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 Status: Claims 1-18 are pending.
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 4-14 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.
Re Claim 4, the limitation “wherein the asymmetric struts have a cross-section comprising a leading edge and a trailing edge, the leading edge forming a first angle and the trailing edge forming a second angle” is indefinite, because it doesn’t describe which angles a first angle and a second angle are referring to.
Para. [0031] discloses that leading-edge angle is angle B and the trailing edge angle is angle C as shown in fig. 3 below.
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However, leading edge is ref# 48 and trailing edge is ref# 50 as shown in fig. 3 above. Based on the claim language alone, the first angle and the second angle can be the curvature of the rounded leading edge and trailing edge and not an angle represented by tangent lines that extend from opposite sides of the leading edge or trailing edge.
Indefiniteness of claim 4 renders its dependent claims indefinite.
Re Claim 5, the limitation “wherein the leading edge of the strut is removed from the outer perimeter of the body portion and at least a portion of the trailing edge is removed from the inner perimeter of the body portion” is indefinite
As shown in instant fig. 3 above, leading edge is ref# 48 and trailing edge is ref# 50. The claim language is unclear in terms of whether the rounded leading edge and trailing edge in fig. 3 are further removed or whether parts of the outer perimeter and the inner perimeter are removed to create the leading edge and trailing edge shown in fig. 3.
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, 2, 4-12, and 14-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Corbett et al. (US 2017/0043075A1).
Re Claim 1, Corbett discloses a percutaneously insertable blood pump assembly (fig. 8, blood pump assembly 800) comprising:
a pump section (fig. 8, para. [0033], a blood pump 801);
a catheter attached to a proximal end of the pump section (fig. 8, para. [0034], catheter 807);
a first apertured section distal to the pump section and in fluid communication therewith (para. [0033], fig. 8, a housing component 802);
a cannula affixed to and in fluid communication with the first apertured section (para. [0033], fig. 8, cannula 804); and
a second apertured section distal to the cannula and in fluid communication therewith (fig. 8, para. [0037], blood inlet manifold 805);
wherein one of the first and second apertured section is a blood outlet from the cannula (para. [0036], When properly positioned, the blood pump assembly 800 delivers blood from the inlet area at the blood inlet manifold 805, which sits inside the left ventricle, through the cannula 804, to the outlet openings of the housing component 802 positioned in the ascending aorta.);
wherein the blood outlet comprises a body portion (fig. 1, para. [0025], peripheral wall at a downstream end 111), an apertured portion (fig. 1, [0025], a plurality of circumferential aperture surfaces 104 and blood exhaust apertures 103 a-f), and a ring portion (fig. 1, para. [0025], peripheral wall 115 at an upstream end 110) wherein a plurality of apertures in the apertured portion are separated and defined by a plurality of struts extending from and joining the body portion to the ring portion (fig. 1, para. [0025], a plurality of circumferential aperture surfaces 104 which span between the inner surface 107 and the outer surface 108, inner edges 116 and outer edges 118 which define blood exhaust apertures 103 a-f, and struts 106 a-f.),
wherein each of the plurality of struts is asymmetric along its length from the body portion of the outlet to the ring portion of the outlet (para. [0029], FIG. 6 shows a strut having a cross section 602 with chamfered corners 603 a-b and sharp corners 603 c-d in which corners 603 a and 603 b are not adjoining corners.).
Re Claim 2, Corbett discloses that the blood outlet is the first apertured section is the blood outlet (para. [0036], When properly positioned, the blood pump assembly 800 delivers blood from the inlet area at the blood inlet manifold 805, which sits inside the left ventricle, through the cannula 804, to the outlet openings of the housing component 802 positioned in the ascending aorta.).
Re Claim 4, Corbett discloses that the asymmetric struts have a cross-section comprising a leading edge and a trailing edge, the leading edge forming a first angle and the trailing edge forming a second angle (para. [0029], FIG. 6 shows a strut having a cross section 602 with chamfered corners 603 a-b and sharp corners 603 c-d in which corners 603 a and 603 b are not adjoining corners; para. [0008], an inner edge with a first chamfered portion having a first chamfer angle and a second chamfered portion having a second chamfer angle greater than the first chamfer angle.).
