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 .
Response to Arguments
Applicant’s arguments, filed 09/26/2025, with respect to the objection of claims 14 and 23 have been fully considered and are persuasive. The objection of claims 14 and 23 has been withdrawn.
Applicant's arguments, filed 09/26/2025, with respect to the rejection of claims 1-24 under 35 U.S.C. 103 have been fully considered but they are not persuasive. Additionally, since the amendments to independent claim 1, where Applicant has amended to add “the pump-outlet tube defining a central cylindrical portion and a distal conical portion that extends to a distal end of the frame and that continuously narrows from the central cylindrical portion of the pump-outlet tube to the distal end of the pump-outlet tube”, changes the scope of claims 1-24 and does not merely incorporate limitations from previous dependent claims, a new grounds of rejection is made in view of previously applied references as explained in further detail below.
Applicant contends that Fig. 17 of D’Ambrosio shows a bulbous expandable filter 1700 having an enlarged inflow area 1702 installed thereon (¶[0117] of D’Ambrosio), and that it is in this context that D’Ambrosio states (¶[0121] of D’Ambrosio) “In general, sizes of the apertures of the plurality of apertures 702-706 increase along the longitudinal axis, in the distal direction, although the increase need not necessarily be monotonic. The apertures 702-706 are arranged in a plurality of generally circumferential, relative to the longitudinal axis, rows of equal-sized apertures, exemplified by rows 1710, 1712 and 1714. Ones of the rows 1710-1714 have different numbers of the apertures 702-706 from others of the rows 1710-1714. For example, a first row 1710 (indicated by a dashed line) of the plurality of generally circumferential rows comprises more apertures 702 than a second row 1712 of the plurality of generally circumferential rows. Each aperture 702 of the first row 1710 has a smaller area than each aperture 704 of the second row 1712.” Applicant further contends that when D’Ambrosio describes the sizes of apertures in a tapered filter section in ¶[0107] that D’ Ambrosio states that “the holes 728 in a distal region of the tapered filter section 518 are narrower, in a circumferential direction, than the holes 702-706 in a proximal region of the tapered filter section 518. In other words, sizes of the apertures 702-706 increase monotonically in the proximal direction, along the longitudinal axis,” where it would not have been obvious to arrive at claim 1 based on Tuval in view of D’Ambrosio as a person of ordinary skill in the art would have assumed that in a tapered filter it is desirable for the sizes of apertures to increase rather than decrease in the proximal direction. Examiner respectfully disagrees.
Tuval is utilized to teach a tapered filter (Figure 2B, central cylindrical portion 38, distal conical portion 40, where the distal conical portion narrows relative to the central cylindrical portion, ¶[0461], where “the distal conical portion is such that the narrow end of the cone is distal with respect to the wide end of the cone”) and D’Ambrosio to teach the change in the size of apertures as well as porosity. In D’Ambrosio, it teaches that a porosity of the distal conical portion of the pump-outlet tube, which defines the blood-inlet openings, is lower within a proximal region of the distal conical portion of the pump-outlet tube than within a distal region of the distal conical portion of the pump-outlet tube that is distal to the proximal region (¶[0122], where the “[s]ize of the apertures 702-706 in each of the plurality of bands 1718-1722 increases monotonically along the longitudinal axis. That is, in general, the apertures in band 1720 are larger than the apertures in band 1718. ... In the embodiment shown in FIG. 17, the size of the apertures 702-706 in each of the plurality of bands 1718-1722 increases monotonically along the longitudinal axis in the distal direction.” Examiner takes the position that as the size of the apertures increases, that the porosity of those areas will also increase such that the distal portion will have a higher porosity than the proximal portion.). D’Ambrosio further teaches that “Other aspects of the aperture sizes and arrangements are similar to those discussed with respect to FIG. 7” (See ¶[0122]), which suggests that this aperture arrangement is usable with a tapered filter. Furthermore, D’Ambrosio teaches that “Disclosed aspects, or portions thereof, may be combined in ways not listed above and/or not explicitly claimed. In addition, embodiments disclosed herein may be suitably practiced, absent any element that is not specifically disclosed herein. Accordingly, the invention should not be viewed as being limited to the disclosed embodiments” (¶[0127]), such that different aperture sizes and arrangements are combinable with other filter types, such as the tapered filter in Figure 7. Therefore, Tuval in combination with D’Ambrosio teaches the limitations as claimed.
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 13-16 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.
Claim 13 recites the limitation "a central cylindrical portion" and "a distal conical portion" in line 2. There is insufficient antecedent basis for this limitation in the claim as it is unclear whether this is the same central cylindrical portion and distal conical portion as claimed in independent claim 1. Examiner interprets that the claim is meant to read “wherein the frame defines the central cylindrical portion and the distal conical portion”. Claims 14-16, which are dependent from claim 13, are rejected for the same reason set forth for claim 13 above.
