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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-15) in the reply filed on 25 Jun 2026 is acknowledged.
Claim Objections
Claims 2, 6, and 14-15 are objected to because of the following informalities:
Claim 2: “at” should be added at the beginning of line 2
Claim 6:
“the subject’s aorta of the subject” in line 3 should read “the aorta of the subject”
“the subject’s left ventricle” in line 4 should read “the left ventricle of the subject” for consistency with parent claim 1
Claim 14: “with respect to the axial shaft and the axial shaft being rigid” in line 7 should read “with respect to the axial shaft, the axial shaft being rigid”
Claim 15: “with respect to the axial shaft being coated with a coating” in lines 4-5 should read “with respect to the axial shaft, the axial shaft being coated with a coating”
Appropriate correction is required.
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 15 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.
The term “substantially” in claim 15 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The degree of vibration of the impeller that is prevented is unclear.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 6-7 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 6-7 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 6 recites “such that a proximal end of the tube is disposed within the subject’s aorta of the subject and a distal end of the tube is disposed within the subject’s left ventricle”, which claims the subject’s aorta and left ventricle.
For the purposes of examination, this limitation will be interpreted as “such that a proximal end of the tube is adapted to be disposed within the subject's aorta and a distal end of the tube is adapted to be disposed within the subject’s left ventricle”.
Claim 7 is also rejected because it is dependent on claim 6.
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.
Claims 1-5 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scheckel et al. (US 20160279310 A1), hereinafter Scheckel.
Regarding claim 1, Scheckel discloses an apparatus, comprising:
a left-ventricular assist device (Fig. 1, paragraph [0045], pump arrangement 1; paragraph [0032]) comprising:
a frame (Fig. 3a, paragraph [0054], pump housing 40) comprising:
proximal and distal frame portions that comprise struts that define cells (Fig. 3a, paragraph [0054], "The pump housing 40 illustrated in FIG. 3a comprises a pump-receiving portion 41, a portion 42 arranged distally of the pump-receiving portion, and a distal end portion 43 arranged distally of the distal portion. The pump housing also comprises a proximal portion 44 arranged proximally of the pump-receiving portion and an end portion 45 arranged proximally of the proximal portion"); and
a central frame portion that comprises helical struts (paragraph [0054], "The pump housing 40 has, in the proximal portion 44 and the distal portion 42, helical struts 46, which are shown by way of example in FIG. 3b. The struts extend here from the proximal end of the pump to the distal end of the pump, in an anticlockwise direction"); and
an impeller disposed inside the frame (Fig. 3a, paragraph [0054], rotor 49), the impeller being configured to rotate such as to pump blood from a left ventricle of a subject to an aorta of the subject (paragraph [0045], "The rotor 5 is formed here in such a way that blood is conveyed in the direction 12 from the ventricle into the aorta, i.e. from the distal end of the pump to the proximal end of the pump").
Regarding claim 2, Scheckel discloses the apparatus according to claim 1, as explained above. Scheckel further discloses that the proximal and distal frame portions are at least partially conical in shape (Fig. 3a, proximal portion 44 and distal portion 42 are illustrated with conical forms).
Regarding claim 3, Scheckel discloses the apparatus according to claim 1, as explained above. Scheckel further discloses that, during operation of the impeller, the impeller is configured to be disposed at least partially within the central frame portion (Fig. 3a, paragraph [0054], "rotor 49 is additionally arranged on the driveshaft in the region of the pump-receiving portion 41 of the housing").
Regarding claim 4, Scheckel discloses the apparatus according to claim 1, as explained above. Scheckel further discloses that, during operation of the impeller, the impeller is configured to be disposed at least partially within the central frame portion (Fig. 3a, paragraph [0054], "rotor 49 is additionally arranged on the driveshaft in the region of the pump-receiving portion 41 of the housing").
Regarding claim 5, Scheckel discloses the apparatus according to claim 1, as explained above. Scheckel further discloses that the helical struts are shaped such that the central frame portion defines a circular cross-sectional shape (Fig. 3b illustrates a circular cross section).
Regarding claim 13, Scheckel discloses the apparatus according to claim 1, as explained above. Scheckel further discloses that the impeller is stabilized with respect to the frame (paragraph [0026], "The rotor is thus prevented from colliding with the pump housing on account of different resistances to bending, and destruction of the pump housing or of the rotor itself is also prevented").
