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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/22/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 04/22/2026. As directed by the amendment: claims 1, 12, and 15 have been amended and claims 15-20 remain withdrawn. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see pages 6-8, filed 04/22/2026, with respect to the USC 112(a) rejections have been fully considered and are persuasive. Applicant’s amendments to the claims to remove claim language without written description support overcomes the rejection. The USC 112(a) rejections of the claims have been withdrawn.
Applicant's arguments, see pages 6-8, filed 04/22/2026, with respect to the rejection of claim 1 under 35 U.S.C. 103 as being unpatentable over Frazier et al (US 20040215230 A1), herein referenced to as “Frazier” and Connor (US 20210236139 A1), herein referenced to as “Connor” have been fully considered but they are not persuasive.
The applicant argues that the combination of Frazier and Connor does not teach the limitations of claim 1, specifically “wherein in the expanded configuration, is adjustable between a circular overall shape in the top view and an ovoid overall shape in the top view”.
The applicant argues that Connor does not teach in the expanded configuration, the device of Connor is adjustable from a circular overall shape in the top view to an ovoid overall shape in the top view. Specifically, they argue that Connor that from the top view that one of ordinary skill in the art would see that Connor in Fig. 20 the upper right quadrant to the lower left quadrant goes from a circle shape in both. The examiner respectfully disagrees.
The cross-section of the left lower quadrant in Fig. 20 shows an ellipsoid cross-section from the top, as explicitly explained in [0196]-[0197] “The lower left quadrant of FIG. 20 shows this device at a third point in time wherein the mesh (or framework) has a double-layer bowl-shaped third configuration which bridges the aneurysm neck after distal and proximal areas of the mesh (or framework) have been longitudinally collapsed toward each other.” [0196] and “In an example, a mesh (or framework) in its bowl-shaped configuration can be a section of a sphere or ellipsoid. In an example, a mesh in its bowl-shaped configuration can be hemispherical. In an example, an opening can be between 5% to 15% of the maximum cross-sectional area of a mesh in its bowl-shaped configuration. In an example, an opening can be between 10% to 30% of the maximum cross-sectional area of a mesh in its bowl-shaped configuration. In an example, a mesh in its bowl-shaped configuration can be represented geometrically by rotating an arc of a circle or ellipse around a vertical axis (in space) which is to the right or left of the circle or ellipse” [0197].
Hence the top cross-section in the bowl-shape is an ellipsoid, because the bowl is formed by rotating the arc of an ellipse which indicates the top geometry has a diameter and/or radius longer along one axis than another, hence generating an overall ovoid shape. The examiner is not relying only on the drawing of Fig. 20 of Connor but explicit support from the specification, however the drawing does show what is described in Connor’s specification as well, see annotated Fig. 20 below. Additionally, Connor points out this occur specifically while in the bowl-shaped configuration, and not in the globular configuration, which is shown in the upper right quadrant.
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In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Frazier to incorporate the teachings of Connor and teach an implantable medical device with having the circular overall shape in a top view and having the ovoid overall shape in the top view. Motivation for such can be found in Connor as this allows further radial expansion within the lumen to have the device extend greater than the width of an opening such as an aneurysm neck to better seat the device in the target lumen (see [0197]).
As such the rejection will be maintained.
Applicant's arguments, see pages 8-9, filed 04/22/2026, with respect to the rejection of claim 12 under 35 U.S.C. 103 as being unpatentable over Frazier et al (US 20040215230 A1), herein referenced to as “Frazier” and Connor (US 20210236139 A1), herein referenced to as “Connor” have been fully considered but they are not persuasive.
The applicant amended claim 12 to further recite “the major axis and the minor axis each extending transverse to a longitudinal axis of the expandable frame”.
While the examiner agrees that Frazier does not explicitly disclose that both axes are transverse to a longitudinal axis of the expandable frame, Connor does teach this, see 103 rejection below.
As such the rejection will be maintained.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5, and 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frazier et al (US 20040215230 A1), herein referenced to as “Frazier” and Connor (US 20210236139 A1), herein referenced to as “Connor”.
