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 . Claims 239-245, 249, 253, 255-257, 260-261, 269 and 342-346 are pending and examined below.
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.
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 249, 253, 255-257, 269, and 346 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 249 recites that the apparatus “wherein the entrance […], inferior vena cava,” where it appears that a superior vena cava and a septal wall or the inferior vena cava is being positively claimed.
Claim 253 recites the apparatus comprises, “a window […], an atrioventricular node,” where it appears that a node of a cardiac conduction system is positively claimed.
Claim 269 recites that the apparatus comprises, “a window […], an atrioventricular node,” where it appears that a node of a cardiac conduction system is positively claimed.
Claim 346 recites that the apparatus “wherein the entrance […], septal wall,” where it appears that an inferior vena cava and a septal wall is being positively claimed.
The claims should be re-written with the term “configured to” prior to the limitations to overcome positively citing human body. Claims 255-257 are rejected as being dependent from a rejected base claim.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 342 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification fails to provide support for an embodiment that includes the arms of claim 239 (only disclosed in Fig. 19-22 and 39) and the limitations including mesh that comprises cells (only disclosed in Fig. 2-4 and 7-9); wherein: the mesh contains a first cell that defines a window; and the first cell has a size that is larger than second cells in the mesh.
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 245, 249, 261, 344, and 346 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 245 and 261 recites “the brace […] extends from an entrance of a chamber to an exit of the chamber.” There are four chambers of the heart, it is unclear which chamber of the heart is the “chamber.” Claims 249 and 346 are rejected as being dependent from a rejected base claim.
Claim 344 recites “the span has […] the outside diameter.” It is unclear what part of the apparatus the outside diameter is referring to.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 239 and 260 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chambers (US 2020/0188101).
Regarding claim 239, Chambers discloses an apparatus (abstract; Fig. 10, device 20) for treating a heart, the apparatus comprising:
a prosthetic heart-valve fitting (Fig. 10 and [0060] discloses a retention body 22 that can be urged to be positioned within a heart chamber) that is configured to be seated in a valve annulus of the heart (Fig. 11; abstract disclose securing the prosthetic valve at a desired location relative to a native mitral valve (e.g., within the mitral valve));
a brace (Fig. 11, support members 42 and [0060]) that: is configured to be urged by an atrial tissue of the heart to maintain a position of the fitting in the annulus (Fig. 11 and [0060], the device 20 still includes a retention body 22, which can include a memory material that urges the body 22 towards a shape as shown in the figures to be positioned within a heart chamber); and
includes: a first arm (see annotated Fig. 10 below); and a second arm (see annotated Fig. 10 below) that is disposed less than 180° about a central axis of the fitting, away from the first arm (Fig. 10 and see also annotated Fig. 10 below where first and second arm are disposed less than 180°).
Regarding claim 260, Chambers further discloses a stand (prosthetic valve 24) that extends from the fitting (Fig. 10, retention body 22); wherein: the stand defines a surface opposite where the stand extends from the fitting (prosthetic valve 24 has a surface that extends longitudinally from the retention body 22, which extends laterally, Fig. 10); the first arm extends to the surface (see annotated Fig. 10, below); and the second arm extends to the surface (see annotated Fig. 10 where first and second arms extend to surface of stand).
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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.
Claims 240, 241, 245, 249, 261, 343, 345 and 346 are rejected under 35 U.S.C. 103 as obvious over Chambers (US 2020/0188101).
Regarding claim 240, the first embodiment (Fig. 9-11) of Chambers does not provide extensive detail wherein: the fitting has an outside diameter; the first arm extends to the outside diameter; and the second arm extends to the outside diameter.
However, a second embodiment (Fig. 7) discloses a similar heart valve (abstract), wherein:
the fitting has an outside diameter (Fig. 7 disclose base section 40 with outside diameter);
the first arm extends to the outside diameter (Fig. 7 disclose support member 42 extended to outside diameter); and
the second arm extends to the outside diameter (Fig. 7 disclose support member 42 extended to outside diameter).
The second embodiment of Chambers teaches that these features are useful in that the device can be collapsed until positioned in a heart chamber, wherein the compliant, spring, or shape memory material will urge the device in an expanded state against the walls of the heart chamber.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to use these above-mentioned features disclosed by the second embodiment with the system disclosed by the first embodiment in order to form a dome-like shape to better conform to the walls of the heart chamber providing sufficient anchoring of the device.