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.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al. (hereinafter “Tuval”) (U.S. Pub. No. 2019/0209758 A1) in view of D'Ambrosio et al. (hereinafter “D’Ambrosio”) (U.S. Pub. No. 2021/0236797 A1).
Regarding claim 1, Tuval teaches an apparatus, comprising: a left-ventricular assist device (¶[0009], where a ventricular assist device includes an impeller … ventricular assist device typically includes a tube, which traverses the subject's aortic valve, such that a proximal end of the tube is disposed in the subject's aorta and a distal end of the tube is disposed within the subject's left ventricle) comprising:
an impeller configured to be placed inside a left ventricle of a subject and to pump blood from the left ventricle to an aorta of the subject, by rotating (¶[0009], “the impeller, the axial shaft and the frame are disposed within a distal portion of the tube inside the subject's left ventricle “ and “the impeller is configured to pump blood from the left ventricle into the aorta by rotating”);
a frame disposed around the impeller (¶[0009], “…with a frame disposed around the impeller”); and
a pump-outlet tube configured to traverse an aortic valve of the subject, such that a proximal end of the tube is disposed within the subject's aorta and a distal end of the pump-outlet tube is disposed within the subject's left ventricle (See ¶[0359]),
the pump-outlet tube defining a central cylindrical portion and a distal conical portion that extends to a distal end of the frame (Fig 2A, distal portion 102 of tube 24 which extends to the distal end of the frame 34, proximal portion 106 of tube 24, central cylindrical portion 38, distal conical portion 40, ¶[0461], where “Referring to FIGS. 2A-C, for some applications, frame 34 is shaped such that the frame defines … a central cylindrical portion 38, and a distal conical portion 40”) and that continuously narrows from the central cylindrical portion of the pump-outlet tube to the distal end of the pump-outlet tube (Figure 2B, central cylindrical portion 38, distal conical portion 40, where the distal conical portion narrows relative to the central cylindrical portion, ¶[0461], where “the distal conical portion is such that the narrow end of the cone is distal with respect to the wide end of the cone”).
Although Tuval teaches that the distal conical portion of the pump-outlet tube defines one or more lateral blood inlet openings (¶[0461], where “tube 24 extends to the end of distal conical portion 40, and the tube defines one or more lateral blood inlet openings, as shown in FIG. 2C”), Tuval does not explicitly teach the distal conical portion of the pump- outlet tube defining more than 10 blood-inlet openings that are sized such as (a) to allow blood to flow from the subject's left ventricle into the tube and (b) to block structures from the subject's left ventricle from entering into the frame, wherein a porosity of the distal conical portion of the pump-outlet tube, which defines the blood-inlet openings, is lower within a proximal region of the distal conical portion of the pump-outlet tube than within a distal region of the distal conical portion of the pump-outlet tube that is distal to the proximal region.
D’Ambrosio teaches an intravascular blood pump that has a plurality of apertures and an intake filter that reduces risk of heart tissue being sucked into an intake port of the pump (Abstract), and further teaches the distal conical portion of the pump-outlet tube defining more than 10 blood-inlet openings (Figure 2, where a filter 130 is attached to a blood flow inlet 126, Figure 13, where a filter 130 exhibits more than 10 apertures. Examiner takes the position that the apertures are equivalent to blood-inlet openings because they allow the blood to pass through to the rest of the system that enters from the blood flow inlet.) that are sized such as (a) to allow blood to flow from the subject's left ventricle into the tube (¶[0019], where the filter includes a tube, ¶[0058], where the intravascular blood pump 100 positioned within a left ventricle 102 of a heart 104 of a patient) and (b) to block structures from the subject's left ventricle from entering into the frame (¶[0052], where an intake filter that reduces the risk of heart tissue being sucked into an intake port of the intravascular blood pump),
wherein a porosity of the distal conical portion of the pump-outlet tube, which defines the blood-inlet openings, is lower within a proximal region of the distal conical portion of the pump-outlet tube than within a distal region of the distal conical portion of the pump-outlet tube that is distal to the proximal region (¶[0122], where the “[s]ize of the apertures 702-706 in each of the plurality of bands 1718-1722 increases monotonically along the longitudinal axis. That is, in general, the apertures in band 1720 are larger than the apertures in band 1718. ... In the embodiment shown in FIG. 17, the size of the apertures 702-706 in each of the plurality of bands 1718-1722 increases monotonically along the longitudinal axis in the distal direction.” Examiner takes the position that as the size of the apertures increases, that the porosity of those areas will also increase such that the distal portion will have a higher porosity than the proximal portion.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of D’Ambrosio, which teaches the distal conical portion of the pump-outlet tube defining more than 10 blood-inlet openings that are sized such as (a) to allow blood to flow from the subject's left ventricle into the tube and (b) to block structures from the subject's left ventricle from entering into the frame, wherein a porosity of the distal conical portion of the pump-outlet tube, which defines the blood-inlet openings, is lower within a proximal region of the distal conical portion of the pump-outlet tube than within a distal region of the distal conical portion of the pump-outlet tube that is distal to the proximal region, into the invention of Tuval in order to reduce the risk of heart tissue being sucked into an intake port of the intravascular blood pump (D’Ambrosio ¶[0052]) and to reduce clotting as larger aperture sizes have a lower chance of clotting than smaller apertures (D’Ambrosio ¶[0106]).