Claim 1
Frazier discloses: An implantable medical device 304 (see Fig. 21-22B, [0130]-[0131]), comprising: an expandable frame the frame of 304/195 (see Figs. 21-22B) moveable between a collapsed configuration (see Fig. 21, [0132], a collapsed axial form for delivery) for delivery and a fully unconstrained configuration (see USC 112a rejection above interpreted as “fully unconstrained” instead of “fully expanded”, see Figs. 22A-22B, [0132], no longer constrained by the delivery catheter, hence unconstrained) for deployment, the expandable frame the frame of 304/195 adjustable when in the fully unconstrained configuration (see Fig. 22A) between having a circular overall shape (see Figs. 22A, a circular shape that is axially compressed into an overall ovoid shape) and having an ovoid overall shape (see Fig. 22B); and an adjustment mechanism 402 + 404 + 340 (see Figs. 21-22B, [0131]-[0132]) disposed within the expandable frame the frame of 304/195, the adjustment mechanism 402 + 404 + 340 adapted to controllably adjust (see [0132], apply rotational torque, to cause axial compression and radial expansion) the expandable frame the frame of 304/195 between the circular overall shape (see Fig. 22A) and the ovoid overall shape (see Fig. 22B).
Frazier (Figs. 21-22B) does not explicitly disclose: between having the circular overall shape in a top view and having the ovoid overall shape in the top view; a covering spanning at least part of the expandable frame.
However, a variant embodiment of Frazier (see Fig. 10) teaches in the same field of invention an implantable medical device 216 (see Fig. 10) with an expandable frame 17 + 195. The variant embodiment (Fig. 10) of Frazier further teaches: a covering 15 (see Fig. 10, [0103]) spanning at least part (see Fig. 10, [0103], can be on one hemisphere, or can be on the entirety of the device) of the expandable frame 15.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Frazier to incorporate the teachings of a variant embodiment (Fig. 10) of Frazier and teach an implantable medical device with a covering spanning at least part of the expandable frame. Motivation for such can be found in Frazier as this barrier can facilitate cellular in-growth (see [0073]).
Frazier does not explicitly teach: between having the circular overall shape in a top view and having the ovoid overall shape in the top view.
However, Connor in a similar field of invention teaches an implantable medical device (see Fig. 20) with an expandable frame 2002 (see Fig. 20) with a fully unconstrained configuration (see Fig. 20 upper right quadrant and lower left quadrant), the expandable frame 2002 adjustable when in the fully unconstrained configuration (see Fig. 20 upper right quadrant and lower left quadrant) between having a circular overall shape (see Fig. 20 upper right quadrant, [0196], globular second configuration after it has been radially-expanded, globular according to the online Oxford English Dictionary means “shaped like or resembling a globe; spherical, round, rounded”, hence It is spherical and has a circular overall shape from the top) and having the ovoid overall shape (see Fig. 20 lower left quadrant, [0197], bowl-shaped configuration is a section of an ellipsoid, hence ovoid overall shape). Connor further teaches: the circular overall shape (see Fig. 20, upper right quadrant, [0196], globular) in a top view (see Fig. 20, upper right quadrant, is a three dimensional image with the view from the top the device has a circular shape, since a sphere has cross-sections of circles from every perspective) and the ovoid overall shape (see Fig. 20 lower left quadrant, [0196], section of an ellipsoid, an ellipsoid according to the online Oxford English Dictionary is “a solid of which all the plane sections one of the axes are ellipses, and all other sections ellipses or circles”, hence all sections from an ellipsoid are ellipses, including a top view) in the top view (see Fig. 20, lower left quadrant, is a three dimensional image with the view from the top the device has an ellipse section, which is an ovoid section).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Frazier to incorporate the teachings of Connor and teach an implantable medical device with having the circular overall shape in a top view and having the ovoid overall shape in the top view. Motivation for such can be found in Connor as this allows further radial expansion within the lumen to have the device extend greater than the width of an opening such as an aneurysm neck to better seat the device in the target lumen (see [0197]).
Claim 2
The combination of Frazier and Connor teaches: The implantable medical device of claim 1, see 103 rejection above. Frazier further discloses: wherein the adjustment mechanism 402 + 404 + 340 is adapted to controllably adjust (see [0130]-[0133]) the expandable frame after the expandable frame the frame of 304/195 has expanded into its expanded configuration (see [0130]-[0133], allows for fitting of the implant within the cavity via rotation of the torque rod).