Regarding claim 241, the first embodiment (Fig. 9-11) of Chambers does not provide extensive detail about the intersection of the first arm and the second arm at a central axis defined by the fitting.
However, a second embodiment (Fig. 7) discloses a similar heart valve (abstract), wherein the first arm (see annotated Fig. 7 below) and the second arm (see annotated Fig. 7 below) intersect each other at a central axis defined by the fitting (Fig. 7 disclose an apex portion 43 wherein the support members 42 congregate at a common point).
The second embodiment of Chambers teaches that these features are useful as it omits any sort of structured upper support member and form a dome-like shape at the apex point.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to use the intersecting arms at a central axis disclosed by the second embodiment with the system disclosed by the first embodiment, as a matter design choice since the apex 43 in Fig. 7 would allow for the retention body to contact a larger surface of the atrium providing sufficient anchoring of the device.
Regarding claim 245, the first embodiment of Chambers further discloses that when the heart is in a delivery state and the apparatus is deployed in the heart:
the brace provides clearance along an access path that extends from an entrance of a chamber to an exit of the chamber (device 20 is configured to be used as a prosthetic mitral valve with a retention body, abstract; placement in the native mitral valve would provide access paths from the pulmonary veins to the left atrium, through the mitral valve into the left ventricle; clearance through lower opening 44, Fig. 10); and
the clearance is not less than that required for passage of a 30 French instrument (the diameter of the left atrium typically ranges from 30-40 mm in men and 27-38 mm in women1, therefore the device, which is configured to expand and conform with the atrial wall, would provide enough clearance for a 30 French instrument [0061]). Additionally, it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (MPEP 2144.04). In the instant case, since the device of Chambers is deployed within the atrium and designed to conform to the atrial walls, modifying the Chambers device to have enough clearance for a 30 Fr instrument would not alter the performance of the device and would be within the ordinary skill level of one having ordinary skill in the art. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the present invention to provide the device of Chambers with a clearance is not less than that required for passage of a 30 French instrument in order to be useable with the typical anatomy of patients.
Regarding claim 249, the first embodiment of Chambers further discloses that the entrance is a superior vena cava and the exit is a septal wall or the inferior vena cava (device 20 can be configured for placement at the right atrium for repair of a tricuspid valve [0037], placement in the native tricuspid valve would provide access paths from the superior vena cava of the right atrium, through the tricuspid valve into the right ventricle, and is capable of providing access paths to a septal wall or the inferior vena cava of the right atrium, from the tricuspid valve; clearance through lower opening 44, Fig. 10).
Regarding claim 261, the first embodiment of Chambers further discloses that when the heart is in a delivery state and the apparatus is deployed in the heart:
the brace provides clearance along an access path that extends from an entrance of a chamber to an exit of the chamber (device 20 is configured to be used as a prosthetic mitral valve with a retention body, abstract; placement in the native mitral valve would provide access paths from the pulmonary veins to the left atrium, through the mitral valve into the left ventricle; clearance through lower opening 44, Fig. 10); and
the clearance is not less than that required for passage of a 30 French instrument (the diameter of the left atrium typically ranges from 30-40 mm in men and 27-38 mm in women2, therefore the device, which is configured to expand and conform with the atrial wall, would provide enough clearance for a 30 French instrument [0061]). Additionally, it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (MPEP 2144.04). In the instant case, since the device of Chambers is deployed within the atrium and designed to conform to the atrial walls, modifying the Chambers device to have enough clearance for a 30 Fr instrument would not alter the performance of the device and would be within the ordinary skill level of one having ordinary skill in the art. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the present invention to provide the device of Chambers with a clearance is not less than that required for passage of a 30 French instrument in order to be useable with the typical anatomy of patients.
Regarding claim 343, the first embodiment of Chambers further discloses that the brace (support members 42, Fig. 11 and [0060]) has a first end and a second end (lower opening 44 and upper support member 43, see also annotated Fig. 10), and further comprises:
a span that extends from the first end to the second end (lower opening 44 at the first end extend to upper support member 43 at the second end, Fig. 10);
wherein: the first end is connected to the fitting (lower opening 44 is connected to retention body 22, Fig. 11); and
the second end contacts the atrial tissue (upper support member 43 at the second end contacts the roof of the atrium, Fig. 11 and [0060]).