Regarding claim 2, Tuval in combination with D’Ambrosio teaches all limitations of claim 1 as described in the rejection above.
D’Ambrosio teaches that each of the blood-inlet openings is shaped such that, in at least one direction, a width of the opening is less than 1 mm (¶[0011], where each aperture of the plurality of apertures may have a largest dimension less than or equal to about 0.5 mm, or less than or equal to about 0.4 mm).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of D’Ambrosio, which teaches that each of the blood-inlet openings is shaped such that, in at least one direction, a width of the opening is less than 1 mm, into the invention of Tuval in order to reduce the risk of heart tissue being sucked into an intake port of the intravascular blood pump (D’Ambrosio ¶[0052]).
Regarding claim 3, Tuval in combination with D’Ambrosio teaches all limitations of claim 1 as described in the rejection above.
D’Ambrosio teaches that a ratio of the porosity of the distal conical portion of the pump-outlet tube within the distal region to the porosity of the distal conical portion of the pump-outlet tube within the proximal region is more than 4:3 (¶[0122], where the “[s]ize of the apertures 702-706 in each of the plurality of bands 1718-1722 increases monotonically along the longitudinal axis. That is, in general, the apertures in band 1720 are larger than the apertures in band 1718. ... In the embodiment shown in FIG. 17, the size of the apertures 702-706 in each of the plurality of bands 1718-1722 increases monotonically along the longitudinal axis in the distal direction.” Examiner takes the position that as the size of the apertures increases, that the porosity of those areas will also increase.).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the combination of Tuval and D’Ambrosio to incorporate the claimed porosity ratio because it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, Applicant has disclosed no criticality to this porosity ratio in the specification filed 03/15/2023, where the specification reads “For example, the ratio of the porosity within distal region 46D to the porosity within proximal region 46P is more than 4:3, or more than 3:2” on page 52 (See MPEP 2144.05 regarding criticality). Porosity is required in order to allow sufficient blood into the pump, and it would be obvious to have a porosity ratio of 4:3 in order to do so since no reasoning is given as to why this specific ratio is optimal. Furthermore, since no optimal reasoning is given for the claimed ratio, Applicant would have had a reasonable expectation of success, and it would not have required undue experimentation to alter Tuval in combination with D’Ambrosio to determine the porosity ratio.
Regarding claim 4, Tuval in combination with D’Ambrosio teaches all limitations of claim 1 as described in the rejection above.
D’Ambrosio teaches that the porosity of the distal conical portion of the pump-outlet tube is varied between the proximal region and the distal region such as to account for varying blood flow dynamics at different regions of the distal conical portion of the pump-outlet tube (¶[0122], where the “[s]ize of the apertures 702-706 in each of the plurality of bands 1718-1722 increases monotonically along the longitudinal axis. That is, in general, the apertures in band 1720 are larger than the apertures in band 1718. ... In the embodiment shown in FIG. 17, the size of the apertures 702-706 in each of the plurality of bands 1718-1722 increases monotonically along the longitudinal axis in the distal direction.” Examiner takes the position that as the size of the apertures increases, that the porosity of those areas will also increase such that the porosity will vary between the distal and proximal portions.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of D’Ambrosio, which teaches that the porosity of the distal conical portion of the pump-outlet tube is varied between the proximal region and the distal region such as to account for varying blood flow dynamics at different regions of the distal conical portion of the pump-outlet tube, into the invention of Tuval in order to reduce the risk of heart tissue being sucked into an intake port of the intravascular blood pump (D’Ambrosio ¶[0052]) and to reduce clotting as larger aperture sizes have a lower chance of clotting than smaller apertures (D’Ambrosio ¶[0106]).
Regarding claim 5, Tuval in combination with D’Ambrosio teaches all limitations of claim 1 as described in the rejection above.