Claim 3
The combination of Frazier and Connor teaches: The implantable medical device of claim 1, see 103 rejection above. Frazier further discloses: The implantable medical device of claim 1, wherein the adjustment mechanism 402 + 404 + 340 comprises a jack-screw mechanism 402 + 404 + 340 (see Figs. 21-22B, the engagement allows rotation of the torque rod to cause axial compression and radial expansion via the coils to allow threadable engagement, see [0134]).
Claim 5
The combination of Frazier and Connor teaches: The implantable medical device of claim 1, see 103 rejection above. Frazier further teaches: wherein the covering is adapted to accommodate changes in dimensions of the expandable frame when the expandable frame is adjusted between the circular overall shape and the ovoid overall shape.
The language, " wherein the covering is adapted to accommodate changes in dimensions of the expandable frame when the expandable frame is adjusted between the circular overall shape and the ovoid overall shape," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Frazier meets the structural limitations of the claim, and is capable of the covering/barrier to accommodate the changes in dimensions of the expandable frame as it is generally flexible material (see [0078]).
Claim 10
The combination of Frazier and Connor teaches: The implantable medical device of claim 1, see 103 rejection above. Frazier further discloses: wherein the implantable medical device 304 comprises a Left Atrial Appendage Closure (LAAC) device (see [0012], left atrial appendage).
Claim 11
The combination of Frazier and Connor teaches: The implantable medical device of claim 10, see 103 rejection above. Frazier further discloses: wherein the LAAC device is adapted to fit into an ovoid ostium of an LAA (left atrial appendage) having a first ratio of long dimension of the ovoid shape and a small dimension of the ovoid shape, and the LAAC device is adapted to achieve the ovoid overall shape having a second ratio of long dimension to short dimension that is greater than the first ratio.
The language, "wherein the LAAC device is adapted to fit into an ovoid ostium of an LAA (left atrial appendage) having a first ratio of long dimension of the ovoid shape and a small dimension of the ovoid shape, and the LAAC device is adapted to achieve the ovoid overall shape having a second ratio of long dimension to short dimension that is greater than the first ratio," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Frazier meets the structural limitations of the claim, and is capable of using the radial expansion of the expandable frame to facilitate a widening of the ovoid ostium of an LAA, to cause a larger ratio between a width versus a height of the ostium.
Claim 12
Frazier discloses: A Left Atrial Appendage Closure (LAAC) device 304 (see Fig. 21-22B, [0130]-[0131]), comprising: an expandable frame the frame of 304/195 (see Figs. 21-22B) moveable between a collapsed configuration (see Fig. 21, [0132], a collapsed axial form for delivery) for delivery and a fully unconstrained configuration (see 112a rejection above interpreted as “fully unconstrained” instead of “full expanded”, see Figs. 22A-22B, [0132], no longer constrained by the delivery catheter, hence unconstrained) for deployment, the expandable frame the frame of 304/195 when expanded into the fully unconstrained configuration (see Fig. 22B) having a non-circular shape (see Fig. 22B, generally ovoid shape).
Frazier (Figs. 21-22B) does not explicitly disclose: non-circular shape in a top view; in which the expandable frame has a major axis having a major dimension and a minor axis having a minor dimension, the major axis and the minor axis each extending transverse to a longitudinal axis of the expandable frame, the expandable frame having a first ratio equal to the major dimension divided by the minor dimension; and a covering spanning at least part of the expandable frame.
However, a variant embodiment of Frazier (see Fig. 10) teaches in the same field of invention an implantable medical device 216 (see Fig. 10) with an expandable frame 17 + 195. The variant embodiment (Fig. 10) of Frazier further teaches: a covering 15 (see Fig. 10, [0103]) spanning at least part (see Fig. 10, [0103], can be on one hemisphere, or can be on the entirety of the device) of the expandable frame 15.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Frazier to incorporate the teachings of a variant embodiment (Fig. 10) of Frazier and teach an implantable medical device with a covering spanning at least part of the expandable frame. Motivation for such can be found in Frazier as this barrier can facilitate cellular in-growth (see [0073]).
