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.
Claims 3, 17, 19 are 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.
Claims 3 and 17 recites the limitation "the helical elongate element" in the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 17, 19 recites the limitation "the spring" in the claim. There is insufficient antecedent basis for this limitation in the claim.
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 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 An apparatus, comprising: a blood pump configured to be placed inside a body of subject, the blood pump comprising: an impeller comprising proximal and distal bushings; an axial shaft configured to pass through the proximal and distal bushings of the impeller, a first one of the proximal and distal bushings of the impeller being axially-fixed to the axial shaft, such that the first bushing is held in an axially-fixed position with respect to the axial shaft, and a second one of the proximal and distal bushings of the impeller not being axially-fixed to the axial shaft, and the impeller defining a radially-constrained configuration in which the impeller is introduced into the subject's body and a non-radially-constrained configuration in which the impeller is configured to pump blood within the subject's body, the impeller being configured to change from its radially-constrained configuration to its non-radially constrained configuration by the second bushing sliding over the axial shaft.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11690521. 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 An apparatus, comprising: a blood pump configured to be placed inside a body of subject, the blood pump comprising: an impeller comprising proximal and distal bushings; an axial shaft configured to pass through the proximal and distal bushings of the impeller, a first one of the proximal and distal bushings of the impeller being axially-fixed to the axial shaft, such that the first bushing is held in an axially-fixed position with respect to the axial shaft, and a second one of the proximal and distal bushings of the impeller not being axially-fixed to the axial shaft, and the impeller defining a radially-constrained configuration in which the impeller is introduced into the subject's body and a non-radially-constrained configuration in which the impeller is configured to pump blood within the subject's body, the impeller being configured to change from its radially-constrained configuration to its non-radially constrained configuration by the second bushing sliding over the axial shaft.
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) 1-11, 13-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Evans et al. (US 20130053623).
Regarding claim 1, Evans discloses an apparatus, comprising: a blood pump configured to be placed inside a body of subject (abstract), the blood pump comprising:
an impeller 500 comprising proximal 532 and distal bushings 632 (Fig. 7F, section 0096-0097);
an axial shaft 630 configured to pass through the proximal and distal bushings of the impeller (Fig. 7F, section 0096-0098),
a first one of the proximal 532 and distal 632 bushings of the impeller 500 being axially-fixed to the axial shaft 630, such that the first bushing is held in an axially-fixed position with respect to the axial shaft, and a second one of the proximal and distal bushings of the impeller not being axially-fixed to the axial shaft (Fig. 7F, section 0096-0098), and
the impeller 500 defining a radially-constrained configuration in which the impeller is introduced into the subject's body and a non-radially-constrained configuration in which the impeller is configured to pump blood within the subject's body (section 0048),
the impeller 500 being configured to change from its radially-constrained configuration to its non-radially constrained configuration by the second bushing sliding over the axial shaft (section 0048).
Regarding claim 2, Evans discloses the apparatus according to claim 1, further comprising a delivery catheter 610 (Fig. 7F, section 0089), wherein:
the delivery catheter 610 is configured to maintain the impeller in its radially-constrained configuration during introduction of the impeller into the subject's body (Section 0048, 0083, 0086-0088),
upon the impeller being released from the delivery catheter, the impeller is configured to self-expand to thereby cause the second bushing to slide over the axial shaft, such that the impeller assumes its non-radially-constrained configuration (sections 0048, 0083), and
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 a 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 causes the second bushing to slide over the axial shaft (Section 0048, 0083, 0086-0088).
Regarding claim 3, Evans discloses The apparatus according to claim 1, wherein the impeller comprises:
at least one curved elongate element 502 that extends from the proximal bushing 532 to the distal bushing 632 (Fig. 7F, section 0096-0098);
an axial element 607 that is disposed inside of the helical elongate element 502 and extends from the proximal bushing to the distal bushing (Fig. 7F, section 0093, 0096-0099); and
material supported between the curved elongate element and the axial element (Fig. 7F, section 0060, 0096-0099).
Regarding claim 4, Evans discloses the apparatus according to claim 3, wherein
the impeller comprises a plurality of blades 502 each of which comprises a respective curved elongate element and the material supported between the curved elongate element and the axial element (Section 0096).
Regarding claim 5, Evans discloses The apparatus according to claim 3, wherein
the axial element 607 comprises an axial spring (Section 0093).
Regarding claim 6, Evans discloses the apparatus according to claim 3, 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. 7F, section 0093, 0096-0099).
Regarding claim 7, Evans discloses The apparatus according to claim 6, wherein
the at least one flexible elongate element being selected from the group consisting of: a string and a wire (Section 0096).
Regarding claim 8, Evans discloses The apparatus according to claim 3, wherein
the material comprises a film of material (Fig. 7F, section 0060, 0096-0099).