D’Ambrosio teaches that the porosity of the distal conical portion of the pump-outlet tube is varied between the proximal region and the distal region such as to account for changes in the shape of the distal conical portion of the pump-outlet tube along its length (¶[0122], where the “[s]ize of the apertures 702-706 in each of the plurality of bands 1718-1722 increases monotonically along the longitudinal axis. That is, in general, the apertures in band 1720 are larger than the apertures in band 1718. ... In the embodiment shown in FIG. 17, the size of the apertures 702-706 in each of the plurality of bands 1718-1722 increases monotonically along the longitudinal axis in the distal direction.” Examiner takes the position that as the size of the apertures increases, that the porosity of those areas will also increase such that the porosity will vary between the distal and proximal portions.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of D’Ambrosio, which teaches that the porosity of the distal conical portion of the pump-outlet tube is varied between the proximal region and the distal region such as to account for changes in the shape of the distal conical portion of the pump-outlet tube along its length, into the invention of Tuval in order to reduce the risk of heart tissue being sucked into an intake port of the intravascular blood pump (D’Ambrosio ¶[0052]) and to reduce clotting as larger aperture sizes have a lower chance of clotting than smaller apertures (D’Ambrosio ¶[0106]).
Regarding claim 6, Tuval in combination with D’Ambrosio teaches all limitations of claim 1 as described in the rejection above.
D’Ambrosio teaches that along the distal region of the distal conical portion of the pump-outlet tube, the pump-outlet tube defines large blood-inlet openings that are configured to reduce a risk of thrombosis relative to if the blood-inlet openings along the distal region of the distal conical portion of the pump-outlet tube were smaller (¶[0106], where the distal outer foil 520 … reduces the effective size of, the first one or more rows of the holes 726 in the transitional zone 724 ... these reduced hole sizes may lead to blood damage or increased risk of clotting. Therefore, the holes 726 in the transitional zone 724 should be chosen to be larger than holes in the tapered filter section 518).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of D’Ambrosio, which teaches that along the distal region of the distal conical portion of the pump-outlet tube, the pump-outlet tube defines large blood-inlet openings that are configured to reduce a risk of thrombosis relative to if the blood-inlet openings along the distal region of the distal conical portion of the pump-outlet tube were smaller, into the invention of Tuval in order to reduce the risk of heart tissue being sucked into an intake port of the intravascular blood pump (D’Ambrosio ¶[0052]) and to reduce the risk of clotting (D’Ambrosio ¶[0106]).
Regarding claim 7, Tuval in combination with D’Ambrosio teaches all limitations of claim 1 as described in the rejection above.
D’Ambrosio teaches that the distal conical portion of the pump-outlet tube defines more than 50 blood-inlet openings (Figure 2, where a filter 130 is attached to a blood flow inlet 126, Figure 13, where a filter 130 exhibits more than 50 apertures. Examiner takes the position that the apertures are equivalent to blood-inlet openings because they allow the blood to pass through to the rest of the system that enters from the blood flow inlet.) that are sized such as (a) to allow blood to flow from the subject's left ventricle into the tube (¶[0019], where the filter includes a tube, ¶[0058], where the intravascular blood pump 100 positioned within a left ventricle 102 of a heart 104 of a patient) and (b) to block structures from the subject's left ventricle from entering into the frame (¶[0052], where an intake filter that reduces the risk of heart tissue being sucked into an intake port of the intravascular blood pump).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of D’Ambrosio, which teaches that the distal conical portion of the pump-outlet tube defines more than 50 blood-inlet openings that are sized such as (a) to allow blood to flow from the subject's left ventricle into the tube and (b) to block structures from the subject's left ventricle from entering into the frame, into the invention of Tuval in order to reduce the risk of heart tissue being sucked into an intake port of the intravascular blood pump (D’Ambrosio ¶[0052]).
Regarding claim 8, Tuval in combination with D’Ambrosio teaches all limitations of claim 1 as described in the rejection above.