Frazier does not explicitly teach: non-circular shape in a top view; in which the expandable frame has a major axis having a major dimension and a minor axis having a minor dimension, the major axis and the minor axis each extending transverse to a longitudinal axis of the expandable frame, the expandable frame having a first ratio equal to the major dimension divided by the minor dimension.
However, Connor in a similar field of invention teaches an implantable medical device (see Fig. 20) with an expandable frame 2002 (see Fig. 20) with a fully unconstrained configuration (see Fig. 20 upper right quadrant and lower left quadrant), the expandable frame 2002 adjustable when in the fully unconstrained configuration (see Fig. 20 upper right quadrant and lower left quadrant) between having a circular overall shape (see Fig. 20 upper right quadrant, [0196], globular second configuration after it has been radially-expanded, globular according to the online Oxford English Dictionary means “shaped like or resembling a globe; spherical, round, rounded”, hence It is spherical and has a circular overall shape from the top) and having the ovoid overall shape (see Fig. 20 lower left quadrant, [0197], bowl-shaped configuration is a section of an ellipsoid, hence ovoid overall shape). Connor further teaches: the non-circular shape (see Fig. 20 lower left quadrant, [0196], section of an ellipsoid, an ellipsoid according to the online Oxford English Dictionary is “a solid of which all the plane sections one of the axes are ellipses, and all other sections ellipses or circles”, hence all sections from an ellipsoid are ellipses, including a top view) in the top view (see Fig. 20, lower left quadrant, is a three dimensional image with the view from the top the device has an ellipse section, which is an ovoid section); in which the expandable frame 2002 has a major axis (see annotated Fig. 20 below) having a major dimension (see annotated Fig. 20 below) and a minor axis (see annotated Fig. 20 below) having a minor dimension (see annotated Fig. 20 below), the major axis (see annotated Fig. 20 below) and the minor axis (see annotated Fig. 20 below) each extending transverse to a longitudinal axis (see annotated Fig. 20 below) of the expandable frame 2002, the expandable frame 2002 having a first ratio equal to the major dimension divided by the minor dimension (the first ratio is equal to the major dimension divided by the minor dimension).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Frazier to incorporate the teachings of Connor and teach the LAAC device with the non-circular shape in a top view; in which the expandable frame has a major axis having a major dimension and a minor axis having a minor dimension, the major axis and the minor axis each extending transverse to a longitudinal axis of the expandable frame, the expandable frame having a first ratio equal to the major dimension divided by the minor dimension. Motivation for such can be found in Connor as this allows further radial expansion within the lumen to have the device extend greater than the width of an opening such as an aneurysm neck to better seat the device in the target lumen (see [0197]).
Claim 13
The combination of Frazier and Connor teaches: The LAAC device of claim 12, see 103 rejection above. The combination of Frazier and Connor further teaches: wherein the expandable frame is adapted to be deployed within a non-circular ostium having a major ostium axis having a major ostium dimension and a minor ostium axis having a minor ostium dimension, the non-circular ostium having a native ratio before implantation of the LAAC device equal to the major ostium dimension divided by the minor ostium dimension and a post-deployment ratio that is greater than the native ratio.
The language, "wherein the expandable frame is adapted to be deployed within a non-circular ostium having a major ostium axis having a major ostium dimension and a minor ostium axis having a minor ostium dimension, the non-circular ostium having a native ratio before implantation of the LAAC device equal to the major ostium dimension divided by the minor ostium dimension and a post-deployment ratio that is greater than the native ratio," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Frazier and Connor meets the structural limitations of the claim, and is capable of being placed into a non-circular ostium having a major and minor axis, making a native ratio, and when the device is placed and torqued with radial expansion to widen the major ostium dimension (the width) which would make the post-deployment ratio greater than the native ratio.
Claim 14
The combination of Frazier and Connor teaches: The LAAC device of claim 13, see 103 rejection above. The combination of Frazier and Connor further teaches: wherein the post-deployment ratio is less than the first ratio.
