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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation " the spring" in last line of the claim. There is insufficient antecedent basis for this limitation in the claim.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-15, 18-19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Schwammenthal et al. (US 20180169313).
The applied reference has a common Applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 1, Schwammenthal discloses an apparatus, comprising:
a blood pump 20 configured to be placed inside a body of subject (Fig. 1A-D, section 0311), the blood pump comprising:
an impeller 28 defining a lumen 116 therethrough (Fig. 8A-C, section 0380-0381); and
an axial shaft 120 that passes through the lumen 116 (Fig. 8A-C, sections 0380-0381), the impeller 28 being configured to assume a radially-constrained configuration by becoming axially elongated (Fig. 2, section 0312, 0327-0328, 0384, 0389).
Regarding claim 2, Schwammenthal discloses the apparatus according to claim 1, wherein
the impeller 28 comprises a proximal bushing 106 and a distal bushing 106 and the lumen 116 extends from the proximal bushing to the distal bushing (Fig. 7C, section 0366, 0379).
Regarding claim 3, Schwammenthal discloses the apparatus according to claim 2, wherein
a first one of the bushings 106 is coupled to the axial shaft 120 (Fig. 8A, , such that the first bushing is held in an axially-fixed position with respect to the axial shaft, and a second one of the bushings 106 is not coupled to the axial shaft 120, such that the second bushing is not held in an axially-fixed position with respect to the axial shaft, and wherein, the impeller 28 is configured to become axially elongated by the second bushing sliding along the axial shaft (Fig. 8A, section 0383).
Regarding claim 4, Schwammenthal discloses the apparatus according to claim 1, wherein
the impeller 28 comprises: at least one curved elongate element (blades) that extends from a proximal end of the impeller to a distal end of the impeller (Fig. 1D, section 0333); and
axial element that defines the lumen (section 0377); and
material supported between the helical elongate element and the spring (section 0264, 0405).
Regarding claim 5, Schwammenthal discloses the apparatus according to claim 4, wherein
the axial element comprises a spring that is disposed inside of the curved elongate element (Section 0264, 0405), and along an axis around which the curved elongate element winds (Section 0333).
Regarding claim 6, Schwammenthal discloses The apparatus according to claim 4, wherein
the curved elongate element 28 comprises a helical elongate element (Section 0266).
Regarding claim 7, Schwammenthal discloses The apparatus according to claim 4, wherein
the material comprises a film of material (section 0286).
Regarding claim 8, Schwammenthal discloses The apparatus according to claim 4, wherein
the impeller 28 comprises a plurality of blades each of which comprises a respective curved elongate element and the material supported between the curved elongate element and the axial element (Fig. 1D, section 0333).
Regarding claim 9, Schwammenthal discloses the apparatus according to claim 4, wherein
in response to the axial elongation of the impeller, the material is configured to change shape without the material breaking (Section 0370).
Regarding claim 10, Schwammenthal discloses the apparatus according to claim 4, wherein
the impeller further comprises at least one flexible elongate element extending from the axial element to the curved elongate element and configured to maintain the curved elongate element within a given distance from the axial element (Fig. 1D, section 0333).
Regarding claim 11, Schwammenthal discloses the apparatus according to claim 10, wherein
the at least one flexible elongate element comprises an element selected from the group consisting of: a string and a wire (section 0374).
Regarding claim 12, Schwammenthal discloses The apparatus according to claim 1, further comprising
a delivery catheter 23, configured to move with respect to the impeller to thereby cause the impeller to assume a radially-constrained configuration by the impeller becoming axially elongated (fig. 8A, section 0311).
Regarding claim 13, Schwammenthal discloses The apparatus according to claim 12, wherein:
the delivery catheter 23 is configured to maintain the impeller in its radially-constrained configuration during introduction of the impeller into the subject's body, and upon the impeller being released from the delivery catheter, the impeller 28 is configured to self-expand, such that the impeller assumes a non-radially-constrained configuration (Fig. 8B-C, section 0383).
Regarding claim 14, Schwammenthal discloses The apparatus according to claim 13, wherein,
in order to retract the impeller from the subject's body, the delivery catheter is configured to cause the impeller to assume its radially-constrained configuration by the distal end of the delivery catheter and the impeller, being moved with respect to one another, such that the distal end of the delivery catheter radially constrains the impeller (section 0382-0383).
Regarding claim 15, Schwammenthal discloses The apparatus according to claim 12, further comprising
a frame 30 disposed around the impeller, wherein the delivery catheter is configured to move with respect to the impeller to thereby cause the frame and the impeller to assume radially-constrained configurations by frame 30 and the impeller 28 becoming axially elongated (Fig. 8A).
Regarding claim 18, Schwammenthal discloses The apparatus according to claim 17, wherein
the impeller is configured such that, when the impeller and the tube are deployed within the subject’s body, a gap 184 between an outer edge of the impeller and an inner surface of the tube is less than 1 mm (Section 0417).
Regarding claim 19, Schwammenthal discloses The apparatus according to claim 18, wherein
the impeller is configured to be stabilized with respect to the tube, such that, during rotation of the impeller, a gap between the outer edge of the impeller and the inner surface of the tube is maintained (Section 0417-0418).
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 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10881770. 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 blood pump configured to be placed inside a body of subject, the blood pump comprising: an impeller defining a lumen therethrough; and an axial shaft that passes through the lumen, the impeller being configured to assume a radially-constrained configuration by becoming axially elongated.
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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