Regarding claim 14, Scheckel discloses the apparatus according to claim 13, as explained above. Scheckel further discloses that:
the left-ventricular assist device further comprises an axial shaft (Fig. 3a, paragraph [0054], driveshaft 48) and proximal and distal radial bearings disposed, respectively, at proximal and distal ends of the frame, the axial shaft passing through the proximal and distal radial bearings (Fig. 4a, paragraph [0057], first bearing 60 and distal bearing 61);
the impeller is coupled to the axial shaft (Fig. 3a, paragraph [0054], "A rotor 49 is additionally arranged on the driveshaft"); and
the impeller is stabilized with respect to the axial shaft and the axial shaft being rigid (paragraph [0062], "core 75 may produce an improved rigidity"; paragraph [0026], "the driveshaft is configured in such a way that a bending resistance of the driveshaft in the region of the proximal portion of the pump housing and distally of the proximal bearing corresponds with a bending resistance of the proximal portion of the pump housing. ... The rotor is thus prevented from colliding with the pump housing on account of different resistances to bending").
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6-12 are rejected under 35 U.S.C. 103 as being unpatentable over Scheckel et al. (US 20160279310 A1), hereinafter Scheckel, in view of Bredenbreuker et al. (US 20140255176 A1), hereinafter Bredenbreuker.
Regarding claim 6, Scheckel discloses the apparatus according to claim 1, as explained above. Scheckel does not explicitly disclose that the left-ventricular assist device further comprises a tube configured to traverse an aortic valve of a subject, such that a proximal end of the tube is disposed within the aorta of the subject and a distal end of the tube is disposed within the left ventricle of the subject, wherein the frame is disposed within at least a portion of the tube.
However, Bredenbreuker teaches a left-ventricular assist device (Fig. 1, paragraphs [0074]-[0076], heart pump 8) comprising:
a tube (Fig. 13, paragraph [0101], exterior skin 43') configured to traverse an aortic valve of a subject (paragraph [0025]), 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 (Fig. 10, paragraphs [0095], [0097]);
wherein the frame is disposed within at least a portion of the tube (Fig. 13, paragraph [0101], reinforcement elements 49).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Scheckel with the teachings of Bredenbreuker so that the left-ventricular assist device further comprises a tube configured to traverse an aortic valve of a subject, such that a proximal end of the tube is disposed within the aorta of the subject and a distal end of the tube is disposed within the left ventricle of the subject, wherein the frame is disposed within at least a portion of the tube, because doing so prevents an expansion of the pump housing beyond a firmly defined state (Bredenbreuker, paragraph [0086]).
Regarding claim 7, the apparatus according to claim 6 is obvious over Scheckel and Bredenbreuker, as explained above. Scheckel further discloses that the helical struts are shaped to define a circular cross-sectional shape at the central portion (Fig. 3b illustrates a circular cross section). Bredenbreuker further teaches helical struts that are shaped such that a portion of the tube disposed around the central frame portion defines a circular cross-sectional shape (paragraph [0095], "cylindrical section of the housing 39"; paragraph [0101], "The stretch-resistant element 50 is cylindrically shaped and has a dimension such that if it is stretched by the reinforcement elements 49, the housing skin 43' is also correspondingly stretched").
Regarding claim 8, Scheckel discloses the apparatus according to claim 1, as explained above. Scheckel does not explicitly disclose that the left-ventricular assist device further comprises an inner lining that lines at least the central frame portion.
However, Bredenbreuker teaches a left-ventricular assist device (Fig. 1, paragraphs [0074]-[0076], heart pump 8) comprising an inner lining that lines at least the central frame portion (Fig. 13, paragraph [0101], stretch-resistant element 50).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Scheckel with the teachings of Bredenbreuker so that the left-ventricular assist device further comprises an inner lining that lines at least the central frame portion, because doing so limits the radial expansion of a pump housing (Bredenbreuker, paragraph [0094]).