Re Claim 5, Corbett discloses that the body portion of the blood outlet comprises an outer perimeter and an inner perimeter (fig. 1, peripheral wall 115, para. [0025], a peripheral wall 115, an inner surface 107, an outer surface 108, a plurality of circumferential aperture surfaces 104 which span between the inner surface 107 and the outer surface 108, inner edges 116 and outer edges 118 which define blood exhaust apertures 103 a-f, and struts 106 a-f.) and wherein the leading edge of the strut is removed from the outer perimeter of the body portion and at least a portion of the trailing edge is removed from the inner perimeter of the body portion (para. [0012], [0038], the outer edge is formed by a rolling process or by removing a right angled edge. the inner edge is rounded or chamfered by a tumbling process, a rolling process, or any other suitable method for removing a right angled edge; para. [0026], The rounded edge portions 105 a-f of circumferential aperture surfaces 104 a-f may be formed via tumbling, rolling, machining, or any other suitable material removal process, such that the circumferential aperture surfaces 104 a-f are rounded, at least in part, in a region between the inner surface 107 and the outer surface 108).
Re Claim 6, Corbett discloses that the first angle and the second angle form acute angles (fig. 6, para. [0006], The chamfered edge may include a chamfer of 10°, 20°, 30°, 40°, 50°, >50°, or any other suitable angle. In some implementations the chamfered inner edge may include an alternate chamfer with two chamfered edges being substantially parallel to the flow of blood through the aperture such that the two edges are positioned opposite one another on a strut; para. [0010], Each first inner edge and each second outer edge of the plurality of struts has a chamfer angle of about 45°.).
Re Claim 7, Corbett discloses that the first angle is about 10 degrees to about 70 degrees (fig. 6, para. [0006], The chamfered edge may include a chamfer of 10°, 20°, 30°, 40°, 50°, >50°, or any other suitable angle. In some implementations the chamfered inner edge may include an alternate chamfer with two chamfered edges being substantially parallel to the flow of blood through the aperture such that the two edges are positioned opposite one another on a strut; para. [0010], Each first inner edge and each second outer edge of the plurality of struts has a chamfer angle of about 45°.).
Re Claim 8, Corbett discloses that the first angle is about 20 degrees to about 45 degrees (fig. 6, para. [0006], The chamfered edge may include a chamfer of 10°, 20°, 30°, 40°, 50°, >50°, or any other suitable angle. In some implementations the chamfered inner edge may include an alternate chamfer with two chamfered edges being substantially parallel to the flow of blood through the aperture such that the two edges are positioned opposite one another on a strut; para. [0010], Each first inner edge and each second outer edge of the plurality of struts has a chamfer angle of about 45°.).
Re Claim 9, Corbett discloses that the first angle is about 30 degrees to about 40 degrees (fig. 6, para. [0006], The chamfered edge may include a chamfer of 10°, 20°, 30°, 40°, 50°, >50°, or any other suitable angle. In some implementations the chamfered inner edge may include an alternate chamfer with two chamfered edges being substantially parallel to the flow of blood through the aperture such that the two edges are positioned opposite one another on a strut.).
Re Claim 10, Corbett discloses that the second angle is about 5 degrees to about 45 degrees (fig. 6, para. [0006], The chamfered edge may include a chamfer of 10°, 20°, 30°, 40°, 50°, >50°, or any other suitable angle. In some implementations the chamfered inner edge may include an alternate chamfer with two chamfered edges being substantially parallel to the flow of blood through the aperture such that the two edges are positioned opposite one another on a strut; para. [0010], Each first inner edge and each second outer edge of the plurality of struts has a chamfer angle of about 45°.).
Re Claim 11, Corbett discloses that the second angle is about 20 degrees (fig. 6, para. [0006], The chamfered edge may include a chamfer of 10°, 20°, 30°, 40°, 50°, >50°, or any other suitable angle. In some implementations the chamfered inner edge may include an alternate chamfer with two chamfered edges being substantially parallel to the flow of blood through the aperture such that the two edges are positioned opposite one another on a strut).
Re Claim 12, Corbett discloses that the at least one of the leading edge and the trailing edge are filleted or rounded or a combination of filleted and rounded (para. [0008], an inner edge with a first chamfered portion having a first chamfer angle and a second chamfered portion having a second chamfer angle greater than the first chamfer angle; para. [0012], [0038], the outer edge is formed by a rolling process or by removing a right angled edge. the inner edge is rounded or chamfered by a tumbling process, a rolling process, or any other suitable method for removing a right angled edge; para. [0026], The rounded edge portions 105 a-f of circumferential aperture surfaces 104 a-f may be formed via tumbling, rolling, machining, or any other suitable material removal process, such that the circumferential aperture surfaces 104 a-f are rounded, at least in part, in a region between the inner surface 107 and the outer surface 108).