D’Ambrosio teaches that the blood-inlet openings are rectangular and are shaped such that a ratio of lengths to widths of each of the blood-inlet openings is between 1.1:1 and 4:1 (¶[0089], where Each aperture of at least a subset of the plurality of apertures 622-626 may have a general rhombus or rhomboid or rectangular shape).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the combination of Tuval and D’Ambrosio to incorporate the claimed length to width ratio of a rectangle because it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, Applicant has disclosed no criticality to this rectangular ratio in the specification filed 03/15/2023, where the specification reads “For some such applications, the ratio of the lengths to the widths of the blood-inlet openings is between 1.1:1 and 4:1, e.g., between 3:2 and 5:2. For some applications, by having such shapes, the blood-inlet openings are configured (a) to block structures from the left ventricle (such as chordae tendineae, trabeculae carneae, and/or papillary muscles) from entering into frame 34, but (b) to provide the portion of the pump-outlet tube that defines the blood-inlet openings with a relatively high porosity” on page 54 (See MPEP 2144.05 regarding criticality). The ratios given define a rectangle, and it would be obvious to have a porosity ratio of between 1.1:1 and 4:1 in order to create a rectangular blood-inlet opening since no reasoning is given as to why this specific ratio is optimal. Furthermore, since no optimal reasoning is given for the claimed ratio, Applicant would have had a reasonable expectation of success, and it would not have required undue experimentation to alter Tuval in combination with D’Ambrosio to determine the rectangular ratio.
Regarding claim 9, Tuval in combination with D’Ambrosio teaches all limitations of claim 1 as described in the rejection above.
D’Ambrosio teaches that the blood-inlet openings are rectangular and are shaped such that a ratio of lengths to widths of each of the blood-inlet openings is between 3:2 and 5:2 (¶[0089], where Each aperture of at least a subset of the plurality of apertures 622-626 may have a general rhombus or rhomboid or rectangular shape).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the combination of Tuval and D’Ambrosio to incorporate the claimed length to width ratio of a rectangle because it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, Applicant has disclosed no criticality to this rectangular ratio in the specification filed 03/15/2023, where the specification reads “For some such applications, the ratio of the lengths to the widths of the blood-inlet openings is between 1.1:1 and 4:1, e.g., between 3:2 and 5:2. For some applications, by having such shapes, the blood-inlet openings are configured (a) to block structures from the left ventricle (such as chordae tendineae, trabeculae carneae, and/or papillary muscles) from entering into frame 34, but (b) to provide the portion of the pump-outlet tube that defines the blood-inlet openings with a relatively high porosity” on page 54 (See MPEP 2144.05 regarding criticality). The ratios given define a rectangle, and it would be obvious to have a porosity ratio of between 3:2 and 5:2 in order to create a rectangular blood-inlet opening since no reasoning is given as to why this specific ratio is optimal. Furthermore, since no optimal reasoning is given for the claimed ratio, Applicant would have had a reasonable expectation of success, and it would not have required undue experimentation to alter Tuval in combination with D’Ambrosio to determine the rectangular ratio.
Regarding claim 10, Tuval in combination with D’Ambrosio teaches all limitations of claim 1 as described in the rejection above.
D’Ambrosio teaches that the distal conical portion of the pump-outlet tube has a porosity of more than 40 percent (¶[0122], where the “[s]ize of the apertures 702-706 in each of the plurality of bands 1718-1722 increases monotonically along the longitudinal axis. That is, in general, the apertures in band 1720 are larger than the apertures in band 1718. ... In the embodiment shown in FIG. 17, the size of the apertures 702-706 in each of the plurality of bands 1718-1722 increases monotonically along the longitudinal axis in the distal direction.” Examiner takes the position that because there are apertures, there will be porosity where they are included, and that as the size of the apertures increases, that the porosity of those areas will also increase.).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the combination of Tuval and D’Ambrosio to incorporate the claimed porosity percentage because it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, Applicant has disclosed no criticality to this porosity ratio in the specification filed 03/15/2023, where the specification reads “Typically, the portion of the pump-outlet tube that defines the blood-inlet openings (e.g., the distal conical portion of the pump-outlet tube) has a porosity of more than 40 percent, e.g., more than 50 percent, or more than 60 percent (where porosity is defined as the percentage of the area of this portion that is porous to blood flow). Thus, on the one hand, the blood-inlet openings are relatively small (in order to prevent structures of the left ventricular from entering the frame), but on the other hand, the porosity of the portion of the pump-outlet tube that defines the blood- inlet openings is relatively high, such as to allow sufficient blood flow into the pump-outlet tube” on page 2 (See MPEP 2144.05 regarding criticality). Porosity is required in order to allow sufficient blood into the pump, and it would be obvious to have a porosity above 40 percent in order to do so since no reasoning is given as to why this specific percentage is optimal. Furthermore, since no optimal reasoning is given for the claimed percentage, Applicant would have had a reasonable expectation of success, and it would not have required undue experimentation to alter Tuval in combination with D’Ambrosio to determine the porosity percentage.
Regarding claim 11, Tuval in combination with D’Ambrosio teaches all limitations of claim 10 as described in the rejection above.
