system of claim 10, wherein
the at least one aperture 218, 220, 230 (Fig. 2) includes at least two apertures 218, 220, 230 , 518A-C divided by strut-like portions 517a-c of the housing (Fig. 2, 5). This allow for the pump to have reduced the risk of occlusion of the apertures, thereby allowing the heart pump assembly to provide more assistance to the heart. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Benkowski by adding at least one aperture includes three apertures as taught by Corbett in order to facilitate pump to have reduced the risk of occlusion of the apertures, thereby allowing the heart pump assembly to provide more assistance to the heart.
Regarding claim 13, Benkowski in view of Corbett, specfically Corbett discloses the system of claim 12, wherein
the strut-like portions 517a-c are circumferentially spaced approximately equally around the longitudinal axis (Figs. 2, 5). This allow for the pump to have reduced the risk of occlusion of the apertures, thereby allowing the heart pump assembly to provide more assistance to the heart.
Regarding claim 14, Benkowski in view of Corbett, specfically Corbett discloses the system of claim 10, wherein
an axial length of the at least one aperture 517a-c in the housing is approximately equal to an axial length of the diffuser (Fig. 2, 5). This allow for the pump to have reduced the risk of occlusion of the apertures, thereby allowing the heart pump assembly to provide more assistance to the heart.
Regarding claim 18, Benkowski in view of Corbett, specfically Corbett discloses The system of claim 15, wherein
the at least one aperture 218, 220, 230 (Fig. 2) includes at least two apertures divided by strut-like portions 517 a-c of the housing (Figs. 2, 5). This allow for the pump to have reduced the risk of occlusion of the apertures, thereby allowing the heart pump assembly to provide more assistance to the heart.
Regarding claim 19, Benkowski in view of Corbett, specfically Corbett discloses The system of claim 18, wherein
an arc length of each of the at least two apertures 1718a-c along a circumference of the housing is greater than an arc length of the strut-like portions along the circumference of the housing (Fig. 17, section 0078). This allow for the pump to have reduced the risk of occlusion of the apertures, thereby allowing the heart pump assembly to provide more assistance to the heart.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796
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