Regarding claim 345, the first embodiment (Fig. 9-11) of Chambers does not provide extensive detail regarding the intersection of the first arm and the second arm.
However, the second embodiment (Fig. 7) discloses a similar heart valve (abstract), wherein:
the first arm (see annotated Fig. 7 below) and the second arm (see annotated Fig. 7 below) extend away from the stand in a direction that is parallel to the central axis and then curves toward the central axis (support members 42 extend from the retention body 22 in a direction that is parallel to the central axis and form a dome-like shape at the apex point 43 [0055], see also annotated Fig. 7 below);
the first arm extends from a first position on the stand to a second position on the stand (support member 42 extend from the retention body 22 to a second position on the retention body due to the it being a dome-like shape, Fig. 7 and [0055]);
the second arm extends from a third position on the stand (another support member 42 extend from a different position on the retention body 22, Fig. 7 and [0055]); and
the first arm and the second arm intersect each other (support members 42 congregate at apex portion 43, Fig. 7 and [0055]).
The second embodiment of Chambers teaches arms that extend from the stand from different positions, and curve towards the central axis where they intersect each other.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply these above-mentioned features disclosed by the second embodiment with the system disclosed by the first embodiment in order to form a dome-like shape to better conform to the walls of the heart chamber providing sufficient anchoring of the device.
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Regarding claim 346, Chambers further discloses that the entrance is an inferior vena cava (device 20 can be configured for placement at the right atrium for repair of a tricuspid valve [0037], placement in the native tricuspid valve would provide access paths from the inferior vena cava of the right atrium, through the tricuspid valve into the right ventricle; clearance through lower opening 44, Fig. 10), and the exit is a septal wall (device 20 is capable of providing passage from the right ventricle from the tricuspid valve into the right atrium, when an exit created in a septal wall, Fig. 10).
Claims 242-244 are rejected under 35 U.S.C. 103 as being unpatentable over Chambers (US 2020/0188101) “Chambers ‘101” as applied to the claims above, and further in view of Chambers (US 11,026,782) “Chambers ‘782”.
Regarding claim 242, Chambers ‘101 does not disclose the apparatus comprising a circumferential stabilizer that extends circumferentially, relative to a central axis defined by the fitting, from the first arm to the second arm.
However, Chambers ‘782 teaches a similar prosthetic heart valve comprising a circumferential stabilizer that extends circumferentially (Fig. 14, intermediate spring-like section 200), relative to a central axis defined by the fitting (Fig. 14, opening 404 defined by central cylinder), from the first arm to the second arm (see annotated Fig. 14 below).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus in Chambers ’101 to include circumferential stabilizer that extends circumferentially, relative to a central axis defined by the fitting, from the first arm to the second arm, as taught and suggested by Chambers ‘782, in order to provide the apparatus with compliance flexing in a plurality of radial directions, and enable the valve to move or comply with the natural movements of the heart (Chambers ‘782, Col.11, lines 21-25).
Regarding claim 243, Chambers ‘101 does not disclose wherein the circumferential stabilizer is disposed, in a direction of the central axis, in a plane that is perpendicular to the central axis.
However, Chambers ‘782 further discloses that the circumferential stabilizer (Fig. 14, intermediate spring-like section 200) is disposed, in a direction of the central axis (Fig. 14, opening 404 defined by central cylinder, see also annotated Fig. 14 below), in a plane that is perpendicular to the central axis (see annotated Fig. 14 below).
Chambers ‘782 teaches that it provides radial expansion force for achieving additional pressure and friction fit against the chamber surfaces.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply these above-mentioned features disclosed by Chambers ‘782 with the system disclosed by Chambers ‘101 in order to utilize the circumferential stabilizer disposed in a plane perpendicular to the central axis to provide sufficient support and anchoring within the atrium.
Regarding claim 244, Chambers ‘101 does not disclose wherein the circumferential stabilizers and arms extend circumferentially for 360°, in a direction of the central axis, in a plane that is perpendicular to the central axis.