D’Ambrosio teaches that the distal conical portion of the pump-outlet tube has a porosity of more than 50 percent (¶[0122], where the “[s]ize of the apertures 702-706 in each of the plurality of bands 1718-1722 increases monotonically along the longitudinal axis. That is, in general, the apertures in band 1720 are larger than the apertures in band 1718. ... In the embodiment shown in FIG. 17, the size of the apertures 702-706 in each of the plurality of bands 1718-1722 increases monotonically along the longitudinal axis in the distal direction.” Examiner takes the position that because there are apertures, there will be porosity where they are included, and that as the size of the apertures increases, that the porosity of those areas will also increase.).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the combination of Tuval and D’Ambrosio to incorporate the claimed porosity percentage because it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, Applicant has disclosed no criticality to this porosity ratio in the specification filed 03/15/2023, where the specification reads “Typically, the portion of the pump-outlet tube that defines the blood-inlet openings (e.g., the distal conical portion of the pump-outlet tube) has a porosity of more than 40 percent, e.g., more than 50 percent, or more than 60 percent (where porosity is defined as the percentage of the area of this portion that is porous to blood flow). Thus, on the one hand, the blood-inlet openings are relatively small (in order to prevent structures of the left ventricular from entering the frame), but on the other hand, the porosity of the portion of the pump-outlet tube that defines the blood- inlet openings is relatively high, such as to allow sufficient blood flow into the pump-outlet tube” on page 2 (See MPEP 2144.05 regarding criticality). Porosity is required in order to allow sufficient blood into the pump, and it would be obvious to have a porosity above 50 percent in order to do so since no reasoning is given as to why this specific percentage is optimal. Furthermore, since no optimal reasoning is given for the claimed percentage, Applicant would have had a reasonable expectation of success, and it would not have required undue experimentation to alter Tuval in combination with D’Ambrosio to determine the porosity percentage.
Regarding claim 12, Tuval in combination with D’Ambrosio teaches all limitations of claim 11 as described in the rejection above.
D’Ambrosio teaches that the distal conical portion of the pump-outlet tube has a porosity of more than 60 percent (¶[0122], where the “[s]ize of the apertures 702-706 in each of the plurality of bands 1718-1722 increases monotonically along the longitudinal axis. That is, in general, the apertures in band 1720 are larger than the apertures in band 1718. ... In the embodiment shown in FIG. 17, the size of the apertures 702-706 in each of the plurality of bands 1718-1722 increases monotonically along the longitudinal axis in the distal direction.” Examiner takes the position that because there are apertures, there will be porosity where they are included, and that as the size of the apertures increases, that the porosity of those areas will also increase.).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the combination of Tuval and D’Ambrosio to incorporate the claimed porosity percentage because it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, Applicant has disclosed no criticality to this porosity ratio in the specification filed 03/15/2023, where the specification reads “Typically, the portion of the pump-outlet tube that defines the blood-inlet openings (e.g., the distal conical portion of the pump-outlet tube) has a porosity of more than 40 percent, e.g., more than 50 percent, or more than 60 percent (where porosity is defined as the percentage of the area of this portion that is porous to blood flow). Thus, on the one hand, the blood-inlet openings are relatively small (in order to prevent structures of the left ventricular from entering the frame), but on the other hand, the porosity of the portion of the pump-outlet tube that defines the blood- inlet openings is relatively high, such as to allow sufficient blood flow into the pump-outlet tube” on page 2 (See MPEP 2144.05 regarding criticality). Porosity is required in order to allow sufficient blood into the pump, and it would be obvious to have a porosity above 60 percent in order to do so since no reasoning is given as to why this specific percentage is optimal. Furthermore, since no optimal reasoning is given for the claimed percentage, Applicant would have had a reasonable expectation of success, and it would not have required undue experimentation to alter Tuval in combination with D’Ambrosio to determine the porosity percentage.
Regarding claim 13, Tuval in combination with D’Ambrosio teaches all limitations of claim 1 as described in the rejection above.
Tuval teaches that the frame defines a central cylindrical portion (¶[0461], where frame 34 is shaped such that the frame defines … a central cylindrical portion 38) and a distal conical portion (¶[0461], where frame 34 is shaped such that the frame defines … a distal conical portion 40), wherein the distal conical portion of the pump-outlet tube is disposed over the distal conical portion of the frame (Figure 2C, distal conical portion 46 and the frame’s central cylindrical portion 38), and wherein the central cylindrical portion of the pump-outlet tube is coupled to the central cylindrical portion of the frame (Figure 2A, proximal portion 106 of tube 24 and cylindrical central portion 44).
Regarding claim 14, Tuval in combination with D’Ambrosio teaches all limitations of claim 13 as described in the rejection above.
Tuval teaches that the central cylindrical portion of the pump-outlet tube is coupled to the central cylindrical portion of the frame via heating (Figure 2A, proximal portion 106 of tube 24 and cylindrical central portion 44. Examiner takes the position that the portions are coupled together and that since the product is what is being claimed that it is irrelevant whether the components are coupled via heating or another means).