The language, " wherein the post-deployment ratio is less than the first ratio," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Frazier and Connor meets the structural limitations of the claim, and is capable of changing the dimensions of the ostium to a ratio less than that of the device, due to the limits of tissue flexibility before significant tissue damage would occur; this is additionally observed in the major dimension difference between the upper right quadrant of Connor and the left lower quadrant of Connor in addition to [0196]-[0197] of Connor as the device shifts from a globular circular configuration to a bowl-shaped ellipsoid configuration to better conform and occlude the ostium.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frazier and Connor as applied to claim 1 above, and further in view of Chanduszko et al (US 20230310003 A1), herein referenced to as “Chanduszko”.
Claim 4
The combination of Frazier and Connor teaches: The implantable medical device of claim 1, see 103 rejection above. Frazier further discloses: wherein the jack-screw mechanism 402 + 404 + 340 comprises: a jack-screw 402 + 404 + 340 (see Figs. 21-22B, this element is a jack-screw as it uses a torquing rotation to change the axial and radial length of a device).
The combination of Frazier and Connor does not explicitly teach: a scissors mechanism engaged with the jack-screw such that rotation of the jack-screw in a first direction causes the scissors mechanism to extend further radially outwardly and rotation of the jack-screw in an opposing second direction causes the scissors mechanism to retract radially inwardly; and a first pad disposed at a first radial extent of the scissors mechanism and a second pad disposed at a second radial extent of the scissors mechanism, the first pad and the second pad adapted to push the expandable frame in radially outward direction when the jack-screw is rotated in the first direction.
However, Chanduszko in a similar field of invention teaches a jack-screw mechanism 200 (see Figs. 2A-2D) for an occlusion of a bodily lumen (see Figs. 2A-2D) with a jack-screw 204 (see Figs. 2A and 2C, [0048]). Chanduszko further teaches: a scissors mechanism 212 + 222 (see Figs. 2A and 2C, [0046]) engaged with the jack-screw 204 such that rotation of the jack-screw 204 in a first direction (see 2A and 2C, [0048]) causes the scissors mechanism 212 + 222 to extend further radially outwardly (see Fig. 2C, [0048]-[0049], rotation, leads to radial expansion and axial shortening) and rotation of the jack-screw 204 in an opposing second direction causes the scissors mechanism 212 + 222 to retract radially inwardly (see [0048]-[0049], rotation in the opposite direction will cause 212 + 222 to axially lengthen and radial shortening); and a first pad 214 (see Figs. 2A and 2C, [0046]) disposed at a first radial extent the left radial extent of 212 (see Figs. 2A and 2C) of the scissors mechanism 212 + 222 and a second pad 224 (see Figs. 2A and 2C, [0047]) disposed at a second radial extent the right radial extent of 222 (see Figs. 2A and 2C) of the scissors mechanism 212 + 222.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Frazier to incorporate the teachings of Chanduszko and teach an implantable medical device with a scissors mechanism engaged with the jack-screw such that rotation of the jack-screw in a first direction causes the scissors mechanism to extend further radially outwardly and rotation of the jack-screw in an opposing second direction causes the scissors mechanism to retract radially inwardly; and a first pad disposed at a first radial extent of the scissors mechanism and a second pad disposed at a second radial extent of the scissors mechanism. Motivation for such can be found in Chanduszko as this allows a directed force to cause a flattening of the lumen that the device is within (see [0052]-[0053]).
The language, " the first pad and the second pad adapted to push the expandable frame in radially outward direction when the jack-screw is rotated in the first direction," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Frazier and Chanduszko meets the structural limitations of the claim, and is capable of as Frazier as modified to include the scissor mechanism with the first and second pad within the expandable frame, connected to the jack-screw would be capable of pads driving the expandable frame radially outward as the jack-screw is rotated in the first direction by pressing against the radial lateral sides of the expandable frame.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frazier and Connor as applied to claim 5 above, and further in view of Hewitt et al (US 20160249934 A1), herein referenced to as “Hewitt”.
Claim 6
The combination of Frazier and Connor teaches: The implantable medical device of claim 5, see 103 rejection above.
The combination of Frazier and Connor does not explicitly teach: wherein the covering comprises: a web of large fibers; and small fibers spanning between the large fibers.