Re Claim 14, Corbett discloses that both the leading edge and the trailing edge are filleted or rounded or a combination of filleted and rounded (para. [0008], an inner edge with a first chamfered portion having a first chamfer angle and a second chamfered portion having a second chamfer angle greater than the first chamfer angle; para. [0012], [0038], the outer edge is formed by a rolling process or by removing a right angled edge. the inner edge is rounded or chamfered by a tumbling process, a rolling process, or any other suitable method for removing a right angled edge; para. [0026], The rounded edge portions 105 a-f of circumferential aperture surfaces 104 a-f may be formed via tumbling, rolling, machining, or any other suitable material removal process, such that the circumferential aperture surfaces 104 a-f are rounded, at least in part, in a region between the inner surface 107 and the outer surface 108).
Re Claim 15, Corbett discloses that each strut of the plurality of struts has a hydrofoil-like cross-section along at least a portion of their length from the body portion of the outlet to the ring portion of the outlet (para. [0029], FIG. 6 shows a strut having a cross section 602 with chamfered corners 603 a-b and sharp corners 603 c-d in which corners 603 a and 603 b are not adjoining corners. As depicted in FIGS. 3-6, the cross-sectional shape of the struts impacts the shear stresses and direction of the flow of blood out of the blood exhaust apertures.).
Re Claim 16, Corbett discloses that each strut of the plurality of struts have a hydrofoil-like cross-section along an entire length from the body portion of the outlet to the ring portion of the outlet (para. [0018], [0029], FIG. 6 shows a strut having a cross section 602 with chamfered corners 603 a-b and sharp corners 603 c-d in which corners 603 a and 603 b are not adjoining corners. As depicted in FIGS. 3-6, the cross-sectional shape of the struts impacts the shear stresses and direction of the flow of blood out of the blood exhaust apertures.).
Re Claim 17, Corbett discloses that the plurality of apertures have dimensions and the dimensions of each aperture are about the same (fig. 1, para. [0025], While the blood exhaust apertures 103 a-f include apertures having rounded corners 112 a-f, in some implementations the apertures may include a round aperture, a circular aperture, or apertures of any suitable shape.).
Re Claim 18, Corbett discloses an atraumatic tip distal to the second apertured section (fig. 8, para. [0037], The distal section 810 of the pigtail extension 806 is flexible with respect to the proximal section 808, to provide an atraumatic tip for contact with the ventricle wall and to allow for guidewire loading.).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Corbett et al. (US 2017/0043075A1) in view of Bernazani (US 2021/0196941A1).
Re Claim 3, Corbett discloses the claimed invention substantially as set forth in claim 1.
Corbett is silent regarding wherein the blood outlet is the second apertured section.
However, Bernazani discloses a blood pump assembly (fig. 1) and teaches that a second apertured section distal to the cannula and in fluid communication therewith is blood outlet (para. [0014], a blood outflow cage 110, a blood inflow cage 106. The distal end of cannula 108 is further coupled to the blood outflow cage 110.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Corbett, by configuring the blood outlet to be the second apertured section, as taught by Bernazani, for the purpose of reducing stress on a patient's vasculature and reducing hemolysis and damage to blood (abstract).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Corbett et al. (US 2017/0043075A1).
Re Claim 13, Corbett discloses the claimed invention substantially as set forth in claims 1, 4, 5, and 12.
Corbett discloses that the rounded edge has a radius of 105 microns or greater (para. [0008], The rounded outer edge has a radius of 40 microns or greater. In other implementations, the rounded outer edge has a radius of 105 microns or greater; para. [0027], the inner edge may have a radius including, but not limited to, 40 microns. In some implementations, the outer edge may have a radius including, but not limited to, 105 microns).
Corbett discloses that cross-sectional shape of the struts impacts the shear stresses and direction of the flow of blood out of the blood exhaust apertures (para. [0029]).
Corbett is silent regarding the fillet having a radius of about 1.25 mm.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Corbett, configuring the fillet to have a radius of about 1.25 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Weber (US 2021/0046231A1) discloses asymmetric struts having a cross-section comprising a leading edge and a trailing edge, the leading edge forming a first angle and the trailing edge forming a second angle (fig. 4C, 4A, para. [0069] as shown in FIG. 4C, the outflow ports 408 may be cut such that the struts 410 have angled side surfaces 420 and 422. The inner surface 424 of each strut may be configured to meet a first adjacent side surface 420 at an angle that is different than an angle at which the inner surface 424 meets a second, opposite, side surface 422).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, August 1, 2026Examiner, Art Unit 3792
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