D'Ambrosio teaches that the porosity is lower within the proximal region of the distal conical portion of the pump-outlet tube, such that damage that may be caused to a material that defines the blood-inlet holes within the proximal region of the distal conical portion of the pump-outlet tube is reduced during the heating relative to if the porosity within the proximal region of the distal conical portion of the pump-outlet tube was higher (¶[0122], where the “[s]ize of the apertures 702-706 in each of the plurality of bands 1718-1722 increases monotonically along the longitudinal axis. That is, in general, the apertures in band 1720 are larger than the apertures in band 1718. ... In the embodiment shown in FIG. 17, the size of the apertures 702-706 in each of the plurality of bands 1718-1722 increases monotonically along the longitudinal axis in the distal direction.” Examiner takes the position that as the size of the apertures increases, that the porosity of those areas will also increase such that the distal portion will have a higher porosity than the proximal portion.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of D’Ambrosio, which teaches that the porosity is lower within the proximal region of the distal conical portion of the pump-outlet tube, such that damage that may be caused to a material that defines the blood-inlet holes within the proximal region of the distal conical portion of the pump-outlet tube is reduced during the heating relative to if the porosity within the proximal region of the distal conical portion of the pump-outlet tube was higher, into the invention of Tuval in order to reduce the risk of heart tissue being sucked into an intake port of the intravascular blood pump (D’Ambrosio ¶[0052]) and to reduce clotting as larger aperture sizes have a lower chance of clotting than smaller apertures (D’Ambrosio ¶[0106]).
Regarding claim 15, Tuval in combination with D’Ambrosio teaches all limitations of claim 13 as described in the rejection above.
D’Ambrosio teaches an inner lining coupled to an inner surface of the central cylindrical portion of the frame, such that the inner lining provides the central cylindrical portion of the frame with a smooth inner surface (¶[0072], where an inside central portion of the housing 122 may have a sleeve or coating 310 (best seen in FIG. 11), which defines a channel, through which the blood is pumped by the impeller 200).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of D’Ambrosio, which teaches an inner lining coupled to an inner surface of the central cylindrical portion of the frame, such that the inner lining provides the central cylindrical portion of the frame with a smooth inner surface, into the invention of Tuval in order to define a channel for the blood to be pumped through by the impeller (D’Ambrosio ¶[0072]).
Regarding claim 16, Tuval in combination with D’Ambrosio teaches all limitations of claim 13 as described in the rejection above.
Tuval teaches that the proximal region of the distal conical portion of the pump-outlet tube extends along a length of 0.5 - 2 mm (¶[0462], where, at its proximal end, the central portion of the tube has a diameter of between 5 and 7 mm, and at its distal end, the central portion of the tube has a diameter of between 8 and 12 mm, ¶[0571], where distal tip portion 120 has a pointed distal region 244 … pointed distal region 244 has a length of less than half (e.g., less than a quarter) of the total length of the distal tip portion. Examiner interprets that this means the distal region is less than 2 mm since it is less than a quarter of the total length of the distal tip portion, and that a small length is necessary in order to fit the device into a patient’s heart.).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the combination of Tuval and D’Ambrosio to incorporate the claimed length of the distal portion because it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, Applicant has disclosed no criticality to this length of the distal portion in the specification filed 03/15/2023, where the specification reads “In some applications, the proximal region of the distal portion of the pump-outlet tube extends along a length of 0.5 - 2 mm.” on page 1 (See MPEP 2144.05 regarding criticality). The claimed length of the distal portion is required in order to fit the device into a patient’s heart, and it would be obvious to have a length between 0.5 and 2 mm in order to do so since no reasoning is given as to why this specific length is optimal. Furthermore, since no optimal reasoning is given for the claimed length, Applicant would have had a reasonable expectation of success, and it would not have required undue experimentation to alter Tuval in combination with D’Ambrosio to determine the length of the distal portion.
Claims 17-24 are rejected under 35 U.S.C. 103 as being unpatentable over Tuval in view of D'Ambrosio as applied to claim 1 above, and further in view of McBride et al. (hereinafter “McBride) (U.S. Pub. No. 2008/0114339 A1).
Regarding claim 17, Tuval in combination with D’Ambrosio teaches all limitations of claim 1 as described in the rejection above.
Neither Tuval nor D’Ambrosio teach that the blood-inlet openings have polygonal shapes.