However, Chambers ‘782 teaches wherein the circumferential stabilizers and arms extend circumferentially for 360° (Fig. 14, intermediate spring-like section 200 with atrial dome 300), in a direction of the central axis (Fig. 14, opening 404 defined by central cylinder, see also annotated Fig. 14 below), in a plane that is perpendicular to the central axis (see annotated Fig. 14 below).
Chambers ‘782 teaches that it is a dome-like shape that can allow some compliance flexing of the intermediate spring-like section 200 in a plurality of radial directions, thereby enabling the implanted prosthetic valve to move or comply with the natural movements of the heart (col.11, lines 21-25).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply these above-mentioned features disclosed by Chambers ‘782 with the system disclosed by Chambers ‘101 in order to extend circumferentially for 360° to provide sufficient support and anchoring within the atrium.
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Claims 253, 255-257, 269, and 342 are rejected under 35 U.S.C. 103 as being unpatentable over Chambers (US 2020/0188101) as applied to the claims above, and further in view of Baldwin et al. (US 2022/0175521) “Baldwin”.
Regarding claim 253, Chambers does not disclose defining a window that: accommodates a node of a cardiac conduction system; and, in operation, faces the node; wherein the node is a sinoatrial node or an atrioventricular node.
However, Baldwin teaches a similar heart valve prostheses which includes a valve component and a frame (abstract) defining a window (window 525, Fig. 24) that:
accommodates a node of a cardiac conduction system (window 525 is positioned at the inflow end and is configured to align with a portion of the conduction system in situ, Fig. 24 and [0218]); and
in operation, faces the node (window 525 is positioned to align with a portion of the conduction system of the heart, and by necessity, faces that tissue, Fig. 24 and [0218]);
wherein the node is a sinoatrial node or an atrioventricular node (portion of the conduction system may include alignment with the left bundle branch of the heart which includes the atrioventricular (AV) node, [0218]).
Baldwin teaches that using a window reduces the outward radial force exerted by the frame of the transcatheter aortic valve prosthesis on the left bundle branch, and thus the frame of the transcatheter aortic valve prosthesis is less likely to negatively impact the conduction system of the heart (see [0218]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve disclosed by Chambers to define a window that accommodates a node of a cardiac conduction system, and in operation faces the sinoatrial or atrioventricular node, as taught by Baldwin in order to allow room for the node and reduce interference with the cardiac conduction system, as taught by Baldwin.
Regarding claim 255, Chambers does not disclose wherein the window is large enough to accommodate the node and a margin around the node, however Baldwin further discloses that the window is large enough to accommodate the node and a margin around the node (the area of window 525 is between 114-116 mm² and large enough to accommodate the entirety of AV node as well as space surrounding the AV node, Fig. 24 and [0220]).
Baldwin further discloses that using a window reduces the outward radial force exerted by the frame of the transcatheter aortic valve prosthesis on the left bundle branch, and thus the frame of the transcatheter aortic valve prosthesis is less likely to negatively impact the conduction system of the heart while also allowing tolerance (see [0218]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve disclosed by Chambers to define the window large enough to accommodate the node and a margin around the node, as taught by Baldwin in order to reduce interference with the cardiac conduction system, as taught by Baldwin.
Regarding claim 256, Chambers does not disclose that the margin has an area that is 2% to 10% larger than an area of the node, however Baldwin further discloses that the margin has an area that is 2% to 10% larger than an area of the node (window 525 has an area between 114-116 mm², window 525 can thus have a margin about 2% to 10% larger than the AV node [0220]; see also Katritsis showing that the AV node has an average length of 5 mm and width of 3mm).
Baldwin teaches a margin for the window to accommodate the node and thus the frame of the transcatheter aortic valve prosthesis is less likely to negatively impact the conduction system of the heart (see [0218], [0220]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve disclosed by Chambers to define the margin having an area that is 2% to 10% larger than an area of the node, as taught by Baldwin in order to reduce interference with the cardiac conduction system, as taught by Baldwin.
Regarding claim 257, Chambers does not disclose wherein the brace defines the window, however, Baldwin further discloses wherein the brace defines the window (frame 510 defines window 525, Fig. 24).