Regarding claim 9, the apparatus according to claim 8 is obvious over Scheckel and Bredenbreuker, as explained above. Scheckel further discloses that the helical struts are shaped to define a circular cross-sectional shape at the central portion (Fig. 3b illustrates a circular cross section). Bredenbreuker further teaches helical struts that are shaped such that a portion of the tube disposed around the central frame portion defines a circular cross-sectional shape (paragraph [0095], "cylindrical section of the housing 39"; paragraph [0101], "The stretch-resistant element 50 is cylindrically shaped and has a dimension such that if it is stretched by the reinforcement elements 49, the housing skin 43' is also correspondingly stretched").
Regarding claim 10, the apparatus according to claim 8 is obvious over Scheckel and Bredenbreuker, as explained above. Bredenbreuker further teaches that the impeller is configured such that a gap is maintained between an outer edge of the impeller and the inner lining throughout operation of the impeller (paragraphs [0036], [0039]).
Regarding claim 11, the apparatus according to claim 10 is obvious over Scheckel and Bredenbreuker, as explained above. Bredenbreuker further teaches that the gap is less than 1 mm (paragraph [0039], "the pump gap should be between 0.01 mm and 1 mm").
Regarding claim 12, the apparatus according to claim 11 is obvious over Scheckel and Bredenbreuker, as explained above. Bredenbreuker further teaches that the gap is less than 0.4 mm (paragraph [0039], "the pump gap should be between 0.01 mm and 1 mm, in particular between 0.01 mm and 0.3 mm, further advantageously between 0.03 mm and 0.15 mm.").
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Scheckel et al. (US 20160279310 A1), hereinafter Scheckel, in view of Pfeffer et al. (US 20180228952 A1), hereinafter Pfeffer.
Regarding claim 15, Scheckel discloses the apparatus according to claim 14, as explained above. Scheckel does not explicitly disclose that the impeller comprises bushings that are disposed around the axial shaft, and at least one of the bushings is configured to be slidable with respect to the axial shaft, wherein the impeller is stabilized with respect to the frame by a region along the axial shaft over which the at least one bushing is configured to be slidable with respect to the axial shaft, the axial shaft being coated with a coating, such as to substantially prevent the impeller from vibrating by the coating reducing a gap between the at least one bushing an the axial shaft.
However, Pfeffer teaches a percutaneous blood pump (paragraph [0012]) wherein the impeller comprises bushings that are disposed around the axial shaft (Fig. 6, paragraph [0094], distal rotor bearing 17 comprising bearing washer 15), and
at least one of the bushings is configured to be slidable with respect to the axial shaft (paragraph [0094], "the distal spacer sleeve 16 of the rotor 3.2 contacts the bearing washer 15 in the manner of a sliding bearing"),
wherein the impeller is stabilized with respect to the frame by a region along the axial shaft over which the at least one bushing is configured to be slidable with respect to the axial shaft being coated with a coating, such as to substantially prevent the impeller from vibrating by the coating reducing a gap between the at least one bushing and the axial shaft (paragraph [0096], blood or serum coats the bearing washer 15).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Scheckel with the teachings of Pfeffer so that the impeller comprises bushings that are disposed around the axial shaft, and at least one of the bushings is configured to be slidable with respect to the axial shaft, wherein the impeller is stabilized with respect to the frame by a region along the axial shaft over which the at least one bushing is configured to be slidable with respect to the axial shaft being coated with a coating, such as to substantially prevent the impeller from vibrating by the coating reducing a gap between the at least one bushing and the axial shaft, because doing so reduces play of the drive shaft (Pfeffer, paragraph [0094]) while also enabling smooth rotation of the impeller.
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, 6, and 8-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-9 of copending Application No. 17/677571 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the instant application is broader than claim 1 of the reference application. Therefore, claim 1 of the instant application anticipates claim 1 of the reference application. A brief matching of the pending claims in each application is provided below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Application No. 18/947762 (Instant Application)
Application No. 17/677571 (Reference Application)
Claim
Element
Claim
Element
1
An apparatus, comprising:
1
An apparatus, comprising:
1
a left-ventricular assist device comprising:
1
a left-ventricular assist device comprising:
1
a frame comprising:
1
the frame defining a plurality of cells, and
1
proximal and distal frame portions that comprise struts that define cells; and
1
the frame being configured such that, in a non-radially-constrained configuration of the frame, the frame comprises a generally cylindrical portion, a width of each of the cells within the cylindrical portion, as measured around a circumference of the cylindrical portion, being less than 2 mm;
1
a central frame portion that comprises helical struts; and
1
an impeller disposed inside the frame, the impeller being configured to rotate such as to pump blood from a left ventricle of a subject to an aorta of the subject.