McBride teaches that the blood-inlet openings have polygonal shapes (¶[0178], which describes “a mesh 631 having a hexagonal structure.” Examiner takes the position that since the mesh is a part of the blood pump system that it will intake blood and consequently have inlet openings with a hexagonal, a type of polygon, structure.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of McBride, which teaches that the blood-inlet openings have polygonal shapes, into the modified invention of Tuval in order to allow expansion in a radial direction when an expandable portion is contracted along an axial direction (McBride ¶[0178]).
Regarding claim 18, Tuval in combination with D’Ambrosio and McBride teaches all limitations of claim 17 as described in the rejection above.
McBride teaches that the blood-inlet openings have hexagonal shapes (¶[0178], which describes “a mesh 631 having a hexagonal structure.” Examiner takes the position that since the mesh is a part of the blood pump system that it will intake blood and consequently have inlet openings with a hexagonal structure.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of McBride, which teaches that the blood-inlet openings have hexagonal shapes, into the modified invention of Tuval in order to allow expansion in a radial direction when an expandable portion is contracted along an axial direction (McBride ¶[0178]).
Regarding claim 19, Tuval in combination with D’Ambrosio and McBride teaches all limitations of claim 17 as described in the rejection above.
D’Ambrosio teaches that within the proximal region of the distal conical portion of the pump-outlet tube, a diameter of a circle enclosed by each of the blood-inlet openings is between 0.1 and 0.6 mm (¶[0095], where “each aperture of the plurality of apertures 622-626 has a largest dimension less than or equal to about 0.5 mm (500 μm)”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of D’Ambrosio, which teaches that within the proximal region of the distal conical portion of the pump-outlet tube, a diameter of a circle enclosed by each of the blood-inlet openings is between 0.1 and 0.6 mm, into the modified invention of Tuval in order to reduce the risk of heart tissue being sucked into an intake port of the intravascular blood pump (D’Ambrosio ¶[0052]).
Regarding claim 20, Tuval in combination with D’Ambrosio and McBride teaches all limitations of claim 17 as described in the rejection above.
McBride teaches that within the proximal region of the distal conical portion of the pump-outlet tube, widths of gaps between adjacent blood-inlet openings are between 0.05 and 0.2 mm (¶[0178], which describes a mesh 631 having a hexagonal structure. Examiner takes the position that because the material is a mesh, that it will have gaps with an inherent width between them.).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the combination of Tuval, D’Ambrosio, and McBride to incorporate the widths of gaps between adjacent blood-inlet openings because it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Additionally, Applicant has disclosed no criticality to the widths of gaps between adjacent blood-inlet openings in the specification filed 03/15/2023, where the specification reads “In some applications, within the proximal region of the distal portion of the pump-outlet tube, widths of gaps between adjacent blood-inlet openings are between 0.05 and 0.2 mm” on page 11 (See MPEP 2144.05 regarding criticality). The claimed widths of gaps between adjacent blood-inlet openings can be utilized in any mesh that is applied to a blood-inlet opening, where a mesh will have some dimension to it between openings, and it would be obvious to have a width between 0.05 and 0.2 mm in order to do so since no reasoning is given as to why this specific width is optimal. Furthermore, since no optimal reasoning is given for the claimed width, Applicant would have had a reasonable expectation of success, and it would not have required undue experimentation to alter Tuval in combination with D’Ambrosio and McBride to determine the widths of gaps between adjacent blood-inlet openings.
Regarding claim 21, Tuval in combination with D’Ambrosio and McBride teaches all limitations of claim 17 as described in the rejection above.
D’Ambrosio teaches that within the distal region of the distal conical portion of the pump-outlet tube, a diameter of a circle enclosed by each of the blood-inlet openings is between 0.2 and 0.8 mm (¶[0095], where each aperture of the plurality of apertures 622-626 has a largest dimension less than or equal to about 0.5 mm (500 μm)).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of D’Ambrosio, which teaches that within the distal region of the distal conical portion of the pump-outlet tube, a diameter of a circle enclosed by each of the blood-inlet openings is between 0.2 and 0.8 mm, into the modified invention of Tuval in order to reduce the risk of heart tissue being sucked into an intake port of the intravascular blood pump (D’Ambrosio ¶[0052]).
Regarding claim 22, Tuval in combination with D’Ambrosio and McBride teaches all limitations of claim 17 as described in the rejection above.
McBride teaches that within the distal region of the distal conical portion of the pump-outlet tube, widths of gaps between adjacent blood-inlet openings are between 0.01 mm and 0.1 mm (¶[0178], which describes a mesh 631 having a hexagonal structure. Examiner takes the position that because the material is a mesh, that it will have gaps with an inherent width between them.).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the combination of Tuval, D’Ambrosio, and McBride to incorporate the widths of gaps between adjacent blood-inlet openings because it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experi