Regarding claim 9, Evans discloses The apparatus according to claim 8, wherein
the impeller is configured to be radially constrained by the curved elongate element and the axial element being axially elongated, and wherein in response to the axial elongation of the curved elongate element and the axial element, the film of material is configured to change shape without the film of material breaking (Section 0048, 0083, 0086-0088).
Regarding claim 10, Evans discloses The apparatus according to claim 1, wherein
the impeller is configured to be placed inside a left ventricle of the subject, and to pump blood from the subject's left ventricle to an aorta of the subject (Section 0105-0106).
Regarding claim 11, Evans discloses The apparatus according to claim 10, further comprising:
a tube configured to traverse an aortic valve of a subject, such that a proximal end of the tube is disposed within an aorta of the subject and a distal end of the tube is disposed within a left ventricle of the subject, the tube comprising a blood-impermeable material (section 0090-0093);
a frame disposed within at least a portion of the tube, wherein the impeller is disposed inside the frame and is configured to rotate such as to pump blood from the left ventricle to the aorta (sections 0090, 0105-0106).
Regarding claim 13, Evans discloses The apparatus according to claim 11, 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 (Sections 0131, 0134).
Regarding claim 14, Evans discloses a method, comprising: inserting a blood pump into a body of subject (Abstract), the blood pump including:
an impeller 500 comprising proximal 532 and distal 632 bushings (Fig. 7F, section 0096-0097);
an axial shaft 630 configured to pass through the proximal 532 and distal 632 bushings of the impeller (Fig. 7F, section 0096-0098),
a first one of the proximal 532 and distal 632 bushings of the impeller 500 being axially-fixed to the axial shaft, such that the first bushing is held in an axially-fixed position with respect to the axial shaft, and a second one of the proximal and distal bushings of the impeller not being axially-fixed to the axial shaft (Fig. 7F, section 0096-0098),
wherein the impeller is maintained in a radially-constrained configuration by a delivery catheter while the impeller is inserted into the subject's body (section 0048);
when the impeller is disposed within the subject's body, causing the impeller to change from its radially-constrained configuration to a non-radially-constrained configuration by allowing the second bushing to slide over the axial shaft, by releasing the impeller from the delivery catheter (section 0048); and
pumping blood through the subject's body using the impeller, while the impeller is disposed in its non-radially-constrained configuration (section 0059, 0113, 0145).
Regarding claim 15, Evans discloses The method according to claim 14, wherein
releasing the impeller from the delivery catheter comprises releasing the impeller from the delivery catheter inside a left ventricle of the subject (section 0048), and
wherein pumping blood through the subject's body using the impeller comprises pumping blood from the subject's left ventricle to an aorta of the subject, using the impeller, while the impeller is disposed inside the subject's left ventricle (sections 0090, 0105-0106).
Regarding claim 16, Evans discloses The method according to claim 14, further comprising
retracting the impeller from the subject's body, by moving a distal end of the delivery catheter and the impeller with respect to one another such that the distal end of the delivery catheter causes the second bushing to slide over the axial shaft (Section 0048, 0083, 0086-0088).
Regarding claim 17, Evans discloses The method according to claim 14, wherein
the impeller includes: at least one curved elongate element 502 that extends from the proximal bushing to the distal bushing, an axial element that is disposed inside of the helical elongate element (Fig. 7F, section 0096-0098), and extends from the proximal bushing to the distal bushing (Fig. 7F, section 0093, 0096-0099), and material supported between the helical elongate element and the spring (Fig. 7F, section 0060, 0096-0099); and
wherein causing the impeller to change from its radially-constrained configuration to a non-radially-constrained configuration by allowing the second bushing to slide over the axial shaft comprises causing the curved elongate element to expand radially, thereby causing the curved elongate element and the material to define a blade of the impeller (section 0048).
Regarding claim 18, Evans discloses The method according to claim 17, wherein
causing the impeller to change from its radially-constrained configuration to a non-radially-constrained configuration by allowing the second bushing to slide over the axial shaft comprises causing the curved elongate element to become axially contracted (Section 0048, 0083, 0086-0088).
Regarding claim 19, Evans discloses The method according to claim 17, wherein
the impeller further includes at least one flexible elongate element extending from the spring to the curved elongate element (Section 0096); and
wherein pumping blood through the subject's body using the impeller comprises maintaining the curved elongate element within a given distance from the axial element using the flexible elongate element, during the pumping of the blood by the impeller (sections 0090, 0105-0106).
Regarding claim 20, Evans discloses The method according to claim 17, wherein:
the curved elongate element comprises a helical elongate element (Fig. 7F, section 0060, 0096-0099);
the axial element comprises an axial spring (Section 0093); and
the material comprises a film of material (Section 0048, 0083, 0086-0088).
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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