1
an impeller disposed inside the frame, the impeller being configured to rotate such as to pump blood from the left ventricle to the aorta,
1
wherein a portion of the impeller that defines a maximum span of the impeller is configured to be disposed within a region of the cylindrical portion of the frame, and
6
The apparatus according to claim 1, wherein the left-ventricular assist device further comprises a tube configured to traverse an aortic valve of a subject, such that a proximal end of the tube is disposed within the aorta of the subject and a distal end of the tube is disposed within the left ventricle of the subject, .
1
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;
6
wherein the frame is disposed within at least a portion of the tube
1
a frame disposed within at least a portion of the tube,
8
The apparatus according to claim 1, wherein the left-ventricular assist device further comprises an inner lining that lines at least the central frame portion.
1
an inner lining that lines at least one of the cylindrical portion of the frame; and
9
The apparatus according to claim 8, wherein the helical struts are shaped such that a portion of the inner lining that lines the central frame portion defines a circular cross-sectional shape.
1
wherein the inner lining defines a substantially circular cross-section within the region of the cylindrical portion of the frame, by virtue of the width of each of the cells within the cylindrical portion being less than 2 mm.
10
The apparatus according to claim 8, wherein the impeller is configured such that a gap is maintained between an outer edge of the impeller and the inner lining throughout operation of the impeller.
4
The apparatus according to claim 1, wherein the impeller is configured such that a gap is maintained between an outer edge of the impeller and the inner lining throughout operation of the impeller.
11
The apparatus according to claim 10, wherein the gap is less than 1 mm.
5
The apparatus according to claim 4, wherein the gap is less than 1 mm.
12
The apparatus according to claim 11, wherein the gap is less than 0.4 mm.
6
The apparatus according to claim 5, wherein the gap is less than 0.4 mm.
13
The apparatus according to claim 1, wherein the impeller is stabilized with respect to the frame.
7
The apparatus according to claim 1, wherein the impeller is stabilized with respect to the frame.
14
The apparatus according to claim 13, wherein:
8
The apparatus according to claim 7, wherein:
14
the left-ventricular assist device further comprises an axial shaft and proximal and distal radial bearings disposed, respectively, at proximal and distal ends of the frame, the axial shaft passing through the proximal and distal radial bearings;
8
the left-ventricular assist device further comprises an axial shaft and proximal and distal radial bearings disposed, respectively, at proximal and distal ends of the frame, the axial shaft passing through the proximal and distal radial bearings;
14
the impeller is coupled to the axial shaft; and
8
the impeller is coupled to the axial shaft; and
14
the impeller is stabilized with respect to the axial shaft and the axial shaft being rigid.
8
the impeller is stabilized with respect to the frame by the impeller being held in a radially-fixed position with respect to the axial shaft and the axial shaft being rigid.
15
The apparatus according to claim 14, wherein the impeller comprises bushings that are disposed aroundn the axial shaft, and
9
The apparatus according to claim 8, wherein the impeller comprises bushings that are disposed around the axial shaft, and
15
at least one of the bushings is configured to be slidable with respect to the axial shaft,
9
at least one of the bushings is configured to be slidable with respect to the axial shaft,
15
wherein the impeller is stabilized with respect to the frame by a region along the axial shaft over which the at least one bushing is configured to be slidable with respect to the axial shaft being coated with a coating, such as to substantially prevent the impeller from vibrating by the coating reducing a gap between the at least one bushing an the axial shaft.
9
wherein the impeller is stabilized with respect to the frame by a region along the axial shaft over which the at least one bushing is configured to be slidable with respect to the axial shaft being coated with a coating, such as to substantially prevent the impeller from vibrating by the coating reducing a gap between the at least one bushing and the axial shaft.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE SISON whose telephone number is (703)756-4661. The examiner can normally be reached 8 am - 5 pm PT, Mon - Fri.
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/CHRISTINE SISON/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796