However, Hewitt in a similar field of invention teaches an implantable medical device 10 (see Figs. 6-10) with a covering 40 (see Figs. 6-10). Hewitt further teaches: wherein the covering 40 comprises: a web the plurality of interwoven 48 (see Figs. 9-10, [0169]) of large fibers 48 (see Fig. 10, [0169]); and small fibers 14 (see Fig. 10, [0169]) spanning between the large fibers 48.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Frazier to incorporate the teachings of Hewitt and teach an implantable medical device with the covering comprises: a web of large fibers; and small fibers spanning between the large fibers. Motivation for such can be found in Hewitt as this allows for the radial stiffness of the covering to be modified to suit the needs of the occlusion device (see [0123]).
Claim 7
The combination of Frazier, Connor, and Hewitt teaches: The implantable medical device of claim 6, see 103 rejection above. Hewitt further teaches: wherein the large fibers 48 comprise more than fifty percent elastomer (see [0184], the large fibers can be made from PEEK, which is an elastomer, and hence more than 50% made of elastomer, see [0075] of the applicant’s patent application publication PEEK is an example of an elastomer) and the small fibers 14 comprise more than fifty percent PET (polyethylene terephthalate) (see [0184], the small fibers are made of PET, hence more than 50% PET).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frazier in view of Connor and Hewitt as applied to claim 6 above, and further in view of Bak-Boychuk et al (US 20210361238 A1), herein referenced to as “Bak-Boychuk”.
Claim 8
The combination of Frazier, Connor, and Hewitt teaches: The implantable medical device of claim 6, see 103 rejection above.
The combination of Frazier, Connor, and Hewitt does not explicitly teach: wherein the large fibers comprise 70 percent elastomer and 30 percent PET.
However, Bak-Boychuk in a similar field of invention teaches an implantable medical device 100 (see Figs. 18-19) with a covering 138 (see Figs. 18-19) with fibers the fibers that make up 138 (see Figs. 18-19, [0128]). Bak-Boychuk further teaches: wherein the fibers comprise 70 percent elastomer and 30 percent PET (see [0128], 70/30% blend of polyurethane/PET, polyurethane is an elastomer according to applicant’s patent application publication, see [0072]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Frazier and Hewitt to incorporate the teachings of Bak-Boychuk and have the large fibers with a 70 percent elastomer and 30 percent PET. This is due to fibers made with 70 percent elastomer and 30 percent PET are common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Claim 9
The combination of Frazier, Connor and Hewitt teaches: The implantable medical device of claim 6, see 103 rejection above.
The combination of Frazier, Connor, and Hewitt does not explicitly teach: wherein the small fibers comprise 70 percent PET and 30 percent elastomer.
However, Bak-Boychuk in a similar field of invention teaches an implantable medical device 100 (see Figs. 18-19) with a covering 138 (see Figs. 18-19) with fibers the fibers that make up 138 (see Figs. 18-19, [0128]). Bak-Boychuk further teaches: wherein the fibers comprise a percentage of PET and elastomer (see [0128], 70/30% blend of polyurethane/PET, polyurethane is an elastomer according to applicant’s patent application publication, see [0072]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Frazier and Hewitt to incorporate the teachings of Bak-Boychuk and have the small fibers with a percentage of PET and elastomer. This is due to fibers made with a percentage of PET and elastomer are common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
As noted in Bak-Boychuk it is necessary for the occluding membrane/covering to close-up and become impermeable to blood overtime (see [0128]). This correlates to the polymer blend percentages of the fibers (see [0128]) and as such the small fibers comprise 70 percent PET and 30 percent elastomer is considered to be a result effective variable since that the polymer blend percentage changes the occluding membrane’s ability to close-up and become impermeable to blood overtime (see [0128]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the combination device of Frazier, Hewitt, and Bak-Boychuk by causing the small fibers comprise 70 percent PET and 30 percent elastomer as a matter of routine optimization since 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Totten et al (US 20230346380 A1) teaches an occlusive implant with major and minor axes with different dimensions with one being greater than the other to better fit native anatomy (see Figs. 16-17, [0207])
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/ Examiner, Art Unit 3771
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