Baldwin teaches a frame that includes a plurality of struts that are arranged to form a plurality of cells arranged circumferentially around a longitudinal axis and includes the window that makes it less likely to negatively impact the conduction system of the heart (see [0217], [0218]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve disclosed by Chambers with wherein the brace defines the window, as taught by Baldwin, in order to provide the window in the most suitable anatomical location.
Regarding claim 269, Chambers does not disclose defining a window that: accommodates a node of a cardiac conduction system; and, in operation, faces the node; wherein the node is a sinoatrial node or an atrioventricular node.
However, Baldwin further discloses a valve component and a frame (abstract) defining a window (window 525, Fig. 24) that: accommodates a node of a cardiac conduction system (window 525 is positioned at the inflow end and is configured to align with a portion of the conduction system in situ, Fig. 24 and [0218]); and, in operation, faces the node (window 525 is positioned to align with a portion of the conduction system of the heart, and by necessity, faces that tissue, Fig. 24 and [0218]); wherein the node is a sinoatrial node or an atrioventricular node (portion of the conduction system may include alignment with the left bundle branch of the heart which includes the atrioventricular (AV) node (see [0218]).
Baldwin teaches that using a window reduces the outward radial force exerted by the frame of the transcatheter aortic valve prosthesis on the left bundle branch, and thus the frame of the transcatheter aortic valve prosthesis is less likely to negatively impact the conduction system of the heart (see [0218]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve disclosed by Chambers to define a window that accommodates a node of a cardiac conduction system, and in operation faces the sinoatrial or atrioventricular node, as taught by Baldwin in order to allow room for the node and reduce interference with the cardiac conduction system, as taught by Baldwin.
Regarding claim 342, Chambers does not disclose including mesh that comprises cells; wherein: the mesh contains a first cell that defines a window; and the first cell has a size that is larger than second cells in the mesh.
However, Baldwin further discloses a mesh that comprises cells (frame 510 includes a plurality of struts 511 that are arranged to form a plurality of cells arranged circumferentially around a longitudinal axis
L
A
, Fig. 24 and [0217]); wherein: the mesh contains a first cell that defines a window (rows
r
1
of first cells
514
1
define window 525, Fig. 24 and [0219]); and the first cell has a size that is larger than second cells in the mesh (window 525 has an area that is approximately double the size of the adjacent cells, Fig. 24 and [0220]).
Baldwin teaches that a mesh comprising of a plurality of cells with some access cells that have enlarged areas provide improved access to a patient’s coronary arteries if an intervention is needed, and reduce conduction disturbances (see [0216], [0217]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve disclosed by Chambers to include a mesh that comprises cells, wherein a first cell defines a window and is larger than second cells, as taught by Baldwin in order to improve access to the coronary arteries through the cells, and prevent the apparatus from affecting the natural conduction of the heart while reducing radial force through the windows, as taught by Baldwin.
Claim 344 is rejected under 35 U.S.C. 103 as being unpatentable over Chambers (US 2020/0188101) as applied to the claims above, and further in view of Marchand et al. (US 2020/0188102) “Marchand”.
Regarding claim 344, Chambers does not disclose that the span has a width that, when the apparatus is in an unconstrained state, is a maximum of 0.8 X the outside diameter.
However, Marchand teaches a similar heart valve anchoring device wherein the span has a width (diameter D3, Fig. 2) that, when the apparatus is in an unconstrained state, is a maximum of 0.8 X the outside diameter (D2 ranges from 10 to 90 millimeters, D3 ranges from 10 to 90 millimeters, Fig. 2, [0134] and [0135]; if the prior art discloses a point within the claimed value, the prior art anticipates the claim, thus, D3 can be a maximum of 0.8 X D2 given the ranges (MPEP 2131.03)).
Marchand teaches a range of diameters in order to better fit the patient’s anatomy and provide
optimal geometrical anchorage (see [0169]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve disclosed by Chambers to include the span width that is a maximum of 0.8 X the outside diameter as taught by Marchand in order to enable better radial sealing while maintaining the structural integrity of the apparatus.
Conclusion
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/N.C.N./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
1 See https://ecgwaves.com/docs/left-and-right-atrium/ (copy attached)
2 See https://ecgwaves.com/docs/left-and-right-atrium/ (copy attached)